chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 6.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical asistant and refers to a 6-year-old (repoted also as 7 year-old), female patient. There was no information about the patient's concomitant therapies or medical history provided. The patient did not have any illnesses at the time of vaccination. On an unknown date, the patient was vaccinated with the first dose of VARIVAX (strength, dose, route of administration lot# and expiration date were not reported). On 07-OCT-2015 at 14:00 (reported also as 2 pm), the patient was vaccinated with an improperly stored second dose of VARIVAX lot # L013068, subcutaneously in the left arm for prophylaxis (dose and expiration date were not reported). The vaccination was in privates doctor's office and administered VARIVAX was purchase with public funds. No adverse event was reported. Previous temperature excursions, the range and time of temperature excursion the administered VARIVAX experienced were not reported. It was unspecified if a digital data logger was involved. A signed informed consent form was not obtained. This is one of several reports from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1611USA014213: US-009507513-1702USA004104: US-009507513-1702USA004102: US-009507513-1702USA004103: US-009507513-1611USA008278: US-009507513-1702USA004109: US-009507513-1702USA004107: US-009507513-1702USA004106: US-009507513-1702USA004105:
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 76-year-old female patient with osteoporosis, high blood pressure, chronic obstructive pulmonary disease, allergies to moxifloxacin hydrochloride (AVELOX), quinine, meloxicam and penicillin (unspecified); and history of a blood clot. On an unspecified date in November 2016, the patient was vaccinated with a dose of an unspecified pneumococcal vaccine (manufacturer unknown) (lot #, expiry date, dose and route of administration were not reported). Subsequently on 13-FEB-2017, she was vaccinated with a dose of PNEUMOVAX23 injection, intramuscularly (lot #, expiry date and dose were unspecified). Concomitant therapies were not reported. On 14-FEB-2017, the patient called the physician's office stating that she was experiencing pain, soreness, swelling, and warmth to the touch at the injection site that began a few hours after the injection was administered, approximately on 13-FEB-2017. No lab diagnostic studies were performed. The patient was given an unspecified treatment for the events. The outcome of the events was reported as not recovered at the time of this report. The investigator did not provide the causality assessment between the events and unspecified pneumococcal vaccine (manufacturer unknown), or PNEUMOVAX23. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, concerning 106 patients of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On an unspecified date, the 106 patients were vaccinated with an inappropriate storage doses of PROQUAD (dose, frequency and route not reported) for prophylaxis; 46 of them were vaccinated with the lot # M017334 with expiration date of 05-OCT-2017, 20 of them were vaccinated with the lot # M018635 with expiration date of 11-OCT-2017, and 40 of them were vaccinated with the lot # M018637 with expiration date of 11-OCT-2017. No adverse effects were reported. The prior temperature excursion of the vaccines was greater than -15°C degrees but less than -10°C (>5°F but <14°F), for a time frame of 10 hours and 15 minutes. The recent temperature excursion of the vaccines was greater than -10°C but less than 8°C (>14°F but <46°F), for a time frame of 14 hours and 18 minutes. No product quality complaint was involved (PQC). Data logger was involved. This is one of two reports received from the same source.  Additional information has been requested. Sender's Comments:  US-009507513-1702USA007854.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse, concerning 54 patients of an unknown age and gender. There were no concurrent conditions, medical history, drug reactions or allergies or concomitant medications reported. On an unspecified date, the 54 patients were vaccinated with inappropriate storage doses of VARIVAX (dose, frequency and route not reported), lot # M006722 with expiration date of 08-FEB-2018, for prophylaxis. No adverse effects were reported. The prior temperature excursion of the vaccines was greater than -15 °C but less than -10 °C (>5°F but <14°F), for a time frame of 10 hours and 15 minutes. The recent temperature excursion of the vaccines was greater than -10 °C but less than 8 °C (>14 °F but <46 °F), for a time frame of 14 hours and 18 minutes. No product quality complaint was involved (PQC). Data logger was involved. This is one of two reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1702USA007136:
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, 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 or concurrent conditions were not reported. On 11-JUL-2016, the patient was vaccinated with the first dose of GARDASIL 9 (which had the lot # M004116, expiration date 12-OCT-2017). Subsequently, on 16-NOV-2016, the patient received the second dose of GARDASIL 9 (which had the lot # M016193, expiration date 24-APR-2018) both for prophylaxis (anatomical site of vaccinations was not informed). Information regarding concomitant medication was not provided. No adverse effects were reported. there was no product quality complaint involved. Additional information has been requested.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist referring to a 72 year old male patient. Information about pertinent medical history, drug reactions or allergies and concomitant medication was unknown by the reporter. Historical drugs included PREVNAR 13 on 09-OCT-2015. On 18-FEB-2017, the patient was vaccinated with PNEUMOVAX23 (lot number, dosage information and anatomical site of vaccination were not reported) intramuscularly, for prophylaxis since the patient never had vaccination. Subsequently, on 18-FEB-2017, the patient developed "a big, hot red area extending away from the injection site" (injection site erythema). It was also reported that laboratory tests were not performed. No treatment was given for the adverse event. The patient contacted the pharmacist and sought medical attention. At the time of reporting, the outcome of injection site erythema was reported as not recovered. The causality assessment between injection site erythema and therapy with PNEUMOVAX23 was not provided. Additional information has been requested.
