chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health care professional refers to unspecified number or patients of unknown age and gender. On unknown dates, between October 2014 and December 2014, the patients were vaccinated with improperly stored doses of VARIVAX (Merck), dose 0.5 ml, subcutaneous, (lot number and expiration date not reported). No symptoms reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Malaise
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a patient of unknown age and gender. On approximately 16-DEC-2014 "6-7 days ago", the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # not reported). The pharmacist reported that in December 2014, the patient experienced feeling under the weather. The patient received treatment with an unspecified dose of prednisone which the patient had not begun taking at the time of the report. The outcome of feeling under the weather was unknown. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 16-DEC-2014 the patient was vaccinated with an expired dose of PNEUMOVAX 23 lot # J007060, expiration date 28-AUG-2014, dose 0.5 ml, intramuscular. No adverse experience reported. Additional information has been requested.
Age: 15.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a currently 15 year old male patient. Medical history and concurrent conditions were not reported. On 23-JUL-2014, the patient was vaccinated with the first dose of GARDASIL (dose, route, lot number and expiry date were not provided). On 04-OCT-2014, the patient was vaccinated with the second dose of GARDASIL (dose, route, lot number and expiry date were not provided). On 09-DEC-2014, the patient was vaccinated with the third dose of GARDASIL 0.5 ml, intramuscular in the left deltoid. Nurse stated the patient was given his third dose early. No adverse effects reported. There was no concomitant medication. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Blood test, Injection site erythema, Injection site injury, Injection site pain, Injection site scab
Clinical narrative: This spontaneous report as received from a physician refers to a 63 year old female patient. The patient's current condition included depression, asthma, and hypertension. On 09-OCT-2014, patient received both PNEUMOVAX23, intramuscular, (lot #, dose and frequency unknown) and FLUZONE (manufacturer unspecified) at the same anatomical site. Concomitant therapies included MACROBID, BACTRIM, CYMBALTA, SINGULAIR and PRINIVIL (manufacturer unspecified0.   On an unspecified date after vaccinated, the patient developed redness, pain, and scabbing all the PNEUMOVAX23 injection site. On 04-NOV-2014, "the scab fell off, and left a deep, gaping wound at the injection site". The patient was started on an unspecified antibiotic (manufacturer unspecified) on an unspecified date. The patient was recovering. Blood test were performed, result not reported. The patient went to see the physician.  The relationship of adverse events and PNEUMOVAX23 was not reported.  Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Drug administered at inappropriate site, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age and gender. On 11-DEC-2014 the patient was inadvertently vaccinated with one dose of PNEUMOVAX 23 (lot number and expiration date were unknown) subcutaneously in the abdomen. No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a register nurse concerning an unspecified number of patients of an unknown age and gender that were vaccinated with a dose of PROQUAD (Merck) (dose, dose number, lot number, expiration date and route were not reported), that were improperly. No adverse effects reported. Medical history and concurrent conditions of the patients were not reported. Co-suspect and concomitant therapies were not reported. This is one (1) of three (3) reports from the same source. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a register nurse concerning an unspecified number of patients of an unknown age and gender that were vaccinated with a dose of VARIVAX (Merck) (dose, dose number, lot number, expiration date, and route were not reported), that were improperly stored. No adverse effects reported. Medical history and concurrent conditions of the patients were not reported. Co-suspect and concomitant therapies were not reported. These is one (1) of three (3) reports from the same source. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age. On an unknown date the patient was vaccinated with a dose of improperly stored PROQUAD (lot#, expiry date, route unspecified). No further details provided. No PQC involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional (Licensed Practical Nurse) refers to a unspecified number of patient of unknown age. Current conditions and medical history was not reported. On an unknown date approximately in 2014, the patients were vaccinated with VAQTA injection (dose, route, lot number and frequency were not reported). Concomitant medications were not reported. On 11-SEP-2014, first excursion of VAQTA occurred and the doses of VAQTA which were exposed to a supported temperature excursion (maximum temperature of 60 Fahrenheit (F) for a maximum of 19.5 hours) and (58F for 34 hours and 35F for 17 days) have been administered to unspecified patients. As per company stability assessment data, VAQTA would not be adversely affected by this specific temperature excursion. No adverse effects have been observed or reported. Outcome of the events was not reported. Product quality complaint was not reported. No additional information was provided. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Injected limb mobility decreased, Injection site pain
Clinical narrative: Pt is having problem with pain in shoulder, and some range of motion problems due to the pain that immunization was given in. Pts Drs office has diagnosed pt with contusion.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Musculoskeletal pain, Myalgia, Neck pain, Pain in extremity
Clinical narrative: Severe muscle soreness in hamstrings, inner thighs and lower back. Is now also in spine, neck, shoulders, knees and feet also pelvic area.
