chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: HPV4
Symptoms: Adverse event
Clinical narrative: This spontaneous report was received from the mother of a female patient (age unknown).  Medical history and concomitant medications were not provided.  The patient received two doses of GARDASIL in approximately 2011 (reported as about six years ago) by an anonymous physician for "cancers caused by human papillomavirus" (route and lot number not provided).  On an unspecified date, the pateint began to experience unspecified "health issues".  The outcome of the even was unknown. Additional information is not expected as the reporter did not provide contact information.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: HER SITE INJECTION IS RED AND SWOLLEN AND SHE CAN BARELY MOVE HER ARM.  IT HURTS ALL THE WAY UNDER HER ARMPIT.  I ADVISED HER TO TAKE SOME BENADRYL AND APPLY HYRDROCORTISONE CRM TO THE SITE.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Mobility decreased, Musculoskeletal stiffness, Neck pain
Clinical narrative: Neck stiffness, pain and decreased mobility.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: LUE erythema, warmth, swelling that began 1 hour after injection. Redness up to shoulder and over left side of chest that resolved before morning of 3/7/17. At time of visit on 3/7/17 patient presents with LUE erythema, warmth, swelling around entire prox UE, just distal to elbow and several cm inf to axilla.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Pain in extremity
Clinical narrative: Patient reports that her arm became sore immediately after injection. The soreness has not gone away ever since and she now suffers from limited arm movement and range of motion. She has sought treatment from her primary care doctor who advised her to exercise the arm. However, the effect (soreness) remains, although it has improved slightly.
Sex: M
Vaccine: MENB
Symptoms: Injection site erythema, Injection site induration, Injection site rash, Injection site swelling, Pain in extremity
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site swelling in a male patient who receive BEXSERO. On 1st March 2017, the patient received the 2nd dose of BEXSERO. In March 2017, less than a week after receiving BEXSERO, the patient experienced injection site swelling, injection site redness, injection site rash, injection site induration and pain in arm. On an unknown date, the outcome of the injection site swelling, injection site redness, injection site rash, injection site induration and pain in arm were unknown. It was unknown if the reporter considered the injection site swelling, injection site redness, injection site rash, injection site induration and pain in arm to be related to BEXSERO. Additional details were provided as follows: This case was reported by the patient's mother. The age at vaccination was not reported. The patient's mother called to report a side effect with BEXSERO. The patient's arm was swollen, red, blotchy and hard a little bit and it hurts after receiving 2nd dose of BEXSERO.
Age: 17.0
Sex: F
Vaccine: HPVX, MENB, MENB
Symptoms: Injection site pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a adolescent female patient who received HPV vaccine. On an unknown date, the patient received HPV vaccine. On an unknown date, an unknown time after receiving HPV vaccine, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to HPV vaccine. Additional details were provided as follows: The age at vaccination was not reported. School nurse reported that the patient had returned to her office for complaining. The dose of HPV vaccine was administered in her left arm. Her left arm was little sore where the patient received HPV vaccine, but negligible compared to her right arm. This case has been linked to case US2017029654, for the same patient.
Age: 17.0
Sex: F
Vaccine: HPVX, MENB, MENB
Symptoms: Injection site pain
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site pain in a 17-year-old female patient who received BEXSERO (batch number 158401, expiry date September 2017). On 23rd February 2017, the patient received the 1st dose of BEXSERO. On an unknown date, less that a week after receiving BEXSERO, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown. It was unknown if the reporter considered the injection site pain to be related to BEXSERO. Additional details were provided as follows: School nurse reported that the patient had returned to her office for complaining. The dose of BEXSERO was administered in right arm about 1 week ago from the date of reporting, and the patient experienced bad right arm pain where she received the vaccine. There was no redness, warmth, bruising or nodule on her arm to indicate why the patient might be experiencing pain. Her left arm a little sore where the patient received an HPV vaccine, but negligible compared to her right arm. This case has been linked to case US2017GSK034273 for the same. The nurse was told by her field rep to call the incident in.
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Periarthritis
Clinical narrative: Patient was diagnosed with frozen shoulder syndrome and believes that immunization was the cause.
Age: 35.0
Sex: M
Vaccine: PPV
Symptoms: Blood culture negative, Chills, Erythema, Headache, Induration
Clinical narrative: 7:00 pm-Malaise, headache, body aches. 3/9/17 AM- Denies sore throat. Arm red, swollen, hard, with unusual rash, no erythema or induration at injection site. Can't move arm well. Chills, fever (100.5F). Given acetaminophen and 1 g ceftriaxone injection in clinic. Home rx for cephalexin 500 mg BID x 7d. As of today (3/13/2017) redness/rash on arm is worse and coming in for another office visit.
