chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse referring to a patient of unknown age and gender. No concurrent or medical history was reported. On 07-JUL-2015 the patient was vaccinated with an improperly stored dose of PROQUAD (Merck), dose, route, frequency and anatomical location were unknown. No adverse event was reported. Additional information has been requested.
Age: 7.0
Sex: U
Vaccine: MMR
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to a 7 year old patient. No concurrent condition or medical history was reported. On 11-DEC-2008, the patient was vaccinated with ATTENUVAX at 12 months of age. On 05-FEB-2009, the patient was vaccinated with MERUVAX. On 23-OCT-2009, the patient was vaccinated with MMR II, (0.5 ml, subcutaneous). No concomitant therapy was reported. No adverse effects were reported. The outcome of the event was unknown. No product quality issue was involved. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Exposure during pregnancy, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous prospective pregnancy report was received from a Registered Nurse via company representative regarding a female patient of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX, subcutaneous (Dose strength and lot number was unknown). No concomitant medication was reported. It was reported that the patient was pregnant (exposure during pregnancy). The last menstrual period (LMP) and estimated date of delivery (EDD) was not known. On an unknown date the patient experienced redness and swelling at injection site. No product quality complaint (PQC) was involved. Patient did not seek any medical attention. It was reported that the therapy was not reintroduced. The pregnancy outcome was unknown. The outcome of redness and swelling at injection site was reported as recovering. Causality between Redness and Swelling at injection site and ZOSTAVAX was unknown. Additional information is not expected because we cannot contact physician.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Cheilitis, Erythema, Injection site erythema, Injection site pruritus, Injection site rash
Clinical narrative: Information has been received from a pharmacist referring to a 62 year old female patient with high cholesterol. The patient was allergic to PERCOCET. On 18-JUL-2015, the patient was vaccinated with a dose of ZOSTAVAX, lot # L006381, expiration date 25-MAY-2015, 0.65 ml, subcutaneously in the left arm. Concomitant therapies included LIPITOR. On an unspecified date in July 2015 the patient experienced redness, itchy, swollen and rash around the injection site of left arm. She also experienced redness and itchiness of her lips and around her jaw line on an unknown date in July 2015. A physician had written a prescription of famciclovir 500 mg three times daily by mouth for treatment. On 20-JUL-2015 (today), the patient came in to the pharmacy to seek medical attention, and the pharmacist stated that although the patient said she had rash around the injection site, but the pharmacist just saw swelling and redness. The outcome of the events was reported as not recovered. Additional information is not expected as the physician was asked not to be contacted.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site swelling, Lip pruritus, Pruritus
Clinical narrative: Information has been received from a pharmacist referring to a 62 year old female patient with high cholesterol. The patient was allergic to PERCOCET. On 18-JUL-2015, the patient was vaccinated with a dose of ZOSTAVAX, lot # L006381, expiration date 25-MAY-2015, 0.65 ml, subcutaneously in the left arm. Concomitant therapies included LIPITOR. On an unspecified date in July 2015 the patient experienced redness, itchy, swollen and rash around the injection site of left arm. She also experienced redness and itchiness of her lips and around her jaw line on an unknown date in July 2015. A physician had written a prescription of famciclovir 500 mg three times daily by mouth for treatment. On 20-JUL-2015 (today), the patient came in to the pharmacy to seek medical attention, and the pharmacist stated that although the patient said she had rash around the injection site, but the pharmacist just saw swelling and redness. The outcome of the events was reported as not recovered. Additional information is not expected as the physician was asked not to be contacted.
