chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Differential white blood cell count normal, Full blood count normal, Myalgia, Pyrexia
Clinical narrative: The day she got the injection, she woke up that night with fever of 101.6 with chills and myalgias after getting a Tdap vaccine at her physical at the clinic yesterday.  She had labs drawn that day and her CBC with diff. looked fine.  Fever didn't resolve and on 6/30/17 she called us with fevers going up to 102F.  She came in for appt with Dr. who deemed it an adverse reaction to vaccine.  Here was plan from Dr. visit: This is likely a reaction to the TDaP vaccine as there is no indication of other underlying pathology. The symptoms appear to already be improving as the myalgias have dissipated and the fever has resolved. Continue to monitor symptoms. For fever and discomfort, take 400-600 mg of ibuprofen every 6 hours for fever and muscle aches. Do not exceed 2000 mg in a day.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Urticaria
Clinical narrative: Hives appeared on left elbow about 3 hours after vaccine injection. Patient has no other signs or symptoms of adverse reaction. Patient was seen by a doctor at the time that she reported to the clinic and was prescribed oral diphenhydramine.
Age: 0.75
Sex: M
Vaccine: HIBV
Symptoms: Pyrexia, Rash generalised
Clinical narrative: Type of vaccine is listed as HIB PRP-T -- I am not sure which one to select in the drop down. On August 22nd, 2016 patient began a fever at 3 PM that climbed to 102.9 by 8 PM. On August 23rd, 2016 the fever continued and a rash began all over his body. We went to the ER. Which they gave him suppositories to reduce the fever.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV9, IPV, MMR, VARCEL
Symptoms: Blood glucose normal, Fatigue, Loss of consciousness, Nausea, Pallor
Clinical narrative: The patient was given 5 vaccine at 5:10PM and I informed the patient to remain seated until I returned with a printed copy of immunization records. When I returned to the room at 5:15PM I found the patient in a seated position, her skin was very pale, and she appeared fatigued. I asked the father what happened and he stated that she momentarily passed out in her seat for no more than 10 seconds after complaining of nausea. I asked the father if she hit her head or fell to the floor and he said no. I proceeded to inform my provider who came to clear her before leaving and I gave her some orange juice to replenish her blood sugar level.
Age: 14.0
Sex: F
Vaccine: HEPA, HPV9, IPV, MMR, VARCEL
Symptoms: Pregnancy test negative, Urine analysis normal
Clinical narrative: The patient was given 5 vaccine at 5:10PM and I informed the patient to remain seated until I returned with a printed copy of immunization records. When I returned to the room at 5:15PM I found the patient in a seated position, her skin was very pale, and she appeared fatigued. I asked the father what happened and he stated that she momentarily passed out in her seat for no more than 10 seconds after complaining of nausea. I asked the father if she hit her head or fell to the floor and he said no. I proceeded to inform my provider who came to clear her before leaving and I gave her some orange juice to replenish her blood sugar level.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Erythema, Urticaria
Clinical narrative: Redness and urticaria lesion.
Age: 22.0
Sex: F
Vaccine: PPV
Symptoms: Blood lactic acid, Cellulitis, Full blood count abnormal, Injection site pain, Limb discomfort
Clinical narrative: Developed 101F fever, painful right arm, malaise 2 days later. Went to UC 6 days later and diagnosed with cellulitis. BACTRIM and Cephalexin have helped cellulitis to resolve, but continues to have 5/10 right deltoid pressure/pain.
Age: 22.0
Sex: F
Vaccine: PPV
Symptoms: Malaise, Metabolic function test, Pain in extremity, Pyrexia, White blood cell count increased
Clinical narrative: Developed 101F fever, painful right arm, malaise 2 days later. Went to UC 6 days later and diagnosed with cellulitis. BACTRIM and Cephalexin have helped cellulitis to resolve, but continues to have 5/10 right deltoid pressure/pain.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling, Rash papular, Skin warm, Ultrasound scan
Clinical narrative: Pain, stiffness & swelling in right arm. Very warm to the touch with red spots. ER Iced packed arm. In ER from 6/30 11:00 pm to 1:00 am. Ultrasound test taken.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site irritation, Injection site nodule
Clinical narrative: Left thigh nodule - still red and irritated with nodule underneath.
Age: 36.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Vaccination site joint movement impairment
Clinical narrative: Extreme soreness, pain in injection arm, patient complains that can't raise her arm!! No redness or swelling at injection site according to pt. via phone conversation. Patient said pain started approx. 1 hr after receiving injection and has persisted since. Pt. advised to take APAP and apply ice to site to relieve pain. Questioned pt. regarding her delay in contacting the pharmacy regarding this issue...she said she thought pain would go away.
Age: 1.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site warmth, Pyrexia, Rash, Urticaria
Clinical narrative: 7 days post vaccination red raised wheal approximately 1.5 cm in diameter appeared. Site was warmer than surrounding skin. Rash on chest, trunk, and neck/chin. 10 days post vaccination fever of 100.4 that lasted for 2 days, but was controlled with ibuprofen. Red raised area persisted for 1-2 weeks and is now a small discolored patch of skin.
Age: 55.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site nodule, Injection site warmth
Clinical narrative: Patient called in on 7/4/2017 saying that injection site is still hard raised knot, red in color and hot to touch.
