chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 82.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Blood test, Constipation, Feeling abnormal, Gastrointestinal infection, Neoplasm skin
Clinical narrative: This non-serious spontaneous consumer report (initial receipt 18-AUG-2013) concerns an 82-year-old female patient. The patient had a medical history of drug reaction/allergies to many unspecified medications. Her concomitant medications included an unspecified thyroid medication, unspecified cholesterol medication, atenolol and Ocuvite.  On an unspecified date in SEP-2013, the patient received unspecified flu shot (manufacturer and batch number not reported) and at the same time, she received Zostavax injection (batch number not reported)  vaccines were given one in each arm.  On an unspecified date, a few days later, the patient developed severely itchy patches on her skin starting on her back, legs, arms and breast. They were like patches of thick skin. Her physician referred them to as "bandades" as they resembled bandades or patches of thick skin. There were growths on her scalp that felt like the head of a nail that was diagnosed as nerve endings. Most of them went away but one or two appeared from time to time. Her itchy skin patches were diagnosed as prurigo. She also felt like there were needles going through her toes. She felt like there were "aliens in her body". Her intestines were infected as she had constipation. She underwent laboratory (blood) tests. She was not diagnosed with shingles. She received treatment with unspecified topical gel, unspecified shots in the patches and colostrum powder for constipation.  The outcome was reported as not recovered.
Age: 82.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Paraesthesia, Prurigo, Pruritus generalised, Rash generalised, Skin hypertrophy
Clinical narrative: This non-serious spontaneous consumer report (initial receipt 18-AUG-2013) concerns an 82-year-old female patient. The patient had a medical history of drug reaction/allergies to many unspecified medications. Her concomitant medications included an unspecified thyroid medication, unspecified cholesterol medication, atenolol and Ocuvite.  On an unspecified date in SEP-2013, the patient received unspecified flu shot (manufacturer and batch number not reported) and at the same time, she received Zostavax injection (batch number not reported)  vaccines were given one in each arm.  On an unspecified date, a few days later, the patient developed severely itchy patches on her skin starting on her back, legs, arms and breast. They were like patches of thick skin. Her physician referred them to as "bandades" as they resembled bandades or patches of thick skin. There were growths on her scalp that felt like the head of a nail that was diagnosed as nerve endings. Most of them went away but one or two appeared from time to time. Her itchy skin patches were diagnosed as prurigo. She also felt like there were needles going through her toes. She felt like there were "aliens in her body". Her intestines were infected as she had constipation. She underwent laboratory (blood) tests. She was not diagnosed with shingles. She received treatment with unspecified topical gel, unspecified shots in the patches and colostrum powder for constipation.  The outcome was reported as not recovered.
Age: 82.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Rash generalised, Skin disorder
Clinical narrative: This non-serious spontaneous consumer report (initial receipt 18-AUG-2013) concerns an 82-year-old female patient. The patient had a medical history of drug reaction/allergies to many unspecified medications. Her concomitant medications included an unspecified thyroid medication, unspecified cholesterol medication, atenolol and Ocuvite.  On an unspecified date in SEP-2013, the patient received unspecified flu shot (manufacturer and batch number not reported) and at the same time, she received Zostavax injection (batch number not reported)  vaccines were given one in each arm.  On an unspecified date, a few days later, the patient developed severely itchy patches on her skin starting on her back, legs, arms and breast. They were like patches of thick skin. Her physician referred them to as "bandades" as they resembled bandades or patches of thick skin. There were growths on her scalp that felt like the head of a nail that was diagnosed as nerve endings. Most of them went away but one or two appeared from time to time. Her itchy skin patches were diagnosed as prurigo. She also felt like there were needles going through her toes. She felt like there were "aliens in her body". Her intestines were infected as she had constipation. She underwent laboratory (blood) tests. She was not diagnosed with shingles. She received treatment with unspecified topical gel, unspecified shots in the patches and colostrum powder for constipation.  The outcome was reported as not recovered.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Pain, Vomiting
Clinical narrative: Case number PHHY2014US144869, is an initial spontaneous report received from a consumer (patient) via Vaccine Adverse Event Reporting System (VAERS reference number: 541754) website 0n 28 OCT 2014. This report refers to a 73-year-old female patient. Medical history and concomitant medications were not reported. She was vaccinated with FLUVIRIN 2014/2015 (batch number: not reported) intramuscularly into her right arm on 28 AUG 2014. One hour after receiving the vaccine she returned home from the doctor's office. Almost immediately , she had severe nausea and vomiting. She vomited at least three times and this lasted for several hours. She also had body aches. On 29 AUG 2014, she was feeling fine. The final outcome of the events was reported as complete recovery. The events were reported as non-serious and the causality of the events was not reported.
Age: 53.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Malaise, Pyrexia
Clinical narrative: Case number PHHY2014US145142, is an initial spontaneous report received Vaccine Adverse Event Reporting System (VAERS reference number: 542545) website on 28 OCT 2014. This report refers to a 53-year-old female patient. Historical conditions were not reported. Vaccination history included yearly influenza vaccine for multiple years with no negative effects. This poly-medicated patient received FLUVIRIN 2014/2015 (batch number: 15304) and Pneumovax (batch number: J010396) intramuscularly on 25 AUG 2014. On 26 AUG 2014, she experienced general malaise and a low grade fever 24 hours after the immunization. She was sent to emergency room. The outcome of the events was complete recovery. The events were reported as non-serious and causality was not reported.
