chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to 4 unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of ROTATEQ (lot # L035637, expiration date 09-JUN-2017, exact doses were not reported, orally). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccines were exposed to temperature of 49.8 degrees Fahrenheit for 30 minutes before administration to the patients. No previous temperature excursion was reported. No adverse symptoms were reported. This is one of the several reports received from the same source. Additional information has been requested.
Age: 24.0
Sex: U
Vaccine: HPVX
Symptoms: Oral discomfort, Throat irritation
Clinical narrative: Pt c/o abnormal sensation to lips (as if swollen) and throat scratchy. Ongoing X 3 days at time of visit; HPV vaccine 5 days prior to visit. VS: T 98.5, RR 16, HR 60, BP 121/65, O2 98%. Pt well appearing. Airway patent. TX: prednisone and advised BENADRYL. Advised F/U allergist.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to 3 unspecified patients of unknown age and gender. No information regarding the patients' pertinent medical history, drug reactions, allergies or concomitant therapies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of VAQTA (lot # M009377, expiration date 17-JUN-2017, exact doses and route of administration were not reported). The reason of the call was temperature alarm received via Digital Data Logger. It was reported that the vaccines were exposed to temperature of 49.8 degree Fahrenheit for 30 minutes before administration to the patients. No previous temperature excursion was reported. No adverse symptoms were reported. This is one of the several reports from the same source. Additional information has been requested.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Fatigue, Headache, Myalgia, Pyrexia
Clinical narrative: Headache, chills, myalgia, fever >102, fatigue, rash. Patient went to ED on 6/2/16 and 6/4/16. WBC > 20,000. Discharged on PO prednisone.
Age: 48.0
Sex: F
Vaccine: PPV
Symptoms: Rash, White blood cell count increased
Clinical narrative: Headache, chills, myalgia, fever >102, fatigue, rash. Patient went to ED on 6/2/16 and 6/4/16. WBC > 20,000. Discharged on PO prednisone.
Age: 32.0
Sex: M
Vaccine: TDAP
Symptoms: Cold sweat, Dizziness, Hepatitis B antibody, Hyperhidrosis, Pallor
Clinical narrative: Client in the immunization room for Tdap, Hep B and VZV titers and PPD. Client said he was going to nursing school and needed these test. Questioned client about passing out in the past. Client stated no. Tdap injected in right arm, no bleeding round bandage. Attempted blood draw in left antecubital and was unable to get any blood. No blood when needle removed, cotton ball and bandage was put on left antecubital. PPD skin test was placed on left forearm. Blood received from right antecubital 2 vials and client started to become very pale and stated felt dizzy. Client would close his eyes but when stated his name he always opened them. Very diaphoretic, pale, skin wet to touch. Vitals every 3-5 minutes, after symptoms started. 0925 BP 70/40, 48 pulse, 96 O2 sat. O2 was given for about 1-2 minutes but the O2 stayed 100% without O2 so it was removed. At 0927 BP 72/38, pulse 58. At 0930 BP 80/56, pulse 57. At 0935 BP 87/55, pulse 57. At 0942 BP 87/57, pulse 56. EMS was called and arrived around 0946. They took BP, talked with him, walked him in the room. Client agreed to have someone pick him up at the HD and drive him home and not to drive for the rest of the day. EMS left at 0958, by this time client had pink color skin, dry skin, states not dizzy. Drank 2 10 oz Cokes. Client placed in the front lobby and was watched by front desk until his ride picked him up at the front door.
Age: 32.0
Sex: M
Vaccine: TDAP
Symptoms: Tuberculin test, Viral titre
Clinical narrative: Client in the immunization room for Tdap, Hep B and VZV titers and PPD. Client said he was going to nursing school and needed these test. Questioned client about passing out in the past. Client stated no. Tdap injected in right arm, no bleeding round bandage. Attempted blood draw in left antecubital and was unable to get any blood. No blood when needle removed, cotton ball and bandage was put on left antecubital. PPD skin test was placed on left forearm. Blood received from right antecubital 2 vials and client started to become very pale and stated felt dizzy. Client would close his eyes but when stated his name he always opened them. Very diaphoretic, pale, skin wet to touch. Vitals every 3-5 minutes, after symptoms started. 0925 BP 70/40, 48 pulse, 96 O2 sat. O2 was given for about 1-2 minutes but the O2 stayed 100% without O2 so it was removed. At 0927 BP 72/38, pulse 58. At 0930 BP 80/56, pulse 57. At 0935 BP 87/55, pulse 57. At 0942 BP 87/57, pulse 56. EMS was called and arrived around 0946. They took BP, talked with him, walked him in the room. Client agreed to have someone pick him up at the HD and drive him home and not to drive for the rest of the day. EMS left at 0958, by this time client had pink color skin, dry skin, states not dizzy. Drank 2 10 oz Cokes. Client placed in the front lobby and was watched by front desk until his ride picked him up at the front door.
