chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 19.0
Sex: M
Vaccine: HPV4
Symptoms: Diarrhoea
Clinical narrative: This spontaneous report was received from a veterinarian regarding an approximately 19 year old male patient who is her son. No medical history or drug allergies were reported. On an unknown date in September 2013 or October 2013, the patient was vaccinated with dose 1 of GARDASIL (Lot #, expiry not reported). No concomitant medications were reported. On an unknown date in 2013, the patient experienced diarrhea after he received his first dose of GARDASIL. He had not received a second dose of GARDASIL. The veterinarian also mentioned that her son started his first year of college at about the same time that the diarrhea began. The reporter stated that she believed the diarrhea may not be a bad now as when it first started. No treatment was given. No laboratory tests were performed. The outcome of diarrhea was unknown. The relatedness of the event to GARDASIL was unknown. No PQC involved. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: HPV4
Symptoms: Injection site erythema, Injection site swelling, Product quality issue
Clinical narrative: This spontaneous report was received from a consumer refers to a 12 year old male patient who is her son. No medical history or drug allergies were reported. On 01-OCT-2013, the patient was vaccinated with dose 2 of GARDASIL (lot # J007354, expiry- 20-FEB-2016). No concomitant medications were reported. She stated that she received a letter from the office where it was administered that her son had received a dose of the recalled lot of GARDASIL. She reported that her son had an injection site reaction, which was red and swollen. She stated that she did not seek treatment for the reaction, but used "hot and col compresses" and the swelling resolved "in a few days". No laboratory tests were performed. She stated that he did not have any injection site reaction to his first injection of GARDASIL. The relatedness of the event to GARDASIL was unknown. No PQC involved. Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. On 24-MAR-2014, the patient was inadvertently administered a dose of ROTATEQ, (Lot # reported as H015715) oral route that had expired on 15-MAR-2014. No adverse effects reported. No PQC involved. Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Had redness and swelling around the sight of the shot.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuralgia
Clinical narrative: This spontaneous report as received from a 81 years old female consumer who was referring to herself. The patient's current conditions included high blood pressure osteoporosis, Sjogren's syndrome and allergy to CIPRO. In August 2007 the patient was vaccinated with ZOSTAVAX (lot number, expiration, dose, route were not reported). No concomitant medications were reported. In March 2014 (reported as last month) the patient experienced a mild case of Shingles. The patient had little nerve pain and was prescribed an unspecified medication for the nerve pain. No lab diagnostics studies were performed. The patient sought medical attention - saw the physician. The outcome of a mild case of Shingles was reported as not recovered/not resolved. The relatedness between the event and ZOSTAVAX was not reported. Additional information has been requested.
Age: 47.0
Sex: M
Vaccine: HEP
Symptoms: Dizziness, Feeling of body temperature change, Generalised erythema, Headache
Clinical narrative: After getting Hep B vaccine #2 at 1100, pt reports he developed headache, feeling hot/cold and redness of face, neck, arms, hands at 1300 with 2 episodes of mild lightheadedness. When seen at Employee Health at 1510, his symptoms of redness were fading, his headache was 4/10 with ALEVE at 1330 and he was not experiencing other symptoms; email from pt next AM states he recovered.
Age: 36.0
Sex: M
Vaccine: TYP
Symptoms: Diarrhoea, Influenza, Pain, Pyrexia
Clinical narrative: Flu symptoms after 1st capsule: fever, aches, diarrheah.
Age: 29.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Meningitis aseptic
Clinical narrative: Aseptic meningitis.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Red, swollen, injection sight extremely hard, hot, arm soreness.
Age: 48.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Rash pruritic, Swelling
Clinical narrative: Baseball size swelling, red, itchy rash.
Age: 1.03
Sex: M
Vaccine: MMR, PNC, VARCEL
Symptoms: Blood test normal, Ear infection, Pyrexia
Clinical narrative: Patient started running fever around 101 at noon. By evening it was 103. The next day (22nd) the fever had skyrocketed to 105 by 5pm. Took to after hours pediatric care and he was test for the flu (negative) and said he could possibly be starting to have an ear infection. The next day (24th) patient still ran 104-105 fever. By the (25th) we took patient back to pediatrician and during that visit he said that he did have an ear infection. Today is the 26th and he still has fever almost a week later. In my opinion, a "possible" ear infection would not cause a fever of 105. I am really concerned that his body is having a bad reacting to his vaccines that were administered on the 18th of March, 2014. Something does not seem right.
Age: 20.0
Sex: M
Vaccine: ANTH, TYP
Symptoms: Blister, Erythema, Papule, Rash pruritic
Clinical narrative: Pruritic rash on both elbows, right knee, and palms of both hands.  Elbows and knees had erythematous, non-scaling, coalescing plaques with satellite papules and vesicles; palms of hands had few scattered discrete dark red papules (2-3 on each palm).  Treated with topical Triamcinolone 0.1% gel TID for itching prn.