Age: 0.33
Sex: F
Vaccine: RV5
Symptoms: Choking, Dyspnoea
Clinical narrative: oThis spontaneous report was received from a medical assistant who also is a nurse practitioner referring to a 6 month old female patient. The patient's concurrent conditions included a G-tube for history of aspiration. None drug reactions/allergies was reported. On 03-JAN-2017, the patient was vaccinated with ROTATEQ (Lot number reported as M038209, expiration date 23-APR-2018) dose was not reported, orally, for prophylaxis. There was no concomitant medication reported. On an unspecified date in 2017, after the patient received the dose of ROTATEQ, the patient experienced choking, she gasped (dyspnoea) and possibly aspirated. The outcome of choking, aspiration and dyspnoea was reported as recovered/resolved, the patient was fine at the time of reporting. Product quality complaint (PQC) was not involved. The reporter did not assess the causal relationship between the adverse events and the vaccination with ROTATEQ. Upon internal review, chocking and aspiration were considered medically significant adverse events. Additional information has been requested.
Sex: U
Vaccine: FLU3, MENB
Symptoms: Balance disorder, Concussion, Fall
Clinical narrative: This is a spontaneous report from a contactable physician via a Pfizer sales representative. A patient of unspecified age, gender and race received the first dose of TRUMENBA at single dose via unspecified route for immunization. On unknown date the patient 'Got wobbly' and fell to the ground resulting in a concussion. The outcome of the events was unknown. Sender's Comments: The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, as appropriate. The case will be reassessed if additional information becomes available.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis
Clinical narrative: This is a spontaneous report from a contactable Pharmacist. The Pharmacist reported similar events on 2 patients. This is case 1 of 2. A patient of unspecified age (after age 65, unit not provided), ethnicity and gender received PREVNAR 13 (Lot # R28321, Expiry Date 01Mar2018, NDC # 0005197102, UPC # 300051971022) intramuscular at 0.5 ml single on an unspecified date for an immunisation. The patient medical history and concomitant medications were not reported. The patient experienced severe reactions on their arms which were described like cellulitis type reactions on an unspecified date with outcome of unknown. The reporter was wondering if they should continue to use the rest of the products from that LOT or if it should be quarantined. Sender's Comments: Based on the information currently available, a contributory role of the suspect vaccine may not be fully excluded towards the occurrence of "severe reactions on arms described like cellulitis type reactions". The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. Linked Report(s) : US-PFIZER INC-2017087964 Same reporter/drug/AE, different patient.
Age: 77.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis
Clinical narrative: This is a spontaneous report from a contactable Pharmacist. The Pharmacist reported similar events on 2 patients. This is case 2nd of 2 cases. A patient of unspecified age (after age 65, unit not provided), ethnicity and gender received PREVNAR 13 (Lot # R28321, Expiry Date 01Mar2018, NDC # 0005197102, UPC # 300051971022) intramuscular at 0.5 ml single on an unspecified date for an immunisation. The patient medical history and concomitant medications were not reported. The patient experienced severe reactions on their arms which were described like cellulitis type reactions on an unspecified date with outcome of unknown. The reporter was wondering if they should continue to use the rest of the products from that LOT or if it should be quarantined. Sender's Comments: Based on the information currently available, a contributory role of the suspect vaccine may not be fully excluded towards the occurrence of "severe reactions on arms described like cellulitis type reactions". The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate. Linked Report(s) : US-PFIZER INC-2017087907 Same reporter/drug/AE, different patient.
Age: 88.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Asthenia, Cough, Malaise, Mobility decreased
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. This female patient of an unspecified age, race and ethnicity received pneumococcal PREVNAR 13 via an unspecified route of administration in the middle of Jan2017 at 0.5 ml single for immunization. The patient was allergic to penicillin, sulfa, codeine and KEFLEX. The patient's concomitant medications were not reported.  Since the vaccination the patient was sick. The patient felt that her sickness was due to the vaccination, because when she woke up the day after having received the vaccine, she was weak and she could not get out of bed. She was also coughing. Outcome was unknown.
