chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Case number PHHY2015US063001, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 568117) website on 12 May 2015. This report refers to a 61-year-old male patient. Medical history included high blood pressure. The patient had no allergies. No concomitant medication was reported. The patient was vaccinated with FLUVIRIN (batch number: 146625) into the right arm on 18 Nov 2014. On the same day after vaccination the patient's arm and shoulder were sore with movement. Final outcome of the event was not recovered. The event was reported as non-serious. Causality was not reported.
Age: 63.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Myalgia
Clinical narrative: Case number PHHY2015US063263, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 568118) website on 12 May 2015. This report refers to a 63-year-old female patient. The patient had sulfa allergy and chronic medical conditions. The patient had no acute illness. The patient was vaccinated with FLUVIRIN (batch number: 146625) into the left arm, along with PNEUMOVAX (batch number: K009105) into the right arm on 17 Nov 2014. On 20 Nov 2014, the patient developed severe muscle aches in both arms. Final outcome of the event was not recovered. The event was reported as non-serious. Causality was not reported.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Ear pruritus, Pruritus, Rash
Clinical narrative: Case number PHHY2015US051528, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 568464) website on 21 Apr 2015. This report refers to a 48-year-old female patient. Her vaccination history included influenza vaccine (manufacturer and batch number: not reported) in 2011 and was well tolerated. She was vaccinated with FLUVIRIN (batch number: 1205901, expiry date: 30 Jun 2013) in the right arm on 09 Oct 2012. On the same date, after vaccination she experienced pruritus from her ears to her throat and a rash on her back. She received 50 mg of diphenhydramine which resolved her pruritus. The event rash also recovered on an unknown date. The events reported as non-serious. The causality of the events was not reported. She was directed to not receive an influenza vaccine again in the year 2013.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Case number PHHY2015US064514, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 568659)) website on 12 May 2015. This report refers to a 40-year-old female patient. She was vaccinated with FLUVIRIN (batch number: 146604) in the left arm on 10 Jan 2015. On 17 Jan 2015, she experienced pain at injection site and cannot lift arm without pain. It was reported that the events lasted for 2 months. The outcome of the events was unknown. The events reported as non-serious. The causality of the events was not reported.
Age: 59.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Headache, Hyperhidrosis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Case number PHHY2015US069635 is an initial spontaneous report from a healthcare professional via Vaccine Adverse Event Reporting System (VAERS ID 569822) received on 09 Jun 2015. This report refers to a 59-year-old female patient. Medical history included benign hypertension. Family history included allergy to sulfa. This polymedicated was vaccinated with FLUVIRIN (batch number 1412201) in her left arm, PNEUMOVAX (other manufacturer, batch number K018528) in her left arm and BOOSTRIX (other manufacturer, batch number 3H432) in her right arm on 09 Mar 2015. On 10 Mar 2015 24 hours after the vaccinations, she had erythema and swelling around injection site. She also had headache, fever and was sweaty. Her left deltoid/upper arm had 8x10 cm red elevated wheal and was mildly tender. The final outcome of the events was unknown. The events were reported as non-serious. Causality was not reported.
Age: 59.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Injection site urticaria, Pyrexia
Clinical narrative: Case number PHHY2015US069635 is an initial spontaneous report from a healthcare professional via Vaccine Adverse Event Reporting System (VAERS ID 569822) received on 09 Jun 2015. This report refers to a 59-year-old female patient. Medical history included benign hypertension. Family history included allergy to sulfa. This polymedicated was vaccinated with FLUVIRIN (batch number 1412201) in her left arm, PNEUMOVAX (other manufacturer, batch number K018528) in her left arm and BOOSTRIX (other manufacturer, batch number 3H432) in her right arm on 09 Mar 2015. On 10 Mar 2015 24 hours after the vaccinations, she had erythema and swelling around injection site. She also had headache, fever and was sweaty. Her left deltoid/upper arm had 8x10 cm red elevated wheal and was mildly tender. The final outcome of the events was unknown. The events were reported as non-serious. Causality was not reported.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site pain
Clinical narrative: Case number PHHY2015US069726, is an initial spontaneous report received from a Vaccine Adverse Events Reporting System (VAERS reference number: 569833) on 09 Jun 2015. This report refers to a 53 years old female patient. Her medical history was not reported. Her concomitant medications included lisinopril, levothyroxine, BUSPAR, omeprazole, RESTORIL, calcium supplements with vitamin D and fish oil. She was vaccinated with FLUVIRIN (batch number: 66521011710) intramuscularly in the right arm on 22 Sep 2014. On same day, immediately after vaccination she experienced right shoulder pain which progressed. The outcome of the event was reported as condition unchanged. The event was reported as non-serious and causality of the event was not reported.
Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: Case number PHHY2015US070535 is an initial spontaneous report from a healthcare professional via Vaccine Adverse Event Reporting System (VAERS ID 571774) received on 09 Jun 2015. This report refers to a 27-year-old male patient. Medical history and concomitant medications were not reported. He was vaccinated with FLUVIRIN (batch number 1412501) in her left arm on 16 Oct 2014. On 20 Dec 2014 he had dull pain in area where shot was administered. The pain was not always present, but comes back every week or so for about a day. The pain was more noticeable with physical exertion. The outcome of the event was not reported. The events were reported as non-serious. Causality was not reported.
