chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Nerve conduction studies, Nuclear magnetic resonance imaging spinal, Restlessness, VIIth nerve paralysis
Clinical narrative: After few days, restless, numbness on feet to upper body. First trip to emergency after falling a couple times. Second trip to emergency with Bell's Palsy. Third trip to emergency with weak legs and very strong symptoms. Diagnosed with Guillain-Barre Syndrome and acute inflammatory demyelinating polyneuropathy.
Age: 25.0
Sex: M
Vaccine: TD
Symptoms: Arthralgia, Arthritis, Encephalomyelitis, Erythema multiforme, Mononeuropathy
Clinical narrative: Peripheral mononeuropathy and arthritis (may be due to work place injury), erythema multiforme, paleness, cold skin, joint pain, sleepiness, brachial neuritis, and encephalomyelitis.  No treatment.
Age: 25.0
Sex: M
Vaccine: TD
Symptoms: Pallor, Peripheral coldness, Radiculitis brachial, Somnolence
Clinical narrative: Peripheral mononeuropathy and arthritis (may be due to work place injury), erythema multiforme, paleness, cold skin, joint pain, sleepiness, brachial neuritis, and encephalomyelitis.  No treatment.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Cough, Hyperaesthesia, Pain, Pyrexia, Rash pustular
Clinical narrative: Mild wheezing and 101 fever that first evening, sore body and sensitive skin the next day followed by intense cough, pox developed by that evening, a total of 6-12 pox over the next day or two. Treated with toddler OTC cough medicine and ibuprofen.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Wheezing
Clinical narrative: Mild wheezing and 101 fever that first evening, sore body and sensitive skin the next day followed by intense cough, pox developed by that evening, a total of 6-12 pox over the next day or two. Treated with toddler OTC cough medicine and ibuprofen.
Age: 71.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Mobility decreased, Pain, Pain in extremity
Clinical narrative: Pt says it hurts to move her arm. It is sore later came to report she could not lift arm above her head.
Age: 28.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Warm, red sore arm at the site of the Varivax immunization.
Age: 1.51
Sex: M
Vaccine: HEPA
Symptoms: Condition aggravated, Dry skin, Eczema, Skin exfoliation
Clinical narrative: Patient had preexisting excema all over body (arms, legs, back, stomach, face). Was told my his doctor that it could just be due to the weather or food allergies. Ruled out weather after seeing happen year round. We have been keeping a close eye on food he intakes to see what could possibly set it off, and have found nothing. After reciving his HEP A shot on 02/05/2015, that evening the immunization spot had the worst eczema we had seen, very scaly and dry. As well as all his other eczema getting worse than it was the days before. We got him on a steroid cream, but does not seem to be working. After lots of research we think that the vaccines may have led to his severe eczema in the first place.
Age: 0.51
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Rotavirus test positive, Vomiting
Clinical narrative: This spontaneous report as received from a physician, through the patient's parent, via company representative refers to a 3 year old female patient. The patient's relevant medical history was not provided. On 06-JUN-2011, 08-AUG-2011 and 08-OCT-2011, the patient was vaccinated with ROTATEQ (lot number not reported) 2 ml, oral. No concomitant medications were reported. On 17-JAN-2015, the patient's parent called to state that the patient experienced diarrhea and vomiting (hospitalization) on 15-JAN-2015. Patient sought medical attention on 19-JAN-2015, the patient was hospitalized (length of stay unknown) and tested positive for rotavirus. Patient was treated with fluids and some other unspecified treatments. The outcome of the events diarrhea and vomiting was reported as recovered. The reporter's causality assessment was unknown. There was no product quality complaints (PQC) involved. No further information was provided. Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: MNQ, VARCEL
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus
Clinical narrative: Patient has a red, itchy, 50mm induration of posterior portion of upper left arm. No treatment necessary.
Age: 41.0
Sex: F
Vaccine: FLUN4
Symptoms: Asthenia, Back pain, Blood immunoglobulin A normal, CSF culture negative, CSF glucose normal
Clinical narrative: 41yo woman, concerned about adverse event(s) following immunization (AEFI), specifically related to influenza vaccine. Most recently dxd with GBS by Neurology and received IVIG as an inpatient 10-14 Oct 2014. GBS dx was temporally associated with receipt of LAIV (quadrivalent) on 30 Sep 2014; approximately 3 days later she developed tingling in hands and feet and increased (above baseline) paresthesia and pain in face, as well as progressively heavy feeling of weakness in back and legs. Dx was primarily based on symptoms, with 4/5 to 5/5 strength on all testing, and cytoalbuminic disassociation changes on CSF; no EMG was performed. She had partial clinical improvement with IVIG during hospitalization. Since return to work in late Oct 2014, she reports improvement in "perceived weakness", but she has continued burning pain and paresthesia in face and feet, dull pain in back and thighs, and extreme fatigue. She has been followed closely by Pain Clinic, and received >12 sphenopalatine ganglion blocks (via intranasal spray of bupivacaine and naloxone) with some relief.