Age: 19.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site warmth
Clinical narrative: Patient presented with redness at site of injection which was slightly warm to touch as well as small hardened lump. Symptoms had appeared approximately 24 hours after injection. Patient advised to seek medical care if lump and redness did not clear or if experiencing fever.
Age: 23.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Dizziness, Feeling hot, Hyperhidrosis, Loss of consciousness, Pallor
Clinical narrative: Patient started to feel light headed, then fainted with 1-2 minutes of receiving the vaccinations.  Patient was unconscious for less than one minute.  Patient was hot, pale and sweaty upon regaining consciousness.
Age: 23.0
Sex: F
Vaccine: HEPAB, TDAP
Symptoms: Syncope
Clinical narrative: Patient started to feel light headed, then fainted with 1-2 minutes of receiving the vaccinations.  Patient was unconscious for less than one minute.  Patient was hot, pale and sweaty upon regaining consciousness.
Age: 53.0
Sex: F
Vaccine: PNC13
Symptoms: Fatigue, Injection site erythema, Injection site inflammation, Injection site pain, Injection site swelling
Clinical narrative: Patient presented to the pharmacy on 7/5/17 at approximately 3:30pm. Patient explained to the pharmacist that later in the evening of 7/3/17, the area around her injection site on her right arm had become inflamed, red, slightly painful and warm to the touch. The patient explained that since that time, her symptoms have become increasing worse and that she has been feeling overly tired since the evening of 7/3/17. The patient explained to the pharmacist that she had been taking both ibuprofen and Benadryl around -the-clock to mange her symptoms.
Age: 53.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site warmth
Clinical narrative: Patient presented to the pharmacy on 7/5/17 at approximately 3:30pm. Patient explained to the pharmacist that later in the evening of 7/3/17, the area around her injection site on her right arm had become inflamed, red, slightly painful and warm to the touch. The patient explained that since that time, her symptoms have become increasing worse and that she has been feeling overly tired since the evening of 7/3/17. The patient explained to the pharmacist that she had been taking both ibuprofen and Benadryl around -the-clock to mange her symptoms.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Blood culture negative, Body temperature increased, Haemoglobin normal, Injection site erythema, Injection site induration
Clinical narrative: Pt developed swelling, redness in right arm within several hours after received vaccination. T 100.6. Called about symptoms next morning. Swelling and induration of right mid arm continued, T < 101. Seen 5/7/17 in office around 10:30 am. Felt pt had local reaction with possible early cellulitis, started pt on oral Clindamycin (with recent allergic reaction to amoxicillin did not want to use AUGMENTIN or KEFLEX). After 2 doses oral antibiotic pt's temp 101.8, with continued redness and swelling and warmth of arm, admitted 5/8/17 to Hospital, for IV Clindamycin. Discharged 5/9/17 about 39 hours later with improvement in swelling (almost completely resolved mid arm) and resolving erythema, good range of motion all joints, afebrile, on oral Clindamycin for 7 more days.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Injection site swelling, Injection site warmth, Local reaction, Lymphocyte percentage increased, Neutrophil percentage decreased
Clinical narrative: Pt developed swelling, redness in right arm within several hours after received vaccination. T 100.6. Called about symptoms next morning. Swelling and induration of right mid arm continued, T < 101. Seen 5/7/17 in office around 10:30 am. Felt pt had local reaction with possible early cellulitis, started pt on oral Clindamycin (with recent allergic reaction to amoxicillin did not want to use AUGMENTIN or KEFLEX). After 2 doses oral antibiotic pt's temp 101.8, with continued redness and swelling and warmth of arm, admitted 5/8/17 to Hospital, for IV Clindamycin. Discharged 5/9/17 about 39 hours later with improvement in swelling (almost completely resolved mid arm) and resolving erythema, good range of motion all joints, afebrile, on oral Clindamycin for 7 more days.
Age: 4.0
Sex: M
Vaccine: MMRV
Symptoms: Platelet count normal, Red blood cell count normal, White blood cell count increased, X-ray limb normal
Clinical narrative: Pt developed swelling, redness in right arm within several hours after received vaccination. T 100.6. Called about symptoms next morning. Swelling and induration of right mid arm continued, T < 101. Seen 5/7/17 in office around 10:30 am. Felt pt had local reaction with possible early cellulitis, started pt on oral Clindamycin (with recent allergic reaction to amoxicillin did not want to use AUGMENTIN or KEFLEX). After 2 doses oral antibiotic pt's temp 101.8, with continued redness and swelling and warmth of arm, admitted 5/8/17 to Hospital, for IV Clindamycin. Discharged 5/9/17 about 39 hours later with improvement in swelling (almost completely resolved mid arm) and resolving erythema, good range of motion all joints, afebrile, on oral Clindamycin for 7 more days.
Age: 1.58
Sex: F
Vaccine: HEP
Symptoms: Wrong drug administered
Clinical narrative: Schedule and mom said child needed Hep B vaccine. Internet down therefore I couldn't verify shot record. When internet up I verified child needed Hep A not Hep B.
Age: 60.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Headache, Injection site erythema, Injection site swelling, Nausea
Clinical narrative: Injection site reaction - redness, swelling, nausea, headache.
Age: 83.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Skin reaction
Clinical narrative: Superficial skin reaction (erythema and induration) left upper arm at injection site. Treated with cool compress, antihistamines.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Diarrhoea, Ear infection, Pyrexia
Clinical narrative: Fever, diarrhea, ear infection. Tx: amoxicillin x7 days.
