chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a certificated medical assistant and refers to 5 patients of unknown age and gender. The patients' pertinent medical history and drug reaction or allergies were not reported. On 29-AUG-2016, the patients were vaccinated with an improperly stored dose of ROTATEQ lot # M012495, expiration date 09-OCT-2017, route of administration defaulted to oral (dose and frequency were not reported). The patients' concomitant therapy was not reported. The administered dose of vaccine was exposed to a temperature of 12.2 degree Celsius, for 1 hour 49 minutes. There were no previous temperature excursions. Data logger was involved. No adverse effects were reported. This is one of the several reports from the same reporter. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from an office manager to unspecified number of patients of unknown age and gender. The pertinent medical history, drug reactions or allergies and concomitant therapies were not reported. On unspecified dates, the patients were vaccinated with improperly stored (temperature 33F for 90 days) doses of PNEUMOVAX 23 of lot # M006141 with expiry date 28-MAY-2017 (dose, strength, route, vaccination site unspecified). Digital data logger was not involved. There was no previous temperature excursions. No adverse effects were reported. Product quality complaint (PQC) was not involved. No additional information was provided. This is one of several reports received from the same reported. Additional information has been requested.
Sex: U
Vaccine: HPV9
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' pertinent medical history, drug reactions and allergies and concomitant medications were not reported. Between 23-AUG-2016 and 09-SEP-2016, the patients were vaccinated with improperly stored doses of GARDASIL 9 (lot # L018351, expiry date 11-AUG-2017; dose and route were not reported). The doses were exposed to temperature of 33F for 20 minutes. There was also a previous excursion 2 days prior: temperature of 33F for 20 minutes. The data logger was involved. No adverse effects were reported. Additional information has been requested.
Age: 79.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Agitation, Arthralgia, Disturbance in attention, Dizziness, Insomnia
Clinical narrative: A. High level of nausea but no vomiting. B. Fever-did not measure on day of shots but it was 99.7 the next day. C. Swollen arm. D. Very sore muscles and joints throughout body. E. Dizziness - almost fell during 1st nite.  F. Difficult to stay focused/effect is similar to chemo-brain effect that I got when I have my leukemia treatment (every 6 weeks). G. Could not sleep - restless and agitated. H. The adverse effects above were much worse than any effects I have gotten from my chemotherapy. My opinion - I would recommend that for older patients who are in treatment for some disease, the shots be administered separately over say a 2 week period. Last year I had no adverse reaction to the flu shot. Chemo at hospital is a combo of Decitabine and SGN-CD33A /a new experimental drug.
Age: 79.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Myalgia, Nausea, Peripheral swelling, Pyrexia, Restlessness
Clinical narrative: A. High level of nausea but no vomiting. B. Fever-did not measure on day of shots but it was 99.7 the next day. C. Swollen arm. D. Very sore muscles and joints throughout body. E. Dizziness - almost fell during 1st nite.  F. Difficult to stay focused/effect is similar to chemo-brain effect that I got when I have my leukemia treatment (every 6 weeks). G. Could not sleep - restless and agitated. H. The adverse effects above were much worse than any effects I have gotten from my chemotherapy. My opinion - I would recommend that for older patients who are in treatment for some disease, the shots be administered separately over say a 2 week period. Last year I had no adverse reaction to the flu shot. Chemo at hospital is a combo of Decitabine and SGN-CD33A /a new experimental drug.
Age: 14.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site reaction, Local reaction, Skin warm
Clinical narrative: Local reaction at injection site.  This happens every year.  His entire upper arm becomes very hot and remains this way for approximately four days.  There is NO respiratory/anaphylactic reaction.
Age: 44.0
Sex: M
Vaccine: FLUC4
Symptoms: Injection site joint movement impairment, Injection site swelling, Musculoskeletal stiffness
Clinical narrative: Left shoulder swelling/stiffness with limited range of motion.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Limb injury, Pain in extremity, Peripheral swelling, Pruritus, Pyrexia
Clinical narrative: Patient hit her arm Friday afternoon and realized that it still hurt. She looked at it and it was swollen, hot, and itchy. That night she developed a fever. On 9/18/16 in the morning the patient sought medical advice and started putting ice on it and applying Benadryl cream. It has improved since.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: Patient hit her arm Friday afternoon and realized that it still hurt. She looked at it and it was swollen, hot, and itchy. That night she developed a fever. On 9/18/16 in the morning the patient sought medical advice and started putting ice on it and applying Benadryl cream. It has improved since.
Age: 1.25
Sex: M
Vaccine: HIBV, MMR
Symptoms: Bacterial infection, Blood culture positive, Chest X-ray normal, Cyanosis, Febrile convulsion
Clinical narrative: Wednesday night while patient was eating he had a seizure, went blue. Dad had to perform CPR on him. Called 911. Had a fever before the seizure. Went to hospital which diagnosed him with febrile seizures. Told to f/u PCP.