Age: 17.0
Sex: M
Vaccine: FLU3, HPV4
Symptoms: Neuralgia
Clinical narrative: Case number PHHY2015US070283, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS, reference number: 573593) on 09 Jun 2015. This report refers to a 17 year old male patient. Medical history included spinal cord injury at level L4 to L5 in Dec 2009. No concomitant medication was reported. His vaccination history included administration of flu vaccines (batch number: not reported) in the past which were well tolerated. He was vaccinated with FLUVIRIN (batch number: 1413101) in right arm and GARDASIL (other manufacturer, batch number: K004205) in left arm on 10 Mar 2015. On 12 Mar 2015, 2 days after vaccination, he experienced significant neuralgia in the area of his old spinal cord injury and mid trunk (front and back) for one and a half week. Final outcome was complete recovery. Event was reported as non-serious. The causality of the events was suspected to vaccination with GARDASIL as he never reacted to flu shots in the past.
Age: 78.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Bone disorder
Clinical narrative: Case number PHHY2015US085593 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 574330) website on 07 Jul 2015. This report refers to a 78-year-old male patient. The patient had no current illness and medical history. Concomitant medications included simvastatin and Levothyroxine. Vaccination history included administration of FLUVIRIN and experienced event (see case: PHHY2015US088056). The patient received FLUVIRIN (batch number: not reported) on 21 Nov 2014. On 10 Dec 2014, the patient had experienced intense pain in left wrist in the vaccinated arm. Wrist X-rays on 07 Jan 2015 was negative for fractures. Further the patient had light pain in left hip and it was only noticeable when lying down. After five months pain was almost gone. Outcome of the event was unknown. The event was reported as non-serious and causality of the event was not reported.
Age: 78.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, X-ray limb normal
Clinical narrative: Case number PHHY2015US085593 is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 574330) website on 07 Jul 2015. This report refers to a 78-year-old male patient. The patient had no current illness and medical history. Concomitant medications included simvastatin and Levothyroxine. Vaccination history included administration of FLUVIRIN and experienced event (see case: PHHY2015US088056). The patient received FLUVIRIN (batch number: not reported) on 21 Nov 2014. On 10 Dec 2014, the patient had experienced intense pain in left wrist in the vaccinated arm. Wrist X-rays on 07 Jan 2015 was negative for fractures. Further the patient had light pain in left hip and it was only noticeable when lying down. After five months pain was almost gone. Outcome of the event was unknown. The event was reported as non-serious and causality of the event was not reported.
Sex: F
Vaccine: FLU3
Symptoms: Exposure during pregnancy, Malaise, Pyrexia
Clinical narrative: Case number PHHY2015US082851 is an initial spontaneous report from a consumer via Vaccine Adverse Event Reporting System (VAERS ID 575377) received on 07 Jul 2015. This report refers to a pregnant female patient of unspecified age. Medical history and concomitant medications were unknown. She was vaccinated with FLUVIRIN (batch number 66521-114) on 30 Jan 2012. On an unknown date she became very sick and was unable to get out of bed due to fever. On Sep 2012 she gave birth to a male child (refer baby case PHHY2015US082588). The outcome, seriousness and causality of the events was not reported.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Vaccination site irritation, Vaccination site pruritus
Clinical narrative: Case number PHHY2015US088726, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 575879) website on 07 Jul 2015. This report refers to a 65-year-old male patient. Historical conditions were not reported. No concomitant medication was reported. The patient received FLUVIRIN (batch number: 146321) intramuscularly into the left arm on 23 Oct 2014. On the same day after vaccination, around the vaccination site the patient had itching and irritation. This had continued for five months. The patient had used hydrocortisone cream and warm soaks with improvement at site. Further the patient purchased over the counter animal ointment/cream and was using that with even more improvement. Final outcome was complete recovery. The events were reported as non-serious. Causality was not reported.
Age: 39.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cellulitis
Clinical narrative: Case number PHHY2016US006162, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 606304) website on 18 Jan 2016. This report refers to a 39 years old female patient. Past medical history included cellulitis and concomitant medications were not reported. She was vaccinated with FLUVIRIN (batch number: 157603) intramuscularly into left arm along with PNEUMOVAX (other manufacturer and batch number: K010466) intramuscularly in left arm both on 23 Oct 2015. On 26 Oct 2015, she developed cellulitis after co administration of PNEUMOVAX and FLUVIRIN. She visited emergency room and was treated with antibiotics (unspecified). The outcome of the event was reported as complete recovery on an unknown date. The seriousness of the event was reported as non serious. The causality of the event was not reported. The seriousness assessment of the event cellulitis was upgraded to medically significant based on the Novartis important medical event list. The quality assurance department reported that, batch review report (reference number: 1011172) received from quality assurance department on 15 Feb 2016: Based on the document review, it was stated that the concerned FLUVIRIN, batch number: 157603, was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. No anomalies were noted during this review. Non significant follow up report received from Quality assurance department (QA reference number: 1011172) on 20 Jan 2016: QA reference number updated. Follow up report received from Quality Assurance department (QA reference number: 1011172) on 15 Feb 2016: Updated batch review report.
