chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: M
Vaccine: UNK
Symptoms: Mobility decreased, Musculoskeletal pain, Musculoskeletal stiffness, X-ray
Clinical narrative: Extreme pain in left shoulder that was not the usual pain after a shot.  Loss of motion and stiffness in that arm.  It has continued since that time and I have notified my doctor.  He prescribed anti-inflammatory drugs and also suggested that I have some physical therapy.  At this time I am having therapy 3 times a week.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Erythema, Injection site pain
Clinical narrative: The day after the vaccine, patient began having severe pain in her right arm at the injection site. She began developing redness and chills over the next week.
Age: 58.0
Sex: M
Vaccine: IPV, TYP, YF
Symptoms: Guillain-Barre syndrome, Lumbar puncture, Paraesthesia
Clinical narrative: Toes were tingling on July 3rd, spread rapidly. Diagnosed with Guillain Barre July 17th.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Pain
Clinical narrative: Patient developed pain within in 12 hours. Within 36 hours patient broke out in blisters across the back of her arm.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Rash erythematous, Rash generalised
Clinical narrative: Huge 2 red oozing spots on body. Had HPV shot again in January now there are numerous spots all over my arm and back and buttocks and waist and breast.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13
Symptoms: Pyrexia, Urticaria
Clinical narrative: Hives developed bilateral legs. Had a fever for 2 days prior.
Age: 1.4
Sex: M
Vaccine: DTAPIPVHIB, MMRV, PNC13
Symptoms: Injection site mass
Clinical narrative: Soft mass/ bump on his right lower anterior part thigh 1-2 weeks after receiving MMRV and PCV-13 on that thigh.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Developed slightly raised red rash to right upper thigh at injection site 6-7 cm, mildly tender to touch.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Activities of daily living impaired, Arthralgia, Blood electrolytes normal, Blood test normal, Chills
Clinical narrative: This is a spontaneous report from a contactable consumer (son) reported for his mother. A 76-years-old female patient received PREVNAR 13, via an unspecified route of administration on 22Oct2015 at 0.5 ml, single. Medical history included ongoing fibromyalgia and osteoarthritis diagnosed years ago. The patient's concomitant medications were not reported. The patient experienced kidney infection on 12Jan2016 with outcome of recovered a rheumatologist did a culture and provided her antibiotics. In Oct2015 the patient got a cold, fever with outcome of recovered and chills with outcome of recovering. The patient also experienced sore body/ soreness all over, trouble walking, swelling in arms, elbow, neck, wrist, stomach, hands, shoulders, legs and feet/ her hands and feet are swollen, can't dress herself in Oct2015 with outcome of not recovered, muscle and joint aches and pains, was told that the shot aggravated fibromyalgia and she can't sleep in the bed on an unspecified date with outcome of unknown. Had rash in Jan2016 with outcome of recovering. The patient began experiencing a majority of these events about a week and a half after receiving the PREVNAR 13 injection. Reporter took the patient to the emergency room where they ran blood tests because she was crying in pain and they told him nothing was wrong, and her events were probably because of the PREVNAR 13 shot. The patient went to her doctor regarding these events, on two occasions. The first visit the doctor did not find anything wrong. The second visit the doctor told her it was probably from the shot, but there was nothing they could do about it now. The patient underwent lab tests and procedures which included blood electrolytes that was fine, blood test: nothing was wrong, and culture: kidney infection, on an unknown date.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Condition aggravated, Crying, Culture positive, Fibromyalgia, Gait disturbance
Clinical narrative: This is a spontaneous report from a contactable consumer (son) reported for his mother. A 76-years-old female patient received PREVNAR 13, via an unspecified route of administration on 22Oct2015 at 0.5 ml, single. Medical history included ongoing fibromyalgia and osteoarthritis diagnosed years ago. The patient's concomitant medications were not reported. The patient experienced kidney infection on 12Jan2016 with outcome of recovered a rheumatologist did a culture and provided her antibiotics. In Oct2015 the patient got a cold, fever with outcome of recovered and chills with outcome of recovering. The patient also experienced sore body/ soreness all over, trouble walking, swelling in arms, elbow, neck, wrist, stomach, hands, shoulders, legs and feet/ her hands and feet are swollen, can't dress herself in Oct2015 with outcome of not recovered, muscle and joint aches and pains, was told that the shot aggravated fibromyalgia and she can't sleep in the bed on an unspecified date with outcome of unknown. Had rash in Jan2016 with outcome of recovering. The patient began experiencing a majority of these events about a week and a half after receiving the PREVNAR 13 injection. Reporter took the patient to the emergency room where they ran blood tests because she was crying in pain and they told him nothing was wrong, and her events were probably because of the PREVNAR 13 shot. The patient went to her doctor regarding these events, on two occasions. The first visit the doctor did not find anything wrong. The second visit the doctor told her it was probably from the shot, but there was nothing they could do about it now. The patient underwent lab tests and procedures which included blood electrolytes that was fine, blood test: nothing was wrong, and culture: kidney infection, on an unknown date.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Insomnia, Joint swelling, Kidney infection, Local swelling, Myalgia