Age: 1.25
Sex: M
Vaccine: HIBV, MMR
Symptoms: Pyrexia, Resuscitation, Seizure
Clinical narrative: Wednesday night while patient was eating he had a seizure, went blue. Dad had to perform CPR on him. Called 911. Had a fever before the seizure. Went to hospital which diagnosed him with febrile seizures. Told to f/u PCP.
Age: 61.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Pain
Clinical narrative: She stated she was very sore at injection site day of the injection then pain while abducting the arm. Patient states she is still having pain abducting her arm one week later.
Age: 5.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Cellulitis, Erythema, Skin warm, Swelling
Clinical narrative: Redness, warmth, swelling was noticed on 9-2-16. Came into office at 11-10 on 9-3-16. Diagnosed with cellulitis. AUGMENTIN started.
Age: 75.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: At approximately 24 hrs after administration, returned to report large erythematous area around injection site. Area was approximately 6 inches in diameter, painful and swollen. She proceeded to the E.D. for follow up and further treatment.
Age: 46.0
Sex: F
Vaccine: FLUC4
Symptoms: Induration, Pain, Pruritus, Swelling
Clinical narrative: 9/9/16 Rxn started. Sat morning swelling itchy, hard, sore, swollen.
Age: 9.0
Sex: F
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to a 9 year old female patient with no known drug allergy. The patient had no illness at time of vaccination. On 04-MAY-2016 at 15:00, the patient was vaccinated with M-M-R II lot # L026553 dose 2, subcutaneously in the left arm. The vaccine was properly stored at 53.2 F for 9 hours and 25 minutes. There were no previous temperature excursions. Digital data logger was involved. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Minor reaction. Swelling, sore, and red at injection site with bruise. Medicine expire date is 2/10/17.
Age: 9.0
Sex: M
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pain, redness, swelling at injection site. Patient received his HPV on Thursday 8/8/16, the following day woke up to pain redness, swelling. Warmth and swelling extended distally to injection site on 9/12/16. ER visit.
Age: 17.0
Sex: F
Vaccine: HEPA
Symptoms: Back pain, Cold sweat, Immunoglobulin therapy, Nausea, Neck pain
Clinical narrative: This spontaneous report was received from a Medical assistant via a company representative referring to a 17 year old female patient. The patients' medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with VAQTA 25/0.5 (lot number, expiration date, dose, frequency and route of administration were not reported). Information regarding concomitant medication was not provided. On an unknown date, the primary reporter stated that the patient experienced arm pain, back pain, and neck pain after the administration of VAQTA, it was also reported that the patient experienced body aches, nausea, fever of 104F, she was pale, and clammy, additionally on an unspecified date, she was admitted to an unspecified hospital and was given two boluses of immunoglobulin. The outcome of pain in extremity, back pain, neck pain, body aches, nausea, pyrexia, pallor and cold sweat was reported as unknown. The causality between VAQTA and the adverse events was unknown. Additional information has been requested.
Age: 17.0
Sex: F
Vaccine: HEPA
Symptoms: Pain, Pain in extremity, Pallor, Pyrexia
Clinical narrative: This spontaneous report was received from a Medical assistant via a company representative referring to a 17 year old female patient. The patients' medical history and concurrent conditions were not provided. On an unknown date, the patient was vaccinated with VAQTA 25/0.5 (lot number, expiration date, dose, frequency and route of administration were not reported). Information regarding concomitant medication was not provided. On an unknown date, the primary reporter stated that the patient experienced arm pain, back pain, and neck pain after the administration of VAQTA, it was also reported that the patient experienced body aches, nausea, fever of 104F, she was pale, and clammy, additionally on an unspecified date, she was admitted to an unspecified hospital and was given two boluses of immunoglobulin. The outcome of pain in extremity, back pain, neck pain, body aches, nausea, pyrexia, pallor and cold sweat was reported as unknown. The causality between VAQTA and the adverse events was unknown. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to 4 year old male patient with blueberries allergy. The patient had no illness at time of vaccination. Concomitant therapies included (Oka/Merck) VARIVAX and KINRIX. On 28-APR-2016 at 16:29, the patient was vaccinated with (wistar ra 27-3) M-M-R II lot # L007577 does 2, subcutaneously in the left thigh. The vaccine was properly stored at 53.2 F for 9 hours and 25 minutes. There were no previous temperature excursions. Digital data logger was involved. No adverse effect was reported. This is one of several reports received rom the same reporter. Additional information has been requested.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Hypersensitivity, Pruritus, Swelling, Urticaria
Clinical narrative: Had allergic reaction to flu vaccine including severe hives, swelling and itching.
Age: 14.0
Sex: M
Vaccine: HEPA, HPV4, MMR, MNQ, TDAP, VARCEL
Symptoms: Hyperventilation, Hypoacusis, Seizure, Syncope
Clinical narrative: After hyperventilating during injections stated could not hear well, slumped over, syncope then 45 sec convulsion. No incontinence. Woke and was fine (BP 100/50, HR 57) - has been fine.
