chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Musculoskeletal chest pain, Musculoskeletal pain, Nausea, Pain, Pain in extremity
Clinical narrative: After shot received at 0830 on Oct 7,2008, arm became very sore.  That evening, had body aches.  I felt a little achy in the morning but by 11am, my back was really hurting from the rt shoulder down to the middle of my back.  Became dizzy and nauseated.  Stayed home the next day, unable to straighten up, back from mid to kidney level pain was intense.  Felt like a baseball bat was being swung at me.  By midafternoon on Thursday, I had become short of breath, unable to take a deep breath, intense back pain, dizzy, and nausea.  I had not been able to sleepdue to the pain. Unable to eat since I felt I wanted to throw up, no longer feeling the aches all over my body, just shoulder,mid and lower back.  The next morning, had increased difficulty breathing, short of breath when I talked, bent over at waist seemed to help increase air flow.  I went to Urgent care,they did an EKG, something sl abnormal.  Sent me to the ER.  EKG,chest xray, bloodwork done.  They gave me perocet that seemed to help.  They sent me home with perocet, felt it was a muscular sprain.  Sat and Sun, symptoms remained the same, just laid in bed.Perocet not working, just caused me to itch.  Monday went to my MD, intense pain on pressure on back, pushing and pulling of hands.  Pain also intense right at the sternum.  tight band around chest, unable to breath.she started me on Naprosyn and Nexiumum.  she said it was a reaction to the flu shot and added to my allergies. Tuesday, I actually felt I could get a good breath in, pain still present but decreased some.  Wednesday, I started to eat again.  Pain was better.  Thursday at present....I can stand almost straight up, still short of breath but feel I can get more air in. Voice sounds short of breath.  Pain down rt shoulder blade,across midback and down and around my rib cage.  I feel like my diaphram is not able to extend as it should. Pain level is back to an 8.  I have a call into my doctor to find out what I should do.
Age: 44.0
Sex: F
Vaccine: FLUX
Symptoms: Sleep disorder, Vaccination complication
Clinical narrative: After shot received at 0830 on Oct 7,2008, arm became very sore.  That evening, had body aches.  I felt a little achy in the morning but by 11am, my back was really hurting from the rt shoulder down to the middle of my back.  Became dizzy and nauseated.  Stayed home the next day, unable to straighten up, back from mid to kidney level pain was intense.  Felt like a baseball bat was being swung at me.  By midafternoon on Thursday, I had become short of breath, unable to take a deep breath, intense back pain, dizzy, and nausea.  I had not been able to sleepdue to the pain. Unable to eat since I felt I wanted to throw up, no longer feeling the aches all over my body, just shoulder,mid and lower back.  The next morning, had increased difficulty breathing, short of breath when I talked, bent over at waist seemed to help increase air flow.  I went to Urgent care,they did an EKG, something sl abnormal.  Sent me to the ER.  EKG,chest xray, bloodwork done.  They gave me perocet that seemed to help.  They sent me home with perocet, felt it was a muscular sprain.  Sat and Sun, symptoms remained the same, just laid in bed.Perocet not working, just caused me to itch.  Monday went to my MD, intense pain on pressure on back, pushing and pulling of hands.  Pain also intense right at the sternum.  tight band around chest, unable to breath.she started me on Naprosyn and Nexiumum.  she said it was a reaction to the flu shot and added to my allergies. Tuesday, I actually felt I could get a good breath in, pain still present but decreased some.  Wednesday, I started to eat again.  Pain was better.  Thursday at present....I can stand almost straight up, still short of breath but feel I can get more air in. Voice sounds short of breath.  Pain down rt shoulder blade,across midback and down and around my rib cage.  I feel like my diaphram is not able to extend as it should. Pain level is back to an 8.  I have a call into my doctor to find out what I should do.
Age: 37.0
Sex: M
Vaccine: ANTH
Symptoms: Arthralgia, Asthenia, Headache, Influenza like illness, Injection site erythema
Clinical narrative: Flu-like symptoms.  Weak/malaise.  Joint pain and Muscle fatigue/soreness with Headache.  Redness/swelling at site (subcutaneous, over the left deltoid) with defined "head".  Swelling/redness extends 2-3 inches beyond injection site and is marked for future observation.  I am self-medicating with beer at this time... :-)  Will follow up with Medical Clinic on 17OCT2008 if redness extends beyond markings.  This is the first time that I have had a reaction this severe for this type of vaccination (Anthrax).  This is my 11th Anthrax vaccine.  I am a certified Allergy/Immunizations Technician and attended the Medical Center's Allergy/Immunization Course in 2003.  I can be reached via the phone number listed or by email. Thank you!
Age: 37.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site swelling, Malaise, Muscle fatigue, Myalgia
Clinical narrative: Flu-like symptoms.  Weak/malaise.  Joint pain and Muscle fatigue/soreness with Headache.  Redness/swelling at site (subcutaneous, over the left deltoid) with defined "head".  Swelling/redness extends 2-3 inches beyond injection site and is marked for future observation.  I am self-medicating with beer at this time... :-)  Will follow up with Medical Clinic on 17OCT2008 if redness extends beyond markings.  This is the first time that I have had a reaction this severe for this type of vaccination (Anthrax).  This is my 11th Anthrax vaccine.  I am a certified Allergy/Immunizations Technician and attended the Medical Center's Allergy/Immunization Course in 2003.  I can be reached via the phone number listed or by email. Thank you!
