chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 12.0
Sex: M
Vaccine: HEPA, HPV9, MNQ, TDAP, VARCEL
Symptoms: Dizziness, Feeling abnormal
Clinical narrative: Client was very nervous and kept moving around to prevent administration of vaccinations. Both he and his mother spoke different language so it was hard to communicate but a coworker translated and mother wanted him to have all five vaccines. Mother raised her voice to him to cooperate and sit still, although as soon as he would sit for the vaccination he would move away and jump up out of the chair. Finally his mother convinced him to sit still for the vaccinations. A few minutes later I asked if he was feeling dizzy as he looked a little dazed (translator not in the room anymore and other nurses busy with clients so I did the best I could to communicate). He shook his head yes, so I utilized an ammonia packet which seemed to bring him to alertness and an ice pack for the back of his neck and forehead.  After a minute or two he shook it off and indicated he was fine. When mom went out to pay at the front desk I asked the desk person to translate to mom to have him sit down in the lobby while she paid.  He was fine and they left.
Age: 1.0
Sex: F
Vaccine: DTAP
Symptoms: Ataxia, Computerised tomogram head, Electroencephalogram, Fall, Full blood count
Clinical narrative: Acute onset of ataxia. Staggering gait, walking into the furniture and wall, frequent falls. Required hospitalization.
Age: 1.0
Sex: F
Vaccine: DTAP
Symptoms: Gait disturbance, Lumbar puncture, Nuclear magnetic resonance imaging brain
Clinical narrative: Acute onset of ataxia. Staggering gait, walking into the furniture and wall, frequent falls. Required hospitalization.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Chills, Headache, Myalgia, Pain in extremity
Clinical narrative: Severe chills, shaking, painful white fingers and toes, joints, headache, muscle aches for 2 days.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Pallor, Tremor
Clinical narrative: Severe chills, shaking, painful white fingers and toes, joints, headache, muscle aches for 2 days.
Age: 79.0
Sex: M
Vaccine: FLU4
Symptoms: Purpura, Rash, Rash maculo-papular
Clinical narrative: Bilateral lower extremity maculopapular purpura rash.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Immediate post-injection reaction, Induration, Injection site pruritus
Clinical narrative: On 09/21/17, pt received an influenza virus vaccine injection in an undesignated arm. Immediately after the injection, pt reported pruritus that extended from injection site to the elbow area. Pt then developed a 3 x 3 red firm area that was warm to the touch. No report of interventions. No documentation of lot number. RN self-reported event. No further information available.
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Cough, Pharyngeal oedema, Throat irritation
Clinical narrative: Cough, clearing of throat, throat swelling.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Petechiae, Thrombocytopenia
Clinical narrative: Petechiae, severe thrombocytopenia.
Age: 27.0
Sex: M
Vaccine: FLU3
Symptoms: Inflammation, Rash, Rash erythematous
Clinical narrative: Rash on both upper extremities and abdomen 3 hours after dose. 10/4/2017 ER visit given IV solumedrol, Benadryl, and pepsid. Symptoms relieved, discharged home. 10/5/2017 rash returned while at work, admitted to ER. Given IM Epi in the R deliod, IV Benadryl, solumedrol, pepsid. Rx for tapering does of prednisone given by ER doctor. 10/6/2017 started prednisone 40mg at 6AM, rash became red and inflamed at work, arrived at occupational health appointment at 09:00
Age: 4.0
Sex: M
Vaccine: TDAP
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Patient received TDap (Adacel) instead of DTap. No adverse outcome has been reported. Primary Provider has been notified.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a 71 year old male patient. The patient's concurrent condition, medical history and concomitant medications were not provided. On 08-JAN-2014, the patient was vaccinated with ZOSTAVAX for prophylaxis (dose, route of administration, lot # and exp date not provided). On an unknown date, the patient developed a case of shingles on his forehead. Patient visited physician on an unknown date after having the case of shingles "for a week" at which the physician prescribed an unspecified antiviral medication as a treatment. The outcome of event was unknown. Causality assessment was not provided.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Immediate post-injection reaction, Injection site erythema, Injection site nodule, Injection site pruritus
Clinical narrative: This spontaneous report was received from a pharmacist via company representative and refers to a 70-year-old female patient. The patient received unspecified medication for hypertension. It was unknown if the patient had any drug reactions or allergies. On 25-SEP-2017, the patient was vaccinated with ZOSTAVAX, subcutaneously for prophylaxis (dose, lot# and expiration date were not reported). Other suspect therapies included sterile diluent (dose, frequency, route of administration, lot# and expiration date were not reported). On 25-SEP-2017, (also reported as "immediately after administration"), the patient felt lightheaded and developed a red, itchy knot at the injection site. Consequently, the pharmacist called emergency services. The emergency services personnel responded to the pharmacy and evaluated the patient. The patient was found to be stable, did not require treatment, and did not require transport to a hospital. The pharmacist added that the patient did not take her usual medication for hypertension prior to going to the pharmacy at the vaccination day. The patient did not receive any treatment for the events. There was no laboratory test performed. Product quality complaint was not reported. The outcome of felt lightheaded and red, itchy knot at the injection site was reported as recovered in approximately September 2017. The relatedness between the events and ZOSTAVAX was not reported.