Age: 53.0
Sex: F
Vaccine: FLU4
Symptoms: Pelvic pain, Rheumatoid factor positive, Spinal pain
Clinical narrative: Severe muscle soreness in hamstrings, inner thighs and lower back. Is now also in spine, neck, shoulders, knees and feet also pelvic area.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Discomfort, Injection site paraesthesia, Injection site rash
Clinical narrative: Patient described development of a localized rash around the injection site area. She described it as uncomfortable, with a tingling sensation at the site. She said the rash started to fade, but then came back and has stayed there since the injection (now over a month ago).
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Patient had very bad pain in the arm/muscle where the immunization was administered.  It has been 2 months since the immunization, and she still has pain even though it has improved some.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain, Joint range of motion decreased, Musculoskeletal pain, Pain, Sleep disorder
Clinical narrative: I received the flu vaccination at work.  I am a RN and it is required to receive a flu vaccine every year.  This year the nurse that gave my shot, gave it very high.  I thought it was unusual but didn't say anything at the time.  The injection hurt more than usual.  I knew I would be sore the next day, but the pain continued.  I took ibuprofen and that didn't help much.  Everyday I had this ache, and pain in my shoulder with the pain worse when I moved a certain way.  In November I went to see my Orthopedic who did shoulder surgery on my other shoulder.  I was getting ready to go out of town and wanted something for the pain.  He put my on steroids and that helped greatly, taking the pain away.  But as soon as I started tapering off the steroid the pain came back.  Now, two months later I still have pain that is keeping me up at night.  I am unable to move my arm a certain way and do not have full range of motion.  I called my Dr. back and will see what is next.  I am also reporting this to our Occupational Health Department on Monday 12/29/2014.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Arthralgia, Chills, Headache
Clinical narrative: Headache, chills, joints ache, belly pain.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Eye disorder, Pruritus, Swelling
Clinical narrative: Patient complained of severe redness, itching, and swelling in immunization arm which resolved after a few days. Patient complains of persistent eye discomfort and trouble seeing 12/19/14 and still persisting through 12/27/14.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain
Clinical narrative: Patient stated headache, pain on left side of head, neck, soreness injection site.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Myalgia
Clinical narrative: Pt states that he still feels muscle soreness from the shot since 10/31/2014. Pt will get tested on 12/29/14. He is unsure if he pulled a muscle, or it is from the shot.
Age: 57.0
Sex: M
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Pain, Pain in extremity
Clinical narrative: Significant sharp pain in mid upper left arm of area near injection site and spread to upper arm and lower shoulder. Range of motion became restricted to approx. 20 degrees less than normal extension upwards. Subsided substantially in about 48 hours. Have had flu vaccines in previous three consecutive years, but never any reaction.
Age: 20.0
Sex: M
Vaccine: FLU3
Symptoms: Generalised tonic-clonic seizure, Postictal state
Clinical narrative: Tonic clonic seizure lasting about 45 sec with post ictal phase of 5 min.
Age: 0.51
Sex: M
Vaccine: DTAP
Symptoms: Agitation, Irritability, Pyrexia, Rash
Clinical narrative: Fever was noted and throughout the night progressed to reach 102.9. Was given infant Tylenol and did not improve so gave infant Motrin per Dr. office. Helped slightly but fever remained until 12/25/2014. Lowest fever ever got was 99 degrees. Two days into the reaction patient developed spotty rash. Patient was also very fussy and agitated.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site discomfort, Injection site reaction, Injection site swelling, Injection site warmth, Sensory disturbance
Clinical narrative: At time of injection patient noted sensation down arm from site of injection. Next day noticed discomfort, swelling and warmth from injection site to elbow. (Lasted about 2 weeks). Still may be a little bit of swelling on 12/27/14.
Age: 62.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Burning sensation, Erythema, Mobility decreased, Pain, Pruritus
Clinical narrative: Pt received BOOSTRIX (L) arm) and ZOSTAVX (R arm) and reports pain (intermittent) and worsened after hot shower. Redness on and off. Reports swelling after injection and "itched" symptoms maintained one month after injection and reports pain as constant "burn" and "aching". Difficult to lift arm. Has taken some ibuprofen.
Age: 62.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Swelling
Clinical narrative: Pt received BOOSTRIX (L) arm) and ZOSTAVX (R arm) and reports pain (intermittent) and worsened after hot shower. Redness on and off. Reports swelling after injection and "itched" symptoms maintained one month after injection and reports pain as constant "burn" and "aching". Difficult to lift arm. Has taken some ibuprofen.
Age: 66.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Cellulitis, Erythema, Swelling
Clinical narrative: Patient developed redness/swelling near injection site on left arm. Diagnosed with cellulitis.
Age: 83.0
Sex: U
Vaccine: PNC13
Symptoms: Pain, Pruritus, Swelling
Clinical narrative: Received vaccine 12/16/14. Soreness that night that lasted 3 days. On 12/19/14 area was itchy then swollen 12/22/14. Patient went to MD 12/23 to get clindamycin 300mg - 1 cap 3x day. Area is fine now.
