chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 78.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Influenza like illness, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Pt experienced fever chills, etc (Flu-like Sx). Patient called regarding swelling and redness around area of injection (6 to 7 in diameter). RPh advised to go to urgent care where she was prescribed antibiotic. We have photo of patient's site of injection and steroid.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient has a huge red area around the injection. Sore, red - kept getting bigger.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient received her PREVNAR 13 on 5-1-2015. Two days later she noted redness and soreness at the injection site. Two days later symptoms reduced significantly. 1-2 days later symptoms became worse. Patient went to her local urgent care where she received a steroid injection, BENADRYL injection and prescribed sulfamethoxazole/trimethoprim 800/600 mg 1 tablet twice daily for 12 days and mupirocin 2% ointment.
Age: 55.0
Sex: F
Vaccine: MNQ
Symptoms: Pyrexia, Skin reaction
Clinical narrative: Fevr 103.4 - for 2 days. Excessive red arm - still 3 days after vaccine.
Age: 87.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Dry mouth, Erythema, Injection site erythema, Nausea
Clinical narrative: Pt received PREVNAR 13 vaccine in (R) deltoid 5/14/15. Pt reports experiencing nausea later in day 5/14/15. Pt went ER 5/15/15 with c/o nausea, chills, dry mouth, redness on right arm. WBC-16.2. Seen for follow up with MD 5/19/15 - entire right upper arm red - abx started.
Age: 87.0
Sex: F
Vaccine: PNC13
Symptoms: White blood cell count increased
Clinical narrative: Pt received PREVNAR 13 vaccine in (R) deltoid 5/14/15. Pt reports experiencing nausea later in day 5/14/15. Pt went ER 5/15/15 with c/o nausea, chills, dry mouth, redness on right arm. WBC-16.2. Seen for follow up with MD 5/19/15 - entire right upper arm red - abx started.
Age: 40.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a other health care worker and refers to an 40 year old female patient with allergies to codeine and theophylline. The office managers informed that on 19-MAR-2015, the patient was vaccinated with the first dose of MMR II (lot# K020188, expiration date 22-OCT-2016) (strength and dosage were not reported) Subcutaneous, left deltoid reported as "Lt Del", that was shipped on 04-MAR-2015 and received on 10-MAR-2015. The product was in transit for 6 days, an the temperature was unspecified. None illness at the time of vaccination was reported. No concomitant medication was reported. No adverse effects were reported. None relevant diagnostic tests and laboratory data were reported. This is one of several reports from the same reporter. Additional information is not expected because all information required was received.
Age: 2.0
Sex: M
Vaccine: HEPA, MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from health care worker and refers to a 2 years old female patient. None known allergies, medical history and concurrent conditions were not reported. The office managers informed that on 23-MAR-2015 at 10:30, the patient was vaccinated with the first dose of MMR II HSA (lot# K020188, expiration date 22-OCT-2016) (strength and dosage were not reported) Subcutaneous, left arm reported as "high", that was shipped on 04-MAR-2015 and received on 10-MAR-2015. The product was in transit for 6 days, an the temperature was unspecified. The same day at the same time, the patient also received as concomitant vaccination the first dose of VAQTA (lot no. K02387, Expiration date was not reported) intramuscular, left (high). None illness at the time of vaccination was reported. No adverse effects were reported. None relevant diagnostic tests and laboratory data were reported. This is one of several reports from the same reporter. Additional information is not expected because all information required was received.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: This spontaneous report was received from a pharmacist via a company representative refers to two patients of unknown age and gender. Concurrent conditions, medical history and allergies were not reported. On an unknown date, the two patients were vaccinated with doses of ZOSTAVAX, (strength, dose, frequency, route, anatomical location, lot number and expiration date were not reported). Other suspect and concomitant therapies were not reported. On an unknown date, the patients experienced rash after receiving ZOSTAVAX. The outcome of both patient's rash was reported as recovered/resolved on an unknown date. The reporter pharmacist considered rash to be not related to ZOSTAVAX. Additional information is not expected because the reporter did not consent further follow up.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age/gender. The patients' concurrent or historical conditions were not provided. Concomitant therapies were not reported. On an unknown date the patients were vaccinated with improperly stored ROTATEQ oral (dose and frequency were not reported). No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant refers to a patient of unknown gender and age. The patient's medical history and concurrent conditions were not reported. On 23-AUG-2013, the patient was vaccinated with the first dose of GARDASIL, intramuscular (dose and lot number were not reported). The patient's concomitant therapies were not reported. On 27-FEB-2015, the patient received the second dose of GARDASIL, intramuscular (dose, lot number and indication were not reported) and on 29-APR-2015, the patient received the third dose of GARDASIL, intramuscular (dose, lot number and indication were not reported). No adverse effects and product quality complaints (PQC) were reported. Additional information has been requested.
