chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse and refers to an unspecified number of patients of unknown age and gender. No information regarding the patients' pertinent medical histories, drug reactions or allergies and concomitant therapies was provided. On 28-JAN-2017, 29-JAN-2017 and 30-JAN-2017, the patients were vaccinated with improperly stored doses of PNEUMOVAX 23 lot # M036728 with expiry date of 20-MAY-2018 (dose, route and site of administration were not reported). There was no adverse effect reported. Administered doses of vaccine experienced the temperature excursion of below 32 degrees Fahrenheit (with minimum temperature of 25 degrees Fahrenheit) for 14 hours. Data logger was involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA014176.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 5 patients of unknown age and gender. On unknown dates, 4 patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L037554 exp date 25-DEC-2017) (dose and route not reported) and 1 patient was vaccinated with an improperly stored dose of GARDASIL 9 (lot # M011840 exp date 01-FEB-2018) (dose and route not reported). The temperature of excursion was 51 F for 144 hours. There was no previous temperature excursion. A data logger issue was reported. No adverse symptoms were reported.       This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments:  US-009507513-1702USA007073: US-009507513-1702USA001077:
Age: 82.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Cough, Nasopharyngitis
Clinical narrative: Initial unsolicited report received from a consumer on 06-Feb-2017. Manufacturer control number: 2016US043962. This case involves an 82-years-old male patient, who was vaccinated with a dose of INFLUENZA VACCINE (FLU SHOT) (batch number, expiry date, dose, site and route of administration were not reported) on unspecified date and a capsule of XTANDI (160 mg dose (also reported as 40 mg), frequency: once daily (batch number: 1543978PC, expiry date: 15-Dec-2016) orally for prostate cancer on 03-Aug-2016 till 15-Dec-2016. The patient's medical history and concomitant medications were not reported. On 26-Oct-2016, unspecified duration following the vaccination, and 84 days following administration of XTANDI, patient experienced cold and cough after receiving a flu shot. The patient's lab data and corrective treatment were not reported. As of 22-Dec-2016, the patient was recovering from the events. Reporter comment: Action was taken with enzalutamide treatment in response to event cough was unknown. However, treatment with enzalutamide was discontinued on 15 Dec 2016 due to an unspecified reason. Action taken with influenza vaccine was not applicable. Reporter assessed cough and cold as non-serious and causal relationship to XTANDI as possible based on the implied temporal association. List of documents held by sender: none.
Age: 82.0
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Cough, Viral upper respiratory tract infection
Clinical narrative: Initial unsolicited report received from a consumer on 06-Feb-2017. Manufacturer control number: 2016US043962. This case involves an 82-years-old male patient, who was vaccinated with a dose of INFLUENZA VACCINE (FLU SHOT) (batch number, expiry date, dose, site and route of administration were not reported) on unspecified date and a capsule of XTANDI (160 mg dose (also reported as 40 mg), frequency: once daily (batch number: 1543978PC, expiry date: 15-Dec-2016) orally for prostate cancer on 03-Aug-2016 till 15-Dec-2016. The patient's medical history and concomitant medications were not reported. On 26-Oct-2016, unspecified duration following the vaccination, and 84 days following administration of XTANDI, patient experienced cold and cough after receiving a flu shot. The patient's lab data and corrective treatment were not reported. As of 22-Dec-2016, the patient was recovering from the events. Reporter comment: Action was taken with enzalutamide treatment in response to event cough was unknown. However, treatment with enzalutamide was discontinued on 15 Dec 2016 due to an unspecified reason. Action taken with influenza vaccine was not applicable. Reporter assessed cough and cold as non-serious and causal relationship to XTANDI as possible based on the implied temporal association. List of documents held by sender: none.
Age: 0.33
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Hyporesponsive to stimuli
Clinical narrative: Patient became hypo responsive. Breathing and heart rate were normal.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Develop redness swelling and itchiness with some tenderness at the injection site.  Patient denies any fever no chills and she has full function and strength of her left arm.  No medication taken.  No shortness of breath no throat swelling no fatigue or generalized myalgia.  Patient describes symptoms as moderate. Prescribed on 2/15/17 with triamcinolone cream, hydroxyzine oral tablets and Bactrim DS x 10 days.
Age: 1.08
Sex: M
Vaccine: MMR
Symptoms: Injection site rash
Clinical narrative: Rash of injection site.
Age: 60.0
Sex: F
Vaccine: FLUC4
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: BASED ON NOTES FROM STAFF (FLOATER): LEFT SHOULDER PAIN, LIMITED RANGE OF MOTION, PAIN (LASTING? DIFFICULT TO READ NOTE FROM STAFF) FROM SHOT OVER 6 WEEKS.