Age: 10.0
Sex: M
Vaccine: FLUN3, HEPA, VARCEL
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: redness and itching at injection site 5 minutes after receiving varivax.  Benadryl elixir 25mg given po.  Observed an additional 15 minutes.  Redness resolving.  No additional s/s noted.
Age: 65.0
Sex: F
Vaccine: VARCEL
Symptoms: Diarrhoea, Injection site pruritus, Injection site urticaria, Injection site warmth
Clinical narrative: 10 x 5 cm welt formed around injection site less than 24 hours after injection. also warm and itching. also had diarrhea night of injection. Treating welt with hydracortisone cream 1%, ice, and benadryl at night
Age: 11.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Skin warm, Urticaria
Clinical narrative: Child given sanofi pastuer fluzone immunization on 10/10/08 at pharmacy.  Presents to our office with redness, warm to touch and hives on 10/13/08.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Back pain, Injection site pain, Myalgia
Clinical narrative: severe pain in left elbow and muscles in upper left back. pain seems to radiate from the point of vaccination.
Age: 3.0
Sex: F
Vaccine: FLU3, PNC
Symptoms: Pyrexia, Rash generalised, Rash maculo-papular
Clinical narrative: Patient developed maculopapular rash over entire body and face and extremities, along with fevers up to 104 within 24 hours of vaccine.
Age: 12.0
Sex: M
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Erythema, Induration, Skin warm
Clinical narrative: overlapping rings of erythema, warm, and induration. Was currently taking omnicef
Age: 38.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Asthma, Autoimmune disorder, Autoimmune thyroiditis, Blood test, Depression
Clinical narrative: I received the Hep B 5/30/97,6/30/97,11/25/97. Varicella 6/30/97, 8/5/97. MMR 6/30/97.TD 5/30/97. PPD 5/30/97, 8/25/97. after receiving all these vaccines in such a short period of time. I was diagnosed with Hashimotos thyroiditis in Oct.97. My immune system crashed. I had no idea that the number of vaccines I received would cause me to have auto-immune disorder. As I get older my allergies keep getting worse. Now I have Chronic fatigue and fibromyalgia. I also have severe asthma. I am now on SSA disablility for depression from all my ailments. I don't have diabetes, but I do have perpheral neuropathy. I take armour thyroid,tegretol,paxil,qvar,proventel,protonix, zantac, vistril, xyzal, fexophen, ultram.  1/16/2009 MR received from PCP from 2/18/1998-2/2002. Pt presents for multiple sick visits with the following DX:  Bronchitis, URI, Fatigue, H/A, hypothyroidism, multiple episode of t sinusitis, disc syndrome, epistaxis, rotator cuff syndrome, UTI, acute pharyngitis, viral illness, NOS. ENT visit for Nasal polyposis and pansinustis. 1/27/2010 I have Hashimotos thyroiditis, peripheral neuropathy, chronic fatgue, adrenal fatigue, autoimmune disorder, severe allergies, environmental and food and drug, asthma.
Age: 38.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Fatigue, Fibromyalgia, Neuropathy peripheral, Sinusitis, Thyroid function test
Clinical narrative: I received the Hep B 5/30/97,6/30/97,11/25/97. Varicella 6/30/97, 8/5/97. MMR 6/30/97.TD 5/30/97. PPD 5/30/97, 8/25/97. after receiving all these vaccines in such a short period of time. I was diagnosed with Hashimotos thyroiditis in Oct.97. My immune system crashed. I had no idea that the number of vaccines I received would cause me to have auto-immune disorder. As I get older my allergies keep getting worse. Now I have Chronic fatigue and fibromyalgia. I also have severe asthma. I am now on SSA disablility for depression from all my ailments. I don't have diabetes, but I do have perpheral neuropathy. I take armour thyroid,tegretol,paxil,qvar,proventel,protonix, zantac, vistril, xyzal, fexophen, ultram.  1/16/2009 MR received from PCP from 2/18/1998-2/2002. Pt presents for multiple sick visits with the following DX:  Bronchitis, URI, Fatigue, H/A, hypothyroidism, multiple episode of t sinusitis, disc syndrome, epistaxis, rotator cuff syndrome, UTI, acute pharyngitis, viral illness, NOS. ENT visit for Nasal polyposis and pansinustis. 1/27/2010 I have Hashimotos thyroiditis, peripheral neuropathy, chronic fatgue, adrenal fatigue, autoimmune disorder, severe allergies, environmental and food and drug, asthma.