Age: 49.0
Sex: M
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager who is also a Health care worker and refers to a currently 50 years old male patient. None preexisting allergies, medical history and concurrent conditions were reported. The healthcare professional nurse informed that on 17-MAR-2015, the patient was vaccinated with the first dose of MMR II (lot# K020188, expiration date 22-OCT-2016) (strength, dosage and route were not reported) right deltoid reported as "Rt Del", that was shipped on 04-MAR-2015 and received on 10-MAR-2015. The product was in transit for 6 days, an the temperature was unspecified. None illness at the time of vaccination was reported. On 22-APR-2015, the patient was vaccinated with the second dose of MMR II (HSA) (lot no. K021950, expiration date not reported) (strength, dosage and route were not reported) left deltoid reported as "Lt Del". None adverse effects were reported. None relevant diagnostic tests and laboratory data were reported. Additional information is not expected because all information required was received.
Age: 1.09
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from the office manager who is also a health care worker and refers to a 13 month old female patient. None known allergies, medical history and concurrent conditions were reported. The office managers informed that on 24-MAR-2015 at 09:30 hrs, the patient was vaccinated with the first dose of MMR II (HSA) (lot# K020188, expiration date 22-OCT-2016) (strength, dosage and route were not reported). Subcutaneous, right arm reported as "high", that was shipped on 04-MAR-2015 and received on 10-MAR-2015. The product was in transit for 6 days, an the temperature was unspecified. The same day at the same time, the patient also received as concomitant vaccination the first dose (Merck) VARIVAX (lot No. K011084, Expiration date was not reported) left arm (high) and one the first dose of VAQTA (lot no. K023870, Expiration date was not reported) left arm (high). None illness at the time of vaccination was reported. No adverse effects were reported. This is one of several reports from the same reporter. Additional information is not expected because all information required was received.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Drug ineffective, Influenza
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of flu in a female patient who received BREO ELLIPTA inhalation powder (batch number R713704, expiry date 31st October 2016) for emphysema and shortness of breath. Co-suspect products included Influenza vaccine. The patient's past medical history included lost weight. Concurrent medical conditions included increased blood pressure, low thyroid and high cholesterol. Additional patient notes included concomitant medications of baby aspirin and unspecified cholesterol medication. Concomitant products included atenolol, levothyroxine and lisinopril. In May 2014, the patient started BREO ELLIPTA (inhaled) 1 puff(s) once daily. In October 2014, the patient received Influenza vaccine. In October 2014, an unknown time after receiving BREO ELLIPTA and Influenza vaccine, the patient experienced lack of drug effect. In March 2015, the patient experienced flu. BREO ELLIPTA was continued with no change. The action taken with Influenza vaccine was unknown. On an unknown date, the outcome of the flu and lack of drug effect were recovered/resolved. The reporter considered the flu to be unrelated to BREO ELLIPTA. It was unknown if the reporter considered the lack of drug effect to be related to BREO ELLIPTA and Influenza vaccine. It was unknown if the reporter considered the flu to be related to Influenza vaccine. Additional Details: A female patient reports that she came down with the flu in March 2015. The patient also noted that she received an unknown manufacturer's brand of influenza vaccine but still came down with the flu. Caller was transferred from another location.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Calcinosis, Immediate post-injection reaction, Injection site injury, Injection site pain, Nuclear magnetic resonance imaging abnormal
Clinical narrative: Immediate pain in (L) arm at time of injection persistent. Chronic pain at site of injection continuously since that time. Found to have tear of tendon at evaluation in May. No interim injury or event to explain pain. VASRI
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Tendon rupture
Clinical narrative: Immediate pain in (L) arm at time of injection persistent. Chronic pain at site of injection continuously since that time. Found to have tear of tendon at evaluation in May. No interim injury or event to explain pain. VASRI
Age: 58.0
Sex: F
Vaccine: PPV
Symptoms: Hypoaesthesia, Mobility decreased, Pain in extremity
Clinical narrative: This spontaneous report as received from a nurse practitioner via a company representative refers to a 58 years old female patient. The patient's medical history, drug reactions/allergies and concurrent conditions were not reported. On 23-APR-2015, the patient was vaccinated with PNEUMOVAX 23 (lot number L001311, expiration date 06-JUL-2016), 0.5 ml, intramuscular, 1 dose (anatomical location was not reported) for routine vaccination. On 23-APR-2015, the patient experienced pain in hr arm, her body was going numb and she had trouble moving after the vaccination with PNEUMOVAX 23. The patient was sent to the emergency room, and was treated with KENALOG and DEPO-MEDROL on an unspecified date. The patient sought medical attention thru office visit on an unspecified date. At the time of the report, the outcome of the pain in her arm, body was going numb and trouble moving was recovered/resolved on an unspecified date in 2015. Additional information has been requested.