Sex: U
Vaccine: RV5
Symptoms: Haematochezia
Clinical narrative: The spontaneous report was received from the physician via company representative refers to three young patients of unknown age and gender. Information about patients medical history, concurrent conditions and concomitants medications were not reported. On an unknown date, the patients were vaccinated with a dose of ROTATEQ (dosing details not provided). Subsequently, on an unknown date, the patients experienced bloody stools. The patients sought medical attention by visiting the physician on an unknown date. The outcome of the event was unknown. Causality assessment was not provided. No product quality (PQC) involved. No other information provided. Upon internal review, the event of haematochezia was determined to be medically significant. Additional information is not expected as the reporter did not wish to be contacted.
Age: 0.6
Sex: U
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a 6 month old patient. The medical history, concurrent condition and concomitant medications were not reported. On 26-MAY-2016, the patient was inadvertently vaccinated with ROTATEQ lot # L039297, 19-JUN-2017, dose 1, oral. No adverse effect was reported. Additional information has been requested.
Age: 71.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin irritation, Urticaria
Clinical narrative: This spontaneous report was received from a pharmacist refers to a 71 year old female patient. The patient's relevant medical history and concurrent conditions were not reported. The patient had none drug reactions/allergies. The patient received an unspecified pneumonia vaccine (manufacture unknown) in the past but could not provide name of vaccine or date of vaccination and did not have any reaction with unspecified pneumonia vaccine (manufacture unknown) in the past. On 20-MAY-2016, the patient was vaccinated with PNEUMOVAX 23 injection (10 Standard packages syringe of 1) lot # L022262 (expiry date: 05-NOV-2016) at a dose of 0.5 ml, intramuscularly in the deltoid area of arm. None concomitant medications reported. On the same day within 24 hours of receiving PNEUMOVAX 23, patient experienced reaction which started as hives and became very red and irritated. The patient sought medical attention. Pharmacist examined patient and reported that reaction was not at injection site (deltoid area of arm) but in upper front arm (biceps area) and toward patient's arm pit. On 21-MAY-2016, when patient came into pharmacy, patient was already taking BENADRYL and reaction area got better. On 23-MAY-2016, pharmacist followed up with patient again and patient told pharmacist that reaction was almost gone. The outcome of the events was recovering. The reporter did not provide any causality assessment between events and PNEUMOVAX 23. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: FLU3, HEPA, MMR, VARCEL, FLUX
Symptoms: Autopsy, Death
Clinical narrative: Initial unsolicited report received from a non-health care professional on 01 June 2016. This case involves a 12 month old patient (gender was not reported) who was vaccinated with a dose of Influenza Vaccine (manufacturer: unknown, batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. Patient's ongoing illness, medical history and concomitant medications were not reported. On an unspecified date post vaccination, the patient passed away. Other lab tests and corrective treatments were not reported. It was not reported whether autopsy was performed or not. List of documents held by sender: none. Sender's Comments: This case is insufficiently documented to assess the role of the vaccine. Additional information regarding the date of vaccination and death, relevant medical history, underlying cause of death, complete autopsy report (if autopsy was performed) are needed for complete assessment of the case. Reported Cause(s) of Death: death nos.
Age: 1.0
Sex: U
Vaccine: FLU3, HEPA, MMR, VARCEL, FLUX
Symptoms: Death
Clinical narrative: Initial unsolicited report received from a non-health care professional on 01 June 2016. This case involves a 12 month old patient (gender was not reported) who was vaccinated with a dose of Influenza Vaccine (manufacturer: unknown, batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. Patient's ongoing illness, medical history and concomitant medications were not reported. On an unspecified date post vaccination, the patient passed away. Other lab tests and corrective treatments were not reported. It was not reported whether autopsy was performed or not. List of documents held by sender: none. Sender's Comments: This case is insufficiently documented to assess the role of the vaccine. Additional information regarding the date of vaccination and death, relevant medical history, underlying cause of death, complete autopsy report (if autopsy was performed) are needed for complete assessment of the case. Reported Cause(s) of Death: death nos.
Sex: U
Vaccine: RV5, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 25-MAR-2016, the patient was vaccinated with an improperly stored dose of ROTATEQ (reported lot # L008990, exp. date: 01-DEC-2016) (dose number and route were not reported). The dose of ROTATEQ was stored in 1.4 Celsius degree for 2 hours and 41 minutes. There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP, HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 24-MAR-2016, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot # L018501, exp. date: 22-JUN-2017) (dose number and route were not reported). The dose of RECOMBIVAX HB was stored in 1.4 Celsius degree for 2 hours and 41 minutes. There was no adverse effect reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 82.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Electromyogram, Erythema, Hypoaesthesia, Injection site hypoaesthesia, Pain in extremity
Clinical narrative: He reports that on October 2, 2015 he received the Fluzone high-dose influenza vaccination in his left arm.  Later that day he had some redness around the injection site.  By the next day he developed bruising at the site and lower down onto arm below the elbow.  A few days later he noted clear liquid discharge from the injection site and later cracks in his skin lower down on his arm that also released clear fluid.  Over this time he also developed a tingling sensation and numbness in his arm and hand.  The skin cracks and fluid released have stopped but some bruising or discoloration of the skin on the arm remains.  He continues to be bothered by pain in his upper arm and numbness and weakness in his hand.  He recently underwent I nerve release in his wrist but this has not helped as yet.  He had previously received annual influenza vaccines and other routine vaccinations uneventfully.