Age: 74.0
Sex: U
Vaccine: PNC13
Symptoms: Erythema, Pyrexia, Swelling
Clinical narrative: On 6/15/17 Pt have a PREVNAR shot, the day after at noon time. By the time she got shower notice swelling on Right shoulder, redness, a little fever got to doctor and prescribe clindamycin and Levocetirizine.
Age: 81.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient received PREVNAR 13 on 6/28/17. Returned to store on 7/3/17 with redness, swelling, warm to the touch. Patch on area that had received injection, possible cellulitis.
Age: 1.0
Sex: F
Vaccine: HEPA, MMRV
Symptoms: Urticaria
Clinical narrative: Received PROQUAD and Hep A on 06/28/2017, uneventful 6/29/17. On 6/30/17, hives developed, rushed her to ER. Upon arrival, the hives (Urticaria) resolved (gone) completely. Doc in ER said its reaction to vaccination. Not seen in office since then, no hives after 6/30/2017.
Age: 7.0
Sex: M
Vaccine: IPV, TDAP
Symptoms: Erythema, Rash, Urticaria
Clinical narrative: Within 12 hrs. of vaccinations, pt. noted rash on gluteus, running down leg. Mother stated it looks like hives, red and raised. Progressed to trunk and arms. Nothing noted on face. No swelling. No breathing difficulties. Dissipated within 26 hrs. No fever. No headache.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: 11/04/16 patient came to clinic reported swelling and warmth and redness to injection site with "stinging". Vaccine was not administered here in clinic but at Dr.'s office at a different location.
Age: 3.0
Sex: F
Vaccine: MNQ
Symptoms: Unevaluable event
Clinical narrative: None listed.
Age: 19.0
Sex: M
Vaccine: HEPA, HPV9, TDAP
Symptoms: Hypersensitivity, Urticaria
Clinical narrative: Hives on Lt. forearm, denies difficulty in. Allergic.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Rash
Clinical narrative: Developed large uniformed red raised rash, both painful and itchy approx 2-3cm wide and 10cm long.
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cellulitis, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Developed large uniformed red raised rash, both painful and itchy approx 2-3cm wide and 10cm long.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Erythema, Injection site erythema, Injection site irritation, Injection site pain, Skin warm
Clinical narrative: Developed rash along entire upper arm starting to fade on day 9. Rash itchy and warm.
Age: 65.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Rash, Rash pruritic, Skin warm
Clinical narrative: Developed rash along entire upper arm starting to fade on day 9. Rash itchy and warm.
Age: 15.0
Sex: F
Vaccine: HPV9, HEPA
Symptoms: Bipolar disorder, Headache, Lethargy, Nausea, Pain in jaw
Clinical narrative: Nausea, lethargic, joint pain in jaw, hand tremors, psychosomatic madness.
Age: 15.0
Sex: F
Vaccine: HPV9, HEPA
Symptoms: Personality change, Tremor, Urticaria, Vomiting, Weight increased
Clinical narrative: Nausea, lethargic, joint pain in jaw, hand tremors, psychosomatic madness.
Age: 15.0
Sex: F
Vaccine: HPV9, HEPA
Symptoms: Lethargy, Nausea, Pain in jaw, Somatic symptom disorder, Tremor
Clinical narrative: Nausea, lethargic, joint pain in jaw, hand tremors, psychosomatic madness.
Age: 28.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Ear swelling, Eyelid oedema, Lip swelling, Nail discolouration, Rash
Clinical narrative: Seen June 30 in our clinic for some itchiness and mild rash, worsened over weekend seen July 1 at Urgent care clinic I do not believe files VAERS, wheals widespread, nausea.
Age: 28.0
Sex: F
Vaccine: VARCEL, VARCEL
Symptoms: Nausea, Pruritus, Rash, Urticaria
Clinical narrative: Seen June 30 in our clinic for some itchiness and mild rash, worsened over weekend seen July 1 at Urgent care clinic I do not believe files VAERS, wheals widespread, nausea.
Age: 64.0
Sex: F
Vaccine: HEP
Symptoms: Bacterial test positive, Blood creatine phosphokinase MB normal, Blood urine present, Chest pain, Dizziness
Clinical narrative: Per ER Doctor: Patient arrived via EMS from Clinic for having chest pain, feeling dizzy, and nauseated. She was given ZOFRAN and something for pain. She states she feels better now and wants to go home. She went to clinic because she got a hepatitis vaccine two days ago and she was told to return if she had any questions. At home she got up and went to the closet and that is when she got lightheaded/dizzy and had the chest pain and nausea. Resting at home did not make it resolve completely and that is when she decided to return to the clinic. She has never had anything like this before.  First dose of Hep B was given to the patient on 08/05/2016 with no   Patient was released the same day from the ER
Age: 64.0
Sex: F
Vaccine: HEP
Symptoms: Electrocardiogram normal, Full blood count normal, Metabolic function test normal, Nausea, Troponin normal
Clinical narrative: Per ER Doctor: Patient arrived via EMS from Clinic for having chest pain, feeling dizzy, and nauseated. She was given ZOFRAN and something for pain. She states she feels better now and wants to go home. She went to clinic because she got a hepatitis vaccine two days ago and she was told to return if she had any questions. At home she got up and went to the closet and that is when she got lightheaded/dizzy and had the chest pain and nausea. Resting at home did not make it resolve completely and that is when she decided to return to the clinic. She has never had anything like this before.  First dose of Hep B was given to the patient on 08/05/2016 with no   Patient was released the same day from the ER
Age: 16.0
Sex: M
Vaccine: HPV9, MNQ
Symptoms: Syncope
Clinical narrative: Patient was on his way out of the building when he fainted by the elevator. He stated that he remained conscious the whole time. He was placed in a supine position with his lower extremities raised by a pillow. Parents reported that he's had history of fainting spells after receiving vaccines, lab work, or any medications that require the use of needles. They also said that he had not eaten anything that day. A pouch of juice was given orally. A fan was turned on towared the patient. He got up after 10 minutes with no other problem noted and walked out with a steady gait.