Age: 1.11
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from the office manager who is also an health care worker and refers to a 13 month female patient with gastroesophageal reflux disease and sensory integration disorder. None known allergies. It was reported that on an 12-MAR-2015 at 16:15 hrs, the patient was vaccinated with the first dose of MMR II HSA (strength, dosage and route were not reported) (lot# K020188, expiration date 22-OCT-2016) Subcutaneous, left arm reported as "high", that was shipped on 04-MAR-2015 and received on 10-MAR-2015. The product was in transit for 6 days, an the temperature was unspecified. on 12-MAR-2015 at 16:15 hrs, the patient also received as concomitant vaccination the first dose of (Merck) VARIVAX (lot No. K011084. Expiration date was not reported) left arm (high) and the first dose of VAQTA (lot no. K023870, Expiration date was not reported) left arm (high). None illness at the time of the vaccination was reported. No adverse effects were reported. Additional information is not expected because all information required was received.
Age: 20.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an unknown source and refers to a 20 years old female patient. None preexistent allergies, medical history and concurrent conditions were reported. It was reported that on 16-MAR-2015, the patient was vaccinated with the first dose of MMR II (HSA) (lot#K020188, expiration date 22-OCT-2016) (strength, dose and route were not reported) left arm reported as "Lt Del", that was shipped on 04-MAR-2015 and received on 10-MAR-2015. The product was in transit for 6 days, an the temperature was unspecified. None illness at the time of the vaccination was reported. On 04-MAY-2015, the patient was vaccinated with the second dose of MMR II (HSA) (lot#K021950, expiration date not reported) (strength, dosage and route were not reported) left arm reported as "Lt Del". None relevant diagnostic tests and laboratory data were reported. No adverse effects were reported. This is one of several reports from the same reporter. Additional information is not expected because all information required was received.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to multiple unspecified patients of unknown age/gender. The patient's concurrent or historical conditions were not provided. Concomitant therapies were not reported. On an unknown date the patients were vaccinated with improperly stored LIQUID PEDVAXHIB (dose, frequency and route were not reported). No adverse effects were reported and no product quality complaint (PQC) was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 89.0
Sex: F
Vaccine: PNC13
Symptoms: Fatigue, Injection site erythema, Injection site swelling, Nausea
Clinical narrative: Nausea, fatigue, and redness with swelling on left deltoid. Will begin taking Loratadine 10 mg daily.
Sex: U
Vaccine: HEP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare professional refers to a 16 day old patient of unknown gender. The patient's medical history was not specified. On an unknown date, a 16 day old instead of 1 month old patient was vaccinated with the second dose of RECOMBIVAX HB (lot #, route and site of administration were not reported). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from healthcare worker regarding an unspecified patients of unknown age and demographics. The patients concurrent condition and medical history was not reported. Between 06-MAR-2015 and 31-MAR-2015, the unspecified number of patients were vaccinated with improperly stored VAQTA 0.5 ml, intramuscular, lot # K004856; expiry date: 07-DEC-2016. No adverse effects reported. No product quality complaint reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from healthcare worker regarding an unspecified patients of unknown age and demographics. The patients concurrent condition and medical history was not reproted. Between 06-MAR-2015 and 31-MAR-2015, the unspecified number of patients were vaccinated with improperly stored GARDASIL, 0.5ml, intramuscular, lot # K006117; expiry date: 14-JAN-2017 and lot# K007828; expiry date: 02-MAR-2017 (dose(s) in series unspecified). No adverse effects reported. No product quality complaint reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nursing assistant referring to a patient of unknown age and gender. On 11-MAY-2015 the patient was inadvertently vaccinated with a dose of (Merck) VARIVAX (lot#, expiration date were unknown, 0.5 ml) subcutaneous which had been improperly stored (incorrect product storage). No adverse effects were reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site hypoaesthesia, Injection site mass, Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a female consumer referring to herself (age unspecified). No current condition and medical history was reported. On an unknown date in 2015, "last week", the patient was vaccinated with ZOSTAVAX (dose, strength, lot number and expired date not reported) subcutaneous. On an unknown date in 2015, "last week", the patient experienced numbness, swelling, a lump, itching and redness at injection site. And the patient also experienced itching around eyes, ears, scalp and neck. The patient did not seek medical attention (also reported as "did seek medical attention"). No lab diagnostics studies were performed. BENADRYL cream (manufacturer unknown) and ice was given at injection site by herself. The outcome of all the adverse events was reported as recovering. Additional information is not expected because the reporter refused additional contact.