Age: 27.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Angina pectoris, Echocardiogram, Electrocardiogram normal, Troponin
Clinical narrative: PT started having heart palpitations 5 days after receiving the vaccine. Was admitted overnight at local E.R.
Age: 27.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Palpitations
Clinical narrative: PT started having heart palpitations 5 days after receiving the vaccine. Was admitted overnight at local E.R.
Age: 27.0
Sex: M
Vaccine: ANTH, SMALL, ANTH, SMALL, ANTH, SMALL
Symptoms: Chest pain, Echocardiogram, Electrocardiogram normal, Full blood count normal, Troponin normal
Clinical narrative: PT started having heart palpitations 5 days after receiving the vaccine. Was admitted overnight at local E.R.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Initial unsolicited report received from a consumer on 05-Jan-2016. This case involves a 46-year-old female patient who was vaccinated with a 0.5 ml intramuscular dose of ADACEL (batch number was not reported) in left arm on an unspecified date. Medical history and concomitant medications were not reported. On an unspecified date, next day after the vaccination (day two as reported) the patient experienced pain as expected, swelling around site, hard like an egg, itchy, hot and patient was tired. It was reported that swelling was 2" wide and 1" high. Lab tests were not reported. Patient had treated herself. Patient was recovered from the event. It was reported that all the symptoms were subsided 48 hours after the shot except but the knot which lasted for a month. Documents held by sender: none.
Age: 46.0
Sex: F
Vaccine: TDAP
Symptoms: Nodule, Pain
Clinical narrative: Initial unsolicited report received from a consumer on 05-Jan-2016. This case involves a 46-year-old female patient who was vaccinated with a 0.5 ml intramuscular dose of ADACEL (batch number was not reported) in left arm on an unspecified date. Medical history and concomitant medications were not reported. On an unspecified date, next day after the vaccination (day two as reported) the patient experienced pain as expected, swelling around site, hard like an egg, itchy, hot and patient was tired. It was reported that swelling was 2" wide and 1" high. Lab tests were not reported. Patient had treated herself. Patient was recovered from the event. It was reported that all the symptoms were subsided 48 hours after the shot except but the knot which lasted for a month. Documents held by sender: none.
Age: 39.0
Sex: F
Vaccine: FLU3
Symptoms: Periarthritis
Clinical narrative: Initial unsolicited report received from a nurse on 03-Feb-2016. This case involves a 39-year-old female patient, who was vaccinated with Fluzone (batch number: UH894AA) (dose, dose in series and site of administration were not reported) via intramuscular route on an unknown date in 2013. Illness at time of vaccination and Pre-existing physician diagnosed allergies, birth defects, medical conditions was reported as unknown. Concomitant medications were not reported. On an unknown date in 2013, following vaccination, the patient experienced frozen shoulder. It was reported that the patient required ER/doctor visit. Laboratory investigations were not reported. Patient was prescribed antibiotics and physical therapy with no positive result and then received a steroid injection to the shoulder and her symptoms improved. On an unknown date, patient recovered from the event. Documents held by sender: none.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Full blood count normal, Lymphadenopathy, X-ray normal
Clinical narrative: Initial unsolicited report received from a Physician on 05 February 2016  This case involves 28-year-old female patient who was vaccinated with a dose of ADACEL (batch number not reported) intramuscularly on left deltoid on 12 January 2016. The patient's medical history includes vaccination with pneumonia vaccine and had experienced axillary and breast lymph node swelling (at some time ago). On an unspecified date and pre-existing physician diagnosed allergies, birth defects, medical conditions includes cyclic vomiting syndrome, allergic to Reglan causes dystonia. The patient's illness at time of vaccination was reported as unknown. The patient's concomitant medications was not reported. On an unspecified date, few days following the vaccination, the patient had experienced swelling in the lymph node area on the left side of the head and neck. The patient was diagnosed with lymphadenopathy of the left head and neck. The patient required ER/doctor visit. Laboratory data includes complete blood count and X-ray was performed and was in normal limit. The patient's corrective treatment was not reported. The patient was not recovered from event. List of documents held by sender: none.
Age: 47.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Upper arm & shoulder pain that has never gone away in three months. Also loss in range of motion in arm as well.
Age: 47.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Mobility decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Upper arm & shoulder pain that has never gone away in three months. Also loss in range of motion in arm as well.
Age: 4.0
Sex: M
Vaccine: FLU3, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Swelling in left arm, warm to touch, redness.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site abscess, Injection site irritation
Clinical narrative: Redness/Irritation at Injection Site.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Pyrexia
Clinical narrative: Headache, low-grade fever, redness, swelling, and burning at the injection site.
