chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dizziness, Pain in extremity
Clinical narrative: At 700 pm I got very dizzy, I needed to sit down. 7:15 pm I got weak, needed to lay down. I stayed down till 8:15, weakness went away. Was still dizzy the whole time. 11:30 pm dizzy was almost gone. By 300 pm 11-19-14 felt better. Right arm hurt like someone punched me in arm since 7 pm on 11-18-14. Still hurt not as bad 11-19-14. Now if I press slight feeling.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Injection site atrophy
Clinical narrative: Patient received a flu vaccine in her (R) arm. Days afterward she noticed an area of indentation high up on her arm where the shot had been administered. She saw a physician who told her the vaccine was administered too high up on her deltoid.
Age: 40.0
Sex: M
Vaccine: FLU3, TYP, YF
Symptoms: Urticaria
Clinical narrative: Pt given Influenza, Yellow Fever, and Oral Typhoid on same day. Oral Typhoid course completed 11/20/14. Ten days after course completion pt developed hives on feet and lower legs. Took BENADRYL and ZYRTEC and CLARITIN. Hives came and went several times over a weeks time.
Age: 17.0
Sex: F
Vaccine: MNQ, TDAP, VARCEL
Symptoms: Erythema, Feeling hot, Swelling
Clinical narrative: Red Swollen, hot
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13
Symptoms: Pyrexia
Clinical narrative: Fever up to 104.1.
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Back pain, Joint range of motion decreased, Joint stiffness, Musculoskeletal pain
Clinical narrative: "I had neck and upper back pain for the 1st five days. That subsided and then pain is in right upper shoulder/tendon ever since. Limited range of motion, soreness and stiffness." Per patient.
Age: 35.0
Sex: M
Vaccine: FLU3
Symptoms: Neck pain, Tendon pain
Clinical narrative: "I had neck and upper back pain for the 1st five days. That subsided and then pain is in right upper shoulder/tendon ever since. Limited range of motion, soreness and stiffness." Per patient.
Age: 29.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Injection site swelling, Local swelling, Rash generalised
Clinical narrative: 24 hours after injection the patient experienced swelling at site of injection and up to the base of neck. Also, full body rash.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Rash, Urticaria
Clinical narrative: Welt-like rash on back, thighs and upper-outer (R) arm. Appeared 3-7 days after flu vaccination. Resolved temporarily with prednisone.
Age: 34.0
Sex: M
Vaccine: FLU3, VARCEL
Symptoms: Arthralgia, Chills, Pyrexia, Rash generalised
Clinical narrative: Received varicella vaccine on 12-1-14. Patient started having bumps all over body on 12 9-10 as well as fevers, chills, and joint aches. Patient has not received any treatment so far.
Age: 54.0
Sex: F
Vaccine: FLUC3
Symptoms: Condition aggravated, Convulsion, Pyrexia, Tremor
Clinical narrative: Fever and shakes then seizures.
Age: 13.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Asthenia, Feeling cold, Heart rate decreased, Nausea, Pallor
Clinical narrative: Few min after receiving HPV and Flu vax - he complained of nausea, feeling weak and cold. While seated lips looked pale, breathing normal. HR strong but somewhat slow - counted 65-70/min RR. Observation done - HR strong at 70/min. Continued observation 15-20 min and recovered.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site reaction, Injection site urticaria, Secretion discharge, Urticaria
Clinical narrative: Unsure of exact time on date.  Welts/hives in a circle pattern around injection and scattered elsewhere on the body primarily torso and arms draining serosanguinous liquid.  New hives appearing 12/22/201.
Age: 13.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Dizziness, Eye movement disorder, Loss of consciousness, Muscle rigidity, Pallor
Clinical narrative: Patient received flu and GARDASIL vaccine roughly 4:25 pm. While listening to heart murmur, patient's head lowered, passed out and was lowered to exam table. Lost color in face, brief rigidity to limbs, eyes rolled back, < 5 secs. came to, sat up A and O x3, said he had a dream. Monitored for next 30 min. given 3 glasses of juice. O2 Sat 100%, HR 75. Pt recovered after laying and sitting for some time. Felt fine and walked out of office. Dizziness resolved.