Age: 82.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Paraesthesia, Peripheral swelling, Sensory loss
Clinical narrative: He reports that on October 2, 2015 he received the Fluzone high-dose influenza vaccination in his left arm.  Later that day he had some redness around the injection site.  By the next day he developed bruising at the site and lower down onto arm below the elbow.  A few days later he noted clear liquid discharge from the injection site and later cracks in his skin lower down on his arm that also released clear fluid.  Over this time he also developed a tingling sensation and numbness in his arm and hand.  The skin cracks and fluid released have stopped but some bruising or discoloration of the skin on the arm remains.  He continues to be bothered by pain in his upper arm and numbness and weakness in his hand.  He recently underwent I nerve release in his wrist but this has not helped as yet.  He had previously received annual influenza vaccines and other routine vaccinations uneventfully.
Age: 82.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Contusion, Hypoaesthesia, Injection site bruising, Injection site discharge, Injection site erythema
Clinical narrative: He reports that on October 2, 2015 he received the Fluzone high-dose influenza vaccination in his left arm.  Later that day he had some redness around the injection site.  By the next day he developed bruising at the site and lower down onto arm below the elbow.  A few days later he noted clear liquid discharge from the injection site and later cracks in his skin lower down on his arm that also released clear fluid.  Over this time he also developed a tingling sensation and numbness in his arm and hand.  The skin cracks and fluid released have stopped but some bruising or discoloration of the skin on the arm remains.  He continues to be bothered by pain in his upper arm and numbness and weakness in his hand.  He recently underwent I nerve release in his wrist but this has not helped as yet.  He had previously received annual influenza vaccines and other routine vaccinations uneventfully.
Age: 82.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Muscular weakness, Pain in extremity, Paraesthesia, Peripheral nerve operation, Secretion discharge
Clinical narrative: He reports that on October 2, 2015 he received the Fluzone high-dose influenza vaccination in his left arm.  Later that day he had some redness around the injection site.  By the next day he developed bruising at the site and lower down onto arm below the elbow.  A few days later he noted clear liquid discharge from the injection site and later cracks in his skin lower down on his arm that also released clear fluid.  Over this time he also developed a tingling sensation and numbness in his arm and hand.  The skin cracks and fluid released have stopped but some bruising or discoloration of the skin on the arm remains.  He continues to be bothered by pain in his upper arm and numbness and weakness in his hand.  He recently underwent I nerve release in his wrist but this has not helped as yet.  He had previously received annual influenza vaccines and other routine vaccinations uneventfully.
Age: 82.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Skin discolouration, Skin fissures
Clinical narrative: He reports that on October 2, 2015 he received the Fluzone high-dose influenza vaccination in his left arm.  Later that day he had some redness around the injection site.  By the next day he developed bruising at the site and lower down onto arm below the elbow.  A few days later he noted clear liquid discharge from the injection site and later cracks in his skin lower down on his arm that also released clear fluid.  Over this time he also developed a tingling sensation and numbness in his arm and hand.  The skin cracks and fluid released have stopped but some bruising or discoloration of the skin on the arm remains.  He continues to be bothered by pain in his upper arm and numbness and weakness in his hand.  He recently underwent I nerve release in his wrist but this has not helped as yet.  He had previously received annual influenza vaccines and other routine vaccinations uneventfully.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Headache, Influenza virus test negative, Pyrexia, Rash erythematous
Clinical narrative: Patient experienced headache, fever and rash 3 days after vaccine administration. Fever subsided, rash lasted for several days.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Rash macular, Urine analysis normal
Clinical narrative: Patient experienced headache, fever and rash 3 days after vaccine administration. Fever subsided, rash lasted for several days.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Pyrexia, Rash
Clinical narrative: Patient experienced headache, fever and rash 3 days after vaccine administration. Fever subsided, rash lasted for several days.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local swelling, Lymph node pain, Lymphadenopathy, Skin warm
Clinical narrative: Swollen/tender left axillar lymph node on 11/11/15 (similar to previous 2-3 years). On 11/12/15 also developed an enlarged left clavicular lymph node that became tender, warm, and erythematous. On 11/13/15 she also developed erythema and swelling of the left lateral neck, no specific lymph node was appreciated. All symptoms resolved by 11/21/15.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Pain, Pyrexia
Clinical narrative: Very sore at point of injection, Fever, headache, body aches, all day 06/07/2016 and into 06/08/2016.  I called Dr.'s office 06/07/2016, left message and they never called me back.