Age: 43.0
Sex: F
Vaccine: HEPA, TYP
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: Pt stated she felt a numbness/ tingling sensation in her arms.
Age: 26.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Local reaction
Clinical narrative: Patient reported a large circle around the injection site of redness and a lot of swelling. She said it started the evening of 2/16 but got worse on 2/17 so she saw her private physician. Per patient physician thought it was just a local reaction but wanted to have the Health Department evaluate. Patient reported she iced the site yesterday and it has improved. I evaluated the site and noted a faint red circular area around the injection site approximately 10 cm then a smaller darker red area in the center slightly raised (probably the injection site)approximately 1cm.
Age: 16.0
Sex: M
Vaccine: FLUN4, HEP, IPV, MMR, TDAP, VARCEL
Symptoms: Injection site reaction, Keloid scar
Clinical narrative: Small raised "keloid like" scar to lower portion of deltoid on right arm within hours of administration.  No other symptoms.
Age: 1.03
Sex: M
Vaccine: DTAP, FLU3, HEPA, HIBV, MMRV, PNC13
Symptoms: Body temperature increased, Culture, Full blood count, Staring, Unresponsive to stimuli
Clinical narrative: Patient's mother contacted DSHS 2/8/16 to report that the patient had been taken to the ER the evening after receiving immunizations. Mom states patient was found unresponsive by an uncle. Per ER records, mother states patient remained breathing, but wouldn't respond, had a blank stare. Family called 911 & child was taken via EMS to the ER. Rectal temp in ER at approx. 7:30PM was 103.8. Mother states patient last had Tylenol around 3PM. Patient was discharged from the ER around 2AM after lab completed & patient's temp returned to normal.
Age: 1.03
Sex: M
Vaccine: DTAP, FLU3, HEPA, HIBV, MMRV, PNC13
Symptoms: Urine analysis
Clinical narrative: Patient's mother contacted DSHS 2/8/16 to report that the patient had been taken to the ER the evening after receiving immunizations. Mom states patient was found unresponsive by an uncle. Per ER records, mother states patient remained breathing, but wouldn't respond, had a blank stare. Family called 911 & child was taken via EMS to the ER. Rectal temp in ER at approx. 7:30PM was 103.8. Mother states patient last had Tylenol around 3PM. Patient was discharged from the ER around 2AM after lab completed & patient's temp returned to normal.
Age: 53.0
Sex: F
Vaccine: FLU3, HEP, PPV, TDAP
Symptoms: Induration, Injection site rash, Pain, Rash erythematous, Skin warm
Clinical narrative: Received vaccine that morning, by night area was warm to touch and "hard feeling" was painful. The next day it was the same. By Friday had a rash on arm looked as if rash started at injection site and spread down and around upper and lower arm. Also, had rash on stomach, back and chest. Rash appeared to be red, raised areas. Started taking BENADRYL every 4-6 hours on Friday until Sunday before rash improved.
Age: 49.0
Sex: M
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Sore at injection site, tender to touch injection site and difficulty raising the same arm.
Age: 44.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: Small area of pain, redness upper arm (deltoid) HA significant "lump" left worsening since Tdap administer.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Guillain-Barre syndrome, Hypoaesthesia, Injected limb mobility decreased, Injection site swelling
Clinical narrative: Arm swelled around shot area, couldn't move arm, as days went by feet and lower legs went numb, went to doctor the next week because not improving. He said it is Guillain-Barre Syndrome reaction to Pneumovax 23 vaccine. He gave me steroids for two weeks and it did seem to help. Going 6 weeks now. Improving but very weak and some numbness comes and goes. Dr said it will take time.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Laboratory test normal
Clinical narrative: Arm swelled around shot area, couldn't move arm, as days went by feet and lower legs went numb, went to doctor the next week because not improving. He said it is Guillain-Barre Syndrome reaction to Pneumovax 23 vaccine. He gave me steroids for two weeks and it did seem to help. Going 6 weeks now. Improving but very weak and some numbness comes and goes. Dr said it will take time.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. Information about medical history and concurrent condition was not reported. On 16-FEB-2015 the patient was vaccinated with improperly stored VAQTA (strength: 25/0.5(unit unspecified), lot # K005323 with expiration date of 10-FEB-2017; dosage and route unspecified). No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: C-reactive protein increased, Chills, Clostridium difficile infection, Pyrexia
Clinical narrative: Chilling fever of 104.8.
Age: 65.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Pain at injection site, (right arm) ever since date of immunization. Employee states he was seen by his primary care doctor on 1/8/16 and has been treating the arm pain with cold compress and ibuprofen as advised by his primary care physician.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, VARCEL
Symptoms: Erythema, Local swelling, Papule
Clinical narrative: Localized redness and swelling. Small papules.
