chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Incorrect route of drug administration, Injection site erythema, Injection site swelling, Injection site warmth, Wrong drug administered
Clinical narrative: Vaccine error, FLUZONE 0.1 cc given intradermal by mistake, instead of PPD. 20 min after 4x2 cm redness, swelling, hot, not change at 1hr, 8.5 x 6.5 cm at 24 hours. Tx: BENADRYL, NSAIDs, Ice.
Age: 66.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Pain in extremity
Clinical narrative: Continuous, chronic pain in Rt arm since injection.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site discolouration, Injection site pain
Clinical narrative: After patient received vaccine she had a mark on arm where administered and pain. The mark is still there to this day and patient still has consistent arm pain from injection site.
Age: 2.0
Sex: F
Vaccine: DTAPHEPBIP, FLU4, HEPA
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Right thigh redness, swelling. Diagnosed cellulitis in E.D. given KEFLEX and recovered. Note patient given PEDIARIX instead of DTaP as indicated.
Age: 12.0
Sex: F
Vaccine: HPV9, TDAP, HPV4, TDAP
Symptoms: Fall, Head injury, Loss of consciousness, Syncope
Clinical narrative: Fainted; fell and struck head on floor. Was unconscious for approximately 30-60 seconds.
Age: 12.0
Sex: F
Vaccine: HPV9, TDAP, HPV4, TDAP
Symptoms: Concussion, Pain in extremity, Syncope, Tremor
Clinical narrative: Fainted; fell and struck head on floor. Was unconscious for approximately 30-60 seconds.
Age: 12.0
Sex: F
Vaccine: HPV9, TDAP, HPV4, TDAP
Symptoms: Fall, Head injury, Loss of consciousness, Syncope
Clinical narrative: Mother calls to report child experienced of top of both hands painful and hurting and shaking for 7 minutes while chasing dogs in yard on 4/2/17. Child seen at ER 3/29 from faint had concussion.
Age: 12.0
Sex: F
Vaccine: HPV9, TDAP, HPV4, TDAP
Symptoms: Concussion, Pain in extremity, Syncope, Tremor
Clinical narrative: Mother calls to report child experienced of top of both hands painful and hurting and shaking for 7 minutes while chasing dogs in yard on 4/2/17. Child seen at ER 3/29 from faint had concussion.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, VARCEL
Symptoms: Dizziness
Clinical narrative: Light headed
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Musculoskeletal pain, Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: SYMPTOMS INCLUDE TENDERNESS, SWELLING (REDNESS) AND PAIN IN THE UPPER ARM. SYMPTOMS ARE SPREADING TO SHOULDER AREA AND TO LOWER ARM. PATIENT CANNOT TAKE DIPHENHYDRAMINE, IBUPROFEN OR ACETAMINOPHEN. PATIENT ALTERNATED AN ICE PACK AND HEAT PAD TO REDUCE PAIN AND SWELLING. PHYSICIAN CALLED IN PREDNISONE AND TRAMADOL.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Fall, Loss of consciousness
Clinical narrative: Pt passed out/lost consciousness about 15 seconds after receiving the vaccine. He hit me as he was falling back, and landed on the table. No injury to the patient.
Age: 18.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Cough, Headache, Influenza virus test positive, Pain, Pyrexia
Clinical narrative: Developed fever of 103, bodyaches, headache and cough. Tested positive for Flu.
Age: 18.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Cough, Headache, Influenza, Influenza virus test positive, Pain
Clinical narrative: Developed fever of 103, bodyaches, headache and cough. Tested positive for Flu.
Age: 18.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Pyrexia, Vaccination failure
Clinical narrative: Developed fever of 103, bodyaches, headache and cough. Tested positive for Flu.
Age: 39.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site pain
Clinical narrative: There were no adverse reaction, just normal pain at injection site.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, PNC13
Symptoms: Seizure, Specialist consultation
Clinical narrative: Seizure x2 post immunizations, hospital observation x24hr, started on KEPPRA.
Age: 6.0
Sex: F
Vaccine: DTAPIPV, HEP, MMR
Symptoms: Chest X-ray normal, Henoch-Schonlein purpura, Laboratory test normal, Oedema peripheral, Rash
Clinical narrative: Henoch-Schonlein purpura. 03/2017: BL ankle edema. No cardiomegaly per CXR. Normal UA. Labs normal. Ended up being early HSP - rash started next day.  recommended bi-weekly f/u for BP and UA. Nl UA and BP 3.27. VAERS to be done given association in time with vaccines.
Age: 6.0
Sex: F
Vaccine: DTAPIPV, HEP, MMR
Symptoms: Urine analysis, Urine analysis normal
Clinical narrative: Henoch-Schonlein purpura. 03/2017: BL ankle edema. No cardiomegaly per CXR. Normal UA. Labs normal. Ended up being early HSP - rash started next day.  recommended bi-weekly f/u for BP and UA. Nl UA and BP 3.27. VAERS to be done given association in time with vaccines.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Abdominal pain, Headache, Oropharyngeal pain, Pyrexia, Sinusitis
Clinical narrative: Abd pain off and on since 3 21 17, HA frontal fever-warm to touch, sore tht, reg strep culture, Dx. Sinusitis 3-27-17.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ
Symptoms: Skin warm, Streptococcus test negative
Clinical narrative: Abd pain off and on since 3 21 17, HA frontal fever-warm to touch, sore tht, reg strep culture, Dx. Sinusitis 3-27-17.