Sex: F
Vaccine: VARZOS
Symptoms: Basosquamous carcinoma, Biopsy skin abnormal, Carcinoma in situ, Impaired healing, Injection site reaction
Clinical narrative: This spontaneous report as received from a physician refers to a currently 57 year old female patient with allergies to penicillin and clindamycin and a previous history of basal squamous cell carcinoma in unspecified locations of the body (date unspecified). On an unknown date, reported as over 1 year ago, the patient was vaccinated with a dose of ZOSTAVAX injection (lot# and expiry date were not reported), 0.65 ml subcutaneously, at an unspecified pharmacy. There were no concomitant therapies. On an unknown date, reported as soon after receiving ZOSTAVAX, the patient developed a lesion at the injection site that "never healed". The patient sought medical attention- she was seen in the physician's office on 21-MAR-2016 and was told to come back to have the area biopsied. The reporter stated that the patient returned to the office on 31-MAY-2016 to have the biopsy performed, and on an unknown date (approximately in 2016), the pathology report revealed basal squamous cell carcinoma in situ. The physician reported that the area was resected on an unknown date in 2016. The outcome of the event was reported as recovered on an unknown date in 2016. The relatedness between ZOSTAVAX and the event was not provided. Upon internal review, the event of basal squamous cell carcinoma in situ was considered to be medically significant. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Skin lesion, Skin neoplasm excision
Clinical narrative: This spontaneous report as received from a physician refers to a currently 57 year old female patient with allergies to penicillin and clindamycin and a previous history of basal squamous cell carcinoma in unspecified locations of the body (date unspecified). On an unknown date, reported as over 1 year ago, the patient was vaccinated with a dose of ZOSTAVAX injection (lot# and expiry date were not reported), 0.65 ml subcutaneously, at an unspecified pharmacy. There were no concomitant therapies. On an unknown date, reported as soon after receiving ZOSTAVAX, the patient developed a lesion at the injection site that "never healed". The patient sought medical attention- she was seen in the physician's office on 21-MAR-2016 and was told to come back to have the area biopsied. The reporter stated that the patient returned to the office on 31-MAY-2016 to have the biopsy performed, and on an unknown date (approximately in 2016), the pathology report revealed basal squamous cell carcinoma in situ. The physician reported that the area was resected on an unknown date in 2016. The outcome of the event was reported as recovered on an unknown date in 2016. The relatedness between ZOSTAVAX and the event was not provided. Upon internal review, the event of basal squamous cell carcinoma in situ was considered to be medically significant. Additional information has been requested.
Age: 0.37
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Atrial septal defect, Autopsy, Cardiac failure congestive, Death, Influenza
Clinical narrative: Infant received PEDIARIX, PREVNAR, PEDVAX and ROTATEQ vaccines on 3/2/16. He had slight fever that evening. In AM afebrile, eating well. Mom put down for nap and 2 hrs later found him unresponsive.
Age: 0.37
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Pyrexia, Unresponsive to stimuli
Clinical narrative: Infant received PEDIARIX, PREVNAR, PEDVAX and ROTATEQ vaccines on 3/2/16. He had slight fever that evening. In AM afebrile, eating well. Mom put down for nap and 2 hrs later found him unresponsive.
Age: 11.0
Sex: M
Vaccine: TDAP
Symptoms: Headache, Insomnia, Lethargy
Clinical narrative: My son developed a severe headache, lethargy and could not get enough sleep.  His older brother had a severe reaction to the DTP vaccine as an infant where he screamed for hours with the first shot and the second could not be woken.  Doctor at the time contacted CDC and he was never given another vaccine of this type.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Dyspnoea, Local swelling, Neck pain, Pain in extremity, Peripheral swelling
Clinical narrative: Developed "slight SOB", right arm/neck pain and swelling approx 6 hours post-vaccination. Reports SOB resolved within 24 hours.  Treated with BENADRYL initially and TYLENOL and ice packs as needed for the pain. Reported vaccine reaction to facility on 6/8/16.  Referred to an allergy specialist for f/u (appt. made for 6/9/16).
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Unevaluable event
Clinical narrative: None.
Age: 69.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Band neutrophil percentage increased, Enterococcus test positive, Injection site cellulitis, Sepsis, Shift to the left
Clinical narrative: Patient admitted to Medical Center with Sepsis secondary to RUE cellulitis.
Age: 69.0
Sex: M
Vaccine: PPV, PPV
Symptoms: White blood cell count increased
Clinical narrative: Patient admitted to Medical Center with Sepsis secondary to RUE cellulitis.
Age: 69.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Cellulitis
Clinical narrative: Patient admitted to Medical Center with Sepsis secondary to RUE cellulitis.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Arthrogram, Bursitis, Injection site pain, Nuclear magnetic resonance imaging, Pain
Clinical narrative: Right should pain progressively worse over two weeks, pain with lifting and abduction.