Age: 35.0
Sex: M
Vaccine: PPV
Symptoms: Influenza virus test negative, Malaise, Mobility decreased, Pain, Peripheral swelling
Clinical narrative: 7:00 pm-Malaise, headache, body aches. 3/9/17 AM- Denies sore throat. Arm red, swollen, hard, with unusual rash, no erythema or induration at injection site. Can't move arm well. Chills, fever (100.5F). Given acetaminophen and 1 g ceftriaxone injection in clinic. Home rx for cephalexin 500 mg BID x 7d. As of today (3/13/2017) redness/rash on arm is worse and coming in for another office visit.
Age: 35.0
Sex: M
Vaccine: PPV
Symptoms: Pyrexia, Rash, White blood cell count increased
Clinical narrative: 7:00 pm-Malaise, headache, body aches. 3/9/17 AM- Denies sore throat. Arm red, swollen, hard, with unusual rash, no erythema or induration at injection site. Can't move arm well. Chills, fever (100.5F). Given acetaminophen and 1 g ceftriaxone injection in clinic. Home rx for cephalexin 500 mg BID x 7d. As of today (3/13/2017) redness/rash on arm is worse and coming in for another office visit.
Age: 25.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Laboratory test, Pericardial effusion, Pericarditis
Clinical narrative: Chronic pericarditis, I was told it was heartburn, for years I thought I had heartburn, until 900mL of fluid build up and I almost died. There are 4 more.
Age: 25.0
Sex: M
Vaccine: SMALL, SMALL
Symptoms: Chest discomfort, Chest pain, Pericarditis
Clinical narrative: Chronic pericarditis, I was told it was heartburn, for years I thought I had heartburn, until 900mL of fluid build up and I almost died. There are 4 more.
Age: 12.0
Sex: M
Vaccine: HPV9, MNQ, TDAP, VARCEL
Symptoms: Injection site rash, Injection site swelling, Injection site urticaria
Clinical narrative: Swelling and rash to left deltoid. Noticed rash/swelling 4 hrs after receiving vaccine. Mom describes rash as "hives" - area the size of her fist.
Age: 0.5
Sex: M
Vaccine: FLU4, HEP, HIBV, IPV, PNC13
Symptoms: Pyrexia, Rash, Vomiting
Clinical narrative: 2pm 3/8/17 Fever rash mom took child to ER.  Doc- rash fever 101 in ER given TYLENOL and BENADRYL and fever and rash disappeared. Never had an appt, vomit, Pt always playful and active F/U call 3/9/17 no rash no fever no meds.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Pt. reports fever, muscle and joint pain. Started PM after AM injection. Arm and joint pain lasted 4 days.
Age: 28.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: Redness, itching at injection site.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Cyanosis, Irritability, Pyrexia, Somnolence, Vomiting
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of irritability in a 4-year-old female patient who received KINRIX. On 24th February 2017, the patient received KINRIX (intramuscular). On 24th February 2017, less than a day after receiving KINRIX, the patient experienced irritability, fever, vomiting and sleepiness. On 26th February 2017, the patient experienced cyanosis. On an unknown date, the outcome of the irritability, cyanosis, fever, vomiting and sleepiness were recovered/resolved. The reporter considered the irritability, fever and vomiting to be probably related to KINRIX. The reporter considered the cyanosis and sleepiness to be possibly related to KINRIX. Additional details were provided as follows: The patient was the caller's daughter. The patient was usually in impeccable health. On 26th February 2016 (Sunday), 2 days after vaccination, the patient turned blue twice.
Sex: U
Vaccine: HEP
Symptoms: Seroconversion test negative
Clinical narrative: Information has been received from the author of a literature, title as stated below. This retrospective, descriptive study was to investigate the hepatitis B virus (HBV) seroconversion rate among health sciences students. The study included pharmacy, doctor of nursing, and medical students over 18 years of age enrolled at a university between 2007 and 2011. The primary end point was HBV seroconversion rates among students at the initial reporting period. Seroconversion was defined as hepatitis B surface antibody (anti-HBs) level greater than or equal to 10 mIU/mL. Multivariate regression analysis was used to determine predictive factors of seroconversion. Of 777 records, data were available for 709 students. An 83.9% seroconversion rate was observed after a mean of 10 years between vaccine receipt and anti-HBs evaluation. Students with incomplete HBV vaccine series and longer time between initial series and evaluation were less likely to exhibit antibody response. This case refers to a patient of unknown age and gender. On an unknown date, the patient was vaccinated with hepatitis b vaccine (recombinant) (manufacturer unknown) (dose, route, lot # and expiration date not reported) for prophylaxis. On an unknown date, after receiving a booster vaccination, the patient's anti-HBs value remained seronegative (nonresponder). The outcome of the event was unknown. The causality between hepatitis b vaccine (recombinant) (manufacturer unknown) and the event was related. This is one of two reports received from the same literature (Linked report MARRS # 1703USA005420). Additional information has been requested. Sender's Comments: US-009507513-1703USA005420.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a currently 1 year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX (lot # L042265, expiration date: 24-FEB-2017 or with lot# M024702, expiration date: 24-APR-2017) (dose and route of administration were not provided). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 14-46 degrees Fahrenheit for a total of 2 hours 48 minutes and 47-77 degrees Fahrenheit for 3 hours. Data logger was involved. Previous excursions were at 14-46 degrees Fahrenheit for 1 hour and 24 minutes. This is one of the two reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1703USA005729.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site vesicles
Clinical narrative: This spontaneous report was received from a 62-year-old female patient, who refers to herself. The patient concurrent conditions included penicillin allergy. The patient's historical conditions included shingles. There was no concomitant medications. On 24-FEB-2017, the patient was vaccinated with a dose of ZOSTAVAX, subcutaneously (dose, strength, anatomical location, lot number and expiration date were not reported) for prophylaxis. On 25-FEB-2017, the patient experienced a red area about size of a quarter, itching blister, patches at the injection site. Due to this events, on an unknown date, the patient applied an unspecified cortisone cream. There was no lab diagnostic studies performed. The patient did not seek medical attention. The product quality complaint was not involved. The outcome of the events was reported as not recovered. The relatedness between the events and ZOSTAVAX was not reported. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Inflammation, Injection site erythema
Clinical narrative: Redness at injection site x 7 days. Fairly vigorous 10 cm x 15 cm. No systemic symptoms. Topical steroid can help W/ inflammation.