Age: 88.0
Sex: F
Vaccine: PNC13, PNC13
Symptoms: Asthenia, Cough, Decreased appetite, Fatigue, Malaise
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. This female patient of an unspecified age, race and ethnicity received pneumococcal PREVNAR 13 via an unspecified route of administration in the middle of Jan2017 at 0.5 ml single for immunization. The patient was allergic to penicillin, sulfa, codeine and KEFLEX. The patient's concomitant medications were not reported.  Since the vaccination the patient was sick. The patient felt that her sickness was due to the vaccination, because when she woke up the day after having received the vaccine, she was weak and she could not get out of bed. She was also coughing. Outcome was unknown.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Pyrexia, Skin warm
Clinical narrative: REDNESS AT INJECTION LOCATION THAT SPREAD TO ELBOW. SKIN IS WARM AND FEVERISH. PT TAKING TYLENOL.
Age: 79.0
Sex: M
Vaccine: PNC13
Symptoms: Pruritus, Urticaria, Vaccination complication
Clinical narrative: Patient had PREVNAR 13 administered at his PCP office on 12/15/2016. He called in reporting to his PCP on 12/23/2016 that he had an ADR to the vaccination. He said he went to local urgent care because he developed hives on his back. The local urgent care prescribed him prednisone and a steroid cream. No other information provided about reaction. Urticaria. Pruritus.
Age: 66.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Fall, Head injury, Middle insomnia, Rash, Syncope
Clinical narrative: Woke up in the middle of the night and fainted. Fell and hit her head requiring medical attention. Developed severe rash on arm and down torso.
Age: 0.5
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Injection site swelling
Clinical narrative: Localized swelling at site of injection on right thigh.
Age: 44.0
Sex: F
Vaccine: FLUR3
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Urticaria
Clinical narrative: Pt stayed after vaccination due to a prior reaction. Pt stated that her arm was itching at injection site. I looked and pt had redness and rash starting on right upper arm. Small hive was visible as well. Pt stayed and was monitored for another 25 min. with no worsening reactions. I suggested benadryl and to seek medical attention if any worsening reactions accrued.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HEP, PNC13, RV5
Symptoms: Extra dose administered, No adverse event
Clinical narrative: 2 Hep B doses were given on the same day, there was no adverse effect to the child.
Age: 1.0
Sex: M
Vaccine: FLU4, HEPA, MMR, VARCEL
Symptoms: Febrile convulsion, Pyrexia, Respiration abnormal, Tremor
Clinical narrative: Developed fever, step parent noticed abnormal breathing and shaking all over, lasted 30 seconds. Went to ER, diagnosed with simple febrile seizure.
Age: 58.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site oedema, Injection site swelling
Clinical narrative: Large amount of edema and swelling at injection site. Also possible Cellulitis in upper arm. Doctor appoint with gp at 01 pm 3/3/2017.
Age: 58.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Large amount of edema and swelling at injection site. Also possible Cellulitis in upper arm. Doctor appoint with gp at 01 pm 3/3/2017.
Age: 17.0
Sex: F
Vaccine: HPV9, MENB
Symptoms: Abdominal pain, Dizziness, Headache, Pain
Clinical narrative: Patient report abdominal pain, generalized body aches, dizziness, headache.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Herpes zoster, Pain
Clinical narrative: Shingles rash on left shoulder, on same side as vaccine, but not at injection site. Headache, body aches.
Age: 74.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Upper arm became extremely painful and within a couple hours I could not lift the arm. Am still putting ice on it per my doctor.
Age: 53.0
Sex: M
Vaccine: HEP
Symptoms: Bursitis, Musculoskeletal pain
Clinical narrative: Pain in right shoulder after injection with a diagnosis of Right Subacrominl bursitis secondary to  hep B injection.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Swelling/redness of arm. I have pictures that I can submit if interested.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient stayed 15 minutes at the pharmacy and we noticed a small quarter sized red spot at the injection site. The patient was counseled to keep an eye on the swelling and if it got worse to contact her doctor or go to the emergency room if it was serious enough. The patient stated that she took benadryl before bedtime and it seemed to help but when she woke up the next morning the site was really red all the way around her arm and hurt. There was also swelling, redness, and heat. The patient did go to her doctors who told her that it looked like an allergic reaction but to let the pharmacy know so we could fill out a report in case it was not and there was something wrong with the vaccine.