Clinical narrative: This is a spontaneous report from a contactable consumer (son) reported for his mother. A 76-years-old female patient received PREVNAR 13, via an unspecified route of administration on 22Oct2015 at 0.5 ml, single. Medical history included ongoing fibromyalgia and osteoarthritis diagnosed years ago. The patient's concomitant medications were not reported. The patient experienced kidney infection on 12Jan2016 with outcome of recovered a rheumatologist did a culture and provided her antibiotics. In Oct2015 the patient got a cold, fever with outcome of recovered and chills with outcome of recovering. The patient also experienced sore body/ soreness all over, trouble walking, swelling in arms, elbow, neck, wrist, stomach, hands, shoulders, legs and feet/ her hands and feet are swollen, can't dress herself in Oct2015 with outcome of not recovered, muscle and joint aches and pains, was told that the shot aggravated fibromyalgia and she can't sleep in the bed on an unspecified date with outcome of unknown. Had rash in Jan2016 with outcome of recovering. The patient began experiencing a majority of these events about a week and a half after receiving the PREVNAR 13 injection. Reporter took the patient to the emergency room where they ran blood tests because she was crying in pain and they told him nothing was wrong, and her events were probably because of the PREVNAR 13 shot. The patient went to her doctor regarding these events, on two occasions. The first visit the doctor did not find anything wrong. The second visit the doctor told her it was probably from the shot, but there was nothing they could do about it now. The patient underwent lab tests and procedures which included blood electrolytes that was fine, blood test: nothing was wrong, and culture: kidney infection, on an unknown date.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Nasopharyngitis, Pain, Peripheral swelling, Pyrexia, Rash
Clinical narrative: This is a spontaneous report from a contactable consumer (son) reported for his mother. A 76-years-old female patient received PREVNAR 13, via an unspecified route of administration on 22Oct2015 at 0.5 ml, single. Medical history included ongoing fibromyalgia and osteoarthritis diagnosed years ago. The patient's concomitant medications were not reported. The patient experienced kidney infection on 12Jan2016 with outcome of recovered a rheumatologist did a culture and provided her antibiotics. In Oct2015 the patient got a cold, fever with outcome of recovered and chills with outcome of recovering. The patient also experienced sore body/ soreness all over, trouble walking, swelling in arms, elbow, neck, wrist, stomach, hands, shoulders, legs and feet/ her hands and feet are swollen, can't dress herself in Oct2015 with outcome of not recovered, muscle and joint aches and pains, was told that the shot aggravated fibromyalgia and she can't sleep in the bed on an unspecified date with outcome of unknown. Had rash in Jan2016 with outcome of recovering. The patient began experiencing a majority of these events about a week and a half after receiving the PREVNAR 13 injection. Reporter took the patient to the emergency room where they ran blood tests because she was crying in pain and they told him nothing was wrong, and her events were probably because of the PREVNAR 13 shot. The patient went to her doctor regarding these events, on two occasions. The first visit the doctor did not find anything wrong. The second visit the doctor told her it was probably from the shot, but there was nothing they could do about it now. The patient underwent lab tests and procedures which included blood electrolytes that was fine, blood test: nothing was wrong, and culture: kidney infection, on an unknown date.
Age: 6.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Injection site swelling, Pain, Pain in extremity, Pyrexia
Clinical narrative: Patient ran a fever that evening. The next morning (2/13/2016) he vomited and again that afternoon. The injection site was reddened (approx 1") and slightly raised.  Patient complained of pain and tenderness regarding whole left arm (8 on Wong Faces Scale). We couldn't touch it and he could not move it without pain. Mild swelling of reddened area. Mild fever (<100*F) throughout the day. Reddened area increased over the next few days to include his whole shoulder and 3/4 length of upper arm to elbow, wrapping around to underside of arm with mild swelling.  Pain and tenderness of that scale continued for 2 more days. Today, 2/16/2016 he reports a pain level of 4 out of 10 on the Wong Faces Scale. Reddening has decreased as has swelling.
Age: 6.0
Sex: M
Vaccine: DTAP
Symptoms: Swelling, Tenderness, Vomiting
Clinical narrative: Patient ran a fever that evening. The next morning (2/13/2016) he vomited and again that afternoon. The injection site was reddened (approx 1") and slightly raised.  Patient complained of pain and tenderness regarding whole left arm (8 on Wong Faces Scale). We couldn't touch it and he could not move it without pain. Mild swelling of reddened area. Mild fever (<100*F) throughout the day. Reddened area increased over the next few days to include his whole shoulder and 3/4 length of upper arm to elbow, wrapping around to underside of arm with mild swelling.  Pain and tenderness of that scale continued for 2 more days. Today, 2/16/2016 he reports a pain level of 4 out of 10 on the Wong Faces Scale. Reddening has decreased as has swelling.