Sex: U
Vaccine: HPV2, HPV4
Symptoms: Inappropriate schedule of drug administration, Interchange of vaccine products, No adverse event
Clinical narrative: Information was received from a registered nurse concerning an unspecified 21 year old patient (gender unknown). No information was provided regarding the patient's past medical history, concurrent conditions or concomitant medication. On 19-OCT-2009, the patient was vaccinated with a first dose of GARDASIL (reported as "GARDASIL 4") (lot number, expiration date, dosage and route of administration not provided). On 18-MAY-2010, the patient received a second dose of GARDASIL (reported as "GARDASIL 4") (lot number, expiration date, dosage and route of administration not provided). On the same day, 18-MAY-2010, the patient also received a "third dose" of CERVARIX (lot number, expiration date, dosage and route of administration not provided). No adverse effect reported. No further information was provided. Additional information has been requested.
Sex: F
Vaccine: HPVX
Symptoms: Skin papilloma
Clinical narrative: This spontaneous report was received from a healthcare worker, via company representative, regarding a female patient of unknown age. The patient's medical history, concurrent conditions, or concomitant therapies were not reported. On an unspecified date, the patient was vaccinated with a dose of an unidentified Merck HPV vaccine (name, strength, dose, lot number and expiration date were not provided) for prophylaxis. On an unknown date (reported as "after receipt of the vaccine"), the patient experienced warts that appeared on different parts of her body and had a long duration (unspecified). The patient received treatment for the event. The outcome of the event was unknown at the reporting time. The reporter did not provide a causality assessment between the event and the suspect vaccine. This is one of two reports of the same reporter. Additional information is not expected as the reporter refused additional contact. Sender's Comments: US-009507513-1703USA005722.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Lymphadenopathy
Clinical narrative: This spontaneous report as received from a physician via a company representative, refers to a 13 year old female patient. The patient's medical history and concurrent conditions were not reported. On 01-MAR-2017, the patient was vaccinated with the first dose of GARDASIL 9 (strength, dose, route of administration, anatomical location, lot number and expiration date were unknown) for prophylaxis (as Centers for disease control (CDC) recommendation). There were no concomitant therapies reported. On an unspecified date in March 2017, the patient developed swollen lymph nodes in the axillary region (lymphadenopathy). It was reported that the patient sought medical attention. The outcome of lymphadenopathy was unknown. The causality between GARDASIL 9 and the event was not provided. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Chest pain, Full blood count normal, Lymphadenopathy, Mass, Metabolic function test normal
Clinical narrative: This spontaneous report as received from a physician via a company representative, refers to a 13 year old female patient. The patient's medical history and concurrent conditions were not reported. On 01-MAR-2017, the patient was vaccinated with the first dose of GARDASIL 9 (strength, dose, route of administration, anatomical location, lot number and expiration date were unknown) for prophylaxis (as Centers for disease control (CDC) recommendation). There were no concomitant therapies reported. On an unspecified date in March 2017, the patient developed swollen lymph nodes in the axillary region (lymphadenopathy). It was reported that the patient sought medical attention. The outcome of lymphadenopathy was unknown. The causality between GARDASIL 9 and the event was not provided. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Mobility decreased, Red blood cell sedimentation rate normal, Swelling, Ultrasound chest
Clinical narrative: This spontaneous report as received from a physician via a company representative, refers to a 13 year old female patient. The patient's medical history and concurrent conditions were not reported. On 01-MAR-2017, the patient was vaccinated with the first dose of GARDASIL 9 (strength, dose, route of administration, anatomical location, lot number and expiration date were unknown) for prophylaxis (as Centers for disease control (CDC) recommendation). There were no concomitant therapies reported. On an unspecified date in March 2017, the patient developed swollen lymph nodes in the axillary region (lymphadenopathy). It was reported that the patient sought medical attention. The outcome of lymphadenopathy was unknown. The causality between GARDASIL 9 and the event was not provided. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Seroconversion test negative