Age: 0.63
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Pyrexia
Clinical narrative: 103 degree fever x 3 days.
Age: 43.0
Sex: F
Vaccine: PPV
Symptoms: Full blood count, Injection site pain, Pain, Red blood cell sedimentation rate, X-ray
Clinical narrative: Left upper arm pain that came on gradually and is now severe with any movement of the arm.  Patient presented the following day with pain. No bony tenderness.
Age: 0.41
Sex: M
Vaccine: HIBV, PNC13
Symptoms: Respiratory distress
Clinical narrative: Pt seen at ED on 03/24/2014, transferred to another hospital, admitted on 03/25/14 at 1:00 AM for respiratory distress MD plans on discharge 03/26 or when a safe discharge plan is in place.
Age: 20.0
Sex: F
Vaccine: HEP
Symptoms: Injection site pruritus, Injection site swelling
Clinical narrative: FELT ITCHING TO RIGHT SHOULDER AND NOTICED SWELLING OF 3 INCHES. SYMPTOMS LASTED UNTIL 3/23/2014. NO TREATMENT ADMINISTERED.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Cellulitis, Chills, Nausea, Pyrexia, Viral infection
Clinical narrative: Nausea, vomiting, fever, chills. Diagnosed with cellulitis, n/v, viral syndrome. Given Keflex 500mg 1 qid x 10d and Zofran tabs 4mg prn q6-8 hrs and given Rocephin 1g IM.
Age: 70.0
Sex: M
Vaccine: PPV
Symptoms: Vomiting
Clinical narrative: Nausea, vomiting, fever, chills. Diagnosed with cellulitis, n/v, viral syndrome. Given Keflex 500mg 1 qid x 10d and Zofran tabs 4mg prn q6-8 hrs and given Rocephin 1g IM.
Age: 1.36
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Blood culture negative, Crying, Culture throat negative, Full blood count normal, Gait disturbance
Clinical narrative: Crying that lasted over 12 hours; refusal to walk for 24 hours; erythematous rash for 12-24 hours; fever to 104 for 24 hours.
Age: 1.36
Sex: M
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Influenza virus test negative, Metabolic function test normal, Pyrexia, Rash erythematous, Streptococcus test negative
Clinical narrative: Crying that lasted over 12 hours; refusal to walk for 24 hours; erythematous rash for 12-24 hours; fever to 104 for 24 hours.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Pain in extremity, Rotator cuff syndrome
Clinical narrative: A few days after shot patient had arm pain.  It progressed to shoulder impingement.  She started PT to help resolve the issue. Still has pain and limited mobility of arm.
Age: 1.04
Sex: M
Vaccine: MMR, MMR
Symptoms: Blood test normal, Convulsion, Electroencephalogram normal
Clinical narrative: Had seizure at 12:00 noon. Temperature immediately following seizure was 97 degrees F. Patient had been eating/drinking/acting normal prior to seizure. We were immedietly brought by ambulance to Medical Center where he had bloodwork & 24 hour EEG performed - all which came back within normal limits.
Age: 1.04
Sex: M
Vaccine: MMR, MMR
Symptoms: Blood test, Convulsion, Electroencephalogram, Pyrexia, Vomiting
Clinical narrative: Had seizure at 12:00 noon. Temperature immediately following seizure was 97 degrees F. Patient had been eating/drinking/acting normal prior to seizure. We were immedietly brought by ambulance to Medical Center where he had bloodwork & 24 hour EEG performed - all which came back within normal limits.
Age: 59.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Activities of daily living impaired, Blood test, Computerised tomogram, Dyspnoea, Pulmonary function test
Clinical narrative: I am a runner and after getting flu shot I started having wheezing and shortness of breath. I ran Oct. of 2012, but after flu shot could not even run a mile without having to stop and get breath. Maybe it was not the flu shot but quite a coincident.  I am still on Symbicort inhaler.
Age: 59.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Wheezing
Clinical narrative: I am a runner and after getting flu shot I started having wheezing and shortness of breath. I ran Oct. of 2012, but after flu shot could not even run a mile without having to stop and get breath. Maybe it was not the flu shot but quite a coincident.  I am still on Symbicort inhaler.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Rash vesicular
Clinical narrative: Non-injection site such as back, under the breast zoster-like rash and blisters.
Age: 60.0
Sex: M
Vaccine: TDAP, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Site injection erythema, swelling, pruritus.
Age: 1.03
Sex: M
Vaccine: HEPA, MMRV
Symptoms: Crying, Irritability
Clinical narrative: Fussiness, crying, inconsolable.