Age: 74.0
Sex: M
Vaccine: PNC13
Symptoms: Headache, Hypertension, Nausea, Vomiting
Clinical narrative: Nausea/vomiting and H.B.P and headache.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Per provider report from pt appointment: "Patient presents with 3 days of rash and swelling in the right arm/shoulder after getting flu immunization 3 days PTA. Area has improved, mom had pictures. Now no distinct borders. Still swollen, tenderness is resolving. Patient to continue icing and using motrin."
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: The patient returned to the pharmacy today to report that she was having shoulder/upper arm pain since the day after vaccination. She had not, as of today, visited a doctor/clinic to be checked out. I recommended she be seen by a doctor for symptom resolution.
Age: 1.5
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site oedema, Injection site vesicles, Local reaction
Clinical narrative: Large localized reaction to thigh of erythema and edema, with small area of vesicle formation overlying erythema (not adjacent to injection site).
Age: 62.0
Sex: M
Vaccine: PPV
Symptoms: Injection site rash
Clinical narrative: Pt has rash on site of injection right deltoid.
Age: 16.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Chills, Nausea, Pain, Pyrexia
Clinical narrative: Fever . Generalized Body Aches. Chills. Nausea.
Age: 36.0
Sex: M
Vaccine: IPV, MNQ, RAB
Symptoms: Decreased appetite, Headache, Injected limb mobility decreased, Injection site pain, Pyrexia
Clinical narrative: Low grade fever (99.5-100.4); significant pain to left upper arm, unable to left arm; headache; difficulty sleeping due to pain; decreased appetite.
Age: 36.0
Sex: M
Vaccine: IPV, MNQ, RAB
Symptoms: Sleep disorder
Clinical narrative: Low grade fever (99.5-100.4); significant pain to left upper arm, unable to left arm; headache; difficulty sleeping due to pain; decreased appetite.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Blood culture, Differential white blood cell count, Full blood count, Mucous stools, Pyrexia
Clinical narrative: Patients mother states infant had increased fever, vomiting and increase mucous in his stools. ED ran labs and US was done. Acetaminophen given for fever.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Ultrasound abdomen, Urine analysis, Vomiting
Clinical narrative: Patients mother states infant had increased fever, vomiting and increase mucous in his stools. ED ran labs and US was done. Acetaminophen given for fever.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Pt came into the office on 2/28/17 and received a PNEUMOVAX vaccine in the Right deltoid. The area was pink and hot on Patient's (R) arm below the injection site this was reported on 3/2/17.
Age: 25.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Abdominal pain, Blood creatine phosphokinase, Chest pain, Full blood count, Headache
Clinical narrative: Hand swelling, Headache, Myalgias- Parasthesias, chest pain - abdominal pain sharp, and was in chest - Allover body aches tachycardia.
Age: 25.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Myalgia, Pain, Paraesthesia, Peripheral swelling, Red blood cell sedimentation rate
Clinical narrative: Hand swelling, Headache, Myalgias- Parasthesias, chest pain - abdominal pain sharp, and was in chest - Allover body aches tachycardia.
Age: 25.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Tachycardia
Clinical narrative: Hand swelling, Headache, Myalgias- Parasthesias, chest pain - abdominal pain sharp, and was in chest - Allover body aches tachycardia.
Age: 1.5
Sex: F
Vaccine: DTAPIPVHIB, HEPA, PNC13
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Pt was given 2 doses of Hep A vaccine. One was a prefilled syringe the other was in a vial drawn up. Given at 1540. No adverse reactions noted and no treatment needed at time of administration.
Age: 52.0
Sex: F
Vaccine: HEPA, MMR, TDAP
Symptoms: Injection site erythema, Injection site pruritus, Mumps antibody test positive
Clinical narrative: 12/16/16 at 1400PM received 3 vaccinations below in Right upper arm. Awoke morning of 12/18/16 at 0700 with itch and redness on under side of Right arm. Area settled down over next 2 days. Declined 2nd MMR vaccination due 1/13/2017. Recheck on Mumps titer 2/27/17 proved (+) Immuno Response.
Age: 5.0
Sex: F
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left leg swelling and erythema 7x6cm.
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Product preparation error
Clinical narrative: Patient was given diluent of ROTARIX without adding the actual powder. Noticed 2+ days after administration. Mother was informed, plans on coming in to have it readministered.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Hypersensitivity, Induration, Swelling
Clinical narrative: Vaccinated with swelling in hour after injection. Now with 10 cm severe local allergic rx (L) arm 5 cm induration. No evidence infection. No systemic symptoms.
Age: 65.0
Sex: U
Vaccine: TDAP
Symptoms: Wrong drug administered
Clinical narrative: Pt came in for Flu Vaccine and received a TDAP.