Age: 55.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: On 5/26/2016 he had an urgent care visit.  CHIEF COMPLAINT: Urgent care appointment. The patient received a PneumoVax injection on  5/24/2016 into his right deltoid. Approximately 12 hours later he called c/o redness, swelling and soreness near the injection site. My associate  instructed him to take Benadryl and Aleve. He took 2 doses of Benadryl and he has not noticed any significant improvement. The area of redness has progressed down his right bicep to the elbow. He denies fever, nausea, vomiting or soa.
Age: 55.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: On 5/26/2016 he had an urgent care visit.  CHIEF COMPLAINT: Urgent care appointment. The patient received a PneumoVax injection on  5/24/2016 into his right deltoid. Approximately 12 hours later he called c/o redness, swelling and soreness near the injection site. My associate  instructed him to take Benadryl and Aleve. He took 2 doses of Benadryl and he has not noticed any significant improvement. The area of redness has progressed down his right bicep to the elbow. He denies fever, nausea, vomiting or soa.
Age: 0.46
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Blood glucose increased, Differential white blood cell count, Full blood count, Haemoglobin urine present, Laboratory test
Clinical narrative: Patient experienced a 30 minute seizure.
Age: 0.46
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13
Symptoms: Platelet count normal, Seizure
Clinical narrative: Patient experienced a 30 minute seizure.
Age: 60.0
Sex: F
Vaccine: PNC13
Symptoms: Flushing, Pruritus, Urticaria, Wheelchair user
Clinical narrative: Within 5 minutes of receiving vaccine, patient developed hives on her arms that began to itch. She began feeling very flushed and was brought to the emergency room by wheelchair. She was given IV BENADRYL and SOLU-MEDROL.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Immediate post-injection reaction, Injection site erythema, Injection site oedema
Clinical narrative: Immediately following administration of PENTACEL in (L) leg annular red patch and localized edema noted. Heat pack administered, reduction seen after 10 minutes.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Hypoaesthesia, Musculoskeletal disorder, Pain in extremity
Clinical narrative: Received pneumococcal vaccine on 7-1-15. Within 4 hours arm numb extreme pain. Went to ER - sent to orthopaedic surgeon. 6+ months physical therapy. Still limited use of arm/shoulder.
Age: 48.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Pain in extremity, Sleep disorder
Clinical narrative: "I do not have full range of motion, I cannot sleep on that shoulder, and that arm hurts in many positions.  Several days I end up taking either Motrin or naproxen at the end of the day so that I can sleep." per patient email to the doctor.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Fatigue, Pain
Clinical narrative: Severe body pain that lasted for about a week. Fatigue that lasted about a week.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Chest X-ray abnormal, Cough, Nasopharyngitis, Pneumonia, Pyrexia
Clinical narrative: Developed tickle in the throat, was clearing his throat, felt like coming down with a cold, cough. Next night, developed fever and had more coughing. Went to see the doctor on Friday (06/03/2016). Xrays showed Pneumonia in one lung.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Throat irritation
Clinical narrative: Developed tickle in the throat, was clearing his throat, felt like coming down with a cold, cough. Next night, developed fever and had more coughing. Went to see the doctor on Friday (06/03/2016). Xrays showed Pneumonia in one lung.
Age: 4.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Arthropod bite, Injection site inflammation, Injection site reaction, Injection site vesicles, Scab
Clinical narrative: Patient developed what mom believed to be insect bites on site where varicella vaccine was administered. Was taken to an urgent care facility where the physician agreed that they could be insect bits and patient was treated with a steroid injection and BENADRYL by mouth. Mom contacted our office today as symptoms had not resolved. On exam all three vesicles had drained clear fluid per mom's recollection and are now crusted with minimal inflammation.
Age: 19.0
Sex: M
Vaccine: HPV9, MEN, MENB
Symptoms: Dyskinesia, Fall, Glassy eyes, Loss of consciousness, Musculoskeletal stiffness
Clinical narrative: Slumped over, pasted out- then laid out and went stiff and began shaking arms and legs and uncontrollable throwing of arms and legs. Eyes were glaring and glassed over - then came out of it.
Age: 19.0
Sex: M
Vaccine: HPV9, MEN, MENB
Symptoms: Tremor
Clinical narrative: Slumped over, pasted out- then laid out and went stiff and began shaking arms and legs and uncontrollable throwing of arms and legs. Eyes were glaring and glassed over - then came out of it.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Blood glucose increased, Erythema, Pyrexia
Clinical narrative: Patient stated has fever, redness and increase in fasting blood sugar level. She is diabetic. She was seen by her primary care physician and received antibiotic on 6/7/2016.
Age: 19.0
Sex: M
Vaccine: HEPA
Symptoms: Road traffic accident, Syncope
Clinical narrative: Patient waited 50 min after receiving HEP A vaccine. Patient experienced syncope while driving, was in an accident, and was taken to the ER.