Age: 28.0
Sex: M
Vaccine: RAB
Symptoms: Incomplete course of vaccination, Staphylococcal infection
Clinical narrative: Case number PHEH2014US005834, is a combined initial and follow up spontaneous report received from a pharmacist on 20 Mar 2014 and on 24 Mar 2014 respectively. This report refers to a 28 year old male patient. His past medical history and concomitant medications were not reported. He was bitten by a dog on the inside of his right leg and the bite wound was very big. He underwent surgical debridement of the bite wound. The patient was vaccinated with the first dose (day 0) of post exposure series of RABAVERT (batch number: 52400c) intramuscularly on 13 Mar 2014. He also received HRIG (human anti-rabies immunoglobulin, other manufacturer, batch number: not reported) on 13 Mar 2014. He was diagnosed with MRSA (methicillin resistant Staphylococcus aureus) infection on 15 Mar 2014. He was treated with Augmentin and clindamycin (manufacturer: not reported, batch number: not reported). The patient missed the day 3 dose of post exposure series of RABAVERT (booster dose missed). The reporter also stated that the patient might have had a prior MRSA infection a long time ago; however, it was not confirmed. The outcome of the event was reported as condition improving. The seriousness of the event was not reported and the pharmacist stated that the event was not related to the administration of RABAVERT.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pruritus, Injection site warmth
Clinical narrative: Red area on (L) arm, BENADRYL helped but now back, warm to touch and red, itchy also.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Erythema, Injection site pruritus, Swelling
Clinical narrative: Mild redness and swelling with some itching over left shoulder.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: (L) arm slightly red and swollen.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a medical assistant refers to a male patient of unknown age. On an unknown date in November 2012, the patient received their first dose of GARDASIL (lot#, expiry not reported) and their second dose in November 2013 and will be receiving their third dose of GARDASIL (lot#, expiry not reported) today on 24-MAR-2014. No adverse effects reported. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: (L) shoulder 1 1/2 " diameter swelling and redness. Not painful (decreasing from day 1) Ice pack, monitor x sx of infections.
Age: 0.36
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Convulsion, Pyrexia
Clinical narrative: Fever 100.4. Seizure evening of vaccine.
Age: 1.56
Sex: F
Vaccine: DTAP, HEPA, HIBV
Symptoms: Injection site erythema, Injection site induration, Injection site pain
Clinical narrative: Erythematous patch, slightly indurated, slightly tender on thigh.
Sex: M
Vaccine: MMRV
Symptoms: Infection
Clinical narrative: Information was received from a lawyer regarding a potential litigation case concerning a minor male (age unknown), who on 11OCT2013, was administered the PROQUAD (Merck), lot #J002307, expiration date 22AUG2014 (dosage and route of administration not provided). On 11OCT2013, the patient developed a serious infection following the vaccination and was hospitalized and caused to undergo an unspecified procedure as a result of the infection. The reporter was concerned that this lot number may be determined to contain contaminants, and noted a potential bodily injury claim. The outcome of the serious infection was not provided. Additional information has been requested.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left upper arm redness and swelling noticed on 3/22/14, looking like a spider bite.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site swelling
Clinical narrative: Left upper arm swelling.
Age: 5.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Left arm redness and swelling about the size of two quarters.
Sex: F
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from certified medical assistant refers to a patient of unknown age and gender who on unknown date was vaccinated with a dose of VARIVAX (Merck), 0.5 ml, subcutaneous that was stored at -12c for a total of 48 hours. No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner student refers to a patient of unknown age. On 14-JAN-2014, the patient was inadvertently vaccinated with ROTATEQ dose 2 orally. On 17-JAN-2014, 3 days after receiving dose 2 of ROTATEQ series, the patient was vaccinated with the third dose of ROTATEQ orally. No adverse effect was reported. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Headache, Malaise, Nausea, Pain
Clinical narrative: This spontaneous report ass received from a consumer reporting on himself a 61 year old male patient who on 23-MAR-2014, was vaccinated with ZOSTAVAX (dose, lot and route not provided). Concomitant therapies included LIPITOR. Consumer stated that his injection arm hurt the same day as administration on 23-MAR-2014, but on 24-MAR-2014, he felt sick and experiencing nausea, vomiting several times, headache and body aches. He stated his symptoms feel like a stomach bug. The patient sought medical attention called pharmacist. The patient said he has seen people had reactions from unspecified flu shots (MARRS # 1403USA012303). NO further AE information provided). The outcome of his injection arm hurt, his symptoms feel like a stomach bug, body aches, headache, vomiting several times, nausea and felt sick were unknown. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Vomiting
Clinical narrative: This spontaneous report ass received from a consumer reporting on himself a 61 year old male patient who on 23-MAR-2014, was vaccinated with ZOSTAVAX (dose, lot and route not provided). Concomitant therapies included LIPITOR. Consumer stated that his injection arm hurt the same day as administration on 23-MAR-2014, but on 24-MAR-2014, he felt sick and experiencing nausea, vomiting several times, headache and body aches. He stated his symptoms feel like a stomach bug. The patient sought medical attention called pharmacist. The patient said he has seen people had reactions from unspecified flu shots (MARRS # 1403USA012303). NO further AE information provided). The outcome of his injection arm hurt, his symptoms feel like a stomach bug, body aches, headache, vomiting several times, nausea and felt sick were unknown. Additional information has been requested.