Clinical narrative: Information has been received from the author of a literature. This retrospective, descriptive study was to investigate the hepatitis B virus (HBV) seroconversion rate among health sciences students. The study included pharmacy, doctor of nursing, and medical students over 18 years of age enrolled at a university between 2007 and 2011. The primary end point was HBV seroconversion rates among students at the initial reporting period. Seroconversion was defined as hepatitis B surface antibody (anti-HBs) level greater than or equal to 10 mIU/mL. Multivariate regression analysis was used to determine predictive factors of seroconversion. Of 777 records, data were available for 709 students. An 83.9% seroconversion rate was observed after a mean of 10 years between vaccine receipt and anti-HBs evaluation. Students with incomplete HBV vaccine series and longer time between initial series and evaluation were less likely to exhibit antibody response. This case refers to two patients of unknown age and gender. On unknown dates, the patients were vaccinated with hepatitis b vaccine (recombinant) (manufacturer unknown) (dose, route, lot #, expiration date not reported) for prophylaxis. On an unknown date, after receiving 3 booster vaccinations, the patients' anti-HBs value remained seronegative (nonresponders). The outcome of the event was unknown. The causality between hepatitis b vaccine (recombinant) (manufacturer unknown) and the event was related. This is one of two reports received from the same literature (Linked report MARRS # 1702USA008162). Additional information has been requested. Sender's Comments: US-009507513-1702USA008162.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a two unspecified patients of unknown age and gender. There was no information about the patients' concurrent conditions, concomitant therapies or medical history provided. On 10-MAR-2017, the patients were vaccinated with an expired dose of ZOSTAVAX 1 DS x 1 vial, lot # L046900 with an expiration date 23-FEB-2017 for prophylaxis (dose and route of administration were not reported). No side effects was reported. There was no product quality complaint involved. Additional information has been requested.
Sex: F
Vaccine: HPVX
Symptoms: Skin papilloma
Clinical narrative: This spontaneous report was received from a healthcare worker, via company representative, regarding a female patient of unknown age. The patient's medical history, concurrent conditions, or concomitant therapies were not reported. On an unspecified date, the patient was vaccinated with a dose of an unidentified Merck HPV vaccine (name, strength, dose, lot number and expiration date were not provided) for prophylaxis. On an unknown date (reported as "after receipt of the vaccine"), the patient experienced warts that appeared on different parts of her body and had a long duration (unspecified). The patient received treatment for the event and sought medical attention from dermatology for removal of a wart on her hand. The outcome of the event was unknown at the reporting time. The reporter did not provide a causality assessment between the event and the suspect vaccine. This is one of two reports from the same reporter. Additional information is not expected as the reporter refused additional contact.; Sender's Comments: US-009507513-1703USA003698:
Age: 93.0
Sex: F
Vaccine: PNC13
Symptoms: Pneumonia
Clinical narrative: This is a spontaneous report from a Contactable Pharmacist, called by a daughter on behalf of her mother. A 93-year-old female patient of an unspecified ethnicity received PREVNAR 13 via an unspecified route of administration at single dose on an unspecified date for immunisation. The patient medical history and medications were not reported. Her mother thought she may had received Prevnar 13 previously but she was uncertain about this. The patient experienced pneumonia on an unspecified date and was in the hospital at the time of reporting. The outcome of the event was unknown.
Age: 51.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Limb injury, Nuclear magnetic resonance imaging abnormal, Pain
Clinical narrative: Pain - MRI was done and shows damage to shoulder and upper arm (according to husband).
Age: 66.0
Sex: F
Vaccine: MMR
Symptoms: Dry mouth, Swelling face, Swollen tongue
Clinical narrative: Right side of tongue was swollen making it difficult to eat, drink or talk.Swelling in right side jaw, same side as injection. Dry mouth. Symptoms have subsided slightly after 10 days. Family doctor told me to go to ER if symptoms got worse.
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Injection site reaction
Clinical narrative: Injection site reaction.
Age: 0.42
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Irritability
Clinical narrative: Less than 12 hrs pt. had 2.5 x 4 cm induration, erythematous mass (R) thigh and tender. Pt. had fever and fussiness (T greater than 102) x 24-36 hrs. 2nd episode (1st time with Merck vaccine, 1st vaccine this was Sanofi Pasteur, 2nd dose with Some reaction).
Age: 0.42
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Pyrexia
Clinical narrative: Less than 12 hrs pt. had 2.5 x 4 cm induration, erythematous mass (R) thigh and tender. Pt. had fever and fussiness (T greater than 102) x 24-36 hrs. 2nd episode (1st time with Merck vaccine, 1st vaccine this was Sanofi Pasteur, 2nd dose with Some reaction).