Age: 6.0
Sex: F
Vaccine: FLU3
Symptoms: Excoriation, Rash
Clinical narrative: Pt's mother states pt developed rash on both arms one week after vaccination. Pt has excoriations and skins on bilateral arms.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site rash
Clinical narrative: Red, inflamed, rashy area around the site of injetion.  Pt said it was a bit itchy at first but went away.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test normal, Cardiomegaly, Depression, Electrocardiogram abnormal, Facial asymmetry
Clinical narrative: First noticed a herpes type rash on the right side of my scrotum. Second, a slow healing cut with rash on my left leg with extreme itching (lasted for about 2-3 months.  Third, another slow healing cut with rash on my left arm lasting for about 3 months.  Fourth, a rash with severe itching at the site of injection on my upper right arm lasting for about 4 months.  I have experienced extreme fatigue and severe depression since this Zoster Vaccine.  Other mild symptoms:  facial itching, headaches, and nightmares.  My doctor placed me on Prednisone.  The slow healing and rashes have stopped.  An EKG shows an enlarged heart.  He now has me scheduled for an electrocardiogram.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Impaired healing, Injection site pruritus, Injection site rash
Clinical narrative: First noticed a herpes type rash on the right side of my scrotum. Second, a slow healing cut with rash on my left leg with extreme itching (lasted for about 2-3 months.  Third, another slow healing cut with rash on my left arm lasting for about 3 months.  Fourth, a rash with severe itching at the site of injection on my upper right arm lasting for about 4 months.  I have experienced extreme fatigue and severe depression since this Zoster Vaccine.  Other mild symptoms:  facial itching, headaches, and nightmares.  My doctor placed me on Prednisone.  The slow healing and rashes have stopped.  An EKG shows an enlarged heart.  He now has me scheduled for an electrocardiogram.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Laceration, Nightmare, Pruritus, Rash, Rash vesicular
Clinical narrative: First noticed a herpes type rash on the right side of my scrotum. Second, a slow healing cut with rash on my left leg with extreme itching (lasted for about 2-3 months.  Third, another slow healing cut with rash on my left arm lasting for about 3 months.  Fourth, a rash with severe itching at the site of injection on my upper right arm lasting for about 4 months.  I have experienced extreme fatigue and severe depression since this Zoster Vaccine.  Other mild symptoms:  facial itching, headaches, and nightmares.  My doctor placed me on Prednisone.  The slow healing and rashes have stopped.  An EKG shows an enlarged heart.  He now has me scheduled for an electrocardiogram.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Big red patch at site of injection, swelling, itching, redness and pain at the site of injection.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: Patient reports numbness and pain occurred in left arm shortly after vaccination and continues to present, however was not reported to pharmacist until 2/16/2016.  Patient has yet to visit her physician to determine what may be the problem.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Calcinosis, Erythema, Hypoaesthesia, Impaired work ability, Injected limb mobility decreased
Clinical narrative: That night on 10/19/15, the day I received the flu shot in my left arm, my left arm was painful and appeared red and swollen for next 2 weeks. It was difficult to sleep on the left side  awakened during the night by pain until this very day. I also couldn't even put arm under pillow. Perhaps most disturbing is that the next day I had very limited range of motion with my left arm.  Specifically, on 10/20/15, I was unable to lift my left arm at to the side more than a few inches, and I was also unable to lift my left arm to the front of my body more than a few inches. The pain in my shoulder became worse over the next few months (Very painful about 6 out of 10).  The pain was initially like a toothache  deep inside arm. Jan 8, 2016- Still same problem with limited range of motion; New symptom of numbness/tingling in area between elbow and wrist, which made doing my job as a college professor difficult (e.g., hard to type  need to take breaks). Weakness in arm  feels heavy  "tired arm." On Jan 19, 2016 I went for a for muscular-skeletal ultrasound, and on Jan 21, 2016 I had an appointment with an orthopedic surgeon who diagnosed me with rotator cuff tendonitis with calcium deposits, and I received a cortisone shot that day.  Although the cortisone shot lessened the pain for a few weeks, I currently have worse pain prior to receiving the shot, and I am left with the same restriction of motion (i.e., inability to move my left arm out to the side more than few inches, and inability to move my left arm to the front more than a few inches; otherwise I am in pain).  It is difficult and painful to put my left arm in a jacket, I can't put my left arm behind my back, and pushing on a soap dispenser or opening a door with my left arm is painful.  These are current symptoms that I still have since receiving the flu shot on 10/19/15.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Limb discomfort, Muscular weakness, Pain in extremity, Paraesthesia, Peripheral swelling
Clinical narrative: That night on 10/19/15, the day I received the flu shot in my left arm, my left arm was painful and appeared red and swollen for next 2 weeks. It was difficult to sleep on the left side  awakened during the night by pain until this very day. I also couldn't even put arm under pillow. Perhaps most disturbing is that the next day I had very limited range of motion with my left arm.  Specifically, on 10/20/15, I was unable to lift my left arm at to the side more than a few inches, and I was also unable to lift my left arm to the front of my body more than a few inches. The pain in my shoulder became worse over the next few months (Very painful about 6 out of 10).  The pain was initially like a toothache  deep inside arm. Jan 8, 2016- Still same problem with limited range of motion; New symptom of numbness/tingling in area between elbow and wrist, which made doing my job as a college professor difficult (e.g., hard to type  need to take breaks). Weakness in arm  feels heavy  "tired arm." On Jan 19, 2016 I went for a for muscular-skeletal ultrasound, and on Jan 21, 2016 I had an appointment with an orthopedic surgeon who diagnosed me with rotator cuff tendonitis with calcium deposits, and I received a cortisone shot that day.  Although the cortisone shot lessened the pain for a few weeks, I currently have worse pain prior to receiving the shot, and I am left with the same restriction of motion (i.e., inability to move my left arm out to the side more than few inches, and inability to move my left arm to the front more than a few inches; otherwise I am in pain).  It is difficult and painful to put my left arm in a jacket, I can't put my left arm behind my back, and pushing on a soap dispenser or opening a door with my left arm is painful.  These are current symptoms that I still have since receiving the flu shot on 10/19/15.