Age: 1.12
Sex: M
Vaccine: FLU3, HEPA
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Client received influenza and hep A vaccine at 4:30 PM on 12-16-2014. Developed low grade fever through the night then good on 12/17/2014 but went to ER at midnight after having febrile seizure. Temp was 103 degrees in ER.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Back pain, C-reactive protein, Constipation, Electromyogram
Clinical narrative: Started with a headache and neck and back pain.  Woke up the next day with numbness to my hands and feet and around my mouth.  Progressed over a week to extreme weakness and numbness and pain from the waistline down and arm weakness.  Has continued for over 5 weeks without improvement.  Have had a spinal tap, lab work several times and an MRI of head and spine.  2 ER visits, 24 hour hospital stay and multiple visits to family MD and neurologist.  Diagnosis is still unclear but possible transverse myelitis vs. Guillain Barre.  To start physical therapy next week due to weakness to lower extremities and difficulty walking.  Also developed hypertension and severe constipation.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Full blood count, Gait disturbance, Headache, Hypertension, Hypoaesthesia
Clinical narrative: Started with a headache and neck and back pain.  Woke up the next day with numbness to my hands and feet and around my mouth.  Progressed over a week to extreme weakness and numbness and pain from the waistline down and arm weakness.  Has continued for over 5 weeks without improvement.  Have had a spinal tap, lab work several times and an MRI of head and spine.  2 ER visits, 24 hour hospital stay and multiple visits to family MD and neurologist.  Diagnosis is still unclear but possible transverse myelitis vs. Guillain Barre.  To start physical therapy next week due to weakness to lower extremities and difficulty walking.  Also developed hypertension and severe constipation.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia oral, Laboratory test, Lumbar puncture, Metabolic function test, Mononucleosis heterophile test
Clinical narrative: Started with a headache and neck and back pain.  Woke up the next day with numbness to my hands and feet and around my mouth.  Progressed over a week to extreme weakness and numbness and pain from the waistline down and arm weakness.  Has continued for over 5 weeks without improvement.  Have had a spinal tap, lab work several times and an MRI of head and spine.  2 ER visits, 24 hour hospital stay and multiple visits to family MD and neurologist.  Diagnosis is still unclear but possible transverse myelitis vs. Guillain Barre.  To start physical therapy next week due to weakness to lower extremities and difficulty walking.  Also developed hypertension and severe constipation.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Muscular weakness, Neck pain, Nerve conduction studies, Nuclear magnetic resonance imaging brain, Nuclear magnetic resonance imaging spinal
Clinical narrative: Started with a headache and neck and back pain.  Woke up the next day with numbness to my hands and feet and around my mouth.  Progressed over a week to extreme weakness and numbness and pain from the waistline down and arm weakness.  Has continued for over 5 weeks without improvement.  Have had a spinal tap, lab work several times and an MRI of head and spine.  2 ER visits, 24 hour hospital stay and multiple visits to family MD and neurologist.  Diagnosis is still unclear but possible transverse myelitis vs. Guillain Barre.  To start physical therapy next week due to weakness to lower extremities and difficulty walking.  Also developed hypertension and severe constipation.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Vitamin B12, Vitamin D
Clinical narrative: Started with a headache and neck and back pain.  Woke up the next day with numbness to my hands and feet and around my mouth.  Progressed over a week to extreme weakness and numbness and pain from the waistline down and arm weakness.  Has continued for over 5 weeks without improvement.  Have had a spinal tap, lab work several times and an MRI of head and spine.  2 ER visits, 24 hour hospital stay and multiple visits to family MD and neurologist.  Diagnosis is still unclear but possible transverse myelitis vs. Guillain Barre.  To start physical therapy next week due to weakness to lower extremities and difficulty walking.  Also developed hypertension and severe constipation.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: C-reactive protein, Chills, Full blood count, Injection site urticaria, Malaise
Clinical narrative: Chills, malaise 16th, 17th and 18th. Hives developed in the region of the vaccine site 12/20/14.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Red blood cell sedimentation rate
Clinical narrative: Chills, malaise 16th, 17th and 18th. Hives developed in the region of the vaccine site 12/20/14.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Extreme pain in vaccinated arm with extremely limited range of motion. Pain and limited motion lasted seven days. Ice and ADVIL first day. No relief. Warm compresses and CELEBREX relieved.
Age: 2.0
Sex: M
Vaccine: FLUN4
Symptoms: Bacteraemia, C-reactive protein increased, Cellulitis, White blood cell count increased
Clinical narrative: Facial cellulitis progressing to bacteremia.
Age: 66.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Erythema, Oedema peripheral, Pain, Vaccination complication, Vaccination site swelling
Clinical narrative: Patient noticed swelling around vaccine site. Swelling continued for a couple of days.  He then experienced edema in feet with redness and extreme pain on 12/20/14.  Advised patient to go to ER, where he was seen.  ER physician indicated to patient that it was most likely a reaction to the tetanus portion of the vaccine.  Followed up with patient on 12/22/14, he was feeling much better and edema had gone down with use of furosemide.
Age: 1.0
Sex: M
Vaccine: FLU3, HEPA, MMR, PNC13, VARCEL
Symptoms: CSF test normal, Cerebellar ataxia, Computerised tomogram head normal, Drug screen negative, Full blood count normal
Clinical narrative: Patient developed acute cerebellar ataxia 2 weeks following varicella vaccine. Symptoms slowly resolving and patient should make full recovery.
Age: 1.0
Sex: M
Vaccine: FLU3, HEPA, MMR, PNC13, VARCEL
Symptoms: Metabolic function test normal
Clinical narrative: Patient developed acute cerebellar ataxia 2 weeks following varicella vaccine. Symptoms slowly resolving and patient should make full recovery.