Sex: F
Vaccine: MMR
Symptoms: Rubella antibody negative
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient in her 40's. On an unknown date the patient was vaccinated with MMR II injection as a baby in the early 1970's (lot #, expiry date, dose and route unknown). The pharmacist stated that she was unsure if the patient received "MMR" or MMR II. She stated that the patient recently had "titers" drawn and her titer for rubella was negative (date unknown). No treatment was given for the event. The patient did not seek medical attention. The patient was not recovered. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: MMR
Symptoms: Rubella antibody negative
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to 68 year old female patient with codeine allergy/drug reaction. The patient's medical history was not reported. On an unknown date, reported as "when she was younger", the patient may have been vaccinated with a dose of MMR II (dose, route, lot number and expiration date not reported). On an unspecified date in 2011 and on 07-MAR-2014, the patient had "lab work drawn" which showed her to be negative for rubella antibodies. At the time of the report outcome for rubella antibodies negative was unknown. It was reported that the patient did not received treatment for the event. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to unspecified patients of unknown ages who on an unknown dates, were vaccinated with a doses of GARDASIL (doses, routes and lot numbers not reported) that were improperly stored. The vaccines were exposed to 31F for 96 hours. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to 2 patients of unknown demographics. The patients current conditions or medical history were not reported. On 26-JUN-2013, the patients were vaccinated with the first dose of GARDASIL 120 y 0.5 ml intramuscular (lot and expiration date were not reported). On 04-SEP-2013, the patients were vaccinated with the second dose of GARDASIL 120 y, 0.5 ml intramuscular (lot and expiration date were not reported). On 27-NOV-2013, patients were administered third doses of GARDASIL 120 y, 0.5 ml intramuscular (lot and expiration date were not reported), less than 24 weeks after the first dose of GARDASIL 120 y 0.5 ml intramuscular, was administered. No adverse effects reported. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Chills, Erythema, Feeling cold
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 58 year old female patient. Relevant medical history and concomitant medication were not provided. On 17-DEC-2013 the patient was vaccinated with PNEUMOVAX 23 lot # J011651, subcutaneously in the right arm. Dose was not provided. Other suspect therapies included ZOSTAVAX lot # J011338, subcutaneously in the right arm and BOOSTRIIX lot # T25EG, intramuscularly in the right deltoid. Dose was not provided. Patient's concomitant medications were not provided. On 17-DEC-2013, the patient experienced arm red dark to elbow, chills and freezes. The outcome of arm red dark to elbow, chills and freezes was reported as recovered/resolved at an unknown date. The reporter causality was unknown. This case linked to the following cases by the same reporter: 1312USA010905, 1403USA003215, 1403USA003216, 1403USA003217, 1403USA003218, 1403USA003219, 1403USA003220, 1403USA003221, 1403USA003222, 1403USA003223, 1403USA003224, 1403USA003225, 1403USA003226, 1403USA003227, 1403USA003228, 1403USA003229, 1403USA003230, 1403USA003231, 1403USA003232, 1403USA003233, 1403USA003234, 1403USA003235, 1403USA003236, 1403USA003237, 1403USA003238, 1403USA003239, 1403USA003240, 1403USA003242, 1403USA003243, 1403USA003244, 1403USA003245, 1403USA003246, 1403USA003247, 1403USA003248, 1403USA003249, 1403USA003250, 1403USA003251, 1403USA003252 and 1403USA003253. Additional information is not expected.