Age: 0.18
Sex: F
Vaccine: RVX
Symptoms: Diarrhoea, Immediate post-injection reaction, Pyrexia, Urticaria, Vomiting
Clinical narrative: Face broke out in red welts as well as on abdomen and leg immediately after oral vaccination. By morning the next day she had a fever of 101 and started vomiting and diarrhea.
Age: 60.0
Sex: F
Vaccine: FLUX
Symptoms: Fatigue, Injected limb mobility decreased, Injection site pain, Musculoskeletal pain, Pain
Clinical narrative: I received a flu vaccine on Oct 3, 2014 in my right arm.  Since then I have had progressively worse pain in my shoulder at the site.  My bicep muscle is so sore it wakes me up at night.  I have tried heat; I have tried ice. These decrease the pain by about 5% maybe although not all the time and this lasts only for a short time - about an hour.  I cannot lift my arm to put plates away in the cupboard and my arm becomes fatigued when I write. I have tremendous pain many times throughout the day especially when I lift the arm or stretch to reach for something.  It's like someone knocked the breath out of me.  Other times it's a dull ache.  I have reported this to my PCP although he is sending me to physical therapy for an unrelated problem in my shoulder as he theorizes the two situations are related to possibly degenerative spondylosis in my neck area.  The pain there appears unrelated to the arm pain although I trust my PCP; he is very good. I wanted to report this to the appropriate persons.  If you are not the correct contact please let me know.  I don't want someone else to go through this pain.  It is very painful. No swelling at the site.  I had shoulder pain prior to this although ONLY shoulder involved - not the entire arm and bicep muscle.  I received the vaccine through my husband's work health provider.  It was given by persons from the pharmacy.
Age: 24.0
Sex: M
Vaccine: FLUX
Symptoms: Dysstasia, Electromyogram abnormal, Fall, Gait disturbance, Guillain-Barre syndrome
Clinical narrative: 24 years old male presented to hospital after a fall on Nov 11.  He started experiencing weakness and numbness in bilateral lower extremities and hands that were ascending to his trunk.  He developed tetraparesis.  Had extensive workup, incluidng MRIs, nerve conduction studies. Diagnosed by Guillain Barre syndrome (AMSAN).  Had almost 16 days of hospitalization and 25 days of acute rehabiliation, still cannot stand up and walk without assistance, has severe neuropathic pain.  Received IVIG 2 courses 5 days each, steroids, Lyrica, Nortriptyline and other medications. Will need further physical therapy as outpatient.  Patient reported only being vaccinated with inactivated influenza vaccine shot at a private doctors office in mid-October, 2014, no other reported viral or other infectious disease.  He cannot recall the address and the exact address of the place, but his brother will know.  The family raised concern that this might be associated with his vaccination as he had no other medical problems, no similar family history. I am the Internal Medicine resident physician following him while he is in the acute rehabiliation unit.  I notified the patient and the family that I will report this case to VAERS.
Age: 24.0
Sex: M
Vaccine: FLUX
Symptoms: Hypoaesthesia, Immunoglobulin therapy, Muscular weakness, Nerve conduction studies abnormal, Neuralgia
Clinical narrative: 24 years old male presented to hospital after a fall on Nov 11.  He started experiencing weakness and numbness in bilateral lower extremities and hands that were ascending to his trunk.  He developed tetraparesis.  Had extensive workup, incluidng MRIs, nerve conduction studies. Diagnosed by Guillain Barre syndrome (AMSAN).  Had almost 16 days of hospitalization and 25 days of acute rehabiliation, still cannot stand up and walk without assistance, has severe neuropathic pain.  Received IVIG 2 courses 5 days each, steroids, Lyrica, Nortriptyline and other medications. Will need further physical therapy as outpatient.  Patient reported only being vaccinated with inactivated influenza vaccine shot at a private doctors office in mid-October, 2014, no other reported viral or other infectious disease.  He cannot recall the address and the exact address of the place, but his brother will know.  The family raised concern that this might be associated with his vaccination as he had no other medical problems, no similar family history. I am the Internal Medicine resident physician following him while he is in the acute rehabiliation unit.  I notified the patient and the family that I will report this case to VAERS.
Age: 24.0
Sex: M
Vaccine: FLUX
Symptoms: Nuclear magnetic resonance imaging, Quadriparesis
Clinical narrative: 24 years old male presented to hospital after a fall on Nov 11.  He started experiencing weakness and numbness in bilateral lower extremities and hands that were ascending to his trunk.  He developed tetraparesis.  Had extensive workup, incluidng MRIs, nerve conduction studies. Diagnosed by Guillain Barre syndrome (AMSAN).  Had almost 16 days of hospitalization and 25 days of acute rehabiliation, still cannot stand up and walk without assistance, has severe neuropathic pain.  Received IVIG 2 courses 5 days each, steroids, Lyrica, Nortriptyline and other medications. Will need further physical therapy as outpatient.  Patient reported only being vaccinated with inactivated influenza vaccine shot at a private doctors office in mid-October, 2014, no other reported viral or other infectious disease.  He cannot recall the address and the exact address of the place, but his brother will know.  The family raised concern that this might be associated with his vaccination as he had no other medical problems, no similar family history. I am the Internal Medicine resident physician following him while he is in the acute rehabiliation unit.  I notified the patient and the family that I will report this case to VAERS.