Sex: U
Vaccine: HPV9
Symptoms: Extra dose administered
Clinical narrative: This spontaneous report as received from a nurse via a company representative refers to an unspecified patients (children) of unknown age and gender. There was no pertinent medical history, drug reactions/allergies and concomitant medications provided. The nurse reported that she watched a webinar (unspecified) for GARDASIL 9 at the Hospital. In the webinar, an unspecified physician stated that he vaccinated his children with three series of doses of GARDASIL (dose, route, lot #, expiration date were not reported) and then gave them a booster dose of GARDASIL 9 (dose, route, lot #, expiration date were not reported) on an unspecified dates. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 21-JUL-2015, the patient was vaccinated with a dose of M-M-R II subcutaneously which expired on 28-JUN-2015. This was supported. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to unspecified patients of unknown age and gender. The patient's pertinent medical history and drug reactions or allergies were not reported. On unknown dates in 2015 (reported as "after the first excursion reported on 19-JUN-2015"), the patients were vaccinated with improperly stored doses of GARDASIL (dose, route of administration, lot # and expiry date were not reported). No improperly stored doses of GARDASIL were administered after the second excursion reported on 16-JUL-2015. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant and refers to a patient of unknown age and gender. No pertinent medical history, drug reactions or allergies and concomitant medications were reported. On 14-JUL-2015 (reported as "today"), the patient was vaccinated with an expired dose of RECOMBIVAX HB (lot # H015537, expiration date 09-JUL-2015) for an unknown indication (dose and route of administration were not reported). No adverse effects were reported. 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 licensed practical nurse refers to unspecified patients of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. On unknown dates in 2015 (reported as "after the first excursion reported on 19-JUN-2015"), the patients were vaccinated with improperly stored doses of RECOMBIVAX HB (dose, route of administration, lot# and expiry date were not reported). No improperly stored doses of RECOMBIVAX HB were administered after the second excursion reported on 16-JUL-2015. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to unspecified patients of unknown age and gender. the patients' pertinent medical history and drug reactions or allergies were not reported. On unknown dates in 2015 (reported as "after the first excursion reported on 19-JUN-2015"), the patients were vaccinated with improperly stored doses of VAQTA (dose, route of administration, lot# and expiry date were not reported). No improperly stored doses of VAQTA were administered after the second excursion reported on 16-JUL-2015. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to unspecified patients of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. On unknown dates in 2015 (reported as "after the first excursion reported on 19-JUN-2015"), the patients were vaccinated with improperly stored doses of (Oka/Merck) VARIVAX (dose, route of administration, lot# and expiry date were not reported). No improperly stored doses of (Oka/Merck) VARIVAX were administered after the second excursion reported on 16-JUL-2015. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.3
Sex: F
Vaccine: DTAP, HEPA, HIBV
Symptoms: Musculoskeletal stiffness, Staring, Unresponsive to stimuli
Clinical narrative: Staring episodes for few seconds to 5 minutes. Unresponsiveness during these episodes. One episode with lower extremity stiffening.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Immediate post-injection reaction, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Severe pain upon injection.  Over next 2 days - Development of 5 inch swollen area at injection site, hot to touch and painful (pt rates 6 on pain scale).
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Immediate post-injection reaction, Injection site discomfort, Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Severe pain upon injection.  Over next 2 days - Development of 5 inch swollen area at injection site, hot to touch and painful (pt rates 6 on pain scale).
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling, Malaise, Nausea
Clinical narrative: Severe pain upon injection.  Over next 2 days - Development of 5 inch swollen area at injection site, hot to touch and painful (pt rates 6 on pain scale).
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to unspecified patients of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. On unknown dates in 2015 (reported as "after the first excursion reported on 19-JUN-2015), the patients were vaccinated with improperly stored doses of oral, ROTATEQ (dose, route of administration, lot# and expiry date were not reported). No improperly stored doses of oral, ROTATEQ were administered after the second excursion reported on 16-JUL-2015. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. No medical history, concurrent conditions and concomitant therapies were reported. On 20-JUL-2015, the patient was administered an improperly stored dose of ZOSTAVA (lot #, expiration date, dose, route of administration and anatomical location were not reported). No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to unspecified patients of unknown age and gender. The patients' pertinent medical history and drug reactions or allergies were not reported. On unknown dates in 2015 (reported as "after the first excursion reported on 19-JUN-2015"), the patients were vaccinated with improperly stored doses of MMR II (dose, route of administration, lot#, albumin status and expiry date were not reported). No improperly stored doses of MMR II were administered after the second excursion reported on 16-JUL-2015. No adverse symptoms were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 67.0
Sex: U
Vaccine: PNC13
Symptoms: Immune thrombocytopenic purpura, Petechiae, Platelet count decreased, Rash, Thrombocytopenia
Clinical narrative: 7-16-15 Reported by phone to PCP office. Patient took to get checked. 7-16-15. Seen at urgent care-rash lower extremities that is spreading to her arm in the last 24 hr. Platelet count low at 8 cm. Rx prednisone-tapered dose. 7-16-15. Seen at medical center dx: Thrombocytopenia petechiae, idiopathic, thrombocytopenia purpura. CBC-at 10:15-pletelets low - 18 cm. Discharged. 7-17-15 CBC-platelets 52.
Age: 67.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Local reaction, Malaise
Clinical narrative: Severe local reaction & chills & malaise no treatment.
Age: 61.0
Sex: F
Vaccine: PNC13, VARZOS, PNC13, VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: PREVNAR 13 given SQ in right arm. Area initially was bruised per right lateral arm. Injection painful. within approx 3 hours, site became red, firm, swollen of approx 4 cm area. Cool pack applied intermittently and Ibuprofen taken q 6 hours x 4days.