Sex: F
Vaccine: VARZOS
Symptoms: Ear pain, Facial pain, Herpes zoster, Tinnitus
Clinical narrative: Information was received from a lawyer regarding a case in litigation concerning a female patient of unknown age. No information was received regarding the patient's medical history, concurrent conditions or concomitant medications. On or about 30-JUL-2015, by a licensed vocational nurse, the patient was inoculated in her left deltoid with ZOSTAVAX (lot number and dosage unknown), for routine health maintenance and for the prevention of shingles.  It was reported that the vaccine did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 04-FEB-2016, the patient was treated by a physician for the onset of severe right ear pain. On or about 12-FEB-2016, the patient received subsequent treatment from another physician and was diagnosed as having herpes zoster, or shingles, accompanied by facial pain and tinnitus, a condition of chronic throbbing and buzzing sounds in the ear.  As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment.  As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages.  Further, as a tragic consequence, the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. The lawyer considered herpes zoster or shingles, severe ear pain/tinnitus, vaccination failure and facial pain to be to disabling. Additional information has been requested.
Age: 19.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Computerised tomogram abdomen, Full blood count, Haematuria, Petechiae, Platelet count decreased
Clinical narrative: This spontaneous report as received from a nurse practitioner, refers to a 19 year old male patient. The patient did not have any medical history, historical drugs, concomitant therapies and concurrent conditions. On 20-SEP-2017, the patient was vaccinated with GARDASIL 9, intramuscular, for prophylaxis (reported as vaccination) (strength, dose, frequency, lot # and expiration date were not reported). On an unspecified date in September 2017 the patient developed lower extremity petechiae and hematuria, so on 29-SEP-2017, he sought for medical attention and went to the emergency room, where he had a a computed tomography (CT) Scan of the abdomen and a complete blood count was performed. The patient was found to have a platelet level of 7 (units not provided) and on an unspecified date in September 2017, was admitted to a hospital for treatment of thrombocytopenia. No intervention to prevent serious criteria was performed. At the time of reporting, the outcome of thrombocytopenia was reported as not recovered. Additionally, the assessment causality between thrombocytopenia with GARDASIL 9 was not provided. The reporter considered thrombocytopenia to be a life threatening event. Upon internal review, thrombocytopenia was determined to be medically significant.
Age: 19.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Thrombocytopenia
Clinical narrative: This spontaneous report as received from a nurse practitioner, refers to a 19 year old male patient. The patient did not have any medical history, historical drugs, concomitant therapies and concurrent conditions. On 20-SEP-2017, the patient was vaccinated with GARDASIL 9, intramuscular, for prophylaxis (reported as vaccination) (strength, dose, frequency, lot # and expiration date were not reported). On an unspecified date in September 2017 the patient developed lower extremity petechiae and hematuria, so on 29-SEP-2017, he sought for medical attention and went to the emergency room, where he had a a computed tomography (CT) Scan of the abdomen and a complete blood count was performed. The patient was found to have a platelet level of 7 (units not provided) and on an unspecified date in September 2017, was admitted to a hospital for treatment of thrombocytopenia. No intervention to prevent serious criteria was performed. At the time of reporting, the outcome of thrombocytopenia was reported as not recovered. Additionally, the assessment causality between thrombocytopenia with GARDASIL 9 was not provided. The reporter considered thrombocytopenia to be a life threatening event. Upon internal review, thrombocytopenia was determined to be medically significant.
Age: 19.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Biopsy bone marrow normal, Blood urine present, Computerised tomogram abdomen normal, Computerised tomogram head normal, Full blood count normal
Clinical narrative: This spontaneous report as received from a nurse practitioner, refers to a 19 year old male patient. The patient did not have any medical history, historical drugs, concomitant therapies and concurrent conditions. On 20-SEP-2017, the patient was vaccinated with GARDASIL 9, intramuscular, for prophylaxis (reported as vaccination) (strength, dose, frequency, lot # and expiration date were not reported). On an unspecified date in September 2017 the patient developed lower extremity petechiae and hematuria, so on 29-SEP-2017, he sought for medical attention and went to the emergency room, where he had a a computed tomography (CT) Scan of the abdomen and a complete blood count was performed. The patient was found to have a platelet level of 7 (units not provided) and on an unspecified date in September 2017, was admitted to a hospital for treatment of thrombocytopenia. No intervention to prevent serious criteria was performed. At the time of reporting, the outcome of thrombocytopenia was reported as not recovered. Additionally, the assessment causality between thrombocytopenia with GARDASIL 9 was not provided. The reporter considered thrombocytopenia to be a life threatening event. Upon internal review, thrombocytopenia was determined to be medically significant.