Age: 56.0
Sex: F
Vaccine: PPV
Symptoms: Infection, Injected limb mobility decreased, Needle issue, Pain in extremity
Clinical narrative: Severe pain in arm.  It got to where I could not even lift my arm.  As of 12/28/2014 the pain is still there.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Fatigue, Myalgia
Clinical narrative: Muscle pain in forearm of arm administered that night and following morning. Exhaustion. Felt faint and dizzy.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Significant swelling, itching and redness in area of injection site. Progressively got worse over the next week. Itching has remained x10 days.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Erythema, Induration, Pain, Pruritus
Clinical narrative: Unusually painful vaccination at the time of administration.  Continued to be sore, red, and swollen for several days.  Then began itching with more swelling and induration. On 15 Dec 14, I was treated at an acute care clinic and ordered Cephalexin 500 mg TID for 10 days to treat cellulitis RUA post 1 wk. of Prevnar 13 vaccination.  Had received first pneumonia vaccination in 2009.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Swelling, Vaccination site pain
Clinical narrative: Unusually painful vaccination at the time of administration.  Continued to be sore, red, and swollen for several days.  Then began itching with more swelling and induration. On 15 Dec 14, I was treated at an acute care clinic and ordered Cephalexin 500 mg TID for 10 days to treat cellulitis RUA post 1 wk. of Prevnar 13 vaccination.  Had received first pneumonia vaccination in 2009.
Age: 0.51
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PPV
Symptoms: Crying, Cyanosis, Depressed level of consciousness, Diet refusal, Electrocardiogram normal
Clinical narrative: Forty minutes of prolonged crying (unusual to our child) and figured that she was hungry.  Tried to nurse her and she would not eat.  This was the first time that she would not eat and it alarmed us.  We figured she was in pain from the vaccinations and gave her infant Tylenol as directed by her doctor.  She calmed down about 5-10 minutes later and put her in the carseat to go home.  Around 5-10 minutes after that she vomited clear liquid.  This was alarming because se had only had breast milk in her life.  She immediately turned white and became very lethargic.  She had a blank stare and trouble staying conscious.  We put her in the car and started to the ER.  On our way she became completely unconscious and turned blue/purple.  At this point we called 911 and got her in an upright position and waited for the ambulance.  She was beginning to regain consciousness when they arrived yet was still blue.  The paramedics gave her oxygen in the ambulance on the way to the ER.  She was admitted immediately.  While at the ER nobody knew what had happened.  They thought it might have been a febrile seizure but while at the ER she was not convulsing or showing any other signs of a seizure at that point.  Her temperature was ok and they monitored her heart rate for a while.  Within a month an EKG and an EEG were administered with normal results.  It was not until her current doctor that our concerns regarding the correlation to the vaccinations were validated.  The nurse at the ER immediately disregarded our concerns saying that vaccinations do not cause any side effects.
Age: 0.51
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PPV
Symptoms: Electroencephalogram normal, Lethargy, Loss of consciousness, Pallor, Staring
Clinical narrative: Forty minutes of prolonged crying (unusual to our child) and figured that she was hungry.  Tried to nurse her and she would not eat.  This was the first time that she would not eat and it alarmed us.  We figured she was in pain from the vaccinations and gave her infant Tylenol as directed by her doctor.  She calmed down about 5-10 minutes later and put her in the carseat to go home.  Around 5-10 minutes after that she vomited clear liquid.  This was alarming because se had only had breast milk in her life.  She immediately turned white and became very lethargic.  She had a blank stare and trouble staying conscious.  We put her in the car and started to the ER.  On our way she became completely unconscious and turned blue/purple.  At this point we called 911 and got her in an upright position and waited for the ambulance.  She was beginning to regain consciousness when they arrived yet was still blue.  The paramedics gave her oxygen in the ambulance on the way to the ER.  She was admitted immediately.  While at the ER nobody knew what had happened.  They thought it might have been a febrile seizure but while at the ER she was not convulsing or showing any other signs of a seizure at that point.  Her temperature was ok and they monitored her heart rate for a while.  Within a month an EKG and an EEG were administered with normal results.  It was not until her current doctor that our concerns regarding the correlation to the vaccinations were validated.  The nurse at the ER immediately disregarded our concerns saying that vaccinations do not cause any side effects.