Age: 41.0
Sex: F
Vaccine: FLUN4
Symptoms: CSF protein increased, CSF white blood cell count negative, Electrophoresis protein normal, Facial pain, Fatigue
Clinical narrative: 41yo woman, concerned about adverse event(s) following immunization (AEFI), specifically related to influenza vaccine. Most recently dxd with GBS by Neurology and received IVIG as an inpatient 10-14 Oct 2014. GBS dx was temporally associated with receipt of LAIV (quadrivalent) on 30 Sep 2014; approximately 3 days later she developed tingling in hands and feet and increased (above baseline) paresthesia and pain in face, as well as progressively heavy feeling of weakness in back and legs. Dx was primarily based on symptoms, with 4/5 to 5/5 strength on all testing, and cytoalbuminic disassociation changes on CSF; no EMG was performed. She had partial clinical improvement with IVIG during hospitalization. Since return to work in late Oct 2014, she reports improvement in "perceived weakness", but she has continued burning pain and paresthesia in face and feet, dull pain in back and thighs, and extreme fatigue. She has been followed closely by Pain Clinic, and received >12 sphenopalatine ganglion blocks (via intranasal spray of bupivacaine and naloxone) with some relief.
Age: 41.0
Sex: F
Vaccine: FLUN4
Symptoms: Full blood count normal, Guillain-Barre syndrome, Immunoglobulin therapy, Laboratory test normal, Limb discomfort
Clinical narrative: 41yo woman, concerned about adverse event(s) following immunization (AEFI), specifically related to influenza vaccine. Most recently dxd with GBS by Neurology and received IVIG as an inpatient 10-14 Oct 2014. GBS dx was temporally associated with receipt of LAIV (quadrivalent) on 30 Sep 2014; approximately 3 days later she developed tingling in hands and feet and increased (above baseline) paresthesia and pain in face, as well as progressively heavy feeling of weakness in back and legs. Dx was primarily based on symptoms, with 4/5 to 5/5 strength on all testing, and cytoalbuminic disassociation changes on CSF; no EMG was performed. She had partial clinical improvement with IVIG during hospitalization. Since return to work in late Oct 2014, she reports improvement in "perceived weakness", but she has continued burning pain and paresthesia in face and feet, dull pain in back and thighs, and extreme fatigue. She has been followed closely by Pain Clinic, and received >12 sphenopalatine ganglion blocks (via intranasal spray of bupivacaine and naloxone) with some relief.
Age: 41.0
Sex: F
Vaccine: FLUN4
Symptoms: Nuclear magnetic resonance imaging brain abnormal, Nuclear magnetic resonance imaging spinal abnormal, Pain, Pain in extremity, Paraesthesia
Clinical narrative: 41yo woman, concerned about adverse event(s) following immunization (AEFI), specifically related to influenza vaccine. Most recently dxd with GBS by Neurology and received IVIG as an inpatient 10-14 Oct 2014. GBS dx was temporally associated with receipt of LAIV (quadrivalent) on 30 Sep 2014; approximately 3 days later she developed tingling in hands and feet and increased (above baseline) paresthesia and pain in face, as well as progressively heavy feeling of weakness in back and legs. Dx was primarily based on symptoms, with 4/5 to 5/5 strength on all testing, and cytoalbuminic disassociation changes on CSF; no EMG was performed. She had partial clinical improvement with IVIG during hospitalization. Since return to work in late Oct 2014, she reports improvement in "perceived weakness", but she has continued burning pain and paresthesia in face and feet, dull pain in back and thighs, and extreme fatigue. She has been followed closely by Pain Clinic, and received >12 sphenopalatine ganglion blocks (via intranasal spray of bupivacaine and naloxone) with some relief.
Age: 41.0
Sex: F
Vaccine: FLUN4
Symptoms: Red blood cells CSF positive, Thyroid function test normal
Clinical narrative: 41yo woman, concerned about adverse event(s) following immunization (AEFI), specifically related to influenza vaccine. Most recently dxd with GBS by Neurology and received IVIG as an inpatient 10-14 Oct 2014. GBS dx was temporally associated with receipt of LAIV (quadrivalent) on 30 Sep 2014; approximately 3 days later she developed tingling in hands and feet and increased (above baseline) paresthesia and pain in face, as well as progressively heavy feeling of weakness in back and legs. Dx was primarily based on symptoms, with 4/5 to 5/5 strength on all testing, and cytoalbuminic disassociation changes on CSF; no EMG was performed. She had partial clinical improvement with IVIG during hospitalization. Since return to work in late Oct 2014, she reports improvement in "perceived weakness", but she has continued burning pain and paresthesia in face and feet, dull pain in back and thighs, and extreme fatigue. She has been followed closely by Pain Clinic, and received >12 sphenopalatine ganglion blocks (via intranasal spray of bupivacaine and naloxone) with some relief.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Cough, Diarrhoea, Dizziness, Dyspnoea
