chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site warmth, Myalgia, Urticaria
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of welts in a 68-year-old female patient who received SHINGRIX (batch number B5EK2, expiry date unknown). Concurrent medical conditions included muscle pain (had trigger point of upper right back muscle where she had sometimes pain before receiving SHINGRIX). Concomitant products included Alendronate. On 3rd April 2018, the patient received the 1st dose of SHINGRIX (intramuscular) .5 ml. On 3rd April 2018, immediately after receiving SHINGRIX, the patient experienced injection site warmth. In April 2018, the patient experienced welts and muscle pain. On an unknown date, the outcome of the welts, injection site warmth and muscle pain were not recovered/not resolved. It was unknown if the reporter considered the welts, injection site warmth and muscle pain to be related to SHINGRIX. Additional details were reported as follows: The reporter is a pharmacist at the pharmacy where the vaccine was administered. The patient had only recently filled an Alendronate prescription at the pharmacy. The reporter was not certain if she had been taking Alendronate since it was dispensed prior to the SHINGRIX vaccine being administered. At 14:25 hours, the patient received SHINGRIX in right deltoid. The patient's right arm felt warm around the injection site area after receiving SHINGRIX. The patient did not know over what exact area of the right arm to which the feeling of warmth extended, as the patient just described the warmth occurred around the injection site. Not right away, but later (less than a week) after receiving SHINGRIX, a large red welt appeared about two inches below the injection site which was described by the patient as being warm and hot upon touch and still felt warm to the touch. The patient did not know when the welt appeared relative to the other symptom of right arm warmth. Less than a week after receiving SHINGRIX, the patient had localized back muscle pain in that same trigger point area of her upper back which she still felt and not yet resolved. The patient did not state, how soon the localized upper right back muscle pain started after the vaccine was administered. The patient thought all the symptoms are all due to the SHINGRIX vaccine. The reporter was not sure if the symptoms are related to the SHINGRIX or not. The patient was referred to a physician instead for her request of him today for evaluation of the symptoms. The patient was hesitant to go to a physician. She might call GlaxoSmithKline (GSK) to further discuss as well. The reporter called to inquire if GSK had any similar data for these types of side effects and next best steps for this patient. The call was transferred to the Medical Information team for further research. The reporter gave consent to contact. The reporter described the funds for the vaccine as public and private because the patient paid co pay but insurance company covered most of the cost.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Anxiety, Arthralgia, Chills, Confusional state, Diplegia
Clinical narrative: Severe pain, muscle/joint focus. Severe headache. Severe shivering. Fever sensation, temperature unknown. Partial paralysis both legs, spastic gait, extreme difficulty walking. Confusion, chaotic thinking. Impaired sleep. Severe anxiety. Period of subsidence/resolution, 03.0 hours after ibuprofen 400 mg. Overall duration 06.0 hours. No discernible permanent effects. Impression of impending recurrence on following night. Inconsequential after ibuprofen 200 mg.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Gait disturbance, Gait spastic, Headache, Insomnia, Myalgia
Clinical narrative: Severe pain, muscle/joint focus. Severe headache. Severe shivering. Fever sensation, temperature unknown. Partial paralysis both legs, spastic gait, extreme difficulty walking. Confusion, chaotic thinking. Impaired sleep. Severe anxiety. Period of subsidence/resolution, 03.0 hours after ibuprofen 400 mg. Overall duration 06.0 hours. No discernible permanent effects. Impression of impending recurrence on following night. Inconsequential after ibuprofen 200 mg.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia, Thinking abnormal
Clinical narrative: Severe pain, muscle/joint focus. Severe headache. Severe shivering. Fever sensation, temperature unknown. Partial paralysis both legs, spastic gait, extreme difficulty walking. Confusion, chaotic thinking. Impaired sleep. Severe anxiety. Period of subsidence/resolution, 03.0 hours after ibuprofen 400 mg. Overall duration 06.0 hours. No discernible permanent effects. Impression of impending recurrence on following night. Inconsequential after ibuprofen 200 mg.
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report was received from a nurse and refers to a 30 year old female patient. The patient had no concomitant medications, pertinent medical history, drug reactions or allergies. On 05-FEB-2018, the patient was vaccinated with VARIVAX injection, subcutaneously (dose, strength, frequency were not reported) (lot # N021720, expiration date on 10-AUG-2019) for "vaccination". Concomitant therapy included sterile diluent. On 20-FEB-2018, the patient was examined by an unspecified obstetrics and gynecology physician. The patient was pregnant. The Last Menstrual Period (LMP) and Estimated Date of Delivery (EDD) was not reported. No treatment was given. No lab diagnostics were performed. The patient sought medical attention.
