chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Blood culture negative, Cellulitis, Computerised tomogram abnormal, Hepatitis B antibody negative, Hepatitis C antibody negative
Clinical narrative: Patient was administered the Fluarix (0.5mL) and Pneumovax 23 (0.5mL) vaccines IM, both in the right deltoid muscle (not in same syringe) approximately 1 inch apart. Approximately 43 hours after the administration of the vaccines, the patient first reported that his upper right arm was red, warm, swollen and tender. Physician was notified and ordered warm compresses and an ID consult. ID saw the patient and the impression was that the patient's persistent fever was probably due to an infection in the deltoid, but due to the possibility of an abscess, a CT of the arm was ordered and the antibiotics changed.  CT of the arm revealed soft tissue stranding consistent with swelling as well as a small amount of fluid and associated air in the musculature of the right upper arm. As the patient continued to have fevers and an elevated WBC while on antibiotics, Surgery was consulted and saw the patient. It was felt that the patient had a cellulitis that would improve with continued antibiotic management and no surgical intervention was required. The patient continued on antibiotics with marked improvement in the cellulitis and was able to be discharged home and continued on oral antibiotics.
Age: 33.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Injection site erythema, Injection site infection, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient was administered the Fluarix (0.5mL) and Pneumovax 23 (0.5mL) vaccines IM, both in the right deltoid muscle (not in same syringe) approximately 1 inch apart. Approximately 43 hours after the administration of the vaccines, the patient first reported that his upper right arm was red, warm, swollen and tender. Physician was notified and ordered warm compresses and an ID consult. ID saw the patient and the impression was that the patient's persistent fever was probably due to an infection in the deltoid, but due to the possibility of an abscess, a CT of the arm was ordered and the antibiotics changed.  CT of the arm revealed soft tissue stranding consistent with swelling as well as a small amount of fluid and associated air in the musculature of the right upper arm. As the patient continued to have fevers and an elevated WBC while on antibiotics, Surgery was consulted and saw the patient. It was felt that the patient had a cellulitis that would improve with continued antibiotic management and no surgical intervention was required. The patient continued on antibiotics with marked improvement in the cellulitis and was able to be discharged home and continued on oral antibiotics.
Age: 33.0
Sex: M
Vaccine: FLU3, PPV, FLU3, PPV, FLU3, PPV
Symptoms: Legionella test, Pyrexia, Soft tissue disorder, White blood cell count increased
Clinical narrative: Patient was administered the Fluarix (0.5mL) and Pneumovax 23 (0.5mL) vaccines IM, both in the right deltoid muscle (not in same syringe) approximately 1 inch apart. Approximately 43 hours after the administration of the vaccines, the patient first reported that his upper right arm was red, warm, swollen and tender. Physician was notified and ordered warm compresses and an ID consult. ID saw the patient and the impression was that the patient's persistent fever was probably due to an infection in the deltoid, but due to the possibility of an abscess, a CT of the arm was ordered and the antibiotics changed.  CT of the arm revealed soft tissue stranding consistent with swelling as well as a small amount of fluid and associated air in the musculature of the right upper arm. As the patient continued to have fevers and an elevated WBC while on antibiotics, Surgery was consulted and saw the patient. It was felt that the patient had a cellulitis that would improve with continued antibiotic management and no surgical intervention was required. The patient continued on antibiotics with marked improvement in the cellulitis and was able to be discharged home and continued on oral antibiotics.
Age: 16.0
Sex: F
Vaccine: FLU3, PPV, TDAP, PPV, DTAP, FLU3, PPV
Symptoms: Chills, Erythema, Fatigue, Inflammation, Skin warm
Clinical narrative: Swelling, pain, redness, encompassing the entire R upper arm.  Clinician confirmed cellulitis. Myalgias.
Age: 16.0
Sex: F
Vaccine: FLU3, PPV, TDAP, PPV, DTAP, FLU3, PPV
Symptoms: Cellulitis, Injection site erythema, Injection site swelling
Clinical narrative: Swelling, pain, redness, encompassing the entire R upper arm.  Clinician confirmed cellulitis. Myalgias.
Age: 16.0
Sex: F
Vaccine: FLU3, PPV, TDAP, PPV, DTAP, FLU3, PPV
Symptoms: Cellulitis, Erythema, Myalgia, Oedema peripheral, Pain in extremity
Clinical narrative: Swelling, pain, redness, encompassing the entire R upper arm.  Clinician confirmed cellulitis. Myalgias.