Age: 26.0
Sex: F
Vaccine: FLUC4
Symptoms: Body temperature increased, Erythema, Injection site pain, Peripheral swelling, Skin warm
Clinical narrative: Injection burning, then next morning temp 99 degree F and right arm red swollen and hot to touch has continued.
Age: 26.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: 9/9/16 3:00 pm, 1 hour after injection swollen, red painful, warm, 3cm. Txt today with steroids , antihistamine.
Age: 67.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Contusion, Rash
Clinical narrative: Pt got PNEUMOVAX and FLUZONE is same arm, and developed a rash on entire arm that looked bruising. Got KEFLEX from doctor.
Age: 70.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Red swelling of lt. upper arm. Warm but not tender.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Aggression, Decreased appetite, Haemoglobin normal, Platelet count normal, Vitamin D decreased
Clinical narrative: Poor appetite, aggression beginning from 3-7 days after vaccines - persisting currently 9/20/16.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: White blood cell count decreased
Clinical narrative: Poor appetite, aggression beginning from 3-7 days after vaccines - persisting currently 9/20/16.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to 1 year old male patient with no known drug allergy. The patient had no illness at time of vaccination. The patient's birth weight was 9lb 1oz. Concomitant therapies included VARIVAX and hepatitis a virus vaccine (unspecified). On 03-MAY-2016 at 10:35, the patient was vaccinated with M-M-R II lot # L026553 dose 1, subcutaneously in the right thigh. The vaccine was properly stored at 53.2 F for 9 hours and 25 minutes. There were no previous temperature excursions. Digital data logger was involved. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 18.0
Sex: M
Vaccine: DT, HEP, HEPA, IPV, MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to an 18 year old male patient with autism, gout, atopic derm and no known drug allergy. The patient had no illness at time of vaccination. Concomitant therapies included hepatitis b virus vaccine (unspecified), hepatitis a virus vaccine (unspecified), poliovirus vaccine inactivated (unspecified), VARIVAX and diphtheria toxoid (+) tetanus toxoid. On 02-MAY-2016 at 12:25, the patient was vaccinated with M-M-R II lot # L026553 dose 2, subcutaneously in the left arm. The vaccine was properly stored at 53.2 F for 9 hours and 25 minutes. There were no previous temperature excursions. Digital data logger was involved. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 3.0
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Injection site infection, Injection site rash
Clinical narrative: Infection at injection site. Rash at injection site.
Age: 16.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Headache, Immediate post-injection reaction, Tinnitus
Clinical narrative: Immediately after vaccine was given on 9-6-16, patient experienced ringing in both ears. Intermittent. Patient states he had headache from hitting his head on 9/3 (prior to vaccines) but denies ringing in ears prior to vaccine, specifically HPV.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to 4 year old female patient with no known drug allergy. The patient had no illness at time of vaccination. Concomitant therapies included (Oka/Merck) VARIVAX and KINRIX. On 09-MAY-2016 at 11:59, the patient was vaccinated with (wistar ra 27-3) M-M-R II lot # L042818 dose 2, subcutaneously in the right thigh. The vaccine was properly stored at 53.2 F for 9 hours and 25 minutes. There were no previous temperature excursions. Digital data logger was involved. No adverse effect was reported. This is one of several reports received rom the same reporter. Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to 4 year old female patient with no known drug allergy. The patient had no illness at time of vaccination. The patient's birth weight was 7lb 8oz and has three siblings. Concomitant therapies included (Oka/Merck) VARIVAX and KINRIX. On 23-MAY-2016 at 16:15, the patient was vaccinated with (wistar ra 27-3) M-M-R II (rHA lot # L032044  dose 2, subcutaneously in the left thigh). The vaccine was properly stored at 53.2 F for 9 hours and 25 minutes. There were no previous temperature excursions. Digital data logger was involved. No adverse effect was reported. This is one of several reports received rom the same reporter. Additional information has been requested.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Blood test normal, Chest X-ray normal, Computerised tomogram thorax normal, Cough, Dysphonia
Clinical narrative: This is a spontaneous report from a contactable physician assistant reported for herself who was reporting on behalf of another HCP. A 74-year-old female patient received PREVNAR 13, via an unspecified route of administration on 28Jul2015 at 0.5ml single for immunization and lisinopril via an unspecified route of administration on an unspecified date till Aug2015 for hypertension. Medical history included hypertension from 2014, glaucoma at 15 years, depression from 1996, blood cholesterol increased at about 20 years, hypothyroidism at about 35 years, all ongoing and blood viscosity increased from an unknown date and unknown if ongoing. Concomitant medication included BABY ASPIRIN 81 mg, 1x/day, atorvastatin 40 mg, 1x/day, VITAMIN D3 2000 IU, 1x/day, dorzolamide hydrochloride, COSOPT 1 drop right eye twice a day, brimonidine tartrate, SIMBRINZA 1 drop left eye three times a day, ZIOPTAN 1 drop each eye at bed time, sertraline 75 mg, 1x/day and levothyroxine 125 ug, 1x/day.  