Clinical narrative: Vaccine administered 1/8/15 7:15pm I.M. Earlier in the day pt c/o sore throat. Afebrile. CEPASTAT lozenges ordered. 1/9/15 pt c/o soreness in left arm at vaccination site and continued sore throat. Afebrile. Left forearm with localized swelling at injection site. Sore throat improved with SUDAFED and lozenges 1/10/15. Left arm tender and mild redness. Cellulitis. Started on KELFEX, MOTRIN and warm compress for comfort. Afebrile. 1/11/15 feeling dizzy. No headache. No chest pain. No S.O.B. No significant EKG findings. Sent to E.D. for eval. Returned from hosp with script for meclizine. 1/12/15 cellulitis resolving no erythema on left upper arm. Complete antibiotic. Afebrile. On 1/15/15 pt became febrile 8:34 AM 101.2 - 127 - 20 131/65 O2 Sat 96%. C/O body aches, headache, congestion, malaise, lungs clear, loose cough non-productive. Rest, fluids, sx control. 1/15/15 12:53 pm PO dropping. Continues tachy and body aches. Give Azithromycin 500mg PO x 1. Start O2 2L via N.C. TORADOL 30mg IM x 1. Encourage PO fluids. IV NS 125ml/hr x 3 bags. I and O. Private room. 1/15/15 1:33 pm now has loose stools, diaphoretic, labored breathing. Transfer pt to ED for closer monitoring. Was admitted with dx of pneumonia.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Electrocardiogram normal, Erythema, Headache, Hyperhidrosis, Injection site swelling
Clinical narrative: Vaccine administered 1/8/15 7:15pm I.M. Earlier in the day pt c/o sore throat. Afebrile. CEPASTAT lozenges ordered. 1/9/15 pt c/o soreness in left arm at vaccination site and continued sore throat. Afebrile. Left forearm with localized swelling at injection site. Sore throat improved with SUDAFED and lozenges 1/10/15. Left arm tender and mild redness. Cellulitis. Started on KELFEX, MOTRIN and warm compress for comfort. Afebrile. 1/11/15 feeling dizzy. No headache. No chest pain. No S.O.B. No significant EKG findings. Sent to E.D. for eval. Returned from hosp with script for meclizine. 1/12/15 cellulitis resolving no erythema on left upper arm. Complete antibiotic. Afebrile. On 1/15/15 pt became febrile 8:34 AM 101.2 - 127 - 20 131/65 O2 Sat 96%. C/O body aches, headache, congestion, malaise, lungs clear, loose cough non-productive. Rest, fluids, sx control. 1/15/15 12:53 pm PO dropping. Continues tachy and body aches. Give Azithromycin 500mg PO x 1. Start O2 2L via N.C. TORADOL 30mg IM x 1. Encourage PO fluids. IV NS 125ml/hr x 3 bags. I and O. Private room. 1/15/15 1:33 pm now has loose stools, diaphoretic, labored breathing. Transfer pt to ED for closer monitoring. Was admitted with dx of pneumonia.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Malaise, Oropharyngeal pain, Pain, Pneumonia, Pyrexia
Clinical narrative: Vaccine administered 1/8/15 7:15pm I.M. Earlier in the day pt c/o sore throat. Afebrile. CEPASTAT lozenges ordered. 1/9/15 pt c/o soreness in left arm at vaccination site and continued sore throat. Afebrile. Left forearm with localized swelling at injection site. Sore throat improved with SUDAFED and lozenges 1/10/15. Left arm tender and mild redness. Cellulitis. Started on KELFEX, MOTRIN and warm compress for comfort. Afebrile. 1/11/15 feeling dizzy. No headache. No chest pain. No S.O.B. No significant EKG findings. Sent to E.D. for eval. Returned from hosp with script for meclizine. 1/12/15 cellulitis resolving no erythema on left upper arm. Complete antibiotic. Afebrile. On 1/15/15 pt became febrile 8:34 AM 101.2 - 127 - 20 131/65 O2 Sat 96%. C/O body aches, headache, congestion, malaise, lungs clear, loose cough non-productive. Rest, fluids, sx control. 1/15/15 12:53 pm PO dropping. Continues tachy and body aches. Give Azithromycin 500mg PO x 1. Start O2 2L via N.C. TORADOL 30mg IM x 1. Encourage PO fluids. IV NS 125ml/hr x 3 bags. I and O. Private room. 1/15/15 1:33 pm now has loose stools, diaphoretic, labored breathing. Transfer pt to ED for closer monitoring. Was admitted with dx of pneumonia.
Age: 57.0
Sex: M
Vaccine: PPV
Symptoms: Respiratory tract congestion, Tachycardia, Tenderness, Vaccination site pain
Clinical narrative: Vaccine administered 1/8/15 7:15pm I.M. Earlier in the day pt c/o sore throat. Afebrile. CEPASTAT lozenges ordered. 1/9/15 pt c/o soreness in left arm at vaccination site and continued sore throat. Afebrile. Left forearm with localized swelling at injection site. Sore throat improved with SUDAFED and lozenges 1/10/15. Left arm tender and mild redness. Cellulitis. Started on KELFEX, MOTRIN and warm compress for comfort. Afebrile. 1/11/15 feeling dizzy. No headache. No chest pain. No S.O.B. No significant EKG findings. Sent to E.D. for eval. Returned from hosp with script for meclizine. 1/12/15 cellulitis resolving no erythema on left upper arm. Complete antibiotic. Afebrile. On 1/15/15 pt became febrile 8:34 AM 101.2 - 127 - 20 131/65 O2 Sat 96%. C/O body aches, headache, congestion, malaise, lungs clear, loose cough non-productive. Rest, fluids, sx control. 1/15/15 12:53 pm PO dropping. Continues tachy and body aches. Give Azithromycin 500mg PO x 1. Start O2 2L via N.C. TORADOL 30mg IM x 1. Encourage PO fluids. IV NS 125ml/hr x 3 bags. I and O. Private room. 1/15/15 1:33 pm now has loose stools, diaphoretic, labored breathing. Transfer pt to ED for closer monitoring. Was admitted with dx of pneumonia.
Age: 60.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Death, Unresponsive to stimuli
Clinical narrative: Client received vaccine at 6pm on 10-1-14. Client was found unresponsive on 10-3-14 at 4:15 AM. Client was pronounced dead at 4:39 AM.