Age: 1.02
Sex: F
Vaccine: HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Injection site induration, Injection site mass, Injection site nodule, Nodule
Clinical narrative: Mom called our office on 2/27/13 saying no redness, no bruising, had fever yesterday but none today.  "Knot the size of a walnut." Office visit notes of 2/28/13:  Had vaccination for 1 year shots on Monday (3 days ago).  2 days ago in the location of the shots given on the right upper anterior thigh patient started to have a "knot" at the injection site. Hard.  No redness, bruising, discharge, fever.  No pain noted.  Moving limbs equally.  Feeding stooling and voiding normally. Subcutaneous hard mass 2cm by 1cm in diameter located on the upper anterior lateral thigh.  No discoloration, discharge or tenderness to palpation.
Age: 37.0
Sex: F
Vaccine: FLU3, MMR
Symptoms: Exposure during pregnancy, Pregnancy test urine positive
Clinical narrative: Pregnant patient was given MMR vaccine.
Sex: F
Vaccine: PPV
Symptoms: Injection site cellulitis
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age without drug reactions/allergies. On an unknown date the patient at a nursing home facility was vaccinated with PNEUMOVAX23 (lot# H013581, expiry date unknown). On an unknown date the patient developed cellulitis at the injection site that required antibiotic therapy. Treatment was given for adverse event. The outcome of cellulitis at the injection site was unknown. The patient had sought medical attention and she was at nursing home facility. The relatedness for cellulitis at the injection site was unknown for PNEUMOVAX23. This is one of several reports received from same pharmacist. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date the patient was vaccinated with the second dose of GARDASIL (lot number not provided). The 2nd dose of GARDASIL had been administered outside of the prescribing information, an unspecified date to the patient 6 months after 1st dose. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Age: 23.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Musculoskeletal pain
Clinical narrative: This spontaneous report was received from a nurse practitioner refers to a 23 year old female patient. The patient has no pertinent medical history, drug allergies or reactions. On 04-MAR-2013, the patient was vaccinated with a 0.5 ml (milliliter) dose of PNEUMOVAX23 (lot number reported as H012650, expiry date 27-FEB-2014, route was intramuscular in the left arm). The patient had no concomitant medications. On 04-MAR-2013, the patient developed pain and burning at the injection site 1 hour after administration of PNEUMOVAX23. The symptoms worsened overnight and the patient had redness and diffuse swelling at the injection site and pain radiating to left scapula. Laboratory tests were not performed. Treatment rendered for the events were BENADRYL and ice compresses. The outcome of the reported events were reported as not recovered. The patient sought medical attention (office visit). Additional information has been requested.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Varicella virus test negative, Wrong drug administered
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a patient. The healthcare worker reported that the 52 year old patient who had negative titer for VARIVAX (Merck) actually received ZOSTAVAX (dose, route, lot number not reported) instead due to a human error. The provider wanted to give VARIVAX (Merck) to the 52 years old patient because the patient had no titer for varicella. No adverse event 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. On 04-MAR-2013 the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous (lot# was not reported). The pharmacist reported that ZOSTAVAX was administered to the patient after ZOSTAVAX had been left unrefrigerated for 48 hours. No adverse experience was reported. The patient did not seek medical attention. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Convulsion, Mechanical ventilation
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. The physician reported that the patient received the second dose of GARDASIL (lot# was not reported) in January 2013. It was not specified when the first dose of this vaccine was given. The patient was hospitalized on 01-MAR-2013 (and was still there) for intractable seizures on 01-MAR-2013. The patient sought medical attention in hospital. Treatment was given for adverse event. The patient in a ventilator. At the time of reporting, the outcome of the patient was unknown. The primary reporter considered intractable seizures as Significant Disability. Additional information has been requested.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Condition aggravated, Contusion, Hemiparesis, Injection site erythema, Scab