Age: 38.0
Sex: F
Vaccine: HEP, MMR, VARCEL
Symptoms: Ultrasound thyroid
Clinical narrative: I received the Hep B 5/30/97,6/30/97,11/25/97. Varicella 6/30/97, 8/5/97. MMR 6/30/97.TD 5/30/97. PPD 5/30/97, 8/25/97. after receiving all these vaccines in such a short period of time. I was diagnosed with Hashimotos thyroiditis in Oct.97. My immune system crashed. I had no idea that the number of vaccines I received would cause me to have auto-immune disorder. As I get older my allergies keep getting worse. Now I have Chronic fatigue and fibromyalgia. I also have severe asthma. I am now on SSA disablility for depression from all my ailments. I don't have diabetes, but I do have perpheral neuropathy. I take armour thyroid,tegretol,paxil,qvar,proventel,protonix, zantac, vistril, xyzal, fexophen, ultram.  1/16/2009 MR received from PCP from 2/18/1998-2/2002. Pt presents for multiple sick visits with the following DX:  Bronchitis, URI, Fatigue, H/A, hypothyroidism, multiple episode of t sinusitis, disc syndrome, epistaxis, rotator cuff syndrome, UTI, acute pharyngitis, viral illness, NOS. ENT visit for Nasal polyposis and pansinustis. 1/27/2010 I have Hashimotos thyroiditis, peripheral neuropathy, chronic fatgue, adrenal fatigue, autoimmune disorder, severe allergies, environmental and food and drug, asthma.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site haematoma, Injection site mass, Myalgia
Clinical narrative: Patient received influenza vaccine on 10/11/2008. (Fluzone)  Had bruising at injection site.  On 10/16/2008 came to store.  Bruise was about 2.5 inches in diameter and a small bump could be palpated at site.  Bruising had begun to resolve and the edges were yellow, to yellow-green. Bruise was not warmer than the surrounding skin.  Patient also complained of soreness in tricep.
Age: 39.0
Sex: F
Vaccine: MMR, TDAP
Symptoms: Injection site induration, Rash generalised
Clinical narrative: Diffuse lenticular rash noticed approximately 16 days following administration; local induration at site of MMR noticed approximately 12 days following administration.
Age: 67.0
Sex: M
Vaccine: LYME
Symptoms: Activities of daily living impaired, Arthralgia, Autoimmune disorder, Bone densitometry, Bone density increased
Clinical narrative: This case was reported by a lawyer and described the occurrence of arthralgia in a male subject of unspecified age who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). On an unspecified date after vaccination with LYMERIX, the subject experienced arthralgia, myalgia, pain in his ankles and legs, gastrointestinal problems, rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated or other mechanism, all reported to be caused by vaccination with LYMERIX. The subject also has decreased activities of daily life and decreased ability to participate in recreational activities. At the time of reporting the outcome of the events was unspecified. This information was received via a Statement of Injuries. Follow up information was received on 06 October 2008 via medical records. On unspecified dates(s), the subject was diagnosed with osteoarthritis, osteopenia, lumbar radiculopathy, and spinal stenosis. Events included neck pain/nuchal pain with neck rotation, leg pain, hip pain, and insomnia. Treatment included ibuprofen, epidural steroid injections, lorazepam, Ambien, and trazodone. He had multiple other concurrent/historical medical conditions. The first and second doses of LYMERIX were administered on 05 March 1999 and 09 April 1999. In December 1999, the subject was evaluated for leg pain resulting in an impression of arthritis. On 11 February 2004, hip x-rays showed severe osteoarthritic changes, and in July 2004 he was diagnosed with avascular necrosis of the left femoral head without associated pain. On 18 October 2005, the subject reported severe leg pain from groin to ankle, ongoing for many years, and was unable to ambulate without support such as a cane. He was hospitalized and required hip replacement on 26 October 2005, and was discharged on 29 October 2005.
Age: 67.0
Sex: M
Vaccine: LYME
Symptoms: Bone scan abnormal, Cognitive disorder, Gait disturbance, Gastrointestinal disorder, Hip arthroplasty
Clinical narrative: This case was reported by a lawyer and described the occurrence of arthralgia in a male subject of unspecified age who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). On an unspecified date after vaccination with LYMERIX, the subject experienced arthralgia, myalgia, pain in his ankles and legs, gastrointestinal problems, rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated or other mechanism, all reported to be caused by vaccination with LYMERIX. The subject also has decreased activities of daily life and decreased ability to participate in recreational activities. At the time of reporting the outcome of the events was unspecified. This information was received via a Statement of Injuries. Follow up information was received on 06 October 2008 via medical records. On unspecified dates(s), the subject was diagnosed with osteoarthritis, osteopenia, lumbar radiculopathy, and spinal stenosis. Events included neck pain/nuchal pain with neck rotation, leg pain, hip pain, and insomnia. Treatment included ibuprofen, epidural steroid injections, lorazepam, Ambien, and trazodone. He had multiple other concurrent/historical medical conditions. The first and second doses of LYMERIX were administered on 05 March 1999 and 09 April 1999. In December 1999, the subject was evaluated for leg pain resulting in an impression of arthritis. On 11 February 2004, hip x-rays showed severe osteoarthritic changes, and in July 2004 he was diagnosed with avascular necrosis of the left femoral head without associated pain. On 18 October 2005, the subject reported severe leg pain from groin to ankle, ongoing for many years, and was unable to ambulate without support such as a cane. He was hospitalized and required hip replacement on 26 October 2005, and was discharged on 29 October 2005.
Age: 67.0
Sex: M
Vaccine: LYME
Symptoms: Insomnia, Lumbar radiculopathy, Musculoskeletal pain, Myalgia, Neck pain
Clinical narrative: This case was reported by a lawyer and described the occurrence of arthralgia in a male subject of unspecified age who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). On an unspecified date after vaccination with LYMERIX, the subject experienced arthralgia, myalgia, pain in his ankles and legs, gastrointestinal problems, rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated or other mechanism, all reported to be caused by vaccination with LYMERIX. The subject also has decreased activities of daily life and decreased ability to participate in recreational activities. At the time of reporting the outcome of the events was unspecified. This information was received via a Statement of Injuries. Follow up information was received on 06 October 2008 via medical records. On unspecified dates(s), the subject was diagnosed with osteoarthritis, osteopenia, lumbar radiculopathy, and spinal stenosis. Events included neck pain/nuchal pain with neck rotation, leg pain, hip pain, and insomnia. Treatment included ibuprofen, epidural steroid injections, lorazepam, Ambien, and trazodone. He had multiple other concurrent/historical medical conditions. The first and second doses of LYMERIX were administered on 05 March 1999 and 09 April 1999. In December 1999, the subject was evaluated for leg pain resulting in an impression of arthritis. On 11 February 2004, hip x-rays showed severe osteoarthritic changes, and in July 2004 he was diagnosed with avascular necrosis of the left femoral head without associated pain. On 18 October 2005, the subject reported severe leg pain from groin to ankle, ongoing for many years, and was unable to ambulate without support such as a cane. He was hospitalized and required hip replacement on 26 October 2005, and was discharged on 29 October 2005.