Age: 0.51
Sex: F
Vaccine: DTAP, HEP, HIBV, IPV, PPV
Symptoms: Vomiting
Clinical narrative: Forty minutes of prolonged crying (unusual to our child) and figured that she was hungry.  Tried to nurse her and she would not eat.  This was the first time that she would not eat and it alarmed us.  We figured she was in pain from the vaccinations and gave her infant Tylenol as directed by her doctor.  She calmed down about 5-10 minutes later and put her in the carseat to go home.  Around 5-10 minutes after that she vomited clear liquid.  This was alarming because se had only had breast milk in her life.  She immediately turned white and became very lethargic.  She had a blank stare and trouble staying conscious.  We put her in the car and started to the ER.  On our way she became completely unconscious and turned blue/purple.  At this point we called 911 and got her in an upright position and waited for the ambulance.  She was beginning to regain consciousness when they arrived yet was still blue.  The paramedics gave her oxygen in the ambulance on the way to the ER.  She was admitted immediately.  While at the ER nobody knew what had happened.  They thought it might have been a febrile seizure but while at the ER she was not convulsing or showing any other signs of a seizure at that point.  Her temperature was ok and they monitored her heart rate for a while.  Within a month an EKG and an EEG were administered with normal results.  It was not until her current doctor that our concerns regarding the correlation to the vaccinations were validated.  The nurse at the ER immediately disregarded our concerns saying that vaccinations do not cause any side effects.
Age: 14.0
Sex: M
Vaccine: FLU3, MNQ
Symptoms: Blood pressure decreased, Dizziness, Nausea, Vomiting
Clinical narrative: Nausea, vomiting x 1, light-headedness/wooziness.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Induration and swelling of vaccine injection site with extension of induration and redness further down upper arm in a triangular pattern about 4inches below site of injection. Patient complains of tenderness.
Age: 12.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza, Vaccination failure
Clinical narrative: Case number PHEH2014US025351, is an initial spontaneous report received from a consumer on 15 Dec 2014. This report refers to a 12 year old male patient. His medical history and concomitant medication were not reported. The patient was vaccinated FLUVIRIN (batch number: not reported) intramuscularly in Sep 2014. Despite vaccination with FLUVIRIN, she developed influenza (vaccination failure) on 12 Dec 2014. The outcome of the event influenza was unknown. Seriousness was not reported. Seriousness assessment of influenza and vaccination failure was upgraded to serious (medically significant) based on NV-key event list. Causality was not reported.
Age: 19.0
Sex: M
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a Registered nurse via a company representative refers to two 19 year old male patients. On an unknown dates in December 2014 (reported as "sometime last week"), the patients were vaccinated with GARDASIL 9 (lot#, strength and frequency unknown), 0.5 ml, intramuscular. The patients fainted shortly after being vaccinated with GARDASIL 9. The patients did not seek medical attention and no treatment was given for the event. The outcome of the event was unknown. This is one of the two reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Transfusion
Clinical narrative: This spontaneous report was received from a healthcare student refers to a male patient of unknown age. No pertinent medical history was reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (strength, dose, route, lot# were not reported) to prevent shingles. On an unknown date, after this, the patient received a blood transfusion for an unspecified reason. On an unspecified date, after this, the patient developed shingles. Patient sought medical attention by calling pharmacist. No Product Quality Complaint (PQC) was involved. The outcome of the events was unknown. Causality was not assessed by the reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Interchange of vaccine products
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender who was enrolled in a market research program. On an unknown date the patient had seen or heard that the PNEUMOVAX 23 should be used as a second follow up vaccine to the initial PREVNAR 13 for most patients. The outcome of event was unknown. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Vaccination complication
Clinical narrative: This spontaneous report as received from a registered nurse via field representative refers to two patients of unknown age and gender. On an unknown date, the patients were vaccinated with ZOSTAVAX (lot # K014834, expiration date 14-DEC-2015, dose, route not provided) for prevention of shingles. On an unknown date, the patients experienced unspecified reactions to ZOSTAVAX. The outcome was unknown. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Syncope
Clinical narrative: This spontaneous report as received from a Registered nurse via a company representative refers to a male patient in early 20's. On an unknown date in December 2014 (reported as "sometime last week"), the patient was vaccinated with GARDASIL 9 (lot#, strength and frequency unknown), 0.5 ml, intramuscular. The patient fainted shortly after being vaccinated with GARDASIL 9. The patient did not seek medical attention and no treatment was given for the event. The outcome of the event was unknown. This is one of the two reported received form the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 22-DEC-2014, a dose of VARIVAX (Merck) (lot#, strength, dosage, frequency and route unknown) which was expired on 30-NOV-2014 was inadvertently administered to the patient. No adverse effects were reported. Additional information has been requested.
Age: 49.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Rash generalised
Clinical narrative: Rash that spread all over body, especially in one area where wears knee brace. Rash is weepy. Started about 2 hours after vaccine and has lasted about 3 wks at this point. Itchy also.