Age: 1.11
Sex: M
Vaccine: HIBV, MMR
Symptoms: Pyrexia, Tympanic membrane perforation
Clinical narrative: Patient had a sudden onset of fever that started out staying around 101-102 degrees Fahrenheit that continued for four days reaching a max of 104.5 degrees Fahrenheit. He also suffered a ruptured tympanic membrane on 02/08/2015. The infant was dosed regularly with Tylenol and Motrin alternating every three hours and fevers continued to stay above 100 degrees Fahrenheit.
Age: 23.0
Sex: F
Vaccine: MMR
Symptoms: Urticaria
Clinical narrative: Generalized hives to upper body, arms, shoulders, back and chest. Resolved 02/09/2015-no longer had hives upon awakening in early am.
Age: 1.34
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Abasia, Body temperature decreased, C-reactive protein increased, Emotional distress, Irritability
Clinical narrative: Excess fussiness day of immunization (11/10/14). High Fever began evening of 11/11/2014. Fever continued through Saturday 11/15/14. Non consolable screaming for over an hour in the evening of Sat., 11/15/14.  Rush to ER, his temperature has dropped to 95.2 degrees.  The hospital botches blood test and sends us home around 5am on 11/16/14 (we went into the ER on 11/15/14 around 10 PMish).  Patient is lethargic and will not walk.  He takes a nap around 10am wakes up an hour or so later is just lying in his bed will not get up.  Does not reach up for me to pick him up.  He will not stand.  He cannot walk on his right leg.  We call after hours, they recommend us to hang up the phone and call 911 to be transported back to the ER.  We immediately go to hospital.  Blood test results in elevated C-protein levels.
Age: 1.34
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Lethargy, Pyrexia, Screaming, Ultrasound scan
Clinical narrative: Excess fussiness day of immunization (11/10/14). High Fever began evening of 11/11/2014. Fever continued through Saturday 11/15/14. Non consolable screaming for over an hour in the evening of Sat., 11/15/14.  Rush to ER, his temperature has dropped to 95.2 degrees.  The hospital botches blood test and sends us home around 5am on 11/16/14 (we went into the ER on 11/15/14 around 10 PMish).  Patient is lethargic and will not walk.  He takes a nap around 10am wakes up an hour or so later is just lying in his bed will not get up.  Does not reach up for me to pick him up.  He will not stand.  He cannot walk on his right leg.  We call after hours, they recommend us to hang up the phone and call 911 to be transported back to the ER.  We immediately go to hospital.  Blood test results in elevated C-protein levels.
Age: 9.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Vision blurred
Clinical narrative: BLURRED VISION, COULD NOT SEE BOARD AT SCHOOL AND NURSE AT THE SCHOOL WAS CONCERNED.  NO PREVIOUS ISSUES WITH ANY VISION PROBLEMS.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Body temperature increased, Hallucination, auditory, Headache, Tremor
Clinical narrative: Auditory Hallucinations - Hearing music. Temp - 103 F. Shaking. Throbbing Headache. All symptoms lasted about 1hour after Tylenol and Cold compresses patients symptoms did not return.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Autoimmune disorder, General physical health deterioration
Clinical narrative: There was no adverse event immediately following the injection. Instead, there was a general decline in health and well being beginning 3-4 months after vaccination. I suspect the vaccine contributed to a generalized Autoimmune response.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Eye discharge, Pruritus, Pyrexia, Rash
Clinical narrative: Low grade fever for 2 days that spiked to 103 F and then resolved. Rash around right eye. Itchy. Initially white discharge that was resolved at visit. No eye redness. No pain. Otherwise no other symptoms. Feeling okay. Normal activity.
Age: 41.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Decreased appetite, Dizziness, Erythema, Fatigue
Clinical narrative: Within 3 hours of getting the shots, patient developed a high fever, shaking chills, fatigue, loss of appetite, and dizziness.  Her L arm was swollen and red. The pain was so severe she could not move the arm. She lost sensation in both hands and only felt tingling.  Patient states her temperature was around 102. Symptoms lasted 48 hours. Patient did not seek evaluation or treatment. She did report occurrence to clinic but did not respond to return telephone calls.
Age: 41.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Mobility decreased, Pain in extremity, Paraesthesia, Peripheral swelling, Pyrexia
Clinical narrative: Within 3 hours of getting the shots, patient developed a high fever, shaking chills, fatigue, loss of appetite, and dizziness.  Her L arm was swollen and red. The pain was so severe she could not move the arm. She lost sensation in both hands and only felt tingling.  Patient states her temperature was around 102. Symptoms lasted 48 hours. Patient did not seek evaluation or treatment. She did report occurrence to clinic but did not respond to return telephone calls.
Age: 41.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Sensory disturbance, Tremor
Clinical narrative: Within 3 hours of getting the shots, patient developed a high fever, shaking chills, fatigue, loss of appetite, and dizziness.  Her L arm was swollen and red. The pain was so severe she could not move the arm. She lost sensation in both hands and only felt tingling.  Patient states her temperature was around 102. Symptoms lasted 48 hours. Patient did not seek evaluation or treatment. She did report occurrence to clinic but did not respond to return telephone calls.