Age: 20.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Injected limb mobility decreased, Injection site bruising, Injection site induration, Injection site urticaria, Injection site warmth
Clinical narrative: Location around the injection site showed urticaria, rigidity to touch, warmth and difficulty to move entire arm. Urticaria spread over the next four days, while the other symptoms remained constant. Was prescribed an antibiotic 3 times a day for 1 week on 1/25/17. Reaction site is still rigid to the touch and shows bruising (as of 2/16/17). Ability to move arm without pain was regained a week after the antibiotics were finished.
Age: 20.0
Sex: F
Vaccine: FLU3, PPV, TDAP
Symptoms: Pain
Clinical narrative: Location around the injection site showed urticaria, rigidity to touch, warmth and difficulty to move entire arm. Urticaria spread over the next four days, while the other symptoms remained constant. Was prescribed an antibiotic 3 times a day for 1 week on 1/25/17. Reaction site is still rigid to the touch and shows bruising (as of 2/16/17). Ability to move arm without pain was regained a week after the antibiotics were finished.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, TYP, VARCEL
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Mild fever, left arm swelling around injection site, soreness, redness, hot to the touch. Patient was given acetaminophen for swelling.
Age: 0.08
Sex: M
Vaccine: DTAP, HEP, MMR, PER, VARCEL
Symptoms: Crying, Eczema, Emotional distress, Hypersensitivity, Rash
Clinical narrative: RASH, ECZEMA, HIVES, CRYING, ALLERGIES, COULD NOT BE CONSOLED.
Age: 0.08
Sex: M
Vaccine: DTAP, HEP, MMR, PER, VARCEL
Symptoms: Urticaria
Clinical narrative: RASH, ECZEMA, HIVES, CRYING, ALLERGIES, COULD NOT BE CONSOLED.
Age: 0.17
Sex: U
Vaccine: RV5, RV5
Symptoms: Drug administration error, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report has been received from a licensed practical nurse referring to a 2 month old patient of unknown gender. Information regarding pertinent medical history, drug reactions, allergies and concomitant therapies was not provided. On 23-JAN-2017, the patient was vaccinated with the first dose of ROTATEQ, orally, lot# L035511 expiration date 21-MAY-2017 for prophylaxis, and then on 30-JAN-2017, the patient received the second dose of ROTATEQ, orally, lot# M025572  expiration date 20-JAN-2018 for prophylaxis due to a documentation error. No adverse experiences were reported. This is one of two reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1702USA005497:
Age: 0.17
Sex: U
Vaccine: RV5, RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report has been received from a licensed practical nurse referring to a 2 month old patient of unknown gender. Information regarding pertinent medical history, drug reactions, allergies and concomitant therapies was not provided. On 23-JAN-2017, the patient was vaccinated with the first dose of ROTATEQ, orally, lot# L035511 expiration date 21-MAY-2017 for prophylaxis, and then on 30-JAN-2017, the patient received the second dose of ROTATEQ, orally, lot# M025572  expiration date 20-JAN-2018 for prophylaxis due to a documentation error. No adverse experiences were reported. This is one of two reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1702USA005497:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician concerning an unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 01-FEB-2017 and on 02-FEB-2017, the patients were vaccinated with improperly stored doses of ROTATEQ orally (lot number M032636 and expiration date 06-APR-2018, dose was not reported) for prophylaxis. The temperature exposure was from 8 Celsius degrees to 25 Celsius degrees for 2 hours and 23 minutes. There was not previous excursions or data logger involved. No adverse effects were reported. A product quality complaint was not involved. Additional information has been requested.; Sender's Comments: US-0095075131702USA003523: Original Case : 1702USA001003 US-009507513-1702USA003522: Original Case : 1702USA001003 US-009507513-1702USA003520: Original Case : 1702USA001003 US-009507513-1702USA001003: Original Case : 1702USA001003
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of PROQUAD with lot # M009745 and expiration date on 23-AUG-2017 (anatomical route of vaccination was not provided) for prophylaxis. It was reported that, PROQUAD was exposed to a temperature of > 5 °F but < 14 °F for a 5 minutes time frame. The vaccine was not involved in a previous temperature excursion and data logger was not stated. Furthermore, it was reported that, no adverse events were suffered and that no product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA007257:
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to 7 patients of unknown age and gender. On unknown dates, 5 patients were vaccinated with improperly stored doses of PNEUMOVAX (lot # L033707 exp date 18-MAY-2017) (dose and route not reported) and 2 patients were vaccinated with improperly stored doses of  PNEUMOVAX (lot # M005287 exp date 08-OCT-2017) (dose and route not reported). The temperature of excursion was 51 F for 144 hours. There was no previous temperature excursion. A data logger issue was reported. No adverse symptoms were reported. This is one of several reports received from the same source. Additional information has been requested. Sender's Comments: US-009507513-1702USA001077: US-009507513-1702USA007072.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a physician referring to a patient of unknown age and gender. Information regarding the patient's pertinent medical history, concurrent conditions, known allergies and concomitant medications was not reported. On an unknown date, the patient was vaccinated with an improperly stored dose of VARIVAX with lot # M007287 and expiration date on 12-FEB-2018 (anatomical route of vaccination was not provided) for prophylaxis. It was reported that, VARIVAX was exposed to a temperature of > 5 °F but < 14 °F for a 5 minutes time frame. The vaccine was not involved in a previous temperature excursion and data logger was not stated. Furthermore, it was reported that, no adverse events were suffered and that no product quality issue was involved. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1702USA004768:
Sex: F
Vaccine: PNC13
Symptoms: Nasal congestion, Sneezing
Clinical narrative: This is a spontaneous report from a Pfizer-sponsored program, Pfizer First Connect. A contactable female consumer received PREVNAR 13 at single dose, on 06Feb2017, for immunisation.  Before vaccination she thought she was getting a sore throat, ears popping: symptoms that she usually had before getting a cold. Concomitant medications were not reported. The consumer was feeling a little stuffy and was sneezing since an unspecified date in Feb2017. Events outcome was unknown.
Age: 69.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Burning sensation, Immediate post-injection reaction, Injection site pain, Pain, Pain in extremity
Clinical narrative: Initial unsolicited report received from a consumer on 07-Feb-2017. This case involves a 69-year-old female patient, who was vaccinated with a dose of INFLUENZA VACCINE (flu Vaccine) via intramuscular route (Batch number: 5673JA; expiry date, dose, and dose in series were not reported) in right deltoid on 22-Sep-2016. Patient's illness at time of vaccination was reported as none. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions included multiple allergies. Concomitant medications were not reported. On 22-Sep-2016, immediately after the vaccination patient had developed arm stung and burning sensation and had pain in that arm and shoulder. The patient had been seen by primary care physician and to be seen by orthopedist on 02-Aug-2017. Laboratory investigations and corrective treatment were not reported. Patient was not recovered from the events. List of documents held by sender: none.
Age: 69.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Burning sensation, Injection site pain, Pain, Pain in extremity
Clinical narrative: Initial unsolicited report received from a consumer on 07-Feb-2017. This case involves a 69-year-old female patient, who was vaccinated with a dose of INFLUENZA VACCINE (flu Vaccine) via intramuscular route (Batch number: 5673JA; expiry date, dose, and dose in series were not reported) in right deltoid on 22-Sep-2016. Patient's illness at time of vaccination was reported as none. Patient's pre-existing physician diagnosed allergies, birth defects, medical conditions included multiple allergies. Concomitant medications were not reported. On 22-Sep-2016, immediately after the vaccination patient had developed arm stung and burning sensation and had pain in that arm and shoulder. The patient had been seen by primary care physician and to be seen by orthopedist on 02-Aug-2017. Laboratory investigations and corrective treatment were not reported. Patient was not recovered from the events. List of documents held by sender: none.
Age: 5.0
Sex: F
Vaccine: DTAP, FLU4, HEPA
Symptoms: Pruritus, Rash
Clinical narrative: Rash and itching on face.
Age: 71.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site reaction, Pain, Pyrexia
Clinical narrative: Patient received PREVNAR 13 on 02/09/17, she reported soreness for a couple of days, 4 days later injection site showed signs of redness with erythema. She also stated she had started a fever.  She had seen her physician for another reason and he  indicated she was having and injection site reaction.
Age: 32.0
Sex: M
Vaccine: HEP
Symptoms: Pain in extremity
Clinical narrative: Prolonged soreness in right arm lasting from vaccination on 11/10/2016 through the date he reported it on 01/18/2017.
Age: 17.0
Sex: F
Vaccine: FLU4, MENB
Symptoms: Injection site erythema, Vaccination site swelling
Clinical narrative: Patient had redness and swelling around vaccine site.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Blood test, Eye disorder, Nuclear magnetic resonance imaging, Ophthalmological examination, Pupil dilation procedure
Clinical narrative: Awoke in the morning and noticed a large gray colored swath across my right eye diminishing my vision by approximately 50%. I sought medical attention the following week when it did not improve.