Age: 12.0
Sex: M
Vaccine: DTAP, MNQ
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse events occurred- CDC notified, responded the vaccine will be counted as adolescent Tdap booster. Parent personally notified of vaccine error.
Age: 1.33
Sex: M
Vaccine: DTAP, HEPA, HIBV
Symptoms: Injected limb mobility decreased, Injection site urticaria
Clinical narrative: Patient received vaccines in office. Later that night broke out in hives around the vaccine site. Patient is favoring the leg. No treatment needed. Hives went away on its own.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Menstruation irregular
Clinical narrative: Family states that after her second HPV vaccine, her periods are much less frequent.
Age: 0.08
Sex: F
Vaccine: HEP
Symptoms: Hypersomnia
Clinical narrative: Child slept unmoving for 24 hours after receiving her 1 mo Hep B.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Neuralgia, Pruritus, Rash, Skin discolouration
Clinical narrative: Redness, swelling and itching spread over back of left arm and last for a week before turning dark like a bruise. Intense burning nerve pain started in upper back Rt side only 2 wks later. It stopped for a few days and then returned with a vengeance 1 wk later. Rash developed 1 wk after that.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Redness, swelling and itching spread over back of left arm and last for a week before turning dark like a bruise. Intense burning nerve pain started in upper back Rt side only 2 wks later. It stopped for a few days and then returned with a vengeance 1 wk later. Rash developed 1 wk after that.
Age: 61.0
Sex: M
Vaccine: HEP, HIBV, IPV, PPV, TD
Symptoms: Cellulitis, Erythema, Hypersensitivity, Injection site pruritus, Local reaction
Clinical narrative: Area of redness and tenderness approx 4x6 itches at right posterolateral upper arm-proximal local allergic reaction vs cellulitis.
Age: 61.0
Sex: M
Vaccine: HEP, HIBV, IPV, PPV, TD
Symptoms: Tenderness
Clinical narrative: Area of redness and tenderness approx 4x6 itches at right posterolateral upper arm-proximal local allergic reaction vs cellulitis.
Age: 33.0
Sex: F
Vaccine: HEP, TDAP, VARCEL
Symptoms: Body temperature increased, Pain in extremity, Skin warm, Swelling, Tenderness
Clinical narrative: Swelling, tenderness, warmth, temp 101, arm pain.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Fatigue, Injection site pain, Nausea
Clinical narrative: Extremely painful arm where shot was give, 5 days. Tired for 5 days. Nauseated for 5 days.
Age: 4.0
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Injection site inflammation, Injection site rash
Clinical narrative: Rash w/localized inflammation in area of injection site from the DTaP and VARIVAX.
Sex: F
Vaccine: HEPA, TYP
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: On 3/20/17 (L) tricep YF-VPX; called today 3/27 with erythema, itchness to site but no fever.
Age: 60.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Injection site discomfort, Injection site pain, Limb discomfort, Musculoskeletal discomfort
Clinical narrative: 2 weeks after vaccine soreness in shoulder and pressure in arm and back and down arm left deltoid - typhoid.
Age: 4.0
Sex: F
Vaccine: DTAP, HEPA, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site vesicles
Clinical narrative: Mom and patient came to HD on 3/27/17 and stated that left arm started getting red and swollen on morning of 3/24/17. Around noon, blisters started showing. Mom took patient to PCP. 1 shot of antibiotic and 1 shot of steroid plus Rx for antibiotics. 3/27/17 Arm is still red, blisters gone.
Age: 16.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Mobility decreased, Pain, Peripheral coldness, Vaccination site warmth
Clinical narrative: Patient and mother specify that after the vaccine administration the patient felt very severe pain and the arm was immobilized. The arm was warm in the area near the vaccination (deltoid) and cold in the distant extremity (the wrist and forearm). Did not observe the red area nor the fast heartbeat.  The symptoms lasted for 5 days.
Age: 5.0
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Culture negative, Injection site cellulitis, Skin culture
Clinical narrative: Developed cellulitis after vaccine from injection. Not a true vaccine reaction. Family requesting that report be made.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site pruritus, Injection site rash, Injection site swelling
Clinical narrative: Injection site locally swelling, rash, pain and itchy.
Age: 21.0
Sex: F
Vaccine: MENB
Symptoms: Injection site hypoaesthesia, Injection site paraesthesia, Mobility decreased, Myalgia, Pain
Clinical narrative: Very sore muscle after vaccine, difficulty extending and lifting arm. Pain then improved. Left shoulder tingling and numbness developed 4 days ago.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Facial paralysis, Facial paresis
Clinical narrative: Left facial weakness and face droop that started on 3/28/17 - to be started on acyclovir and prednisone today (3/29/17).