Age: 26.0
Sex: M
Vaccine: HEPA
Symptoms: Blood creatine phosphokinase increased, Brain natriuretic peptide increased, Catheterisation cardiac, Congestive cardiomyopathy, Ejection fraction decreased
Clinical narrative: Shortly after receiving vaccine, patient stated he felt flushed and his heart racing. Patient states sat in his vehicle for approximately 20 minutes without resolution of symptoms. Patient returned into clinic due to symptoms. Patient reported had protein shake in morning, and some water, nothing else. Patient laid on stretcher to rest for approximately 15 minutes during which time his vital signs were monitored. Initial HR approximately 100 with BP of 142/80. Repeated HR 90s with BP of 130/80. Primary care physician was notified and stated patient should rest for awhile in clinic and leave when feeling better. Patient denied any other symptoms. Reported feeling better with HR of 80s after about 15 minutes. Patient reported resolution of symptoms and left department. On 06 JUL 17, received hospital notes that patient reported to ER due to return of symptoms, worse than previous. Patient had full cardiac workup performed and found with dilated cardiomyopathy with an EF of less than 15%. Also with diagnosis of SVT, possible myocarditis and elevated CK / Troponin levels. In ER, troponin level noted slightly greater than 6. Once admitted to ICU, troponin noted of 110.0. Patient then transferred to another Hospital for further evaluation including cardiac cath. Patient currently admitted to hospital. No further information at this time.
Age: 26.0
Sex: M
Vaccine: HEPA
Symptoms: Flushing, Intensive care, Palpitations, Supraventricular tachycardia, Troponin increased
Clinical narrative: Shortly after receiving vaccine, patient stated he felt flushed and his heart racing. Patient states sat in his vehicle for approximately 20 minutes without resolution of symptoms. Patient returned into clinic due to symptoms. Patient reported had protein shake in morning, and some water, nothing else. Patient laid on stretcher to rest for approximately 15 minutes during which time his vital signs were monitored. Initial HR approximately 100 with BP of 142/80. Repeated HR 90s with BP of 130/80. Primary care physician was notified and stated patient should rest for awhile in clinic and leave when feeling better. Patient denied any other symptoms. Reported feeling better with HR of 80s after about 15 minutes. Patient reported resolution of symptoms and left department. On 06 JUL 17, received hospital notes that patient reported to ER due to return of symptoms, worse than previous. Patient had full cardiac workup performed and found with dilated cardiomyopathy with an EF of less than 15%. Also with diagnosis of SVT, possible myocarditis and elevated CK / Troponin levels. In ER, troponin level noted slightly greater than 6. Once admitted to ICU, troponin noted of 110.0. Patient then transferred to another Hospital for further evaluation including cardiac cath. Patient currently admitted to hospital. No further information at this time.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Musculoskeletal stiffness, Periarthritis
Clinical narrative: Employer-required flu vaccine given in October. By January, I was having shoulder pain/stiffness/limited ROM. I finally had time to go to a sports medicine clinic in May - diagnosed with frozen shoulder. Undergoing physical therapy and massage - it's helping.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Seizure
Clinical narrative: Patient seized after receiving vaccine.
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Swelling below injection site 5-6 inches long and 5 inches wide, redness and soreness. Advil given last night, still swollen and sore this am.
Age: 33.0
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Chills, Dizziness, Feeling hot, Influenza virus test negative
Clinical narrative: On day of vaccination, pt started to feel chills at night and noticed shoulder was hurting. He took an ibuprofen. The following day, pt felt warm, dizzy, and lethargic. Temp 107.5F at this time. Went to the ER and was told his temp was 103F. Pt was hospitalized at Medical Center x 2 days (ongoing). Per documentation, pt reported experiencing nausea, vomiting, dizziness. Pt was given vancomycin and ceftriaxone due to risk of infection. Pt's arm is still sore, but he notes that his symptoms are improving.
Age: 33.0
Sex: M
Vaccine: PPV
Symptoms: Lethargy, Musculoskeletal pain, Nausea, Pain in extremity, Vomiting
Clinical narrative: On day of vaccination, pt started to feel chills at night and noticed shoulder was hurting. He took an ibuprofen. The following day, pt felt warm, dizzy, and lethargic. Temp 107.5F at this time. Went to the ER and was told his temp was 103F. Pt was hospitalized at Medical Center x 2 days (ongoing). Per documentation, pt reported experiencing nausea, vomiting, dizziness. Pt was given vancomycin and ceftriaxone due to risk of infection. Pt's arm is still sore, but he notes that his symptoms are improving.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Electroencephalogram normal, Eye movement disorder, Musculoskeletal stiffness, Nuclear magnetic resonance imaging normal, Seizure
Clinical narrative: 7 days after vaccination pt had seizure (rolling of eyes upward, shaking / stiffening of the extremities, no fever. Pt. was brought to hospital where MRI and EEG were done. Result: Normal.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Tremor
Clinical narrative: 7 days after vaccination pt had seizure (rolling of eyes upward, shaking / stiffening of the extremities, no fever. Pt. was brought to hospital where MRI and EEG were done. Result: Normal.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Allergy test positive, Anaphylactic shock, Full blood count normal, Laboratory test normal
Clinical narrative: Anaphylactic shock 07/05/2016 7:00 a.m. BENADRYL injection by EMS. NSIV and Prednisone in ED. Allergy testing and asthma testing and treatment. Allergy medications and shots incl. carry EPIPEN at all times.