Age: 31.0
Sex: F
Vaccine: FLU4, HEP, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swelling, tenderness, warmth, and redness in L arm (deltoid) at site of Hepatitis B and Flu Vaccine injections. Area of swelling measured with 60mm diameter.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dyspnoea, Feeling abnormal, Hypoaesthesia oral, Injection site pruritus
Clinical narrative: After receiving the flu shot I almost right away felt weird, a little dizzy, I felt as though my eyes couldn't catch up with what I was looking at, a little blurry eyed I can call it. So I hung out a little in the doctors office, I was told it was normal. I left the office feeling a itchy where I received the shot, by time I got home I was all hived out on my right upper arm where I got the flu shot, my face broke out as well in hives, I then had trouble breathing, tight throat, tingling numb like tongue, hives, dizzy, swollen painful upper arm. The next day the same as above but I then developed a knot on my right arm that kept getting bigger.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site urticaria, Local swelling, Nodule, Pain in extremity, Paraesthesia oral
Clinical narrative: After receiving the flu shot I almost right away felt weird, a little dizzy, I felt as though my eyes couldn't catch up with what I was looking at, a little blurry eyed I can call it. So I hung out a little in the doctors office, I was told it was normal. I left the office feeling a itchy where I received the shot, by time I got home I was all hived out on my right upper arm where I got the flu shot, my face broke out as well in hives, I then had trouble breathing, tight throat, tingling numb like tongue, hives, dizzy, swollen painful upper arm. The next day the same as above but I then developed a knot on my right arm that kept getting bigger.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Throat tightness, Urticaria, Vision blurred
Clinical narrative: After receiving the flu shot I almost right away felt weird, a little dizzy, I felt as though my eyes couldn't catch up with what I was looking at, a little blurry eyed I can call it. So I hung out a little in the doctors office, I was told it was normal. I left the office feeling a itchy where I received the shot, by time I got home I was all hived out on my right upper arm where I got the flu shot, my face broke out as well in hives, I then had trouble breathing, tight throat, tingling numb like tongue, hives, dizzy, swollen painful upper arm. The next day the same as above but I then developed a knot on my right arm that kept getting bigger.
Age: 33.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Local swelling, Tenderness
Clinical narrative: SWELLING, TENDERNESS IN INJECTED ARM, THEN PERSISTENT REDNESS.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event
Clinical narrative: No adverse efects to date. Was advised by my clinical coordinator to fill this out as vaccine was administered out of state protocol (patient was 55 and state protocol allows vaccination of patients over 60 years old).  I realized patient was under 60 hence I should not have administered this vaccine after it was given.
Age: 11.0
Sex: F
Vaccine: DTAP, HEPA, MENB
Symptoms: Injection site erythema, Pruritus, Tenderness
Clinical narrative: Patient mother reports. Seen by RN on 12/22/2014 erythema at sight approximately 3 inches in diameter. Pt reports itching and pain to touch. Pt mother reported using hot and cold compress. Pt seen by provider on 12/22/14 at 9:57 AM and Benadryl 12.5mg/5ml was prescribed.
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope, Vomiting
Clinical narrative: SYNCOPE AND VOMITING.
Age: 56.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: Very sore arm.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Aphonia
Clinical narrative: Lost her voice for more than a month.  Recovered with Antiviral and cortical steroid regimen. Per Patient on 12/18/2014 that she is "80% better".
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Injection site erythema, Injection site pain, Injection site pruritus, Pain
Clinical narrative: Wed, 12/17 - 5pm vaccine into triceps left arm. Thu, 12/18 - In the afternoon the arm felt sore and it hurt when I used my left arm. Fri, 12/19 - Soreness continued, but now also strong itch and 5inch long oval red skin, very difficult not to scratch. Sat, 12/20 - Strong itching continued, soreness however slightly less, slowly disappearing over the day. Sun, 12/21 - Soreness gone, former red spot normal color again and little itching, but now a 1 inch wide border around the former spot is red and itching, towards elbow; injection spot still red, itch also on rear of arm/shoulder rotator cuff area. Mon, 12/22 - Slight sensitivity when touching the triceps area, but no other issues.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Pruritus
Clinical narrative: Wed, 12/17 - 5pm vaccine into triceps left arm. Thu, 12/18 - In the afternoon the arm felt sore and it hurt when I used my left arm. Fri, 12/19 - Soreness continued, but now also strong itch and 5inch long oval red skin, very difficult not to scratch. Sat, 12/20 - Strong itching continued, soreness however slightly less, slowly disappearing over the day. Sun, 12/21 - Soreness gone, former red spot normal color again and little itching, but now a 1 inch wide border around the former spot is red and itching, towards elbow; injection spot still red, itch also on rear of arm/shoulder rotator cuff area. Mon, 12/22 - Slight sensitivity when touching the triceps area, but no other issues.
Age: 46.0
Sex: M
Vaccine: FLU4, TD
Symptoms: Arthralgia, Back pain, Chills, Fatigue, Headache
Clinical narrative: See previous notes - major complaint joint pain and fever.
Age: 46.0
Sex: M
Vaccine: FLU4, TD
Symptoms: Hyperhidrosis, Lymphadenopathy, Measles antibody negative, Myalgia, Pain
Clinical narrative: See previous notes - major complaint joint pain and fever.