Age: 21.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report as received from a nurse practitioner refers to a 21 year old pregnant female patient with bipolar disorder and gastric sleeve. On 21-FEB-2018, the patient was vaccinated for prophylaxis with the first dose of GARDASIL 9 lot # N017832, expiration date 16-NOV-2019, intramuscularly. Concomitant therapies included escitalopram, venlafaxine, naltrexone hydrochloride (VIVITROL) and albuterol sulfate (VENTOLIN). The patient's last menstrual period was on 25-DEC-2017. Conception date was estimated as 08-JAN-2018 and estimated delivery date was 01-OCT-2018. The pregnancy outcome was pending. The patient had an office visit. No treatment was given.
Sex: U
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: Information has been received from a medical assistant referring to a 23 year old patient of unknown gender. The patient's concurrent condition, medical history and concomitant therapy were unknown. On 22-SEP-2016, the patient was vaccinated with a dose of GARDASIL (dose, frequency and route were unknown, lot # L042837, expiration date:27-MAY-2017) for prophylaxis. On 13-FEB-2018, the patient received a dose of GARDASIL 9 (dose, frequency and route were unknown, N021571, expiration date:13-APR-2020) for prophylaxis. (interchange of vaccine products). No adverse effects reported.
Age: 20.0
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, Pregnancy test positive
Clinical narrative: This spontaneous prospective pregnancy report as received from nurse refers to a currently 20 year old female patient. The patient's pertinent medical history was reported as none. No drug reactions/allergies were reported. The patient's concomitant medication was not reported. On 03-APR-2018 the patient was vaccinated with GARDASIL 9 injection (lot # N021571, expiry date: 29-APR-2020) (dose and frequency were not reported) intramuscularly for prophylaxis. On 10-APR-2018, pregnancy test revealed positive. It was unknown if the patient was pregnant at the time of administration of GARDASIL 9. It was unknown how long the patient had been pregnant. The last menstrual period (LMP) and estimated delivery date (EDD) was unknown. It was reported that, the patient sought medical attention and reported pregnancy to immunization official. No product quality complaint was involved.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a physician assistant refers to a patient of unknown age and gender. The patient's concurrent conditions, medical history, drug reactions and allergies were unknown. Concomitant therapy included Diluent Merck Inj. On an unknown date the patient was vaccinated with ZOSTAVAX vial 19400 PFU (dose, units and frequency were unknown) (lot # N025704 and expiration date 16-DEC-2018). It was reported that on an unspecified date "a year later" patient inadvertently received an additional dose of ZOSTAVAX (extra dose administered). No adverse effects reported. There was no product quality complaint (PQC) reported.
Sex: F
Vaccine: FLUR3
Symptoms: Condition aggravated, Disability, Pre-existing disease
Clinical narrative: Initial unsolicited report received from health authority (under the reference number: 713567) on 03-Apr-2018. This case involves a 31 years old female patient who was vaccinated with a dose of FLUBLOK (Batch number, dose, dose in series, route, site of administration and expiration date were not reported) on 01 Oct 2015. Patient's medical history included chronic fatigue syndrome as underlying disease, other history included chronic Lyme disease. As Concomitant medications, patient received RESTORIL and propranolol. On 01 Oct 2015, same day following the vaccination, patient developed increased overall worsening of pre-existing health conditions to the point patient became disabled. No Lab tests were performed. Corrective treatment was not reported. Outcome of the events was reported as unknown. Case was assessed as serious by the reporter due to disability. List of documents held by sender: none. Sender's Comments: This adult's pre-existing condition got aggravated and had disability following vaccination with FLUBOK TIV. Medical history included chronic fatigue syndrome/ME (ongoing) and chronic Lyme disease. Time to onset was compatible. Additional information would be needed for further assessment. Based on limited information provided the role of vaccine cannot be assessed.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Myalgia, Nausea, Pyrexia
Clinical narrative: Fever, chills, muscle aches, headache, nausea.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Abdominal pain upper, Agitation, Allergy test, Dysplasia, Headache
Clinical narrative: Neck pain, vomiting, stabbing head and stomach pain, dysplasia, loss of weight. agitation, numbness in arms and legs.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Hepatobiliary scan, Hypoaesthesia, Laboratory test, Lumbar puncture, Neck pain
Clinical narrative: Neck pain, vomiting, stabbing head and stomach pain, dysplasia, loss of weight. agitation, numbness in arms and legs.