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthma, Condition aggravated, Feeling abnormal, Injection site pruritus, Injection site reaction
Clinical narrative: Vaccine administered Sat 2/4/17, on Sunday morning injection site was itchy, patient scratched it, put ice on it. Rash similar to bulls eye and was darker red and swollen in center. About a 3 inch rash. Patient felt out of it on Monday and Tuesday. Patient has asthma and was wheezing on Monday and Tuesday as well.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Rash erythematous, Wheezing
Clinical narrative: Vaccine administered Sat 2/4/17, on Sunday morning injection site was itchy, patient scratched it, put ice on it. Rash similar to bulls eye and was darker red and swollen in center. About a 3 inch rash. Patient felt out of it on Monday and Tuesday. Patient has asthma and was wheezing on Monday and Tuesday as well.
Age: 71.0
Sex: M
Vaccine: PPV, TDAP
Symptoms: Arthralgia
Clinical narrative: Patient reports joint pain in both wrists.
Age: 26.0
Sex: M
Vaccine: FLU3
Symptoms: Deafness, Dizziness, Feeling abnormal, Feeling hot
Clinical narrative: Pt. got really hot in temp., dizzy, felt like collapsing, loss of hearing w/in 5 min. of receiving flu vaccine.
Age: 37.0
Sex: F
Vaccine: MMR, VARCEL
Symptoms: Erythema, Induration, Pain in extremity, Peripheral swelling, Tenderness
Clinical narrative: Painful, red, swelling in (R) posterior arm. Tender induration of soft tissue palpated in 3X4 inch in same region. No discharge, bleeding or signs of active infection noted. BENADRYL given and follow up appt 3/10/17. Advised cold compresses to site. LPN.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Rash erythematous, Rash pruritic, Urticaria, Vaccination site reaction, Vaccination site warmth
Clinical narrative: One week after shot was given, itchy red rash on left shoulder where vaccination was administered. Rash warm to the touch. Went to urgent care, was given MEDROL oral tablet therapy pack for six days and took BENADRYL.
Age: 13.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Head injury, Loss of consciousness
Clinical narrative: Patient sitting on exam table, TDaP, MENACTRA administered, Patient stated felt okay, HPV given patient stated felt okay and then immediately passed out.  I caught her torso but she hit her head on the wall. I assisted her to supine position and monitored her for 15 minutes. Another RN assisted me with obtaining vitals. Supine until patient no longer felt symptomatic.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Blood culture positive, Computerised tomogram thorax abnormal, Cough, Dyspnoea, Pneumococcal sepsis
Clinical narrative: Developed cough and shortness of breath. Admitted to hospital and found to have Strep pnuemo sepsis.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Pneumonia
Clinical narrative: Developed cough and shortness of breath. Admitted to hospital and found to have Strep pnuemo sepsis.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site irritation
Clinical narrative: Redness and irritation at injection site.
Age: 7.0
Sex: F
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to a patient of unknown gender and age. No information regarding the patient's concurrent conditions, medical history, or concomitant medication was provided. On 21-FEB-2017, the patient received an expired dose of PNEUMOVAX 23 injection (dose and route of administration were not provided; lot number: K021578, expiration date 25-JUN-2016) for prophylaxis. No adverse effects were reported. No product quality complaint was involved. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Altered state of consciousness, Chest pain, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: This spontaneous report was received from a nurse, the patient's mother, and refers to a 13 year old female patient. The patient's medical history included appendicitis at 4th grade and ear tubes at 1 year of age. No concurrent conditions or concomitant therapies were reported. The patient did not have any allergies. On 21-JUL-2016, the patient was vaccinated with the first dose of GARDASIL 9 injection (lot # M011117) (dose, anatomical location and expiration date were not reported) intramuscularly as recommended vaccination. Approximately on 11-AUG-2016 (reported as around three after receiving GARDASIL 9), the patient experienced dizziness and headache that lasted all day long, and on an unspecified date in August 2016 (reported as the week before 18-AUG-2016), she almost passed out in school. The patient sought medical attention with multiple unspecified specialists described as Neurologist, endocrinologist and cardiologist on unspecified dates. The first week of September 2016, the patient underwent a magnetic resonance imaging (MRI) and the result was normal. On an unspecified date, the patient was hospitalized trying to control the headaches. Since that, she experienced tremors in her hands, chest pain, palpitations, fatigue and brain fog (feeling abnormal). The reported stated that she was told that a diagnosis of Postural orthostatic tachycardia syndrome (POTS) orthostatic intolerance and possible Hashimoto's disease (Autoimmune thyroiditis) would occur. It was unknown if the patient received any treatment. The reporter stated that a follow up appointment was scheduled with an unspecified endocrinologist in 6 months (September 2017). The patient had not recovered from the events. The causality between all the events and GARDASIL 9 was not reported. Upon internal review, the event autoimmune thyroiditis was considered as medically significant. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Headache, Nuclear magnetic resonance imaging normal, Orthostatic intolerance, Palpitations, Postural orthostatic tachycardia syndrome