Age: 49.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Rash generalised, Rash pruritic, Secretion discharge
Clinical narrative: Rash that spread all over body, especially in one area where wears knee brace. Rash is weepy. Started about 2 hours after vaccine and has lasted about 3 wks at this point. Itchy also.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP, FLUN4, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Crying, Cyanosis, Eye movement disorder, Hypotonia, Pulse absent
Clinical narrative: Immunazations given per order. As last injection was given the child stopped breathing (Went limp, turned blue, eyes rolled back in head, no pulse). MA started CPR. I called Dr. into the room. Asked other MA's in building to call 911. I went and got the ambu bag and oxygen. CPR was given for around 3 min. Blow by oxygen was administered by Dr at a level of 2. Child then started crying. I obtained vitals and monitored child till squad arrived. Child was taken to ED by medic.
Age: 2.0
Sex: M
Vaccine: DTAPHEPBIP, FLUN4, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Respiratory arrest, Resuscitation
Clinical narrative: Immunazations given per order. As last injection was given the child stopped breathing (Went limp, turned blue, eyes rolled back in head, no pulse). MA started CPR. I called Dr. into the room. Asked other MA's in building to call 911. I went and got the ambu bag and oxygen. CPR was given for around 3 min. Blow by oxygen was administered by Dr at a level of 2. Child then started crying. I obtained vitals and monitored child till squad arrived. Child was taken to ED by medic.
Age: 12.0
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Death
Clinical narrative: This spontaneous report as received from a patient's mother refers to a 12 year old healthy female patient and was identified during social media monitoring. Current conditions and medical history was not reported. On an unknown date, the patient was vaccinated with GARDASIL injection (strength, route, dose, frequency and indication not provided). No concomitant medication was reported. On an unknown date, the patient died. The outcome of the event was fatal. The causality assessment was provided as related (reported as GARDASIL suspected). Product quality complaint was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4, HPV4
Symptoms: Death
Clinical narrative: This spontaneous report as received from the mother of a female patient of unknown age via Social Media (Twitter). On an unknown date the patient was vaccinated with GARDASIL (route, dosage, dose number and lot number unknown). It was reported the patient died from getting GARDASIL. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain
Clinical narrative: Pain in shoulder with raising arm overhead activities and upper body dressing, has become worse.
Age: 33.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Continued pain in left shoulder following flu shot.  Pain at night. Unable to lift arm with pressure.  Pain improved after 2 months, but still present.
Age: 41.0
Sex: F
Vaccine: ANTH, IPV, MMR, TYP
Symptoms: Injected limb mobility decreased, Injection site erythema, Peripheral swelling, Vaccination site rash, Vaccination site swelling
Clinical narrative: Swelling, redness, and rash around Anthrax vaccine site, unable to raise right arm, swelling down right arm and bilateral swelling to hand.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Insomnia, Musculoskeletal pain, Pain
Clinical narrative: I received a flu shot and the next few days my shoulder was sore the pain did not go away with time or rest.  My shoulder would hurt at different times and with different movements never the same movement twice.   I had difficulty dressing and sleeping.  Never had shoulder pain discomfort before flu shot this year.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain
Clinical narrative: Started with bad back pain.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Drug administered at inappropriate site, Hypoaesthesia, Mobility decreased, Pain
Clinical narrative: I feel that the injection was not in the deltoid muscle as intended.  The injection was in the shoulder joint. I have had pain achiness, sharp pains and numbness and tingling.  It has been approx. 6 weeks now and I cont. to have pain and decreased mobility requiring assistance taking off my shirt and coat.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: I feel that the injection was not in the deltoid muscle as intended.  The injection was in the shoulder joint. I have had pain achiness, sharp pains and numbness and tingling.  It has been approx. 6 weeks now and I cont. to have pain and decreased mobility requiring assistance taking off my shirt and coat.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Drug administered at inappropriate site, Pain
Clinical narrative: Received annual flu shot as usual, but injection given superior to deltoid muscle into the left shoulder capsule.  Pain & weakness have been present 8 weeks, typically only last 1 - 2 days.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Injection site pain
Clinical narrative: Flu shot administered in left shoulder joint line per employee. Pain in left shoulder since flu shot given.
Age: 76.0
Sex: M
Vaccine: PNC13
Symptoms: Chills, Confusional state, Hyperhidrosis, Injection site cellulitis, Pyrexia
Clinical narrative: Fever (101.2), sweats, chills, confusion. 12/24/2014 cellulitis at injection site started.
Age: 56.0
Sex: M
Vaccine: FLUX, TDAP
Symptoms: Epistaxis, Immunoglobulin therapy, Melaena, Oral disorder, Platelet count decreased
Clinical narrative: Patient experienced profound thrombocytopenia causing epistaxis, melena, and painless oral lesions. This required an emergency room visit, and hospitalization on the general medical floor to receive steroids, IVIG, and 4 platelet transfusions.
Age: 56.0
Sex: M
Vaccine: FLUX, TDAP
Symptoms: Platelet transfusion, Thrombocytopenia
Clinical narrative: Patient experienced profound thrombocytopenia causing epistaxis, melena, and painless oral lesions. This required an emergency room visit, and hospitalization on the general medical floor to receive steroids, IVIG, and 4 platelet transfusions.