Age: 61.0
Sex: F
Vaccine: PNC13, VARZOS, PNC13, VARZOS
Symptoms: Incorrect route of drug administration, Injection site erythema, Vaccination site nodule, Vaccination site pain
Clinical narrative: PREVNAR 13 given SQ in right arm. Area initially was bruised per right lateral arm. Injection painful. within approx 3 hours, site became red, firm, swollen of approx 4 cm area. Cool pack applied intermittently and Ibuprofen taken q 6 hours x 4days.
Age: 61.0
Sex: F
Vaccine: PNC13, VARZOS, PNC13, VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Patient was seen for wellness exam, vaccinations were being updated. The patient received the PREVANR vaccine SQ instead of the correct IM route. The next day the patient called to report PREVNAR vaccine site sore, red and a "knot" at that point discovered vaccine given incorrect route. Provider advised patient in symptom management. Monitor for any further reaction. 7 days for soreness to resolve.
Age: 61.0
Sex: F
Vaccine: PNC13, VARZOS, PNC13, VARZOS
Symptoms: Incorrect route of drug administration, Injection site erythema, Vaccination site nodule, Vaccination site pain
Clinical narrative: Patient was seen for wellness exam, vaccinations were being updated. The patient received the PREVANR vaccine SQ instead of the correct IM route. The next day the patient called to report PREVNAR vaccine site sore, red and a "knot" at that point discovered vaccine given incorrect route. Provider advised patient in symptom management. Monitor for any further reaction. 7 days for soreness to resolve.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Chest pain, Dyspnoea, Myalgia
Clinical narrative: Severe trouble breathing. Muscle pain all over the body. Chest pain.
Age: 84.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Pain
Clinical narrative: (L) deltoid red, hot and swollen after PCV13 vaccine. Also c/o body aches.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Chest discomfort, Chills, Cough, Flushing, Pyrexia
Clinical narrative: Patient noted she had a dry wheezy cough shortly after vaccine administered. Fever/ chills, flushing to face, tightness in chest (denied chest pain).  Patient took Aspirin, stayed hydrated, and got reassessed at clinic day after.
Age: 66.0
Sex: F
Vaccine: TDAP
Symptoms: Wheezing
Clinical narrative: Patient noted she had a dry wheezy cough shortly after vaccine administered. Fever/ chills, flushing to face, tightness in chest (denied chest pain).  Patient took Aspirin, stayed hydrated, and got reassessed at clinic day after.
Age: 90.0
Sex: F
Vaccine: PNC13
Symptoms: Loss of consciousness
Clinical narrative: Patient was fine within 20 minutes of vaccination. She reported doing some other errands following her vaccine, then once home, approximately 1 hour later, she said she blacked out briefly.
Age: 17.0
Sex: M
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: This spontaneous report as received from a pediatric center via other company refers to a 17 year old male patient. On an unknown date, the patient was vaccinated with GARDASIL 9 (dose, route of administration, lot# and expiry date were not reported). On the date of administration of the vaccine, the patient was not within the indicated age range. Additional information has been requested.
Age: 49.0
Sex: M
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: Soreness began night of injection. Localized on (L) deltoid. Patient not sure when redness began but noted a lump formed on injection site on 7/21/15. No fever, chills, sweats.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. There were no concomitant medications, concurrent conditions and medical history reported. On an unknown date, the patient was vaccinated with VARIVAX (Merck) (dose, lot number and expiration date were not reported). The patient received a dose of VARIVAX (Merck) that was stored improperly. There was no adverse effects reported. Additional information has been requested.
Age: 1.0
Sex: U
Vaccine: PPV
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to an 1 year old patient of unknown gender. No concurrent condition, medical history or allergy/drug reactions were reported. On 09-JUL-2015, the patient was vaccinated with PNEUMOVAX23 injection (dose, strength and lot number or batch number unspecified) intramuscular, in error. No concomitant medications were reported. No known adverse effects were reported. The outcome of the event was unknown. There were no product quality complaints (PQC) involved. No further information was provided. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site irritation
Clinical narrative: Local site irritation reaction.
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Angioplasty, Chest pain, Chills, Clot retraction, Cough
Clinical narrative: Immediate: intense pain spread in arm. First Week: chills & aches, swollen tongue & throat, can't breathe deep, cough, chest pain. 2nd & 3rd Weeks: gradually worse. 19th night: heart attack, to ER in time, angioplasty, remove clot, stent, intensive care. Following Month: very gradual improvement (not all gone).
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Dyspnoea, Immediate post-injection reaction, Intensive care, Laboratory test, Myocardial infarction
Clinical narrative: Immediate: intense pain spread in arm. First Week: chills & aches, swollen tongue & throat, can't breathe deep, cough, chest pain. 2nd & 3rd Weeks: gradually worse. 19th night: heart attack, to ER in time, angioplasty, remove clot, stent, intensive care. Following Month: very gradual improvement (not all gone).