Age: 16.0
Sex: M
Vaccine: HPV9, MENB
Symptoms: Nuclear magnetic resonance imaging, Sinus operation, Vomiting, Weight decreased, X-ray
Clinical narrative: Neck pain, vomiting, stabbing head and stomach pain, dysplasia, loss of weight. agitation, numbness in arms and legs.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: Escalating pain from time of injection, NSAIDS were taken, upon awakening next day barely able to move right arm due to pain, ice and heat applied along with NSAIDS with minimal relief; reported to physician office via phone - they "are short staffed" and a message was left for the physician and/or nurse.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site reaction, Pain, Rash, Rash macular
Clinical narrative: Big red painful blotches on injection site.Headache and body aches. Rash getting bigger body aches not as bad today.
Age: 18.0
Sex: M
Vaccine: MEN
Symptoms: Erythema, Neck pain, Pain, Pyrexia
Clinical narrative: Fever, neck pain, red painful spots on feet and hands.
Age: 0.5
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse regarding a 6-month old patient. The patient's concurrent conditions, concomitant therapy, medical history and historical drugs were not reported. On 15-MAY-2017, the 6 month old patient was vaccinated with first dose of ROTATEQ orally, (lot # M031650, expiry date: 16-MAR-2018) for prophylaxis (drug administered to patient of inappropriate age). No adverse effects were reported. No product quality complaint involved.
Sex: F
Vaccine: PNC13
Symptoms: Cough, Delirium, Dyspnoea, Fatigue, Memory impairment
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported for herself. A 64-year-old female patient of unknown race received PREVNAR 13 for immunization at single dose in 2016 via unspecified route of administration. Medical history included Oxygen consumption since 2011 and ongoing, chronic obstructive pulmonary disease, lung neoplasm malignant, cardiac disorder, hypothyroidism, spinal operation, walking aid user and dyspnoea ongoing.  Concomitant medications were unknown. The patient experienced pneumococcal pneumonia on unknown date which was specified as  cough every day using nebulizers, short of breath (oxygen 24/7), delirious, fatigue and fever. The patient was hospitalized for the event from 07Mar2018 to 19Mar2018. The outcome of the events was recovered as according to doctor the pneumonia was cleared from lungs. It was mentioned that she is now dealing with a mass on her Kidney, which MRI has been ordered as a mass was found on kidney while in hospital in March. She has a walker to get around. She also said her brain has been affected and can't remember things like she used to. No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: PNC13
Symptoms: Pneumonia pneumococcal, Pyrexia, Renal mass
Clinical narrative: This is a spontaneous report from a Pfizer sponsored program. A contactable consumer reported for herself. A 64-year-old female patient of unknown race received PREVNAR 13 for immunization at single dose in 2016 via unspecified route of administration. Medical history included Oxygen consumption since 2011 and ongoing, chronic obstructive pulmonary disease, lung neoplasm malignant, cardiac disorder, hypothyroidism, spinal operation, walking aid user and dyspnoea ongoing.  Concomitant medications were unknown. The patient experienced pneumococcal pneumonia on unknown date which was specified as  cough every day using nebulizers, short of breath (oxygen 24/7), delirious, fatigue and fever. The patient was hospitalized for the event from 07Mar2018 to 19Mar2018. The outcome of the events was recovered as according to doctor the pneumonia was cleared from lungs. It was mentioned that she is now dealing with a mass on her Kidney, which MRI has been ordered as a mass was found on kidney while in hospital in March. She has a walker to get around. She also said her brain has been affected and can't remember things like she used to. No follow-up attempts are possible; information about batch number cannot be obtained. No further information is expected.
Age: 4.0
Sex: F
Vaccine: DTAPHEPBIP, IPV, MMR, VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Patient was given PEDIARIX (DTAP/HIB/IPV) instead of DTAP. This was caught after the immunization had been administered. Parent has been notified and is aware.
Age: 54.0
Sex: M
Vaccine: ANTH, MMR, TYP
Symptoms: Injection site pain
Clinical narrative: Patient received Anthrax and MMR vaccine in the left arm on 5 April 2018. Patient started experiencing pain from the bottom of the left shoulder area to the neck on his left side 2 days following these vaccinations. Pain lasted about 5 days total. I talked to patient today (13 April 2018) and patient is no longer experiencing any pain.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site rash, Rash, Rash pruritic, Urticaria
Clinical narrative: Patient received vaccines on Monday 4/9/18 and started having reaction on 4/10/18. Rash spreading from legs, feet, arms, stomach, and face (described to be itchy and look like welts.) Parent giving BENADRYL to patient, no fevers.
Age: 36.0
Sex: F
Vaccine: HEPAB, MMRV, TDAP
Symptoms: Injection site swelling
Clinical narrative: Provider documented - Annular swollen areas where vaccination was given, around 6 cm in diameter, no warmth, no drainage.