Sex: U
Vaccine: FLU3
Symptoms: Influenza, Vaccination failure
Clinical narrative: This case was reported by a healthcare professional (medical assistant) and described the occurrence of viral influenza in at least 5 subjects of unspecified age and gender who were vaccinated with FLULAVAL (GlaxoSmithKline). Beginning in September 2013 the subjects received 1st dose of FLULAVAL (.5 ml, unknown route, left arm). The medical assistant could "recall at least 5 patients, mix of male and female (unknown numbers of each sex) that received the FLULAVAL Trivalent." Specific details were not known. The medical assistant reported that the office "only had one lot number" of FLULAVAL Trivalent. Within months of vaccination with FLULAVAL, specific dates not reported, the subjects experienced viral influenza and vaccination failure. Per the reporter, "various" subjects "are coming back into the office with the flu." The medical assistant reported that other subjects "that received the FLUARIX Quadrivalent at their office have not returned to the office with the flu." This case was assessed as medically serious by GSK. At the time of reporting the events were unresolved.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to an unspecified number of patients of unknown age and gender. On an unknown dates, the patients were vaccinated with an improperly stored doses of ROTATEQ (oral suspension, dose, frequency, lot# and expiration date were not reported). No adverse effects were reported. Product quality issue (PQC) was not involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Gait disturbance, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness, warmth, swelling at the injection site on Left thigh. Limping when walking d/t pain.
Age: 9.0
Sex: M
Vaccine: HEPA
Symptoms: Chills, Gastroenteritis viral, Injection site urticaria, Urticaria
Clinical narrative: Cluster hives on elbow where vacc was administered. Patient was given 25mg Benedryl. More outbreak of hives as of 2/9/2014 and chills. Taken to Dr., said was stomach virus. Mother not happy.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: Syncope, supportive care.
Age: 47.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash generalised
Clinical narrative: Spreading rash.
Age: 2.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: High fever to 102.7 (tympanic temp), extensive swelling around the injection site associated with erythema and pain.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Aphasia, Blister, Cerebrovascular accident, Laryngitis, Rash erythematous
Clinical narrative: Erythematous, maculopapular rash with vesicles appeared on 12/12/2014. Rash covered entire body except feet and head. Treated with prednisone on 01/01/2015.  Rash began to improve at this time.  Laryngitis began 01/14/2015.  Aphasia began 01/16/2015.  He was hospitalized and diagnosed with CVA.  He has shown some improvement at this time.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash generalised, Rash maculo-papular
Clinical narrative: Erythematous, maculopapular rash with vesicles appeared on 12/12/2014. Rash covered entire body except feet and head. Treated with prednisone on 01/01/2015.  Rash began to improve at this time.  Laryngitis began 01/14/2015.  Aphasia began 01/16/2015.  He was hospitalized and diagnosed with CVA.  He has shown some improvement at this time.
Age: 58.0
Sex: M
Vaccine: HEP
Symptoms: Dehydration, Dizziness, Laboratory test, Tremor
Clinical narrative: C/o feeling "light headed" after receiving vaccine. Was seen at Medical Center x 3 since vaccine. States "had shakes." Was seen 1 week after vaccine & again following week. Per patient, was dehydrated and fluids were given. Also seen at Medical Center in January, 2015, due to dizziness. Pt. did not receive any diagnosis this visit.
Age: 22.0
Sex: F
Vaccine: HEPA, MEN, TYP, YF
Symptoms: Myalgia, Oropharyngeal pain, Pruritus, Rash erythematous
Clinical narrative: Erythematous rash (Appears like a full body sunburn, slightly itchy, muscle achy and slight sore throat.
Age: 1.59
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HEPA, HIBV, MMRV, PNC13
Symptoms: Febrile convulsion, Musculoskeletal stiffness, Pyrexia, Tremor
Clinical narrative: At 9:45 PM, foster mother notices child was shaking and stiff after arriving at store parking lot.  Foster mother removed child from car seat & ran into store. Requested 911 be called. Child was transported to hospital via ambulance.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Muscular weakness
Clinical narrative: Exact date not known- patient said sometime after her vaccination she developed weakness and pain in that arm (right arm) from shoulder to elbow. It has lasted from that time (1/21/15) until now (2/9/15).
Age: 12.0
Sex: F
Vaccine: HPV4
Symptoms: Injection site reaction, Muscle atrophy
Clinical narrative: PT DEVELOPED MUSCLE ATROPHY AT INJECTION SITE.
Age: 19.0
Sex: M
Vaccine: TDAP
Symptoms: Nausea, Tinnitus, Vision blurred
Clinical narrative: After injection patient became nauseated with blurred vision and ringing in his ears. Patient was fanned and had ice pack applied. Recovered fully in 10 min.
Age: 0.16
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: No adverse event. Pt was given vaccine incorrectly. The Rotarix vaccine was not mixed with the diluent. Patient only recieved the diluent no vaccine.
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Insomnia, Mobility decreased, Musculoskeletal pain, Pain
Clinical narrative: Pain in shoulder movement becoming severe by nighttime and lasting through the next day, inability to lift affected arm, inability to sleep normally due to pain.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Head titubation, Pyrexia
Clinical narrative: Fever for 4 days of 101 and shaking of head occasionally.
Age: 0.13
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: No adverse event, Wrong technique in drug usage process
Clinical narrative: No adverse event. Pt was given vaccine incorrectly. The Rotarix vaccine was not mixed with the diluent. Patient only recieved the diluent no vaccine.