Age: 58.0
Sex: M
Vaccine: PPV
Symptoms: Bursitis, Periarthritis, Tendonitis
Clinical narrative: Patient received 0.5ml PNEUMOVAX 23 in left deltoid. Patient experienced tendinitis, bursitis, capsulitis.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Bursitis
Clinical narrative: Bursitis of left shoulder. Diagnosed by primary care md and now having physical therapy that is ongoing for last month and still continuing.
Age: 29.0
Sex: F
Vaccine: FLU3
Symptoms: Medication error
Clinical narrative: Vaccine administered to participant who indicated either pregnant or nursing on consent form.
Age: 83.0
Sex: F
Vaccine: FLU3
Symptoms: Bone pain, Decreased appetite, Fatigue
Clinical narrative: Pt's husband reports she experienced bone pain, fatigue, lack of appetite for months (2-3 months).
Age: 83.0
Sex: M
Vaccine: FLU3
Symptoms: Bone pain, Decreased appetite, Fatigue
Clinical narrative: Pt reports bone pain, fatigue, lack of appetite for months (2-3 months). Didn't mention txt taken.
Age: 13.0
Sex: F
Vaccine: FLU4, MNQ
Symptoms: Malaise, Oropharyngeal pain, Pyrexia
Clinical narrative: Client complained of not feeling well 12/18/14 after school. Complained of sore throat, and had a fever of 102.9. Parent contacted nurse on 12/19/14, and was advised to have client seen by a Dr (at that point client had taken ibuprofen and consumed popsicles). Nurse called mother 12/29/14 for an update, and was informed that client began to feel better on 12/23/14, and is no longer feeling ill at this time.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash
Clinical narrative: Rash developed around injection site approx. 4" in diameter. Patient was seen at walk in and treated for possible cellulitis.
Age: 26.0
Sex: F
Vaccine: ANTH, TYP
Symptoms: Activities of daily living impaired, Joint range of motion decreased, Joint swelling, Pain in extremity
Clinical narrative: Patient is a 27-year-old female with no significant past medical history who describes an adverse reaction to her anthrax vaccine received on 9 January 2014 (Manufacturer Emergent Biodefense Operations; Lot # FAV328A, Left Arm, Intramuscularly). Specifically, patient described receiving the vaccine and almost immediately developed pain to the left arm. This pain progressed to develop swelling that extended almost to her wrist and lasted for greater than one week. She denied any weakness, numbness, paresthesias or systemic symptoms. She specifically denied any lip swelling, tongue swelling, throat tightness, or any airway or vascular compromise. She denied any skin lesions or rash at other sites noncontiguous with the vaccine site. Patient stated the pain and swelling was so extensive she was unable to perform her normal duties, or social activities for more than one week. She stated her range of motion was extremely limited and pain was severe. Patient stated she did seek medical attention in the emergency department and was treated with BENADRYL and anti-inflammatories with slow improvement. She denied any long-term sequelae or permanent symptoms from this adverse reaction.
Age: 28.0
Sex: M
Vaccine: RAB
Symptoms: Drug administered at inappropriate site, Immediate post-injection reaction, Injected limb mobility decreased, Injection site discomfort, Injection site pain
Clinical narrative: Patient described receiving rabies #2 vaccine on November 14, 2014 (Novartis pharmaceuticals, lot #541011A, 1mL IM in the left arm). Of note, he described receiving the vaccine very high on the arm very close to the acromion process. He endorsed immediate onset tightness of the left arm that progressed over the next 2-3 days and began to significantly limit his range of motion. He described normal activity such as turning the steering wheel or placing deodorant caused significant discomfort. He described a constant pain 2/10 in intensity with significant exacerbations up to 7-8/10 intensity with certain motions. He denied any true weakness of the arm. He denied any associated rash, urticaria, lip swelling, tongue swelling, throat tightness, or any airway or vascular compromise. Additionally, he denied any associated fevers, chills, night sweats, nausea, vomiting, diarrhea, generalized muscle aches/pains or synovitis. He was treated with MOTRIN for his symptoms which partially relieved the pain, but upon discontinuation the pain returned with increased intensity.