The patient previously took PNEUMOVAX. The patient then received a influenza vaccine on 30Sep2015. The patient experienced pneumonia on Oct2015, primary infection site was the left lower lobe, cough on Aug2015, coughed until she vomited on an unspecified date, spiked a high fever of 103 degrees Fahrenheit on Oct2015, the physician heard the rales in her lung on an unspecified date, she had sinus and vocal cords infections on an unspecified date, she was left with gravelly voice on an unspecified date. The patient was hospitalized for pneumonia, approximately from 20Oct2015 until 23Oct2015.  The outcome of the events pneumonia and cough was recovered, the outcome of the other adverse event was unknown. Relevant Tests in Oct 2015: Chest X-ray: Negative, Blood work: Normal, Sputum culture Pneumococcus Pneumonia and Chest CAT scan of the lung in Dec 2015:  Negative. The patient took Ibuprofen 400mg tablet by mouth one dose only for the fever, then she went to the emergency room. Received IV antibiotics while hospitalized. Sender's Comments: Based on the information provided in the case, a lack of efficacy with PREVNAR 13 in this patient cannot be excluded. Further information like serotyping results is needed for a full medical assessment.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Infection, Pneumonia pneumococcal, Pyrexia, Rales, Sinusitis
Clinical narrative: This is a spontaneous report from a contactable physician assistant reported for herself who was reporting on behalf of another HCP. A 74-year-old female patient received PREVNAR 13, via an unspecified route of administration on 28Jul2015 at 0.5ml single for immunization and lisinopril via an unspecified route of administration on an unspecified date till Aug2015 for hypertension. Medical history included hypertension from 2014, glaucoma at 15 years, depression from 1996, blood cholesterol increased at about 20 years, hypothyroidism at about 35 years, all ongoing and blood viscosity increased from an unknown date and unknown if ongoing. Concomitant medication included BABY ASPIRIN 81 mg, 1x/day, atorvastatin 40 mg, 1x/day, VITAMIN D3 2000 IU, 1x/day, dorzolamide hydrochloride, COSOPT 1 drop right eye twice a day, brimonidine tartrate, SIMBRINZA 1 drop left eye three times a day, ZIOPTAN 1 drop each eye at bed time, sertraline 75 mg, 1x/day and levothyroxine 125 ug, 1x/day.  The patient previously took PNEUMOVAX. The patient then received a influenza vaccine on 30Sep2015. The patient experienced pneumonia on Oct2015, primary infection site was the left lower lobe, cough on Aug2015, coughed until she vomited on an unspecified date, spiked a high fever of 103 degrees Fahrenheit on Oct2015, the physician heard the rales in her lung on an unspecified date, she had sinus and vocal cords infections on an unspecified date, she was left with gravelly voice on an unspecified date. The patient was hospitalized for pneumonia, approximately from 20Oct2015 until 23Oct2015.  The outcome of the events pneumonia and cough was recovered, the outcome of the other adverse event was unknown. Relevant Tests in Oct 2015: Chest X-ray: Negative, Blood work: Normal, Sputum culture Pneumococcus Pneumonia and Chest CAT scan of the lung in Dec 2015:  Negative. The patient took Ibuprofen 400mg tablet by mouth one dose only for the fever, then she went to the emergency room. Received IV antibiotics while hospitalized. Sender's Comments: Based on the information provided in the case, a lack of efficacy with PREVNAR 13 in this patient cannot be excluded. Further information like serotyping results is needed for a full medical assessment.
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Sputum culture positive, Streptococcus test positive, Vocal cord disorder, Vomiting
Clinical narrative: This is a spontaneous report from a contactable physician assistant reported for herself who was reporting on behalf of another HCP. A 74-year-old female patient received PREVNAR 13, via an unspecified route of administration on 28Jul2015 at 0.5ml single for immunization and lisinopril via an unspecified route of administration on an unspecified date till Aug2015 for hypertension. Medical history included hypertension from 2014, glaucoma at 15 years, depression from 1996, blood cholesterol increased at about 20 years, hypothyroidism at about 35 years, all ongoing and blood viscosity increased from an unknown date and unknown if ongoing. Concomitant medication included BABY ASPIRIN 81 mg, 1x/day, atorvastatin 40 mg, 1x/day, VITAMIN D3 2000 IU, 1x/day, dorzolamide hydrochloride, COSOPT 1 drop right eye twice a day, brimonidine tartrate, SIMBRINZA 1 drop left eye three times a day, ZIOPTAN 1 drop each eye at bed time, sertraline 75 mg, 1x/day and levothyroxine 125 ug, 1x/day.  The patient previously took PNEUMOVAX. The patient then received a influenza vaccine on 30Sep2015. The patient experienced pneumonia on Oct2015, primary infection site was the left lower lobe, cough on Aug2015, coughed until she vomited on an unspecified date, spiked a high fever of 103 degrees Fahrenheit on Oct2015, the physician heard the rales in her lung on an unspecified date, she had sinus and vocal cords infections on an unspecified date, she was left with gravelly voice on an unspecified date. The patient was hospitalized for pneumonia, approximately from 20Oct2015 until 23Oct2015.  The outcome of the events pneumonia and cough was recovered, the outcome of the other adverse event was unknown. Relevant Tests in Oct 2015: Chest X-ray: Negative, Blood work: Normal, Sputum culture Pneumococcus Pneumonia and Chest CAT scan of the lung in Dec 2015:  Negative. The patient took Ibuprofen 400mg tablet by mouth one dose only for the fever, then she went to the emergency room. Received IV antibiotics while hospitalized. Sender's Comments: Based on the information provided in the case, a lack of efficacy with PREVNAR 13 in this patient cannot be excluded. Further information like serotyping results is needed for a full medical assessment.