Age: 46.0
Sex: M
Vaccine: FLU4, TD
Symptoms: Palpitations, Pyrexia, Tuberculin test negative
Clinical narrative: See previous notes - major complaint joint pain and fever.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Convulsion
Clinical narrative: This case was reported by a healthcare professional (Quality Clinical Coordinator) via sales representative and described the occurrence of seizure in a subject of unspecified age and gender who was vaccinated with PEDIARIX (GlaxoSmithKline). On an unspecified date the subject received unspecified dose of PEDIARIX (unknown). Within hours of vaccination with PEDIARIX, the subject experienced seizure. The healthcare professional reported the subject experienced seizures within a couple hours of being administered PEDIARIX. The subject was sent to the hospital (unknown if admitted) and "it was later determined that the seizures were not thought to be related to PEDIARIX"; no other details were provided. It was unknown if the series with PEDIARIX was delayed or discontinued. This case was assessed as medically serious by GSK. At the time of reporting the outcome of the seizure was unspecified. The healthcare professional  considered the event of seizure as unrelated to vaccination with PEDIARIX.
Age: 31.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness, swelling and pain around injection site. Also warm to touch.
Age: 74.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Joint injection, Periarthritis
Clinical narrative: (L) shoulder pain/+ROM; cortisone inject; Needs physical tx for adhesive capsulitis of shoulder.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site bruising, Injection site pain
Clinical narrative: Pt experienced bruising and soreness of the upper left arm.
Age: 56.0
Sex: U
Vaccine: FLUX
Symptoms: Melanoderma, Skin exfoliation
Clinical narrative: Black spots, and skin started peeling all over my body. On Dec 18th I went and seen doctor. He gave me prescription Triamcinolone 0.1% cream. Also using GOLD BOND lotion.
Age: 0.73
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Pyrexia, Rash
Clinical narrative: Fever 101
Age: 28.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Local reaction
Clinical narrative: Pt reports local reaction at site within 30 minutes post injection with redness and swelling, which increased to 4 x 3 inches, indurated without drainage. Tender, able to move joint. No oral airway sx. No fever or rash. Endorses no egg allergy. Advised: NSAIDS or TYLENOL OTC. Cool compress. Antihistamine. Reviewed indications for urgent care.
Age: 0.32
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PPV, RVX
Symptoms: Constipation, Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a consumer (subject's parent) and described the occurrence of red bump at injection site in a 4-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline). A physician or other health care professional has not verified this report. The subject's medical history included jaundice at birth. Concurrent vaccination included HIB;manufacturer unspecified; unknown; unknown given on 20 September 2013; live attenuated human rotavirus vaccine ;manufacturer unspecified; unknown given on 20 September 2013; Pneumococcal vaccine (Non-GSK); Other manufacturer; unknown; unknown given on 20 September 2013. On 20 September 2013 the subject received unspecified dose of PEDIARIX (unknown, right thigh/hip). On 20 September 2013, within hours of vaccination with PEDIARIX, the subject experienced red lump at injection site and constipation off and on. The mother reported the subject received PEDIARIX on 20 September 2013. He developed a bump the size of a quarter on the same day on his leg, the bump was red for a couple of days. The bump has reduced in size and it is now the size of pea. The mother also reported that the subject had bowel problems after the vaccination. The bowel problems were further described as he would be constipated for a few days and then would go back to using the bathroom normally, this cycle continued for two to three weeks after the shot. The mother reported that the physician told her that the bump was normal and not to massage the bump. The physician also told her to give her son prune juice for the constipation. The immunization series with PEDIARIX was not delayed or discontinued. At the time of reporting the constipation resolved and red bump at injection site was improved.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Cough, Crying, Feeding disorder, Irritability, Pyrexia
Clinical narrative: This case was reported by a physician and described the occurrence of persistent crying in a 4-month-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline), ACTHIB (non-gsk), PREVNAR (non-gsk) and ROTARIX. On 17 January 2014 at 15:00 the subject received unspecified dose of PEDIARIX (unknown details), unspecified dose of ACTHIB (unknown details), unspecified dose of PREVNAR (unknown details), unspecified dose of ROTARIX (oral). At approximately midnight, 18 January 2014, 9 hours after vaccination with PEDIARIX, ACTHIB, PREVNAR and ROTARIX, the subject experienced persistent crying. The subject's mother consulted the physician. On the night of 18 January 2014, 1 day after vaccination with PEDIARIX, ACTHIB, PREVNAR and ROTARIX, the subject experienced persistent crying (described as "still crying"), feeding disturbance (described as "feedings off"), cough and runny nose. The mother of the subject consulted the physician again and reported to the physician that the subject "only stops crying when they are rocking her." On 19 January 2014, 2 days after vaccination with PEDIARIX, ACTHIB, PREVNAR and ROTARIX, the subject experienced fever, runny nose, persistent crying and whining (described as "still crying and whiny"), and coarse rhonchi. The subject was examined by the physician on 19 January 2014. The physician reported that they had "never seen this type of event in 24 years of practice". The physician also reported that he considered "the event to be moderate." Relevant test results included body temperature taken on 19 January 2014 with results of 100.5 degree temperature. The physician reported that on physical examination, he noted coarse rhonchi and also noted that it was "not a good lung exam." At the time of reporting the outcome of the events were unspecified.