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Ultrasound Doppler, Visual acuity reduced, Visual field tests
Clinical narrative: Awoke in the morning and noticed a large gray colored swath across my right eye diminishing my vision by approximately 50%. I sought medical attention the following week when it did not improve.
Age: 0.25
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Diarrhoea, Injection site induration, Pyrexia, Vomiting
Clinical narrative: Fever, vomiting, diarrhea, induration at injection site.
Age: 66.0
Sex: F
Vaccine: FLUC4, PNC13, TDAP, VARZOS
Symptoms: Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: On 2/10/17 patient received 4 vaccinations. ZOSTAVAX (NDC 00006-4963-41) in her right arm, PREVNAR 13 (NDC 00005-1971-02) in her left arm (upper IM), BOOSTRIX (NDC 58160-0842-52) in her right arm, and FLUZONE HD (NDC 49281-399-88) in her left arm (upper IM). All shots were given under the IMZ Standing Order Physician. Patient just came in complaining of fever, pain/soreness and redness at injection sites. I asked her if she had tried to take anything to help and she said no. I recommended her trying to take Ibuprofen or Tylenol and she stated she did not want to. I asked her if there was anything I could do for her and she said no. I then recommended she reach out to her physician. I will also be contacting her physician to let them know of the occurrence.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Erythema, Induration
Clinical narrative: Hard and red area. When inform to Dr. Dx: Cellulitis. Treatment: Cefadroxil 500 b.i.d. x 7d, hydrocortisone 0.5 oint., mupirocin ointment
Age: 41.0
Sex: F
Vaccine: HEP, HEPA, TDAP, VARCEL
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity
Clinical narrative: Pt. called office 2/15/17 stating since injection was given she is experiencing increased pain from site shooting down to elbow and now to wrist. Pt. reports she is seeing another doctor secondary to losing ROM w/left shoulder. Pt. was seen for f/u in our office on 11/3/17, and did not c/o pain or restricted ROM. Pt. seen for immigration PE, citizen of another country.
Age: 33.0
Sex: F
Vaccine: FLUX, FLUX
Symptoms: Inflammation, Joint stiffness, Musculoskeletal pain, Rotator cuff syndrome
Clinical narrative: Extreme inflammation, pain and tightness in left shoulder following flu vaccine. Symptoms worsened. Has been in physical therapy since December 2016 - on-going treatment - to stretch and strengthen shoulder muscles.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site reaction, Musculoskeletal stiffness, Periarthritis, X-ray
Clinical narrative: Patient received FLUZONE QUAD 2016-17 vaccine on 2-8-2017. The following day, she noticed stiffness and shoulder pain on the right side. She went to orthopedic doctor and was told it was frozen shoulder. Received a steroid shot from orthopedic doctor on 2/10/2017.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Mobility decreased, Sleep disorder, X-ray limb
Clinical narrative: Pt received flu vac on 12/13/16. Pt states after the injection her upper arm was sore and she couldn't sleep on it for a few days. States she didn't/couldn't move her arm/shoulder and it has continued to get worse since. Came in to see doctor on 2/13/17 to report symptoms.
Age: 1.58
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMR, PNC13, VARCEL
Symptoms: Febrile convulsion, Full blood count, Haemoglobin normal, Metabolic function test normal, Viral rash
Clinical narrative: Febrile Sz. Viral Exanthema.
Age: 1.58
Sex: F
Vaccine: DTAPHEPBIP, HIBV, MMR, PNC13, VARCEL
Symptoms: White blood cell count normal
Clinical narrative: Febrile Sz. Viral Exanthema.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Local reaction
Clinical narrative: Erythema at injection site. Local reaction, several cm (approximately 6 cm) diameter.
Age: 17.0
Sex: F
Vaccine: MENB, MNQ
Symptoms: Flushing, Hyperhidrosis, Nausea, Pain
Clinical narrative: shortly after received MENVEO and BEXSERO vaccines (Given simultaneously in different arms)-2/15/17 at 4pm. Developed  flushing, nausea, body aches, sweats. Continued until today's apt (2/16/17 at 0900).
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain
Clinical narrative: Came to the pharmacy with pain and redness in the area. Call Dr. She prescribed Cefprozil 500 bid x 8 d.
Age: 1.5
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Pyrexia, Rash
Clinical narrative: Fever of 102.7 and rash.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Injection site swelling
Clinical narrative: Swollen (R) shoulder. Resolved, no cellulitis.
Age: 13.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Injection site swelling
Clinical narrative: Swollen (R) shoulder after vaccinated. No antibiotic give.
