chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 3.0
Sex: F
Vaccine: FLUN3
Symptoms: Body temperature increased, Crying, Headache, Pain in extremity, Vomiting
Clinical narrative: 7:00 am patient received flu nasal vaccine. 1 hour later patient complained of headache. Mom took temp 102 degrees, gave TYLENOL patient slept 1 hour, then woke crying complaining of headache. Mom gave another TYLENOL dose. Temp now 98.2 she called Dr office, Dr called her back 2 hrs later and patient was having leg aches. Dr instructed mom to give MOTRIN 4- 6 hours and TYLENOL x 24 hours. Patient felt better the next day, no more fever but did have emesis that night before. No more problems.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Client returned to office for #2 GARDASIL states 'after last shot broke out in Hives'.
Age: 1.2
Sex: F
Vaccine: DTAP, FLU3, IPV
Symptoms: Blood test normal, Chest X-ray normal, Febrile convulsion, Pyrexia
Clinical narrative: Vaccines given at approximately 11:45 am, febrile seizure at 11:50 pm on 12-18-08. Spiked fever 102  and seen at local ER, chest X-ray and blood work WNL. Treated with MOTRIN.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Body temperature decreased, Chills, Hypoaesthesia, Pyrexia, Tremor
Clinical narrative: 6 hours after injections severe chills, shaking, couldn't feel fingertips, temp. didn't register on thermometer (under 95 degrees), got under down comforter for 1 1/2 hours, began to warm up, then fever of 100 degrees lasting all night.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Chills, Dyspnoea, Eye swelling, Hyperhidrosis
Clinical narrative: Tightness in my chest and throat, SOB, swelling in my eyes. Fever, aches, chills, sweats, SOB and chest tightness lasted about 3 hrs, other symptoms until Monday 12/8
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pyrexia, Throat tightness
Clinical narrative: Tightness in my chest and throat, SOB, swelling in my eyes. Fever, aches, chills, sweats, SOB and chest tightness lasted about 3 hrs, other symptoms until Monday 12/8
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Woke up 11-5-08 with pain in (R) arm. (R) deltoid tender to touch. Arm from shoulder to elbow warm, red. Used warm, moist compresses to remove medicine from muscle. 11-6-08. (R) arm not as swelled, still hurts, and is red. Has used Aleve for pain.
Age: 5.0
Sex: M
Vaccine: HEP
Symptoms: Fatigue, Headache, Platelet count, Pyrexia, Vomiting
Clinical narrative: Patient began feeling tired with headaches and vomiting had fever but not sure what temp was. Took child to Dr. next day. Dr states not sure of the cause of symptoms could be viral. Pt has history of ITPP. Platelets were tested and WNL.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Arthralgia, Immediate post-injection reaction, Injection site pain
Clinical narrative: Patient reported immediate soreness at site of injection right deltoid, 10/12/08 noted increased soreness, no swelling. Two weeks after getting worse, increased pain,  #7 scale of 1-10. Pain now down elbow. Suggested that she visit her Doctor for evaluation and gave her our number to inform us of the outcome of that visit.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Cough, Oropharyngeal pain
Clinical narrative: Patient reports: 9/29/08, sore throat, later on a a non productive cough. started on TUSSIN DM, CEPACOL Lozenges which seem to help.
Age: 1.0
Sex: M
Vaccine: UNK
Symptoms: Rash
Clinical narrative: Spots all over extremities
Age: 2.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Injection site pain, Injection site rash
Clinical narrative: Rash/tenderness at injection site
Age: 56.0
Sex: M
Vaccine: HEPAB
Symptoms: Headache, Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: 12/19- Hep A/B- give LA vaccine from Hep C program. He stated by Thurs 12/11- rash head to toe, red, skin feel lumpy with touch, itchy, HA (headache) 2-3 days. Today 12/16- rash-reddened-not raised before, continues to be itchy. Went to family MD- Fri 12/5 MD felt reaction to shot. Started a new BP(blood pressure) pill, 12/5 COZAAR 50mg.
Age: 11.0
Sex: M
Vaccine: DTAP, HEP, HIBV, IPV, MMR
Symptoms: Inappropriate schedule of drug administration, Rash
Clinical narrative: Spots on back, chest , legs and face.
Age: 27.0
Sex: M
Vaccine: HEP, HEPA, IPV, MNQ, TDAP, TYP, YF
Symptoms: Injection site erythema, Injection site swelling, Pruritus, Rash macular
Clinical narrative: Complain of itching after YF immunization. After approximately 8 min patient complain of itching, site was red, raised to size of 50 cent piece. Patient refused PO(by mouth) BENADRYL. Ice pack put onto site. After approximately 10 min, redness and swelling down by 3/4. FM call, patient stated that night his face and chest became blotchy; he took BENADRYL. States he is ok now.
Age: 46.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Eye discharge, Lymphadenopathy, Ocular hyperaemia, Throat tightness
Clinical narrative: Patient said he developed a deep chest cough, throat seemed a lttle tight, glands seemed puffy and tight and his eyes became very reddened and mattery.  Everything was fine the next morning.  Wondered if it could have beena recation to flu shot.  This was his first flu shot.  No other allergies.