Age: 58.0
Sex: F
Vaccine: PPV, TDAP, VARZOS
Symptoms: Chills, Malaise, Pain
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 58 year old female patient. Relevant medical history and concomitant medication were not provided. On 17-DEC-2013 the patient was vaccinated with PNEUMOVAX 23 lot # J011651, subcutaneously in the right arm. Dose was not provided. Other suspect therapies included ZOSTAVAX lot # J011338, subcutaneously in the right arm and BOOSTRIX lot # T25EG, intramuscularly in the right deltoid. Dose was not provided. Patient's concomitant medications were not provided. On 17-DEC-2013, the patinet experienced achy, chills and sicker than a dog. The outcome of achy, chills and sicker than a dog was reported as recovered/resolved at an unknown date. The reporter causality was unknown. This case is linked to the following cases by the same reporter: 1312USA010905, 1403USA0003215, 1403USA003216, 1403USA003217, 1403USA003218, 1403USA003219, 1403USA003220, 1403USA003221, 1403USA003222, 1403USA003223, 1403SA003224, 1403USA003225, 1403USA003226, 1403USA003227, 1403USA003228, 1403USA003229, 1403USA003230, 1403USA003231, 1403USA003232, 1403USA003233, 1403USA003234, 1403USA003235, 1403USA003236, 1403USA003237, 1403USA003238, 1403USA003239, 1403USA003240, 1403USA003241, 1403USA003243, 1403USA003244, 1403USA003245, 1403USA003246, 1403USA003247, 1403USA003248, 1403USA003249, 1403USA003250, 1403USA003251, 1403USA003252 and 1403USA003253. Additional information is not expected.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Adverse reaction
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant refers to a currently 67 year old female patient with osteoarthritis and psoriatic arthritis and a history of unspecified reaction to SULFA. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot #, dose, route and site of administration not reported). Concomitant therapies included ENBREL 50 mg, calcium, PRILOSEC, SYNTHROID, WELLBUTRIN and etodolac. It was reported that the patient that received ZOSTAVAX developed an unspecified reaction (dates not provided). It was unknown if the patient sought medical attention. The outcome of unspecified reaction is unknown. Causality was not provided. Follow up information was received from a physician refers to a 51 year old female patient. Patient's identifier was updated and confirmed in the follow-up. On 13-SEP-2013, the patient was vaccinated with ZOSTAVAX, (dose strength, number of dose, route of administration was not reported). Concomitant medication reported ALEVE and Prednisone (manufacturer unknown). On 17-SEP-2013, 4 days after onset of therapy the patient experienced sinusitis (disability). Laboratory test done were CBC (result =22mm/h), white blood cell count (result =6.8 thousand/1/4L, red blood cell count (result= 3.96million/1/4L), hemoglobin (result= 12.4 g/dl), hematocrit (result= 37.9%). The outcome of sinusitis was reported as recovering (partially recovered). Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Adverse reaction, Full blood count, Haematocrit normal, Haemoglobin normal, Mean cell haemoglobin concentration normal
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant refers to a currently 67 year old female patient with osteoarthritis and psoriatic arthritis and a history of unspecified reaction to SULFA. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot #, dose, route and site of administration not reported). Concomitant therapies included ENBREL 50 mg, calcium, PRILOSEC, SYNTHROID, WELLBUTRIN and etodolac. It was reported that the patient that received ZOSTAVAX developed an unspecified reaction (dates not provided). It was unknown if the patient sought medical attention. The outcome of unspecified reaction is unknown. Causality was not provided. Follow up information was received from a physician refers to a 51 year old female patient. Patient's identifier was updated and confirmed in the follow-up. On 13-SEP-2013, the patient was vaccinated with ZOSTAVAX, (dose strength, number of dose, route of administration was not reported). Concomitant medication reported ALEVE and Prednisone (manufacturer unknown). On 17-SEP-2013, 4 days after onset of therapy the patient experienced sinusitis (disability). Laboratory test done were CBC (result =22mm/h), white blood cell count (result =6.8 thousand/1/4L, red blood cell count (result= 3.96million/1/4L), hemoglobin (result= 12.4 g/dl), hematocrit (result= 37.9%). The outcome of sinusitis was reported as recovering (partially recovered). Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Mean cell haemoglobin normal, Mean cell volume normal, Platelet count normal, Red blood cell count decreased, Red cell distribution width normal