Age: 19.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Haemorrhage, Immune thrombocytopenic purpura, Laboratory test normal, Petechiae, Platelet count decreased
Clinical narrative: This spontaneous report as received from a nurse practitioner, refers to a 19 year old male patient. The patient did not have any medical history, historical drugs, concomitant therapies and concurrent conditions. On 20-SEP-2017, the patient was vaccinated with GARDASIL 9, intramuscular, for prophylaxis (reported as vaccination) (strength, dose, frequency, lot # and expiration date were not reported). On an unspecified date in September 2017 the patient developed lower extremity petechiae and hematuria, so on 29-SEP-2017, he sought for medical attention and went to the emergency room, where he had a a computed tomography (CT) Scan of the abdomen and a complete blood count was performed. The patient was found to have a platelet level of 7 (units not provided) and on an unspecified date in September 2017, was admitted to a hospital for treatment of thrombocytopenia. No intervention to prevent serious criteria was performed. At the time of reporting, the outcome of thrombocytopenia was reported as not recovered. Additionally, the assessment causality between thrombocytopenia with GARDASIL 9 was not provided. The reporter considered thrombocytopenia to be a life threatening event. Upon internal review, thrombocytopenia was determined to be medically significant.
Age: 19.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Platelet transfusion, Rash, Ultrasound abdomen normal, Ultrasound skull normal
Clinical narrative: This spontaneous report as received from a nurse practitioner, refers to a 19 year old male patient. The patient did not have any medical history, historical drugs, concomitant therapies and concurrent conditions. On 20-SEP-2017, the patient was vaccinated with GARDASIL 9, intramuscular, for prophylaxis (reported as vaccination) (strength, dose, frequency, lot # and expiration date were not reported). On an unspecified date in September 2017 the patient developed lower extremity petechiae and hematuria, so on 29-SEP-2017, he sought for medical attention and went to the emergency room, where he had a a computed tomography (CT) Scan of the abdomen and a complete blood count was performed. The patient was found to have a platelet level of 7 (units not provided) and on an unspecified date in September 2017, was admitted to a hospital for treatment of thrombocytopenia. No intervention to prevent serious criteria was performed. At the time of reporting, the outcome of thrombocytopenia was reported as not recovered. Additionally, the assessment causality between thrombocytopenia with GARDASIL 9 was not provided. The reporter considered thrombocytopenia to be a life threatening event. Upon internal review, thrombocytopenia was determined to be medically significant.
Age: 54.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Pyrexia, Urticaria
Clinical narrative: This is a spontaneous report from a contactable consumer (patient). A 54-year-old male patient received PREVNAR 13 via an unspecified route of administration on 26Sep2017 between 16:00 to 16:30 at a single dose in the left arm for preventative at the physician's office. Medical history included ongoing migraine from an unknown date since the patient was a teenager (about 30 to 40 years ago) and was taking timolol and flu vaccination from an unknown date (also reported as FLUZONE). Concomitant medication included ongoing timolol taken for migraine. On 27Sep2017, almost 24 hours after administration of pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein) the patient had a fever that maxed to 101. The patient took ibuprofen at 600mg every 6 hours and reported that he was taking it at 12-14 hours at the time of the report. The patient also took TYLENOL at 2 of 500 mg tablets every 4 hours in response to fever. On the same day of 27Sep2017, the patient also noticed a large welt across his left arm that is at least 5 inches across. The patient reported that he noticed it a little on 27Sep2017 and reported that it was getting worse at the time of the report and was not resolving yet. The patient has not recovered from large welt across his left arm while the patient was recovering from fever.
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. This pharmacist reported similar events for two patients. This is the first of two reports. A female patient of unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunization at the pharmacy/drug store. The patient's medical history was not reported.  Concomitant medication included influenza vaccine for immunization. The patient experienced swelling at the injection site that lasted 5 to 7 days on an unspecified date, reported to have occurred a few days ago but exact date was unknown. It was reported that the patient also had a flu shot that was administered on the same day at a different injection site. The outcome of the event was unknown. Sender's Comments: Linked Report(s): US-PFIZER INC-2017427867 different patient, same reporter, product, event.
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a sales representative. This pharmacist reported similar events for two patients. This is the second of the two reports. A female patient of an unspecified age and ethnicity received PREVNAR 13, via an unspecified route of administration on an unspecified date as a single dose for immunization at the pharmacy/drug store. The patient's medical history was not reported. Concomitant medication included influenza vaccine for immunization. The patient experienced swelling at the injection site that lasted 5 to 7 days on an unspecified date. It was reported that the patient also had a flu shot that was administered to her on the same day at a different injection site. Outcome of the event was unknown. Sender's Comments: Linked Report(s): US-PFIZER INC-2017427753 different patient, same product, same event.