Sex: U
Vaccine: FLU3, PPV
Symptoms: Injection site cellulitis
Clinical narrative: Case number PHHY2014US169481, is an initial spontaneous report from a pharmacist via Vaccine Adverse Event Reporting System (VAERS reference number: 544188) website received on 29 Dec 2014, with the follow-up information received from Quality Assurance Department (reference number: 344684) on 13 Jan 2015. This report refers to a patient of unknown demographics. Historical conditions were not reported. The patient was on no other medications. The patient was vaccinated with FLUVIRIN (batch number: not reported) along with PNEUMOVAX 23 (batch number: J014399, expiration date: 20 Nov 2014) on 12 Aug 2014. On an unknown date after vaccination in 2014, the patient was diagnosed with cellulitis near the injection site of the PNEUMOVAX 23. The pharmacist did not specify if the patient had received any treatment for the event. The outcome of the event was unknown. The event was reported as non-serious; however the case was internally upgraded as medically significant based on NVS-IME list. Causality was not reported. Based on the investigation performed, QA department stated that, since the batch number was not reported, a batch specific review could not be performed. Based on the Annual Product Review (APR) of the years 2014/2015 for FLUVIRIN vaccine, it was concluded that FLUVIRIN manufacturing process was operated at a good level of overall control and the supporting systems are effective in supporting the compliant production, testing and supply processes for FLUVIRIN vaccine. From this conclusion there was no reason or explanation to account for the reported adverse event. Non-significant follow up information received from the Quality Assurance Department (reference number: 344684) on 30 Dec 2014: Updated QA reference number. Follow-up information received from the Quality Assurance Department (reference number: 344684) on 13 Jan 2015: Updated Annual Product Review report.
Age: 1.51
Sex: M
Vaccine: DTAP, HEPA, DTAP, HEPA, DTAP, HEPA
Symptoms: Asthenia, Cough, Crying, Erythema, Lip swelling
Clinical narrative: This spontaneous report as received from the patient's mother refers to an 18 month old male patient with asthma, food allergies and generalized eczema. On 12-JAN-2015 the patient was vaccinated with VAQTA injection, in the thigh (unspecified which one) lot # K005323, (route, dosage and expiration date were not reported). On the same date the patient was vaccinated with DTAP in the other thigh (unspecified) lot# C4694AA, (each vaccine was administered in each thigh). Concomitant therapies included albuterol (manufacturer unknown), PROAIR and QVAR. On 12-JAN-2015, approximately 15 minutes later after injections while the mother was driving home with the child, he started to cough that became persistent, then started to feel asthenia, developed urticaria on his lower face and his neck and his lips were swollen. His mother stated that she immediately administered EPIPEN injection, oral BENADRYL and called to 911. Also informed that the child was rushed to the hospital by ambulance and her child was treated with IV solutions (unspecified) and IV steroids (unspecified). The child had some wheezing and his mother informed that the child was monitored for several hours at the hospital and was released, the patient was not hospitalized. He continued treatment of oral steroids (unspecified) twice a day for 5 days, oral BENADRYL every 6 hours for 2 days. The patient's mother stated that he was fine, just a little off from the steroids. There were not laboratories studies performed. The outcome of the events was recovered on an unknown date in January 2015. Upon internal review, the events wheezing, urticaria, asthenia, cough and lip swelling were considered medically significant. Additional information has been requested.
Age: 1.51
Sex: M
Vaccine: DTAP, HEPA, DTAP, HEPA, DTAP, HEPA
Symptoms: Urticaria, Wheezing
Clinical narrative: This spontaneous report as received from the patient's mother refers to an 18 month old male patient with asthma, food allergies and generalized eczema. On 12-JAN-2015 the patient was vaccinated with VAQTA injection, in the thigh (unspecified which one) lot # K005323, (route, dosage and expiration date were not reported). On the same date the patient was vaccinated with DTAP in the other thigh (unspecified) lot# C4694AA, (each vaccine was administered in each thigh). Concomitant therapies included albuterol (manufacturer unknown), PROAIR and QVAR. On 12-JAN-2015, approximately 15 minutes later after injections while the mother was driving home with the child, he started to cough that became persistent, then started to feel asthenia, developed urticaria on his lower face and his neck and his lips were swollen. His mother stated that she immediately administered EPIPEN injection, oral BENADRYL and called to 911. Also informed that the child was rushed to the hospital by ambulance and her child was treated with IV solutions (unspecified) and IV steroids (unspecified). The child had some wheezing and his mother informed that the child was monitored for several hours at the hospital and was released, the patient was not hospitalized. He continued treatment of oral steroids (unspecified) twice a day for 5 days, oral BENADRYL every 6 hours for 2 days. The patient's mother stated that he was fine, just a little off from the steroids. There were not laboratories studies performed. The outcome of the events was recovered on an unknown date in January 2015. Upon internal review, the events wheezing, urticaria, asthenia, cough and lip swelling were considered medically significant. Additional information has been requested.