Age: 46.0
Sex: F
Vaccine: FLU3
Symptoms: Rotator cuff syndrome, Sleep disorder, Ultrasound scan, X-ray limb
Clinical narrative: That night on 10/19/15, the day I received the flu shot in my left arm, my left arm was painful and appeared red and swollen for next 2 weeks. It was difficult to sleep on the left side  awakened during the night by pain until this very day. I also couldn't even put arm under pillow. Perhaps most disturbing is that the next day I had very limited range of motion with my left arm.  Specifically, on 10/20/15, I was unable to lift my left arm at to the side more than a few inches, and I was also unable to lift my left arm to the front of my body more than a few inches. The pain in my shoulder became worse over the next few months (Very painful about 6 out of 10).  The pain was initially like a toothache  deep inside arm. Jan 8, 2016- Still same problem with limited range of motion; New symptom of numbness/tingling in area between elbow and wrist, which made doing my job as a college professor difficult (e.g., hard to type  need to take breaks). Weakness in arm  feels heavy  "tired arm." On Jan 19, 2016 I went for a for muscular-skeletal ultrasound, and on Jan 21, 2016 I had an appointment with an orthopedic surgeon who diagnosed me with rotator cuff tendonitis with calcium deposits, and I received a cortisone shot that day.  Although the cortisone shot lessened the pain for a few weeks, I currently have worse pain prior to receiving the shot, and I am left with the same restriction of motion (i.e., inability to move my left arm out to the side more than few inches, and inability to move my left arm to the front more than a few inches; otherwise I am in pain).  It is difficult and painful to put my left arm in a jacket, I can't put my left arm behind my back, and pushing on a soap dispenser or opening a door with my left arm is painful.  These are current symptoms that I still have since receiving the flu shot on 10/19/15.
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Decreased appetite, Fatigue, Hyperhidrosis, Insomnia
Clinical narrative: C/O INSOMNIA, DIAPHORESIS, LACK OF APPETITE AND OVERWHELMING FATIGUE.
Age: 75.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Her arm was red and swelling.
Age: 1.34
Sex: M
Vaccine: DTAPIPV, MENHIB
Symptoms: Crying, Heart rate increased, Insomnia, Irritability, Pyrexia
Clinical narrative: Fussy, fever, crying for hours, wouldn't sleep last night. Gave Tylenol and it helped somewhat. Rapid heartbeat.
Age: 18.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Agitation, Anger, Injection site erythema, Injection site induration, Injection site swelling
Clinical narrative: Patient's Mother reports swelling around the injection site. Warm and hard to the touch. Mother reports that around 5-6 pm 2/16/2016 he started to think bad things, feel angry/agitated, feeling suicidal and he fainted. Once he fainted and woke up he felt fine. Patient's Mother didn't take him to the ER. She contacted the CDC and contacted our office the following day on 2/17/2016. Dr. was informed and advised that the swelling at the injection site was normal and if he wasn't having the other symptoms at this time he should be fine. Mother was advised to monitor the patient. Spoke with Mother today reports that he is doing much better. He still has the warmth at the injection site and the area is pink. Pt continues with normal activities.
Age: 18.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Injection site warmth, Suicidal ideation, Syncope, Thinking abnormal
Clinical narrative: Patient's Mother reports swelling around the injection site. Warm and hard to the touch. Mother reports that around 5-6 pm 2/16/2016 he started to think bad things, feel angry/agitated, feeling suicidal and he fainted. Once he fainted and woke up he felt fine. Patient's Mother didn't take him to the ER. She contacted the CDC and contacted our office the following day on 2/17/2016. Dr. was informed and advised that the swelling at the injection site was normal and if he wasn't having the other symptoms at this time he should be fine. Mother was advised to monitor the patient. Spoke with Mother today reports that he is doing much better. He still has the warmth at the injection site and the area is pink. Pt continues with normal activities.