Age: 7.0
Sex: F
Vaccine: DT, HEPA, IPV, MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to a 7 year old female patient with enuresis and no known drug allergy. The patient had no illness at time of vaccination. Concomitant therapies included VARIVAX, diphtheria toxoid (+) tetanus toxoid, hepatitis a virus vaccine (unspecified) and poliovirus vaccine inactivated (unspecified). On 19-APR-2016 at 10:24, the patient was vaccinated with M-M-R II lot # reported as L042818 dose 2, subcutaneously in the left thigh. The vaccine was properly stored at 53.2 F for 9 hours and 25 minutes. There were no previous temperature excursions. Digital data logger was involved. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to 1 year old female patient with no known drug allergy. The patient had no illness at time of vaccination. The patient's birth weight was 6lb 3oz . Concomitant therapies included (Oka/Merck) VARIVAX and hepatitis A (unspecified). On 22-APR-2016 at 11:56, the patient was vaccinated with (wistar ra 27-3) M-M-R II lot # reported as L042818  dose 1, subcutaneously in the left thigh. The vaccine was properly stored at 53.2 F for 9 hours and 25 minutes. There were no previous temperature excursions. Digital data logger was involved. No adverse effect was reported. This is one of several reports received rom the same reporter. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to 4 year old male patient with dermatitis atopic and no know drug allergy. The patient had no illness at time of vaccination. Concomitant therapies included (Oka/Merck) VARIVAX and KINRIX. On 23-MAY-2016 at 13:03, the patient was vaccinated with (wistar ra 27-3) M-M-R II (rHA lot # L032044  dose 2, subcutaneously in the left thigh). The vaccine was properly stored at 53.2 F for 9 hours and 25 minutes. There were no previous temperature excursions. Digital data logger was involved. No adverse effect was reported. This is one of several reports received rom the same reporter. Additional information has been requested.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to a 1 year old male patient with no known drug allergy. The patient had no illness at time of vaccination. The patient's birth weight was 7lb 2 oz. Concomitant therapies included VARIVAX and hepatitis a virus vaccine (unspecified). On 12-MAY-2016 at 12:08, the patient was vaccinated with M-M-R II lot # reported as L042818 dose 1, subcutaneously in the right arm. The vaccine was properly stored at 53.2 F for 9 hours and 25 minutes. There were no previous temperature excursions. Data digital logger was involved. No adverse effect was reported. This is one of several reports received from the sane reporter. Additional information has been requested.
Age: 55.0
Sex: M
Vaccine: FLU4
Symptoms: Malaise, Pyrexia
Clinical narrative: Fever (100.5), malaise.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injection site erythema, Injection site induration, Injection site pain, Injection site warmth
Clinical narrative: Red hot painful hard area at injection site. Right leg weakness, myalgias, malaise, chills.
Age: 52.0
Sex: F
Vaccine: PPV
Symptoms: Malaise, Muscular weakness, Myalgia
Clinical narrative: Red hot painful hard area at injection site. Right leg weakness, myalgias, malaise, chills.
Age: 0.35
Sex: M
Vaccine: DTAP, HIBV, PNC, RV5
Symptoms: Consciousness fluctuating, Crying, Cyanosis, Eye movement disorder, Hypotonia
Clinical narrative: All PM. Approx 5:30 - extremem fussiness/crying/inconsolable 6:15: head drooping to side. 6:55-7:05: turned pale white and blue, body went limp. 7:05 - 7:15: Blue tint to skin all over, listless, in/out consciousness and eyes rolling back. 7:15 Vomiting. 7:20 limpness subsided. 7:22 vomit. 7:25 color returning to skin. 7:30 normal behavior returning.
Age: 0.35
Sex: M
Vaccine: DTAP, HIBV, PNC, RV5
Symptoms: Irritability, Listless, Pallor, Posture abnormal, Vomiting
Clinical narrative: All PM. Approx 5:30 - extremem fussiness/crying/inconsolable 6:15: head drooping to side. 6:55-7:05: turned pale white and blue, body went limp. 7:05 - 7:15: Blue tint to skin all over, listless, in/out consciousness and eyes rolling back. 7:15 Vomiting. 7:20 limpness subsided. 7:22 vomit. 7:25 color returning to skin. 7:30 normal behavior returning.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Swelling
Clinical narrative: I notice some swelling during the day, when I looked at it around 6:00 PM It had swollen up the size of a baseball and there was a red 1/2 inch line under the swelling.