Age: 80.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Pain in extremity, Pharyngeal oedema, Stent placement, Swollen tongue
Clinical narrative: Immediate: intense pain spread in arm. First Week: chills & aches, swollen tongue & throat, can't breathe deep, cough, chest pain. 2nd & 3rd Weeks: gradually worse. 19th night: heart attack, to ER in time, angioplasty, remove clot, stent, intensive care. Following Month: very gradual improvement (not all gone).
Age: 74.0
Sex: F
Vaccine: PNC13
Symptoms: Cellulitis, Rash erythematous
Clinical narrative: Night received vaccine started developing red spots arm, which Dr diagnosed as cellulitis on 7/26/15. Received cephalexin for cellulitis.
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Activities of daily living impaired, Erythema, Feeling abnormal, Pain, Peripheral swelling
Clinical narrative: Itching, rash=legs, stomach, arms, swelling calfs, redness. Pain. I had no temperature. I used over the counter "NATUREPLEX" hydrocortisone 1% lotion for itch, helped, but as of 05/18/2015 still itching calfs of legs. Feel bad, unable to function normal.
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Pruritus, Rash
Clinical narrative: Itching, rash=legs, stomach, arms, swelling calfs, redness. Pain. I had no temperature. I used over the counter "NATUREPLEX" hydrocortisone 1% lotion for itch, helped, but as of 05/18/2015 still itching calfs of legs. Feel bad, unable to function normal.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Hypersensitivity, Injection site erythema, Injection site nodule, Injection site warmth
Clinical narrative: Imm given 6/26/15 at 9:00 AM. Mom states (L) arm had a "little red dot". 6/28/15 mom states child "ran into something" and the area became very red and warm and had a "huge knot". Took to ER was told it was allergic reaction to vaccine.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Blood test normal, Chest X-ray normal, Chills, Dysphagia, Dyspnoea
Clinical narrative: Patient experienced tightening of throat, blood shot, watery eyes (looked like they were bleeding). Severe chills, fever, hard time swallowing, S.O.B. Started about 1 1/2 hrs after injection. Treatment: Diphenhydramine 50mg Q 4hrs x 24 hrs.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Lacrimation increased, Ocular hyperaemia, Pyrexia, Throat tightness
Clinical narrative: Patient experienced tightening of throat, blood shot, watery eyes (looked like they were bleeding). Severe chills, fever, hard time swallowing, S.O.B. Started about 1 1/2 hrs after injection. Treatment: Diphenhydramine 50mg Q 4hrs x 24 hrs.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Blood thyroid stimulating hormone, Chest X-ray, Cough, Differential white blood cell count, Dizziness
Clinical narrative: 7-7-15 5:PM flu symptoms-fatigue all night. 7-8-15 10:45 AM almost fainted-legs trembling-fast heartbeat-dizziness, swelling of throat. Went to the urgent care-TSH test-Chem 8-Troponin single Biosite, CBC w/ auto differential-Strep-A screen- Chest X-ray. 7-9-15 4:PM the arm where I got the injection is swollen-lots of pain, getting hives and rash-running nose-little bit of cough.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Fatigue, Full blood count, Heart rate increased, Influenza, Laboratory test
Clinical narrative: 7-7-15 5:PM flu symptoms-fatigue all night. 7-8-15 10:45 AM almost fainted-legs trembling-fast heartbeat-dizziness, swelling of throat. Went to the urgent care-TSH test-Chem 8-Troponin single Biosite, CBC w/ auto differential-Strep-A screen- Chest X-ray. 7-9-15 4:PM the arm where I got the injection is swollen-lots of pain, getting hives and rash-running nose-little bit of cough.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Metabolic function test, Pain, Peripheral swelling, Pharyngeal oedema, Rash
Clinical narrative: 7-7-15 5:PM flu symptoms-fatigue all night. 7-8-15 10:45 AM almost fainted-legs trembling-fast heartbeat-dizziness, swelling of throat. Went to the urgent care-TSH test-Chem 8-Troponin single Biosite, CBC w/ auto differential-Strep-A screen- Chest X-ray. 7-9-15 4:PM the arm where I got the injection is swollen-lots of pain, getting hives and rash-running nose-little bit of cough.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Rhinorrhoea, Streptococcus test, Tremor, Troponin, Urticaria
Clinical narrative: 7-7-15 5:PM flu symptoms-fatigue all night. 7-8-15 10:45 AM almost fainted-legs trembling-fast heartbeat-dizziness, swelling of throat. Went to the urgent care-TSH test-Chem 8-Troponin single Biosite, CBC w/ auto differential-Strep-A screen- Chest X-ray. 7-9-15 4:PM the arm where I got the injection is swollen-lots of pain, getting hives and rash-running nose-little bit of cough.