Clinical narrative: This spontaneous report was received from a nurse, the patient's mother, and refers to a 13 year old female patient. The patient's medical history included appendicitis at 4th grade and ear tubes at 1 year of age. No concurrent conditions or concomitant therapies were reported. The patient did not have any allergies. On 21-JUL-2016, the patient was vaccinated with the first dose of GARDASIL 9 injection (lot # M011117) (dose, anatomical location and expiration date were not reported) intramuscularly as recommended vaccination. Approximately on 11-AUG-2016 (reported as around three after receiving GARDASIL 9), the patient experienced dizziness and headache that lasted all day long, and on an unspecified date in August 2016 (reported as the week before 18-AUG-2016), she almost passed out in school. The patient sought medical attention with multiple unspecified specialists described as Neurologist, endocrinologist and cardiologist on unspecified dates. The first week of September 2016, the patient underwent a magnetic resonance imaging (MRI) and the result was normal. On an unspecified date, the patient was hospitalized trying to control the headaches. Since that, she experienced tremors in her hands, chest pain, palpitations, fatigue and brain fog (feeling abnormal). The reported stated that she was told that a diagnosis of Postural orthostatic tachycardia syndrome (POTS) orthostatic intolerance and possible Hashimoto's disease (Autoimmune thyroiditis) would occur. It was unknown if the patient received any treatment. The reporter stated that a follow up appointment was scheduled with an unspecified endocrinologist in 6 months (September 2017). The patient had not recovered from the events. The causality between all the events and GARDASIL 9 was not reported. Upon internal review, the event autoimmune thyroiditis was considered as medically significant. Additional information has been requested.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Tremor
Clinical narrative: This spontaneous report was received from a nurse, the patient's mother, and refers to a 13 year old female patient. The patient's medical history included appendicitis at 4th grade and ear tubes at 1 year of age. No concurrent conditions or concomitant therapies were reported. The patient did not have any allergies. On 21-JUL-2016, the patient was vaccinated with the first dose of GARDASIL 9 injection (lot # M011117) (dose, anatomical location and expiration date were not reported) intramuscularly as recommended vaccination. Approximately on 11-AUG-2016 (reported as around three after receiving GARDASIL 9), the patient experienced dizziness and headache that lasted all day long, and on an unspecified date in August 2016 (reported as the week before 18-AUG-2016), she almost passed out in school. The patient sought medical attention with multiple unspecified specialists described as Neurologist, endocrinologist and cardiologist on unspecified dates. The first week of September 2016, the patient underwent a magnetic resonance imaging (MRI) and the result was normal. On an unspecified date, the patient was hospitalized trying to control the headaches. Since that, she experienced tremors in her hands, chest pain, palpitations, fatigue and brain fog (feeling abnormal). The reported stated that she was told that a diagnosis of Postural orthostatic tachycardia syndrome (POTS) orthostatic intolerance and possible Hashimoto's disease (Autoimmune thyroiditis) would occur. It was unknown if the patient received any treatment. The reporter stated that a follow up appointment was scheduled with an unspecified endocrinologist in 6 months (September 2017). The patient had not recovered from the events. The causality between all the events and GARDASIL 9 was not reported. Upon internal review, the event autoimmune thyroiditis was considered as medically significant. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect route of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with a dose of M-M-R II, intramuscularly (strength, dose, anatomical location, lot number and expiration date were unknown) for prophylaxis. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse and refers to a currently 4-year-old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD (lot # M031945, expiration date: 24-APR-2017) (dose and route of administration were not provided). There was no adverse effect reported. Administered dose of vaccine experienced the temperature excursion of 14-46 degrees Fahrenheit for a total of 2 hours 48 minutes and 47-77 degrees Fahrenheit for 3 hours. Data logger was involved. Previous excursions were at 14-46 degrees Fahrenheit for 1 hour and 24 minutes. This is one of the two reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA010801:
Age: 79.0
Sex: M
Vaccine: PPV
Symptoms: Cough
Clinical narrative: Dry Cough.
Age: 80.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Respiratory tract congestion
Clinical narrative: Congestion 3/9. Fever 101F 3/11. Presently no fever.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Cellulitis, Erythema, Pain, Swelling
Clinical narrative: Red, raised, painful area. diagnosed as cellulitis. treated with doxycycline.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Chills, Injection site pain, Pain
Clinical narrative: Temperature 101.2. Very, Very sore arm around the sight. Chills. Ache all over.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Confusional state, Dizziness, Injection site erythema, Injection site swelling
Clinical narrative: Patient reported dizziness, confusion, fever, and chills for 2 days post vaccine. She also has swelling, redness, and heat of entire upper arm in which vaccine was administered.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site warmth, Pyrexia
Clinical narrative: Patient reported dizziness, confusion, fever, and chills for 2 days post vaccine. She also has swelling, redness, and heat of entire upper arm in which vaccine was administered.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Decreased appetite, Fatigue, Irritability, Listless, Malaise
Clinical narrative: He became tired, cranky, decreased appetite, listless. He acted like he was sick but had no cough, congestion, or fever.  It started suddenly, lasted 3 weeks, then went away.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a medical assistant referring to a 3 unspecified patients of unknown age and gender. The patients' pertinent medical history, drug reaction, allergies, concurrent conditions and concomitant therapies were not provided. On an unknown date, the patients were vaccinated with an improperly stored  VARIVAX with lot # M033905, expiration date 20-JUL-2018 (strength, route of administration, anatomical location, dose and frequency were not provided) for prophylaxis. The reporter stated that the temperature range of the vaccine  was >5F but <14F and the time frame was 5 days, 9 hours, 12 minutes, and also >14F but <46F for 24 minutes, also she stated that the previous temperature excursion was not involved, this information was registered in a digital data logger. No adverse effects were reported nor product quality complaint was not involved. Additional information has been requested.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient stated that the morning of 3/11/2017 she started having red area, painful and swollen. Patient still has red area around injection site (3X4cm), tender to touch and slight warmth noted. Patient has done nothing to treat area.