Age: 67.0
Sex: M
Vaccine: LYME
Symptoms: Nervous system disorder, Nuclear magnetic resonance imaging abnormal, Osteoarthritis, Osteonecrosis, Osteopenia
Clinical narrative: This case was reported by a lawyer and described the occurrence of arthralgia in a male subject of unspecified age who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). On an unspecified date after vaccination with LYMERIX, the subject experienced arthralgia, myalgia, pain in his ankles and legs, gastrointestinal problems, rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated or other mechanism, all reported to be caused by vaccination with LYMERIX. The subject also has decreased activities of daily life and decreased ability to participate in recreational activities. At the time of reporting the outcome of the events was unspecified. This information was received via a Statement of Injuries. Follow up information was received on 06 October 2008 via medical records. On unspecified dates(s), the subject was diagnosed with osteoarthritis, osteopenia, lumbar radiculopathy, and spinal stenosis. Events included neck pain/nuchal pain with neck rotation, leg pain, hip pain, and insomnia. Treatment included ibuprofen, epidural steroid injections, lorazepam, Ambien, and trazodone. He had multiple other concurrent/historical medical conditions. The first and second doses of LYMERIX were administered on 05 March 1999 and 09 April 1999. In December 1999, the subject was evaluated for leg pain resulting in an impression of arthritis. On 11 February 2004, hip x-rays showed severe osteoarthritic changes, and in July 2004 he was diagnosed with avascular necrosis of the left femoral head without associated pain. On 18 October 2005, the subject reported severe leg pain from groin to ankle, ongoing for many years, and was unable to ambulate without support such as a cane. He was hospitalized and required hip replacement on 26 October 2005, and was discharged on 29 October 2005.
Age: 67.0
Sex: M
Vaccine: LYME
Symptoms: Pain in extremity, Spinal X-ray abnormal, Spinal column stenosis, X-ray abnormal
Clinical narrative: This case was reported by a lawyer and described the occurrence of arthralgia in a male subject of unspecified age who was vaccinated with LYMERIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). On an unspecified date after vaccination with LYMERIX, the subject experienced arthralgia, myalgia, pain in his ankles and legs, gastrointestinal problems, rheumatologic, neurologic, and/or cognitive impairment of an autoimmune, immune-mediated or other mechanism, all reported to be caused by vaccination with LYMERIX. The subject also has decreased activities of daily life and decreased ability to participate in recreational activities. At the time of reporting the outcome of the events was unspecified. This information was received via a Statement of Injuries. Follow up information was received on 06 October 2008 via medical records. On unspecified dates(s), the subject was diagnosed with osteoarthritis, osteopenia, lumbar radiculopathy, and spinal stenosis. Events included neck pain/nuchal pain with neck rotation, leg pain, hip pain, and insomnia. Treatment included ibuprofen, epidural steroid injections, lorazepam, Ambien, and trazodone. He had multiple other concurrent/historical medical conditions. The first and second doses of LYMERIX were administered on 05 March 1999 and 09 April 1999. In December 1999, the subject was evaluated for leg pain resulting in an impression of arthritis. On 11 February 2004, hip x-rays showed severe osteoarthritic changes, and in July 2004 he was diagnosed with avascular necrosis of the left femoral head without associated pain. On 18 October 2005, the subject reported severe leg pain from groin to ankle, ongoing for many years, and was unable to ambulate without support such as a cane. He was hospitalized and required hip replacement on 26 October 2005, and was discharged on 29 October 2005.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Ear pain, Eye irritation, Eye pruritus, Headache
Clinical narrative: Developed wheezing and coughing, and ear pain approx. 4 hr. after getting flu vaccine. 6 hrs. after getting vaccine, she developed intensely itchy and irritated eyes. Took husband's antihistamine (allergy med) (name unknown) - improved. Next day just had headache and body aches
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Wheezing
Clinical narrative: Developed wheezing and coughing, and ear pain approx. 4 hr. after getting flu vaccine. 6 hrs. after getting vaccine, she developed intensely itchy and irritated eyes. Took husband's antihistamine (allergy med) (name unknown) - improved. Next day just had headache and body aches
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Induration, Oedema peripheral
Clinical narrative: Patient had no difficulty breathing. Arm swelled. Was initially the size of a golf ball. Really hard to the touch. After 20 minutes it got smaller. Then 20 minutes later got little smaller and less hard. Gave patient 1 BENADRYL tablet.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Contusion, Erythema, Hypoaesthesia, Injection site haemorrhage, Injection site pain
Clinical narrative: At vaccine administration, lots of bleeding and very sore. Starting 2 hours after administration, lots of itching and redness. Bruising. 9 hours later, arm numbness and tingling lips. 1 day post immunization, lots of lips and arm itching and tingling.