Age: 1.51
Sex: M
Vaccine: DTAP, HEPA, DTAP, HEPA, DTAP, HEPA
Symptoms: Asthenia, Cough, Lip swelling, Urticaria, Wheezing
Clinical narrative: This spontaneous report as received from the patient's mother refers to an 18 month old male patient with asthma, food allergies and generalized eczema. On 12-JAN-2015 the patient was vaccinated with VAQTA injection, in the thigh (unspecified which one) lot # K005323, (route, dosage and expiration date were not reported). On the same date the patient was vaccinated with DTAP in the other thigh (unspecified) lot# C4694AA, (each vaccine was administered in each thigh). Concomitant therapies included albuterol (manufacturer unknown), PROAIR and QVAR. On 12-JAN-2015, approximately 15 minutes later after injections while the mother was driving home with the child, he started to cough that became persistent, then started to feel asthenia, developed urticaria on his lower face and his neck and his lips were swollen. His mother stated that she immediately administered EPIPEN injection, oral BENADRYL and called to 911. Also informed that the child was rushed to the hospital by ambulance and her child was treated with IV solutions (unspecified) and IV steroids (unspecified). The child had some wheezing and his mother informed that the child was monitored for several hours at the hospital and was released, the patient was not hospitalized. He continued treatment of oral steroids (unspecified) twice a day for 5 days, oral BENADRYL every 6 hours for 2 days. The patient's mother stated that he was fine, just a little off from the steroids. There were not laboratories studies performed. The outcome of the events was recovered on an unknown date in January 2015. Upon internal review, the events wheezing, urticaria, asthenia, cough and lip swelling were considered medically significant. Additional information has been requested.
Age: 1.51
Sex: M
Vaccine: DTAP, HEPA, DTAP, HEPA, DTAP, HEPA
Symptoms: Choking, Retching
Clinical narrative: This spontaneous report as received from the patient's mother refers to an 18 month old male patient with asthma, food allergies and generalized eczema. On 12-JAN-2015 the patient was vaccinated with VAQTA injection, in the thigh (unspecified which one) lot # K005323, (route, dosage and expiration date were not reported). On the same date the patient was vaccinated with DTAP in the other thigh (unspecified) lot# C4694AA, (each vaccine was administered in each thigh). Concomitant therapies included albuterol (manufacturer unknown), PROAIR and QVAR. On 12-JAN-2015, approximately 15 minutes later after injections while the mother was driving home with the child, he started to cough that became persistent, then started to feel asthenia, developed urticaria on his lower face and his neck and his lips were swollen. His mother stated that she immediately administered EPIPEN injection, oral BENADRYL and called to 911. Also informed that the child was rushed to the hospital by ambulance and her child was treated with IV solutions (unspecified) and IV steroids (unspecified). The child had some wheezing and his mother informed that the child was monitored for several hours at the hospital and was released, the patient was not hospitalized. He continued treatment of oral steroids (unspecified) twice a day for 5 days, oral BENADRYL every 6 hours for 2 days. The patient's mother stated that he was fine, just a little off from the steroids. There were not laboratories studies performed. The outcome of the events was recovered on an unknown date in January 2015. Upon internal review, the events wheezing, urticaria, asthenia, cough and lip swelling were considered medically significant. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: HEPAB, HEP, HEPA
Symptoms: Hypersensitivity, Paraesthesia, Pharyngeal oedema
Clinical narrative: Sore throat, numbness, tingling all over, throat numbing and constricting, dizziness, seeing black spots, headache, shortness of breath, rapid heart beat, elevated blood pressure, hives all over body.
Age: 35.0
Sex: F
Vaccine: HEPAB, HEP, HEPA
Symptoms: Blood pressure increased, Dizziness, Dyspnoea, Headache, Heart rate increased
Clinical narrative: Sore throat, numbness, tingling all over, throat numbing and constricting, dizziness, seeing black spots, headache, shortness of breath, rapid heart beat, elevated blood pressure, hives all over body.
Age: 35.0
Sex: F
Vaccine: HEPAB, HEP, HEPA
Symptoms: Hypoaesthesia, Oropharyngeal pain, Paraesthesia, Pharyngeal hypoaesthesia, Throat tightness
Clinical narrative: Sore throat, numbness, tingling all over, throat numbing and constricting, dizziness, seeing black spots, headache, shortness of breath, rapid heart beat, elevated blood pressure, hives all over body.
Age: 35.0
Sex: F
Vaccine: HEPAB, HEP, HEPA
Symptoms: Urticaria, Visual impairment
Clinical narrative: Sore throat, numbness, tingling all over, throat numbing and constricting, dizziness, seeing black spots, headache, shortness of breath, rapid heart beat, elevated blood pressure, hives all over body.
Sex: F
Vaccine: HPV4
Symptoms: Alopecia, Autoimmune haemolytic anaemia, Haemoglobin decreased, Malaise
Clinical narrative: This spontaneous report as received from a consumer (the patient's mother) refers to a female patient of unknown age. No information on her medical history or concurrent conditions was provided. In approximately March 2014, reported as in the Spring 2014, the patient was vaccinated with her first dose of GARDASIL (1 single shot, route, lot# and expiration date were not reported). In approximately 2014, reported as 12 days after vaccination with GARDASIL, the patient began to get very sick. On an unknown date, the patient had been hospitalized (specific reason and duration were unknown), the patient's hair had been falling out, hemoglobin levels were declining (values and units were not reported) and the patient was diagnosed with autoimmune hemolytic anemia. On an unknown date, the patient was treated with steroids (dosage and frequency were unknown). At the time of the report, the outcome of the events was not recovered. The relatedness between the events and GARDASIL was not reported. No PQC (product quality complaint) was involved. Additional information has been requested.
Age: 57.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Pain in extremity
Clinical narrative: Pain down (L) arm into wrist and fingers - Pain started 2-3 days after shot.