Age: 58.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Fatigue, Flushing, Lethargy, Pharyngeal oedema, Swollen tongue
Clinical narrative: Approximately 3 hours of vaccination, patient started to feel that his throat was swollen, tongue was swollen, airway was restricted. Patient felt very tired and lethargic. Patient was flushed. Patient felt this way for several hours. Patient did not take anything to relieve symptoms. Awoke feeling fine.
Age: 58.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Throat tightness
Clinical narrative: Approximately 3 hours of vaccination, patient started to feel that his throat was swollen, tongue was swollen, airway was restricted. Patient felt very tired and lethargic. Patient was flushed. Patient felt this way for several hours. Patient did not take anything to relieve symptoms. Awoke feeling fine.
Age: 58.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Lethargy, Malaise, Pharyngeal oedema, Swollen tongue
Clinical narrative: Approximately 3 hours of vaccination, patient started to feel that his throat was swollen, tongue was swollen, airway was restricted. Patient felt very tired and lethargic. Patient was flushed. Patient felt this way for several hours. Patient did not take anything to relieve symptoms. Awoke feeling fine.
Age: 62.0
Sex: F
Vaccine: PNC13
Symptoms: Rash, Rash generalised, Rash papular
Clinical narrative: PREVENAR 13 administered approx. 10 or 11AM on 4/10/18. Notice non pruritic red papular rash on medial thighs about 10pm that night. Next morning rash over torso, ant/post, lightly scattered on arms, upper legs. No SOB, wheeze, swelling of lip to tongue, throat. Felt normal other than the rash. No Hx of rashes. Hx Amox allergy.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysuria, Fatigue, Feeling hot, Pyrexia, Somnolence
Clinical narrative: Patient had fever (not high grade) within 8 hours after injection on 4/11/18 (patient felt overheated after tending to garden at 6 p.m. that evening), had started feeling hot around noon (2 hours after injection). The patient also reported that she had some difficulty with urination (with burning) around the afternoon. The patient also reported severe drowsiness and fatigue starting mid-afternoon after the injection. She is ambulating normally and just is getting over the fever on 4/13/18.
Age: 12.0
Sex: M
Vaccine: TDAP
Symptoms: Syncope
Clinical narrative: Client fainted during check out. Client was checked out by clinic nurses and found to have no injuries. Client left clinic ambulatory with mom.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site swelling, Injection site warmth, Ultrasound scan
Clinical narrative: Right thigh/knee swelling, hot to touch.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: 1 day after vaccine pt experienced soreness, redness and swelling at site of injection. Redness approx. 7 inches in diameter and induration approx. 3 inches in diameter. No fever.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to a patient of unknown age and gender. Information about concurrent condition, concomitant medication and medical history was not reported. On 13-MAR-2018, the patient was vaccinated with an expired stored properly dose of PNEUMOVAX23 (batch/lot # M020521, expiration date 17-NOV-2017; dose and route were not provided) for prophylaxis (expired vaccine used). No adverse effects were reported.
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 unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On 03-APR-2018 the patient was vaccinated with improperly stored VAQTA (dosing details were not reported) (lot # N005274, expiry date: 03-APR-2018) for prophylaxis (product storage error). The vaccine was stored at a temperature of 47 degree Fahrenheit to 77 degree Fahrenheit (59.6 degree Fahrenheit) for a time frame of 8 hours. No adverse effects reported. Previous temperature excursions was reported as "yes". There was a digital data logger involved. No product quality complaint involved. This is one of the several reports received from same reporter. Sender's Comments: US-009507513-1804USA005621; US-009507513-1804USA005625; US-009507513-1804USA005629; US-009507513-1804USA005628; US-009507513-1804USA005624; US-009507513-1804USA005623; US-009507513-1804USA005626; US-009507513-1804USA005630; US-009507513-1804USA005627; US-009507513-1804USA005622.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On 20-MAR-2018, the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) (lot # M041184, expiry date: 31-MAY-2018) orally for prophylaxis (product storage error). The vaccine was stored at a temperature of 47 degree Fahrenheit to 77 degree Fahrenheit (59.6 degree Fahrenheit) for a time frame of 8 hours. No adverse effects reported. Previous temperature excursions was reported as "yes". There was a digital data logger involved. No product quality complaint involved. This is one of the several reports received from same reporter. Sender's Comments: US-009507513-1804USA004718.