Age: 25.0
Sex: F
Vaccine: FLUX
Symptoms: Abortion spontaneous, Blood test, Exposure during pregnancy, Haemorrhage, Ultrasound antenatal screen
Clinical narrative: I was pregnant at the time of the flu shot, Influenza Four-QIV Preservative Free 3+ Years IM 2015/16. After receiving the flu shot I began bleeding 2 days later. On 4/16/16 I miscarried and was 7-8 weeks pregnant at the time of miscarriage.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Fatigue, Headache, Influenza like illness, Pyrexia, Respiratory disorder
Clinical narrative: Fever, headache, flu-like symptoms, wheezing, respiratory difficulties, fatigue x 1 week.
Age: 15.0
Sex: F
Vaccine: MNQ
Symptoms: Wheezing
Clinical narrative: Fever, headache, flu-like symptoms, wheezing, respiratory difficulties, fatigue x 1 week.
Age: 21.0
Sex: F
Vaccine: MMR, MNQ
Symptoms: Immediate post-injection reaction, Loss of consciousness, Musculoskeletal stiffness, Mydriasis
Clinical narrative: Immediately following IM administration of MENACTRA, the patient's eyes dilated, she became stiff and passed out for less than 15 seconds. We moved her to the floor and she immediately recovered.
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Dizziness
Clinical narrative: Dizziness for 20 minutes.
Age: 1.12
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Injection site pruritus, Injection site reaction, Rash papular
Clinical narrative: 6 blister like papules noted on right thigh and 2 on right arm, pruritic.
Age: 16.0
Sex: M
Vaccine: HPV4
Symptoms: Benign lymph node neoplasm, Biopsy site unspecified normal, Mass, Mass excision
Clinical narrative: My son was getting ready to shower and felt something weird. Showed me the mass on his left clavicle. No fever, no diversion from normal life schedule.
Age: 35.0
Sex: F
Vaccine: IPV
Symptoms: Chills, Injection site erythema, Injection site pain, Injection site swelling, Nausea
Clinical narrative: Pt. reported to PCP (& Occupational Health clinic) body aches, chills, low-grade fever (38 C), nausea; pain, redness and swelling at the site of injection. PCP recommended (via telephone consult) to take Advil and OTC antihistamine.
Age: 35.0
Sex: F
Vaccine: IPV
Symptoms: Pain, Pyrexia
Clinical narrative: Pt. reported to PCP (& Occupational Health clinic) body aches, chills, low-grade fever (38 C), nausea; pain, redness and swelling at the site of injection. PCP recommended (via telephone consult) to take Advil and OTC antihistamine.
Age: 17.0
Sex: F
Vaccine: MEN
Symptoms: Anxiety, Arthralgia, Asthenia, Blood test abnormal, Dizziness
Clinical narrative: Headaches, fatigue, nose bleeds, muscle and joint pain and weakness, dizziness, anxiety, sever nausea, all daily. Low blood platelets, bad blood work results, fibro adenomas in both breasts, hypothyroidism symptoms. Prescribed antibiotics and lots of rest to no avail. Multiple other symptoms and treatments.
Age: 17.0
Sex: F
Vaccine: MEN
Symptoms: Epistaxis, Fatigue, Fibroadenoma of breast, Headache, Hypothyroidism
Clinical narrative: Headaches, fatigue, nose bleeds, muscle and joint pain and weakness, dizziness, anxiety, sever nausea, all daily. Low blood platelets, bad blood work results, fibro adenomas in both breasts, hypothyroidism symptoms. Prescribed antibiotics and lots of rest to no avail. Multiple other symptoms and treatments.
Age: 17.0
Sex: F
Vaccine: MEN
Symptoms: Myalgia, Nausea, Platelet count decreased
Clinical narrative: Headaches, fatigue, nose bleeds, muscle and joint pain and weakness, dizziness, anxiety, sever nausea, all daily. Low blood platelets, bad blood work results, fibro adenomas in both breasts, hypothyroidism symptoms. Prescribed antibiotics and lots of rest to no avail. Multiple other symptoms and treatments.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site pain, Nausea
Clinical narrative: Patient called noting severe pain at injection site on the shoulder. Enough pain that it was causing her to be nauseous. Started taking Ibuprofen and using an ice compress.
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site reaction, Rash erythematous, Rash pruritic, Vaccination complication
Clinical narrative: Patient alerted the pharmacy that she had a reaction to the vaccine on June 8, 2016. She had developed a red rash on her arm approximately 4x6 inches that was very itchy around the injection site. The Dr was notified and the patient was seen the same day we were notified. The Dr advised the patient to take Benadryl initially and continue with daily Zyrtec and to monitor and alert them if it worsens.
Sex: M
Vaccine: MENB
Symptoms: Erythema, Headache, Local swelling, Pyrexia, Tenderness
Clinical narrative: Fever, headache, wheal, tender, local red swelling - arm 48 hours.
Sex: M
Vaccine: MENB
Symptoms: Urticaria
Clinical narrative: Fever, headache, wheal, tender, local red swelling - arm 48 hours.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Injection site discolouration, Injection site erythema, Injection site swelling
Clinical narrative: 19cm x 16cm redness and slight nontender swelling on the left anterior thigh w/ 9cm x 6cm more dark red discoloration in the center.