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Chills, Hypoaesthesia, Injection site pain, Musculoskeletal stiffness, Pain
Clinical narrative: Mom describes: about 2 hours after receiving the TRUMENBA vaccine patient was having severe pain on right arm on the injection site, numbness of hands/fingers, stiff neck, shaking of arms, teeth shattering, feeling like throat closing but especially in a lot of pain.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Throat tightness, Tremor
Clinical narrative: Mom describes: about 2 hours after receiving the TRUMENBA vaccine patient was having severe pain on right arm on the injection site, numbness of hands/fingers, stiff neck, shaking of arms, teeth shattering, feeling like throat closing but especially in a lot of pain.
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Unevaluable event
Clinical narrative: None stated.
Age: 69.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site swelling, Pyrexia
Clinical narrative: Induration, swelling, fever, erythema and cellulitis in right upper arm. DEPO MEDROL 40 mg IM, DECADRON 8 mg IM. ROCEPHIN 1 gm IM. BACTRIM 800/160 mg BID x 10d PO. Cephalexin 500 mg BID x 10d. 3/14/17. Improved but not resolved in 1 week.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left arm red, swollen and warm to the touch 2 days after immunization given. Treated w. BACTIM and completely resolved within 2-3 days of starting antibiotic.
Age: 12.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt was due for Tdap, HPV and MENVEO and I had all 3 syringes in container. I drew up MENVEO and set syringe in container then cleaned of lid on GARDASIL and grabbed the same syringe MENVEO was in on accident and drew up and administered. MOC came back at 2:40 with sibs WC and stated daughter is doing just fine.
Age: 1.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site erythema, Pyrexia
Clinical narrative: Vaccine administered on 03/24/17. Redness at injection site on left leg started on 04/02/17, also had fever 102. Prescription for cephalexin given to parent for patient for 5 days.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Chest discomfort, Influenza virus test negative, Laboratory test, Pain, Pain in extremity
Clinical narrative: On 3/24/17 at approximately 7-8 p.m. client reported onset of generalized pruritus which was continuous until 3/29/17 and intensified each evening. 9/25/17 a.m. onset of severe lower leg pain which persisted until 3/29/17 with tolerable generalized body pain. Pressure in mid chest on inspirations only. No shortness of breath, cough, or rash with above complaints. Return to normal 3/30/17. Client reported that her paternal grandmother was severely allergic to Td. Client had Td - 12 yrs ago and did okay. Dr. advised against future Td.
Age: 37.0
Sex: F
Vaccine: TDAP
Symptoms: Pruritus generalised
Clinical narrative: On 3/24/17 at approximately 7-8 p.m. client reported onset of generalized pruritus which was continuous until 3/29/17 and intensified each evening. 9/25/17 a.m. onset of severe lower leg pain which persisted until 3/29/17 with tolerable generalized body pain. Pressure in mid chest on inspirations only. No shortness of breath, cough, or rash with above complaints. Return to normal 3/30/17. Client reported that her paternal grandmother was severely allergic to Td. Client had Td - 12 yrs ago and did okay. Dr. advised against future Td.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Dehydration, Headache, Vomiting
Clinical narrative: Pt. husband reported pt started with headache 2 hours after administration then started vomiting went to ER that night and ER physician felt it was due to ZOSTAVAX. Pt received a RX for ZOFRAN 4mg OPT and was sent home. Pt went back to ER on 4-3-17 due to dehydration. Pt was not admitted and was given fluids and another ZOFRAN RX.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Erythema
Clinical narrative: Pt. given routine PNEUMOVAX, has localized (L) increased arm redness, approx. 3" x 3", advised to take 25mg BENADRYL PO, also advised of advancing allergic reaction S/Sx i.e.: swollen tongue, throat closing.
Age: 1.0
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Erythema, Induration, Pyrexia
Clinical narrative: Fever 102-103. Localised induration 3-cm. Redness - 5-6 cm.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Syncope
Clinical narrative: Patient collapsed forward minutes after given vaccines.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Inappropriate schedule of drug administration, Wrong drug administered
Clinical narrative: Pt and MD thought she has PREVNAR 3 yrs ago. Prescribed PNEUMOVAX booster. After vaccination given, found out she had PNEUMOVAX 3 yrs ago. Is due for PREVNAR.