Age: 54.0
Sex: M
Vaccine: PPV
Symptoms: Bronchospasm, Chest discomfort, Cough, Dyspnoea, Impaired work ability
Clinical narrative: I had a little spasticity in my airways on the night of 01/16/2015. Next morning started having sore throat and minor coughing. This morning at 4:30 am my airways was so tight and had serious trouble breathing, Started using my rescue inhalers. I prepared myself to call 911 in my breathing did start to stabilize.
Age: 54.0
Sex: M
Vaccine: PPV
Symptoms: Oropharyngeal pain
Clinical narrative: I had a little spasticity in my airways on the night of 01/16/2015. Next morning started having sore throat and minor coughing. This morning at 4:30 am my airways was so tight and had serious trouble breathing, Started using my rescue inhalers. I prepared myself to call 911 in my breathing did start to stabilize.
Age: 9.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Later that evening site became very swollen, sore, warm to the touch and reddened.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Aphasia, Confusional state, Crying, Disorientation, Influenza virus test
Clinical narrative: PATIENT WAS DISORIENTED, CONFUSED, CRYING HYSTERICALLY, STARTED SHAKING IN A SEIZURE MANNER, WALKED INTO WALLS, DID NOT KNOW WHERE TO GO, WOULD NOT TALK.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Seizure like phenomena, Tremor
Clinical narrative: PATIENT WAS DISORIENTED, CONFUSED, CRYING HYSTERICALLY, STARTED SHAKING IN A SEIZURE MANNER, WALKED INTO WALLS, DID NOT KNOW WHERE TO GO, WOULD NOT TALK.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Injection area became red/swollen. I reported to employee health was given cream after examined by NP. I filed on the adverse reaction, but I have endured intermittent pain injection area since the injection 2 years. Reason for filing additional claim.
Age: 18.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Activities of daily living impaired, Arthralgia, Balance disorder, Chills, Dizziness
Clinical narrative: Chills, hard knot, hurting with terrible pain down right arm. Swelling, redness, and fever, low grade.  Continued pain over next 3 days and nights. Swollen and hurting joints in fingers and leg pain. Dizzy and able to walk.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Induration, Joint swelling, Nodule, Pain
Clinical narrative: Chills, hard knot, hurting with terrible pain down right arm. Swelling, redness, and fever, low grade.  Continued pain over next 3 days and nights. Swollen and hurting joints in fingers and leg pain. Dizzy and able to walk.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity, Pyrexia, Swelling
Clinical narrative: Chills, hard knot, hurting with terrible pain down right arm. Swelling, redness, and fever, low grade.  Continued pain over next 3 days and nights. Swollen and hurting joints in fingers and leg pain. Dizzy and able to walk.
Age: 59.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Axillary pain, Headache, Injection site pain, Myalgia
Clinical narrative: Joint and muscle aches, headache, pain at site (right upper arm and arm pit) that evening into and through the 17th (Saturday).
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Injection site swelling, Rash
Clinical narrative: Bilateral rash, itching, swelling, redness at site of injection; rash spread to right leg lower and upper back.
Age: 14.0
Sex: F
Vaccine: FLUN4, HPV4
Symptoms: Presyncope
Clinical narrative: Near syncope after vaccine.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema
Clinical narrative: One day after vaccines she developed redness around injection site that has gotten larger -> redness of skin covered the lower third of anterior left thigh.
Age: 9.0
Sex: M
Vaccine: MMR
Symptoms: Erythema, Skin warm
Clinical narrative: (L) arm with redness about half dollar size, hot to the touch, not painful, no fever.
Age: 80.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Paraesthesia
Clinical narrative: PATIENT STATED THAT IN HIS RIGHT ARM HE HAD SHARP PAIN AT THE SIGHT OF THE INJECTION AND IS CURRENTLY HAVING SOME PAIN.  HE STATED HE HAD SOME NUMBNESS OR TINGLING IN HIS RIGHT HAND AND CURRENTLY HAS LIMITED MOBILITY AND NOT ABLE TO COMPLETELY LIFT HIS RIGHT ARM WITHOUT ASSISTANCE.  PATIENT STATES THIS HAS BEEN ONGOING SINCE 1/7/2015 AND HAS NOT RESOLVED.
Age: 80.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Hypoaesthesia, Injection site pain, Mobility decreased, Paraesthesia
Clinical narrative: PATIENT STATED THAT IN HIS RIGHT ARM HE HAD SHARP PAIN AT THE SIGHT OF THE INJECTION AND IS CURRENTLY HAVING SOME PAIN.  HE STATED HE HAD SOME NUMBNESS OR TINGLING IN HIS RIGHT HAND AND CURRENTLY HAS LIMITED MOBILITY AND NOT ABLE TO COMPLETELY LIFT HIS RIGHT ARM WITHOUT ASSISTANCE.  PATIENT STATES THIS HAS BEEN ONGOING SINCE 1/7/2015 AND HAS NOT RESOLVED.
Age: 1.06
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEPA, MMR, PNC13, VARCEL
Symptoms: Rash
Clinical narrative: Rash on neck, back and legs.
Age: 62.0
Sex: F
Vaccine: FLU4
Symptoms: Chills, Nausea, Pain, Pain in extremity, Pyrexia
Clinical narrative: Severe chills, nausea, fever, severe body aches, sore arm for several hours the night of receiving the vaccine. Was feeling better the following morning.