Sex: U
Vaccine: HEPA, HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On 01-MAR-2018, the patient was vaccinated with improperly stored VAQTA (dosing details were not reported) (lot # N005274, expiry date: 03-APR-2018) and GARDASIL 9 (dosing details were not reported) (lot # N020353, expiry date: 28-APR-2020) for prophylaxis (product storage error). The vaccine was stored at a temperature of 47 degree fahrenheit to 77 degree fahrenheit (59.6 degree fahrenheit) for a time frame of 8 hours. No adverse effects reported. Previous temperature excursions was reported as "yes". There was a digital data logger involved. No product quality complaint involved. This is one of the several reports received from same reporter. Sender's Comments: US-009507513-1804USA004718.
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 unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On 22-FEB-2018, the patient was vaccinated with improperly stored VAQTA (dosing details were not reported) (lot # N005274, expiry date: 03-APR-2018) for prophylaxis (product storage error). The vaccine was stored at a temperature of 47 degree Fahrenheit to 77 degree Fahrenheit (59.6 degree Fahrenheit) for a time frame of 8 hours. No adverse effects reported. Previous temperature excursions was reported as "yes". There was a digital data logger involved. No product quality complaint involved. This is one of the several reports received from same reporter. Sender's Comments: US-009507513-1804USA004718.
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 unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On 03-APR-2018, the patient was vaccinated with improperly stored VAQTA (dosing details were not reported) (lot # N005274, expiry date: 03-APR-2018) for prophylaxis (product storage error). The vaccine was stored at a temperature of 47 degree Fahrenheit to 77 degree Fahrenheit (59.6 degree Fahrenheit) for a time frame of 8 hours. No adverse effects reported. Previous temperature excursions was reported as "yes". There was a digital data logger involved. No product quality complaint involved. This is one of the several reports received from same reporter. Sender's Comments: US-009507513-1804USA004718.
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On 02-APR-2018, the patient was vaccinated with improperly stored ROTATEQ (dosing details were not reported) (lot # M041184, expiry date: 31-MAY-2018) orally for prophylaxis (product storage error). The vaccine was stored at a temperature of 47 degree Fahrenheit to 77 degree Fahrenheit (59.6 degree Fahrenheit) for a time frame of 8 hours. No adverse effects reported. Previous temperature excursions was reported as "yes". There was a digital data logger involved. No product quality complaint involved. This is one of the several reports received from same reporter. Sender's Comments: US-009507513-1804USA004718.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On 19-FEB-2018, the patient was vaccinated with improperly stored  GARDASIL 9 (dosing details were not reported) (lot # N020353, expiry date: 28-APR-2020) for prophylaxis (product storage error). The vaccine was stored at a temperature of 47 degree fahrenheit to 77 degree fahrenheit (59.6 degree fahrenheit) for a time frame of 8 hours. No adverse effects reported. Previous temperature excursions was reported as "yes". There was a digital data logger involved. No product quality complaint involved. This is one of the several reports received from same reporter. Sender's Comments: US-009507513-1804USA004718.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On 22-FEB-2018, the patient was vaccinated with improperly stored GARDASIL 9 (dosing details were not reported) (lot # N020353, expiry date: 28-APR-2020) for prophylaxis (product storage error). The vaccine was stored at a temperature of 47 degree fahrenheit to 77 degree fahrenheit (59.6 degree fahrenheit) for a time frame of 8 hours. No adverse effects reported. Previous temperature excursions was reported as "yes". There was a digital data logger involved. No product quality complaint involved. This is one of the several reports received from same reporter. Sender's Comments: US-009507513-1804USA004718.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On 08-MAR-2018, the patient was vaccinated with improperly stored GARDASIL 9 (dosing details were not reported) (lot # N020353, expiry date: 28-APR-2020) for prophylaxis (product storage error). The vaccine was stored at a temperature of 47 degree fahrenheit to 77 degree fahrenheit (59.6 degree fahrenheit) for a time frame of 8 hours. No adverse effects reported. Previous temperature excursions was reported as "yes". There was a digital data logger involved. No product quality complaint involved. This is one of the several reports received from same reporter. Sender's Comments: US-009507513-1804USA004718.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On 08-MAR-2018 the patient was vaccinated with improperly stored GARDASIL 9 (dosing details were not reported) (lot # N020353, expiry date: 28-APR-2020) for prophylaxis (product storage error). The vaccine was stored at a temperature of 47 degree fahrenheit to 77 degree fahrenheit (59.6 degree fahrenheit) for a time frame of 8 hours. No adverse effects reported. Previous temperature excursions was reported as "yes". There was a digital data logger involved. No product quality complaint involved. This is one of the several reports received from same reporter. Sender's Comments: US-009507513-1804USA004718.