Age: 4.0
Sex: M
Vaccine: MMR
Symptoms: Anxiety, Blood test, Formication, Sleep disorder
Clinical narrative: 5 days following MMR patient developed intense formication, to the point of not being able to wear clothes, sleep disturbance, and anxiety.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pain, Rash, Scab, Scar
Clinical narrative: Got vaccinated 6/6/16, 6/13/16 7 days later I noticed a rash on patient's (left) side of tummy that evening the rash spread to his (left) side of leg and (left) side of back. Patient was in pain screaming if I touched it. The rashes began to get worse before it got better. By 7/2/16 the scabbing went away and he is now scarred. The vaccination had spread to me (mother) on 6/16/16.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PPV
Symptoms: Infantile spasms, Seizure
Clinical narrative: Initial unsolicited report received from a consumer (patient's mother) on 22-Mar-2017 and additional information received on 23-Mar-2017. This case involves a four-month-old female patient, who was vaccinated with first dose of PENTACEL (batch number: C4257AA; expiry date, dose and route not reported) in thigh and PNEUMOCOCCAL VACCINE (batch number: 918245; expiry date, dose, route and site of administration not reported) on 02-Oct-2012. Patient's Illness at time of vaccination was reported as none and pre-existing physician diagnosed allergies, birth defects, medical conditions were reported as none. Patient was healthy meeting all milestones. Patient's concomitant medication was not reported and any other vaccinations within four weeks of vaccinations were reported as none. On 02-Oct-2012 at night, same day after the vaccination, patient had begun seizing. After that patient experienced daily seizures and had been diagnosed with infantile Spasms. Patient required an emergency room or doctor visit. Patient was hospitalized on an unknown date. Lab test and corrective treatment was not reported. Outcome of the events were reported as not recovered. It was stated that patient never fully recovered. Case was also considered serious for the life-threatening illness and resulted in permanent disability. Documents held by sender: none. Sender's Comments: A 4 month old patient received DIPHTHERIA/TETANUS/5 HYBRID AC PERTUSSIS/IPV (MRC5)/HIB (PRP/T) VACCINE following which patient developed seizures on the same day for which she was hospitalized and diagnosed with infantile spasms. Though there is a temporal relationship, additional information regarding patient's medical history, concomitant medications, vaccination history and reactions are needed to full assessment. Based on available information the role of vaccine cannot be assessed. Seizures are listed with the vaccine.
Age: 15.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Dizziness postural, Fatigue, Headache, Immunology test normal, Migraine
Clinical narrative: Given anthrax vaccine intradermally by error to patient (instead of PPD) Intractable headaches started the night of the injection and have not resolved. Follow up to VAERS #661700-2: Pt developed headache beginning the night of receiving vaccine and she continues with constant, persistent headaches, and intermittent migraines. She also spends long hours in bed, has unrefreshing sleep, intermittent orthostatic dizziness and chronic fatigue. Fatigue necessitates part time home tutoring rather than full time attendance at school. Evaluation by Allergy Immunology and Neurology including MRI of the brain and multiple diagnostics for autoimmune and /or infectious disease have yielded negative results. No diagnosis has been determined. Patient now awaiting sleep study.
Age: 15.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Nuclear magnetic resonance imaging brain abnormal, Poor quality sleep, Viral titre
Clinical narrative: Given anthrax vaccine intradermally by error to patient (instead of PPD) Intractable headaches started the night of the injection and have not resolved. Follow up to VAERS #661700-2: Pt developed headache beginning the night of receiving vaccine and she continues with constant, persistent headaches, and intermittent migraines. She also spends long hours in bed, has unrefreshing sleep, intermittent orthostatic dizziness and chronic fatigue. Fatigue necessitates part time home tutoring rather than full time attendance at school. Evaluation by Allergy Immunology and Neurology including MRI of the brain and multiple diagnostics for autoimmune and /or infectious disease have yielded negative results. No diagnosis has been determined. Patient now awaiting sleep study.
Age: 15.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Blood pressure decreased, Body temperature decreased, Dizziness, Erythema, Fatigue
Clinical narrative: Given anthrax vaccine intradermally by error to patient (instead of PPD) Intractable headaches started the night of the injection and have not resolved. Follow up to VAERS #661700-2: Pt developed headache beginning the night of receiving vaccine and she continues with constant, persistent headaches, and intermittent migraines. She also spends long hours in bed, has unrefreshing sleep, intermittent orthostatic dizziness and chronic fatigue. Fatigue necessitates part time home tutoring rather than full time attendance at school. Evaluation by Allergy Immunology and Neurology including MRI of the brain and multiple diagnostics for autoimmune and /or infectious disease have yielded negative results. No diagnosis has been determined. Patient now awaiting sleep study.
Age: 15.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Feeling abnormal, Headache, Induration, Limb mass, Loss of consciousness
Clinical narrative: Given anthrax vaccine intradermally by error to patient (instead of PPD) Intractable headaches started the night of the injection and have not resolved. Follow up to VAERS #661700-2: Pt developed headache beginning the night of receiving vaccine and she continues with constant, persistent headaches, and intermittent migraines. She also spends long hours in bed, has unrefreshing sleep, intermittent orthostatic dizziness and chronic fatigue. Fatigue necessitates part time home tutoring rather than full time attendance at school. Evaluation by Allergy Immunology and Neurology including MRI of the brain and multiple diagnostics for autoimmune and /or infectious disease have yielded negative results. No diagnosis has been determined. Patient now awaiting sleep study.