Age: 54.0
Sex: F
Vaccine: HEP
Symptoms: Blister, Lymphadenopathy, Pruritus
Clinical narrative: The above named employee presented to Employee Health Nurse for Hepatitis B vaccination. Employee transferred from another facility within company and states she was never offered the Hepatitis B vaccination series. The employee was educated via VIS and stated an undestanding of teaching. Employee denied being pregnant, allergic to Baker's yeast or any bread, any illness, or cardiopulmonary disease. Hepatitis B vaccine was administered on 12/19/2008. Employee reported to Employee Health Nurse on 12/22/2008 of facial itching, red vesicles around nose and left side of lip, and enlarged gland under left side of neck. Administrative Assistant was notified.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Pain in extremity, Rash
Clinical narrative: Thigh Pain and scabbed over rash X 2 months duration.  Mother is quite certain this rash occured after his immunization.
Age: 0.22
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Abdominal X-ray, Enema administration, Intussusception, Pain, Ultrasound abdomen
Clinical narrative: Pain, vomiting, emesis. Diagnosed as intussusseption.
Age: 0.22
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Vomiting
Clinical narrative: Pain, vomiting, emesis. Diagnosed as intussusseption.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Induration, Lethargy, Pain, Pyrexia
Clinical narrative: Woke up the next morning with a "hard" knot on my left arm.  Fever, aching and lethargy.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Dreamy state, Hyperhidrosis, Musculoskeletal stiffness, Pallor, Posture abnormal
Clinical narrative: Client present with his mother and brother for immunizations.  He needs tdap and #2 varicella and mom is requesting menigiococcal.  After obtaining written permission and supplying VIS sheets to mom, I administered boostrix in the R deltoid IM and menactra im in the L deltoid.  Patient sorta had been laughing throught the entire procedure. After administering the second vaccine patient got very pale, as his color had been normal dring the vaccines. He stiffened out in the chair arching his head back momentarily.  He was able to respond and answer questions appropriately through out this but was still very pale, hot to the touch and diaphoretic.  He said he felt like he was "dreaming".  I called Rn and she came in the exam room and assisted.  After he was able to compose himself he was still very pale and we assisted him with the help of three to the exam room where we layed him on a table while checking his Bp and pulse which wer 96/40 and 72.  He gradually regained color and felt well enough to sit up and eat a container of strawberry banana yogurt and drink some water.  Patient was also up late last night and had only eaten a clementine this am.  Mother informs us after this episode that her other son had passed out in the past giving blood and that her ex husband their dad passes out when he receives shots.  We advised her to always tell any practioner ahead of time that they need to lay down for any procedures/injections.  Patient is up with good color and walking around before he leaves the clinic.  Will defer #2 varicella for about a month due to his reaction today.  Advised mom I would be filling out VAERS today.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Skin warm
Clinical narrative: Client present with his mother and brother for immunizations.  He needs tdap and #2 varicella and mom is requesting menigiococcal.  After obtaining written permission and supplying VIS sheets to mom, I administered boostrix in the R deltoid IM and menactra im in the L deltoid.  Patient sorta had been laughing throught the entire procedure. After administering the second vaccine patient got very pale, as his color had been normal dring the vaccines. He stiffened out in the chair arching his head back momentarily.  He was able to respond and answer questions appropriately through out this but was still very pale, hot to the touch and diaphoretic.  He said he felt like he was "dreaming".  I called Rn and she came in the exam room and assisted.  After he was able to compose himself he was still very pale and we assisted him with the help of three to the exam room where we layed him on a table while checking his Bp and pulse which wer 96/40 and 72.  He gradually regained color and felt well enough to sit up and eat a container of strawberry banana yogurt and drink some water.  Patient was also up late last night and had only eaten a clementine this am.  Mother informs us after this episode that her other son had passed out in the past giving blood and that her ex husband their dad passes out when he receives shots.  We advised her to always tell any practioner ahead of time that they need to lay down for any procedures/injections.  Patient is up with good color and walking around before he leaves the clinic.  Will defer #2 varicella for about a month due to his reaction today.  Advised mom I would be filling out VAERS today.
Age: 15.0
Sex: M
Vaccine: MNQ
Symptoms: Dizziness, Feeling hot, Hyperhidrosis, Pallor
Clinical narrative: Client come in for immunizations accompanied by his mother and brother.  Mother requuesting menigiococcal vaccine for him.  PHN is also present in the exam room for this vaccine, as she was helping with his brother who also had a adverse event.  After obtaining written permission and supplying VIS to mother , vaccine was given to him in L deltoid while sitting in a chair.  He did fine with the procedure and had good color, but as soon as he stood up to leave he stated he was going to faint and became very pale.  With the help of three we got him onto the exam table and he continued to be very pale, hot and diphoretic.  We applied cold compresses and tok his blood pressure and pulse which were 110/70 and 60.  After he felt better he sat up and had some vitamin water and a graham cracker.  His color was better.  He had not eaten this am and was up late last night.  He ad passed out one other time after giving blood.  That time it was right after football practice and he had not eaten or drank anything but went right from practice.  Also his father has a history of passing out when getting shots and his borther fainted right before him while getting his shots.  We wheeled him to the front door in a wheel chair and his mother helped him out to the car.  Mom advised to tell any other providers that he should lay down when giving blood or receiving immunizations.  mother advisied we would be doing vaer.  Called mom after they left clinic and she said they were both doing better as they had eaten.