Sex: U
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This is a spontaneous report from a contactable pharmacist via a Pfizer sales representative. This pharmacist reported same event for two patients. This is the first of two reports. A patient of unspecified age, ethnicity and gender received PREVNAR 13, via an unspecified route of administration on an unspecified date at a single dose for immunization. The patient's medical history and concomitant medications were not reported. On an unspecified date, the patient had local redness and swelling at injection site 2 days post dose of pneumococcal 13-valent conjugate vaccine (diphtheria crm197 protein). The events took place after the use of the product. The outcome of the events was unknown. No follow up attempts are possible. No further information is expected. Sender's Comments: Linked Report(s): US-PFIZER INC-2017428834 same reporter/drug/event, different patient.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Muscular weakness, Neurological examination normal
Clinical narrative: Patient received vaccine at mass dispensing clinic (flu drive-by clinic) and staffed by the Public Health Department sometime during the hours of 8:30 AM-3:30 PM on 09/27/17. Patient notified clinic 2 days later that she had experienced muscle weakness to all extremities starting the evening of the date of administration (09/27/17) and was seen by her physician's office on 09/28/17. Clinic notes received from physician's office. Per clinic notes, neurological exam in office normal, but due to patient's complaints of weakness the prior evening, notes state for patient to list flu vaccine as an allergy. Per the clinic notes, symptoms were listed as Guillain Barre' type symptoms. Recommendations from physician's office were to increase fluids and ibuprofen and go to ER if symptoms worsen. When health department contacted clinic 2 days after vaccination, patient stated she was feeling better and was returning to work that day.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Discomfort, Herpes zoster, Injection site reaction, Paraesthesia
Clinical narrative: A classic shingles rash broke out several months after vaccination, but the interesting thing was where it started. The rash started exactly in the area where the injection was given, at the left upper arm, and spread down the forearm. Tingling and discomfort along the C8 dermatome. The patient is a board certified pediatrician and I am a retired pediatric nurse practitioner. We had the rash confirmed by a local MD.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Patient stated having round redness around injection site that is slowly getting larger and warm to touch. No pain, tenderness, and itching. Recommended seeing PCP and letting them take a look at it just to be safe. Pt. stated having an appointment scheduled.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain, Peripheral swelling, Skin warm
Clinical narrative: Approximately 4 in dia redness. Warm to touch. Painful, swollen upper arm.
Age: 1.08
Sex: M
Vaccine: HEPA, HIBV, HPV9, MMR, VARCEL
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: HPV9 given to 1 year old pt. suppose to receive PCV13. Spoke to parent no reaction to vaccine.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Erythema, Fatigue, Injection site pain, Injection site pruritus
Clinical narrative: Employee stated that approximately 3 hours after receiving the vaccine she began itching at the injection. She further stated that upon taking the band aid off, she noticed that there was swelling and warmth at the site, as well as pain and increased itching. As the night progressed (approximately 16 hours after the vaccine was given), she began to have night sweats and fatigue. The employee reported to the occupational health clinic with area (approximately 65" x 55"), noted with erythema and warmth, and continues to complain of itching, fatigue, weakness, and no pain unless the area it touched.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site swelling, Injection site warmth, Night sweats, Skin warm
Clinical narrative: Employee stated that approximately 3 hours after receiving the vaccine she began itching at the injection. She further stated that upon taking the band aid off, she noticed that there was swelling and warmth at the site, as well as pain and increased itching. As the night progressed (approximately 16 hours after the vaccine was given), she began to have night sweats and fatigue. The employee reported to the occupational health clinic with area (approximately 65" x 55"), noted with erythema and warmth, and continues to complain of itching, fatigue, weakness, and no pain unless the area it touched.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Headache, Pyrexia
Clinical narrative: Experienced fatigue, fever, and headache for about 1.5 days after shot that cleared up on their own.  The only thing I took for them were garlic pills and ibuprofen.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Patient was given a flu shot meant for 3 years or older, patient is 2 years old. Patient is feeling fine, no adverse reaction noted.
Age: 49.0
Sex: M
Vaccine: FLUX
Symptoms: Burning sensation, Fall, Hypoaesthesia
Clinical narrative: Stood up and fell to the floor. Legs numb and on fire. Family member put me into a wheelchair. Took me out to vehicle, drove me to ER.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Eye pain, Facial spasm, Immunodeficiency, Muscle twitching, Rash
Clinical narrative: As part of our annual Physical exam, we were routed to a room where the Shingles vaccine was being administered. We were not given documentation outlining side-effects, especially for immunocompromised patients. My wife was a given the vaccine and within a week or so developed a rash and twitching of her face and pain in her right eye. She had been immunocompromised by chemotherapy (5FU). These problems have increased with time and clonazepam no longer controls it. She is in daily agony. Is there no antiviral that can shut down chicken pox?
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: As part of our annual Physical exam, we were routed to a room where the Shingles vaccine was being administered. We were not given documentation outlining side-effects, especially for immunocompromised patients. My wife was a given the vaccine and within a week or so developed a rash and twitching of her face and pain in her right eye. She had been immunocompromised by chemotherapy (5FU). These problems have increased with time and clonazepam no longer controls it. She is in daily agony. Is there no antiviral that can shut down chicken pox?
Age: 1.33
Sex: M
Vaccine: HEP
Symptoms: Loss of consciousness, Pyrexia, Seizure
Clinical narrative: Fever 106. Seizure, loss of consciousness.