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant refers to a currently 67 year old female patient with osteoarthritis and psoriatic arthritis and a history of unspecified reaction to SULFA. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot #, dose, route and site of administration not reported). Concomitant therapies included ENBREL 50 mg, calcium, PRILOSEC, SYNTHROID, WELLBUTRIN and etodolac. It was reported that the patient that received ZOSTAVAX developed an unspecified reaction (dates not provided). It was unknown if the patient sought medical attention. The outcome of unspecified reaction is unknown. Causality was not provided. Follow up information was received from a physician refers to a 51 year old female patient. Patient's identifier was updated and confirmed in the follow-up. On 13-SEP-2013, the patient was vaccinated with ZOSTAVAX, (dose strength, number of dose, route of administration was not reported). Concomitant medication reported ALEVE and Prednisone (manufacturer unknown). On 17-SEP-2013, 4 days after onset of therapy the patient experienced sinusitis (disability). Laboratory test done were CBC (result =22mm/h), white blood cell count (result =6.8 thousand/1/4L, red blood cell count (result= 3.96million/1/4L), hemoglobin (result= 12.4 g/dl), hematocrit (result= 37.9%). The outcome of sinusitis was reported as recovering (partially recovered). Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Synovitis, White blood cell count normal
Clinical narrative: This spontaneous report as received from a Certified Medical Assistant refers to a currently 67 year old female patient with osteoarthritis and psoriatic arthritis and a history of unspecified reaction to SULFA. On an unknown date, the patient was vaccinated with ZOSTAVAX (lot #, dose, route and site of administration not reported). Concomitant therapies included ENBREL 50 mg, calcium, PRILOSEC, SYNTHROID, WELLBUTRIN and etodolac. It was reported that the patient that received ZOSTAVAX developed an unspecified reaction (dates not provided). It was unknown if the patient sought medical attention. The outcome of unspecified reaction is unknown. Causality was not provided. Follow up information was received from a physician refers to a 51 year old female patient. Patient's identifier was updated and confirmed in the follow-up. On 13-SEP-2013, the patient was vaccinated with ZOSTAVAX, (dose strength, number of dose, route of administration was not reported). Concomitant medication reported ALEVE and Prednisone (manufacturer unknown). On 17-SEP-2013, 4 days after onset of therapy the patient experienced sinusitis (disability). Laboratory test done were CBC (result =22mm/h), white blood cell count (result =6.8 thousand/1/4L, red blood cell count (result= 3.96million/1/4L), hemoglobin (result= 12.4 g/dl), hematocrit (result= 37.9%). The outcome of sinusitis was reported as recovering (partially recovered). Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: TTOX
Symptoms: Incorrect route of drug administration, Injection site erythema, Wrong drug administered
Clinical narrative: My wife was administered the tetanus vaccine intradermally instead of the PPD skin test. (Mantoux test) Erythema spread from the insertion site throughout my wife's forearm approx 10cm x 7cm. Further treatment was necesasry to help alleviate symptoms associated with this incident. My wife was prescribed a 6 day course of Methylprednisolone PO, PRN Claritin and anti-itch ointment.
Age: 1.0
Sex: M
Vaccine: VARCEL
Symptoms: Immunodeficiency, Renal transplant, Skin lesion, Varicella post vaccine
Clinical narrative: This spontaneous report as received from a physician refers to an approximately 12 year old male patient. Concomitant therapy included unspecified immunosuppressive medication. In 1996 the patient was vaccinated with the first dose of VARIVAX (Merck), 0.5 ml, subcutaneously (lot number not reported). In 2008 the patient experienced renal transplant. On 25-FEB-2014 the patient was vaccinated with the second dose of VARIVAX (Merck), 0.5 ml, subcutaneously (lot number not reported). On 25-MAR-2014 the patient was admitted to the hospital with a diagnosis of chickenpox. The reporting physician stated that the lesions were primarily located on the patient's upper extremities, face and scalp. The patient was immunocompromised due to a renal transplant. The outcome of renal transplant and chickenpox was reported as not recovered/not resolved. The relatedness between the events and the therapy was not reported. Upon internal review, renal transplant was considered to be medically significant. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Herpes zoster, Neuralgia, Pruritus, Scab
Clinical narrative: This spontaneous report as received from a 75 year old male patient refers to himself. Patients medical history, drug reactions and allergies reported as none. Approximately on an unknown date in 2011, (two to three years ago), the patient was vaccinated with ZOSTAVAX Subcutaneous Injection, (dose, frequency were unspecified). Concomitant therapy included unspecified many medications (names, dose and manufacturers were unspecified). On 15-JAN-2014, the patient was diagnosed with shingles. The patient sought medical attention, visited physicians office. The patient was treated with ACYCLOVIR, dose and manufacturer unspecified. No lab diagnostics studies were performed. The patient's blisters have scabbed over, but he was still experiencing itchiness and nerve pain. No other symptoms were provided. No product quality complaint was involved. The outcome of shingles was reported as not recovered. The reporters causality assessment for the event shingles with the therapy of ZOSTAVAX was not reported. No further information was provided. Additional information has been requested.