Age: 15.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Musculoskeletal pain, Pain in extremity, Seizure, Skin irritation, Vomiting
Clinical narrative: Given anthrax vaccine intradermally by error to patient (instead of PPD) Intractable headaches started the night of the injection and have not resolved. Follow up to VAERS #661700-2: Pt developed headache beginning the night of receiving vaccine and she continues with constant, persistent headaches, and intermittent migraines. She also spends long hours in bed, has unrefreshing sleep, intermittent orthostatic dizziness and chronic fatigue. Fatigue necessitates part time home tutoring rather than full time attendance at school. Evaluation by Allergy Immunology and Neurology including MRI of the brain and multiple diagnostics for autoimmune and /or infectious disease have yielded negative results. No diagnosis has been determined. Patient now awaiting sleep study.
Age: 15.0
Sex: F
Vaccine: ANTH, ANTH
Symptoms: Wrong drug administered
Clinical narrative: Given anthrax vaccine intradermally by error to patient (instead of PPD) Intractable headaches started the night of the injection and have not resolved. Follow up to VAERS #661700-2: Pt developed headache beginning the night of receiving vaccine and she continues with constant, persistent headaches, and intermittent migraines. She also spends long hours in bed, has unrefreshing sleep, intermittent orthostatic dizziness and chronic fatigue. Fatigue necessitates part time home tutoring rather than full time attendance at school. Evaluation by Allergy Immunology and Neurology including MRI of the brain and multiple diagnostics for autoimmune and /or infectious disease have yielded negative results. No diagnosis has been determined. Patient now awaiting sleep study.
Age: 26.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Myalgia
Clinical narrative: This spontaneous report was received from a pharmacist via a company employee and refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 21-FEB-2017, the patient was vaccinated with a first dose of GARDASIL 9 intramuscularly (dose, lot# and expiration date were not reported) to prevent human papillomavirus (HPV). On the same day, the patient experienced injection site pain. It was unspecified what exactly the pain was. The patient was still feeling injection site pain and had not recovered at the time of report. The patient seek medical attention by contacting the pharmacist. The relatedness between the event of injection site pain and GARDASIL 9 was not reported. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Injection site pain
Clinical narrative: This spontaneous report was received from a pharmacist via a company employee and refers to a female patient of unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 21-FEB-2017, the patient was vaccinated with a first dose of GARDASIL 9 intramuscularly (dose, lot# and expiration date were not reported) to prevent human papillomavirus (HPV). On the same day, the patient experienced injection site pain. It was unspecified what exactly the pain was. The patient was still feeling injection site pain and had not recovered at the time of report. The patient seek medical attention by contacting the pharmacist. The relatedness between the event of injection site pain and GARDASIL 9 was not reported. Additional information has been requested.
Age: 1.5
Sex: M
Vaccine: FLU4, HEPA, FLUX, HEPA, FLU4, HEPA
Symptoms: Autopsy, Death, Unresponsive to stimuli
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of sudden infant death syndrome in a 18-month-old male patient who received HAVRIX pediatric (batch number 9TS3T, expiry date 9th November 2018). The patient's past medical history included penis disorder. Concomitant products included Influenza vaccine. On 23rd February 2017, the patient received HAVRIX pediatric .5 ml. On 23rd February 2017, less than a day after receiving HAVRIX pediatric, the patient experienced sudden infant death syndrome (serious criteria death and GSK medically significant). On an unknown date, the outcome of the sudden infant death syndrome was fatal. The patient died on 23rd February 2017. The reported cause of death was sudden infant death syndrome. It was unknown if the reporter considered the sudden infant death syndrome to be related to HAVRIX pediatric. Additional details were reported as follows: This case was also reported to VAERS. The patient was seen for a penis abnormality on the same day when he received the vaccinations. Concomitantly, the patient received a flu vaccine manufactured by other manufacturer. The patient passed away in his sleep that same night. It was unknown if an autopsy was performed. The doctor believed that it might be a sudden infant death syndrome (SIDS) as there were no other reports made by patients receiving this same lot.
Age: 1.5
Sex: M
Vaccine: FLU4, HEPA, FLUX, HEPA, FLU4, HEPA
Symptoms: Death, Sudden infant death syndrome
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of sudden infant death syndrome in a 18-month-old male patient who received HAVRIX pediatric (batch number 9TS3T, expiry date 9th November 2018). The patient's past medical history included penis disorder. Concomitant products included Influenza vaccine. On 23rd February 2017, the patient received HAVRIX pediatric .5 ml. On 23rd February 2017, less than a day after receiving HAVRIX pediatric, the patient experienced sudden infant death syndrome (serious criteria death and GSK medically significant). On an unknown date, the outcome of the sudden infant death syndrome was fatal. The patient died on 23rd February 2017. The reported cause of death was sudden infant death syndrome. It was unknown if the reporter considered the sudden infant death syndrome to be related to HAVRIX pediatric. Additional details were reported as follows: This case was also reported to VAERS. The patient was seen for a penis abnormality on the same day when he received the vaccinations. Concomitantly, the patient received a flu vaccine manufactured by other manufacturer. The patient passed away in his sleep that same night. It was unknown if an autopsy was performed. The doctor believed that it might be a sudden infant death syndrome (SIDS) as there were no other reports made by patients receiving this same lot.