Age: 1.45
Sex: M
Vaccine: DTAP
Symptoms: Injection site abscess, Pyrexia
Clinical narrative: Fever and abscess at site of injection.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Erythema, Imaging procedure, Peripheral swelling, Skin warm
Clinical narrative: Left arm swelling, red, warm to the touch. Treated with antihistamines. Child with Factor IX deficiency - vaccine given Sub Q.
Age: 18.0
Sex: F
Vaccine: MENB
Symptoms: Fatigue, Injection site pain, Nausea
Clinical narrative: Left upper arm painful, fatigue nausea, no fever.
Age: 1.6
Sex: F
Vaccine: HIBV, TDAP
Symptoms: Wrong drug administered
Clinical narrative: Misadministration of Vaccine. Patient was scheduled for DTAP vaccine. Patient was given Tdap vaccine.  The Nurse Practitioner spoke with Pediatrician by phone, he informed her this would not hurt the child, if anything it would boost her immunity. Patient parent was notified by phone of this misadministration of vaccine. Parent states patient is doing fine, no problems with vaccinations.
Age: 1.01
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Rash macular
Clinical narrative: Child had immunizations Friday 5/27/16, returned to office Tues. 5/31/16 with a rash that started that a.m. very suddenly. The macular rash was located on the scalp, face, upper back, lower leg and left arm. She also had a fever of 103 degrees.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Infection, Peripheral swelling, Pyrexia
Clinical narrative: After receiving vaccine within 24 hours, redness/swelling on arm, pt had fever and it was getting worse. Patient took 10 days of cephalexin and symptoms resolved.
Age: 1.61
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Abdominal pain, Chills, Decreased appetite, Dehydration, Diarrhoea
Clinical narrative: Chills, drowsiness, fatigue, injection site redness and swelling (day 2), irritability, abdominal pain, diarrhea, decreased appetite, nausea, vomiting, high fever, dehydration, skin rash (chest), over the course of 6 days.
Age: 1.61
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Irritability, Nausea
Clinical narrative: Chills, drowsiness, fatigue, injection site redness and swelling (day 2), irritability, abdominal pain, diarrhea, decreased appetite, nausea, vomiting, high fever, dehydration, skin rash (chest), over the course of 6 days.
Age: 1.61
Sex: M
Vaccine: HEPA, PNC13
Symptoms: Pyrexia, Rash, Somnolence, Vomiting
Clinical narrative: Chills, drowsiness, fatigue, injection site redness and swelling (day 2), irritability, abdominal pain, diarrhea, decreased appetite, nausea, vomiting, high fever, dehydration, skin rash (chest), over the course of 6 days.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Cold sweat, Disorientation, Gait disturbance, Loss of consciousness, Pallor
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of passed out in a 16-year-old male patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, less than a day after receiving BEXSERO, the patient experienced passed out (serious criteria GSK medically significant), stumbling, disorientation, pallor, clamminess and blurred vision. On an unknown date, the outcome of the passed out, stumbling, disorientation, pallor, clamminess and blurred vision were unknown. It was unknown if the reporter considered the passed out, stumbling, disorientation, pallor, clamminess and blurred vision to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. At the time of discharge, the patient went to the restroom and came out of bathroom stumbling, disoriented, pale and clammy. He developed extreme blurred vision for about 3 minutes and almost completely passed out on to the reporter. The patient's blood pressure was measured as 82 per 48, but 100% oxygen saturation was noted. The reporter was able to stabilize the patient after about 8 to 10 minutes and then he was monitored for a while after and was discharged in stable condition. The patient had not eaten in almost 22 hours, so the reporter was sure that it had a lot to do with the events, but just wanted to report it and see if this was something occurring more frequently.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Vision blurred
Clinical narrative: This case was reported by a nurse via sales rep and described the occurrence of passed out in a 16-year-old male patient who received BEXSERO. On an unknown date, the patient received BEXSERO at an unknown dose. On an unknown date, less than a day after receiving BEXSERO, the patient experienced passed out (serious criteria GSK medically significant), stumbling, disorientation, pallor, clamminess and blurred vision. On an unknown date, the outcome of the passed out, stumbling, disorientation, pallor, clamminess and blurred vision were unknown. It was unknown if the reporter considered the passed out, stumbling, disorientation, pallor, clamminess and blurred vision to be related to BEXSERO. Additional details were provided as follows: The age at vaccination was not reported. At the time of discharge, the patient went to the restroom and came out of bathroom stumbling, disoriented, pale and clammy. He developed extreme blurred vision for about 3 minutes and almost completely passed out on to the reporter. The patient's blood pressure was measured as 82 per 48, but 100% oxygen saturation was noted. The reporter was able to stabilize the patient after about 8 to 10 minutes and then he was monitored for a while after and was discharged in stable condition. The patient had not eaten in almost 22 hours, so the reporter was sure that it had a lot to do with the events, but just wanted to report it and see if this was something occurring more frequently.