Age: 53.0
Sex: F
Vaccine: FLUC4
Symptoms: Vertigo
Clinical narrative: Vertigo that came on between 30-60 minutes post-injection and lasted for approximately 30 hours.
Age: 72.0
Sex: F
Vaccine: FLU3
Symptoms: Dyspnoea, Limb mass, Pruritus
Clinical narrative: Patient states she developed a large lump on arm/shoulder. It was itchy and when she went home had trouble breathing which she thinks may have been from the flu shot, but she states it was only for a short period of time.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Local reaction, Swelling
Clinical narrative: Localized reaction, redness, swelling.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Pain
Clinical narrative: Red, sore, swollen area at injection site. Body aches.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site warmth, Limb discomfort
Clinical narrative: Large, red, warm and hard area around injection site. States her arm feels "heavy".
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising
Clinical narrative: Large bruised area at site of injection. No treatment required.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Eye swelling, Rash, Rash pruritic, Skin swelling
Clinical narrative: Itchy rash on neck, bilateral eye swelling, redness below left eye, swelling on skin next to inner canthus.
Age: 70.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling, Skin tightness, Vaccination complication
Clinical narrative: Pt. had reaction to vaccine. Whole upper arm was swollen and red. Pt. complained about it being tight and painful.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to 1 year old female patient with "murmur" and no known drug allergy. The patient had no illness at time of vaccination. The patient's birth weight was 7lb 9oz. Concomitant therapies included hepatitis A (unspecified) and (Oka/Merck) VARIVAX. On 22-APR-2016 at 11:26, the patient was vaccinated with (wistar ra 27-3) M-M-R II  lot # reported as L042818 dose 1, subcutaneously in the left thigh). The vaccine was properly stored at 53.2 F for 9 hours and 25 minutes. There were no previous temperature excursions. Digital data logger was involved. No adverse effect was reported. This is one of several reports received rom the same reporter. Additional information has been requested.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: This case was reported by a nurse and described the occurrence of injection site induration in a 11-year-old female patient who received MENVEO (batch number X15099, expiry date unknown). On 9th June 2016, the patient received the 1st dose of MENVEO. On an unknown date, less than a year after receiving MENVEO, the patient experienced injection site induration and injection site redness. On an unknown date, the outcome of the injection site induration and injection site redness were recovered/resolved. It was unknown if the reporter considered the injection site induration and injection site redness to be related to MENVEO. Additional details were provided as follows: In the morning of reporting date, the sales representative called the office nurse and at this visit they discussed that there were a high number of patients with severe local reactions to the MENVEO and BEXSERO vaccines. These patients were returning to the reporter's office with very large, reddened, swollen, hardened, warm induration at the injection site and the surrounding area, many times measuring 6 inches or more from the injection site. The physician had prescribed oral antibiotics for most of these patients. The patient concerned in this case had experienced 6 to 8 mm induration and redness at injection site after MENVEO vaccination, which had lasted for 7 days. She was monitored for the events. The reporter had tried several different methods of mixing the vaccine (letting it sit, administering it immediately, etc) but none had proved effective in reducing reaction rates. The reporter requested for suggestions on how they could possibly reduce the potential for a local reactions. Also, they inquired if there had been any problems with certain lot numbers of the vaccine, so that they could compare those numbers to the vaccines which they administered to their patients. This case has been linked to 4 other cases (MENVEO vaccine), reported by the same reporter.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Cellulitis, Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: This case was reported by a nurse and described the occurrence of cellulitis of arm in a 12-year-old female patient who received MENVEO (batch number X15147, expiry date unknown). On 9th August 2016, the patient received the 1st dose of MENVEO. In August 2016, less than a month after receiving MENVEO, the patient experienced cellulitis of arm (serious criteria GSK medically significant), injection site induration and injection site redness. The patient was treated with Antibiotic. On an unknown date, the outcome of the cellulitis of arm was unknown and the outcome of the injection site induration and injection site redness were recovered/resolved. It was unknown if the reporter considered the cellulitis of arm, injection site induration and injection site redness to be related to MENVEO. Additional details were provided as follows: In the morning of reporting date, the sales representative called the office nurse and at this visit they discussed that there were a high number of patients with severe local reactions to the MENVEO and BEXSERO vaccines. These patients were returning to reporter's office with very large, reddened, swollen, hardened, warm induration at the injection site and the surrounding area, many times measuring 6 inches or more from the injection site. The physician had prescribed oral antibiotics for most of these patients. The patient concerned in this case had experienced 12 mm induration and redness at injection site (arm) after MENVEO vaccination, which had lasted for 7 days. An antibiotic was prescribed by the physician for cellulitis of arm. The reporter had tried several different methods of mixing the vaccine (letting it sit, administering it immediately, etc) but none had proved effective in reducing reaction rates. The reporter requested for suggestions on how they could possibly reduce the potential for a local reactions. Also, they inquired if there had been any problems with certain lot numbers of the vaccine, so that they could compare those numbers to the vaccines which they administered to their patients. This case has been linked to 4 other cases (MENVEO vaccine), reported by the same reporter.