Age: 5.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site cellulitis, Injection site erythema
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site erythema in a 5-year-old female patient who received KINRIX (batch number Y2N22, expiry date 12th February 2019). On 20th June 2017, the patient received KINRIX (intramuscular). On 20th June 2017, less than a day after receiving KINRIX, the patient experienced injection site erythema and injection site cellulitis. The patient was treated with cephalexin. On an unknown date, the outcome of the injection site erythema and injection site cellulitis were recovering/resolving. The reporter considered the injection site erythema and injection site cellulitis to be probably related to KINRIX. Additional details were provided as follows: This case was received from a licensed practical nurse. The patient received the dose of KINRIX on right thigh. After the injection, the patient went for swimming in a chlorinated pool. The patient was seen in the office and was prescribed cephalexin. The patient was improving. This case was linked with case US2017098855, reported by same reporter.
Sex: F
Vaccine: MENB
Symptoms: Documented hypersensitivity to administered product, Hypersensitivity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of allergic reaction in a female patient who received BEXSERO. Concurrent medical conditions included latex allergy. In June 2017, the patient received BEXSERO. In June 2017, less than a month after receiving BEXSERO, the patient experienced allergic reaction and documented hypersensitivity to administered product. On an unknown date, the outcome of the allergic reaction was recovering/resolving and the outcome of the documented hypersensitivity to administered product was unknown. It was unknown if the reporter considered the allergic reaction to be related to BEXSERO. Additional details were reported as follows: The age at vaccination was not reported. The patient reported that her physician was aware about the latex allergy, but administered the vaccine anyway. She was vaccinated 12 days before the reporting date and her physician told her that she had received one dose of GSK's meningitis B vaccine. The patient did have a reaction after vaccination. The patient did not want to provide additional information at this the reporting time. The caller was transferred to a pharmacist for additional information.
Age: 58.0
Sex: M
Vaccine: TDAP
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Pt returned to pharmacy on 07/05 complaining arm still hurts and said it was swollen shortly after the injection.
Age: 18.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Injection site swelling, Laboratory test, Paraesthesia, Syncope
Clinical narrative: Syncope after injection, swelling of area within 48 hours, since then and for at least 4 weeks, intermittent episodes of weakness and parasthesias of lower ext. and face. Some intermittent tachycardia also.
Age: 18.0
Sex: F
Vaccine: TDAP
Symptoms: Tachycardia
Clinical narrative: Syncope after injection, swelling of area within 48 hours, since then and for at least 4 weeks, intermittent episodes of weakness and parasthesias of lower ext. and face. Some intermittent tachycardia also.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Arthralgia, Dyskinesia, Injection site erythema, Injection site swelling, Joint stiffness
Clinical narrative: Swelling, redness at injection site on left thigh (MMR vaccine site) at 8 days post vaccination. Mild rash on back at 9 days post vaccination. Systemic rash 10 days post vaccination. Fever 100.1 degrees fahrenheit (rectal) 8 and 9 days post vaccination; stopped at 10 days post vaccination. Temporary pain and stiffness in knee joints and some jerking at 9 days post vaccination
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Pyrexia, Rash, Skin warm
Clinical narrative: Swelling, redness at injection site on left thigh (MMR vaccine site) at 8 days post vaccination. Mild rash on back at 9 days post vaccination. Systemic rash 10 days post vaccination. Fever 100.1 degrees fahrenheit (rectal) 8 and 9 days post vaccination; stopped at 10 days post vaccination. Temporary pain and stiffness in knee joints and some jerking at 9 days post vaccination
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Chronic inflammatory demyelinating polyradiculoneuropathy, Ear infection, Guillain-Barre syndrome, Lumbar puncture abnormal
Clinical narrative: Influenza 3 years & above with Preservative is the vaccine. Chills, fever the night of the vaccine, then developed 1st ever ear infection then progressed to Guillain Barre Syndrome and advanced to CIDP.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: Influenza 3 years & above with Preservative is the vaccine. Chills, fever the night of the vaccine, then developed 1st ever ear infection then progressed to Guillain Barre Syndrome and advanced to CIDP.
Age: 23.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Blood glucose abnormal, Infection, Pyrexia
Clinical narrative: Patient's mother called to report an adverse event following receiving the ADACEL and PNEUMOVAX 23 on 7/2/17. All events reported via the mother, who was informed by the patient. The patient, a 23 year old type 1 diabetic, left for another state the evening after getting the vaccinations. After a day or so of being there he spiked a fever and his blood sugars were out of normal range. Once at the hospital, he was found to have an infection and was admitted. The mother wanted us to know this happened following the vaccinations and was concerned that he received the incorrect shots. I explained that he did qualify for the vaccines he received. She asked if we use a new needle for each patient and I informed her that we use a new sterile needle for each vaccination even for the same patient.