Age: 28.0
Sex: M
Vaccine: RAB
Symptoms: Nuclear magnetic resonance imaging abnormal, Pain, Tendon disorder
Clinical narrative: Patient described receiving rabies #2 vaccine on November 14, 2014 (Novartis pharmaceuticals, lot #541011A, 1mL IM in the left arm). Of note, he described receiving the vaccine very high on the arm very close to the acromion process. He endorsed immediate onset tightness of the left arm that progressed over the next 2-3 days and began to significantly limit his range of motion. He described normal activity such as turning the steering wheel or placing deodorant caused significant discomfort. He described a constant pain 2/10 in intensity with significant exacerbations up to 7-8/10 intensity with certain motions. He denied any true weakness of the arm. He denied any associated rash, urticaria, lip swelling, tongue swelling, throat tightness, or any airway or vascular compromise. Additionally, he denied any associated fevers, chills, night sweats, nausea, vomiting, diarrhea, generalized muscle aches/pains or synovitis. He was treated with MOTRIN for his symptoms which partially relieved the pain, but upon discontinuation the pain returned with increased intensity.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as receivef from a Licensed Practical Nurse refers to a patient of unknown age and gender. On 22-DEC-2014 the patient was vaccinated with ROTATEQ, oral (Lot # not reported) for an unknown indication. And the patient received ROTATEQ improperly stored and administered. No adverse event were reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Medication error
Clinical narrative: This spontaneous report as received from a pharmacist via Bayer refers to a patient of unknown age who enrolled in a Market Research Program. On an unknown date the patient was vaccinated with a dose of PNEUMOVAX 23 (lot #, expiration date and route unspecified) 8 weeks after PREVNAR. The seriousness of adverse experience was unknown. Additional information is not expected because the reporter refused additional contact.
Age: 40.0
Sex: U
Vaccine: TDAP
Symptoms: Blood thyroid stimulating hormone, Cellulitis, Full blood count, Haemoglobin, Lipids
Clinical narrative: Initial unsolicited report received from a nurse on 22 December 2014. It pertains to one of three patients from the same facility who experienced similar events after receiving ADACEL; the other two reports are captured in case numbers 2014SA145943 and 2014SA177586. A 40-year-old patient, with no past medical history, received a left deltoid intramuscular injection of ADACEL (lot number U4874AA) on 09 October 2014. One day post-vaccination, the patient experienced arm swelling, soreness, and pain, and was seen by a physician on 14 October 2014. The patient was diagnosed with cellulitis and treated with BACTRIM. The patient underwent testing (CBC, CMP, lipids, TSH, Hemoglobin) but results were not reported. The event resolved on an unspecified date, and the patient did not return for follow-up. Documents held by sender: None.
Age: 40.0
Sex: U
Vaccine: TDAP
Symptoms: Local swelling, Metabolic function test, Pain
Clinical narrative: Initial unsolicited report received from a nurse on 22 December 2014. It pertains to one of three patients from the same facility who experienced similar events after receiving ADACEL; the other two reports are captured in case numbers 2014SA145943 and 2014SA177586. A 40-year-old patient, with no past medical history, received a left deltoid intramuscular injection of ADACEL (lot number U4874AA) on 09 October 2014. One day post-vaccination, the patient experienced arm swelling, soreness, and pain, and was seen by a physician on 14 October 2014. The patient was diagnosed with cellulitis and treated with BACTRIM. The patient underwent testing (CBC, CMP, lipids, TSH, Hemoglobin) but results were not reported. The event resolved on an unspecified date, and the patient did not return for follow-up. Documents held by sender: None.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Local swelling, Pain
Clinical narrative: Initial unsolicited report received from a nurse on 22 December 2014. It pertains to one of three patients from the same facility who experienced similar events after receiving ADACEL; the other two reports are captured in case numbers 2014SA145943 and 2014SA177591. A 27-year-old female patient, with no past medical history, received a left deltoid intramuscular injection of ADACEL (lot number U4874) on 29 August 2014. One day post-vaccination, she experienced arm swelling, soreness, and pain, and was seen by a nurse. She was diagnosed with cellulitis and treated with CLEOCIN. No laboratory testing was performed. The event resolved on an unspecified date, and the patient did not return for follow-up. Documents held by sender: None.
Age: 77.0
Sex: M
Vaccine: FLU4
Symptoms: Blood lactic acid increased, Chest X-ray normal, Chills, Confusional state, Disorientation
Clinical narrative: Initial report received from a healthcare professional on 17 December 2014 and follow-up information was received on 19 December 2014. A 77-years-old male patient, whose concomitant medications were not reported, had received a dose of FLUZONE QUADRIVALENT (Dose number, Batch number, expiry date, route and site of vaccination were not reported), on 16 December 2014. The patient had LASIX allergy and asthma as medical history. On 16 December 2014, after vaccination the patient had shivers, chills, myalgia, nausea and fever of body temperature 103F within the next few hours. By 9 pm he was disoriented and confused. He was taken to ER and diagnosed with Right Lower Lobe Pneumonia. On admission the patient's body temperature was about 101 and his blood lactic acid was elevated. He had no shortness of breath, bronchospasm, or any injection-site reaction. The patient had started on an antibiotic in the emergency room. The allergist consulted on the case who stated there was not IgG response to vaccine. Chest X-ray did not show definitive infiltrates. By 5 am on 17 Dec 2014, he was back to baseline with respect to his mental status and on the same day the patient was expected to be discharged from the hospital on an oral antibiotic. Illness at the time of vaccination, birth defects and medical conditions were unknown. At the time of this report, the outcome of the adverse events was not recovered. List of documents held by sender: none.