Age: 31.0
Sex: F
Vaccine: FLUX
Symptoms: Paraesthesia oral, Pruritus
Clinical narrative: At vaccine administration, lots of bleeding and very sore. Starting 2 hours after administration, lots of itching and redness. Bruising. 9 hours later, arm numbness and tingling lips. 1 day post immunization, lots of lips and arm itching and tingling.
Sex: M
Vaccine: FLU3, PPV
Symptoms: Dry skin, Oedema peripheral, Pruritus, Skin warm
Clinical narrative: Swelling of arm from shoulder to elbow, very warm area around muscle. Itching. Skin is rough to touch/no treatment.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site swelling, Pain in extremity
Clinical narrative: Injection site turned red later, the same day after injection. Next morning, injection site was swollen and sore under arm. Pt couldn't lift arm without feeling pain. On appt 10/10/08, pt was still swollen a little, but could lift arm.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Asthenia, Dizziness, Fatigue, Headache
Clinical narrative: Day after injection; weak/tired - stuffy nose. Weakness increased and went home from work. Wednesday AM - Dizzy spells and felt "drained" Wednesday thru Saturday: Headache
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Nasal congestion
Clinical narrative: Day after injection; weak/tired - stuffy nose. Weakness increased and went home from work. Wednesday AM - Dizzy spells and felt "drained" Wednesday thru Saturday: Headache
Age: 40.0
Sex: M
Vaccine: TDAP
Symptoms: Headache, Myalgia
Clinical narrative: Severe myalgias and HA - symptomatic treatment - VICODIN
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Depression, Emotional disorder, Mental impairment, Thinking abnormal
Clinical narrative: Depression, emotional, mental fog, unclear thinking, sadness.
Age: 80.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Blood creatinine, Blood glucose, Blood urea, Injection site erythema, Injection site oedema
Clinical narrative: Patient complained of edema and redness on her left arm at the injection site. Patient given KIFLEX 500 mg, BENADRYL 75 mg and nebulizer treatment.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Skin warm
Clinical narrative: Red, warm to touch. KEFLEX, 500 mg, qid x 7 days. BENADRYL, 25-50, every 6 hours, PRN. Ibuprofen, 400 mg, every 4-6 hours, PRN.
Age: 24.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: Right and Left Deltoid red and hot at touch. States noted redness and swelling on 10/15/08 but thought it was normal. Suggested to be seen by an MD. Size 3-4 inches. redness remains on upper arm.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Abdominal pain, Body temperature increased, Chills, Fatigue, Frequent bowel movements
Clinical narrative: Vomiting, frequent bowel movements, abdominal cramping, headache, chills, fatigue, and temperature of 99.6 degrees F.
Age: 39.0
Sex: F
Vaccine: TDAP
Symptoms: Headache, Vomiting
Clinical narrative: Vomiting, frequent bowel movements, abdominal cramping, headache, chills, fatigue, and temperature of 99.6 degrees F.
Age: 5.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: RUE, started 10/16/08, AM. 6 x 6 cm, raised, pink. Slight tender, no d/c.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, HPV4
Symptoms: Drug exposure during pregnancy, Pregnancy test positive
Clinical narrative: MENACTRA given in early pregnancy, GARDASIL given in early pregnancy.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, HPV4
Symptoms: Alpha 1 foetoprotein, Diagnostic procedure, Drug exposure during pregnancy, Nausea, Pregnancy test positive
Clinical narrative: MENACTRA given in early pregnancy, GARDASIL given in early pregnancy.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ, HPV4
Symptoms: Ultrasound scan normal
Clinical narrative: MENACTRA given in early pregnancy, GARDASIL given in early pregnancy.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Myalgia, Pain in extremity
Clinical narrative: Approximately 2 1/2 hours after vaccination, patient complained about both legs being "really sore", i.e., generalized myalgia. She stated "it's no big deal", and then left for lunch.
Sex: F
Vaccine: FLU3, PPV
Symptoms: Axillary pain, Fatigue, Mass, Pain, Pyrexia
Clinical narrative: Felt sore in the afternoon. At 4am had pain in arm it became more hot and sore as the day progressed eventually it became bumpy, sore all around all the way to arm pit. Low grade fever 100.9 by night. Today called doctor who recommended cold compresses and Motrin for fever. Fever is down but still area is red and lumpy. Separate lumps have grouped together into one large one, feels swollen tired.
Sex: F
Vaccine: FLU3, PPV
Symptoms: Rash, Skin warm, Swelling
Clinical narrative: Felt sore in the afternoon. At 4am had pain in arm it became more hot and sore as the day progressed eventually it became bumpy, sore all around all the way to arm pit. Low grade fever 100.9 by night. Today called doctor who recommended cold compresses and Motrin for fever. Fever is down but still area is red and lumpy. Separate lumps have grouped together into one large one, feels swollen tired.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Chills, Feeling cold, Hyperhidrosis, Hypokinesia
Clinical narrative: Turned cold, with chills continuously shaking in 15-20 minute intervals like convulsions. Vomited violently all over, can't move, very weak, sweaty, wet.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Tremor, Vomiting
Clinical narrative: Turned cold, with chills continuously shaking in 15-20 minute intervals like convulsions. Vomited violently all over, can't move, very weak, sweaty, wet.