Age: 53.0
Sex: F
Vaccine: FLUN3
Symptoms: Body temperature increased, Chills, Cough, Nasal congestion, Oropharyngeal pain
Clinical narrative: Nasal congestion, cough, temp 100.9, chills sore throat
Age: 0.2
Sex: F
Vaccine: RV5
Symptoms: Choking, Hypotonia, Pallor
Clinical narrative: 2 month old girl here for PE. As rotavirus vax was being administered, she had a choking spell, turned dusky and limp. Recovered in a couple of minutes with positioning and stimulation. Probably layngospasm episode.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, HEPA, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: Right thigh urticaria at site of injections.  Lungs clear.  Given Benadryl 1 1/2 tsp x1.  Rechecked after 20 minutes, rash resolved with exception of one hive at varivax administration site.  Decreased redness and size of hive.
Age: 3.0
Sex: F
Vaccine: FLU3, HEPA, PNC
Symptoms: Injection site haematoma, Injection site vesicles
Clinical narrative: SMALL HEMATOMA (BLISTER) APPROXIMATELY 2CM IN DIAMETER ON LEFT THIGH.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC, RV5
Symptoms: Anorexia, Injection site erythema, Irritability
Clinical narrative: Shots this morning around 11 AM  Fussiness and not eating since shots.  Tylenol at 12:45 and again in office at 4 PM.  Cool compresses applied to both legs.  Right and left thighs red.
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Injection site cellulitis, Oedema peripheral, Pain in extremity
Clinical narrative: patient reports cellulitis to right arm from injection site to wrist.  Right arm swollen, red and painful
Age: 51.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral, Pain in extremity
Clinical narrative: Patient arm became swollen, red and painful.  Patient was given a course of Moxifloxacin
Age: 33.0
Sex: F
Vaccine: TD
Symptoms: Cellulitis, Erythema, Rash pruritic, Skin irritation, Skin warm
Clinical narrative: Patient received Td vaccine on Friday 12/19/08 in her left vastus lateralis muscle. She had just received several allergy injections in both of her deltoids 1 day prior. To minimize irritation, her Td injection was given in her thigh. Patient states her thigh became edematous, reddened, and pruritic by Saturday, 12/20/08 night. She was self administering NSAIDS with GI protection and Anti-histamines as recommended. She spoke with the on -call provider on Saturday who suggested she continue with the above medication regimen, and return to the clinic on Monday for a visual assessment. On Monday, 12/22/08, patient was seen by RN + MD. A 3X2 inch inundated area surrounded a 1 inch reddened area in the mid left vastus lateralis mm area. Her left groin lymph node was also tender and edematous. She was afebrile. the area was warm, reddened and tender to the touch. She was prescribed Keflex 500 mgs p.o. 4 X's daily X 7 days, and was told to return to the clinic in 24-48 hrs if no decrease of symptoms.Her only know allergies is to Latex and Vicodin which produce pruritis.
Age: 33.0
Sex: F
Vaccine: TD
Symptoms: Tenderness
Clinical narrative: Patient received Td vaccine on Friday 12/19/08 in her left vastus lateralis muscle. She had just received several allergy injections in both of her deltoids 1 day prior. To minimize irritation, her Td injection was given in her thigh. Patient states her thigh became edematous, reddened, and pruritic by Saturday, 12/20/08 night. She was self administering NSAIDS with GI protection and Anti-histamines as recommended. She spoke with the on -call provider on Saturday who suggested she continue with the above medication regimen, and return to the clinic on Monday for a visual assessment. On Monday, 12/22/08, patient was seen by RN + MD. A 3X2 inch inundated area surrounded a 1 inch reddened area in the mid left vastus lateralis mm area. Her left groin lymph node was also tender and edematous. She was afebrile. the area was warm, reddened and tender to the touch. She was prescribed Keflex 500 mgs p.o. 4 X's daily X 7 days, and was told to return to the clinic in 24-48 hrs if no decrease of symptoms.Her only know allergies is to Latex and Vicodin which produce pruritis.
Age: 60.0
Sex: F
Vaccine: MMR
Symptoms: Antinuclear antibody positive, Arthralgia, Back pain, Blood potassium increased, Blood urea
Clinical narrative: MMR given on 10/6-employee reported pain and stiffness in knees and wrist on 10/21. On 11/13, employee reports pain and swelling of knees, wrist, neck, low back pain, and left hip pain radiating down left leg (notes Hx of sciatica 10 yrs. ago)
Age: 60.0
Sex: F
Vaccine: MMR
Symptoms: Condition aggravated, Full blood count, Joint stiffness, Laboratory test, Mean cell volume abnormal
Clinical narrative: MMR given on 10/6-employee reported pain and stiffness in knees and wrist on 10/21. On 11/13, employee reports pain and swelling of knees, wrist, neck, low back pain, and left hip pain radiating down left leg (notes Hx of sciatica 10 yrs. ago)
Age: 60.0
Sex: F
Vaccine: MMR
Symptoms: Neck pain, Red blood cell sedimentation rate, Rheumatoid factor, Systemic lupus erythematosus
Clinical narrative: MMR given on 10/6-employee reported pain and stiffness in knees and wrist on 10/21. On 11/13, employee reports pain and swelling of knees, wrist, neck, low back pain, and left hip pain radiating down left leg (notes Hx of sciatica 10 yrs. ago)
Age: 28.0
Sex: M
Vaccine: FLUN3
Symptoms: Immediate post-injection reaction, Road traffic accident, Syncope
Clinical narrative: Syncopal episode which occurred five minutes after intranasal vaccine was given.  This happened while patient was driving and resulted in an accident with no injuries, but car was totalled.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: patient complains of a swollen area where the injection was administered.  She stated that the injection hurt when administered.  She claims the area is very sore to the touch 1 month after the injection was given.