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Vaccine given to 57 year old patient error.
Age: 66.0
Sex: U
Vaccine: FLU3
Symptoms: Needle issue
Clinical narrative: Administered vaccine using the wrong needle-tip - used 5/8" instead of 1". Administered vaccine in an intramuscular fashion.
Age: 38.0
Sex: F
Vaccine: FLU4, HEP, HEPA, MMR, TDAP, VARCEL
Symptoms: Blister, Burning sensation
Clinical narrative: Received 6 vaccines (including varicella) and PPD test on 2/28. That night developed burning blisters apprx 6 in to the Lt. of her midline abd. area. Possible shingles, blister/vesicles still present, no s/s of infection. Referred to medical clinic.
Age: 51.0
Sex: U
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: After administering the flu shot medical record showed that the patient had received the flu shot on 9/30/16 at pharmacy causing the dose administered on 10/04/16 to be invalid.
Age: 1.17
Sex: U
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age, Wrong drug administered
Clinical narrative: Patient 2 years of age received FLUARIX 0.5 ml instead of pediatric FLUZONE 0.25ml.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Wrong drug administered
Clinical narrative: Patient came as a walk in to get her flu shot. Gave her the questionnaires and VIS form for her to fill out. After giving her the vaccine patient left. I went to lunch and after coming from it I was documenting the vaccine and I realized the vaccine FLULAVAL had preservatives on. Since at the clinic I was working at, they didn't have FLUARIX QUADRIVALENT which is the vaccine that is preservative free and is for private insurances, I gave FLULAVAL which according to RN it is private at the moment. I asked him what could we do and I filled out an incident report. After that the RN working at the moment called HC for further assistance.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Underdose
Clinical narrative: Patient and younger sibling in room with mother for the flu vaccine. The room was somewhat chaotic with children running around and patient and sibling close to the same size so 0.25ml dose was given to the patient who was 3years 2months of age and she needed to get the 0.5ml dose.
Age: 80.0
Sex: M
Vaccine: FLU3
Symptoms: Extra dose administered
Clinical narrative: Patient's wife came into the pharmacy and asked why we gave her husband a second flu shot. I checked and she was correct. The patient has a bit of dementia and he didn't remember the one given to him a month before.
Age: 0.3
Sex: F
Vaccine: FLU4, PNC13
Symptoms: Wrong drug administered
Clinical narrative: Daughter was given the flu shot without parent consent. Daughter, who is 4 months old, was to be given the PREVNAR shot but the nurse administered the flu shot instead. According to the office manager, the nurse opened the wrong patient file; the patient after my daughter was to get the flu shot.
Age: 87.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administration error
Clinical narrative: Used incorrect needle tip size for administration. Used a 5/8" instead of 1" but still gave in an IM fashion.
Age: 1.5
Sex: U
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Nurse gave 0.5 ml dose for ages 3+ years to an 18 month old.
Age: 17.0
Sex: U
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: Patient was given Influenza vaccine x 2 d/t documentation error on list. Patient given Influenza vaccine on 10/12/16 and 10/20/16.
Age: 2.0
Sex: U
Vaccine: FLU4
Symptoms: Incorrect dose administered
Clinical narrative: Given 0.5 ml to 30 months old baby, supposed to be 0.25ml.
Age: 16.0
Sex: U
Vaccine: FLU4
Symptoms: Exposure during pregnancy
Clinical narrative: This immunization was given to a 16yr old pregnant lady.
Age: 75.0
Sex: M
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient states pain in her left arm 4 weeks after the vaccine was administered and limited mobility of that arm.
Age: 22.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: Redness, Sore and warm to touch for 3 days. Treated with Antibiotics.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema
Clinical narrative: Patient's arm has become red from the injection site to the elbow.
Age: 23.0
Sex: M
Vaccine: TYP
Symptoms: Blood test, Chills, Decreased appetite, Diarrhoea, Dizziness
Clinical narrative: Patient states he received the Typhoid Vaccine on Monday FEB 27, 2017.  This was his first injection with this vaccine.  Pt began to experience a severe migraine, chills, nausea and diarrhea, light-headedness and a foggy head.  Symptoms lasted for two days.  Pt went to an ER off-post for evaluation.  He states that he was given IV fluids, HA medication through the IV and had blood work done.  States that his headache improved but that he continues to experience nausea and diarrhea five times a day since the injection.  Pt denies that he experienced rash, SOA, chest pain, swelling of the face / throat / extremities, numbness and tingling. Feeling tired (fatigue) and chills. Headache Pounding headache over the frontal lobe. Decreased appetite, nausea, and diarrhea. Dizziness and lightheadedness.