Age: 44.0
Sex: F
Vaccine: FLU4
Symptoms: Drug administered at inappropriate site, Injection site erythema, Injection site swelling
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of injection site swelling in a 44-year-old female patient who received FLUARIX QUADRIVALENT (batch number 5C2L4, expiry date 18th June 2016. On 26th October 2015, the patient received FLUARIX QUADRIVALENT. On 26th October 2015, an unknown time after receiving FLUARIX QUADRIVALENT, the patient experienced wrong injection technique. On an unknown date, the patient experienced site swelling and injection site erythema. On an unknown date, the outcome of the injection site swelling, injection site erythema and wrong injection technique were unknown. It was unknown if the reporter considered the injection site swelling and injection site erythema to be related to FLUARIX QUADRIVALENT. Additional details were received as follows: The reporter reported the patient believed the FLUARIX QUADRIVALENT was given too high up, and too close to the joint rather than the muscle, which led to wrong technique. An unknown time after receiving FLUARIX QUADRIVALENT, the patient experienced reddened raised area at injection site. The batch number reported for Flu vaccine (5C214) did not exist and was updated to be 5C2L4. as per sale database.
Age: 35.0
Sex: F
Vaccine: FLU3, MMRV, TDAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient was administered PROQUAD vaccine (MMRV) instead of MMR vaccine. No s/s or tx noted/given.
Age: 17.0
Sex: F
Vaccine: FLUN4, HEPA, HPV9, MNQ
Symptoms: Dizziness, Feeling hot, Immediate post-injection reaction, Pallor, Retching
Clinical narrative: Client dry-heaved 5 times, turned completely pale, stated feeling faint, and also stated that she suddenly felt very hot immediately following the administration of the HPV vaccine. Cool and moistened paper towels were placed on the back of client's neck. Blood pressure was taken - 68/49, and after approx. 7 min. it was repeated to show a rebound of 86/72. Client was monitored for 15 minutes before releasing from clinic in good condition and walking on her own without further incident.
Age: 26.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Abasia, Blood test, Electromyogram, Guillain-Barre syndrome, Lumbar puncture
Clinical narrative: Muscle weakness resulting in the inability to walk or control speech or bladder. Guillain-Barre syndrome.
Age: 26.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Muscular weakness, Nuclear magnetic resonance imaging, Speech disorder, Urinary incontinence
Clinical narrative: Muscle weakness resulting in the inability to walk or control speech or bladder. Guillain-Barre syndrome.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Very red and swollen in the area of the injection. 5" x 2" long.
Age: 41.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Abnormal dreams, Asthenia, Cognitive disorder, Depressed level of consciousness, Disturbance in attention
Clinical narrative: Extreme daytime Sleepiness, couldn't arouse from sleep, napping uncontrollably during day, while driving, etc. Fell over repeatedly numerous times; couldn't move one foot when awakening; vivid dreams; widespread pain, debilitating fatigue; cognitive decline, forgetfulness, inability to concentrate.
Age: 41.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Fall, Fatigue, Fibromyalgia, Hypersomnia, Impaired driving ability
Clinical narrative: Extreme daytime Sleepiness, couldn't arouse from sleep, napping uncontrollably during day, while driving, etc. Fell over repeatedly numerous times; couldn't move one foot when awakening; vivid dreams; widespread pain, debilitating fatigue; cognitive decline, forgetfulness, inability to concentrate.
Age: 41.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Memory impairment, Mobility decreased, Narcolepsy, Pain, Small fibre neuropathy
Clinical narrative: Extreme daytime Sleepiness, couldn't arouse from sleep, napping uncontrollably during day, while driving, etc. Fell over repeatedly numerous times; couldn't move one foot when awakening; vivid dreams; widespread pain, debilitating fatigue; cognitive decline, forgetfulness, inability to concentrate.
Age: 41.0
Sex: F
Vaccine: FLUN(H1N1)
Symptoms: Somnolence
Clinical narrative: Extreme daytime Sleepiness, couldn't arouse from sleep, napping uncontrollably during day, while driving, etc. Fell over repeatedly numerous times; couldn't move one foot when awakening; vivid dreams; widespread pain, debilitating fatigue; cognitive decline, forgetfulness, inability to concentrate.
Age: 1.01
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Bronchial hyperreactivity, Chest X-ray abnormal, Cyanosis, Dyspnoea, Urticaria
Clinical narrative: Had 1 episode of gasping for breath lasting 3 seconds, another one 5 minutes later lasting 3 seconds. Parents brought him back to office, was evaluated with no acute findings or respiratory symptoms. Three hours later at home a another episode lasting 5 seconds, lips turned purple, and was taken to ER. When arrived at ER, had another episode (4 total) lasting 2 seconds. On exam in ER, had hives on face, back, neck, and was wheezing. CXR showed reactive airway findings. Given steroids and Benadryl, observed and sent home four hours later with symptoms resolved. Mom denies any new foods or milk given that day.
Age: 1.01
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Wheezing
Clinical narrative: Had 1 episode of gasping for breath lasting 3 seconds, another one 5 minutes later lasting 3 seconds. Parents brought him back to office, was evaluated with no acute findings or respiratory symptoms. Three hours later at home a another episode lasting 5 seconds, lips turned purple, and was taken to ER. When arrived at ER, had another episode (4 total) lasting 2 seconds. On exam in ER, had hives on face, back, neck, and was wheezing. CXR showed reactive airway findings. Given steroids and Benadryl, observed and sent home four hours later with symptoms resolved. Mom denies any new foods or milk given that day.