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions and concomitant medications were not reported. No previous drug reactions or allergies were reported. On 19-FEB-2018, the patient was vaccinated with improperly stored GARDASIL 9 (dosing details were not reported) (lot # N020353, expiry date: 28-APR-2020) for prophylaxis (product storage error). The vaccine was stored at a temperature of 47 degree fahrenheit to 77 degree fahrenheit (59.6 degree fahrenheit) for a time frame of 8 hours. No adverse effects reported. Previous temperature excursions was reported as "yes". There was a digital data logger involved. No product quality complaint involved. This is one of the several reports received from same reporter. Sender's Comments: US-009507513-1804USA004718.
Age: 0.5
Sex: U
Vaccine: MNQ
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: No adverse symptoms noted. MENACTRA was administered instead of PENTACEL.
Age: 0.33
Sex: M
Vaccine: MNQ
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: No adverse symptoms noted or reported. MENACTRA was administered instead of PENTACEL.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Swelling and redness at site. Hard and hot to touch. Reaction occurred less than 24 hrs. after injection.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Muscle aches for about 2 days.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Decreased appetite, Injection site pain, Lethargy
Clinical narrative: Sore injection site & arm muscle, pain in knee joints, fever of 100.9, chills, lethargic, loss of appetite. lasted 2.5 days.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: Sore injection site & arm muscle, pain in knee joints, fever of 100.9, chills, lethargic, loss of appetite. lasted 2.5 days.
Age: 83.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Pruritus, Rash
Clinical narrative: Patient's arm was sore, red and "broke out" down to her elbow. She also had itching. Symptoms lasted for 4 days. No other symptoms.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain, Myalgia, Pyrexia, Somnolence
Clinical narrative: Pain at injection site, muscle pain, fever, very tired & sleepy.
Age: 78.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Pain, erythema at site of injection. Mild induration.
Age: 0.42
Sex: M
Vaccine: MNQ
Symptoms: Wrong drug administered
Clinical narrative: No adverse symptoms noted. MENACTRA was administered instead of PENTACEL. No reported adverse events or symptoms.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Nausea, Vomiting
Clinical narrative: Gave patient PNEUMOVAX 23 early morning. Patient came back around 2 PM her arm was swollen at injection site was warm to touch and red. She felt nauseous and vomited once was pale. When patient felt better we recommend she ice injection site and take BENADRYL.
Age: 68.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: Redness and swelling of arm above and below on 7-13 cm of RUE vaccination site.
Age: 68.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Tremor, Vomiting
Clinical narrative: Patient developed fever (102 F), vomiting x3, and shakiness for 48 hours after receiving the vaccination.
Age: 58.0
Sex: F
Vaccine: HEP, HEPA, YF
Symptoms: Bronchitis, Cough, Laryngitis, Oropharyngeal pain, Pyrexia
Clinical narrative: Mild fever for 2 days, cough and sore throat that felt like laryngitis or bronchitis for 3 weeks.
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Nausea, Pyrexia, Vomiting
Clinical narrative: Patient described having fever and chills along with nausea and vomiting for 2 days after receiving the vaccine. When I followed up with him today on the 4th day after taking the vaccine he said he felt much better. I counseled the patient that if he starts feeling this way again to call his doctor.
Age: 18.0
Sex: M
Vaccine: FLU4, HPV9, MENB, MNQ
Symptoms: Muscle twitching, Unresponsive to stimuli
Clinical narrative: Pt was brought down to the floor, his head made some movements 3-4 times like twitching. After abour 30-45 seconds, he responded when asked his name. Pulse 90/ min regular, Heart RRR, no murmurs. 911 called; they took him to ER for observation.
Age: 77.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Large red, sore area upper left arm.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Arthralgia, Diarrhoea, Malaise, Mobility decreased
Clinical narrative: Patient stated he woke up at 4:30am on 4/11/18 not feeling well. He began to ache and hurt all over, especially his joints and muscles. He couldn't hardly move. The following on 4/12/2018, his stomach began hurting and having diarrhea. On Friday 4/13/18 his soreness has been noticably less. His stomach has continued to hurt and have diarrhea. He has been taking pepto for his stomach. He did take 2 extra strength acetaminophen 500mg tabs on 4/12 and 4/13.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Myalgia, Pain
Clinical narrative: Patient stated he woke up at 4:30am on 4/11/18 not feeling well. He began to ache and hurt all over, especially his joints and muscles. He couldn't hardly move. The following on 4/12/2018, his stomach began hurting and having diarrhea. On Friday 4/13/18 his soreness has been noticably less. His stomach has continued to hurt and have diarrhea. He has been taking pepto for his stomach. He did take 2 extra strength acetaminophen 500mg tabs on 4/12 and 4/13.