Age: 18.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to an 18 year old patient of unknown gender. Patient's medical history and concurrent conditions were not reported. On 11-MAY-2015, the patient was vaccinated with a dose of improperly stored VARIVAX (Merck) lot number K021487 (dose and route were not reported) and a dose of improperly stored M-M-R II lot number K015374 (dose and route were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: PNC13
Symptoms: Cellulitis, Erythema
Clinical narrative: This is a spontaneous report from a physician through a Pfizer sales representative. A patient of unspecified age, gender and ethnicity received on unknown date PREVNAR 13 at single via an unspecified route of administration. Relevant medical history and concomitant medications were not reported. The patient experienced acute cellulitis and redness. It was red from elbow to shoulder for 10 days and doctor treated the patient with antibiotics. The outcome of the events was reported as unknown.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report has been received from a Registered Nurse referring to a patient of unknown gender and age. No concurrent or medical history were reported. On 18-MAY-2015 the patient was vaccinated with VARIVAX (dose, route and frequency unknown, Lot number reported as J013278 - expiration date 30-Oct-2015 (the lot number was not valid for VARIVAX). The nurse reported that the VARIVAX was improperly stored. No adverse event was reported. No further information was provided. This is one of several cases received from the same source (#MARRS 1506USA012333, 1504USA005104, 150USA020362). Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker concerning multiple patients of unknown demographics. On unknown dates, multiple different unspecified patients received a dose of M-M-R II that was improperly stored. No adverse effects reported. No product quality complaint was involved. The case is also related to 1506USA002056, 1507USA010861 and 1507USA010859 (same reporter link). Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report has been received from a physician via a company representative, concerning a 16 year old female patient. None concurrent conditions or pertinent medical history and drug reactions/allergies were reported. It was stated that the patient was not pregnant. On 20-JUN-2014, the patient was vaccinated with the first dose of GARDASIL (lot # J013324, exp. date on 12-FEB-2016), intramuscular injection, (strength and dose not provided). There was no concomitant medication reported. On the same date, after receiving GARDASIL, the patient experienced pain in her arm and that pain traveled all the way up her arm. The patient did not seek medical attention, therefore, there was no treatment given for the event and none laboratories diagnostics were performed. At the reporting time, the patient still was experiencing pain occasionally in her arm over a year later. The causal relationship of pain in the patient's arm to GARDASIL was not reported. The reporter physician stated that he was not who administered the GARDASIL, it was administered by a physician who is currently retired. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to five unspecified patients of unknown age and gender. No pertinent medical history was reported. On an unknown date, the patients were vaccinated with improperly stored GARDASIL inj (lot # K004205 expiration date 12-JAN-2017 and lot# K006960 expiration date 19-FEB-2017) (dose and route were not reported). No adverse effects reported. No Product Quality Complaint (PQC) was involved. Additional information has been requested.
Age: 0.51
Sex: M
Vaccine: DTAPHEPBIP, PNC13, RV5
Symptoms: Pyrexia, Screaming
Clinical narrative: Fever of 103.2. Screaming for 3 hours.
Age: 4.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 year old patient of unknown gender. Patient's medical history and concurrent conditions were not reported. On 15-MAY-2015, the patient was vaccinated with a dose of improperly stored (Oka/Merck) VARIVAX lot number K010441 (dose and route were not reported) and a dose of improperly stored MMR II lot number reported as 002528 (dose and route were not reported). No adverse effects were reported. This is the one of the several reports from the same reporter source. Lot number 002528 is an invalid lot number for stored MMR II. Additional information has been requested.
Age: 20.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza, Pyrexia
Clinical narrative: This medically confirmed spontaneous report (initial receipt 08-Jan-2015) concerns a 20 year-old male patient who received the flu shot (non-CSL product) in the past without any issues. The patient did not take any concomitant medications, and had no history of febrile reactions to any vaccines, including previous flu shots. He did not receive other recent immunisations.  On 07-Jan-2015, in the evening, the patient received intramuscular AFLURIA (batch number 09949221A) 0.5mL annually. This was the first time he received AFLURIA. On 08-Jan-2015, in the morning, the patient reported that he experienced 102 degrees Fahrenheit (oral) after the AFLURIA administration. The patient believed that AFLURIA caused his fever and that he now has the flu. The patient will see his physician later on 08-Jan-2015 for further assessment. The outcome was reported as unknown. Reporter's comments: The reporter counseled the patient on flu incubation periods and antibody responses, reported that the fever was related to the AFLURIA, and reported that the patient could have received H1N1 vaccine at another pharmacy (there were none listed in the patient's pharmacy profile) at the reporter's pharmacy. Follow-up (16-Jan-2015): Clinical course, AE start date and outcome.