Age: 13.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Swelling
Clinical narrative: Swollen (R) shoulder after vaccinated. No antibiotic give.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ, TDAP
Symptoms: Erythema, Injection site erythema, Injection site reaction, Skin discolouration, Vaccination complication
Clinical narrative: Localized mottled erythema, non-itching, spreading across upper chest from both deltoids (injection sites).
Age: 16.0
Sex: M
Vaccine: FLU4, MENB, MNQ
Symptoms: Hypoaesthesia, Pain, Pyrexia
Clinical narrative: Fever, body aches, generalized numbness, especially around ears, neck and torso.
Age: 76.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Pain, Pain in extremity, Pyrexia
Clinical narrative: Patient that evening developed fever greater than 100 degrees F, chills, aches. Arm was sore as well.
Age: 58.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Erythema, Injection site rash, Skin warm
Clinical narrative: Rash on (R) arm at injection site. Redness, hot to touch, red streak to inside of arm.
Age: 10.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Joint range of motion decreased, Oedema, Tenderness, Vaccination complication
Clinical narrative: Tenderness, Edema, decease in ROM, Vaccine, Related adverse effect.
Age: 11.0
Sex: M
Vaccine: HPV9, HPV9
Symptoms: Headache, Pyrexia, Vomiting
Clinical narrative: Vomited, fever, headache.
Age: 67.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Erythema, Pruritus
Clinical narrative: Redness, Bruising, Itching, Soreness, Runny Nose - still have.
Age: 67.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Contusion, Erythema, Pain, Pruritus, Rhinorrhoea
Clinical narrative: Redness, Bruising, Itching, Soreness, Runny Nose - still have.
Age: 0.17
Sex: U
Vaccine: RV5, RV5
Symptoms: Drug administration error, Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report has been received from a licensed practical nurse referring to a 2 month old patient of unknown gender. Information regarding pertinent medical history, drug reactions, allergies and concomitant therapies was not provided. On 23-JAN-2017, the patient was vaccinated with the first dose of ROTATEQ, orally, lot# L035511 expiration date 21-MAY-2017 for prophylaxis, and then on 30-JAN-2017, the patient received the second dose of ROTATEQ, orally,lot# M025572 expiration date 20-JAN-2018 for prophylaxis due to a documentation error. No adverse experiences were reported. This is one of two reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1702USA000262:
Age: 0.17
Sex: U
Vaccine: RV5, RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report has been received from a licensed practical nurse referring to a 2 month old patient of unknown gender. Information regarding pertinent medical history, drug reactions, allergies and concomitant therapies was not provided. On 23-JAN-2017, the patient was vaccinated with the first dose of ROTATEQ, orally, lot# L035511 expiration date 21-MAY-2017 for prophylaxis, and then on 30-JAN-2017, the patient received the second dose of ROTATEQ, orally,lot# M025572 expiration date 20-JAN-2018 for prophylaxis due to a documentation error. No adverse experiences were reported. This is one of two reports from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1702USA000262:
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy
Clinical narrative: This spontaneous prospective pregnancy report was received from a female patient of unknown age and refers to herself. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  The patient reported, that she was 2 weeks pregnant at the time of the report (last menstrual period (LMP) was calculated as 09-JAN-2017, with estimated delivery date of 16-OCT-2017. On 16-JAN-2017, she was vaccinated with a dose of VARIVAX (route of administration, lot# and expiration date were not provided). The patient sought medical attention by speaking to physician. The pregnancy outcome was pending. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 lot # M013636, expiration date: 15-FEB-2018, intramuscularly route per reporter (strength, dose and frequency were not reported) for prophylaxis, which was improperly stored at 32 and 36 Farenheit degrees for an unknown time. This excursion was detected due to a digital data logger, however no previous temperature excursion was reported.  No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA010177: US-009507513-1701USA013133: US-009507513-1701USA013139: US-009507513-1701USA013136: US-009507513-1701USA013137: US-009507513-1701USA013138: US-009507513-1701USA013132: US-009507513-1701USA013135:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 lot # M013636, expiration date: 15-FEB-2018, intramuscularly route per reporter (strength, dose and frequency were not reported) for prophylaxis, which was improperly stored at 32 and 36 Farenheit degrees for an unknown time. This excursion was detected due to a digital data logger, however no previous temperature excursion was reported.  No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA013139: US-009507513-1701USA013136: US-009507513-1701USA013137: US-009507513-1701USA013138: US-009507513-1701USA013133: US-009507513-1701USA013134: US-009507513-1701USA010177: US-009507513-1701USA013132:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 lot # M013636, expiration date: 15-FEB-2018, intramuscularly route per reporter (strength, dose and frequency were not reported) for prophylaxis, which was improperly stored at 32 and 36 Farenheit degrees for an unknown time. This excursion was detected due to a digital data logger, however no previous temperature excursion was reported.  