Sex: U
Vaccine: MENB
Symptoms: Arthralgia, Fatigue, Injection site erythema, Injection site pain, Nausea
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a adolescent patient who received BEXSERO. On 20th June 2017, the patient received BEXSERO. On 20th June 2017, less than a day after receiving the BEXSERO, the patient experienced injection site pain, joint pain, nausea, injection site erythema and fatigue. On an unknown date, the outcome of the injection site pain, joint pain, nausea, injection site erythema and fatigue were not recovered/not resolved. It was unknown if the reporter considered the injection site pain, joint pain, nausea, injection site erythema and fatigue to be related to BEXSERO. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced soreness at the injection site. The pharmacist reported that her information was limited to a small sticky note. The patient's injection was given at another facility (unknown).
Age: 70.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Client called the clinic the morning of 7/5/2017 stating that one of her arms were swollen, hot, and painful where she received the vaccine 2 days prior. She stated the other arm was fine. I told her that I would pull her record and call her back. After looking at the record I called her back and asked which arm she was having problems with and she said the right. Documentation showed that it was the arm where the varicella was administered. I instructed her to apply heat to the arm. I called again prior to leaving the facility in the afternoon. The client stated that she had been putting the heat on the arm with warm towels. Explained to the client that because she is diabetic to monitor the site and the amount of heat to prevent burns. She stated she was watching it closely. Called the client this AM, 7/6/2017 at 9 am. The client states that the swelling at the site on the right arm has decreased, and the pain has decreased. She stated that she was ok.
Age: 10.0
Sex: M
Vaccine: HEP, HEPA, IPV, MMR, VARCEL
Symptoms: Erythema, Peripheral swelling, Tenderness
Clinical narrative: Right arm swelling and redness; it was tender for 2 days and stopped hurting today.
Age: 0.5
Sex: M
Vaccine: PNC13, RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Infant got extra dose of PCV13 and Rotavirus within 16 days of each other due to MCIR interface error. No adverse effect occurred at clinic--mother was educated on the error and DHD was notified of this.
Age: 18.0
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: Fainted, administered Epi Pen checked BP every 5 min until EMS arrived then EMS Took him to ER to get follow up by DR.
Age: 67.0
Sex: F
Vaccine: MNQ, PPV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Pt was given MENACTRA by error of medical assistant. No adverse reactions and tolerated well. Pt arm was not sore and no erythema or swelling. No other symptoms currently.
Age: 77.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling, Pain
Clinical narrative: Pt. reports that the next day, left arm was swollen from injection site to elbow and complained of pain.
Age: 19.0
Sex: F
Vaccine: HEPA, MENB
Symptoms: Chills, Dyspnoea, Erythema, Fatigue, Headache
Clinical narrative: Sudden onset of extreme exhaustion, nausea, chills, low grade temp, face bright red & puffy, breathing labored. Severe right arm pain & inability to move it. Went to ER. Treated with oxygen & IV fluids. Symptoms resolved spontaneously after approximately an hour. Residual headache & arm pain.
Age: 19.0
Sex: F
Vaccine: HEPA, MENB
Symptoms: Injected limb mobility decreased, Nausea, Pain in extremity, Pyrexia, Swelling face
Clinical narrative: Sudden onset of extreme exhaustion, nausea, chills, low grade temp, face bright red & puffy, breathing labored. Severe right arm pain & inability to move it. Went to ER. Treated with oxygen & IV fluids. Symptoms resolved spontaneously after approximately an hour. Residual headache & arm pain.
Age: 11.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Left deltoid swelling and erythema developed about 36 hours after vaccine administration, and 12 hours after that it became painful, red, hot, and firm. Presented to care at that time, and Rx for cephalexin given. Abx started today.
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: Sore right arm still and getting worse. She is going to speak with her dr. Hoped it would go away. Just told me/us today 07/06/2017.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB, MNQ, TDAP
Symptoms: Dizziness, Syncope
Clinical narrative: Minor fainted 20 minutes after receiving all vaccines. He fainted again 30 after that and a few minutes later, he vomited. Minor continued to complain of feeling dizzy even after taking two sugary drinks and a granola bar. Vital Signs were stable during this time, but  because minor continued to complain of feeling dizzy, he was sent to the ER via ambulance in stable condition.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Peripheral swelling
Clinical narrative: SWELLING OF THE ARM THE SIZE OF WIFE'S HAND AND REDNESS AROUND THE INJECTION SITE. PAINFUL. RECOMMENDED PATIENT TO APPLY ICE AND TAKE OTC IBUPROFEN FOR PAIN PRN AND TO KEEP MOVING THE ARM.