Age: 1.5
Sex: M
Vaccine: FLU4, HEPA, FLUX, HEPA, FLU4, HEPA
Symptoms: Autopsy, Death, Laboratory test
Clinical narrative: This case was reported by a physician via sales rep and described the occurrence of sudden infant death syndrome in a 18-month-old male patient who received HAVRIX pediatric (batch number 9TS3T, expiry date 9th November 2018). The patient's past medical history included penis disorder. Concomitant products included Influenza vaccine. On 23rd February 2017, the patient received HAVRIX pediatric .5 ml. On 23rd February 2017, less than a day after receiving HAVRIX pediatric, the patient experienced sudden infant death syndrome (serious criteria death and GSK medically significant). On an unknown date, the outcome of the sudden infant death syndrome was fatal. The patient died on 23rd February 2017. The reported cause of death was sudden infant death syndrome. It was unknown if the reporter considered the sudden infant death syndrome to be related to HAVRIX pediatric. Additional details were reported as follows: This case was also reported to VAERS. The patient was seen for a penis abnormality on the same day when he received the vaccinations. Concomitantly, the patient received a flu vaccine manufactured by other manufacturer. The patient passed away in his sleep that same night. It was unknown if an autopsy was performed. The doctor believed that it might be a sudden infant death syndrome (SIDS) as there were no other reports made by patients receiving this same lot.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Death, Fatigue
Clinical narrative: My son was extremely tired after getting shots I had to wake him to feed him the next morning he passed away.
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 16-OCT-2013, the patient was administered PNEUMOVAX23 intramuscularly, lot number: J007059, expiry date: 31-JUL-2014).  On 10-MAR-2017, the patient was inadvertently vaccinated with PNEUMOVAX23 intramuscularly, lot number: M029681, expiry date: 22-JAN-2018. No adverse effect was reported. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Interchange of vaccine products, No adverse event
Clinical narrative: This spontaneous report as received from a registered practical nurse via a company representative refers to a female patient of an unknown age. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 16-APR-2014 the patient was vaccinated with her first dose of GARDASIL, (route, dosage, lot number, and expiration date not reported). On 05-DEC-2016 was vaccinated with second dose of GARDASIL 9 (route, dosage, lot number, and expiration date not reported). On 27-FEB-2017 she was vaccinated with a third dose of   GARDASIL 9 (route, dosage, lot number, and expiration date not reported). No adverse event was reported. No additional information was provided. 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 medical assistant refers to unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. In March 2017, reported as on 15-MAR-2017 and 16-MAR-2017, the patients were vaccinated with improperly stored VAQTA, lot # M039202, expiry date 11-MAR-2018 (dose, route and site of administration were not reported) for prophylaxis. No adverse effects noted. Administered doses of vaccines underwent a temperature excursion of 32 to 35 degrees Fahrenheit for 10 hours. Data logger was involved. Previous temperature excursion reported was between 32 to 35 degrees Fahrenheit for 18 hours. This is one of several cases received from the same reporter. Additional information is not expected, as there was no consent given for further contact. Sender's Comments: US-009507513-1704USA000918: US-009507513-1704USA000916: US-009507513-1704USA000917.
Age: 9.0
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage
Clinical narrative: This spontaneous report was received from a medical assistant, referring to two unspecified patients of unknown genders and ages. No information regarding the patient's medical history, concurrent conditions or concomitant therapies was provided. On an unknown date, the patients were vaccinated with improperly stored dose of GARDASIL 9 with a Lot # L014415 and an expiration date of 25-JUL-2017 (strength, dose and route were not reported) for prophylaxis, however no adverse effects reported. It was reported that the vaccine was exposed to temperature of 32 Fahrenheit degrees (°F) to 35 °F for a time frame of 35 days and 4 hours. The temperature excursion was recorded by a data logger and no previous excursions were reported for the vaccine. There was no product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: No adverse event, Underdose
Clinical narrative: Information has been received from a nurse concerning an adult patient of unknown gender. The patient's medical history, concomitant medications, concurrent conditions and drug reactions/allergies were not provided. On an unknown date, the patient was vaccinated with a third dose of a pediatric dose of RECOMBIVAX HB (strength, frequency, route of administration, lot# and expiration date were not provided), for prophylaxis. No adverse symptoms were reported. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Dyspnoea, Hypersensitivity, Injection site swelling, Pruritus generalised, Throat tightness
Clinical narrative: This spontaneous report was received from a 60-year-old female nurse, who was reporting on herself. The patient stated she had no pertinent medical history, however she admitted having a big history of allergies (not otherwise specified). On 23-MAR-2017, the patient received a dose of ZOSTAVAX vial (exact dose, lot # and expiry date were not reported) together with diluent (exact dose, lot # and expiry date were not reported), subcutaneously for prophylaxis. Concomitant therapies included hydrochlorothiazide (reported as "HCTZ") and unspecified estrogen replacement therapy. On the same day, the patient developed raised area at injection site and generalized itching. Following day, she started an unspecified antihistamine treatment. Then, on 26-MAR-2017, the patient experienced shortness of breath and throat tightening which was treated with prednisone (manufacturer unknown). The patient had no lab diagnostics studies performed. The outcome of the events and causality between the event and suspect therapies were not reported. Upon internal review, the events of shortness of breath and throat tightening were considered to be medically significant as they appear to be part of the clinical presentation of an allergic reaction which required medical intervention given by treatment with prednisone (manufacturer unknown) to prevent from jeopardizing the patient. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician assistant refers to an unspecified number of patients of unknown age and gender. No historical conditions, concurrent conditions or concomitant medications were reported for these patients. On an unknown dates, the patients were vaccinated with improperly stored PEDVAXHIB (lot #, expiration dates, dose and route of administration were not provided) for prophylaxis. PEDVAXHIB was exposed to 33 degrees F for 23 minutes. The excursion was captured via a Digital Data Logger. There was no previous temperature excursion. There was no adverse effect reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1704USA000922.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unspecified demographics. The nurse reported that, the patients received improperly stored doses of VARIVAX administered subcutaneously on 01-MAR-2017 (lot number M027344, expiration date 01-JUN-2018, dose was not reported) and on 07-MAR-2017 (lot number M033906, expiration date 20-JUL-2018, dose was not reported). No adverse events were reported. The doses of vaccine experienced a temperature excursion of 61F and 47F to 77F for 27.5 hours which was detected by a digital data logger. There was no previous excursion reported. No product quality complaint (PQC) was reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA004285.
Sex: M
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 14 year old male patient. The patient's concurrent conditions and medical history were not reported. On 06/24/2014, the patient was vaccinated with GARDASIL 9 first dose (dose, route, lot number and expiry date were not reported) for prophylaxis. Later, on 26-JUL-2015, the patient received his second dose of GARDASIL 9 (dose, route, lot number and expiry date were not reported) for prophylaxis. No adverse effects were reported. No product quality complaint (PQC) was involved. Additional information is not expected, because the reporter did not allow any follow up contact with the physician.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Joint swelling, Local reaction, Pain in extremity, Peripheral swelling, Pruritus
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 74 year old female patient. No medical history and concurrent condition were reported. On 30-MAR-2017, the patient was vaccinated with PNEUMOVAX23, dose 0.5 ml, intramuscularly, (lot # M043987, expiry date 30-JUN-2018) for prophylaxis. The vaccine was not prescribed by a physician but administered via pharmacy protocol by a pharmacist other than the reporter. Concomitant therapies included atenolol and levocetirizine dihydrochloride(XYZAL). On 30-MAR-2017, the patient developed a localized reaction. On 31-MAR-2017, she experienced swelling from the elbow up with arm soreness and itching. During this time she also experienced a rash. She took cetirizine(ZYRTEC) on 31-MAR-2017 in the morning for the symptoms and already she was taking  levocetirizine dihydrochloride(XYZAL). Relevant laboratory data was unknown. At the time of the report, the patient continued to experience joint swelling, rash, local reaction, pruritus and pain in extremity. Causality assessment was not provided. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 74 year old female patient. No medical history and concurrent condition were reported. On 30-MAR-2017, the patient was vaccinated with PNEUMOVAX23, dose 0.5 ml, intramuscularly, (lot # M043987, expiry date 30-JUN-2018) for prophylaxis. The vaccine was not prescribed by a physician but administered via pharmacy protocol by a pharmacist other than the reporter. Concomitant therapies included atenolol and levocetirizine dihydrochloride(XYZAL). On 30-MAR-2017, the patient developed a localized reaction. On 31-MAR-2017, she experienced swelling from the elbow up with arm soreness and itching. During this time she also experienced a rash. She took cetirizine(ZYRTEC) on 31-MAR-2017 in the morning for the symptoms and already she was taking  levocetirizine dihydrochloride(XYZAL). Relevant laboratory data was unknown. At the time of the report, the patient continued to experience joint swelling, rash, local reaction, pruritus and pain in extremity. Causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to unspecified patients of unknown age and gender. The patients' concurrent conditions, medical history and concomitant medications were not reported. In March 2017, reported as on 15-MAR-2017 and 16-MAR-2017, the patients were vaccinated with improperly stored RECOMBIVAX HB, lot # M042322, expiry date 21-FEB-2019, lot # M039642, expiry date 03-JUL-2019 (dose, route and site of administration were not reported) for prophylaxis. No adverse effects noted. Administered doses of vaccines underwent a temperature excursion of 32 to 35 degrees Fahrenheit for 10 hours. Data logger was involved. Previous temperature excursion reported was between 32 to 35 degrees Fahrenheit for 18 hours. This is one of several cases received from the same reporter. Additional information is not expected, as there was no consent given for further contact. Sender's Comments: US-009507513-1704USA000917: US-009507513-1704USA000918: US-009507513-1703USA008776.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a physician assistant refers to an unspecified number of patients of unknown age and gender. No historical conditions, concurrent conditions or concomitant medications were reported for these patients. On unknown dates, the patients were vaccinated with improperly stored ROTATEQ (lot #, expiration dates and doses were not provided). The vaccine was exposed to a temperature of 33 degrees F for 23 minutes. The excursion was captured via a Digital Data Logger. There was no previous temperature excursion. There was no adverse effect reported. This is one of two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA013043.