Age: 0.7
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Rash
Clinical narrative: Rash left upper extremity. Tylenol administered by mom. Progressing to 2/16.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain in extremity, Pyrexia, Urticaria
Clinical narrative: Prevnar was administered to patient between 12:30-1pm and said she'd experienced arm pain, redness, and fever. She'd been taking otc pain meds and applied ice patches to the area. Patient came to the pharmacy on 2/15 in the morning (approximately 5 days after administration) complaining of arm pain and the development of localized hives around her upper arm. She's attempting to book an appointment with the doctor.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: A circular redness around injection site; warm to touch; itching; and painful at injection site.
Age: 1.06
Sex: F
Vaccine: FLU3, HIBV, MMR, PNC13, VARCEL
Symptoms: Urticaria
Clinical narrative: Patient developed 14 hives 15 minutes within receiving Varivax, Pedvax Hib, MMR, Fluzone & PCV13.  Patient was given Benadryl and observed for 30 minutes.  Hives were gone within 10 minutes of giving Benadryl. Patient to follow-up with Allergist.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site induration
Clinical narrative: Parent stated that arm was hard at the injection site.
Age: 33.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Bursitis
Clinical narrative: Pt states has developed bursitis as result of flu vaccine.
Age: 33.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Burning sensation, Immediate post-injection reaction, Inflammation, Joint range of motion decreased, Musculoskeletal pain
Clinical narrative: Pt states has developed bursitis as result of flu vaccine.
Age: 33.0
Sex: F
Vaccine: FLU3, FLUX
Symptoms: Nuclear magnetic resonance imaging, Pain, Ultrasound scan, X-ray
Clinical narrative: Pt states has developed bursitis as result of flu vaccine.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Angiogram, CSF pressure increased, Computerised tomogram head abnormal, Ear discomfort, Hydrocephalus
Clinical narrative: Pressure in my right ear. "Whoosing sound in right ear". Felt like head cold but isolated to the right side. I work as a RN, a work a case of vertigo sent me to the ER 10/11/15 CT Showed mild hydrocephalus.
Age: 25.0
Sex: F
Vaccine: FLU4
Symptoms: Nasopharyngitis, Nuclear magnetic resonance imaging brain, Tinnitus, Venogram, Vertigo
Clinical narrative: Pressure in my right ear. "Whoosing sound in right ear". Felt like head cold but isolated to the right side. I work as a RN, a work a case of vertigo sent me to the ER 10/11/15 CT Showed mild hydrocephalus.
Age: 0.36
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Pyrexia, Rash generalised, Respiratory rate increased
Clinical narrative: Mother of the baby stated that the patient develop a rash through the body, fever and fast breathing.
Age: 29.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site oedema, Injection site pain, Pyelonephritis
Clinical narrative: PNEUMOVAX 23 to (R) deltoid - edema, redness, pain, induration at injection site. Patient was hospitalized a few days after immunization for strep and pyelonephritis, treated with steroids and vancomycin. Had 103 fever. At 6 wks out induration at site still present.
Age: 29.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pyrexia, Streptococcal infection
Clinical narrative: PNEUMOVAX 23 to (R) deltoid - edema, redness, pain, induration at injection site. Patient was hospitalized a few days after immunization for strep and pyelonephritis, treated with steroids and vancomycin. Had 103 fever. At 6 wks out induration at site still present.
Age: 22.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Contusion, Diarrhoea, Headache, Impaired work ability, Influenza
Clinical narrative: All flu symptoms, vomiting, diarrhea, sore and bruised arm. It lasted about 4 days. I had to call out sick for work. Also, fever, weight loss, headaches.
Age: 22.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Pain in extremity, Pyrexia, Vomiting, Weight decreased
Clinical narrative: All flu symptoms, vomiting, diarrhea, sore and bruised arm. It lasted about 4 days. I had to call out sick for work. Also, fever, weight loss, headaches.
Age: 22.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Abdominal pain, Contusion, Diarrhoea, Headache, Influenza like illness
Clinical narrative: All flu symptoms, vomiting, diarrhea, sore and bruised arm. It lasted about 4 days. I had to call out sick for work. Also, fever, weight loss, headaches.
Age: 22.0
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Pyrexia, Vomiting, Weight decreased
Clinical narrative: All flu symptoms, vomiting, diarrhea, sore and bruised arm. It lasted about 4 days. I had to call out sick for work. Also, fever, weight loss, headaches.
Age: 57.0
Sex: F
Vaccine: FLUX
Symptoms: Mobility decreased, Nuclear magnetic resonance imaging, Pain, X-ray
Clinical narrative: Flu vaccine given 10-5-15 to upper (L) shoulder. Continue pain with decreased mobility. Started on NAPROXYN (not effective; now on CELECOXIB and VOLTAREN 1% gel). Have had x-ray's; MRI done 2-4-16...to see ortho MD 2-10-16...