Age: 47.0
Sex: M
Vaccine: LYME
Symptoms: Activities of daily living impaired, Alopecia, Arthralgia, Burning sensation, Confusional state
Clinical narrative: This case was reported by a lawyer and described the occurrence of joint pain in a male subject of unspecified age who was vaccinated with LYMERIX. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). At an unspecified time after vaccination with LYMERIX, the subject experienced pain and swelling in his joints, fatigue, possible neurological injuries, possible autoimmune disease, and decreased activities of daily life. At the time of reporting the outcome of the events were unspecified. This information was received via a Statement of Injuries. Follow up information was received on 17 December 2008 via an interview between the subject and attorney (s). The subject was vaccinated with LYMERIX at his place of employment on 11 February 2000, 17 March 2000, and 22 February 2001. After the first vaccine, he developed joint pain. He was reportedly advised that he had rheumatoid arthritis. After the third LYMERIX vaccine and prior to April 2002, he developed fatigue and insomnia. On unspecified dates after the third LYMERIX vaccine he developed depression and brain fog (including confusion). In 2002 he developed hair loss and nausea. In 2006 he developed burning, tingling, and shooting pains. In 2007 he developed high blood pressure. Treatment included VIOXX, prednisone, and methotrexate, which he eventually discontinued due to side effects. With the exception of brain fog, the events were unresolved at the time of reporting. This case was assessed by GSK to be medically significant based upon follow up information.
Age: 47.0
Sex: M
Vaccine: LYME
Symptoms: Depression, Fatigue, Feeling abnormal, Insomnia, Joint swelling
Clinical narrative: This case was reported by a lawyer and described the occurrence of joint pain in a male subject of unspecified age who was vaccinated with LYMERIX. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). At an unspecified time after vaccination with LYMERIX, the subject experienced pain and swelling in his joints, fatigue, possible neurological injuries, possible autoimmune disease, and decreased activities of daily life. At the time of reporting the outcome of the events were unspecified. This information was received via a Statement of Injuries. Follow up information was received on 17 December 2008 via an interview between the subject and attorney (s). The subject was vaccinated with LYMERIX at his place of employment on 11 February 2000, 17 March 2000, and 22 February 2001. After the first vaccine, he developed joint pain. He was reportedly advised that he had rheumatoid arthritis. After the third LYMERIX vaccine and prior to April 2002, he developed fatigue and insomnia. On unspecified dates after the third LYMERIX vaccine he developed depression and brain fog (including confusion). In 2002 he developed hair loss and nausea. In 2006 he developed burning, tingling, and shooting pains. In 2007 he developed high blood pressure. Treatment included VIOXX, prednisone, and methotrexate, which he eventually discontinued due to side effects. With the exception of brain fog, the events were unresolved at the time of reporting. This case was assessed by GSK to be medically significant based upon follow up information.
Age: 47.0
Sex: M
Vaccine: LYME
Symptoms: Nausea, Pain, Paraesthesia, Rheumatoid arthritis
Clinical narrative: This case was reported by a lawyer and described the occurrence of joint pain in a male subject of unspecified age who was vaccinated with LYMERIX. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). At an unspecified time after vaccination with LYMERIX, the subject experienced pain and swelling in his joints, fatigue, possible neurological injuries, possible autoimmune disease, and decreased activities of daily life. At the time of reporting the outcome of the events were unspecified. This information was received via a Statement of Injuries. Follow up information was received on 17 December 2008 via an interview between the subject and attorney (s). The subject was vaccinated with LYMERIX at his place of employment on 11 February 2000, 17 March 2000, and 22 February 2001. After the first vaccine, he developed joint pain. He was reportedly advised that he had rheumatoid arthritis. After the third LYMERIX vaccine and prior to April 2002, he developed fatigue and insomnia. On unspecified dates after the third LYMERIX vaccine he developed depression and brain fog (including confusion). In 2002 he developed hair loss and nausea. In 2006 he developed burning, tingling, and shooting pains. In 2007 he developed high blood pressure. Treatment included VIOXX, prednisone, and methotrexate, which he eventually discontinued due to side effects. With the exception of brain fog, the events were unresolved at the time of reporting. This case was assessed by GSK to be medically significant based upon follow up information.