Age: 1.95
Sex: F
Vaccine: MMR
Symptoms: Injection site rash, Pruritus, Pyrexia, Rash, Rash maculo-papular
Clinical narrative: Fever and rash. Fever Tm <102 so far. Rash started on legs and went upward. Very itchy. Initially mac-pap, but now very itchy.
Age: 47.0
Sex: M
Vaccine: TDAP
Symptoms: Back pain, Chills, Gait disturbance, Hypoaesthesia, Paraesthesia
Clinical narrative: Chills which turned to a low grade fever, tingling in extremities, and the fever of 100 continued through the 14th.  Then, legs and feet went numb.  On 1/18, upper back pain and tingling in hands began.  Still no feeling in legs or feet.  Some difficulty walking.
Age: 47.0
Sex: M
Vaccine: TDAP
Symptoms: Pyrexia
Clinical narrative: Chills which turned to a low grade fever, tingling in extremities, and the fever of 100 continued through the 14th.  Then, legs and feet went numb.  On 1/18, upper back pain and tingling in hands began.  Still no feeling in legs or feet.  Some difficulty walking.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Blister, Herpes zoster
Clinical narrative: Developed Shingles- Multiple blister eruptions on left torso (mid back, under breast and side).
Age: 0.38
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Abdominal X-ray, Haematochezia, Screaming, Ultrasound abdomen, Vomiting
Clinical narrative: Woke up screaming, bloody diaper, vomiting and bouts of screaming and quiet.
Age: 1.58
Sex: F
Vaccine: DTAPIPVHIB, HEPA, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site urticaria
Clinical narrative: Hives, red raised large spots in a cluster around injection site. Benadryl given and patient monitored in office.
Age: 47.0
Sex: F
Vaccine: PNC13
Symptoms: Gait disturbance, Injection site pain, Musculoskeletal stiffness
Clinical narrative: Extreme tenderness, soreness and stiffness on entire upper left arm (injection site) and soreness and stiffness of lower right back and glute muscle (old injury); took over 10 days for symptoms to subside enough for me to walk normally and without pain.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Herpes zoster, Insomnia, Pain, Pyrexia
Clinical narrative: Pain on right side of body stared on day of shot, and fever and body aches started, but main concern was Shingles developing within 24 hours of High Dosage Flu Shot and lasting 6-8 weeks. Loss of 6 weeks of work outside home.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: PATIENT HAD SWELLING, ITCHING, REDNESS, WARMTH, AND SORENESS AT THE INJECTION SITE 2 DAYS AFTER IMMUNIZATION.
Age: 0.18
Sex: M
Vaccine: HEPA, MMR, RVX
Symptoms: Abnormal behaviour, Crying, Decreased appetite, Emotional distress, Pyrexia
Clinical narrative: Began running fever, began screaming. Inconsolable for 7 hours. Didn't eat for 8 hours. Has not been normal since vaccination. Constantly cries, doesn't want to eat or be held unless it's in the morning. Baby is completely different upon vaccinations.
Age: 0.18
Sex: M
Vaccine: HEPA, MMR, RVX
Symptoms: Screaming
Clinical narrative: Began running fever, began screaming. Inconsolable for 7 hours. Didn't eat for 8 hours. Has not been normal since vaccination. Constantly cries, doesn't want to eat or be held unless it's in the morning. Baby is completely different upon vaccinations.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5, DPP, HEP, HIBV, RVX
Symptoms: Cardiac monitoring, Full blood count, Hypotonic-hyporesponsive episode, Metabolic function test, Pallor
Clinical narrative: Sudden onset hyporesponsive, hypotonic, and pallor. Most severe lasted about 10 minutes. Took approximately 1.5 hours for patient to return to normal.
Age: 1.01
Sex: M
Vaccine: HEPA, HIBV, MMR, PPV
Symptoms: Pyrexia
Clinical narrative: Fever of 101.1.
Age: 16.0
Sex: M
Vaccine: HEPA, HPV4
Symptoms: Feeling hot, Head injury, Loss of consciousness, Wound closure
Clinical narrative: Pt mother c/o her son being hot. I administered his vaccines, I returned to my desk, Mother was yelling help! I ran in, helped pt to the table, and I applied pressure to his head. Mother stated he was hot grabbed on the table (both sides), pt was slipping, passed out, hit his head on the cabinet. Staples was applied.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient presented 3 days after injection for shingles concerned about raised and warm to the touch area at injection site; A follow-up phone call 1/19/15 1 pm with patient was done and patient noted area was improved-not as red and warm to touch.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Rash pruritic
Clinical narrative: Pruritic rash, bilateral axilla, spread to waist and groin, vesicles. No treatment required.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, PPV
Symptoms: Blood pressure decreased, Cellulitis, Culture negative, Erythema, Heart rate increased
Clinical narrative: 1-8-15: fever 101, vomiting, increased HR, WBC-62K, decreased BP 80/60 (per ER) ICU. RA very sore after vaccines, red and hot to touch. Vaccines in question: right arm.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, PPV
Symptoms: Intensive care, Pain in extremity, Pyrexia, Skin warm, Vomiting
Clinical narrative: 1-8-15: fever 101, vomiting, increased HR, WBC-62K, decreased BP 80/60 (per ER) ICU. RA very sore after vaccines, red and hot to touch. Vaccines in question: right arm.