Age: 1.6
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Cough, Gait disturbance, Limb discomfort, Pyrexia, Vomiting
Clinical narrative: Starting at 4pm, complained about leg.  When she tried to walk, she had a severe limp.  Quickly developed a fever of 100.1.  Gave cool bath with Epsom salts and ibuprofen.  At 1am, she vomited and her fever had increased to 102.   Gave her Tylenol.  She was coughing regularly all night.  Fever and coughing has continued throughout the next day (2/16/16).
Age: 45.0
Sex: F
Vaccine: HEPAB
Symptoms: Anaphylactic reaction, Flushing, Oropharyngeal pain, Pharyngeal oedema
Clinical narrative: Client left the clinic after receiving immunization.  Reports that after approximately 30-45 minutes her throat felt swollen and sore and her skin was flushing.  Patient was transported by ambulance to local hospital where she was treated for anaphylaxis per the patient.
Age: 21.0
Sex: F
Vaccine: HEPA, HPV9, PPV
Symptoms: Erythema, Pain in extremity, Upper extremity mass
Clinical narrative: C/o lower right arm hurting, states has a red lump, denies being hot to the touch. Instructed to apply cold pack 20 min on, 20 min off, mark borders of area, take medication for pain. Client scheduled to come in tomorrow for TB reading. Will assess then.
Age: 1.17
Sex: M
Vaccine: DTAP, FLU3, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site pustule
Clinical narrative: CHILD HAS 3 SMALL POXS AROUND THE SITE OF INJECTION OF THE VARICELLA VACCINE.
Age: 45.0
Sex: F
Vaccine: PNC13
Symptoms: Fatigue, Mobility decreased, Muscular weakness, Myalgia, Pain in extremity
Clinical narrative: Localized pain in right arm progressing to pain and weakness in arm then slowly to generalized muscle pain and weakness and extreme fatigue, with difficulty sitting up or getting out of bed.
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Detoxification, Exposure to toxic agent, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Mom describes that within one week of vaccination, the patient developed a rash on her neck and face that both hurt and itched. The rash was described as also being red and swollen and about the size of acne without the pustule. Mom gave the patient Benadryl and the rash went away, but returned as soon as the Benadryl was stopped. The patient underwent testing at her chiropractor who determined that she was exposed to chemicals and needed to be detoxified. She was "chemically detoxified" 3 times, with the rash returning after each treatment. At this time, the chiropractor has this patient taking daily Adrenal Cortex, ADB5, and Bio D as she can no longer have the chemical detoxification treatments and the rash is no longer present with these daily supplements.
Age: 72.0
Sex: M
Vaccine: PNC13, TDAP
Symptoms: Injection site pain
Clinical narrative: Patient reporting that he noticed pain in his left (deltoid) arm last week-no other c/o's and can move his arm without difficulty-he can feel the area where it hurts when he applies pressure on it-has not tried any home remedies and has not been evaluated by his physician at this time.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Dizziness, Loss of consciousness, Neurological examination normal
Clinical narrative: Patient new onset of dizziness and blackout around 18 hrs post vaccination.
Age: 0.37
Sex: M
Vaccine: HIBV, PPV
Symptoms: Crying, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Swollen and red at injection site, inconsolable crying over 1 hour, warm to touch at injection site, cries more when injection site is moved or touched.
Age: 0.37
Sex: M
Vaccine: HIBV, PPV
Symptoms: Pain
Clinical narrative: Swollen and red at injection site, inconsolable crying over 1 hour, warm to touch at injection site, cries more when injection site is moved or touched.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Feeling abnormal, Injection site erythema, Injection site nodule, Injection site pain
Clinical narrative: Around 5pm I notice that my arm was getting very sore and there was a small red spot a injection site.  The follow morning-2/12/16 there was swelling and a larger red area above the site of the injection.  I was also feeling achy, etc.  Started running a low grade fever.  Took 800mg Ibuprofen.  By 5pm the redness had moved even further up my body.  It advanced across my collar bone and up my neck to my hairline.  The redness in that area was sensitive to touch.  By this time my fever was around 102 and I really felt lousy.  I took a 25mg Benadryl and 800mg of ibuprofen and went to bed.  Had fever all night.  By 2/13/16 I felt better.  The redness up my neck and collar bone was diminishing.  The top of my shoulder and in injection site were still red.  Still had fever around 100.  On 2/15/16 the redness at the top of my shoulder had diminished.  There was still a knot a little smaller than a golf ball at the injection site with the redness now going down under the injection site.  As of 2/16/16 there is still the knot that is tender to the touch and slight redness.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Pain, Pain in extremity, Pyrexia, Tenderness
Clinical narrative: Around 5pm I notice that my arm was getting very sore and there was a small red spot a injection site.  The follow morning-2/12/16 there was swelling and a larger red area above the site of the injection.  I was also feeling achy, etc.  Started running a low grade fever.  Took 800mg Ibuprofen.  By 5pm the redness had moved even further up my body.  It advanced across my collar bone and up my neck to my hairline.  The redness in that area was sensitive to touch.  By this time my fever was around 102 and I really felt lousy.  I took a 25mg Benadryl and 800mg of ibuprofen and went to bed.  Had fever all night.  By 2/13/16 I felt better.  The redness up my neck and collar bone was diminishing.  The top of my shoulder and in injection site were still red.  Still had fever around 100.  On 2/15/16 the redness at the top of my shoulder had diminished.  There was still a knot a little smaller than a golf ball at the injection site with the redness now going down under the injection site.  As of 2/16/16 there is still the knot that is tender to the touch and slight redness.