Age: 0.3
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Rhinorrhoea, Rhonchi
Clinical narrative: This case was reported by a physician and described the occurrence of persistent crying in a 4-month-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline), ACTHIB (non-gsk), PREVNAR (non-gsk) and ROTARIX. On 17 January 2014 at 15:00 the subject received unspecified dose of PEDIARIX (unknown details), unspecified dose of ACTHIB (unknown details), unspecified dose of PREVNAR (unknown details), unspecified dose of ROTARIX (oral). At approximately midnight, 18 January 2014, 9 hours after vaccination with PEDIARIX, ACTHIB, PREVNAR and ROTARIX, the subject experienced persistent crying. The subject's mother consulted the physician. On the night of 18 January 2014, 1 day after vaccination with PEDIARIX, ACTHIB, PREVNAR and ROTARIX, the subject experienced persistent crying (described as "still crying"), feeding disturbance (described as "feedings off"), cough and runny nose. The mother of the subject consulted the physician again and reported to the physician that the subject "only stops crying when they are rocking her." On 19 January 2014, 2 days after vaccination with PEDIARIX, ACTHIB, PREVNAR and ROTARIX, the subject experienced fever, runny nose, persistent crying and whining (described as "still crying and whiny"), and coarse rhonchi. The subject was examined by the physician on 19 January 2014. The physician reported that they had "never seen this type of event in 24 years of practice". The physician also reported that he considered "the event to be moderate." Relevant test results included body temperature taken on 19 January 2014 with results of 100.5 degree temperature. The physician reported that on physical examination, he noted coarse rhonchi and also noted that it was "not a good lung exam." At the time of reporting the outcome of the events were unspecified.
Age: 1.46
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HIBV, MMR, PNC13, VARCEL
Symptoms: Rash generalised, Rash maculo-papular, Wrong drug administered
Clinical narrative: This case was reported by a pharmacist and described the occurrence of maculopapular rash all over the body in a 18-month-old female subject who was vaccinated with PEDIARIX (GlaxoSmithKline), Hib (non-gsk), seasonal influenza vaccine (non-gsk), MMR (non-gsk), PREVNAR 13 (non-gsk) and varicella virus vaccine (non-gsk). The subject's medical history included neonatal jaundice. On 23 January 2014 the subject received a dose of PEDIARIX (.5 ml, unknown, right deltoid), 4th dose of Hib (Non-GSK) (unknown), 2nd dose of Seasonal influenza vaccine (Non-GSK) (unknown), 1st dose of MMR (Non-GSK) (unknown), 3rd dose of PREVNAR 13 (unknown), 1st dose of Varicella virus vaccine (Non-GSK) (unknown). The PEDIARIX was given as the 4th dose in the DTaP series, the 3rd in the hepatitis B series, and the 4th dose in the IPV series and experienced wrong vaccine administered. PEDIARIX is indicated as the 1st, 2nd, and 3rd doses of DTaP, Hepatitis B and IPV series. On 23 January 2014, 6 days after vaccination with Hib (Non-GSK), MMR (Non-GSK), PEDIARIX, PREVNAR 13, Seasonal influenza vaccine (Non-GSK) and Varicella virus vaccine (Non-GSK), the subject experienced maculopapular rash all over the body. Per the pharmacist, the immunization series was not discontinued or delayed. The subject was treated with BENADRYL. At the time of reporting the events were unresolved.
Age: 0.18
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Strabismus
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of eyes crossing in a 2-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline), haemophilus influenzae type b vaccine (non-GSK), PREVENAR (non-GSK) and rotavirus vaccine (non-GSK). The subject's medical history included jaundice as a newborn. On 12 May 2014, the subject received 1st dose of PEDIARIX route unknown, right thigh), 1st dose of Haemophilus influenzae type b vaccine (Non-GSK) (unknown), 1st dose of PREVENAR (unknown) and 1st dose of Rotavirus vaccine (Non-GSK) (unknown). On 12 May 2014, 3 hours after vaccination with Haemophilus influenzae type b vaccine (Non-GSK), PEDIARIX, PREVENAR, and Rotavirus vaccine (Non-GSK), the subject experienced eyes crossing. He had about 5 to 6 episodes of eye crossing that lasted about 15 to 20 seconds each. No other episodes. On 12 May 2014, the event was resolved. According to EMS, it could be an allergic reaction to the pertussis component of PEDIARIX. Follow-up information received on 13 June 2014: On 13 May 2014, the event was resolved with sequelae (unspecified which).
Age: 65.0
Sex: M
Vaccine: FLU3, PNC13
Symptoms: Chills, Tremor
Clinical narrative: Starting 12/12/14 at 9 PM patient reports having shakes, chills, and possible fever. Lasted until 12/13/14 at 4 AM.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Joint range of motion decreased
Clinical narrative: 10/20/14 Injection given slowly in the left deltoid approx. 3.6 in below the acromion process. Patient does not have a thin arm. No pain noted at the time but soreness did develop at the injection site within hours. Five hours following the injection pain extended to the entire arm. The following AM (10/21/14) noted loss of most mobility of arm. Following days continued lack of movement and guarding of the arm. At this time also noted a jelly/numbness feeling in thigh muscles, this has since resolved. 11/18/14-Visited the ER x 1 due to left arm pain and limited mobility. The patient has tried shoulder acupuncture, multiple massages, laser treatment to relieve discomfort and promote mobility. Currently she is receiving OT ROM and strength has improved but notes decreased ROM when not participating in routine OT. Patient has had MRI (attached) and pain mgt consult.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: 10/20/14 Injection given slowly in the left deltoid approx. 3.6 in below the acromion process. Patient does not have a thin arm. No pain noted at the time but soreness did develop at the injection site within hours. Five hours following the injection pain extended to the entire arm. The following AM (10/21/14) noted loss of most mobility of arm. Following days continued lack of movement and guarding of the arm. At this time also noted a jelly/numbness feeling in thigh muscles, this has since resolved. 11/18/14-Visited the ER x 1 due to left arm pain and limited mobility. The patient has tried shoulder acupuncture, multiple massages, laser treatment to relieve discomfort and promote mobility. Currently she is receiving OT ROM and strength has improved but notes decreased ROM when not participating in routine OT. Patient has had MRI (attached) and pain mgt consult.