Age: 42.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Erythema, Injection site swelling, Pyrexia, Skin warm
Clinical narrative: Little swelling at site. Redness - warm to touch, fever 102 degrees
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site warmth, Pain in extremity, Pruritus
Clinical narrative: (R) deltoid area red and warm - approx 3 - 3 1/2" radius. T. 98.6, orally. No adenopathy. Painful upper arm. Tx: symptomatic (pruritis only). F/U redness resolved in few days.
Age: 5.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMR, VARCEL
Symptoms: Injection site warmth
Clinical narrative: Left deltoid area. warmness around the sit of injection. BENADRYL 12.5/5ml, 2 tsp by mouth 96 degrees as needed, warm compress.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Headache, Musculoskeletal stiffness
Clinical narrative: Stiff neck and headache, starting 1 1/2 hours after flu shot administered.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Eye swelling, Swelling face, Urticaria, Wheezing
Clinical narrative: Patient reported severe hives - all over 4 days after getting flu shot, swelling around eyes and face, minor wheezing. Hives appeared suddenly Monday evening. Resolved without treatment in 1-2 days.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Pt. received a FLUVIRIN vaccine on 10/13/08. On 10/15/08, approximately 12 PM, pt. stated she noticed red spots and lumps on her back, sides, and shoulders. Besides, feeling ..., the pt does not feel sick or have any difficulty with breathing. She took a CLARITIN to help with the rash and itchiness. I also advised her to apply hydrocortisone cream to the rash, if CLARITIN does not help with the itchiness.
Age: 7.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swollen, tender and erythema around the vaccine site. Left shoulder.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, PNC, RV5, RV5
Symptoms: Bowel movement irregularity, Dehydration, Haematochezia, Intussusception, Mucous stools
Clinical narrative: No BM from 10/11/08, vomiting, decreased diaper wetting, dehydration.  Currant jelly stool 10/14.  Intussusception -> hospitalized 10/14/08.  Required surgical intervention.  Pt. currently admitted to PICU at hospital. 12/1/08-records received for DOS 10/14-//-DC DX: Intussusception. Exploratory laparotomy, reduction of intussusception, small bowel resection incidental appendectomy. Presented with 1 day of emesis.  Following morning developed recurrent emesis and repeat ultrasound demonstrated recurrent intussusception and similarly reduced, however patient suffered a respiratory arrest during this procedure. Marked distention of abdomen and lethargy. Surgery demonstrated bowel eviscerated.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, PNC, RV5, RV5
Symptoms: Urine output decreased, Vomiting
Clinical narrative: No BM from 10/11/08, vomiting, decreased diaper wetting, dehydration.  Currant jelly stool 10/14.  Intussusception -> hospitalized 10/14/08.  Required surgical intervention.  Pt. currently admitted to PICU at hospital. 12/1/08-records received for DOS 10/14-//-DC DX: Intussusception. Exploratory laparotomy, reduction of intussusception, small bowel resection incidental appendectomy. Presented with 1 day of emesis.  Following morning developed recurrent emesis and repeat ultrasound demonstrated recurrent intussusception and similarly reduced, however patient suffered a respiratory arrest during this procedure. Marked distention of abdomen and lethargy. Surgery demonstrated bowel eviscerated.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, PNC, RV5, RV5
Symptoms: Decreased appetite, Ear infection, Haematochezia, Infrequent bowel movements, Intussusception
Clinical narrative: No BM from 10/11/08, vomiting, decreased diaper wetting, dehydration.  Currant jelly stool 10/14.  Intussusception -> hospitalized 10/14/08.  Required surgical intervention.  Pt. currently admitted to PICU at hospital. 12/1/08-records received for DOS 10/14-//-DC DX: Intussusception. Exploratory laparotomy, reduction of intussusception, small bowel resection incidental appendectomy. Presented with 1 day of emesis.  Following morning developed recurrent emesis and repeat ultrasound demonstrated recurrent intussusception and similarly reduced, however patient suffered a respiratory arrest during this procedure. Marked distention of abdomen and lethargy. Surgery demonstrated bowel eviscerated.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, PNC, RV5, RV5
Symptoms: Pyrexia, Stool analysis abnormal, Surgery, Upper respiratory tract infection, Urine output decreased
Clinical narrative: No BM from 10/11/08, vomiting, decreased diaper wetting, dehydration.  Currant jelly stool 10/14.  Intussusception -> hospitalized 10/14/08.  Required surgical intervention.  Pt. currently admitted to PICU at hospital. 12/1/08-records received for DOS 10/14-//-DC DX: Intussusception. Exploratory laparotomy, reduction of intussusception, small bowel resection incidental appendectomy. Presented with 1 day of emesis.  Following morning developed recurrent emesis and repeat ultrasound demonstrated recurrent intussusception and similarly reduced, however patient suffered a respiratory arrest during this procedure. Marked distention of abdomen and lethargy. Surgery demonstrated bowel eviscerated.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, PNC, RV5, RV5
Symptoms: Vomiting
Clinical narrative: No BM from 10/11/08, vomiting, decreased diaper wetting, dehydration.  Currant jelly stool 10/14.  Intussusception -> hospitalized 10/14/08.  Required surgical intervention.  Pt. currently admitted to PICU at hospital. 12/1/08-records received for DOS 10/14-//-DC DX: Intussusception. Exploratory laparotomy, reduction of intussusception, small bowel resection incidental appendectomy. Presented with 1 day of emesis.  Following morning developed recurrent emesis and repeat ultrasound demonstrated recurrent intussusception and similarly reduced, however patient suffered a respiratory arrest during this procedure. Marked distention of abdomen and lethargy. Surgery demonstrated bowel eviscerated.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Swelling
Clinical narrative: Received 3 vaccines in Rt thigh on 10/13. Swelling noted that was increasing in size. Treated with Clindamycin.