Age: 63.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pain in extremity
Clinical narrative: Patient reports persistent soreness radiating down arm.
Age: 63.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site pain
Clinical narrative: Patient reports persistent soreness radiating down arm.
Age: 41.0
Sex: M
Vaccine: FLUC3, PPV
Symptoms: Injection site pain, Ultrasound scan, X-ray
Clinical narrative: Pain at administration site. The pain got worse and the patient sought treatment. They were given an unknown antibiotic and naproxen. x-ray and ultrasound was performed. Patient was given an injection of lidocaine/cortisone. Patient was instructed to follow up in two weeks.
Age: 75.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Myalgia, Pain, Pain in extremity
Clinical narrative: I am not sleeping due to the pain in my upper arm, chronic musle aching, reduced range of motion of my right arm, dull ache.
Age: 1.29
Sex: M
Vaccine: FLUX, MMR
Symptoms: Rash generalised, Rash morbilliform
Clinical narrative: Rash over entire body that looks like measles.
Age: 18.0
Sex: M
Vaccine: MENB
Symptoms: Headache, Meningitis bacterial, Musculoskeletal stiffness, Pyrexia, Vaccination failure
Clinical narrative: This case was reported by a consumer and described the occurrence of vaccination failure in a male patient who received BEXSERO. Co-suspect products included BEXSERO. Concurrent medical conditions included exposure to communicable disease (total 3 students including the patient had become sick with meningococcal disease). On an unknown date, the patient received the 1st dose of BEXSERO. In October 2015, the patient received the 2nd dose of BEXSERO. In February 2016, an unknown time after receiving BEXSERO and 91 days after receiving BEXSERO, the patient experienced vaccination failure (serious criteria GSK medically significant), bacterial meningitis (serious criteria hospitalization and GSK medically significant), headache, stiff neck and fever. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the bacterial meningitis, headache, stiff neck and fever were recovered/resolved. It was unknown if the reporter considered the vaccination failure, bacterial meningitis, headache, stiff neck and fever to be related to BEXSERO and BEXSERO. Additional details were provided as follows: The patient was previously healthy and had no chronic conditions or medications. There were total 3 students (including the patient) who had become sick with meningococcal disease outbreak at the university. Approximately 3 and half months after vaccination with 2nd dose of BEXSERO, the patient experienced the events. The patient was hospitalized for 3 days and was released. There were no complications. The reporter did not know about any results of diagnostic testing on cerebrospinal fluid. This case was considered as suspected vaccination failure since the details regarding confirmatory laboratory tests were not provided.
Age: 68.0
Sex: F
Vaccine: PNC13, VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Had large red itchy area around injection site.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Urticaria, Wheezing
Clinical narrative: Diffuse urticarial and wheezing after vaccine administration. Given BENADRYL, SQ epinephrine, sent to ED, observed and discharged home.
Age: 74.0
Sex: F
Vaccine: PNC13, PNC13, PNC13
Symptoms: Arthralgia, Blood test, Decreased appetite, Fatigue, Tremor
Clinical narrative: Loss of appetite - 4 weeks. Joint pain - 4 weeks. Fatigue - 8 weeks. Shaking - 8 weeks.
Age: 74.0
Sex: F
Vaccine: PNC13, PNC13, PNC13
Symptoms: Arthralgia, Decreased appetite, Fatigue, Tremor
Clinical narrative: Loss of appetite - 4 weeks. Joint pain - 4 weeks. Fatigue - 8 weeks. Shaking - 8 weeks.
Age: 74.0
Sex: F
Vaccine: PNC13, PNC13, PNC13
Symptoms: Arthralgia, Blood test normal, Decreased appetite, Fatigue, Tremor
Clinical narrative: Loss of appetite - 4 weeks. Joint pain - 4 weeks. Fatigue - 8 weeks. Shaking - 8 weeks.
Age: 72.0
Sex: M
Vaccine: PNC13
Symptoms: Body temperature increased, Tremor, Vaccination complication
Clinical narrative: At routine provider visit today, patient stated to physician that approximately one (1) hour after receiving vaccine he spiked a temperature and his left arm shook uncontrollably. Symptoms resolved and patient did not seek medical care. Physician is classifying this as a reaction to the vaccine.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site bruising, Injection site nodule, Injection site pain, Injection site swelling
Clinical narrative: Bruising and swollen knot at injection site with pain still on 2/2/16.