Age: 67.0
Sex: F
Vaccine: PNC10, VARZOS
Symptoms: Dizziness, Injection site erythema, Injection site swelling
Clinical narrative: REDNESS AND SWELLING AT SITE OF INJECTION. FELT DIZZY FOR 24 HOURS.
Age: 1.75
Sex: M
Vaccine: DTAP
Symptoms: Blood test normal, Computerised tomogram head normal, Febrile convulsion, Seizure
Clinical narrative: Seizure - lasted about 15 minutes - CEMS and Emergency report states Multiple seizures.Final Diagnosis from emergency was Febrile Seizure- Complex.
Age: 64.0
Sex: F
Vaccine: HEPA
Symptoms: Intercepted drug prescribing error
Clinical narrative: Vaccine was ordered for Hep A and it was too soon(minimum interval is 6 months) Vaccine not given.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Sleep disorder
Clinical narrative: PATIENT CALLED PHARMACY ON 03/12/2017, 3 DAYS AFTER RECEIVING THE SHOT COMPLAINING ABOUT PAIN AT SITE OF INJECTION, SWELLING, REDNESS, PATIENT COULDNT SLEEP ON THAT SIDE.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Dizziness, Nausea
Clinical narrative: After administration of HPV#1 vaccine, patient felt faint, thought she was going to vomit, had to lie down.
Age: 44.0
Sex: M
Vaccine: MNQ
Symptoms: Feeling hot, Pain, Pruritus, Rash
Clinical narrative: BOOSTER DOSE (NO REACTION TO ORIGINAL DOSE). 5 HR POST ADMIN PT DEVELOPED RASH/ITCH ON ARMS, BACK, POSTERIOR NECK (RESOLVED WITHIN 48 HR); BODY ACHE + FEBRILE SENSATION (HOWEVER (-) FEVER) DEVELOPED LATE EVENING (11 PM) POST ADMIN (@ 48 HRS SYMPTOMS SIGNIFICANTLY IMPROVED).
Age: 0.17
Sex: M
Vaccine: 6VAX-F, PNC13
Symptoms: Flatulence, Insomnia, Nasal congestion, Vomiting
Clinical narrative: Patient received HEXYON and PREVENAR 13 shots. After an afternoon with few naps, but successful feedings, at night patient couldn't sleep, had gas and would vomit after feedings. Symptoms continued until 6:30 AM 03/11/2017 at which point baby paracetamol was provided. Patient then slept 4 hours and resumed normal feeding. But had stuffy green/yellow mucus in his nose all weekend.
Age: 16.0
Sex: M
Vaccine: HEPA, HPVX, MNQ, VARCEL
Symptoms: Blood glucose increased, Glycosylated haemoglobin, Type 1 diabetes mellitus
Clinical narrative: Type 1 Diabetes. This was his diagnosis date, but I found out later he had been experiencing symptoms since the GARDASIL Vaccine.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Antibody test, Autoimmune thyroiditis, Blood thyroid stimulating hormone, Epstein-Barr virus infection, Epstein-Barr virus test
Clinical narrative: Hashimoto's Thyroiditis. No prior history. Also diagnosed with EBV.
Age: 16.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Thyroxine, Tri-iodothyronine
Clinical narrative: Hashimoto's Thyroiditis. No prior history. Also diagnosed with EBV.
Age: 12.0
Sex: F
Vaccine: HPVX
Symptoms: Autoimmune disorder, Vitiligo
Clinical narrative: Vitiligo autoimmune.