Sex: F
Vaccine: FLUX
Symptoms: Iritis
Clinical narrative: This medically confirmed health authority report (initial receipt 20-Jan-2015) concerns a female patient. On an unspecified date, the patient received influenza virus vaccine (batch number not reported). On an unspecified date, the patient experienced iritis. The outcome was not reported. Linked case: 2015048238 (same patient).
Age: 4.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 year old patient of unknown gender. Patient's medical history and concurrent conditions were not reported. On 20-MAY-2015, the patients was vacinated with a dose of improperly stored VARIVAX (Merck) lot number K010441 (dose and route were not reported) and a dose of improperly stored M-M-R II lot number reported as 002528 (dose and route were not reported). Concomitant medications were not reported. No adverse effects were reported. This is the one of the several reports from the same reporter source. Lot number 002528 is an invalid lot number for stored M-M-R II. Additional information has been requested.
Age: 25.0
Sex: M
Vaccine: FLUX
Symptoms: Condition aggravated, Seizure
Clinical narrative: This medically confirmed health authority report (initial receipt 16-Feb-2015) concerns a 25-year-old male patient. The patient had medical history of cerebral palsy and seizure disorder. On an unspecified date, the patient received influenza (seasonal) vaccine (manufacturer and batch number not reported). On an unspecified date, the patient experienced seizure. The outcome was not reported. Linked case: 2015048258 (same patient).
Sex: F
Vaccine: FLUX
Symptoms: Paralysis
Clinical narrative: This medically confirmed health authority report (initial receipt 27-Oct-2014) concerns a female patient. On an unspecified date, the patient received the influenza virus vaccine (manufacturer and batch number not reported). On an unspecified date, the patient developed right and left hand paralysis. Outcome was not reported.  Linked to 2014046394.
Sex: U
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome
Clinical narrative: This serious spontaneous report (initial receipt 05-Dec-2014) concerns an unknown patient. On an unspecified date, the patient received AFLURIA injection (batch number not provided). On an unspecified date, following the AFLURIA administration, the patient experienced Guillain Barre Syndrome (GBS). Outcome was not reported.
Age: 45.0
Sex: F
Vaccine: YF
Symptoms: Unevaluable event
Clinical narrative: Unknown.
Age: 12.0
Sex: M
Vaccine: DTAP, MEN
Symptoms: Muscle twitching, Posture abnormal, Staring
Clinical narrative: Patient slumped over with eyes open in a vacant stare and then facial twitching started.
Age: 18.0
Sex: F
Vaccine: HPV4, MNQ
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: Right upper arm swelling, mild erythema, induration and heat occurred within 24 hours of administration.
Age: 3.0
Sex: M
Vaccine: IPV
Symptoms: Disturbance in attention, Injection site pain, Tremor
Clinical narrative: Right leg pain. He also had some generalized shaking to his face, his chin started to quiver. He had another episode of ten to 15 minutes where he was not focusing. He seemed to be looking right through his parents. His mother thought his pupils looked large and asymmetrical. No generalized shaking. No loss of consciousness. No obvious postictal stage. No prior neurological problems.
Age: 5.0
Sex: M
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Large 10 cm swelling/redness around site.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Body temperature increased, Diarrhoea, Headache, Hypertension, Injection site pruritus
Clinical narrative: Patient reports headache, diarrhea, slight increase in temp to Tmax of 100, onset of itching and swelling at injection site up to size of baseball. Rash and hives on chest.
Age: 45.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Rash, Tachycardia, Upper extremity mass, Urticaria
Clinical narrative: Patient reports headache, diarrhea, slight increase in temp to Tmax of 100, onset of itching and swelling at injection site up to size of baseball. Rash and hives on chest.
Age: 5.0
Sex: M
Vaccine: MMR
Symptoms: Immunoglobulin therapy, Petechiae, Platelet count, Rash, Skin discolouration
Clinical narrative: Developed purple-like rash/petechiae. Otherwise acting OK. Happy. Eating and drinking. No fever. No outside travel.