Age: 22.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Injection site pain, Nausea, Swelling
Clinical narrative: Pain at injection sight = 12/18/14 Advised to take MOTRIN.  Redness and swelling = 12/19/14 nausea and vomiting advised to take BENADRYL and to see MD if sx worsen. 12/20 pt given abx. Diagn cellulitis.
Age: 22.0
Sex: F
Vaccine: PPV
Symptoms: Vomiting
Clinical narrative: Pain at injection sight = 12/18/14 Advised to take MOTRIN.  Redness and swelling = 12/19/14 nausea and vomiting advised to take BENADRYL and to see MD if sx worsen. 12/20 pt given abx. Diagn cellulitis.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, PNC13
Symptoms: Cough, Rash
Clinical narrative: Slight rash after vaccine. No fever. Also has cough.
Age: 1.38
Sex: M
Vaccine: DTAPIPVHIB, VARCEL
Symptoms: Injection site rash, Pyrexia
Clinical narrative: Fever 102. Small bumpy rash at site of vaccine.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Neck pain, Pain in extremity, Peripheral swelling
Clinical narrative: Pt. states after given the injection, had severe arm and neck pain on the side of injection-states also upper arm and shoulder was red and swollen.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Pruritus, Skin warm
Clinical narrative: Dec 17th noted silver dollar size redness at site of injection. Dec 18th worse extending from elbow to shoulder, redness, warm and itching. Dec 19th the redness remains with itching but feeling better. Advised to cover and use calamine lotion or oatmeal packs to relieve itching. Also BENADRYL. See dr. if breathing issues.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site warmth, Musculoskeletal pain, Pain, Tenderness
Clinical narrative: Shoulder sore (arm sore to lift) and not site of injection but top of (L) shoulder slightly red and warm to touch. Treated with ibuprofen, ice, ZRYTEC. Pt is recovering less tender and red but still has some signs she reports. Does not want to be seen.
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Urticaria
Clinical narrative: Hives - onset within 24 hours, entire body. No other symptoms of illness, e.g. fever, vomiting, cold symptoms.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Burning sensation, Diarrhoea, Erythema, Pain, Pruritus
Clinical narrative: It started itching in 15 min. Then it grew red about the size of a orange. Then it spread under my arm. Burning and stinging between my legs. Went to emergency. They gave me a epi shot, cyproheptadine 4mg. and lansoprazole. None of this helped. To this day it still itches but not as bad. I've had diarrhea ever since.
Age: 11.0
Sex: F
Vaccine: HPV2
Symptoms: Headache, Malaise, Pain in extremity, Pallor
Clinical narrative: Strong headache, paleness, general malaise, pain on the legs. BP 80/40 HR 120/min Temp: 38.1.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Very swollen and tender at injection site for 3 days. Bumpy, itchy rash the size of a silver dollar for 2 weeks (at injection site).
Age: 0.44
Sex: M
Vaccine: DT
Symptoms: Expired product administered
Clinical narrative: Requested for vaccine to be given w/out pertussis component. DT vial taken from fridge, drawn and administered w/out noticing vaccine expired. No harm to patient. They will return for updated vaccine.
Age: 35.0
Sex: F
Vaccine: VARCEL
Symptoms: Feeling hot, Peripheral swelling, Pruritus, Pyrexia, Varicella post vaccine
Clinical narrative: Pt. c/o itchiness, hands swollen, low grade fever, sore throat and general not feeling well within 1 1/2 hours of injection. Took BENADRYL at home.
Age: 89.0
Sex: M
Vaccine: PPV
Symptoms: Amnesia, Blood calcium normal, Blood thyroid stimulating hormone normal, Computerised tomogram head abnormal, Full blood count normal
Clinical narrative: On 9/4/14 the patient's spouse reported that the patient began experiencing effects two days after the administration of the vaccine. The injection site returned black, the patient's face turned red a few days later for which she administered BENADRYL twice and it went away, and he experienced memory loss. The patient was evaluated by his primary care provider on 9/9 and he described difficulty recalling numbers. The Mental Status exam (MS) was completed and the patient scored 10/30, falling in the dementia range. On 9/15 the patient's wife mentioned the patient had been struggling with memory for a few months. On 11/14, the patient was evaluated in the memory clinic. Repeat MS was 27/30, suggestive of normal cognition. Other testing was consistent with mild cognitive testing. The patient reported abrupt memory loss after vaccination and gradually improving with time. The patient's spouse reported his memory and cognition are now back to baseline.