Sex: U
Vaccine: PNC13
Symptoms: Cellulitis, Oedema, Pyrexia, Rash erythematous, Skin plaque
Clinical narrative: The initial case was missing the following minimum criteria: Unspecified number of patients. Upon receipt of follow-up information on 27Mar2017, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer or other non HCP (a manager) and from a contactable Physician. This Physician reported similar events for 2 patients. This is 1st of 2 reports. A patient of unspecified age ethnicity and gender received PREVNAR 13 intramuscular at single dose at right deltoid on 13Jan2017 11:00 for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced erythematous rash, which progressed to a tender, edematous plaque with fever, all treated for a cellulitis episode. The outcome of the events was apparently recovering. The AEs required an emergency room or physician visit. The patient was apparently recovering. Sender's Comments: Linked Report(s) : US-PFIZER INC-2017135693 same reporter/drug/AE, different pt; US-PFIZER INC-2017070703 same reporter/vaccine/ event, different patient.
Sex: U
Vaccine: PNC13
Symptoms: Tenderness
Clinical narrative: The initial case was missing the following minimum criteria: Unspecified number of patients. Upon receipt of follow-up information on 27Mar2017, this case now contains all required information to be considered valid. This is a spontaneous report from a contactable consumer or other non HCP (a manager) and from a contactable Physician. This Physician reported similar events for 2 patients. This is 1st of 2 reports. A patient of unspecified age ethnicity and gender received PREVNAR 13 intramuscular at single dose at right deltoid on 13Jan2017 11:00 for immunisation. The patient medical history and concomitant medications were not reported. On an unspecified date the patient experienced erythematous rash, which progressed to a tender, edematous plaque with fever, all treated for a cellulitis episode. The outcome of the events was apparently recovering. The AEs required an emergency room or physician visit. The patient was apparently recovering. Sender's Comments: Linked Report(s) : US-PFIZER INC-2017135693 same reporter/drug/AE, different pt; US-PFIZER INC-2017070703 same reporter/vaccine/ event, different patient.
Sex: F
Vaccine: FLUX, PPV, FLUX, PPV
Symptoms: Allergy to vaccine
Clinical narrative: This is a spontaneous report from a contactable nurse. A currently, 63-year-old female patient of an unspecified ethnicity received pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) (manufacturer not provided), via an unspecified route of administration from an unspecified date to an unspecified date at an unspecified dose for immunization and influenza vaccine (manufacturer not provided), via an unspecified route of administration from an unspecified date to an unspecified date at an unspecified dose for immunization. The patient's medical history included allergies to adhesive tape. Concomitant medications were not reported. On an unknown date, the patient experienced allergies to "pneumonia vaccines and influenza vaccines". The clinical outcome of the event, allergies to "pneumonia vaccines and influenza vaccines, was unknown. Pfizer is a marketing authorization holder of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) in the reporter's country. This may be a duplicate report if another marketing authorization holder of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein) has submitted the same report to the regulatory authorities.
Age: 16.0
Sex: M
Vaccine: MNQ
Symptoms: Epistaxis, Injection site inflammation, Pyrexia
Clinical narrative: High fever (actual temp not recorded), inflammation at injection site, bloody nose-reported by pt.'s mother, states nose bled on lasted short time and other sx a few hours.
Age: 57.0
Sex: F
Vaccine: VARCEL
Symptoms: Pruritus, Urticaria
Clinical narrative: This spontaneous report as received from a female patient of unknown age reporting on herself. The patient did not have any known allergies or reactions. Information regarding concomitant medications was not provided. In approximately October 2015 (also reported as "about a year and a half ago"), the patient was vaccinated with VARIVAX (strength, dose, frequency, lot number and expiration date were not provided) subcutaneously for prophylaxis. The patient advised that after receiving the second dose, on an unspecified date, she developed what "seems like hives" on her legs which was very itchy (urticaria). The symptoms have been getting worse for a year and a half. Her physician referred her to an anonymous dermatologist and an anonymous allergist on unspecified dates. There have been unspecified tests performed on unspecified dates, but no diagnosis and treatment of her symptoms. She was prescribed steroid cream, but the hives go away and then have come back on unspecified dates. There was no product quality complaint (PQC) involved. At the reporting time the outcome of urticaria was reported as not recovered. The reporter did not assess the causality between urticaria and VARIVAX. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report has been received from a nurse and refers to a female patient of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. In July 2013, the patient was vaccinated with the first dose of quadrivalent GARDASIL (dose, route of administration, lot # and expiration date were not reported), in September 2013 with the second dose and on 23-MAR-2017, the patient came into the office to receive her third dose. No adverse effect were reported. No product quality complaint was involved. Additional information has been requested.