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus
Clinical narrative: Information has been received from a female consumer referring to herself (age unspecified). No current condition and medical history was reported. On an unknown date in 2015, "last week", the patient was vaccinated with ZOSTAVAX (dose, strength, lot number and expired date not reported) subcutaneous. On an unknown date in 2015, "last week", the patient experienced numbness, swelling, a lump, itching and redness at injection site. And the patient also experienced itching around eyes, ears, scalp and neck. The patient did not seek medical attention (also reported as "did seek medical attention"). No lab diagnostics studies were performed. BENADRYL cream (manufacturer unknown) and ice was given at injection site by herself. The outcome of all the adverse events was reported as recovering. Additional information is not expected because the reporter refused additional contact.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered, Medication error
Clinical narrative: Information has been received from a pharmacist referring to unspecified number of patients of unknown ages and gender human immunodeficiency virus (HIV). The patients always received 2 doses of ZOSTAVAX (started date, strength, lot#, dosage, frequency and route unspecified) (extra dose administered and medication error). This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a two patients of unknown age and gender. On an unknown dates two patients were vaccinated intramuscularly with a dose of improperly stored GARDASIL (doses were not reported) (lot # J009788, exp. date: 17-MAR-2016). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse referring to multiple patients of unknown age and gender. On unknown dates the patients were vaccinated with a dose of improperly stored (Merck) VARIVAX (strength, lot# and route not provided) (incorrect product storage). No adverse effects were reported. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Joint lock, Nodule, Pain in extremity, Swelling
Clinical narrative: Information has been received from an approximately 60 years old male patient concerning himself. The patient was allergic to penicillin or derivative. The patient had no medical history. On an unknown date (reported as on Tuesday) the patient was vaccinated with a dose of ZOSTAVAX (one shot, lot# and route were not reported) in the right arm. No concomitant medications was reported. On Thursday night his arm started hurting and he had a large know with swelling about the size of a half a dollar show up, he put ice on it and the swelling went down. On 15-MAY-2015 (reported as today) in the morning his left knee hurt but it went away. Now his right knee was hurting and was locking up, the pain from one to ten was a 9.75. He sought medical attention via calling his doctor but had not gotten a call back. No treatment was given for these events. No lab diagnostics studies were performed. The outcome of left knee hurt was recovered on 15-MAY-2015, the outcome of right knee hurt was not recovered, the outcome of swelling was recovering, the outcome of other events was unknown. The relationship between these events and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a healthcare worker referring to 17 unspecified patients of unknown age and gender. The patient's medical history and current conditions were not provided. On an unknown dates, the patients were vaccinated with doses of improperly stored (Merck) VARIVAX (strength, lot#, dose and route were not reported) (incorrect product storage). No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered pharmacist referring to a patient of unknown age and gender. Concurrent conditions or pertinent medical history were not reported. On 06-MAY-2015, the patient was vaccinated with an expired dose of ZOSTAVAX (lot # J012679 - Expiration date: 21-JAN-2015) (frequency was not reported), and no adverse symptoms were reported. Concomitant therapies were not reported. ZOSTAVAX was found to be supported with post-expiry in Company house data. Additional information has been requested.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Information has been received from a 61 year old female patient concerning herself with allergic to sulfa. No pertinent medical history was reported. On 07-MAY-2015 the patient was vaccinated with ZOSTAVAX (lot # K010969, expire date unspecified). Concomitant therapies include Loratadine and Triamterene. On 09-MAY-2015, the patient experienced redness, itching, swelling, tenderness and "an area about the size of a large egg" at the injection site after receiving ZOSTAVAX. The patient sought medication attention. Ice, hydrocortisone treatments were given to the patient via contacting pharmacist. At the time of reporting, the patient was not recovered form the adverse events. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a healthcare student referring to a unspecified patient of unknown age and gender. On 18-MAY-2015 the patient was inadvertently administered an expired dose of ZOSTAVAX (lot # J014809, expiration date: 20-FEB-2015, route and dose were unknown) (expired vaccine used). No adverse effect was reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant (C.M.A.) refers to 3 patients of unknown age and gender. On an unknown date, the patients were vaccinated with improperly stored (Merck) VARIVAX (dose, frequency, route of administration, lot# and expiration date were not reported). No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Age: 24.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Induration, Injection site erythema, Injection site swelling, Pyrexia, Swelling
Clinical narrative: Hives, fever, bump on arm swollen arm.