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Influenza like illness, Pain in extremity
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 38 years old female patient with allergic rhinitis. On 20-MAR-2014 the patient was vaccinated with PNEUMOVAX 23 (lot # J013345 exp date 11-JAN-2015) dose 1, .5ml, intramuscular in the left arm. Concomitant therapies included ZYRTEC and FLONASE. Medical assistant does not think the patient has received PNEUMOVAX in the past. In March 2014 the patient experienced flu-like symptoms and soreness of the left arm. The outcome of flu-like symptoms and soreness of the left arm was reported as recovering. The patient sought medical assistance at the office on 24-MAR-2014, none labs were performed and the patient was treated with acetaminophen/hydrocodone tablet. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a patient of unknown age and gender. The patient received dose 2 of GARDASIL (lot#, expiry not reported) on an unspecified date several years ago and this patient was currently in the office on 25-MAR-2014 and would receive dose 3. No adverse effects reported. No PQC involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 24-MAR-2014 the patient was vaccinated with an expired VARIVAX (Merck) (dose route was not reported) (lot# reported as 0604AE exp. 23-MAR-2014) no adverse effect was reported. The patient's outcome was unknown. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a office manager (also reported as healthcare worker) refers to patients of unknown age. On an unknown date between 17-FEB-2014 to 21-MAR-2014, the patients were vaccinated with a dose of MMR II, (lot number, expiry date was not reported which was improperly stored and no adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Age: 51.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash generalised, Rash vesicular
Clinical narrative: This spontaneous report as received from nurse refers to a 51 year old female patient. Patient's medical history, drug reaction and allergies were reported as none. On 26-FEB-2014, the patient was vaccinated with first dose of VARIVAX (Merck) injection, (lot number J007350, expiry date 13-JUN-2015), dose 0.5 ml once, subcutaneous as she was in an environment where there was a chickenpox outbreak. Concomitant therapies included atenolol and hydrochlorothiazide. On 20-MAR-2014, the patient called (yesterday) into the office, reporting that she got vesicular like rash on her body. No treatment was given for the event. No lab diagnostics were performed. No product quality complaint was involved. The outcome of vesicular like rash on her body was reported as not recovered. The reporters causality assessment for the event of vesicular like rash on her body with the therapy of VARIVAX (Merck) was not reported. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Amenorrhoea, Headache
Clinical narrative: This spontaneous report as received from a consumer, a mother of a child via Stericycle Expert Solution (4420859). The reporter states that her child, a female of unknown age, had been administered the first dose of GARDASIL (lot # reported as J007354) on 14-OCT-2013 (information on dose and route not reported) and the second dose of GARDASIL (lot # reported as J007354) (information on dose and route not reported) on 31-JAN-2014. On unknown date the child started to have headaches for a month and GARDASIL and the events was not assessed by the reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site mass, Injection site pruritus
Clinical narrative: This spontaneous report as received from a female consumer (patient's age reported as 67, height reported as 5'14 and weight reported as 170 units unspecified) with allergic to sulfa novacaim, abnormal blood pressure and thyroid disorder, refers to herself. On 05-MAR-2014 the patient was vaccinated with ZOSTAVAX (dose, lot #, expiration date and route of administration not reported). Concomitant therapies included multivitamin, fish oil, blood pressure pills and thyroid medicine. On 05-MAR-2014 (reported as the same day of vaccination), the patient experienced redness and itching at site of insertion right away. On 06-MAR-2014 (reported as the next day), the patient experienced lumps around the insertion site and headaches lasting all day. There was no treatment given for the events. The outcome of the events was not reported. The relatedness between the events and ZOSTAVAX was not reported. Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with ROTATEQ (lot number and expiry date unknown) (dosing regimen and frequency unknown) 2 ml, orally that was exposed to a lowest temperature of 33F between 04-MAR-2014-07-MAR-2014 for a total time of 1 hour was administered. No adverse event was reported. No product quality issue was reported. This case is linked to case number 1403USA012573 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a office manager (also reported as healthcare worker) refers to a patient of unknown age. On an unknown date, the patient was vaccinated with a dose of VAQTA, (lot number, expiry date was not reported) which was improperly stored and no adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report has been received from a registered nurse, who reported that unspecified number of patient has been vaccinated with MMR II (lot #, rHA/HAS status not reported), which underwent an unsupported excursion in December 2013. No adverse effects reported. The nurse reported also that unspecified number of patients was also administered GARDASIL, RECOMBIVAX, Oral ROTATEQ and PEDVAXHIB which underwent supported excursion in December 2013. Additional information has been requested.
Age: 51.0
Sex: M
Vaccine: PPV, TDAP, VARZOS
Symptoms: Chills, Nausea, Pain, Pyrexia
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 51 year old male patient. Relevant medical history and concomitant medications were not provided. On 17-DEC-2013 the patient was vaccinated with PNEUMOVAX23 lot # J011651, subcutaneously in the right arm. Dose was not provided. Other suspect therapies included ZOSTAVAX lot # J011338, subcutaneously in the right arm and BOOSTRIX lot # T25EG, intramuscularly in the right deltoid. Dose was not provided. On 17-DEC-2013, the patient experienced achy, fever, nausea and chills. The outcome of p achy, fever, nausea and chills was reported as recovered/resolved at an unknown date. The reporter causality was unknown. This case is linked to the following cases by the same reporter: 1312USA010905, 1403USA003215, 1403USA003216, 1403USA003217, 1403USA003218, 1403USA003219, 1403USA003220, 1403USA003221, 1403USA003222, 1403USA003223, 1403USA003224, 1403USA003225, 1403USA003226, 1403USA003227, 1403USA003228, 1403USA003229, 1403USA003230, 1403USA003231, 1403USA003232, 1403USA003233, 1403USA003234, 1403USA003235, 1403USA003236, 1403USA003237, 1403USA003238, 1403USA003240, 1403USA003241, 1403USA003242, 1403USA003243, 1403USA003244, 1403USA003245, 1403USA003246, 1403USA003247, 1403USA003248, 1403USA003249, 1403USA003250, 1403USA003251, 1403USA003252 and 1403USA003253. Additional information is not expected.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Skin warm
Clinical narrative: Area warm to touch, enlarged area of redness.