Age: 12.0
Sex: F
Vaccine: MNQ
Symptoms: Cellulitis, Injection site erythema, Injection site induration
Clinical narrative: This case was reported by a nurse and described the occurrence of cellulitis of arm in a 12-year-old female patient who received MENVEO (batch number X15147, expiry date unknown). On 2nd August 2016, the patient received the 1st dose of MENVEO. In August 2016, less than a month after receiving MENVEO, the patient experienced cellulitis of arm (serious criteria GSK medically significant), injection site induration and injection site erythema. On an unknown date, the outcome of the cellulitis of arm was unknown and the outcome of the injection site induration and injection site erythema were recovered/resolved. It was unknown if the reporter considered the cellulitis of arm, injection site induration and injection site erythema to be related to MENVEO. Additional details were provided as follows: In the morning of reporting date, the sales representative called the office nurse and at this visit they discussed that there were a high number of patients with severe local reactions to the MENVEO and BEXSERO vaccines. These patients were returning to their office with very large, reddened, swollen, hardened, warm induration at the injection site and the surrounding area, many times measuring 6 inches or more from the injection site. The physician had prescribed oral antibiotics for most of these patients. The patient concerned in this case had experienced 10 mm induration and redness at injection site (arm) after MENVEO vaccination, which had lasted for 6 days. An antibiotic was prescribed by the physician for cellulitis of arm. The reporter had tried several different methods of mixing the vaccine (letting it sit, administering it immediately, etc) but none had proved effective in reducing reaction rates. The reporter requested for suggestions on how they could possibly reduce the potential for a local reactions. Also, they inquired if there had been any problems with certain lot numbers of the vaccine, so that they could compare those numbers to the vaccines which they administered to their patients. This case has been linked to 4 other cases (MENVEO vaccine), reported by the same reporter.
Age: 49.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Chest pain, Dyspepsia, Paraesthesia, Paraesthesia oral
Clinical narrative: Case PHEH2016USA023709, is an initial spontaneous report received from a pharmacist on 15 Sep 2016. This report refers to a 49 years old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with one single dose of FLUCELVAX QUADRIVALENT (batch number: 185285) at a dose of 0.5 ml, intramuscularly on 15 Sep 2016. On 15 Sep 2016, after vaccination, she complained of tingling in the left arm and tingling of the lips and also heartburn, not first time patient has received flu shot. It was stated that, effects were experienced 02 hours after getting the vaccination. Pharmacist advised to patient to go to emergency room due to chest pains. The outcome of the events was reported as unknown. The seriousness of the event heartburn was not reported and event chest pain was reported as serious. The seriousness of the events tingling in the left arm and tingling of the lips was reported as non-serious. The causality of the events was not reported.
Age: 49.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Dyspepsia, Paraesthesia, Paraesthesia oral
Clinical narrative: Case PHEH2016USA023709, is an initial spontaneous report received from a pharmacist on 15 Sep 2016. This report refers to a 49 years old female patient. Past medical history and concomitant medications were not reported. She was vaccinated with one single dose of FLUCELVAX QUADRIVALENT (batch number: 185285) at a dose of 0.5 ml, intramuscularly on 15 Sep 2016. On 15 Sep 2016, after vaccination, she complained of tingling in the left arm and tingling of the lips and also heartburn, not first time patient has received flu shot. It was stated that, effects were experienced 02 hours after getting the vaccination. Pharmacist advised to patient to go to emergency room due to chest pains. The outcome of the events was reported as unknown. The seriousness of the event heartburn was not reported and event chest pain was reported as serious. The seriousness of the events tingling in the left arm and tingling of the lips was reported as non-serious. The causality of the events was not reported.
Age: 49.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Chest pain, Dyspepsia, Paraesthesia, Paraesthesia oral
Clinical narrative: Patient received FLUCELAVAX on  9/15/16 around lunch time on the(L) deltoid. 2 hrs later she called saying she had tingling on the (L) arm, lips and heart  burn. She went to her primary doctor to make sure it was not her heart. Pt was fine the next day.
Age: 49.0
Sex: F
Vaccine: FLUC4, FLUC4
Symptoms: Dyspepsia, Paraesthesia, Paraesthesia oral
Clinical narrative: Patient received FLUCELAVAX on  9/15/16 around lunch time on the(L) deltoid. 2 hrs later she called saying she had tingling on the (L) arm, lips and heart  burn. She went to her primary doctor to make sure it was not her heart. Pt was fine the next day.