Age: 21.0
Sex: M
Vaccine: FLU3
Symptoms: Loss of consciousness, Tremor
Clinical narrative: Started shaking, passed out.
Age: 3.0
Sex: F
Vaccine: FLUN4, MMRV
Symptoms: Erythema, Injection site pain, Injection site warmth, Skin warm
Clinical narrative: Patient's mother reported by phone that her daughter's right upper arm was hot and red. I received this report shortly before 5 p.m. on 02/17/2016. With another staffer, we called the patient's mother to assess her daughter. The daughter's behavior was normal and the child had no fever. I advised the mother to offer the child acetaminophen or ibuprofen before bedtime and that she take the child to the doctor if the redness and heat got worse overnight. At 9:15 a.m. on 02/18/16, through yet a third staffer, we called the client's mother for a report on the child. The child had no fever; slept well overnight; the extent of the redness was the same as the evening before; behavior was as usual; and "Motrin" had been given the previous evening. The injection site still "hurts a lot" and is "warm." I advised the mother, through the interpreter, to continue pain medication and to outline the extent of the redness to be able to monitor its progression. Another follow-up call at 4:20 PM 02/18/16 yielded the same information: child is behaving as normal; had "Motrin" during the day; slept well overnight; no fever; arm "hurts a lot"; no change in extent of redness.
Age: 64.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Myalgia, Pain
Clinical narrative: Muscle aches, pain all over.
Age: 64.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Asthenia, Pain
Clinical narrative: Muscle aches, pain all over.
Age: 64.0
Sex: M
Vaccine: PPV, PPV, PPV
Symptoms: Pain
Clinical narrative: Muscle aches, pain all over.
Age: 58.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site discolouration, Injection site scab, Injection site ulcer
Clinical narrative: The injection area formed a sore like area which formed a deep scab about an inch in diameter. The color was purplish.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Alanine aminotransferase, Inflammation
Clinical narrative: I woke up with the sensation of an inflamed liver or near the liver and it still bothers me as of today but not as bad as the first few days following the flu shot. There was no inflamed sensations for several week prior.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, PNC13
Symptoms: Blood culture, Culture urine, Febrile convulsion, Full blood count, Pyrexia
Clinical narrative: Febrile seizure 1 day after receiving vaccines. Fever persisted for several days afterwards, suggesting a viral illness.
Age: 1.0
Sex: M
Vaccine: HEPA, MMRV, PNC13
Symptoms: Viral infection
Clinical narrative: Febrile seizure 1 day after receiving vaccines. Fever persisted for several days afterwards, suggesting a viral illness.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Gait disturbance, Immunoglobulin therapy, Injection site pain, Myalgia
Clinical narrative: Severe pain, aching at injection site, constant muscle pain across left shoulder to right shoulder. Muscle and joint pain. Myasthenia Gravis reaction had to have (5) session IVIG. Also having walking gait issues.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Myasthenia gravis
Clinical narrative: Severe pain, aching at injection site, constant muscle pain across left shoulder to right shoulder. Muscle and joint pain. Myasthenia Gravis reaction had to have (5) session IVIG. Also having walking gait issues.
Age: 1.2
Sex: M
Vaccine: DTAPIPVHIB, FLU3, HEP, MMRV, PNC13
Symptoms: Injection site nodule, Injection site rash, Rash generalised
Clinical narrative: 2/1/16 Brought in for evaluation of rash on (L) thigh. Foster mom states 1-2 days after vaccines he developed a knot on left thigh and rash that was generalized - more focused on left thigh. Resolved with symptomatic care.
Age: 2.0
Sex: F
Vaccine: DTAP, FLU4, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Low grade fever 101, rash arms, buttock and legs.
Age: 25.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Asthenia, Fatigue, Loss of consciousness, Paraesthesia, Vision blurred
Clinical narrative: Patient stated she became lightheaded, then suddenly got a tingling sensation throughout her whole body, let her foot off the car's accelerator knowing something was wrong. States she blacked-out and didn't regain consciousness until after emergency responders were surrounding her. Patient was involved in a low speed single vehicle accident, was taken to ER and diagnosed with: MVA, facial contusion and vasovagal syncope. Discharged with treatment plan of supportive self/home care. Patient described temperature in car as not too hot or too cold.
Age: 25.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Computerised tomogram head, Contusion, Culture urine, Differential white blood cell count, Dizziness
Clinical narrative: Patient stated she became lightheaded, then suddenly got a tingling sensation throughout her whole body, let her foot off the car's accelerator knowing something was wrong. States she blacked-out and didn't regain consciousness until after emergency responders were surrounding her. Patient was involved in a low speed single vehicle accident, was taken to ER and diagnosed with: MVA, facial contusion and vasovagal syncope. Discharged with treatment plan of supportive self/home care. Patient described temperature in car as not too hot or too cold.