Age: 23.0
Sex: M
Vaccine: TYP
Symptoms: Fatigue, Feeling abnormal, Headache, Migraine, Nausea
Clinical narrative: Patient states he received the Typhoid Vaccine on Monday FEB 27, 2017.  This was his first injection with this vaccine.  Pt began to experience a severe migraine, chills, nausea and diarrhea, light-headedness and a foggy head.  Symptoms lasted for two days.  Pt went to an ER off-post for evaluation.  He states that he was given IV fluids, HA medication through the IV and had blood work done.  States that his headache improved but that he continues to experience nausea and diarrhea five times a day since the injection.  Pt denies that he experienced rash, SOA, chest pain, swelling of the face / throat / extremities, numbness and tingling. Feeling tired (fatigue) and chills. Headache Pounding headache over the frontal lobe. Decreased appetite, nausea, and diarrhea. Dizziness and lightheadedness.
Age: 1.67
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Local reaction, Macule
Clinical narrative: Mother of pt states pt left thigh has been red, swollen and warm to the touch since 06:00 AM on 03/03/2017. Pt was seen by provider 03:20 PM on 03/03/2017 with documentation of localized adverse reaction to DTAP vaccine, left thigh. Large Blotch, red macule with blanching on pressure, irregular, over two inches in diameter.
Age: 1.67
Sex: M
Vaccine: DTAP, HEPA
Symptoms: Pallor, Rash macular
Clinical narrative: Mother of pt states pt left thigh has been red, swollen and warm to the touch since 06:00 AM on 03/03/2017. Pt was seen by provider 03:20 PM on 03/03/2017 with documentation of localized adverse reaction to DTAP vaccine, left thigh. Large Blotch, red macule with blanching on pressure, irregular, over two inches in diameter.
Sex: F
Vaccine: HPV9
Symptoms: Maternal exposure before pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a medical assistant refers to a female patient of unknown age. There was no information about patient's concomitant medications and pertinent medical history reported. On an unknown dates, the patient was vaccinated with GARDASIL 9 dose 1 and dose 2, (dose, route, anatomical location, lot numbers and expiration dates were not provided) for prophylaxis. The patient was in the office to receive her 3rd dose, but informed that she was currently 11 weeks pregnant. The patient became pregnant with Last Menstrual Period of 03-MAY-2016 and Estimated Delivery Date of 07-FEB-2017. The medical assistant stated that the patient did not receive a vaccine during pregnancy. No other suspect medications or concomitant therapies were reported. No product quality complaint was involved. At the time of the report, the outcome of the event was unknown. Additional information has been requested. Sender's Comments: MERCK 1607USA007927: Mfr number.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from an office administrator referring to a 25 year old female patient. The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 02-FEB-2017, the patient was vaccinated with the third dose of GARDASIL 9 injection (strength, route, anatomical location, lot number and expiration date were not provided) for prophylaxis, which was administered "too early" as the patient was supposed to receive it on 11-MAR-2017. No adverse events and no product quality complaint (PQC) were involved. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report was received from a registered nurse concerning an adult patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. The nurse reported that on 03-FEB-2017, the patient was vaccinated with a pediatric dose of VAQTA injection (strength, dose, frequency, lot number and expiration date were not reported) for prophylaxis. No adverse effects were reported and no product quality complaint was involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Oral herpes
Clinical narrative: This spontaneous report was received from a pharmacist via a employee and refers to a female patient of unknown age. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On 02-DEC-2016, the patient was vaccinated with ZOSTAVAX vial 19400 PFU, 1 injection (route, lot number and expiration date were not reported) for prophylaxis (reported as "vaccine").  On 06-DEC-2016, the patient "had an outbreak of cold sores" lasting for an unknown duration of time. After the outbreak of cold sores, the patient began therapy with valacyclovir(VALTREX). At the time of reporting, the patient was "fully recovered". No product quality complain was reported. The causal relationship between the event and the suspect therapy was not provided. Additional information has been requested.