Age: 18.0
Sex: F
Vaccine: HEPA, VARCEL
Symptoms: Cellulitis, Erythema, Swelling, Tenderness
Clinical narrative: At 24 hrs. was a fifty cent piece size. Reaction - red, tender, swelling. At 48 hrs., reaction was 7 x 4 cms. Dx'd as cellulitis and given AUGMENTIN.
Age: 1.3
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Oedema peripheral, Skin warm
Clinical narrative: 4 inch x 4 inch in diameter, swelling on (L) thigh with warmth and redness. Treated with AUGMENTIN, 600 mg/5ml-25ml, PO, BID.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Heat erythema, swelling around injection site.
Age: 63.0
Sex: U
Vaccine: PPV
Symptoms: Joint stiffness, Pain in extremity
Clinical narrative: C/O arm soreness the evening after her PNEUMOVAX. 10/6 on 10/9, she stated that her wrist and hand felt stiff and sore. She went to her PCP that day. No tx noted in chart.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Oedema peripheral, Pain in extremity, Skin infection
Clinical narrative: Pt reported swelling in injected arm. Pt experienced pain in arm and an injection of the skin that required antibiotic therapy.
Age: 38.0
Sex: F
Vaccine: UNK
Symptoms: Dysphagia, Paraesthesia
Clinical narrative: About 20-30 minutes after injection, warm tingling feeling in throat, difficulty swallowing. Took 3 ADVIL PM, and was found to be relieved when I awoke 5 hours later (did not have plain BENADRYL at home).
Sex: U
Vaccine: RV5
Symptoms: Cyanosis, Dyspnoea, Gaze palsy, Malaise, Staring
Clinical narrative: Information has been received from a nurse concerning some babies (number unspecified) who were vaccinated orally with 2 ml doses of ROTATEQ. Subsequently the patients got a light blue color on their lips, a goofy look and "seemed like" they could not breath for a second. The patients outcomes were unknown. They sought medical attention at the office. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available. Additional information has been received from a nurse indicating that she could not pinpoint the patient's names but that the incidents happened to 4-6 patients over several appointments during the winter to spring months of 2008. She witnessed "like a perioral cyanosis" after giving p.o. ROTATEQ to several infants anywhere from 2 and 4 months old. She did not think it was an adverse event until it happened several times to different infants, then she began to wonder. Also, the infant would briefly have a staring look or eyes would roll back for a split second with cyanosis periorbital. After waiting 15-40 seconds, it went away and the patient looked normal. There were no illnesses at time of vaccination and no diagnostic test performed. Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Rash
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with a dose of ROTATEQ (date, dose and route not reported). The patient received concomitant vaccines (not known which vaccines were administered). The physician reported that the patient developed a rash after administration of ROTATEQ. The patient sought medical attention at an office visit. The course of treatment and outcome were not reported. A product quality complaint was not involved. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: DTAP, HIBV, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Information has been received from a medical assistant concerning an 8 week old male with no allergies and medical history, who on 22-APR-2208, was vaccinated PO with the third 2.0 ml dose of ROTATEQ (lot # 660376/0019X). Suspect vaccine therapy included PEDVAXHIB. TRIPEDIA, (CRM197) PREVNAR. The medical assistant reported that on 22-APR-2008, 25 minutes after receiving the ROTATEQ, the patient vomited. Medical attention was sought by calling the office. The outcome was reported as recovered (date unspecified). A product quality complaint was not involved. Additional information has been requested.
Age: 0.1
Sex: F
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a physician concerning a patient who was vaccinated with oral ROTATEQ at one week of age. No product quality complaint. Additional information has been received from a nurse indicating that the 5 day old female was given 1 pouch of ROTATEQ on 06-AUG-2008. The patient has shown no adverse effects. She has been seen by the office twice since receiving the ROTATEQ on normal well baby visits and had no symptoms or problems. Additional information has been requested.
Age: 0.34
Sex: F
Vaccine: RV5
Symptoms: Clostridium difficile toxin test, Culture stool negative, Diarrhoea, Faeces discoloured, Laboratory test abnormal
Clinical narrative: This is in follow-up to report(s) previously submitted on 10/13/2008. Information has been received from a physician concerning a 2 or 4 month old female(Dr. couldn't remember the exact age) who was vaccinated with ROTATEQ. Subsequently the patient experienced diarrhea for two weeks receiving the vaccine. The patient recovered without any additional injuries or issues. Additional information has been received from a physician concerning a 6 month old female with a history of 34 weeks premature, who on 11-JUL-2008, received the second dose of oral ROTATEQ (lot # 660681/0210X) at 10:00 am. There were no concomitant therapies. On 14-JUL-2008, within 3 days of receiving ROTATEQ, he patient had diarrhea consisting of 10-12 stools per day that were green and watery. This persisted for 17 days with the patient recovering on 31-JUL-2008. Stool culture and c-diff toxin was sent and came back negative. There was no illness at time of vaccination reported. Additional information is not expected. Additional information received from a physician indicating that on 21-JUl-2008 a stool culture was performed and results resolved to salmonella shigella, campylobacter, E.-coli or significant stahpylococcus auteus or yeast isolated. Additional information is not expected.