Age: 59.0
Sex: M
Vaccine: LYME
Symptoms: Activities of daily living impaired, Arthralgia, Autoimmune disorder, Back pain, Cognitive disorder
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. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). At an unknown time after vaccination with LYMERIX, the subject experienced Arthralgia, back pain, swelling, rheumatological symptoms, neurological impairment, cognitive impairment, autoimmune disease, decreased ability to perform daily activities and decreased activity level. 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 17 December 2008 via an interview between the subject and attorney(s). The subject was vaccinated with LYMERIX in April 1999, May 1999 and April 2000, In approximately 2001 he developed premature ejaculation and erectile dysfunction. Between 2001 and 2003 he developed difficulty writing and joint stiffness. In approximately 2005 he developed thumb joint pain. In approximately 2006 he developed left arm neck and numbness. treatment included VIAGRA. The events were unresolved at the time of this report. This case was assessed as medically significant based upon follow up information.
Age: 59.0
Sex: M
Vaccine: LYME
Symptoms: Decreased activity, Dysgraphia, Erectile dysfunction, Hypoaesthesia, Joint stiffness
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. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). At an unknown time after vaccination with LYMERIX, the subject experienced Arthralgia, back pain, swelling, rheumatological symptoms, neurological impairment, cognitive impairment, autoimmune disease, decreased ability to perform daily activities and decreased activity level. 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 17 December 2008 via an interview between the subject and attorney(s). The subject was vaccinated with LYMERIX in April 1999, May 1999 and April 2000, In approximately 2001 he developed premature ejaculation and erectile dysfunction. Between 2001 and 2003 he developed difficulty writing and joint stiffness. In approximately 2005 he developed thumb joint pain. In approximately 2006 he developed left arm neck and numbness. treatment included VIAGRA. The events were unresolved at the time of this report. This case was assessed as medically significant based upon follow up information.
Age: 59.0
Sex: M
Vaccine: LYME
Symptoms: Nervous system disorder, Neurological symptom, Premature ejaculation, Swelling
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. A physician or other health care professional has not verified this report. On an unspecified date the subject received unspecified dose of LYMERIX (unknown). At an unknown time after vaccination with LYMERIX, the subject experienced Arthralgia, back pain, swelling, rheumatological symptoms, neurological impairment, cognitive impairment, autoimmune disease, decreased ability to perform daily activities and decreased activity level. 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 17 December 2008 via an interview between the subject and attorney(s). The subject was vaccinated with LYMERIX in April 1999, May 1999 and April 2000, In approximately 2001 he developed premature ejaculation and erectile dysfunction. Between 2001 and 2003 he developed difficulty writing and joint stiffness. In approximately 2005 he developed thumb joint pain. In approximately 2006 he developed left arm neck and numbness. treatment included VIAGRA. The events were unresolved at the time of this report. This case was assessed as medically significant based upon follow up information.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Lymphadenopathy, Periarthritis
Clinical narrative: This case was reported by healthcare professional and described the occurrence of swollen glands under arms in a 57-year-old male subject who was vaccinated with FLUARIX (GlaxoSmithKline) for prophylaxis. On the morning of 22-October 2008, the subject received a dose of FLUARIX (.5 unknown, unknown, left arm). On 24 October 2008. 2 days after vaccination with FLURIX, the subject experienced swollen glands under arms. ON 16 December 2008,  the subject experienced a "reoccurrence" frozen shoulder and decreased range of motion arm. A healthcare professional reported that a subject received FLUARIX on 22 October 2008 and two days later called to say that his left underarm had a swollen gland. He was treated with KEFLEX and the swelling resolved. On 16 December, his wife called this office to say that he had a "reoccurrence" and his left arm had decreased range of motion. He was treated at an orthopedic office and was told he had a frozen shoulder. He was given cortisone injections and physical therapy. The subject was treated with KEFLEX, CORTISONE and physical therapy. At the time of reporting the events were unresolved. The healthcare professional considered the events were possibly related vaccination with FLUARIX. The orthopedist also mentioned to the subject's wife that this is the third case of frozen shoulder he has seen this year following flu vaccination. Additional cases see A0761286A and A0761289A.
Age: 0.6
Sex: F
Vaccine: FLU3
Symptoms: Apnoea, Chest X-ray normal, Cough, Cyanosis, Full blood count normal
Clinical narrative: This female subject was enrolled in a study. On October 2008 and November 13 2008, she received the 1st and 2nd dose of THIMEROSAL free, FLUARIX or FLUZONE. This subject received FLUARIX 0.5ml. On 30 November 2008, 17 days after the 2nd dose of blinded vaccine, this eight-month-old subject developed cyanosis and apnea. The subject was hospitalised. The events resolved on 30 November 2008. The investigator considered that there was a reasonable possibility that the apnea and cyanosis may have been caused by investigational vaccine and that the events were possibly due to suspected gastroesophageal reflux (not proven). Investigator comments: Subject is an 8 month old female who entered the study on 8 October 2008. On 30 November 2008, 17 days after receiving the 2nd dose of study vaccine, the subject was admitted into the hospital due to an episode of apnea with cyanosis. As per mother, the subject has not had any previous occurrence of apnea. However, she reported that the subject has had a cough, congestion and Rhinorrhea on the day of the event. On admission, the subject was not in acute distress. Oxygen saturation was 99 %. Heart sounds had regular rate and rhythm. On lung examination, coarse breath sounds were heard. CBC, electrolytes and urinalysis results were within normal limits. CXR was done and showed no acute disease. Pneumogram study was done and was normal. No other episodes of apnea were observed while admitted. Subject was discharged after 3 days. Investigator believes there is a possibility that event is related to study vaccine. Other possible causes of event include gastroesophageal reflux (not proven).