Age: 83.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Local reaction
Clinical narrative: Large local reaction to right arm reported to extend from upper arm to proximal forearm, with redness, warmth and induration, improved on evaluation today in clinic. No systemic symptoms.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient's arm became swollen and slightly erythematous in a 3 by 3 inch area at the injection site. Area is tender. Symptoms appeared the same day as the injection and has not disappeared by day 7.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Skin warm
Clinical narrative: Red, warm to touch, sore.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Eye movement disorder, Immediate post-injection reaction, Muscle rigidity, Postictal state, Pyrexia
Clinical narrative: Per mom, immediate seizure like activity, eye rolling, rigidity all lasting approx 3 min. Pt was then postictal and developed a fever to 104 F that evening.
Age: 0.17
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Seizure like phenomena
Clinical narrative: Per mom, immediate seizure like activity, eye rolling, rigidity all lasting approx 3 min. Pt was then postictal and developed a fever to 104 F that evening.
Age: 86.0
Sex: F
Vaccine: PPV
Symptoms: Injection site rash, Injection site swelling, Injection site warmth, Rash
Clinical narrative: Patient's husband called Thursday evening (4/12/18 at 6:50pm) to report that patient has had swelling that is warm to touch and rash at injection site that has spread down to her leg and up to her cheek.
Sex: F
Vaccine: HPV4
Symptoms: Exposure during pregnancy, Human papilloma virus test positive, Papilloma viral infection
Clinical narrative: This spontaneous prospective pregnancy report was received from a consumer referring herself as a 22 year old female patient. The patient's concurrent conditions were not reported. The patient had no known medical history, drug reactions and allergies. The patient was not receiving any concomitant medications at the time of report. On an unknown date in 2011, reported as when she was 15 years old, the patient was vaccinated with GARDASIL (dose, units and frequency not reported) (lot# and expiration date not reported) intramuscularly. On an unknown date in 2015, reported as 3 years ago, pap smear test was performed to the patient which resulted negative for human papilloma virus. On an unknown date, patient reported that, she was eleven and a half weeks pregnant (Exposure during pregnancy). On 10-APR-2018 (also reported as last week), pap smear test was performed to the patient, which resulted positive for human papilloma virus (papilloma viral infection). The patient planned to follow-up with her physician. The patient was not recovered from the events. The reporter did not provide causal relationship for the events with suspect therapy GARDASIL. No product quality complaint was involved.
Sex: F
Vaccine: HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a physician assistant refers to a female patient of unknown age. The patient's concurrent conditions, medical history, drug reactions, allergies and concomitant medications were not reported. On 11-OCT-2017, the patient was vaccinated with first dose of GARDASIL 9 (dose, units, route and frequency not reported) (lot# and expiration date not reported). On 11-JAN-2018, the patient was vaccinated with second dose of GARDASIL 9 (dose, units, route and frequency not reported) (lot# N017833 and expiration date: 16-NOV-2019), it was reported that, the second dose of GARDASIL 9 was given late to the patient (inappropriate schedule of drug administration) and third dose GARDASIL 9 was given on 11-APR-2018. No adverse effects were reported. No product quality complaint was involved.
Age: 52.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Pain
Clinical narrative: Redness, itchiness, swelling on left arm around injection and burning pain around left wrist; started 4/10 5 days after vaccination.
Age: 77.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Red, swollen area around site of injection. About 1 and 1/2 inches diameter. Patient did not notice until 8 days after the vaccination date. Patient did not report pain or raised skin.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Nausea
Clinical narrative: Shivering, nausea, and dizziness, occurring approx. 13 hours after vaccination given. Symptoms nearly gone by 25 hours after vaccination given.
Age: 24.0
Sex: F
Vaccine: UNK
Symptoms: Lip swelling, Peripheral swelling, Pruritus
Clinical narrative: Patient developed itching and swelling to lips and bilateral fingers. Treated with antihistamine.
Age: 4.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site mass, Injection site pruritus, Injection site reaction, Rash erythematous
Clinical narrative: Mother reports a lump near the injection site, and now a raised red rash on L leg. His is not acting sick or any other symptoms but does scratch at the site at times.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Injection site pain, Injection site swelling, Insomnia, Local reaction
Clinical narrative: About 12 hours after receiving the SHINGRIX, pt began to feel aching in the whole body with chills and fever and was not able to sleep. He had more pain and swelling at the site of the injection. He had an outbreak of shingles in 9/2016. Now about 28 hours after vaccine and have recommended that the patient put ice on the local reaction and that he take tylenol for the systemic symptoms.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: About 12 hours after receiving the SHINGRIX, pt began to feel aching in the whole body with chills and fever and was not able to sleep. He had more pain and swelling at the site of the injection. He had an outbreak of shingles in 9/2016. Now about 28 hours after vaccine and have recommended that the patient put ice on the local reaction and that he take tylenol for the systemic symptoms.