Age: 23.0
Sex: M
Vaccine: SMALL
Symptoms: Dermatitis, Robust take following exposure to vaccinia virus
Clinical narrative: Member developed robust take due to smallpox vaccine.  Appear to have a breakout of deratitis around back of neck and uper shoulders. Appears to be improving
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Dizziness, Drug hypersensitivity, Dysstasia, Headache, Hypoaesthesia
Clinical narrative: Following the vaccine patient had pain in her arm with numbness and tingling. She became lightheaded, dizzy, and had nausea. She reported visual disturbance with the lights becoming very bright. She then had nuchal rigidity and headache. She became very lethargic and was unable to stand, sit up, or keep her head up. She could not keep her eyes open for more than a few seconds. Vital signs taken on site were: BP:176/107, Pulse 77, O2 on room air 99%. EMS was called transported her to Emergency Room.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Lethargy, Nausea, Nuchal rigidity, Pain in extremity, Paraesthesia
Clinical narrative: Following the vaccine patient had pain in her arm with numbness and tingling. She became lightheaded, dizzy, and had nausea. She reported visual disturbance with the lights becoming very bright. She then had nuchal rigidity and headache. She became very lethargic and was unable to stand, sit up, or keep her head up. She could not keep her eyes open for more than a few seconds. Vital signs taken on site were: BP:176/107, Pulse 77, O2 on room air 99%. EMS was called transported her to Emergency Room.
Age: 28.0
Sex: F
Vaccine: HEP
Symptoms: Photophobia, Visual impairment
Clinical narrative: Following the vaccine patient had pain in her arm with numbness and tingling. She became lightheaded, dizzy, and had nausea. She reported visual disturbance with the lights becoming very bright. She then had nuchal rigidity and headache. She became very lethargic and was unable to stand, sit up, or keep her head up. She could not keep her eyes open for more than a few seconds. Vital signs taken on site were: BP:176/107, Pulse 77, O2 on room air 99%. EMS was called transported her to Emergency Room.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Blister, Burning sensation, Erythema, Injection site pain, Injection site streaking
Clinical narrative: Burning and swelling in left arm. Visible streak from injection site on upper arm to blisters on forearm. Fever, soreness in areas where the streaks were.
Age: 20.0
Sex: F
Vaccine: HPV4
Symptoms: Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Burning and swelling in left arm. Visible streak from injection site on upper arm to blisters on forearm. Fever, soreness in areas where the streaks were.
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 year old patient of unknown gender. Patient's medical history and concurrent conditions were not reported. On 20-MAY-2015, the patient was vaccinated with a dose of improperly stored M-M-R II lot number reported as 002528 (dose and route were not reported). Concomitant medications were not reported. No adverse effects were reported. This is the one of the several reports from the same reporter source. Lot number 002528 is an invalid lot number for stored M-M-R II. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMR, VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 year old patient of unknown gender. Patients' medical history and concurrent conditions were not reported. On 28-MAY-2015, first patient was vaccinated with a dose of improperly stored M-M-R II lot number reported as 002528 (dose and route were not reported). Concomitant medications were not reported. No adverse effects were reported. This is the one of the several reports from the same reporter source. Lot number 002528 is an invalid  lot number for stored M-M-R II. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a healthcare worker concerning multiple patients of unknown demographics. On unknown dates, multiple different unspecified patients received a dose of VARIVAX (unspecified lot # and expiry date) that was improperly stored. No adverse effects reported. No product quality complaint was involved. This case is also related to 1506USA002056, 1507USA010860 and 1507USA010859. Additional information has been requested.
Age: 9.0
Sex: U
Vaccine: FLU3
Symptoms: Influenza
Clinical narrative: This spontaneous consumer report (initial receipt 06-Jan-2015) concerns a 9 year-old patient. On an unspecified date, the patient received AFLURIA injection (batch number not provided). On an unspecified date, the patient developed the flu after being injected with AFLURIA. The outcome was unknown.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Cellulitis, Injection site erythema
Clinical narrative: This medically confirmed spontaneous report (initial receipt 13-Nov-2014) concerns a 77 year old female patient. On the 09-Nov-2014, the patient received AFLURIA (batch number T51208) 0.5mL annually in an unspecified arm. On the 09-Nov-2014, the patient developed redness at the injection site. On the 10-Nov-2014, the patient received her ZOSTAVAX vaccine (batch number not reported) in the opposite arm as the AFLURIA injection. On the 11-Nov-2014, the injection site redness worsened so the patient visited her primary care provider who diagnosed her with cellulitis and was being treated with cephalexin (dose and duration unspecified). The doctor specified that the AFLURIA injection was given below the deltoid which may have caused the cellulitis. The pharmacist stated that the injection was given in the deltoid. Outcome was reported as not yet recovered.
Age: 60.0
Sex: F
Vaccine: FLUX
Symptoms: Feeling hot, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: This medically confirmed report (initial receipt 25-Mar-2015) concerns a 60 year old female patient who had a medical history of asthma. Concomitant medications included fexofenadine. The patient did not receive other recent immunisations within the last 3 months. In Oct-2014, the patient received an unspecified influenza virus vaccine injection (manufacturer and batch number not specified). On an unspecified date, following the flu vaccine administration, the patient developed an injection site adverse event. The patient developed redness and swelling from her elbow up to her shoulder in the arm which she received the flu vaccine (not both arms) and it lasted for about one week. It looked almost like a cellulitis. The patient also had a fever for four days and described feeling hot. On an unspecified date, the patient visited the clinic and she did not have a measured elevated temperature. No treatment was given for redness, swelling or fever symptoms. Outcome was recovered in Mar-2015. Follow-up (01-Apr-2015): Reporter details, AE #3 and AE #4 as-reported terms, clinical course, new AE, outcome.