Age: 6.0
Sex: M
Vaccine: MMR
Symptoms: Dyspnoea, Fatigue, Feeling abnormal, Feeling cold, Headache
Clinical narrative: Everything around him is moving very fast and really loud and scary, happened once yesterday for 30 sec and this one lasted for 3-5 minutes. 2nd MMR yesterday. No vomiting. No numbness and tingling. No vision changes, everything just seems to moving fast.  No dizziness, no sense of falling over. Woke up with last night with headache that improved with Motrin. Normal this morning. Mom notices that he starts breathing erratically and shuts eyes tightly. Seems a little panicked. After shot last night, more tired and cold and fell asleep at 5pm. Sneezing but no overt URI symptoms. Has felt a little warmer than normal.
Age: 6.0
Sex: M
Vaccine: MMR
Symptoms: Panic reaction, Skin warm, Sneezing
Clinical narrative: Everything around him is moving very fast and really loud and scary, happened once yesterday for 30 sec and this one lasted for 3-5 minutes. 2nd MMR yesterday. No vomiting. No numbness and tingling. No vision changes, everything just seems to moving fast.  No dizziness, no sense of falling over. Woke up with last night with headache that improved with Motrin. Normal this morning. Mom notices that he starts breathing erratically and shuts eyes tightly. Seems a little panicked. After shot last night, more tired and cold and fell asleep at 5pm. Sneezing but no overt URI symptoms. Has felt a little warmer than normal.
Age: 21.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood pressure increased, Disorientation, Dyspnoea, Malaise, Urticaria
Clinical narrative: The patient reported that she did not feel well 10-15 minutes after receiving the vaccine, generalized not feeling well.  She thought it was because she hadn't eaten, She got lunch and left the store.  After getting home she felt worse, disoriented, difficulty breathing, hives, and increased blood pressure one hour after the shot and went to the ER for treatment.
Age: 0.52
Sex: M
Vaccine: DTAPIPVHIB, FLU4, HEP, PNC13, RV5
Symptoms: Convulsion, Posture abnormal, Pyrexia, Unresponsive to stimuli
Clinical narrative: Had fever and then had approx. 10 min episode of head back and unresponsive - probable seizure.
Age: 29.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Dyspnoea, Hypersensitivity, Throat tightness
Clinical narrative: Throat tightening (mild), coughing, difficulty breathing. Thought it was an allergic reaction (I ate both squid and peanuts), but I have never had allergies to those items and have eaten both items since with zero reaction. Lasted several hours 3-4.  I took Benadryl liquid, 50mg after about 1.5 hour of symptoms. Did not help, only made me extremely drowsy.  I think I slept it off. Woke up next day completely fine.
Age: 1.28
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Irritability, Pyrexia, Rash erythematous, Rash generalised, Somnolence
Clinical narrative: 101 degree fever, extreme fussiness which is very out of character for child, wanted to go to bed an hour early.  Fever lasted 2 days on and off, next came red spots all over body that lasted 2-3 days, still extremely fussy.  As of date of this submission 2/9/15 she is otherwise in good health but extremely fussy and it is very out of character for her.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blood test, Burning sensation, Discomfort, Pain, Paraesthesia
Clinical narrative: I first had little pin prick pains on different areas of body. Maybe 4 or 5 a day. In about 2 weeks chronic prickling, tingling, burning and some stabbing pain started. This has been on going now ever since. Some days a better than others. This is a very uncomfortable feeling.  I think it has gotten better. Today isn't a good day. This has been going on for over 4 months. I am taking Doxepin 2 10 milligram capsules.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Vaccination complication
Clinical narrative: I first had little pin prick pains on different areas of body. Maybe 4 or 5 a day. In about 2 weeks chronic prickling, tingling, burning and some stabbing pain started. This has been on going now ever since. Some days a better than others. This is a very uncomfortable feeling.  I think it has gotten better. Today isn't a good day. This has been going on for over 4 months. I am taking Doxepin 2 10 milligram capsules.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blood test, Burning sensation, Knee operation, Pain, Paraesthesia
Clinical narrative: I first had little pin prick pains on different areas of body. Maybe 4 or 5 a day. In about 2 weeks chronic prickling, tingling, burning and some stabbing pain started. This has been on going now ever since. Some days a better than others. This is a very uncomfortable feeling.  I think it has gotten better. Today isn't a good day. This has been going on for over 4 months. I am taking Doxepin 2 10 milligram capsules.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Urine analysis
Clinical narrative: I first had little pin prick pains on different areas of body. Maybe 4 or 5 a day. In about 2 weeks chronic prickling, tingling, burning and some stabbing pain started. This has been on going now ever since. Some days a better than others. This is a very uncomfortable feeling.  I think it has gotten better. Today isn't a good day. This has been going on for over 4 months. I am taking Doxepin 2 10 milligram capsules.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Blood test, Burning sensation, Discomfort, Feeling abnormal, Knee operation
Clinical narrative: I first had little pin prick pains on different areas of body. Maybe 4 or 5 a day. In about 2 weeks chronic prickling, tingling, burning and some stabbing pain started. This has been on going now ever since. Some days a better than others. This is a very uncomfortable feeling.  I think it has gotten better. Today isn't a good day. This has been going on for over 4 months. I am taking Doxepin 2 10 milligram capsules.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Pain, Paraesthesia, Urine analysis
Clinical narrative: I first had little pin prick pains on different areas of body. Maybe 4 or 5 a day. In about 2 weeks chronic prickling, tingling, burning and some stabbing pain started. This has been on going now ever since. Some days a better than others. This is a very uncomfortable feeling.  I think it has gotten better. Today isn't a good day. This has been going on for over 4 months. I am taking Doxepin 2 10 milligram capsules.