Age: 24.0
Sex: F
Vaccine: TDAP, VARCEL
Symptoms: Urticaria
Clinical narrative: Hives, fever, bump on arm swollen arm.
Age: 33.0
Sex: F
Vaccine: ANTH
Symptoms: Erythema, Pain
Clinical narrative: Painful erythemic area approximatley 5 inch diameter.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HEP, PNC13, RV1
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: None.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Eye swelling, Urticaria
Clinical narrative: 8 hours after vaccine HPV was given patient had swelling of eye and hives on face. Went to ER. Given EPIPEN and DECADRON.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Site of injection red, warm swollen itchy.  Improving over the next 24 hours.  No treatment.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Rash
Clinical narrative: Six days post vaccine, patient developed painful rash on right side of chest that started in the back and radiates around to the front following the dermatome. Pain in area before rash showed up.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Blood creatine phosphokinase increased, C-reactive protein increased, Cardiac stress test normal, Chest X-ray normal, Headache
Clinical narrative: MENVEO vaccine given AM 5/19/15. Onset of headache and hypersomnolence that evening. 5/20/15 developed fever 102.9 with associated headache and neck stiffness. Seen in the ER with negative lab workup.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Hypersomnia, Influenza virus test negative, Metabolic function test normal, Musculoskeletal stiffness, Pyrexia
Clinical narrative: MENVEO vaccine given AM 5/19/15. Onset of headache and hypersomnolence that evening. 5/20/15 developed fever 102.9 with associated headache and neck stiffness. Seen in the ER with negative lab workup.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Red blood cell sedimentation rate normal, White blood cell count increased
Clinical narrative: MENVEO vaccine given AM 5/19/15. Onset of headache and hypersomnolence that evening. 5/20/15 developed fever 102.9 with associated headache and neck stiffness. Seen in the ER with negative lab workup.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain
Clinical narrative: 10 cm red indurated painful mass (L) upper arm.
Age: 14.0
Sex: M
Vaccine: HEPA, MNQ
Symptoms: Injection site reaction
Clinical narrative: 2 vaccines given (R) deltoid - nickel size reaction present, No antibiotics needed.
Sex: F
Vaccine: RUB
Symptoms: Hypersensitivity
Clinical narrative: This spontaneous report was received from a female patient above 60 years of age reporting on herself. The patient's concurrent conditions and concomitant medications were not reported. The patient inquired about ZOSTAVAX and at the same time she stated, that in her early childhood (date unspecified) she was vaccinated with rubella virus vaccine live (Wistar ra 27-3) (manufacturer unknown) (also reported as "German Measles vaccine") (dose volume, route of administration, lot number were not reported) and she had an allergic reaction to it. No descriptions of the symptoms were provided. The patient sought a medical attention via contacting the office. The outcome of the event was recovered/resolved. The causality between the event and rubella virus vaccine live (Wistar ra 27-3) (manufacturer unknown) was related. Additional information is not expected because the patient did not provide her contact details.
Age: 21.0
Sex: M
Vaccine: MENB
Symptoms: Blood glucose decreased, Chills, Delirium, Feeling abnormal, Feeling cold
Clinical narrative: This is a spontaneous report from a cont actable consumer. A 21-year-old male patient received the second dose of TRUMENBA at 0.5 ml single dose on 13May2015 18:00, intramuscular on left arm for immunization. The patient experienced that his body went into shock because of low blood sugar, was delirious, he was cold, shivering, he was very sensitive, had flu like symptoms, nausea, his right leg was in a lot of pain and he could not walk on it, experienced appetite and thirst excessive and headache. The patient's sister received the first dose of the same vaccine at 18-year-old and experienced sick symptoms. The outcome of the events was reported as recovering.