No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA013138: US-009507513-1701USA013135: US-009507513-1701USA010177: US-009507513-1701USA013137: US-009507513-1701USA013132: US-009507513-1701USA013134: US-009507513-1701USA013133: US-009507513-1701USA013139.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 lot # M013636, expiration date: 15-FEB-2018, intramuscularly route per reporter (strength, dose and frequency were not reported) for prophylaxis, which was improperly stored at 32 and 36 Farenheit degrees for an unknown time. This excursion was detected due to a digital data logger, however no previous temperature excursion was reported.  No adverse effect was reported. This is one of several reports received from the same reporter.  Additional information has been requested.; Sender's Comments:  US-009507513-1701USA013133: US-009507513-1701USA013134: US-009507513-1701USA013139: US-009507513-1701USA013136: US-009507513-1701USA010177: US-009507513-1701USA013138: US-009507513-1701USA013132: US-009507513-1701USA013135:
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with GARDASIL 9 lot # M013636, expiration date: 15-FEB-2018, intramuscularly route per reporter (strength, dose and frequency were not reported) for prophylaxis, which was improperly stored at 32 and 36 Farenheit degrees for an unknown time. This excursion was detected due to a digital data logger, however no previous temperature excursion was reported.  No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1701USA013133: US-009507513-1701USA013134: US-009507513-1701USA013139: US-009507513-1701USA013136: US-009507513-1701USA013137: US-009507513-1701USA010177: US-009507513-1701USA013132: US-009507513-1701USA013135.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant referring to an unspecified number of patients of unknown age and gender. The patients' medical history, concurrent conditions, drug reactions/allergies and concomitant therapies were not reported. On an unknown date, the patient was vaccinated with ROTATEQ lot # M004726, expiration date: 19-OCT-2017, orally (strength, dose, route of administration and frequency were not reported) for prophylaxis, which was improperly stored at 32 and 36 Farenheit degrees for an unknown time. This excursion was detected due to a digital data logger, however no previous temperature excursion was reported.  No adverse effect was reported. This is one of several reports received from  the same reporter. Additional information has been requested.; Sender's Comments: US-009507513-1701USA013134: US-009507513-1701USA010177: US-009507513-1701USA013137: US-009507513-1701USA013138: US-009507513-1701USA013132: US-009507513-1701USA013135: US-009507513-1701USA013133: US-009507513-1701USA013136:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a practitioner nurse, concerning 8 patients of an unknown age and gender. There were no concurrent conditions, medical history and concomitant medications reported. On unspecified date in January 2017 (between 24-JAN-2017 and 28-JAN-2017), the patients were vaccinated with improperly stored doses of PROQUAD (dose, frequency and route not reported), lot # M031568 with expiration date of 24-DEC-2017 for prophylaxis. No adverse effects were reported. The temperature excursion of the vaccine was greater than 5 Fahrenheit degrees but less than 14 Fahrenheit degrees, for a time frame of 26 hours. No product quality complaint was involved (PQC). Data logger was involved. No further information was provided. This is one of two reports received from the same source.   Additional information has been requested.; Sender's Comments:  US-009507513-1702USA002796:
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history, concurrent conditions and concomitant therapies were not reported. On unknown dates, the patient was vaccinated with the first, second and third doses of GARDASIL for prophylaxis (dose, route, lot/batch number and expiration date were not reported). On an unknown date, the patient was vaccinated with a dose of GARDASIL 9 for prophylaxis (dose, route, lot/batch number and expiration date were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Neurological symptom
Clinical narrative: This spontaneous report has been received from a registered nurse via company representative referring to a patient of unknown age and gender. Information regarding medical history, drug reactions, allergies, concurrent conditions and concomitant therapies was not provided. On an unknown date, the patient was vaccinated with GARDASIL (route of administration, lot#, and expiration date were not reported) for prophylaxis. The reporter stated that on an unknown date, the patient could had experienced neurological side effects. At the time of reporting, the outcome of neurological side effects was unknown. The relatedness between the neurological side effects and GARDASIL, was not provided. Additional information is not expected no reporter details were provided.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant referring to an unknown number of patients of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. It was reported that on an unknown date, the patients may have received an unknown number of doses of PROQUAD strength, dose and route of administration were not provided (Lot # M034692 with expiration date of 24-JAN-2018) for prophylaxis. The doses of the vaccine were following a temperature excursion of 14-46 degrees Fahrenheit for 63 hours. No adverse effects were reported in any patients. No product quality complaint was involved. Data logger was not involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested. Sender's Comments: US-009507513-1702USA007384.