Age: 0.6
Sex: F
Vaccine: FLU3
Symptoms: Laboratory test normal, Oxygen saturation normal, Respiratory syncytial virus test negative, Respiratory tract congestion, Rhinorrhoea
Clinical narrative: This female subject was enrolled in a study. On October 2008 and November 13 2008, she received the 1st and 2nd dose of THIMEROSAL free, FLUARIX or FLUZONE. This subject received FLUARIX 0.5ml. On 30 November 2008, 17 days after the 2nd dose of blinded vaccine, this eight-month-old subject developed cyanosis and apnea. The subject was hospitalised. The events resolved on 30 November 2008. The investigator considered that there was a reasonable possibility that the apnea and cyanosis may have been caused by investigational vaccine and that the events were possibly due to suspected gastroesophageal reflux (not proven). Investigator comments: Subject is an 8 month old female who entered the study on 8 October 2008. On 30 November 2008, 17 days after receiving the 2nd dose of study vaccine, the subject was admitted into the hospital due to an episode of apnea with cyanosis. As per mother, the subject has not had any previous occurrence of apnea. However, she reported that the subject has had a cough, congestion and Rhinorrhea on the day of the event. On admission, the subject was not in acute distress. Oxygen saturation was 99 %. Heart sounds had regular rate and rhythm. On lung examination, coarse breath sounds were heard. CBC, electrolytes and urinalysis results were within normal limits. CXR was done and showed no acute disease. Pneumogram study was done and was normal. No other episodes of apnea were observed while admitted. Subject was discharged after 3 days. Investigator believes there is a possibility that event is related to study vaccine. Other possible causes of event include gastroesophageal reflux (not proven).
Age: 0.6
Sex: F
Vaccine: FLU3
Symptoms: Urine analysis normal
Clinical narrative: This female subject was enrolled in a study. On October 2008 and November 13 2008, she received the 1st and 2nd dose of THIMEROSAL free, FLUARIX or FLUZONE. This subject received FLUARIX 0.5ml. On 30 November 2008, 17 days after the 2nd dose of blinded vaccine, this eight-month-old subject developed cyanosis and apnea. The subject was hospitalised. The events resolved on 30 November 2008. The investigator considered that there was a reasonable possibility that the apnea and cyanosis may have been caused by investigational vaccine and that the events were possibly due to suspected gastroesophageal reflux (not proven). Investigator comments: Subject is an 8 month old female who entered the study on 8 October 2008. On 30 November 2008, 17 days after receiving the 2nd dose of study vaccine, the subject was admitted into the hospital due to an episode of apnea with cyanosis. As per mother, the subject has not had any previous occurrence of apnea. However, she reported that the subject has had a cough, congestion and Rhinorrhea on the day of the event. On admission, the subject was not in acute distress. Oxygen saturation was 99 %. Heart sounds had regular rate and rhythm. On lung examination, coarse breath sounds were heard. CBC, electrolytes and urinalysis results were within normal limits. CXR was done and showed no acute disease. Pneumogram study was done and was normal. No other episodes of apnea were observed while admitted. Subject was discharged after 3 days. Investigator believes there is a possibility that event is related to study vaccine. Other possible causes of event include gastroesophageal reflux (not proven).
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU3, MMR, VARCEL
Symptoms: Allergy to vaccine, Hypersensitivity, Injection site erythema, Injection site pruritus
Clinical narrative: Allergic reaction to vaccine consisting of erythematous area measuring 15 cm, very pruritic of (L) thigh. No fever. No tenderness.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP, PNC, RV5
Symptoms: Unevaluable event
Clinical narrative: None stated
Age: 4.0
Sex: M
Vaccine: DTAP, FLUN3, IPV, MMR, VARCEL
Symptoms: Injection site pain, Injection site swelling, Local reaction
Clinical narrative: DTap (L) leg 12/7. 12/18 - presented with swelling pain (L) leg from site of vaccine to (L) knee. No fever, redness, from A/P. Local reaction, Rx Ibuprofen.
Age: 6.0
Sex: M
Vaccine: FLU3, HEPA, VARCEL
Symptoms: Oedema peripheral
Clinical narrative: Received vaccines on 12/18/08. Played basketball on 12/20/08 on the night of 12/20/08 noticed left arm swelling no pain/tenderness.