Age: 1.75
Sex: M
Vaccine: FLU4, HEPA, IPV
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a 21 month old patient of unknown gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 27-DEC-2016, the patient was vaccinated with a first dose of VAQTA 25/0.5 unit not reported, intramuscularly (site of administration were not reported) lot #M022924 and expiration date: 24-JAN-2018. On 14-FEB-2017, the patient was vaccinated with a second dose of VAQTA, intramuscularly injections (site of administration was not reported) lot # M036458 and expiration date: 02-MAR-2018. The patient did not experience any adverse effect. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received on 20-FEB-2017 from a medical assistant regarding two 4 year old patients of unknown gender. The patients' concurrent conditions, medical history and concomitant therapy were not reported. On 20-FEB-2017 the patients were vaccinated with VARIVAX lot # M037642 expiration 01-SEP-2018 (dose and route not reported) for prophylaxis after a supported temperature excursion. The vaccine was stored at 15.4F for 1 hour and 45 minutes. There was no previous temperature excursion. The call was made because of a data logger. No adverse events were reported. No further information was reported. On 20-FEB-2017, 1 day after onset of therapy the patient experienced incorrect product storage and no adverse event.  The outcome of incorrect product storage and no adverse event is unknown. The reporter considered incorrect product storage to be not related to VARIVAX. Additional information has been requested.; Sender's Comments: US-009507513-1703USA001826:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a registered nurse who stated that some improperly stored VARIVAX (lot numbers M032495, expiration date 06-JUL-2018 and M032494, expiration date 06-JUL-20018) were administered to unspecified patients on unspecified dates (dosages and routes of administration not provided).  No adverse effects reported. Temperature > 5° F but < 14°F; time frame: 30 minutes. Previous temperature excursion: > 5°F but < 14°F for 2 hours. Cumulative total with current excursion is 2 hours 30 minutes. Call was reported to be because of a data logger. Additional information is not expected.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning an unknown number of patients of unknown age and gender. There was no information about the patients' medical history, concurrent conditions or concomitant therapies reported. On 21-FEB-2017, the patients were vaccinated with an improperly stored VAQTA intramuscularly, lot number reported as M027809 with expiration date of 24-JAN-2018;  lot number: M036459 with expiration date of 18-JAN-2018; lot number: M047658 with expiration date of 28-OCT-2017 (strength, dosage schedule and anatomical location were not provided) for prophylaxis, and the administered doses were exposed to a temperature higher than 8°C but lower than 25°C for 5 hours and 43 minutes (digital data logger) without any previous temperature excursion. No adverse effects were reported. There was no product quality complaint involved. Lot number [M027809] is an invalid lot number for VAQTA. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA011533:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning an unknown number of patients of unknown age and gender. There was no information about the patients' medical history, concurrent conditions or concomitant therapies reported. On 21-FEB-2017, the patients were vaccinated with an improperly stored ROTATEQ orally, lot number M022371 with expiration date of 18-FEB-2018;  lot number: M006111 with expiration date of 18-NOV-2017; lot number: M004544 with expiration date of 18-OCT-2017 (strength, dosage schedule and anatomical location were not provided) for prophylaxis, and the administered doses were exposed to a temperature higher than 8°C but lower than 25°C for 5 hours and 43 minutes (digital data logger) without any previous temperature excursion. No adverse effects were reported. There was no product quality complaint involved. This is one of two reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1702USA010922:
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided. On 01-MAR-2017, the patient inadvertently received an expired dose of PROQUAD subcutaneously, lot # L032757 with an expiration date of 24-FEB-2017 (exact dose and anatomical location were not provided). No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple unspecified patients. No information regarding the patients' pertinent medical history, concomitant medications, drug reactions or allergies was provided. On unknown dates, the patients were vaccinated with improperly stored doses of ZOSTAVAX 19400 plaque-forming units (PFU) injection (dose, route of administration, lot# and expiration date were not provided) or VARIVAX injection (dose, route of administration, lot# and expiration date were not provided). The nurse could not provide lot# and expiration date of the properly stored sterile water diluent (manufacturer unknown) used to ZOSTAVAX or VARIVAX. No adverse events was reported. The recent temperature excursions (temperature and time frame) for the vaccines were unknown by the reporter. It was also unknown whether the vaccines had experienced any previous temperature excursion. Digital data logger was involved. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received on 20-FEB-2017 from a medical assistant regarding two 4 year old patients of unknown gender. The patients' concurrent conditions, medical history and concomitant therapy were not reported. On 20-FEB-2017 the patients were vaccinated with VARIVAX lot # M037642 expiration 01-SEP-2018 (dose and route not reported) for prophylaxis after supported temperature excursion. The vaccine was stored at 15.4F for 1 hour and 45 minutes. There was no previous temperature excursion. The call was made because of a data logger. No adverse events were reported. No further information was reported. On 20-FEB-2017, 1 day after onset of therapy the patient experienced incorrect product storage and no adverse event.  The outcome of incorrect product storage and no adverse event is unknown.  The reporter considered incorrect product storage to be not related to VARIVAX. Additional information has been requested.; Sender's Comments: US-009507513-1702USA009195:
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site reaction, Rash, Skin discolouration
Clinical narrative: Patient developed rash within 1 min of injection, with mottling of upper arm in area of injection. Patient reported itching with previous HPV vaccinations after injection today.  MD in to eval. Benadryl 50mg po given to treat rash. Monitored for 20 min after admin of treatment. Cleared by MD to leave office after treatment. Assisted leaving office. Guardian accompanied patient from office.