Age: 89.0
Sex: M
Vaccine: PPV
Symptoms: Mini mental status examination abnormal, Vitamin B12 normal, White blood cell count normal
Clinical narrative: On 9/4/14 the patient's spouse reported that the patient began experiencing effects two days after the administration of the vaccine. The injection site returned black, the patient's face turned red a few days later for which she administered BENADRYL twice and it went away, and he experienced memory loss. The patient was evaluated by his primary care provider on 9/9 and he described difficulty recalling numbers. The Mental Status exam (MS) was completed and the patient scored 10/30, falling in the dementia range. On 9/15 the patient's wife mentioned the patient had been struggling with memory for a few months. On 11/14, the patient was evaluated in the memory clinic. Repeat MS was 27/30, suggestive of normal cognition. Other testing was consistent with mild cognitive testing. The patient reported abrupt memory loss after vaccination and gradually improving with time. The patient's spouse reported his memory and cognition are now back to baseline.
Age: 0.37
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Extra dose administered, Irritability
Clinical narrative: This case was reported by a physician and described the occurrence of cranky in a 4-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline). On 13 February 2014 and 28 January 2014 the subject received 3rd dose and 2nd dose of PEDIARIX (unknown). On 28 January 2014, less then one day after vaccination with PEDIARIX, the subject experienced cranky. The physician reported that PEDIARIX was administered on 28 January 2014 was the 2nd dose in the series and the subject received another on 13 February 2014 by mistake. The physician reported the mother of the subject mentioned that the he was a little bit cranky from the PEDIARIX dose he received on 28 January 2014. The physician stated no symptoms occurred with the dose received on 13 February 2014. At the time of reporting the event of cranky was resolved. PEDIARIX is recommended to be administered in three doses at the ages of 2,4 and 6 months.
Age: 0.16
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Pyrexia
Clinical narrative: This case was reported by a physician via sales representative and described the occurrence of fever in a 2-month-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline). On 1 November 2013 the subject received 1st dose of PEDIARIX (unknown). On the evening of 1 November 2013, within hours of vaccination with PEDIARIX, the subject experienced fever greater than 100 degrees. Early on the morning of 2 November 2013. the fever was resolved. It was reported that the physician intends to complete the PEDIARIX vaccination series. The sales representative reported another case on behalf of the physician with INFANRIX, please see A1049741A.
Age: 0.34
Sex: M
Vaccine: DTAPHEPBIP, HEP
Symptoms: Extra dose administered
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of accidental overdose in a 4-month-old male subject who was vaccinated with PEDIARIX, (GlaxoSmithKline), ENGERIX B pediatric. On 5 June 2014 the subject received unspecified dose of PEDIARIX (unknown route and injection site) and unspecified dose of ENGERIX B pediatric (unknown route and injection site) which led to an accidental overdose of Hepatitis B.
Age: 0.2
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Expired product administered
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of expired vaccine used in a 3-month-old male subject who was vaccinated with PEDIARIX, (GlaxoSmithKline). In September 2014, the subject received an expired dose of PEDIARIX (administration site and route unknown).
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Extra dose administered
Clinical narrative: This case was reported by a healthcare professional and described the occurrence of extra dose administered in a child subject of unspecified gender who was vaccinated with PEDIARIX, (GlaxoSmithKline). On an unspecified date, the subject received 4th extra dose of PEDIARIX (unknown route, injection site and batch number). No further information was available. The case was closed.
Sex: U
Vaccine: DTAPHEPBIP
Symptoms: Pyrexia
Clinical narrative: This case was reported by a physician and described the occurrence of medically attended fever in an infant subject of unspecified gender who was vaccinated with PEDIARIX (GlaxoSmithKline). Concurrent vaccination included HIB (manufacturer unspecified, unknown route, injection site and batch) given on an unspecified date; rotavirus vaccine (manufacturer unspecified, unknown route, injection site and batch number) given on an unspecified date; pneumococcal vaccines (non-gsk manufacturer, unknown route, injection site and batch number) given on an unspecified date. On an unspecified date, the subject received 3rd dose of PEDIARIX (unknown). At an unspecified time after vaccination with PEDIARIX, the subject experienced medically attended fever. At the time of reporting the outcome of the event was unspecified.
Sex: M
Vaccine: DTAPHEPBIP
Symptoms: Hepatitis B antibody negative, Injury associated with device
Clinical narrative: This case was reported by a healthcare professional via a sales representative and described the occurrence of Hepatitis B antibody negative in a 6-7 year-old male subject who was vaccinated with PEDIARIX (GlaxoSmithKline). On unspecified dates, the subject received full schedule of PEDIARIX (unknown routes and injection sites, batch numbers not provided). On 23 April 2014, at an unspecified time after vaccinations with PEDIARIX, the subject had a needle stick injury. They had Hepatitis B titers drawn and they were either low or non-existent. No adverse events were reported.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Inflammation, Skin warm
Clinical narrative: Patient presented his arm to a pharmacist at a pharmacy location other than the one that administered the vaccination. His arm was red, inflamed, and warm to touch. About 4 inches in diameter.
Age: 1.51
Sex: M
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Within 20 minutes of receiving Hep A vaccine, patient noted to have diffuse hives. No wheezing or airway involvement. BENDARYL given. Well appearing.