Age: 0.6
Sex: M
Vaccine: DTAPIPVHIB, PNC
Symptoms: Injection site erythema
Clinical narrative: Redness of injection site
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Alopecia
Clinical narrative: Hair loss/thining at 2 mos after administration of 2nd GARDASIL shot on 7/7/08
Age: 0.6
Sex: U
Vaccine: DTAP, FLU3, HIBV, PNC, RV5
Symptoms: Rash pruritic, Urticaria
Clinical narrative: Rash itchy and urticarial. Scattered wheals. ORAPRED 15mg/5mg, 1/2 tsp BID.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Allergy test positive, Cough, Dyspnoea, Hypoaesthesia, Hypoaesthesia facial
Clinical narrative: Patient presented at ER 11/07/08 with shortness of breath, swelling of lips, mouth, numbness of hands and face. She responded to 50 mg oral BENADRYL and was released. 12/02/08 and 12/03/08 she presented to ER with similar signs/symptoms but also hives, "croupy" cough she was given BENADRYL 50 mg by mouth then EPINEPHRINE 1:1000 0.3 ml sq and PREDISONE. Symptoms improved and she was released.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Lip swelling, Oedema mouth, Urticaria
Clinical narrative: Patient presented at ER 11/07/08 with shortness of breath, swelling of lips, mouth, numbness of hands and face. She responded to 50 mg oral BENADRYL and was released. 12/02/08 and 12/03/08 she presented to ER with similar signs/symptoms but also hives, "croupy" cough she was given BENADRYL 50 mg by mouth then EPINEPHRINE 1:1000 0.3 ml sq and PREDISONE. Symptoms improved and she was released.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Immediate post-injection reaction, Migraine
Clinical narrative: Migraine immediately after GARDASIL injection
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site haemorrhage, Injection site pain, Injection site scab, Myalgia
Clinical narrative: 10/23/08 injection shot hurt when given, muscle soreness, point of injection stayed red x3 wks, (and area) scab over point of injection-would bleed when scratched. Muscle stayed sore, painful to use hand x 2 mo. Seen by dR 12/17/08, antibiotic (KEFLEX) given and MOTRIN (800 mg) prn for discomfort. Much improved except not healed completely-remains sore in one spot.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: 10/23/08 injection shot hurt when given, muscle soreness, point of injection stayed red x3 wks, (and area) scab over point of injection-would bleed when scratched. Muscle stayed sore, painful to use hand x 2 mo. Seen by dR 12/17/08, antibiotic (KEFLEX) given and MOTRIN (800 mg) prn for discomfort. Much improved except not healed completely-remains sore in one spot.
Age: 1.5
Sex: F
Vaccine: DTAP, FLU3, VARCEL
Symptoms: Blister, Rash papular
Clinical narrative: 4 lesions in various stages including papules and 1 vesicle with onset 8 days after VARIVAX.
Age: 50.0
Sex: F
Vaccine: MMR
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Vaccinated for MMR approximately 3 weeks post vaccine developed redness and swelling at injection sight . No fever, auxiliary nodes etc. advised to follow up if persist.
Age: 1.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Rash in face and trunk area, rash lasting 4 days
Age: 14.0
Sex: M
Vaccine: MNQ
Symptoms: Lip swelling, Pharyngeal oedema
Clinical narrative: Lip and throat swelling 4 hour after MENACTRA vaccine.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Eye swelling, Headache, Nausea, Pain in extremity
Clinical narrative: Approx. 30-40" after vaccination experienced following symptom: sharp pain in head; increased resp. rate, nausea, dizziness, pre-syncope; throat tightening, eyes swelling. Pain in arm that was use for vaccination.
Age: 47.0
Sex: F
Vaccine: TDAP
Symptoms: Presyncope, Respiratory rate increased, Throat tightness
Clinical narrative: Approx. 30-40" after vaccination experienced following symptom: sharp pain in head; increased resp. rate, nausea, dizziness, pre-syncope; throat tightening, eyes swelling. Pain in arm that was use for vaccination.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Rash generalised
Clinical narrative: Injection was given 12/8/2008. Patient notified pharmacy 12/22 at 9:40 am. Full body rash. Called Dr. Dr told her to take ZYRTEC and ZANTAC OTC.
Age: 14.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Dizziness, Headache, Nausea, Tremor
Clinical narrative: Several hrs after vaccine she developed severe HA, dizziness and shaking. Evaluated in office. TYLENOL given after 30 min symptoms improved. Back to normal approximately 4 hrs later. But had persistent HA, dizziness, nausea x 2 more days.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Left dorsal arm redness and swelling from mid upper arm to wrist.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Local reaction
Clinical narrative: Patient was given Pneumovax 12-16-2008 with localized reactions to right arm. Arm was swollen right deltoid site of injection exendsdistally to upper elbow measures 2X3 inches at injection site 4X4.5 inches to area above elbow
Age: 1.6
Sex: F
Vaccine: FLU3
Symptoms: Upper respiratory tract infection, Urticaria
Clinical narrative: Generalized hives within 24 hours of DTaP administration, concurrent with URI, no fever.
Age: 2.0
Sex: F
Vaccine: FLUN3
Symptoms: Cough, Post-tussive vomiting
Clinical narrative: HPI: Cough began 12/7/08 then persisted with worsening symptoms, including post tussive emesis x 1. PMHx: has had rare episode of RAD in past - last episode remote from FLUMIST administration on 11/11/2008. Acute symptoms. Have not had f up assessment as of yet.