Age: 50.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Pain in extremity
Clinical narrative: Patient said arm was sore and red.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Chills, Diarrhoea, Dizziness, Hypersomnia, Inflammation
Clinical narrative: Dizzy slept for 3 days, vomiting, swelling of throat very inflamed, chills, fever and diarrhea. Throat still has lumps in it. Very tender. A week later. Have pictures of symptoms.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Pharyngeal oedema, Pyrexia, Sensation of foreign body, Tenderness, Vomiting
Clinical narrative: Dizzy slept for 3 days, vomiting, swelling of throat very inflamed, chills, fever and diarrhea. Throat still has lumps in it. Very tender. A week later. Have pictures of symptoms.
Age: 28.0
Sex: F
Vaccine: PPV
Symptoms: Cough, Full blood count, Metabolic function test, Myalgia, Pyrexia
Clinical narrative: Fever 01.6, dry cough, severe myalgia left axillae, left pectoralis, radiating into left neck.
Age: 11.0
Sex: M
Vaccine: HPV9, MNQ, TDAP
Symptoms: Rash, Rash macular
Clinical narrative: Macular rash on R arm, L arm and buttock area.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender. The patient's medical history was not reported. On 08-SEP-2016 the patient was vaccinated with an expired dose of (wistar ra 27-3) M-M-R II (route and dosage unknown; lot number reported as M001200 EXP 28-AUG-2016). Additional information has been requested.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to 4 year old female patient with no known drug allergy. The patient had no illness at time of vaccination. The patient's birth weight was 7lb 6oz and has two siblings. Concomitant therapies included VARIVAX and KINRIX. On 28-APR-2016 at 10:19, the patient was vaccinated with M-M-R II lot # reported as L042818 dose 2, subcutaneously in the left thigh. The vaccine was properly stored at 53.2 F for 9 hours and 25 minutes. There were no previous temperature excursions. Digital data logger was involved. No adverse effect was reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.17
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to 1 year old male patient with dermatitis atopic and no known drug allergy. The patient had no illness at time of vaccination. The patient's birth weight was 6lb 4oz. Concomitant therapies included (Oka/Merck) VARIVAX and hepatitis A virus (unspecified). On 10-MAY-2016 at 09:34, the patient was vaccinated with (wistar ra 27-3) M-M-R II lot # L042818  dose 1, subcutaneously in the left thigh. The vaccine was properly stored at 53.2 F for 9 hours and 25 minutes. There were no previous temperature excursions. Digital data logger was involved. No adverse effect was reported. This is one of several reports received rom the same reporter. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: MNQ
Symptoms: Injection site erythema, Injection site induration
Clinical narrative: This case was reported by a nurse and described the occurrence of injection site induration in a 12-year-old male patient who received MENVEO (batch number X15099, expiry date unknown). On 9th June 2016, the patient received the 1st dose of MENVEO. On an unknown date, less than a year after receiving MENVEO, the patient experienced injection site induration and injection site redness. On an unknown date, the outcome of the injection site induration and injection site redness were recovered/resolved. It was unknown if the reporter considered the injection site induration and injection site redness to be related to MENVEO. Additional details were provided as follows: In the morning of reporting date, the sales representative called the office nurse and at this visit they discussed that there were a high number of patients with severe local reactions to the MENVEO and BEXSERO vaccines. These patients were returning to reporter's office with very large, reddened, swollen, hardened, warm induration at the injection site and the surrounding area, many times measuring 6 inches or more from the injection site. The physician had prescribed oral antibiotics for most of these patients. The patient concerned in this case had experienced 8 mm induration and redness at injection site after MENVEO vaccination, which had lasted for 5 days. He was monitored by his parents. The reporter had tried several different methods of mixing the vaccine (letting it sit, administering it immediately, etc) but none had proved effective in reducing reaction rates. The reporter requested for suggestions on how they could possibly reduce the potential for a local reactions. Also, they inquired if there had been any problems with certain lot numbers of the vaccine, so that they could compare those numbers to the vaccines which they administered to their patients. This case has been linked to 4 other cases (MENVEO vaccine), reported by the same reporter.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to multiple unspecified patients. The patients' pertinent medical history, concomitant medication and drug allergies/reactions were not reported. On an unknown date, multiple unspecified patients were vaccinated with improperly stored PROQUAD (lot # M002055; Expiration date: 11-JUL-2017) (Dosing regimen and frequency unspecified). No adverse events were reported. No product quality complaint was filed. Additional information has been requested.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, MMR
Symptoms: Autism, Decreased appetite, Decreased eye contact, Decreased interest, Pyrexia
Clinical narrative: He began breaking out with measles-like rash, followed by fever. The doctor said this was normal to give Tylenol/Motrin. Over the next 3 months he regressed and lost all language, eye contact, interest in people, stopped eating, etc.
Age: 1.25
Sex: M
Vaccine: DTAPIPVHIB, MMR
Symptoms: Rash morbilliform, Regressive behaviour, Speech disorder developmental
Clinical narrative: He began breaking out with measles-like rash, followed by fever. The doctor said this was normal to give Tylenol/Motrin. Over the next 3 months he regressed and lost all language, eye contact, interest in people, stopped eating, etc.