Age: 73.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site warmth, Local reaction
Clinical narrative: 1-28-16 Area (1" x 1 1/2") of redness noted at injection site. 2-2-16 Area (13cm x 16cm) of redness and warmth at injection site. 2-3-16 Area assessed by Dr.: Lg. red well demarcated area Kw/mild warmth. Local rxn to vaccine, no tx needed. Treatment: TYLENOL, CLARITIN, Naproxen, cold compress.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Fatigue, Influenza A virus test, Influenza B virus test, Injection site erythema
Clinical narrative: Redness, swelling, pain upper arm of injection site occurring within 24 hours of injection and referred by day #3 post injection. Systemic symptoms including body aches, fatigue, shaking chills.
Age: 57.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Pain, Tremor
Clinical narrative: Redness, swelling, pain upper arm of injection site occurring within 24 hours of injection and referred by day #3 post injection. Systemic symptoms including body aches, fatigue, shaking chills.
Age: 24.0
Sex: F
Vaccine: MMR
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient developed increased pain, swelling and redness at site of MMR injection one week post vaccine administration, evaluated, diagnosed with cellulitis.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site swelling, Rash generalised, Urticaria
Clinical narrative: Redness and swelling at injection site, hive-like rash all over body; resolving with oral BENADRYL administration.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Vaccine administered, pt tolerated well. The following morning pt awoke with pain at injection site. Unable to lift arm due to pain. Pain continued for the next few days as well as redness, swelling and warmth at injection site. Pain was severe and lasted app. 3 days. Redness, swelling and warmth lasted 3-5 days. Pt was prescribed MOTRIN.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Pain
Clinical narrative: Vaccine administered, pt tolerated well. The following morning pt awoke with pain at injection site. Unable to lift arm due to pain. Pain continued for the next few days as well as redness, swelling and warmth at injection site. Pain was severe and lasted app. 3 days. Redness, swelling and warmth lasted 3-5 days. Pt was prescribed MOTRIN.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Erythema, Injection site erythema, Injection site swelling, Injection site warmth, Pain in extremity
Clinical narrative: Pt. rec. vaccine on 02/01/16, tolerated well. The following morning she awoke with severe pain, redness and puffiness to (L) arm. Redness and pain with swelling continued and pt. returned to the office on 02/03/16 with concerns of adverse rxn warmth, redness and swelling documented throughout entire Lt upper arm. Pt advised to do BENADRYL, MOTRIL for 48 hours.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Peripheral swelling
Clinical narrative: Pt. rec. vaccine on 02/01/16, tolerated well. The following morning she awoke with severe pain, redness and puffiness to (L) arm. Redness and pain with swelling continued and pt. returned to the office on 02/03/16 with concerns of adverse rxn warmth, redness and swelling documented throughout entire Lt upper arm. Pt advised to do BENADRYL, MOTRIL for 48 hours.
Age: 5.0
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Mom stated, 'my child had a head to toe rash, and high fever after receiving MMR and VZV, on 6-22-15.' This child was vaccinated at another facility.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Nausea, Pain, Peripheral swelling
Clinical narrative: About 20 minutes after shot began experiencing pain. Arm swelled. By Saturday afternoon, pain from lifting caused me to feel nauseated.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Condition aggravated, Migraine, Photosensitivity reaction, Rash
Clinical narrative: Intense flare up of pre-existing systemic photosensitivity from drug induced lupus originally tetracycline 1995. 3 types of rashes - optic migraines heightened sensitivity to light source. Calmed to pre-existing light sensitivity level (permanent state) over 5 months. No treatment available.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Pruritus, Rash macular
Clinical narrative: Two days following vaccination pt. developed "pink, itchy blotches", smaller than a dime on both arms and both legs. Approx. "20 blotches". No other symptoms. Reported by patient's grandmother 2/5/16.
Age: 0.35
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Interchange of vaccine products
Clinical narrative: At 4m visit ROTARIX was given. 2m visit ROTATEQ was started.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Mom stated 'my child had a head to toe rash, and high fever after receiving MMR and VZV on 6-22-15.' This child was vaccinated at another facility.
Age: 0.53
Sex: M
Vaccine: DTAP
Symptoms: Partial seizures, Seizure
Clinical narrative: Pt. had seizures - four of them lasting 15-20 min. each. Has had tx with pediatric neurologist - focal seizures.