Age: 81.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema peripheral, Pain, Tenderness, Vaccine positive rechallenge
Clinical narrative: patient received flu vaccine IM/LD and pneumonia vaccine IM/LD on 10-14-08 per LPN. patient returned to clinic on 10-16-08 with swelling, redness and tenderness in Lt arm from shoulder to elbow on front side only. Patient then tells nurse she had a reaction 6 yrs ago and had forgotten it was from a pneumonia shot. Instructed patient to put warm moist compresses, TYLENOL for pain and BENADRYL for allergic reaction. Will call clinic in am and relate progress, have been unable to reach patient for last 2 weeks.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1, RV1
Symptoms: Enema administration, Intussusception, Surgery, Urinary system X-ray
Clinical narrative: This case was reported by a physician via sales representative and described the occurrence of adverse reaction in a subject of unspecified age and gender who was vaccinated with ROTARIX (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of ROTARIX (unknown). At an unspecified time after vaccination with ROTARIX, the subject experienced adverse reaction and inappropriate route of vaccination. The sales representative reported a physician called to discuss an adverse reaction of a subject who had received ROTARIX shot, but the call was disconnected. No other information was provided. At the time of reporting the outcome of the events were unspecified. Follow-up information was received on 22 December 2008, via physician who reported the 6-month old female subject received ROTATEQ for 1st and 2nd doses and 3rd dose ROTARIX on 30 October 2008, lot number reported as "A41FA692A". One week after receiving ROTARIX on 06 November 2008, the subject experienced intussusception. The physician considered the events were life threatening and clinically significant (or requiring intervention). On 9 November 2008, the events were resolved. The physician considered the events were possibly related to vaccination with ROTARIX.
Age: 0.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1, RV1
Symptoms: Adverse reaction, Incorrect route of drug administration, Intussusception
Clinical narrative: This case was reported by a physician via sales representative and described the occurrence of adverse reaction in a subject of unspecified age and gender who was vaccinated with ROTARIX (GlaxoSmithKline). On an unspecified date, the subject received unspecified dose of ROTARIX (unknown). At an unspecified time after vaccination with ROTARIX, the subject experienced adverse reaction and inappropriate route of vaccination. The sales representative reported a physician called to discuss an adverse reaction of a subject who had received ROTARIX shot, but the call was disconnected. No other information was provided. At the time of reporting the outcome of the events were unspecified. Follow-up information was received on 22 December 2008, via physician who reported the 6-month old female subject received ROTATEQ for 1st and 2nd doses and 3rd dose ROTARIX on 30 October 2008, lot number reported as "A41FA692A". One week after receiving ROTARIX on 06 November 2008, the subject experienced intussusception. The physician considered the events were life threatening and clinically significant (or requiring intervention). On 9 November 2008, the events were resolved. The physician considered the events were possibly related to vaccination with ROTARIX.
Age: 30.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Autoimmune disorder, Nerve injury
Clinical narrative: Seriousness Criteria: Other-Medically Significant. Initial report received on 10 December 2008 from a health care professional. A 30-year-old female patient, who had concurrent illness of TB Adenitis and allergies to many drugs (unspecified), had received an intramuscular left upper extremity injection of FLUZONE SV 2008-2009 (lot number U2798EA) on 12 November 2008. Two days after vaccination, the patient developed "autoimmune plexography" involving the right arm. It was not reported whether the patient required medical attention or evaluation by a physician, or if any diagnostic tests or laboratory data were performed. Treatments prescribed were not provided. The recovery status of the patient was also not provided. Documents held by sender: None
Age: 30.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Autoimmune disorder
Clinical narrative: Seriousness Criteria: Other-Medically Significant. Initial report received on 10 December 2008 from a health care professional. A 30-year-old female patient, who had concurrent illness of TB Adenitis and allergies to many drugs (unspecified), had received an intramuscular left upper extremity injection of FLUZONE SV 2008-2009 (lot number U2798EA) on 12 November 2008. Two days after vaccination, the patient developed "autoimmune plexography" involving the right arm. It was not reported whether the patient required medical attention or evaluation by a physician, or if any diagnostic tests or laboratory data were performed. Treatments prescribed were not provided. The recovery status of the patient was also not provided. Documents held by sender: None
Age: 45.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Asthenia, Dizziness, Electromyogram, Fatigue, Injection site pain
Clinical narrative: None stated.
Age: 45.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Nerve conduction studies, Pain in extremity, Paraesthesia
Clinical narrative: None stated.
Age: 45.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Electromyogram, Nerve conduction studies, Unevaluable event
Clinical narrative: None stated.
Sex: F
Vaccine: HEP
Symptoms: Candidiasis, Congenital anomaly, Dermatitis diaper, Diarrhoea, Dry skin
Clinical narrative: Information has been received from a physician through medical records concerning a 1 day old female, who on 12-AUG-2008, was vaccinated with the first dose of RECOMBIVAX HB, manufacturer unknown. On 26-AUG-2008, the 2 week check noted thrush to the infants mouth and a small umbilical hernia. On 30-SEP-2008, the patient was seen for dry skin to the face and ears that had been noted for a week. There was white exudated noted in the infants throat and diaper rash was reported. The child was diagnosed with dry skin, continued thrush and diaper dermatitis, petrolatum, white (VASELINE), nystatin oral solution and nystatin topical cream were prescribed. On 13-OCT-2008, the patient was seen for a 2 month check up. It was reported that thrush was not better, DIFLUCAN was prescribed. The patient was also vaccinated with PEDIARIX, HIB, manufacturer unknown, rotavirus vaccine (unspecified), and pneumococcal conj vaccine (unspecified). On 25-NOV-2008, the patient was seen for diarrhea for one day. The child had 3 diarrhea diapers. The child was noted to be "fine" on the day of the visit. The diagnosis was a questionable milk protein intolerance. Soy formula was prescribed. No skin rash was noted at this visit. Small umbilical hernia was noted to be a congenital anomaly. Additional information has been requested. Medical records provided upon request.