Age: 32.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: Approx 80 mm circular area of raised, red and warm to touch. Denies any systemic complaints. Recommended follow up with PCP. Advised to use antihistamine.
Age: 9.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site mass, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: At injection site: Fever, Lump, Soreness, Significant rash covering more than 120 CM2.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Diarrhoea, Nausea, Pyrexia, Tremor
Clinical narrative: Has fever, chills, shaking, nausea, vomiting, and diarrhea.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Has fever, chills, shaking, nausea, vomiting, and diarrhea.
Age: 14.0
Sex: M
Vaccine: HPV9
Symptoms: Erythema, Pruritus, Urticaria
Clinical narrative: Patient noted red welt on right arm after injection on 10/3. Patient returned to office afternoon of 10/4 with noted 3.5in red welt on right arm. Patient stated slightly itchy, but denied pain, SOB, fevers.  Patient stated the size of the welt had grown larger since first started on 10/3. Patient instructed to treat with benadryl 50mg Q6H, tylenol or ibuprofen for pain and cool compresses.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Blood bicarbonate decreased, Dehydration, Diarrhoea, Laboratory test
Clinical narrative: Diarrhea requiring 12 hour hospitalization for dehydration and low bicarb.
Age: 81.0
Sex: M
Vaccine: FLU4
Symptoms: Adverse drug reaction, Pruritus, Rash, Rash maculo-papular
Clinical narrative: SYMMETRICAL maculopapular RASH ON ARMS AND LEGS; DIFFUSE RASH COVERING ALMOST ENTIRE BACK. LOOKED LIKE A CLASSICAL DRUG REACTION. Onset within 24 hours of administration. I needed a two month course of prednisone treatment. As of 10/6 the rash is clearing and the itching is almost gone.
Age: 10.0
Sex: M
Vaccine: FLU4, HPV9, TDAP
Symptoms: Injection site erythema, Injection site oedema, Injection site warmth, Local reaction
Clinical narrative: LOCALIZED REACTION - AREA OF WARMTH, REDNESS & SLIGHT EDEMA APPROX 6.5CM IN DIAMETER RIGHT DELTOID @ FLU VACCINE INJECTION SITE. PATIENT DENIED PAIN, RASH, HIVES, BREATHING PROBLEMS.
Age: 40.0
Sex: M
Vaccine: TDAP
Symptoms: Arthralgia, Back pain, Fatigue, Insomnia
Clinical narrative: Bilateral knee joint pain, fatigue, insomnia and back pain started the next day after vaccination. (10/4/17).
Age: 95.0
Sex: F
Vaccine: PPV
Symptoms: Feeling abnormal, Hypotension, Peripheral swelling, Skin warm, Syncope
Clinical narrative: Left here after her shot and went to the pharmacy. Reports to ARNP-C that she started feeling "bad" at that time. Then her arm is now swollen and warm to touch. Got up in the middle of the night and had a syncope episode. ARNP-C called us and is treating with fluids for hypo-tension today. She has not been not been hospitalized at this time. Flu vaccine was not given.
Sex: U
Vaccine: HEPA
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a patient of unknown age and gender. The patient's concurrent condition, medical history and concomitant medications were not reported. On 15-FEB-2010, the patient was vaccinated with a first dose of VAQTA for prophylaxis (dose, route of administration, lot # and exp date was not provided). On 19-MAY-2010, the patient received the second dose of VAQTA. No adverse effect was reported.
Sex: F
Vaccine: VARCEL
Symptoms: Anaphylactic reaction, Dyspnoea, Erythema, Rhinorrhoea, Skin test positive
Clinical narrative: Information has been received from the authors in published literature article. This report concerned an 8 year old female patient which concurrent  conditions included milk allergy and sickle cell anaemia. On an unknown date (reported as "7 years previously,") the patient received her first vaccination with an unspecified varicella virus vaccine live (oka/merck)(manufacturer unknown) (dose, route, lot number and expiry date were not reported) for prophylaxis. At that time, there were no adverse events experienced. Also, it was reported that, on an unknown date (reported as "2 years previously") the patient experienced shortness of breath shortly after receiving an injectable unspecified influenza vaccine. Later, on an unknown date, the patient received diphenhydramine before administration of her second dose of unspecified influenza vaccine, without complications. Later, on an unknown date, the patient received her second dose of varicella virus vaccine live (oka/merck)(manufacturer unknown) (dose, route, lot number and expiry date were not reported) for prophylaxis. Then, 15 minutes after vaccination, the patient had shortness of breath, sneezing, rhinorrhea, and diffuse erythema and, due to that, the patient  required oral diphenhydramine and she was sent to emergency room where she received epinephrine (anaphylactic reaction). It was unknown if the patient was hospitalized. After that, on an unknown date, she was discharged with a prescription of oral corticosteroids and instruction to follow up with an allergy clinic. Also, on an unknown date, the patient underwent a skin test, that was negative to hepatitis A and influenza vaccines and positive to gelatin. At the reporting time, the outcome of anaphylactic reaction was not reported. The reporter considered anaphylactic reaction to be related to VARIVAX. Upon internal review, the event anaphylactic reaction was considered to be a medically significant event.