Age: 15.0
Sex: F
Vaccine: HPV4, MNQ, PPV
Symptoms: White blood cell count increased
Clinical narrative: 1-8-15: fever 101, vomiting, increased HR, WBC-62K, decreased BP 80/60 (per ER) ICU. RA very sore after vaccines, red and hot to touch. Vaccines in question: right arm.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased
Clinical narrative: Patient states that on evening of vaccination she noticed decreased range of motion in her arm. She visited MD and they were not concerned, told her it would improve w/time. Symptoms are continuing to improve.
Age: 1.5
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Furuncle, Injection site discharge, Injection site reaction, Injection site swelling
Clinical narrative: No fever and no problem until today when mom noticed swollen (L) thigh. (4 1/2" x 2 3/4"). Injection sites appeared like "boils" and drained clear, gray fluid.
Age: 11.0
Sex: F
Vaccine: PNC
Symptoms: Meningitis pneumococcal
Clinical narrative: This is a spontaneous report from a contactable physician reported via Pfizer employee. The physician reported that an 11 year old, female patient who started to receive PREVNAR since an unknown date at unknown dose and frequency. Relevant medical history and concomitant medications were unknown. It was reported that the patient experienced pneumococcal meningitis on an unknown date while being on PREVNAR therapy due to which she was hospitalized on an unknown date for an unspecified duration of time. Relevant laboratory data was unknown. Last action taken with PREVNAR was unknown. Therapeutic measures taken in response to the reported event were unknown. Clinical outcome of the reported event was unknown at the time of report. Follow-up (14JUN2013): Follow-up attempts completed. No further information expected.
Age: 50.0
Sex: M
Vaccine: PNC
Symptoms: Bed rest, Chills, Fatigue, Influenza like illness, Pain in extremity
Clinical narrative: This is a spontaneous report from a contactable occupational health nurse. A 50-year-old male patient of an unspecified ethnicity received PREVNAR (Lot Number: F8804; Expiration Date: 30Sep2013), intramuscular on 22Jan2013 at 10:00 hours at 0.5ml single dose on left (deltoid) upper arm. Medical history included an ongoing allergy to penicillin. Concomitant medications included FLUZONE (Lot Number: UN713AB; Expiration Date: 30Jan2013) on the left upper arm on 16Jan2013. The patient previously received the flu vaccine on 25Oct2011. The patient previously received MENACTRA on 03Nov2010 at the age of 48-years-old and experienced fever. It was also reported that the patient had body aches and fatigue after receiving an unspecified immunization on an unknown date in 2010. On an unknown date, the patient experienced flu like symptoms and fever, which lasted 2-3 days. On 22Jan2013, the patient had body aches, chills, and left arm soreness. The patient experienced fatigue on 23Jan2013. The patient was advised to be on bed rest. The clinical outcome of the events, flu like symptoms and fever, was recovered on an unknown date. The clinical outcome of the event, body aches, chills, and fatigue, was recovered on 25Jan2013. The clinical outcome of the event, left arm soreness, was recovered on 26Jan2013. The nurse assessed the events, flu-like symptoms and fever, as possibly related to the PREVNAR. The nurse assessed the events, body aches, chills, left arm soreness, and fatigue, as related to PREVNAR. Follow-up attempts completed. No further information expected. Follow-up (25Mar2013): New information received from the same contactable health nurse includes: suspect product data, past drug event, reaction data (added events: left arm soreness and chills), causality of events, body aches, chills, left arm soreness, and fatigue (related). Follow-up attempts completed. No further information expected.
Age: 50.0
Sex: M
Vaccine: PNC
Symptoms: Pyrexia
Clinical narrative: This is a spontaneous report from a contactable occupational health nurse. A 50-year-old male patient of an unspecified ethnicity received PREVNAR (Lot Number: F8804; Expiration Date: 30Sep2013), intramuscular on 22Jan2013 at 10:00 hours at 0.5ml single dose on left (deltoid) upper arm. Medical history included an ongoing allergy to penicillin. Concomitant medications included FLUZONE (Lot Number: UN713AB; Expiration Date: 30Jan2013) on the left upper arm on 16Jan2013. The patient previously received the flu vaccine on 25Oct2011. The patient previously received MENACTRA on 03Nov2010 at the age of 48-years-old and experienced fever. It was also reported that the patient had body aches and fatigue after receiving an unspecified immunization on an unknown date in 2010. On an unknown date, the patient experienced flu like symptoms and fever, which lasted 2-3 days. On 22Jan2013, the patient had body aches, chills, and left arm soreness. The patient experienced fatigue on 23Jan2013. The patient was advised to be on bed rest. The clinical outcome of the events, flu like symptoms and fever, was recovered on an unknown date. The clinical outcome of the event, body aches, chills, and fatigue, was recovered on 25Jan2013. The clinical outcome of the event, left arm soreness, was recovered on 26Jan2013. The nurse assessed the events, flu-like symptoms and fever, as possibly related to the PREVNAR. The nurse assessed the events, body aches, chills, left arm soreness, and fatigue, as related to PREVNAR. Follow-up attempts completed. No further information expected. Follow-up (25Mar2013): New information received from the same contactable health nurse includes: suspect product data, past drug event, reaction data (added events: left arm soreness and chills), causality of events, body aches, chills, left arm soreness, and fatigue (related). Follow-up attempts completed. No further information expected.