Age: 21.0
Sex: M
Vaccine: MENB
Symptoms: Gait disturbance, Headache, Increased appetite, Influenza like illness, Malaise
Clinical narrative: This is a spontaneous report from a cont actable consumer. A 21-year-old male patient received the second dose of TRUMENBA at 0.5 ml single dose on 13May2015 18:00, intramuscular on left arm for immunization. The patient experienced that his body went into shock because of low blood sugar, was delirious, he was cold, shivering, he was very sensitive, had flu like symptoms, nausea, his right leg was in a lot of pain and he could not walk on it, experienced appetite and thirst excessive and headache. The patient's sister received the first dose of the same vaccine at 18-year-old and experienced sick symptoms. The outcome of the events was reported as recovering.
Age: 21.0
Sex: M
Vaccine: MENB
Symptoms: Nausea, Pain in extremity, Shock, Shock hypoglycaemic, Thirst
Clinical narrative: This is a spontaneous report from a cont actable consumer. A 21-year-old male patient received the second dose of TRUMENBA at 0.5 ml single dose on 13May2015 18:00, intramuscular on left arm for immunization. The patient experienced that his body went into shock because of low blood sugar, was delirious, he was cold, shivering, he was very sensitive, had flu like symptoms, nausea, his right leg was in a lot of pain and he could not walk on it, experienced appetite and thirst excessive and headache. The patient's sister received the first dose of the same vaccine at 18-year-old and experienced sick symptoms. The outcome of the events was reported as recovering.
Age: 0.48
Sex: F
Vaccine: PNC13, DTAPIPVHIB, HEP, PNC13
Symptoms: Abscess drainage, Injection site abscess, Laboratory test abnormal, Staphylococcus test positive, Surgery
Clinical narrative: This is a spontaneous report from a contactable nurse. A 7-month-old female patient of an unspecified ethnicity received third single dose of PREVNAR 13 (lot L04916, expiry date 31Jul2016, NDC# 00005197101) on an unspecified date in Apr2015. The patient medical history was not reported. Concomitant medication included MOTRIN as needed. On an unknown date in Apr2015, two days after vaccination, the patient experienced an abscess at the site which required hospitalization from 26Apr2015. Since unknown date in 2015 she was also positive for MRSA. The patient underwent an unspecified lab work with unknown result. Therapeutic measures were taken as a result of the abscess at the site (it had to be drained, surgery was done and she was put on antibiotics). The patient recovered on unknown date from abscess at the site. Outcome of 'positive for MRSA' was not provided. Nurse did not believe the adverse events were because of the vaccine.
Age: 0.48
Sex: F
Vaccine: PNC13, DTAPIPVHIB, HEP, PNC13
Symptoms: Injection site abscess, Staphylococcal infection, Staphylococcus test positive
Clinical narrative: This is a spontaneous report from a contactable nurse. A 7-month-old female patient of an unspecified ethnicity received third single dose of PREVNAR 13 (lot L04916, expiry date 31Jul2016, NDC# 00005197101) on an unspecified date in Apr2015. The patient medical history was not reported. Concomitant medication included MOTRIN as needed. On an unknown date in Apr2015, two days after vaccination, the patient experienced an abscess at the site which required hospitalization from 26Apr2015. Since unknown date in 2015 she was also positive for MRSA. The patient underwent an unspecified lab work with unknown result. Therapeutic measures were taken as a result of the abscess at the site (it had to be drained, surgery was done and she was put on antibiotics). The patient recovered on unknown date from abscess at the site. Outcome of 'positive for MRSA' was not provided. Nurse did not believe the adverse events were because of the vaccine.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition and medical history was reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dosing regimen unspecified) that underwent a supported temperature excursion. No adverse experiences reported. No further information provided. No product quality complaint reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition and medical history was reported. On an unknown date, the patient was vaccinated with improperly stored ZOSTAVAX (dosing regimen unspecified). No adverse effects reported. No further information provided. No product quality complaint reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unknown number of patients of unknown age and gender. Current conditions and medical history were not reported. On an unknown date, the patients were vaccinated with 3 doses of improperly stored ROTATEQ (unknown dose and strength; route defaulted to oral). Concomitant medications were not reported. No adverse effects were reported. The outcome of the events was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. No concurrent condition and medical history was reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dosing regimen unspecified) that underwent supported temperature excursion. No adverse experiences reported. No further information provided. No product quality complaint reported. This one of several reports received from the same reporter. Additional information has been requested.