Age: 64.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Headache, Injection site erythema, Injection site induration, Injection site pain, Local reaction
Clinical narrative: SUBJECTIVE: 64-year-old woman, patient of Dr., in for acute visit. At time of patient's CPE visit 3 days ago, she received injection of shingles vaccine in right upper arm. Over the subsequent 3 days, patient has developed an area of fairly severe soreness and tenderness at site of injection, with an expanding oval area of pink erythema. She has not developed any vesicular or chickenpox-like lesions, but she has developed some nausea and headache. No fever. Patient did have one episode of actual zoster, in the lower back, about 6 years ago. For the current soreness, patient has been using some ice, but has not tried any other medication so far. Prefers not to take BENADRYL, since it has made her very tired in past. However, she has taken CLARITIN in past, and agrees to try that now. Please see below. Patient does have diabetes and is on metformin, says her blood sugars have been quite well controlled lately, and the physical exam note documents excellent weight loss. AT BEGINNING OF TODAY'S VISIT: Current Meds: CALCIUM 500 MG TABS (CALCIUM) 1 by mouth twice a day; FREESTYLE LITE TEST STRP (GLUCOSE BLOOD) BID testing; FREESTYLE LANCETS MISC (LANCETS) Use for blood glucose monitoring two times per day; DX : E11.9; LISINOPRIL 10 MG TABS (LISINOPRIL) Take 1 tablet by mouth once daily; METFORMIN HCL 500 MG TABS (METFORMIN HCL) Take 1 tablet by mouth twice daily with breakfast and dinner; ASPIR-LOW 81 MG TBEC (ASPIRIN) Take 1 tablet by mouth once daily. OBJECTIVE: Very pleasant woman, vital signs as above. Exam of right upper arm shows a large oval-shaped area of erythema, 3" x 5" to my measurement, with central induration and tenderness at presumptive ZOSTAVAX injection site. I see no papular vesicular lesions. ASSESSMENT: Localized reaction to shingles vaccine, moderately severe, and patient does report at least subtle systemic symptoms of nausea and headache, but no fever. PLAN: Discussed the nature of localized reactions to vaccinations, and this should be self-limited. I did recommend patient use an over-the-counter antihistamine, nonsedating, such as CLARITIN or ZYRTEC or ALLEGRA; also supported her continuing use of ice as helpful, and the use of either ibuprofen or naproxen as helpful. The latter to be taken with food. While patient was in the office, I actually did call infectious disease consultant Dr. on the telephone, to ask if there would be any point in considering acyclovir or other measures, and he felt that it should not be necessary to use that nor prednisone. Patient expresses understanding and agreement, I did use a purple skin marking pen to outline the current size of the localized reaction, and I asked patient to notify us if it is expanding significantly further, or if she is having other worsening. Please see end of visit instructions below.
Age: 64.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Nausea
Clinical narrative: SUBJECTIVE: 64-year-old woman, patient of Dr., in for acute visit. At time of patient's CPE visit 3 days ago, she received injection of shingles vaccine in right upper arm. Over the subsequent 3 days, patient has developed an area of fairly severe soreness and tenderness at site of injection, with an expanding oval area of pink erythema. She has not developed any vesicular or chickenpox-like lesions, but she has developed some nausea and headache. No fever. Patient did have one episode of actual zoster, in the lower back, about 6 years ago. For the current soreness, patient has been using some ice, but has not tried any other medication so far. Prefers not to take BENADRYL, since it has made her very tired in past. However, she has taken CLARITIN in past, and agrees to try that now. Please see below. Patient does have diabetes and is on metformin, says her blood sugars have been quite well controlled lately, and the physical exam note documents excellent weight loss. AT BEGINNING OF TODAY'S VISIT: Current Meds: CALCIUM 500 MG TABS (CALCIUM) 1 by mouth twice a day; FREESTYLE LITE TEST STRP (GLUCOSE BLOOD) BID testing; FREESTYLE LANCETS MISC (LANCETS) Use for blood glucose monitoring two times per day; DX : E11.9; LISINOPRIL 10 MG TABS (LISINOPRIL) Take 1 tablet by mouth once daily; METFORMIN HCL 500 MG TABS (METFORMIN HCL) Take 1 tablet by mouth twice daily with breakfast and dinner; ASPIR-LOW 81 MG TBEC (ASPIRIN) Take 1 tablet by mouth once daily. OBJECTIVE: Very pleasant woman, vital signs as above. Exam of right upper arm shows a large oval-shaped area of erythema, 3" x 5" to my measurement, with central induration and tenderness at presumptive ZOSTAVAX injection site. I see no papular vesicular lesions. ASSESSMENT: Localized reaction to shingles vaccine, moderately severe, and patient does report at least subtle systemic symptoms of nausea and headache, but no fever. PLAN: Discussed the nature of localized reactions to vaccinations, and this should be self-limited. I did recommend patient use an over-the-counter antihistamine, nonsedating, such as CLARITIN or ZYRTEC or ALLEGRA; also supported her continuing use of ice as helpful, and the use of either ibuprofen or naproxen as helpful. The latter to be taken with food. While patient was in the office, I actually did call infectious disease consultant Dr. on the telephone, to ask if there would be any point in considering acyclovir or other measures, and he felt that it should not be necessary to use that nor prednisone. Patient expresses understanding and agreement, I did use a purple skin marking pen to outline the current size of the localized reaction, and I asked patient to notify us if it is expanding significantly further, or if she is having other worsening. Please see end of visit instructions below.
Age: 45.0
Sex: F
Vaccine: DTAP
Symptoms: Chills, Cough, Dyspnoea, Erythema, Exposure during pregnancy
Clinical narrative: 30 weeks pregnant, EDD 09/06/2017. Expected/disclosed side effects of injection site soreness and redness experienced immediately. By bedtime, general malaise including body aches and headache. Injection site welt visible. By 8am the next day, continued tiredness with shortness of breath. By 6pm and after a two hour nap, arm redness drastically increased, shortness of breath worsened, jaw soreness and coughing. Contacted pharmacy who advised contacting on call doctor. Doctor advised ice packs and TYLENOL. Should shortness of breath continue, advised to go to emergency room. No fever. At 2 AM, severe chills experienced for approximately 2 hours. Continued redness increased to upper left arm. Redness subsided by 06/03/2017.