Age: 14.0
Sex: F
Vaccine: FLU3, HPV9
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from an office manager concerning a 14 year old patient of an unknown gender. The patient's concurrent conditions, medical history, historical drugs and concomitant therapies were not reported. On 21-DEC-2015, the patient was vaccinated with the first dose of GARDASIL 9 (lot number M032650, dose, route and expiration date were not reported) and on 28-DEC-2016, the patient was vaccinated with the second dose of GARDASIL 9 (lot number M032650, dose, route and expiration date were not reported) for prophylaxis. No adverse effects were reported. A product quality complaint was not involved. Additional information has been requested.
Age: 37.0
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: This spontaneous report as received from a physician refers to a 37-year-old female patient with allergy to sulfonamides (referred to as "sulfa" allergy). On 09-FEB-2017, the patient was vaccinated with M-M-R II for prophylaxis, because she had negative titers and had never received this vaccine previously. Dose, route, lot number and albumin status were not reported. The patient did not receive any concomitant therapy. On 12-FEB-2017, the patient developed an unspecified rash on both her arms, back and hips. She was seen by the physician on 13-FEB-2017, but did not have any laboratory tests done after the event onset and did not receive any treatment. The patient did not recover from the rash at the time of the reporting. The relatedness between the rash and the suspect vaccine was not provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information was received from a registered nurse, who reported that an unspecified number of patients (demographics not provided) received an improperly stored dose of VARIVAX lot number M006156, expiration date 05-FEB-2018 and lot number M033313, expiration date 13-JUL-2018, (dose number, dosage and route of administration not provided), for prophylaxis.  The outcome of the event is unknown.  No adverse effects reported. Temperature excursion reported as: Temperature: > 15°C but < -10°C; highest temperature -14°C. Time frame: 20 minutes. Previous temperature excursions reported as: -14°C for 10 minutes, -13°C for 40 minutes, -13°C for 4 hours 20 minutes, -13°C for 1 hour 40 minutes, -8°C for 3 hours 40 minutes, -9°C for 13 hours, -11°C for 63 hours. No further details provided. 17-FEB-2017: Lot #M033313 was determined to not be a valid lot number for VARIVAX. Additional information has been requested.; Sender's Comments:  US-009507513-1701USA007838:
Sex: M
Vaccine: MMR
Symptoms: Metal poisoning
Clinical narrative: This spontaneous report was received from the patient's mother concerning her son of unknown age. The patient's pertinent medical history, concurrent conditions, concomitant therapies, drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with a dose of M-M-R II (dose, route, anatomical location, lot # and expiration date were not reported) for prophylaxis. On an unknown date, the patient experienced mercury poisoning (metal poisoning). The outcome of metal poisoning was unknown at the time of the report. The casual relationship between the aforementioned event and M-M-R II was not established or mentioned by the reporter. Upon internal review, the event of metal poisoning was considered as medically significant. Additional information has been requested.
Sex: F
Vaccine: HPV9
Symptoms: Rash macular, Skin discolouration
Clinical narrative: This spontaneous report has been received from a medical assistant via company representative and refers to a 25 year old female patient. There was no information about the patient's concurrent conditions, concomitant therapies, drug reactions or allergies and medical history provided. On 30-JAN-2017, the patient was vaccinated with GARDASIL 9 injection, lot # M028323, expiration date 26-SEP-2018 (strength, dose and route of administration were not reported). On 30-JAN-2017, after the  the patient experienced blotching and discoloration on her hands off and on for fifteen minutes. The medical assistant advised the patient to take diphenhydramine hydrochloride (BENADRYL) when she got home. No product quality complaint was involved. The outcome of the events was not reported. The relatedness between the events and GARDASIL 9 was not reported. Additional information is not expected because there was no consent to contact physician.