Age: 26.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, Smear cervix abnormal
Clinical narrative: This spontaneous report was received from a Medical Assistant referring to a 26 year old female patient. The patient's pertinent medical history and concurrent conditions were not reported. In March 2007, the patient was vaccinated with the 1st dose of GARDASIL (anatomical route of vaccination, lot number and expiration date were not provided). Furthermore, in July 2007, she was vaccinated with the 2nd dose and in November 2007 with the 3rd dose of GARDASIL. In 2015, during the patient's annual physical examination, her Papanicolaou smear results were abnormal. At the time of the report, the outcome of smear cervix abnormal was unknown. The relatedness between the adverse event and vaccination with GARDASIL was not provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: The spontaneous report was received a pharmacist, referring to a patient of unknown age and gender. The patient's medical history or concurrent conditions were not reported. On 07-JUN-2016, the patient was vaccinated with an expired dose of ZOSTAVAX (which had the lot # L006392, expiration date 26-MAY-2016) (dose and route were not provided) subcutaneously. Information regarding concomitant medication was not provided. No adverse effects reported and there was not product quality complaint involved. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant medication were not reported. On 23-MAY-2016, the patient was inadvertently administered an expired dose of ROTATEQ lot # K009900 with expiration date on 04-MAY-2016, oral (strength, dose and anatomical location were not reported). No adverse effect was reported and no product quality complaint was involved. Additional information has been requested.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report has been received from a pharmacist concerning a 67 year old male patient. The patient's concurrent conditions included allergy to LEVAQUIN. None pertinent history was reported. On 19-May-2016, the patient was vaccinated with a dose of ZOSTAVAX vial 19400 PFU, (lot # L037791, expiration date of 30-DEC-2016), (dose and route of administration were not provided). The patient's concomitant therapy included CRESTOR. On 25-MAY-2016 (reported as today), the patient went back to the pharmacy and reported that he had been experiencing forearm pain in the injection arm since an unspecified date in May 2016. The patient self administered MOTRIN as treatment for the adverse event. There was none laboratories diagnostics studies performed. A product quality complaint was not involved. At the reporting time, the outcome of forearm pain in the injection arm was not reported. The causal assessment of forearm pain in the injection arm to ZOSTAVAX was not reported. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: VARCEL
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: This spontaneous report was received from a consumer concerning her 5 year old daughter, via company representative. The patient's concurrent conditions, medical history and concomitant medications were not reported. On approximately 25-MAY-2016, also reported as "a week ago", the patient was vaccinated with VARIVAX (dose, strength, dose number, route of administration and lot number were not reported). On an unspecified date in 2016, the patient developed a swollen, itchy leg (unspecified which leg). At the time of reporting, the outcome of peripheral swelling and pruritus was unknown. The casual relationship between peripheral swelling and pruritus with VARIVAX was unknown. Additional information is not expected since no consent for follow up was provided.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to an unspecified number of patients of unknown age and gender who on an unknown date were vaccinated with improperly stored doses of VARIVAX (route not reported). The lot numbers were L036831, expiration date 24-SEP-2017; L049532, expiration date 08-DEC-2017; L043622, expiration date 03-NOV-2017, stored at a temperature of -7.7C and with a time frame of 3 hours. No adverse effects were reported. At the time of the report, the patients' status was unknown. Additional information has been requested.
Sex: M
Vaccine: VARCEL
Symptoms: Antibody test negative
Clinical narrative: This spontaneous report was received from a physician assistant via company representative regarding a male patient of unknown age. Information on the concurrent conditions and medical history of the patient were not reported. On an unknown date, varicella titers were run on the patient which demonstrated the patient had no evidence of ever having chicken pox. On unknown date, the patient was then administered a dose (dose 1) of VARIVAX (lot, expiration date, route and anatomical location were not specified) and on an unknown date later, patient was administered a second dose of VARIVAX (lot, expiration date, route and anatomical location were not specified). Concomitant medication were not reported. On an unknown date after vaccination, the varicella titers were run again and the patient demonstrated negative seroconversion. Outcome of the event was unknown at the time of report. There was no Product Quality Complaint (PQC) involved. Relatedness of the event with VARIVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist regarding a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On 14-APR-2016, the patient was vaccinated with an improperly stored dose of M-M-R II (dose and route were not reported, lot # L011528, expiration date 30-APR-2017). There was no adverse effect reported. The administered dose of vaccine experienced the temperature excursion of 47 degrees Fahrenheit for 144 hours. There was no data logger involved. There were no previous excursions reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. No information about the patient's pertinent medical history, concomitant medications, drug reactions or allergies was provided. On 06-JUN-2016, the patient was vaccinated with an expired dose of properly stored VAQTA lot/batch # reported as 1018498, expiration date 28-APR-2016 (dose and route of administration not reported). No adverse events reported. Additional information has been requested.