Sex: F
Vaccine: VARCEL
Symptoms: Sneezing
Clinical narrative: Information has been received from the authors in published literature article. This report concerned an 8 year old female patient which concurrent  conditions included milk allergy and sickle cell anaemia. On an unknown date (reported as "7 years previously,") the patient received her first vaccination with an unspecified varicella virus vaccine live (oka/merck)(manufacturer unknown) (dose, route, lot number and expiry date were not reported) for prophylaxis. At that time, there were no adverse events experienced. Also, it was reported that, on an unknown date (reported as "2 years previously") the patient experienced shortness of breath shortly after receiving an injectable unspecified influenza vaccine. Later, on an unknown date, the patient received diphenhydramine before administration of her second dose of unspecified influenza vaccine, without complications. Later, on an unknown date, the patient received her second dose of varicella virus vaccine live (oka/merck)(manufacturer unknown) (dose, route, lot number and expiry date were not reported) for prophylaxis. Then, 15 minutes after vaccination, the patient had shortness of breath, sneezing, rhinorrhea, and diffuse erythema and, due to that, the patient  required oral diphenhydramine and she was sent to emergency room where she received epinephrine (anaphylactic reaction). It was unknown if the patient was hospitalized. After that, on an unknown date, she was discharged with a prescription of oral corticosteroids and instruction to follow up with an allergy clinic. Also, on an unknown date, the patient underwent a skin test, that was negative to hepatitis A and influenza vaccines and positive to gelatin. At the reporting time, the outcome of anaphylactic reaction was not reported. The reporter considered anaphylactic reaction to be related to VARIVAX. Upon internal review, the event anaphylactic reaction was considered to be a medically significant event.
Sex: U
Vaccine: VARZOS
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant therapies were not reported. On 02-OCT-2017, the patient was vaccinated with improperly stored dose of ZOSTAVAX lot# N015628 and expiration date 30-JUL-2018 (dose and route of administration were not reported) reconstituted with sterile diluent, lot# N008379 and expiration date 14-NOV-2019. There were no adverse effects reported. Administered dose of vaccine experienced the temperature excursion from 15 to 46 degrees Fahrenheit for 16 hours 41 minutes. There was previous excursion reported, 15 to 46 (39.5) degrees Fahrenheit for 21 hours. Data logger was involved. Sterile diluent was properly stored.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of an unknown age and gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with improperly stored VAQTA lot number N017094, expiration date 31-AUG-2018 (dose and route was not reported) for prophylaxis. No adverse effect was reported. Temperature: 9 grades Celsius to 25 grades Celsius "(10.1 C)". Time frame: 1 hour and 56 minutes. There was no previous temperature excursion involved. This is one of several reports received from the same source. Sender's Comments: US-009507513-1710USA003169: Original Case: 1710USA003115, US-009507513-1710USA003166: Original Case: 1710USA003115, US-009507513-1710USA003167: Original Case: 1710USA003115, US-009507513-1710USA003168: Original Case: 1710USA003115, US-009507513-1710USA003164: Original Case: 1710USA003115, US-009507513-1710USA003163: Original Case: 1710USA003115, US-009507513-1710USA003165: Original Case: 1710USA003115.
Sex: M
Vaccine: FLUX, PPV
Symptoms: Pyrexia, Rash, Vomiting
Clinical narrative: This spontaneous report was received from a pharmacist, via a company representative, and refers to a male patient of unknown age. The patient's concurrent conditions, medical history and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX 23 route reported as "intramuscularly or subcutaneouslly" for prophylaxis (strength, dose, frequency, lot/batch # and expiration date were not reported). Other suspect therapies included unspecified "flu shot", influenza virus vaccine inactivated (unspecified) (strength, dose, route, frequency, indication, lot/batch # and expiration date were not reported). On an unknown date, after received the therapy the patient "had a rash", and that night after therapy the patient had "vomiting and fever (pyrexia)".  The outcome of rash, pyrexia and vomiting was unknown. The causality between rash, pyrexia and vomiting with PNEUMOVAX 23 was not reported.
Age: 65.0
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Adverse reaction
Clinical narrative: This is spontaneous report from a contactable other healthcare professional based on information received from agency. A patient of unspecified age, ethnicity and gender received PREVNAR 13 via an unspecified route of administration on an unspecified date at a single dose in the arm for immunization. The patient has no medical history. There were no concomitant medications. On an unspecified date, the reporter stated that after the patient received pneumococcal 13-valent conjugated vaccine (diphtheria crm197 protein), patient experienced had a bad reaction on right arm. The outcome of the event was unknown.