Sex: U
Vaccine: MMR
Symptoms: Mumps
Clinical narrative: Information has been received from a physician via company representative through an online article referring to unspecified number of patients of unknown age and gender. The patients' concurrent conditions, medical histories and concomitant therapies were not reported. On unknown dates, the patients were vaccinated with doses of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (manufacturer unknown) (lot #, expiration date, dose and route were unknown) for prophylaxis. On unknown dates, the patients who had a known vaccination status caught the mumps. It reported that although getting a vaccine may not prevent illness, it probably helped those who do get sick avoid serious complications. During the pre-vaccine era, between 20% and 50% of boys would develop orchitis: swollen testicles, of those, a third would develop infertility. Only 17 boys were seen to develop orchitis in this outbreak, much fewer than in the pre-vaccination era. It was also reported that only six hospitalizations (reason unspecified) were seen and the vaccine was definitely making the illness milder than it would otherwise be. The outcome of the events was unknown. The reporter did not assess the causality. 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 registered nurse refers to a patient of unknown age and gender. On 04-JAN-2017, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot # M000442 exp date 31-MAR-2018) (dose and route not reported). The temperature of excursion was below 32 F (-12F) for 24 hours. There was no previous temperature excursion. Data logger issue was reported. No adverse experiences were reported. This is one of several reports received from the same source.  Additional information has been requested.; Sender's Comments:  US-009507513-1702USA007386:
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant referring to an unknown number of patients of unknown age. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided. It was reported that on an unknown date, the patients may have received an unknown number of doses of VARIVAX strength, dose and route of administration were not provided (Lot # M035141 with expiration date of 03-AUG-2018) for prophylaxis. The doses of the vaccine were following a temperature excursion of 14-46 degrees Fahrenheit for 63 hours. No adverse effects were reported in any patients. No product quality complaint was involved. Data logger was not involved. There were no previous excursions reported. This is one of several reports received from the same reporter. Additional information has been requested.; Sender's Comments:  US-009507513-1702USA002892:
Age: 16.0
Sex: M
Vaccine: HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 06-FEB-2017, the patient was vaccinated with an improperly stored dose of RECOMBIVAX HB (lot # M000442 exp date 31-MAR-2018) (dose and route not reported). The temperature of excursion was below 32 F (-12F) for 24 hours. There was no previous temperature excursion. Data logger issue was reported. No adverse experiences were reported. This is one of several reports received from the same source. Additional information has been requested.; Sender's Comments: US-009507513-1702USA007064:
Sex: M
Vaccine: FLUX, FLUX
Symptoms: Influenza
Clinical narrative: Initial unsolicited report received from consumer on 06 Feb 2017. The case was linked with 2017SA021390 (Same reporter). This case involves a male patient (age not reported) who was vaccinated with a dose of INFLUENZA VACCINE (FLU SHOT) (batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unknown date in "November". The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient had developed flu (a week before of this report). The patient's laboratory data and corrective treatment was not reported. The outcome of event was not reported. List of documents held by sender: none.
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Headache, Hypoaesthesia, Pain in extremity, Paraesthesia
Clinical narrative: Patient reported tingling, numbness, and pain in the arm and leg after receiving the Gardasil Vaccine. Pt was unable to identify which arm but remembers it was the side where the vaccine was given. Patient was unable to give an onset or duration but estimated that it lasted 30-40 minutes. Patient also reported a headache.
Age: 1.08
Sex: F
Vaccine: MMR
Symptoms: Rash
Clinical narrative: Rash.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Chills, Erythema, Fatigue, Feeling abnormal
Clinical narrative: That night, I initially felt I been hit by a truck. By the next day I had a 102 fever and chills (about 24 hours after shot) and pain in arm. Fever and intense chills persisted next few days, white blood count shot up to 19,000 by Friday and arm swelled (bright red) with extreme pain (from below elbow to shoulder). I could not move my arm. I continued to feel that I had been beaten up and had extreme pain in arm and head. Was hospitalized starting Thursday (went to emergency room then) and was released Sunday evening. They believed I might have had a blood infection and/or blood clot but later determined was severe adverse reaction to shot. Horrible experience and I still have some pain in my elbow.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Headache, Inappropriate schedule of drug administration, Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: That night, I initially felt I been hit by a truck. By the next day I had a 102 fever and chills (about 24 hours after shot) and pain in arm. Fever and intense chills persisted next few days, white blood count shot up to 19,000 by Friday and arm swelled (bright red) with extreme pain (from below elbow to shoulder). I could not move my arm. I continued to feel that I had been beaten up and had extreme pain in arm and head. Was hospitalized starting Thursday (went to emergency room then) and was released Sunday evening. They believed I might have had a blood infection and/or blood clot but later determined was severe adverse reaction to shot. Horrible experience and I still have some pain in my elbow.
Age: 49.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia, Vaccination complication, White blood cell count increased
Clinical narrative: That night, I initially felt I been hit by a truck. By the next day I had a 102 fever and chills (about 24 hours after shot) and pain in arm. Fever and intense chills persisted next few days, white blood count shot up to 19,000 by Friday and arm swelled (bright red) with extreme pain (from below elbow to shoulder). I could not move my arm. I continued to feel that I had been beaten up and had extreme pain in arm and head. Was hospitalized starting Thursday (went to emergency room then) and was released Sunday evening. They believed I might have had a blood infection and/or blood clot but later determined was severe adverse reaction to shot. Horrible experience and I still have some pain in my elbow.