Age: 80.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Pruritus
Clinical narrative: Arm became edematous and erythematous. It is pruritic, painful. Symptoms worsened over time.
Age: 53.0
Sex: M
Vaccine: PNC13
Symptoms: Abasia, Blood test, Dizziness, Dysarthria, Electrocardiogram
Clinical narrative: Dizzy. Can't walk. Blurred vision nausea, headache. I have missed 5 weeks of work and everything is getting worse. I cant walk without falling or running into walls. I think I got another auto immune disease from this.
Age: 53.0
Sex: M
Vaccine: PNC13
Symptoms: Headache, Impaired work ability, Nausea, Nuclear magnetic resonance imaging, Visual impairment
Clinical narrative: Dizzy. Can't walk. Blurred vision nausea, headache. I have missed 5 weeks of work and everything is getting worse. I cant walk without falling or running into walls. I think I got another auto immune disease from this.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Gastroenteritis viral, Maternal exposure before pregnancy, Pregnancy test positive, Product use issue
Clinical narrative: This spontaneous prospective pregnancy report has been received from a 28 year old female patient concerning herself. The patient's concurrent condition included polycystic ovary syndrome (PCOS). The patient had experienced full-body hives "within 24 hours" of taking penicillin (unspecified). She was also allergic to mold and pollen. On 03-APR-2015 the patient was prescribed (Oka/Merck) VARIVAX (strength: 1350 U, dose, lot # and route were not reported) for a pre-existing condition, polycystic ovary syndrome (PCOS). Concomitant therapies included metformin. The patient reported that she became pregnant after she received (Oka/Merck) VARIVAX. The last menstruation (LMP) was on 08-APR-2015. The date of contraception was estimated on 22-APR-2015. On 27-APR-2015, the patient experienced "a stomach flu". Her physician prescribed an unspecified medication to manage the symptoms of her stomach flu. The patient was fully recovered from the stomach flu on 02-MAY-2015. The patient received only one dose of (Oka/Merck) VARIVAX. The patient stated she took pregnancy test on 15-MAY-2015 and the test was positive. She emailed her physician the results to inform that she was pregnant. The estimated date of delivery was estimated on 13-JAN-2016. The fetal outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healtcare worker refers to unknown number of patients of unknown age and gender. Current conditions and medical history were not reported. On an unknown date, the patients were vaccinated with 4 doses of improperly stored RECOMBIVAX HB (dose, strength and route were unknown). Concomitant medications were not reported. No adverse effects were reported. The outcome of the events was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to unknown number of patients of unknown age and gender. Current conditions and medical history were not reported. On an unknown date, the patients were vaccinated with 6 doses of improperly stored MMR II (unknown dose, strength and dose). Concomitant medications were not reported. No adverse effects were reported. The outcome of the events was unknown. No product quality complaint was involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: M
Vaccine: MMR
Symptoms: Seroconversion test negative
Clinical narrative: This spontaneous report was received from a healthcare worker and refers to approximately 60 year old male patient. No pertinent medical history or concurrent conditions were reported. On an unknown date, the patient was vaccinated with M-M-R II. Concomitant medications were not known. Antibody titre's were drawn and it was found that the patient failed to seroconvert (seroconversion test negative). Patient sought medical attention. Outcome of the event was unknown. Causality assessment was not provided. Additional information is not expected as the reporter did not wish to be contacted further.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site swelling
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a patient of unknown age and gender. No information on patient's medical history and concurrent conditions was provided. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX (dose, route, lot # and expiration date was not reported). Concomitant therapy was not provided. On an unknown date after the injection, the patient's ZOSTAVAX injection site "swelled up like a golf ball". The patient sought medical attention by speaking with the pharmacist. The outcome of the event was unknown. The relatedness between the event and the vaccination with ZOSTAVAX was not provided. Additional information has been requested.
Age: 14.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 14 year old male patient. The patient's relevant medical history and concomitant medications were not reported. On 29-APR-2015 (reported as "yesterday"), the patient was vaccinated intramuscularly with an adult dose of VAQTA (1 ml in right upper arm, lot # L001627, expiration date 11-NOV-2015), instead of the pediatric dose. No adverse effects were reported. No PQC (product quality complaint was involved. Additional information is not expected, as there was no consent for further contact.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Varicella
Clinical narrative: Information has been received from a registered nurse referring to a 9 year old male patient. There's no pertinent medical history. The drug reactions or allergies were unspecified. In 2007, the patient was vaccinated with PROQUAD (lot number, dose and route were unknown). On 16-MAR-2011 the patient was vaccinated with (Oka/Merck) VARIVAX (lot number and dose were unknown) subcutaneously. There were no concomitant medications. On 13-MAY-2015 the patient developed chicken pox. The patient sought medical attention via office visit. No treatment was given for the event. At the time of the report, the patient did not recover from the event. The relationship between th event and suspect therapies were not reported. Additional information has been requested.