Sex: U
Vaccine: PNC
Symptoms: Rash
Clinical narrative: This is a spontaneous report from a contactable physician communicated to a Merck sales representative based on the information received by Pfizer from Merck & Co., Inc. (Service Request Number: 1-10332411622). An infant patient of unknown age and ethnicity received PREVNAR, on an unspecified date for immunization. Medical history and concomitant medications were unknown. On an unspecified date, the patient developed a rash on the right side of the face, which then moved to the left side. The clinical outcome of rash on the right side of the face, which then moved to the left side was unknown. No follow-up attempts possible. No further information expected.
Age: 0.19
Sex: M
Vaccine: DTAP, HIBV, PNC, RV5, HIBV, PNC
Symptoms: Injection site discolouration, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable pediatrician. A 4-month-old male patient received PREVNAR (lot number G6330; expiration date 01Sep2014), ACTHIB (lot number UH857AA; expiration date 07Nov2014); DAPTACEL (lot number C4454BA, expiration date 05Dec2015), and ROTATEQ (lot number 0283AE; expiration date 24Oct2013) orally; all on 23Aug2013 at the standard dose (as reported) for immunization. The patient had no medical history and was not taking concomitant medications. On 23Aug2013, the patient experienced swelling in the right leg and the right leg became blue after administering the aforementioned vaccines. Therapeutic measures were taken as a result of the events and included treatment with pseudoephedrine; dose and frequency were unknown. The clinical outcome of the events, swelling in the right leg and the right leg became blue, were unknown. Follow-up (13DEC2013): Follow-up attempts completed. No further information expected.
Age: 0.19
Sex: M
Vaccine: DTAP, HIBV, PNC, RV5, HIBV, PNC
Symptoms: Injection site discolouration, Injection site discomfort, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable pediatrician. A 4-month-old male patient received PREVNAR (lot number G6330; expiration date 01Sep2014), ACTHIB (lot number UH857AA; expiration date 07Nov2014); DAPTACEL (lot number C4454BA, expiration date 05Dec2015), and ROTATEQ (lot number 0283AE; expiration date 24Oct2013) orally; all on 23Aug2013 at the standard dose (as reported) for immunization. The patient had no medical history and was not taking concomitant medications. On 23Aug2013, the patient experienced swelling in the right leg and the right leg became blue after administering the aforementioned vaccines. Therapeutic measures were taken as a result of the events and included treatment with pseudoephedrine; dose and frequency were unknown. The clinical outcome of the events, swelling in the right leg and the right leg became blue, were unknown. Follow-up (13DEC2013): Follow-up attempts completed. No further information expected.
Age: 0.4
Sex: U
Vaccine: DTAPHEPBIP, HIBV, PNC, RV1
Symptoms: Diarrhoea, Rotavirus infection
Clinical narrative: This is a spontaneous report based on information received by Pfizer from GlaxoSmithKline (Manufacturer Report Number: A1025426A). This case was reported by a physician via sales representative for a child patient (age and gender unknown). On an unspecified date, around 4 months of age, the subject received second dose of ROTARIX (oral), second dose of PEDIARIX (unknown details), second dose of PREVNAR (unknown details), second dose of PEDVAXHIB (unknown details). It was not specified as to which vaccination was co-suspect to the events. No dates of administration were provided. The second dose of ROTARIX was administered around 4 months of age. On an unspecified date, 4 days after vaccination with second dose of ROTARIX formulation, PEDIARIX, PEDVAXHIB, and PREVNAR, the subject experienced diarrhea and rotavirus infection. Relevant test results included a stool sample of the diarrhea. The stool sample showed child was positive for rotavirus. At the time of reporting the outcome of the events were unspecified. Follow-up (16-AUG-2013) Follow-up attempts completed. No further information expected.
Age: 46.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site pain, Nuclear magnetic resonance imaging abnormal, Rotator cuff syndrome, Tendon rupture
Clinical narrative: Information was received from an Immunization nurse on behalf of a patient on 10JUL2013, 09AUG2013, 21AUG-2013, 04SEP2013 and 21OCT2013. On 14MAY2013, a 46 year old male received dose #4 of BIOTHRAX (lot FAV429) intramuscularly in the left deltoid. On that same day he began to experience persistent pain in the area of the injection site. At three days post immunization the pain became "less intense", but has persisted without change in intensity from that point. On 10JUL2013, the patient returned to the Immunization clinic to report the persistent pain. He was referred to an occupational health clinic for evaluation. On 12JUL2013, was seen by a physician. On exam, his left shoulder area was tender. He was prescribed MOBIC for the pain and physical therapy with home exercises. 30JUL2013 - MRI shoulder left w/o contrast indicated 1. Partial thickness undersurface tear of the insertion of the mild to superior fibers of the subscapularis, involving up to 50% of the tendon thickness. 2. Infraspinatus tendinosis. 3. Small superior to posterosuperior glenoid labral tear. The subject completed physical therapy with home exercises program and MOBIC therapy as prescribed. He reports that he was fully recovered on 03SEP2013.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: This case was reported by a nurse and described the occurrence of expired vaccine used in a patient who received FLUARIX Quadrivalent 2014-2015 (batch number: FS575, expiry date 30th JUNE 2014). On 23rd OCTOBER 2014, the patient received FLUARIX Quadrivalent 2014-2015 .5ml. On 23rd OCTOBER 2014, an unknown time after receiving FLUARIX Quadrivalent 2014-2015, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional information: 18 patients were involved and investigation still ongoing. Called did  not have patients info. Maladministration caught on 23OCT2014.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: This case was reported by a nurse and described the occurrence of expired vaccine used in a patient who received FLUARIX Quadrivalent 2014-2015 (batch number FS575, expiry date 30th JUNE 2014).  On 23rd OCTOBER 2014, the patient received FLUARIX Quadrivalent 2014-2015. On 23rd OCTOBER 2014, an unknown time after receiving FLUARIX Quadrivalent 2014-2015, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional information: 18 patients involved and investigation still ongoing. Caller did not have patient info. Maladministration caught on 23OCT2014.