Age: 2.0
Sex: F
Vaccine: DTAP, HEP, MMR, VARCEL
Symptoms: Chills, Pyrexia
Clinical narrative: Date of vaccines given was 3/5/14, child given dose of Tylenol at 7:30pm, she awoke at 10:30pm shivering and fever of 105.4f.  Taken to ER and ER MD told grandmother that child had too many vaccines that overwhelmed the child's system and that is what caused the fever.  When released from the ER fever was 99.1.
Age: 3.0
Sex: M
Vaccine: DTAP, FLU4, HIBV
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Left arm from shoulder to elbow warm to touch, red, and swollen. No fever.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Urticaria
Clinical narrative: Urticaria face, trunk, advised to give Benadryl.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a office manager (also reported as healthcare worker) refers to a patient of unknown age. On an unknown date, the patient was vaccinated with a dose of RECOMBIVAX HB, (lot number, expiry date was not reported) which was improperly stored and no adverse effects were reported. This is one of the several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site mass
Clinical narrative: This spontaneous report was received from a registered nurse concerning her sister, a female patient of unknown age. Medical history and concurrent conditions were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, strength, lot number, expiration date and route were not reported). Co-suspect and concomitant therapies were not reported. The register nurse reported that on an unknown date, the patient had redness and a lump at injection after receiving ZOSTAVAX. Nurse stated that the redness and lump lasted for a week (also reported the outcome as unknown). At the time of the report the outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Eye pruritus, Pruritus
Clinical narrative: This spontaneous report was received from a female patient of unknown age regarding herself. On an unknown date, the patient was vaccinated with a dose of ZOSTAVAX, (lot number, expiry date was unknown). On an unknown date, the patient experienced itchy eyes and has itching sensation of her neck and face. The outcome of the events were unknown. Additional information is not expected.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report as received from nurse practitioner refers to a 57 year old female patient with multiple sclerosis and not drug allergies. On 22-MAR-2014 the patient was vaccinated with ZOSTAVAX (lot # J003483 exp date 29-JUN-2014), subcutaneous. Concomitant medication were not reported. On 24-MAR-2014, the patient experienced redness and swelling that extended down the right arm from the site of injection. She also developed a headache. The outcome of redness and swelling that extended down the right arm from the site of injection and headache was reported as not recovered. The patient sought medical attention at the physician and nurse office, and no lab were performed. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: HPV4
Symptoms: Muscular weakness
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a 16 year old female patient. On an unknown date the patient was vaccinated with her first dose of GARDASIL (dose, route and lot # not reported). The nurse practitioner reported that on approximately 11-FEB-2014 (about 6 weeks ago), the patient experienced muscle weakness after receiving her first dose of GARDASIL. The muscle weakness resolved without treatment on an unspecified date in 2014. The patient made phone call to office for medical attention. No lab diagnostics studies were performed. Additional information is not expected.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Erythema, Swelling
Clinical narrative: MENVEO given in (R) deltoid. 2 days later with 2.5 in x 2.5 in red swollen area.
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a male pharmacist of unknown age refers to himself. On an unknown date, the patient was vaccinated with a dose of Hep B vaccine (manufacturer unknown) (lot#, expiry date, dose, strength, route and indication not reported). On an unknown date, the patient was vaccinated with the second dose of Hep B vaccine (manufacturer unknown), Intramuscular, (lot#, expiry date, dose and strength not reported), possibly greater than 6 months after the first dose, and had not received the third dose as of today (18-MAR-2014). No adverse effect reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose and route not reported) lot # reported as J013452, expiration date 24-JAN-2015. The ZOSTAVAX went through an unsupported temperature excursion on unknown date. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to unspecified patient(s). The nurse reported that improperly stored M-M-R II (dose, route, lot# and expiration date not provided) may have been administered on an unspecified date. No adverse event was reported. This is one of several reports received form the same source. Additional information is not expected.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a other professional refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with GARDASIL, (lot number and expiry date unknown) (dosing regimen and frequency unknown) 0.5 ml, intramuscular that was exposed to a lowest temperature of 33F between 04-MAR-2014-07-MAR-2014 for a total time of 1 hour was administered. No adverse event was reported. No product quality issue was reported. This case is linked to case number 1403USA012476 via same reporter link. Additional information has been requested.