Age: 0.4
Sex: M
Vaccine: DTAPHEPBIP, RV5
Symptoms: Body height, Condition aggravated, Infantile spitting up, Weight
Clinical narrative: Information has been received from a physician and medical records concerning a 4 month old male infant whose medical history and concurrent conditions included the following visits to the physician: on 14-MAR-2008 had normal 1 week exam. His weight was 9lbs 3 ozs and length was 21 inches. On 20-MAR-2008 the physician reported that the baby had several different issues. He was doing some vomiting up of fluid and basically the fluid that he was coughing up was probably from overfeeding, because the mother admitted to feeding him more than 4 oz. if he was hungry. His umbilical cord was healing well, dried blood was scraped off. He had a temperature of 97.1 degrees. The baby was put on glycerin suppositories to use for constipation. On 27-MAR-2008, the baby was seen and the physician reported that he had "lots of matter in the left eye". He had conjunctivitis of the left eye which was treated with SODIUM SULAMYD 10% eye drops to each eye. On 7-APR-2008 the physician reported that the baby had cough with congestion and couldn't catch breath "lots of day". His temperature was 98 degrees and his weight was 11 lbs 13 ozs. The physician reported that the baby had issues with GERD and was having a lot of problems with vomiting up small amounts after he ate. The baby was put on ZANTZC 2 mg per kg per day, divided doses and he was getting 1/4 ml TID every eight hours. On 18-APR-2008 the baby was seen by the physician who reported that the exam was normal except that there was concern that the GERD problem was not getting any better. His ZANTAC was increased to 1/2 CC BID at 15 per CC as his weight had changed. His weight was 11 lbs 10 ozs and length of 23 inches. The baby was to be seen in 2 months. On 15-MAY-2008 was vaccinated with a first dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (human-bovine) (lot # 660425/0278X). On 10-JUL-2008 the baby was vaccinate with a second dose of rotavirus G1 G2 G3 G4 P1 reassortant vaccine live (lot # 66425/0278X). Concomitant therapy included ACTHIB (lot # UF573AB) on 10-JUL-2008, PEDIARIX (lot # AC21B1330A/AC21B156EA) on 15-MAY-2008 and 10-JUL-2008 respectively, and PREVNAR (lot # C547UZ and C65048) on 15-MAY-2008 and 10-JUL-2008 respectively. Physician's exam shower that the baby weight of 12 lbs 12 ozs and length 24 1/2 inches. Current concerns were diarrhea for awhile. On 10-JUL-2008 the baby was seen by the physician who reported a weight of 14 lbs 12 ozs, a length of 25 inches and head circumference of 17 inches. The physician's concern was that the baby "was still spitting up". On 31-JUL-2008, the baby had a follow up with the physician who reported that ZANTAC was increased to 3/4 tsp BID as the baby had grown to the point where the medication was not working as good as it was prior. On 10-JUL-2008 the baby was seen by the physician and was still spitting up. The next visit was to be scheduled as needed (PRN). Additional information has been requested.
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Ultrasound scan abnormal, Vomiting
Clinical narrative: Information has been received from a physician concerning a 9 week old female who on 13-AUG-2008 was vaccinated PO with the first dose of ROTATEQ. On 16-AUG-2008 the patient developed severe vomiting and diarrhea that lasted for a week. The patient underwent an ultrasound that was negative. The patient sought medical attention at an office visit. The patient recovered fully. A product quality complaint was not involved. Additional information has been requested.
Age: 0.33
Sex: M
Vaccine: DTAP, HIBV, PPV, RV5
Symptoms: Culture stool negative, Diarrhoea
Clinical narrative: Information has been received from a physician concerning a 4 month old male with no medical history or allergies who on 25-JUN-2008 was vaccinated with 2 ml dose of ROTATEQ. Concomitant therapy included diphtheria toxoid (+) pertussis vaccine (unspecified) (+) tetanus toxoid, PNEUMOVAX 23 (manufacturer unknown) and PEDVAXHIB (manufacturer unknown). The physician reported that the patient developed diarrhea after receiving his first dose and only dose of ROTATEQ on approximately 25-JUN-2008. The patient experienced 8 to 10 diarrhea episodes daily. The patient was seen by the physician. It was reported "the culture resulted negative." Subsequently, the patient recovered from the diarrhea 17 days later. No further information is available. A product quality complaint was not involved. Additional information has been requested. Follow-up information was received from the physician on 24-OCT-2005. The physician reported that her son developed diarrhea when he was 4 months ild after his second dose of ROTATEQ (previuosly reported as the first dose). The diarrhea lasted 2 weeks (previously reported as 17 days). It was unspecified iif this physician brought her son back to the pediatrician's office related to the diarrhea. This name infant spit out his third dose of ROTATEQ . No other information available at this time. Additional information has been requested.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: Information has been received from a registered nurse (RN) concerning a 6 month old patient who on 09-MAY-2008 was vaccinated PO with the first dose of ROTATEQ and was in the office on 09-SEP-2008 to receive the second dose ROTATEQ. The RN reported that there were no problems. It is unknown if the patient sought medical attention. A product quality complaint was not involved. Follow-up information was received on 29-SEP-2008 from a registered nurse who reported that there no adverse reactions or problems when the patient was vaccinated on 09-SEP-2008 with the second dose of ROTATEQ. No further information to be provided.