Sex: U
Vaccine: RV1
Symptoms: Incorrect product formulation administered, No adverse event
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of inappropriate preparation of medication in a unk patient who received ROTARIX (batch number A41CB4464, expiry date 30th January 2016). On 14th October 2014, the patient received ROTARIX (oral). On an unknown date, the dose was an unknown dose. On 14th October 2014, an unknown time after receiving ROTARIX, the patient experienced inappropriate preparation of medication. On an unknown date, the outcome of the inappropriate preparation of medication was unknown. Additional information received: RN reported to Account Manager that 5 patients had inadvertently received only the diluent portion of the ROTARIX vaccine. All five patients returned to the physician office that day to receive the vaccine and diluent product. No AE's were reported. It is thought that one child may have been 2 months old, it is unknown if any had received ROTATEQ previously as the office was changing over Vaccine manufacturers.
Sex: U
Vaccine: FLU3
Symptoms: Exposure during pregnancy
Clinical narrative: This female subject was enrolled in an open label study title FLUARIX, FLULAVAL, FLUARIX Quadrivalent, FLULAVAL Quadrivalent Pregnancy Registry: a prospective, exploratory. cohort study to detect and describe any abnormal pregnancy outcomes in women intentionally or unintentionally vaccinated with either FLUARIX or FLUARIX Quadrivalent or FLUVLAL or FLULAVAL Quadrivalent during pregnancy or within 28 days preceding conception. The subject received FLUVIRIN on an unknown date.  On an unknown date, an unknown time after receiving FLUARIX the subject developed vaccine exposure during pregnancy (non-serious). The outcome of vaccine exposure during pregnancy was unknown. It was unknown if the investigator considered the vaccine exposure during pregnancy to be related to FLUARIX.   Additional information received: Consumer's initials and date of birth were unknown. The Consumer was about to receive the vaccine. The reporter was first calling to see if the vaccine contains mercury and stated the Consumer has walked away. She stated she would inform Consumer to contact GSK if she finds out she is pregnant. Consumer may be pregnant. She is trying to become pregnant and doesn't know if she is pregnant. The healthcare provider didn't have any additional information.
Age: 12.0
Sex: F
Vaccine: PNC
Symptoms: Meningitis bacterial
Clinical narrative: This is a spontaneous report by a contactable Pfizer internal colleague. This female Pfizer internal colleague reported on behalf of her 12-year old niece of an unspecified ethnicity who received PREVNAR via an unspecified route of administration on an unknown date. The patient's medical history and concomitant medications were unknown. It was unknown if other vaccines were given on the same day. Vaccines taken within the last four weeks were unknown. On an unknown date the patient developed bacterial meningitis. It was unknown if the patient had any siblings. Relevant lab data was unknown. The clinical outcome of the bacterial meningitis was unknown. Follow-up (20Jun2013) Follow-up attempts completed. No further information expected.
Age: 47.0
Sex: F
Vaccine: ANTH
Symptoms: Dysgeusia
Clinical narrative: Information was received from an immunization nurse on behalf of a patient on 08JUL2013. On 11JUN2013, a 47 year old female received a 14th dose of BioThrax (lot FAV429) in the left arm. Approximately 30 minutes after immunization she experienced a metallic taste in her mouth. The taste persisted throughout the day to evening despite eating, drinking and rinsing her mouth. The metallic taste was gone upon waking the following day.
Age: 41.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Report received from a clinic nurse regarding a 41 year old male who experienced injection site induration with pain, swelling and warmth. On 28JUN2013, the male received his fifth dose of BioThrax intramuscularly. On 27July2013 (greater than 24 hours after injection), he called the clinic to report a finger width size bump around the area of the shot accompanied by pain, warmth and swelling. He denied the symptoms with previous injections. At the time of report, the outcome was unknown. Further information was requested but not received.
Age: 26.0
Sex: M
Vaccine: ANTH
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Information was received from an employee on behlf of her brother who reported an adverse event. A male experienced injection site redness, swelling, pain and hot to touch after immunization with BIOTHRAX. On 11Jun2013, the male received his sixth dose of BIOTHRAX by an unknown route in the right arm, lot FAV322A. On the same day he experienced redness, swelling, pain and hot to touch at the injection site. All symptoms resolved after 3 days. No medications or treatments were given for symptoms. BIOTHRAX immunizatoin history: Dose# 1 14Apr2007, FAV102 Dose #2: 05May2007, FAV102 Dose #3: 20May2007, FAV104 Dose #4: 12 Oct2010, FAV249 Dose #5: 01Dec2012, FAV309 Dose #6: 11Jun2013, FAV322A
Age: 33.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information received from a nurse on 29AUG2013 regarding a 33 year old female who was administered expired vaccine without adverse event. On 28AUG2013 the female received dose 3 of BioThrax (Lot FAV308; exp. 14AUG2013) and a primary dose of Typhoid vaccine both intramuscularly in an unspecified arm. It was later noted, that the BioThrax had exceeded its expiry date at the time of administration. There were no reported adverse events.