Sex: U
Vaccine: FLU3
Symptoms: Local reaction, Malaise, Nausea, Pyrexia, Respiratory disorder
Clinical narrative: Initial unsolicited report received from a non-healthcare professional (office staff) on 20-Sep-2017. This case involves a four patient (age and gender not reported) who was vaccinated with a dose of FLUZONE HIGH DOSE (batch number, expiry date, route and site of administration were not reported), on an unknown date. The patient's medical history and concomitant medications were not reported. On an unknown date, within 24 hours following the vaccination, the patient's become sick, sickness ranged from localized reactions, to nausea, fevers, and mild respiratory issues. The patient's laboratory data and corrective treatment were not reported. The events outcome was not reported. List of documents held by sender: none.
Age: 79.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site oedema, Injection site urticaria, Rash erythematous, Rash generalised, Rash pruritic
Clinical narrative: Initial unsolicited case received from a physician on 19 Sep 2017. This case involves 80-year-old male patient who was vaccinated with 0.5 ml one dose of FLUZONE QUADRIVALENT (Batch number, expiry date, dose in series and site of administration were not reported) via intramuscularly on 13 Sep 2017. Patient medical history and concomitant medications were not reported. On an unknown date, three days after the vaccination, the patient developed urticaria and edema at the left deltoid and a widespread rash over his body. Rash was red and itchy. The patient was seen by the MD and a course of steroids was prescribed. Relevant lab tests and other corrective treatment were not reported. The outcome of all the events were reported as recovering. List of documents held by sender: none.
Sex: F
Vaccine: TTOX
Symptoms: Pyrexia
Clinical narrative: Initial unsolicited case received from a consumer (patient herself) on 19 Sep 2017. This case involves a female patient (age not reported) who was vaccinated with a dose of TETANUS TOXOID (TETANUS VACCINE) (Batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date years ago. The patient medical history and concomitant medications were not reported. On an unknown date, after receiving unknown tetanus vaccine in the past, the patient developed high fever. Lab tests and corrective treatment were not reported. Outcome of the event was not reported. List of documents held by sender: none.
Age: 79.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Fatigue, Pyrexia, Respiratory tract congestion, Sneezing
Clinical narrative: Initial unsolicited report received from a pharmacist on 19-Sep-2017. This case involves a 79-year-old female patient who was vaccinated with a 0.5 ml single dose of FLUZONE HIGH-DOSE (batch number UI853AB) via intramuscular route on 18-Sep-2017. The patient had a medical history of allergy to codeine. It was reported that patient completed chemo Aug-2017 but reporter did not know what type of cancer. Concomitant medications were not reported. On 19-Sep-2017, one day following the vaccination, the patient woke up at 2AM in the morning with fever, chills and her blood pressure was 206/90. On an unknown date reported as today, patient had a temp of 97.8F; blood pressure is 143/61 and was feeling tired and has sneezing and congestion. The patient's corrective treatment was not reported. The patient's outcome reported as recovering. List of documents held by sender: none.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Patient developed cellulitis surrounding injection site (erythema, warmth, and induration). Patient treated with ten day course of Clindamycin. Significant improvement within 24 hours after starting antibiotics.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Rash erythematous
Clinical narrative: Flu Vaccine given on Monday, 10/2/17 early afternoon. On Wednesday (10/4/17) evening at home, began to have mild itching with mild flat red rash on left arm, which rash spread to torso, other arm and upper legs. No SOB, nausea or vomiting. Started Loradtine Thursday, 10/5/17 am, and saw Employee Health 10/5/17 afternoon. Using Benadryl at bedtime.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Pruritus, Urticaria
Clinical narrative: The next morning I began to break out in hives. They kept getting worse. I knew it couldn't be from anything I ate, because I can't eat anything but soup, pudding or jello having all my teeth removed.  Today is day 4 and I'm taking benedryl every 3 hours. I've noticed an increase difficulty in breathing and called dr Office today and left message to either prescribe me something for the itchy hives or prescribe cream that can be used on it
Age: 63.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Red circular area, warm to touch around site of injection.
Age: 75.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Dyspnoea, Injection site erythema, Injection site rash, Respiratory arrest, Vomiting
Clinical narrative: During the night patient complained that she stopped breathing, vomiting, continued dyspnea, red rash at FLUZONE HD injection site. Did not report to granddaughter caregiver until nearly noon the next day. Went to clinic and received steroid treatment and was improving at the clinic when I spoke to granddaughter around 1:30 PM.
Age: 49.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Pain, Pain in extremity, Sleep disorder
Clinical narrative: Immediately after the shot, my arm was very sore. Since then, I have had pain when stretching my arm or lifting objects. I also cannot sleep on my left arm and I have very strong pain when taking my blood pressure in that arm.
Age: 29.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pain
Clinical narrative: Erythema, pain: Left arm proximal humeral aspectthere is a band of erythema approximately 4 cm by 10 cm wide. No subcutaneous crepitus, fluctuance, or purulant drainage. No other abnormality. Normal ROM of left upper extremity. Benadryl for itch, Clindamycin 300 mg by mouth in ED and 300 mg every 6 hours for 7 days.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site oedema, Injection site warmth
Clinical narrative: L deltoid edematous, circumference increased significantly, hot to touch; treated with antibiotic; much improved after a week.