Age: 1.06
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Blister, Papule, Rash erythematous
Clinical narrative: Rash: red papules about 10. Multiple hard erythematous papules, several on the LE with vesicles.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth, Pain in extremity
Clinical narrative: Received vaccine mid AM. Later that day arm became sore and lasted about 3 days. About 3 days after shot developed redness around site - warm, itchy. Grew to size of small orange. Stabilizing now but very itchy - MD recommended BENADRYL q 6 hours (12/22/14) to see MD if does not start to recede.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Feeling hot, Nausea, Pain, Pyrexia
Clinical narrative: W/in 24 hours of receiving vaccine he had low grade fever, some nausea, swelling, redness, heat, soreness which got worse over 48 hours. Redness and heat was from elbow to shoulder. By 12/22 - it was getting better but not completely clear.
Age: 63.0
Sex: M
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: W/in 24 hours of receiving vaccine he had low grade fever, some nausea, swelling, redness, heat, soreness which got worse over 48 hours. Redness and heat was from elbow to shoulder. By 12/22 - it was getting better but not completely clear.
Age: 52.0
Sex: F
Vaccine: HEP, HEPA
Symptoms: Fatigue, Pain, Pyrexia, Wheezing
Clinical narrative: Patient called the pharmacy today 12-22-14 at about 2:50 PM reporting body aches and high temperature 102.3 (last night). Wheezing, tiredness.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Pruritus, Throat irritation, Urticaria
Clinical narrative: Within 1 hr of vaccine given, pt c/o scratchy throat, itching, and hives. Mom gave BENADRYL, sx subsided by next morning. Then 2 days after vaccine given hives returned.
Age: 12.0
Sex: M
Vaccine: MNQ, TDAP, MNQ, TDAP
Symptoms: Cellulitis, Local swelling
Clinical narrative: Case number PHHY2014US148675, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 540231) website on 13 Nov 2014 and with the follow-up information received from Quality Assurance Department (reference number: 337716) on 16 Dec 2014. This report refers to a 12-year-old male patient. Medical history and concomitant medications were not reported. He was vaccinated with MENVEO (batch number: M13053 and expiry date: May 2015) intramuscularly in left arm on 15 Aug 2014. On the same day, he was also vaccinated with ADACEL (batch number: C4506AC, other manufacturer). On 17 Aug 2014, he experienced cellulitis and localised swelling of right arm above elbow. He had a visit to emergency room due to these events. Outcome of the events was reported as unknown. These events were reported as non-serious. Causality of the events was not reported. Seriousness assessment of cellulitis was upgraded based on the NVS-IMS list. Based on the investigation performed, the QA department stated that, MENVEO vaccine (batch number: M13053) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow-up report received from the Quality Assurance Department (reference number: 337716) on 18 Nov 2014: Updated QA number. Follow-up information received from the Quality Assurance Department (reference number: 337716) on 16 Dec 2014: Updated MENVEO expiry date and batch review report.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Erythema, Local reaction, Local swelling
Clinical narrative: Case number PHHY2014US150324, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 541795) website on 13 Nov 2014, with follow-up information received from Quality Assurance Department (reference number: 338714) on 17 Dec 2014. This report refers to a 63-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with FLUVIRIN (batch number: 145302), along with PNEUMOVAX (batch number: K005957) intramuscularly into the left arm on 27 Aug 2014. On the same day after vaccination in the evening, she developed raised and red localized reaction. She took BENADRYL and kept ice packs on the location. She went to the doctor and received an antibiotic KEFLEX 500mg TID for 10 days for possible cellulitis. The outcome of the events was unknown. The events were reported as non-serious; however the case was internally upgraded as medically significant based on the NVD Key event list. Causality of the events was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 145302) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow-up information received from the Quality Assurance Department (reference number: 338714) on 21 Nov 2014: Updated QA reference number only. Follow-up information received from the Quality Assurance Department (reference number: 338714) on 17 Dec 2014: Updated FLUVIRIN batch review report.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV, FLU3, PPV
Symptoms: Erythema, Local reaction, Swelling
Clinical narrative: Case number PHHY2014US150324, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 541795) website on 13 Nov 2014, with follow-up information received from Quality Assurance Department (reference number: 338714) on 17 Dec 2014. This report refers to a 63-year-old female patient. Historical conditions were not reported. No concomitant medication was reported. She was vaccinated with FLUVIRIN (batch number: 145302), along with PNEUMOVAX (batch number: K005957) intramuscularly into the left arm on 27 Aug 2014. On the same day after vaccination in the evening, she developed raised and red localized reaction. She took BENADRYL and kept ice packs on the location. She went to the doctor and received an antibiotic KEFLEX 500mg TID for 10 days for possible cellulitis. The outcome of the events was unknown. The events were reported as non-serious; however the case was internally upgraded as medically significant based on the NVD Key event list. Causality of the events was not reported. Based on the investigation performed, the QA department stated that, FLUVIRIN (batch number: 145302) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Non-significant follow-up information received from the Quality Assurance Department (reference number: 338714) on 21 Nov 2014: Updated QA reference number only. Follow-up information received from the Quality Assurance Department (reference number: 338714) on 17 Dec 2014: Updated FLUVIRIN batch review report.