Age: 34.0
Sex: F
Vaccine: HEP, MNQ, PPV
Symptoms: Headache, Injection site rash, Pyrexia
Clinical narrative: High Fever, Headache, and Rash at injection site.
Age: 0.0
Sex: M
Vaccine: HEP
Symptoms: Cyanosis, Hypotonia, Lethargy, Pallor, Vasculitic rash
Clinical narrative: Baby, cyanotic, flaccid. Possible seizure/postictal state. Vasculitic rash that blanched with pressure. No fever. Pt received O2 blow-by, pinked up, remained lethargic for a bit, but then all resolved within 1/2 hour and pt O2 Sat 100% on room air.
Age: 49.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site mass
Clinical narrative: PATIENT HAD A LUMP SINCE THE DAY OF INJECTION ON THE INJECTION SITE.
Age: 56.0
Sex: F
Vaccine: FLU4, PNC
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient reported pain, swelling and redness in injection site.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient had already recieved the PNEUMOVAX immunization at her primary care dr office, but did not remember so she ended up getting it again with the pharmacy. She has not reported any side effects, but the PCP is upset the vaccine was repeated.
Age: 0.5
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Febrile convulsion
Clinical narrative: Febrile seizure.
Age: 61.0
Sex: M
Vaccine: PPV
Symptoms: Cold sweat, Dizziness, Dyspnoea, Fatigue, Peripheral swelling
Clinical narrative: Patient's spouse described patient having swollen arm, fatigue, dizziness, cold sweats, shortness of breath.
Age: 64.0
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: At an outpatient oncology clinic patient came in for B12 and decided to receive the influenza vaccine at the end of the appointment. Expired influenza vaccines were in an old supply refrigerator (no longer regulated by pharmacy) and the nurse was unaware of the new stock in the ADU refrigerator. The dose was pulled from the supply fridge (this was where the vaccines were kept last year) and administered. The order was entered and document after administration. The error was discovered when the RN went to document the lot and exp. number and was subsequently reported to pharmacy.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age, Exposure during pregnancy
Clinical narrative: High dose vaccine given to 36 year old pregnant female.
Age: 17.0
Sex: U
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: Patient who does not turn 18 until December 2016 was administered FLUZONE ID. There was no adverse reaction and pt BMI is such that we are certain it was delivered ID and not SQ.
Age: 0.6
Sex: U
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Administered 0.5 ml Quadrivalent Influenza vaccine to 7 month old child. Wrong age/wrong dosage.
Age: 8.0
Sex: U
Vaccine: FLU4
Symptoms: Incorrect product formulation administered, Wrong drug administered
Clinical narrative: Given patient infant dose instead of adult.
Age: 18.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: High dose flu vaccine given to 18 year old pregnant pt.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: High dose vaccine given to 50 year old female.
Age: 30.0
Sex: U
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: High dose vaccine given to 30 year old female.
Age: 41.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Redness, swelling across entire bicep/upper arm, vancomycin given at hospital.
Age: 0.5
Sex: U
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Pt received adult dose of influenza.
Age: 57.0
Sex: U
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: High dose given to patient age 57.
Age: 2.0
Sex: U
Vaccine: FLU4
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Gave a 27 mo old a 30 mo old dose of flu.
Age: 1.5
Sex: U
Vaccine: FLU4
Symptoms: Wrong drug administered
Clinical narrative: Provider ordered influenza vaccine 0.25 instead 0.5 FLUARIX was given.
Age: 2.0
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Underdose
Clinical narrative: Local board of health nurse administered 0.25 of FLULAVAL QUADRIVALENT vaccine to a 2 year old patient. (Vaccine licensed for 3 and older). She contacted the State Department of Public Health, who let her know that most likely the patient would need to be contacted and revaccinated. The Local Board of Health nurse stated there were no adverse events noted in the patient. The nurse at the State DPH contacted GSK to ensure that this was indeed the case. A pharmacist at GSK stated that they do not have any data on the 0.25 dose, only on 0.5 dose and that they had recently filed papers to extend the age limit down to 6 months on FLULAVAL, but using a 0.5 dose. The GSK pharmacist confirmed that this patient should be revaccinated with the correct flu vaccine for her age. This was communicated to the Local Board of Health nurse by the State DPH nurse.