Age: 31.0
Sex: F
Vaccine: HEP
Symptoms: Chest discomfort, Flushing, Lip pruritus, Nausea, Skin warm
Clinical narrative: Facial Flushing and warmth. Complained of itching feeling in lips and mouth. Given 50mg BENADRYL orally at 10:07. Complained of chest pressure, nausea. Given 80 mg SOLUMEDROL IV at 12:10, ZOFRAN 4mg at 12:10, TORADOL 30mg at 13:16.
Age: 83.0
Sex: F
Vaccine: FLUA3
Symptoms: Erythema, Nausea, Pain in extremity
Clinical narrative: Patient noted severe arm soreness, along with redness down the arm to the elbow. These symptoms have persisted through today (10/6/17) but have slowly decreased in severity. The patient also stated she experiences nausea after receiving the vaccines for a few days.
Age: 4.0
Sex: M
Vaccine: FLU4, HEP, MMR
Symptoms: Erythema, Swelling face, Urticaria
Clinical narrative: Day 1 child has redness under eyes. Day 2- redness merged and covered nose. Day 3 - hives over body. Day 4- swelling of face - saw Dr. at this time.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site pruritus, Injection site rash, Injection site swelling, Vaccination complication
Clinical narrative: Reaction to ZOSTAVAX vaccine. Rash (itchy, swollen, hard spot around injection site).
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Neck pain, Pain in extremity, Pyrexia
Clinical narrative: Extreme arm pain that spread down the arm and across the shoulder to neck/shoulder and neck pain, arm was extremely warm. Pt ran fever 100.9 in office while taking ibuprofen. Pt did require steroid dose to counteract reaction. Very limited ROM. Started 1st 24 hrs through 3d. Later could not use arm.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Skin warm
Clinical narrative: Extreme arm pain that spread down the arm and across the shoulder to neck/shoulder and neck pain, arm was extremely warm. Pt ran fever 100.9 in office while taking ibuprofen. Pt did require steroid dose to counteract reaction. Very limited ROM. Started 1st 24 hrs through 3d. Later could not use arm.
Age: 3.0
Sex: M
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Had FLUZONE 10/3/17. Was seen in ER for hives 10/4/17. Treated with BENADRYL and DECADRON.
Age: 18.0
Sex: M
Vaccine: FLU4
Symptoms: Cough, Influenza virus test, Influenza virus test negative, Pain, Pyrexia
Clinical narrative: Fever, body aches, cough after receiving flu vaccine.
Age: 28.0
Sex: M
Vaccine: FLU4
Symptoms: Blood culture negative, Chest X-ray normal, Dyspnoea, Hypoxia, Pyrexia
Clinical narrative: Developed fever, dyspnea, hypoxia shortly after receiving vaccination on 9/27/17.
Age: 12.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Peripheral swelling, Tenderness
Clinical narrative: Redness, tenderness, swelling (L) arm.
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Rash, Rhinorrhoea
Clinical narrative: Rash 2 days after vaccine, mild runny nose. Maybe viral but no enathem or other symptoms monitoring currently.
Age: 8.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Skin warm, Vomiting
Clinical narrative: Erythema, warm, (can be expected) but very itchy and then vomited. Non tender. Occurred 12 hours after given. Same reaction last year. Parents wonder if allergic reaction. She has significant erythema of right upper arm from shoulder to lower bicep on 9/29/17.
Age: 17.0
Sex: F
Vaccine: VARCEL
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Patient received her 2nd dose of varicella vaccine on 10/2/17 on Tuesday, injection site right arm was red, hot, and swollen, 10/4/17. Patient went to clinic diagnosis: cellulitis of right arm-moist heat, BENADRYL at night, ALLEGRA and PEPCID 13x10 cm area on posterior arm. MOTRIN for pain Cephalexin 500 mg tablet TID x 7 days.
Age: 56.0
Sex: F
Vaccine: TDAP
Symptoms: Erythema, Pruritus, Skin warm, Swelling
Clinical narrative: Redness, raised, itchiness, warm to touch started next day. Pt used ice/heat and ibuprofen which helped.
Age: 0.17
Sex: F
Vaccine: DTAP, HIBV
Symptoms: Erythema, Swelling face
Clinical narrative: Swelling and redness on left side of face in distribution of ophthalmic branch of trigeminal nerve.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: The area of the upper arm under where the vaccinations were given was hardened, red, swollen, and warm to the touch. The area also itched. This was treated with OTC Benadryl and Cortisone 10 cream. Symptoms are starting to improve per patient.
Age: 0.75
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MNQ
Symptoms: Product preparation error
Clinical narrative: A 9 month old female came to a Dept of Health outreach clinic for her vaccinations. The ACTHIB was accidentally reconstituted with MENACTRA instead of the provided diluent and given to the child in her left thigh. The error was not caught until after the patient left the clinic. Once the error was discovered, Sanofi Pasteur was called and it was stated that there was no danger to the child. The mother of the patient was then notified of the error, that there was no danger to the child, and that the dose of HIB was invalid and would be re-administered next month.