Age: 26.0
Sex: M
Vaccine: TDAP
Symptoms: Musculoskeletal pain, Pain
Clinical narrative: DONOR REPORTED AT CENTER FEELING PAIN AND SORENESS TO RIGHT SHOULDER BLADE OPPOSITE OF INJECTION ARM.
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Nuclear magnetic resonance imaging brain normal, Speech disorder, Tremor
Clinical narrative: Pt received ZOSTAVAX 10/25/13. About Nov. 2013 hand started shaking. Rt side is affected. Rt leg shakes. Speech slightly impaired. Dr cannot find a cause. Pt states she is worse.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Urinary tract infection
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 68 year old female patient. On 13-MAY-2014, the patient was vaccinated with a dose of ZOSTAVAX (lot # L003217, expiration date 30-APR-2016, 0.65 ml, subcutaneously). ON 15-MAY-2014, the patient experienced urinary tract infection. The patient sought medical attention: saw unspecified physician. CIRPO was given as a treatment of the event. The outcome of urinary tract infection was unknown. Relatedness between the event and a vaccination with ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: Information has been received from a pharmacist referring to 2 patients of unknown age and gender. The patient's medical history was not reported. On an unknown date the patients were vaccinated with PNEUMOVAX23 (dose, lot# and route unknown). No concomitant medication was reported. The patients did not receive the same lot #/exp of PNEUMOVAX23. On an unknown date the patients experienced cellulitis at the injection site where PNEUMOVAX23 was administered. The outcome was unknown. The patients has sought unspecified medical attention. No product quality issue (PQC) was involved. Causality was not provided. Additional information is not expected since the reporter did not allow to follow up.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to a patient of unknown age and gender. Information about concurrent conditions and medical history was not provided. On 08-OCT-2104 the patient was vaccinated with the first dose of GARDASIL (lot#, dose and route not reported). The patient received the second dose of GARDASIL on 05-NOV-2014 (Inappropriate schedule of vaccine administered) and the third dose on 25-FEB-2015. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse (R.N.) refers to unspecified number of patients. No medical history was reported. Since 21-APR-2015, the unknown number of patients (names unspecified) have been vaccinated with ROTATEQ, orally (lot number, dose and frequency not reported) and GARDASIL intramuscularly (lot number, dose and frequency not reported. No concomitant medications were reported. The group of patients underwent supported temperature excursion (incorrect product storage) and did not experience any adverse event. The outcome of the reported events were unknown. The reporter considered the events to be not related to GARDASIL and ROTATEQ. No product quality complaint (PQC) was filed. No further information was provided. Additional information has been requested.
Age: 52.0
Sex: M
Vaccine: TDAP
Symptoms: Abdominal distension, Abdominal pain, Chromaturia, Diarrhoea, Eating disorder
Clinical narrative: This case was reported by a contact via call center representative and described the occurrence of diarrhea in a 52-year-old male patient who received BOOSTRIX (batch number 87PC3?, expiry date 12th SEPTEMBER 2016). On 27th FEBRUARY 2015 10:00, the patient received BOOSTRIX. On 27th FEBRUARY 2015, less than a day after receiving BOOSTRIX, the patient experienced fatigue, vomiting, urine color abnormal, gas pain and eating disorder. On 27th FEBRUARY 2015 11:45, the patient experienced diarrhea and abdominal cramp. On 28th FEBRUARY 2015, the outcome of the vomiting was recovered/resolved. On 1st MARCH 2015, the outcome of the diarrhea, abdominal cramp, fatigue, urine color abnormal, gas pain and eating disorder were recovered/resolved.  The reporter considered the diarrhea, abdominal cramp, fatigue, vomiting, urine color abnormal, gas pain and eating disorder to be possibly related to BOOSTRIX. Additional information received: Reporter which is a GSK employee stated that all symptoms were suspected to be related to the BOOSTRIX vaccine that her husband received. He immediately reported the symptoms to his doctor who unfortunately did not follow up.