Sex: F
Vaccine: PPV
Symptoms: Eye disorder, Eye operation
Clinical narrative: This spontaneous report was received from a female patient of an unknown age concerning herself. The patient's relevant medical history, concurrent condition and concomitant medication were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 injection (dosage and route not reported). On an unknown date, the patient was having "eye surgery on her right eye" for an unspecified reasons. The outcome of the event was unknown. The reporter did not provide any causality assessment between event and PNEUMOVAX 23. The reporter declined to participate in answering questions within this adverse event report. No further adverse event information was provided. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health professional refers to a patient of unknown gender and age. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On 09-FEB-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ (lot # L026741, expiry date: 18-MAY-2017). The temperature excursion details were reported as follows: temperature 0.6 degree C, time frame 30 hours, 20 minutes. COMVAX and GARDASIL appeared on the product list since they were involved in the excursion, however no improperly stored doses of these vaccines were administered. No adverse effect was reported. This is one of the eight reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MNQ
Symptoms: Accidental exposure to product, Laceration, Product container issue
Clinical narrative: Case number PHEH2015US020362, is a combined initial and follow up spontaneous report received from a healthcare professional via GSK via phone from management (reference number: 392182) on 14 Sep 2015 and 16 Sep 2015 respectively. This is also a quality complaint report (QA reference number: 397898). This report refers to a patient of unknown age and gender. Past medical history and concomitant medications were not reported. The patient vaccinated with MENVEO (batch number: M15015 and expiry date: not reported) on an unknown date. It was reported that, bottom of MENVEO vial broke and cut health care professional on the hand. The outcome, seriousness and causality of the event hand injury was not reported. No further information was available. Batch review report (reference number [392182] received from quality assurance department on 13 Oct 2015: Based on the document review, it was stated that the concerned MENVEO batch number (M15015) was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up information from quality assurance department received on 13 Oct 2015: Updated investigation summary report.
Age: 11.0
Sex: F
Vaccine: HPV2, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Case number PHEH2015US009582 is an initial spontaneous report from a nurse received on 14 May 2015 with a follow up report received on 13 Jul 2015. This report refers to a 11-year-old female patient. Medical history and concomitant medications were not reported. She was vaccinated with MENVEO (batch number A14088, expiry Nov 2015) subcutaneously in her right arm on 12 May 2015 and 14 May 2015. She was also vaccinated with TDAP (batch number 45MH5) and CERVARIX (batch number L001442) on 12 May 2015. On 13 May 2015 she had symptoms of redness, swelling, hot and itchy and tenderness (mild) at the injection site. On 15 May 2015 she still had slight erythema which was 7 1/4 x 9 cm, warm, slightly itchy but not tender. The outcome of the events was unknown. The events were reported as non-serious. Causality was not reported. Follow up report from a nurse received on 13 Jul 2015: Updated patient demographics, co-suspect vaccines (TDAP and HPV) and event (tenderness).
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. Information about concurrent conditions, medical history and concomitant medication was not provided. On 05-JAN-2016 the patient was vaccinated with an expired dose of ZOSTAVAX (lot # K009771, expiration date 09-OCT-2015, dose, dose# and route unknown). No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to 9 unspecified patients of unknown age and gender. Medical history, concurrent conditions and concomitant medications were not reported. On unspecified dates since 29-JUN-2015, patients were vaccinated with doses of improperly stored VARIVAX (Merck) injection, lot K007979, expiry date 03-JUN-2016; lot K021485, expiry date 03-NOV-2016; or lot L001330, expiry date 13-JAN-2017, (dose, route and frequency not reported). No adverse effect reported for these patients. The outcome of the events was unknown. No product quality complaint (PQC) was reported. No further information provided regarding these patients. This is one of three reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health professional refers to a patient of unknown gender and age. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On 08-FEB-2016, the patient was vaccinated with an improperly stored dose of oral, ROTATEQ (lot # L013202, expiry date: 27-JAN-2017). The temperature excursion details were reported as follows: temperature 0.6 degree C, time frame 30 hours, 20 minutes. COMVAX and GARDASIL appeared on the product list since they were involved in the excursion, however, no improperly stored doses of these vaccines were administered. No adverse effect was reported. This is one of the eight reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to multiple unspecified patients of unknown age and gender. There was no concurrent condition or medical history reported. On multiple unspecified dates, improperly stored oral ROTATEQ (lot # L006184, expiration date 13-DEC-2016) (dosage and strength unknown) (temperature: low 32.2 degree F, time frame: 53 hours 25 minutes) were administered to the patients. There was no concomitant medication reported. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 10.0
Sex: F
Vaccine: MNQ
Symptoms: Pain in extremity
Clinical narrative: Case number PHEH2015US021623 is an initial spontaneous report received from a pharmacist on 22 Oct 2015. This report refers to a 10 years old female patient. Medical history and concomitant medications were not reported as none. The patient was inadvertently administered only MenCYW-135 liquid conjugate of MENVEO (batch number, batch number, not reported) on 28 Sep 2015 ay 09:30 AM. On the same day the patient was also administered other unspecified vaccines. Post vaccinations the patient had a sore arm. It was not known which vaccine caused the event. The outcome, seriousness and causality of the event were not reported. The patient was given the full vaccine on the date of this reporting.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health professional refers to a patient of unknown gender and age. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On 08-FEB-2016, the patient was vaccinated with an improperly stored dose of oral, ROTATEQ (lot # L013202, expiry date: 27-JAN-2017). The temperature excursion details were reported as follows: temperature 0.6 degree C, time frame 30 hours, 20 minutes. COMVAX and GARDASIL appeared on the product list since they were involved in the excursion, however no improperly stored doses of these vaccines were administered. No adverse effect was reported. This is one of the eight reports received from the same reporter. Additional information has been requested.