Sex: U
Vaccine: FLU3
Symptoms: Anaphylactic reaction
Clinical narrative: This spontaneous medically confirmed report (initial receipt 25-Nov-2014) concerns a patient. On an unspecified date, the patient received AFLURIA (batch number not reported). On an unspecified date, the patient experienced anaphylactic reaction. Outcome was not reported.
Age: 57.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Arthralgia, Chills, Erythema, Induration, Local swelling
Clinical narrative: Pain, redness, swelling, fever, chills, widespread muscle aches & joint pain. Redness & swelling, measured 8 x 10 cm total induration & erythema was 16 x 18 cm.
Age: 57.0
Sex: F
Vaccine: PNC13, TDAP
Symptoms: Myalgia, Pain, Pyrexia
Clinical narrative: Pain, redness, swelling, fever, chills, widespread muscle aches & joint pain. Redness & swelling, measured 8 x 10 cm total induration & erythema was 16 x 18 cm.
Age: 29.0
Sex: F
Vaccine: MENB
Symptoms: Injection site discomfort, Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Vaccinated on 7/16/15, reactoin appeared on 7/20/15. Slightly raised erythemic area on left deltoid, AMOX 100 mm x 84 mm. Mild discomfort  warm tou touch.
Age: 12.0
Sex: M
Vaccine: HPV4, MNQ, MNQ, TDAP
Symptoms: Pyrexia, Wrong technique in drug usage process
Clinical narrative: Suspected that powder component of MENVEO was diluted with MENACTRA and injected IM. Pt. had a fever for 2 days treated with TYLENOL and MOTRIN. No other symptoms, no arm redness or soreness. Recommended by CDC to repeat dose and mom informed on and plans to do.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Hyperhidrosis, Immediate post-injection reaction, Limb discomfort, Pallor
Clinical narrative: HPV vaccination (R) deltoid IM - immediately upon administration patient c/o heavy arm, then became pale/diaphoretic-moved patient to supine position with legs elevated. Patient took approx 10 minutes to return to baseline. 7/23/15.
Sex: U
Vaccine: MMR, MMRV
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information has been received from a healthcare worker(medical assistant) referring to a patient of unknown age and gender. Information about patient's concurrent conditions and medical history was not reported. On 22-JUL-2015 the patient inadvertently received a dose of PROQUAD (Merck) (dose, route not reported, lot # K025766 with expiration date 08-JUN-2016) instead of an intended dose of VARIVAX (Merck) (wrong vaccine administered). The patient also received a dose of M-M-R II during the same visit on 22-JUL-2015. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site reaction, Injection site swelling
Clinical narrative: This spontaneous report was received from other refers to a patient of unknown age and gender. No pertinent medical history was reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route and lot# were not reported). No concomitant therapies were reported. On an unknown date, the patient experienced injection site reaction to ZOSTAVAX. She experienced injection site erythema, injection site hard to the touch, injection site swelling and injection site pruritus. No Product Quality Complaint (PQC) was involved. Action taken was unknown. The outcome of events were unknown. The reporter did not provide the causality between the event and the suspect therapy. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse referring to a patient of unknown age and gender. On 20-JUL-2015 the patient received a dose of expired VARIVAX (lot# reported as J008981, expiration date: 19-JUL-2015, subcutaneous, dose was unknown). There were no known adverse effects. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information has been received from a 25 year old female consumer concerning herself who was not pregnant. The patient's medical history, concurrent condition and concomitant therapy were not provided. The patient reported that she missed doses of GARDASIL. In approximately 2013 (reported as some time "2 to 3 year ago"), the patient was vaccinated with the first dose of GARDASIL (lot#, expiration date and dose not reported), intramuscularly. Then 9 months later in February 2014, the patient administered the second dose (intramuscular, lot# and dose not reported) (inappropriate schedule of vaccine administration), and she had not received her third dose of vaccine a year and half later. No adverse effect was reported. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Erythema, Headache, Injection site pain, Joint range of motion decreased
Clinical narrative: 0.5 mL given IM in left deltoid at approximately 8:30 am. There was a large localized reaction on the LA-erythema, swelling, and tenderness. Subjective fever, afebrile today. Nausea, malaise, HA, arthralgia, severe left shoulder pain, decreased ROM. Circle drawn around spot, told to return if extends. Told to ice and use BENADRYL prn.