Age: 0.71
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Eye swelling
Clinical narrative: On the morning of 10/08/2014, We visited the pediatrician office for the first time.  My then 8 month old, received the Pediarix vaccine combination, which was prescribed by the Physician who did her exam and was administered by the nurse.  About an hour or two later, that afternoon, I noticed a swelling around patient's left eye.  She had not had any falls or other injuries during the day, and the only thing that occurred was her receiving a vaccination.  I'm a dentist, so I thought to look up the side effects of the Pediarix on drugs.com, which stated a possible side effect of "hives or hive like swelling on the face, eyelids..."  So I called the physician's office to report the findings and my concern.  I left a message, and the nurse called me back.  Upon explaining to her my observation, she immediately dismissed me, saying that patient must've hit her face and that swelling of the eye doesn't happen.  I then insisted on speaking with the physician Dr, who called me back later.  I again explained the situation to the physician, who dismissed me as well, and said that it's not a side-effect and that in all her years of practice, she's never seen or heard of it.  I told her I looked up the drug side-effects and explained what I read.  I informed that doctor that next time, I didn't want the Pediarix administered, but wanted the vaccines individually administered, because patient hadn't had any side-effects when she received her first doses individually at a previous doctor's office.  The Physician told me that she will make a note of it in patient's chart.  The swelling resolved in a few hours.  Upon returning to the office in December 2014 for patient's next round of vaccines, she was seen by different Physician.  I explained to him what happened with the Pediarix, expecting him to see/read the notes in patient's chart, which Dr said she would write.  However, he noted that there was no mention of patient's reaction to the Pediarix.  On the December visit, patient received the vaccines separately, and without incident.
Sex: F
Vaccine: MMR
Symptoms: Adverse event
Clinical narrative: Information has been received from a mother concerning her daughter of unknown age. The patient's medical history and concurrent condition were not reported. On an unknown date the patient was vaccinated with M-M-R II (strength, dose, frequency, route and lot# not provided). The reporter stated that after receiving M-M-R II the patient was diagnosed with a "serious issue" on unknown date. The outcome of "serious issue" was unknown. The causality was not reported. The reporter considered the serious issue was medical significant. Additional information is not expected as there is no contact information.
Age: 0.51
Sex: F
Vaccine: RV5
Symptoms: Dehydration, Diarrhoea, Rotavirus test positive, Vomiting, Weight decreased
Clinical narrative: Information has been received from a physician via a company representative referring to a female patient of unknown age. Concurrent conditions, medical history and allergies were not reported. The patient was vaccinated with three doses of ROTATEQ, oral solution, 2 ml orally, on 20-SEP-2009 (also reported as 25-SEP-2009) (lot# reported as 03194), 30-NOV-2009 (Lot# reported as 04334) and 02-FEB-2010 (Lot# reported as 14424) respectively. Other suspect and concomitant therapies were not reported. On 10-JAN-2015 the patient came to the office after experiencing vomiting, diarrhea, weight loss, and severe dehydration after receiving ROTATEQ (events onset date was unknown). On 14-JAN-2015 the patient was admitted into the hospital (demographics and length of stay was unknown) and tested positive for rotavirus. Patient sought medical attention via office visit. Fluids and other unspecified treatments were given for the events. The outcome of the events was reported as recovered on an unknown date in 2015. Therapy with ROTATEQ was also reported to be continued. The relatedness between the event and therapy with ROTATEQ was not reported. Additional information has been requested.
Age: 54.0
Sex: M
Vaccine: HEP
Symptoms: Cancer surgery, Injection site reaction, Pathology test, Squamous cell carcinoma
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of squamous cell carcinoma in a 54-year-old male patient who received ENGERIX B (batch number AHBVC064CA, expiry date 22nd March 2014). Previously administered products included ENGERIX B (1st dose - AHBVC018BA - left deltoid) and Hepatitis B vaccine (2nd dose - H010965 (Merck) - the left deltoid). Concomitant products included omeprazole, ramipril and simvastatin. On 20th November 2013, the patient received the 3rd dose of ENGERIX B. On 24th November 2013, 4 days after receiving ENGERIX B, the patient experienced squamous cell carcinoma (serious criteria GSK medically significant and other). On 8th January 2014, the outcome of the squamous cell carcinoma was recovered/resolved. It was unknown if the reporter considered the squamous cell carcinoma to be related to ENGERIX B. Additional information was received: 4 days after receiving the 3rd dose of vaccine, the patient reported a growth near the injection site. The growth was on the left deltoid. As per the patient, the growth grew rapidly. On 10 December 2013, the patient went to his PCP (different doctor) and had the growth removed. On 17 December 2013, the pathology report came back stating that the growth was squamous cell carcinoma. On 8 January 2014, the plastic surgeon confirmed that the carcinoma had been removed in total.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Chronic lymphocytic leukaemia, Knee arthroplasty, Neck pain, Rash
Clinical narrative: This spontaneous report was received from an approximately 67 year old female nurse practitioner, who is also the patient, with severe arthritis since 1999 and KEFLEX drug allergy, regarding herself. On an unknown date in summer 2006, the patient was vaccinated with a dose of ZOSTAVAX (route, lot number and expiration date were not provided). Concomitant therapies included XARELTO. On an unknown date in 2007, the patient was diagnosed with chronic lymphocytic leukemia (CLL), she also experienced that same year, blood clots that were determined to be related to CLL. On an unspecified date in November 2011, the patient underwent a knee replacement due to her severe arthritis. On 30-JAN-2015, the patient experienced neck pain. Subsequently on 03-FEB-2015, the reporter developed a red rash on her neck that, on the next day, became blistered and extended from the back of her neck to her shoulder and down the midline to her chest. It was reported that the patient did not seek for medical attention, no treatment was given for the events. Nor labs diagnostics studies were performed. The outcome of the events was reported as not recovered. Upon internal assessment the events of chronic lymphocytic leukemia was considered to be medically significant. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash erythematous, Rash vesicular, Thrombosis
Clinical narrative: This spontaneous report was received from an approximately 67 year old female nurse practitioner, who is also the patient, with severe arthritis since 1999 and KEFLEX drug allergy, regarding herself. On an unknown date in summer 2006, the patient was vaccinated with a dose of ZOSTAVAX (route, lot number and expiration date were not provided). Concomitant therapies included XARELTO. On an unknown date in 2007, the patient was diagnosed with chronic lymphocytic leukemia (CLL), she also experienced that same year, blood clots that were determined to be related to CLL. On an unspecified date in November 2011, the patient underwent a knee replacement due to her severe arthritis. On 30-JAN-2015, the patient experienced neck pain. Subsequently on 03-FEB-2015, the reporter developed a red rash on her neck that, on the next day, became blistered and extended from the back of her neck to her shoulder and down the midline to her chest. It was reported that the patient did not seek for medical attention, no treatment was given for the events. Nor labs diagnostics studies were performed. The outcome of the events was reported as not recovered. Upon internal assessment the events of chronic lymphocytic leukemia was considered to be medically significant. Additional information has been requested.