Age: 70.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Pruritus
Clinical narrative: Patient presented to PC for New Patient Appointment. Was administered PREVNAR Pneumonia Vaccine, left deltoid, at 9:05 AM. While in exam with PCP, stared developing systemic redness and itching, not local at injection site. Reported allergies of MIRALAX and ALEVE- also rash. Reports Band-Aids cause damage to skin at application site. Methylprednisolone 125 mg once, diphenhydramine 25 mg once.
Age: 84.0
Sex: M
Vaccine: PNC13
Symptoms: Chills, Confusional state, Nausea, Pyrexia, Vomiting
Clinical narrative: Confusion, nausea vomiting and shivers, low grade fever.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to multiple unspecified patients of unknown age and gender. Concurrent condition and medical history were not reported. On an unknown dates, the patients were vaccinated with improperly stored oral, ROTATEQ (strength, dose and frequency were not reported, lot # L020859, expiry date: 19-JAN-2017). No adverse events were reported. No further information was provided. Product quality complaint was not filed. This case is one of several reports received from the same reporter. Additional information has been requested.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist regarding a 69 year old female patient. The patient's pertinent medical history and concomitant therapies were not reported. The patient had no drug reactions or allergies. On 09-FEB-2015, the patient was vaccinated with a dose of ZOSTAVAX (subcutaneously, dose was not reported, lot # L037797, expiration ate 03-DEC-2016). On 10-FEB-2016, the patient experienced a "red patch" at the site of the injection. On an unspecified day in February 2016, the patient came to the pharmacy to show the pharmacist the "red patch". The area around the injection site "red and warm to the touch." There were no raised areas nor rash present. The patient informed she would apply an unspecified steroid cream to the "red patch". The patient's outcome was not recovered/not resolved. The relatedness between the events and the ZOSTAVAX was not provided. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health professional refers to a patient of unknown gender and age. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On 05-FEB-2016, the patient was vaccinated with an improperly stored dose of oral ROTATEQ (lot # L026741, expiry date: 18-MAY-2017). The temperature excursion details were reported as follows: temperature 0.6 degree C, time frame 30 hours, 20 minutes. Hepatitis B vaccine COMVAX and GARDASIL appeared on the product list since they were involved in the excursion, however no improperly stored doses of these vaccines were administered. No adverse effects was reported. This is one of the eight reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health professional refers to a patient of unknown gender and age. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On 08-FEB-2016, the patient was vaccinated with an improperly stored dose of oral ROTATEQ (lot # L026741, expiry date: 18-MAY-2017). The temperature excursion details were reported as follows: temperature 0.6 degree C, time frame 30 hours, 20 minutes. Hepatitis B vaccine COMVAX and GARDASIL appeared on the product list since they were involved in the excursion, however no improperly stored dose of these vaccines were administered. No adverse effect was reported. This is one of the eight reports received from the same reporter. Additional information has been requested.
Age: 73.0
Sex: U
Vaccine: VARZOS
Symptoms: Drug hypersensitivity
Clinical narrative: This spontaneous report was received from a neurologist via Pfizer, Inc. and refers to a currently 73 year old patient of unknown gender. No medical history or concurrent conditions were reported. On an unknown date the patient was vaccinated with ZOSTAVAX (dosage, dosage number, route of administration, lot # and expiration date were unknown). On an unknown date, the reporter stated that vaccination with ZOSTAVAX caused the patient to become allergic to neomycin. The outcome of being allergic to neomycin was unknown. The reporter considered the event of being allergic to neomycin to be related to ZOSTAVAX. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a health professional refers to a patient of unknown gender and age. Information regarding patient's medical history, concurrent condition, drug reactions/allergies and concomitant therapy were not provided. On 09-FEB-2016, the patient was vaccinated with an improperly stored dose of oral, ROTATEQ (lot # L026741, expiry date: 18-MAY-2017). The temperature excursion details were reported as follows: temperature 0.6 degree C, time frame 30 hours, 20 minutes. COMVAX and GARDASIL appeared on the product list since they were involved in the excursion, however no improperly stored doses of these vaccines were administered. No adverse effect was reported. This is one of the eight reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: This spontaneous report was received from a physician via a company representative, referring to a patient of unknown age and gender. The patient's concurrent conditions and medical history were not provided. On an unknown date, the patient was vaccinated with GARDASIL 9 (lot number, dose, administration route, anatomical site of injection and frequency were not reported). Concomitant therapies were not provided. It was reported that the patient fainted at the physician's office, a while afterwards receiving the vaccination. No product quality complaint (PQC) was involved. At the time of this report, the outcome of syncope was unknown. The reporter did not provide a causality between the reported event and the GARDASIL 9 administration. Additional information has been requested.