Age: 45.0
Sex: F
Vaccine: DTAP
Symptoms: Fatigue, Headache, Injection site erythema, Injection site urticaria, Malaise
Clinical narrative: 30 weeks pregnant, EDD 09/06/2017. Expected/disclosed side effects of injection site soreness and redness experienced immediately. By bedtime, general malaise including body aches and headache. Injection site welt visible. By 8am the next day, continued tiredness with shortness of breath. By 6pm and after a two hour nap, arm redness drastically increased, shortness of breath worsened, jaw soreness and coughing. Contacted pharmacy who advised contacting on call doctor. Doctor advised ice packs and TYLENOL. Should shortness of breath continue, advised to go to emergency room. No fever. At 2 AM, severe chills experienced for approximately 2 hours. Continued redness increased to upper left arm. Redness subsided by 06/03/2017.
Age: 45.0
Sex: F
Vaccine: DTAP
Symptoms: Pain, Pain in jaw
Clinical narrative: 30 weeks pregnant, EDD 09/06/2017. Expected/disclosed side effects of injection site soreness and redness experienced immediately. By bedtime, general malaise including body aches and headache. Injection site welt visible. By 8am the next day, continued tiredness with shortness of breath. By 6pm and after a two hour nap, arm redness drastically increased, shortness of breath worsened, jaw soreness and coughing. Contacted pharmacy who advised contacting on call doctor. Doctor advised ice packs and TYLENOL. Should shortness of breath continue, advised to go to emergency room. No fever. At 2 AM, severe chills experienced for approximately 2 hours. Continued redness increased to upper left arm. Redness subsided by 06/03/2017.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Injection site cellulitis, Injection site erythema
Clinical narrative: MMR was given 6/19/2017. By 6/27/20017 mother noted redness and the injection site which increased in size. Child was evaluated in the clinic and diagnosed with cellulitis of the left thigh. Improvement was noted with oral antibiotics on 6/30/2017.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Dizziness, Injection site swelling
Clinical narrative: A little swelling at injection site and little dizziness.
Age: 29.0
Sex: F
Vaccine: MMRV
Symptoms: Erythema, Induration, Pruritus, Rash, Swelling
Clinical narrative: Pt noticed next day large localized rash, redness, swelling, induration and itching. Pt stated it was larger than a quarter size and by the time of appt it was the size of a quarter.
Age: 57.0
Sex: F
Vaccine: TDAP
Symptoms: Asthenia, Fatigue, Injection site erythema, Injection site pain
Clinical narrative: Patient received vaccine Monday and called back Thursday stating she has been experiencing redness and pain around the injection site and still feels very weak/tired. She was only concerned because her husband also received the vaccine but experienced no adverse reaction. We explained to her that the effects were very common and that TYLENOL should be taken. Pain was not her main concern, more the weakness. She was advised to see the doctor if conditions worsened or simply did not improve over the next 24 hours. Patient is not experiencing fever or sickness.
Age: 24.0
Sex: M
Vaccine: ANTH, JEV1, TYP
Symptoms: Urticaria
Clinical narrative: 24 yo presents himself to facility for a F/U with the ER after another break out of hives around 1900. Medics gave pt three pills, pt only knows that one of them was diphenhydramine. Upon arrival ER could not evaluate pt due to the fact that the hives were no longer present. Pt was sent back home and around 2030, pt broke out in more hives around his neck and thighs. Pt returned to ER and was given a prescription of diphenhydramine. Pt has taken x1 capsule around 1200 today, 7/6/17. Pt has only taken x1 Zyrtec yesterday and has not repeated. Pt states that he was told to come in to get tested for Allergies. Pt states only having one runny.
Age: 69.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema
Clinical narrative: Patient called us today complaining of red streaks on her bicep 4 days after receiving the vaccination, she said she was going to see her physician today to see if there was anything wrong with her arm.
Age: 11.0
Sex: M
Vaccine: PPV
Symptoms: C-reactive protein increased, Chest X-ray normal, Culture urine, Decreased appetite, Full blood count
Clinical narrative: Within 2 hours of injection pt developed fever, emesis. By the next day, he had redness, swelling and pain at the injection site. His fevers persisted though the emesis resolved. He was lethargic and not eating. He was hospitalized on 6/29/17 for IV fluids and labs. His CRP was over 6 with a normal WBC. He had a normal UA and CXR.
Age: 11.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Lethargy, Metabolic function test
Clinical narrative: Within 2 hours of injection pt developed fever, emesis. By the next day, he had redness, swelling and pain at the injection site. His fevers persisted though the emesis resolved. He was lethargic and not eating. He was hospitalized on 6/29/17 for IV fluids and labs. His CRP was over 6 with a normal WBC. He had a normal UA and CXR.
Age: 11.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia, Urine analysis normal, Vomiting, White blood cell count normal
Clinical narrative: Within 2 hours of injection pt developed fever, emesis. By the next day, he had redness, swelling and pain at the injection site. His fevers persisted though the emesis resolved. He was lethargic and not eating. He was hospitalized on 6/29/17 for IV fluids and labs. His CRP was over 6 with a normal WBC. He had a normal UA and CXR.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Pt. has redness and swelling to injection site. Area is raised and warm to touch. Raised area measures 50 x 60 mm.