Age: 0.45
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Screaming, Seizure
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of seizure of a 1-year-old male patient who received PEDIARIX (batch number 5XK44, expiry date 11th December 2016). Co-suspect products included ROTARIX (batch number A41CB465A, expiry date 4th February 2016). Concomitant products included Hib vaccine and PREVNAR 13. On 30th January 2015 11:30, the patient received the 2nd dose of PEDIARIX (intramuscular). On an unknown date, the dose was an unknown dose. On 30th January 2015 11:30, the patient received the 2nd dose of ROTARIX (oral). On 31st January 2015, 1 days after receiving PEDIARIX and ROTARIX, the patient experienced screaming. On 1st February 2015, the patient experienced seizure (serious criteria GSK medically significant). PEDIARIX was discontinued. ROTARIX was discontinued. On an unknown date, the outcome of the seizure and screaming were recovered/resolved. The reporter considered the seizure and screaming to be related to PEDIARIX and ROTARIX. Additional information received: This case was reported by a consumer via call center representative and described the occurrence of seizure in a 1-year-old male patient who received PEDIARIX (batch number 5XK44, expiry date 11th December 2016). Co-suspect products included ROTARIX (batch number A41CB465A, expiry date 4th February 2016). Concomitant products included Hib and PREVNAR 13. On 30th January 2015 11:30, the patient received the 2nd dose of PEDIARIX (intramuscular). On 30th January 2015 11:30, the patient received the 2nd dose of ROTARIX (oral). On 31st January 2015, 1 days after receiving PEDIARIX and ROTARIX, the patient experienced screaming. On 1st February 2015, the patient experienced seizure. PEDIARIX was discontinued on 30th January 2015. ROTARIX was discontinued on 30th January 2015. On an unknown date, the outcome of the seizure and screaming were recovered/resolved. The reporter considered the seizure to be related to PEDIARIX and ROTARIX. It was unknown if the reporter considered the screaming to be related to PEDIARIX and ROTARIX.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Pain in extremity, Pruritus, Rash
Clinical narrative: Within a month after receiving the Shingles Vaccine (ZOSTAVAX), I experienced and am still experiencing a rash with severe pain in my feet up to my knees in both legs. I have tried everything, creams, witch hazel to relieve the pain and rash. It occurs without warning and I have to submerge my legs in a tub of ice cold water and it helps the pain and itching. The palms of my hands also itch but no pain. I have tried to determine if it was food but that was not the case since eliminating foods and replacing did not make a difference. Will this get better? This rash and pain has been going on over a year now and the occurrence is more frequently now.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Acoustic stimulation tests abnormal, Deafness unilateral, Sudden hearing loss
Clinical narrative: Pt received ZOSTAVAX vaccine on 8/19/2014 and experienced sudden hearing loss on the (R) side 5 days later.
Age: 0.59
Sex: F
Vaccine: RV5
Symptoms: Diarrhoea, Rotavirus test positive, Vomiting
Clinical narrative: Information has been received from a physician via a company representative referring to a 7 month old female patient. Patient's current condition or medical history was not reported. On 12-AUG-2014 the patient was vaccinated with a dose of ROTATEQ (lot# reported as K006455, dose 2 ml, oral). On 07-NOV-2014 the patient was vaccinated with another dose of ROTATEQ (lot# reported as K009182, dose 2 ml, oral). On 26-JAN-2015 the patient was vaccinated with another dose of ROTATEQ (lot# reported as K023530, dose 2 ml, oral). Concomitant medications were not provided. On 02-FEB-2015 the patient experienced diarrhea, vomiting and tested positive for rotavirus. The patient came to the physician's office on 03-FEB-2015 for medical attention. Fluids and other unspecified treatments were given for the events. Therapy was reported as not discontinued. The patient recovered from the events on an unspecified date in February 2015. The causality was not provided. Additional information has been requested.