Age: 40.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Fatigue, Injection site erythema, Injection site swelling, Night sweats
Clinical narrative: Site pain with upper arm redness and swelling.  Fever, chills, night sweats, fatigue.
Age: 40.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Site pain with upper arm redness and swelling.  Fever, chills, night sweats, fatigue.
Age: 33.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site cellulitis, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Large, hot, red swollen area (cellulitis) at injection site.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Blood test, Diarrhoea, Erythema, Paraesthesia oral, Peripheral swelling
Clinical narrative: DIARRHEA, LIPS AND TONGUE TINGLING. SHE WOKE UP AT 2AM AND FAINTED FOR 30 SECONDS. HUSBAND APPLIED COLD COMPRESSES TO HEAD AND ARM DUE TO REDNESS AND SWELLING OF RIGHT ARM.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Syncope
Clinical narrative: DIARRHEA, LIPS AND TONGUE TINGLING. SHE WOKE UP AT 2AM AND FAINTED FOR 30 SECONDS. HUSBAND APPLIED COLD COMPRESSES TO HEAD AND ARM DUE TO REDNESS AND SWELLING OF RIGHT ARM.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain upper, Arthralgia, Blood test, Diarrhoea, Immediate post-injection reaction
Clinical narrative: DIARRHEA, LIPS AND TONGUE TINGLING. SHE WOKE UP AT 2AM AND FAINTED FOR 30 SECONDS. HUSBAND APPLIED COLD COMPRESSES TO HEAD AND ARM DUE TO REDNESS AND SWELLING OF RIGHT ARM.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site rash, Injection site swelling, Insomnia, Myalgia
Clinical narrative: DIARRHEA, LIPS AND TONGUE TINGLING. SHE WOKE UP AT 2AM AND FAINTED FOR 30 SECONDS. HUSBAND APPLIED COLD COMPRESSES TO HEAD AND ARM DUE TO REDNESS AND SWELLING OF RIGHT ARM.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Nausea, Pain, Syncope, Urticaria
Clinical narrative: DIARRHEA, LIPS AND TONGUE TINGLING. SHE WOKE UP AT 2AM AND FAINTED FOR 30 SECONDS. HUSBAND APPLIED COLD COMPRESSES TO HEAD AND ARM DUE TO REDNESS AND SWELLING OF RIGHT ARM.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Facial paresis
Clinical narrative: Pt reported to clinic today with right sided facial weakness that started yesterday around 7:30pm. Received Shingrix vaccine on 04/04/18 at her local pharmacy. Pt started on prednisone and soothe eyedrops. Pt advised to go to ER if increased weakness, slurred speech, or imbalance.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Facial paralysis
Clinical narrative: Pt reported to clinic today with right sided facial weakness that started yesterday around 7:30pm. Received Shingrix vaccine on 04/04/18 at her local pharmacy. Pt started on prednisone and soothe eyedrops. Pt advised to go to ER if increased weakness, slurred speech, or imbalance.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Injection site swelling, Local reaction
Clinical narrative: Patient had large local reaction with large swelling on left thigh extending to the knee.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: Given SQ not IM. No adverse reactions reported at this time.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Influenza like illness, Pain, Pyrexia
Clinical narrative: Flu like symptoms, joints and body, slight fever. 24 hours - took over Ibuprofen for two days.
Age: 62.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site pain, Joint range of motion decreased, Musculoskeletal stiffness, Nuclear magnetic resonance imaging abnormal, Ultrasound scan normal
Clinical narrative: Patient describes developing right shoulder pain within 48 hours of receiving her 0.5mL FLUCELVAX (SEQ; lot#195248) IM to right deltoid, on 18 December 2017 that has been significant and persistent.  Patient does not recall exact location of vaccine administration, but does not recall receiving the vaccine high on the shoulder. She describes developing significant soreness at the vaccine site (without any observable swelling or redness) that progressed to stiffness and decreased range of motion that has persisted for more than 2 months. She describes the pain as a "dull achy pain" that can be 7 out of 10 in intensity with movement (especially internal rotation of the shoulder) and may be absent or minimal at rest. She notes decreased range of motion mostly with internal rotation. She has tried topical VOLTAREN GEL without any significant improvement. She has not, started any oral NSAIDs. She has not had any physical therapy to date. Workup by her PCM has included plain films and shoulder ultrasound that were reportedly unremarkable. She is currently pending an MRI of the shoulder. She has had a total of 3 PCM visits related to her shoulder pain thus far. Patient queries what can be done for this pain and how long will it last. Patient denies any other known adverse events following immunizations. And until now has received annual influenza vaccine without adverse events.