Age: 64.0
Sex: M
Vaccine: PNC13, VARZOS
Symptoms: Injection site erythema
Clinical narrative: Pt. came pharmacy to show reaction to PREVNAR 13 vaccine given 3/6/17. It appears red around the deltoid area all the way down to elbow and an large circular area. I called his MD and he prescribed 50 mg of BENADRYL x 1 dose and a MEDROL dose pack. Pt. was instructed to call his MD if not better by Wed 3/15/17 in AM.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Alanine aminotransferase normal, Anaphylactic reaction, Anion gap normal, Aspartate aminotransferase normal, Basophil count normal
Clinical narrative: Pt. had reaction to PNEUMOVAX 23 vaccine this morning and EPIPEN used and pt had some relief, breathing treatment and oxygen started at this time. Pt began having an anaphylactic reaction while in the care of my LPN and I was called in to find pt beginning to have an anaphylactic reaction to the PREVNAR 23 vaccination. He c/o shortness of breath and then a crushing chest pain. The nurse was instructed to give the patient an epinephrine IM injection and start O2 by N/C. As soon as the Epi was given, pt symptoms began to recover. He had diffuse wheezes and an albuterol aerosol treatment was additionally given. Pt with COPD baseline wheezes but he was becoming more distant and this also improved well with treatment. Upon the arrival of EMT, we advised pt to go on to ER for further evaluation and he agreed. EMS here to pick up pt. Patient transferred to local hospital for evaluation. Epinephrine 0.3 mg once, albuterol nebulizer treatment once, oxygen.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Basophil percentage, Bilirubin conjugated normal, Blood albumin normal, Blood alkaline phosphatase normal, Blood bilirubin normal
Clinical narrative: Pt. had reaction to PNEUMOVAX 23 vaccine this morning and EPIPEN used and pt had some relief, breathing treatment and oxygen started at this time. Pt began having an anaphylactic reaction while in the care of my LPN and I was called in to find pt beginning to have an anaphylactic reaction to the PREVNAR 23 vaccination. He c/o shortness of breath and then a crushing chest pain. The nurse was instructed to give the patient an epinephrine IM injection and start O2 by N/C. As soon as the Epi was given, pt symptoms began to recover. He had diffuse wheezes and an albuterol aerosol treatment was additionally given. Pt with COPD baseline wheezes but he was becoming more distant and this also improved well with treatment. Upon the arrival of EMT, we advised pt to go on to ER for further evaluation and he agreed. EMS here to pick up pt. Patient transferred to local hospital for evaluation. Epinephrine 0.3 mg once, albuterol nebulizer treatment once, oxygen.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Blood calcium normal, Blood chloride normal, Blood cholesterol normal, Blood creatinine increased, Blood glucose normal
Clinical narrative: Pt. had reaction to PNEUMOVAX 23 vaccine this morning and EPIPEN used and pt had some relief, breathing treatment and oxygen started at this time. Pt began having an anaphylactic reaction while in the care of my LPN and I was called in to find pt beginning to have an anaphylactic reaction to the PREVNAR 23 vaccination. He c/o shortness of breath and then a crushing chest pain. The nurse was instructed to give the patient an epinephrine IM injection and start O2 by N/C. As soon as the Epi was given, pt symptoms began to recover. He had diffuse wheezes and an albuterol aerosol treatment was additionally given. Pt with COPD baseline wheezes but he was becoming more distant and this also improved well with treatment. Upon the arrival of EMT, we advised pt to go on to ER for further evaluation and he agreed. EMS here to pick up pt. Patient transferred to local hospital for evaluation. Epinephrine 0.3 mg once, albuterol nebulizer treatment once, oxygen.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Blood potassium increased, Blood sodium normal, Blood thyroid stimulating hormone normal, Blood triglycerides normal, Blood urea normal
Clinical narrative: Pt. had reaction to PNEUMOVAX 23 vaccine this morning and EPIPEN used and pt had some relief, breathing treatment and oxygen started at this time. Pt began having an anaphylactic reaction while in the care of my LPN and I was called in to find pt beginning to have an anaphylactic reaction to the PREVNAR 23 vaccination. He c/o shortness of breath and then a crushing chest pain. The nurse was instructed to give the patient an epinephrine IM injection and start O2 by N/C. As soon as the Epi was given, pt symptoms began to recover. He had diffuse wheezes and an albuterol aerosol treatment was additionally given. Pt with COPD baseline wheezes but he was becoming more distant and this also improved well with treatment. Upon the arrival of EMT, we advised pt to go on to ER for further evaluation and he agreed. EMS here to pick up pt. Patient transferred to local hospital for evaluation. Epinephrine 0.3 mg once, albuterol nebulizer treatment once, oxygen.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Blood urine absent, Carbon dioxide normal, Chest pain, Chromaturia, Dyspnoea
Clinical narrative: Pt. had reaction to PNEUMOVAX 23 vaccine this morning and EPIPEN used and pt had some relief, breathing treatment and oxygen started at this time. Pt began having an anaphylactic reaction while in the care of my LPN and I was called in to find pt beginning to have an anaphylactic reaction to the PREVNAR 23 vaccination. He c/o shortness of breath and then a crushing chest pain. The nurse was instructed to give the patient an epinephrine IM injection and start O2 by N/C. As soon as the Epi was given, pt symptoms began to recover. He had diffuse wheezes and an albuterol aerosol treatment was additionally given. Pt with COPD baseline wheezes but he was becoming more distant and this also improved well with treatment. Upon the arrival of EMT, we advised pt to go on to ER for further evaluation and he agreed. EMS here to pick up pt. Patient transferred to local hospital for evaluation. Epinephrine 0.3 mg once, albuterol nebulizer treatment once, oxygen.