Clinical narrative: This spontaneous report was received from a 79 year old male patient who is also a pharmacist regarding himself. Drug reactions and allergies were reported as none. The patient's medical history included bilateral knee replacement, right hand tremor and right sided weakness. Approximately on 05-MAR-2011 (reported as 2 years ago from the reported date), the patient was vaccinated with a dose of ZOSTAVAX (lot number expiry date and dose were not reported) subcutaneously. Concomitant therapies included lisinopril (manufacturer Lupin pharmaceuticals), FLOMAX, aspirin and carbidopa, levodopa (manufacturer Actavis Pharma). Approximately on 05-MAR-2011, the patient developed a red area about the size of a dime on his arm at the injection site after receiving ZOSTAVAX. On an unknown date in December 2012, the patient experienced right sided weakness. On 05-FEB-2013 (reported as a month ago from the reported date), the patient developed a bruised area on the upper right side of his buttocks about the size of a quarter which was now crusted over. The physician thought that it might be a bug bite. The patient sought medical attention (office visit) and no treatment was provided. No laboratory tests were performed. The outcome of right sided weakness was reported as not recovered. The outcome of developed a bruised area on the upper right side of his buttocks about the size of a quarter which was now crusted over was reported as recovering/resolving. The outcome of developed a red area about the size of a dime on his arm at the injection site was reported as recovered/resolved at an unspecified time. Upon internal review, the event of right sided weakness was considered as medically significant event. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: UNK
Symptoms: Erythema, Induration, Pruritus, Skin warm
Clinical narrative: 3/5 pm had IZ's. 3/6 430pm (R) arm started itching no swelling up - mom put ice pk. APAP & rubbed calamine lotion. Mom to continue ice & give BENADRYL x 5 days today 3/7 on exam upper (R) arm 7" x 6" firm pink warm patch (R) arm and (L) arm circ 8".
Age: 28.0
Sex: F
Vaccine: HPV4
Symptoms: Cervical dysplasia, Fatigue, Human papilloma virus test positive, Migraine
Clinical narrative: This spontaneous report was received from a physician refers to a 28 year old female patient. The patient had no known allergies. On an unknown date in 2008, the patient was vaccinated with a dose of GARDASIL series, (lot number, expiry date and route was not reported). On 17-DEC-2012, the patient had HPV DNA test done and the results of the tests was abnormal. It was positive ASCUS, undetermined significance. The physician stated that the patient was at high risk for cervical cancer. The patient was feeling some fatigue and having some migraines too. The patient would follow up for colposcopy. The patient had not recovered from the events. The patient sought medical attention. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a consumer refers to herself, a 68 year old female patient. On an unspecified date in 2009 (date assumption based on AE onset information) the patient was vaccinated with ZOSTAVAX. Patient route of administration and lot no. information was not provided. Sometime in June 2012 the patient contracted shingles, which was "about three years after" receiving ZOSTAVAX. She described this first occurrence as mild. On 29-JAN-2013 the patient experienced her second case of shingles, which she described as severe. She has seen the HCP for treatment three times (on unspecified dates) since 29-JAN-2013. Treatment received: VALTREX, Prednisone, "steroid shot" and LORTAB. The outcome of contracted shingles "about three years after" receiving ZOSTAVAX is unknown. The outcome of second case of shingles was reported as not recovered/not resolved. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: FLU3
Symptoms: Rash generalised
Clinical narrative: Rash started on arm vaccine given in spread to body 2 days post vaccine, treated with BENADRYL. 3/4/13 improved, still with mild symptoms. Pt reports that grandmother also has adverse reaction to flu vaccine.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, PNC13, VARCEL
Symptoms: Body temperature increased, Bronchitis, Chest X-ray abnormal, Febrile convulsion, Feeling abnormal
Clinical narrative: Mom called at 10 AM 3/5/13. Child had school entry shots here 3/4/13. Day care provider reported child has temp of 104 degrees F. He is "Out of it" & body is twitching; I told mom to call provider; Have her dial 911 & have pt taken to ER. At hospital DX: Febrile seizure & Bronchitis. Child sent home with mom with ZITHROMAX x5 days. TYLENOL/ADVIL for temp control.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, HEPA, MMR, PNC13, VARCEL
Symptoms: Muscle twitching
Clinical narrative: Mom called at 10 AM 3/5/13. Child had school entry shots here 3/4/13. Day care provider reported child has temp of 104 degrees F. He is "Out of it" & body is twitching; I told mom to call provider; Have her dial 911 & have pt taken to ER. At hospital DX: Febrile seizure & Bronchitis. Child sent home with mom with ZITHROMAX x5 days. TYLENOL/ADVIL for temp control.
Sex: U
Vaccine: RV5
Symptoms: Drug administered to patient of inappropriate age, 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 who was a nine month old was administered the third dose of oral ROTATEQ (lot number, expiry date and route were not reported), orally. No adverse effects reported. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Injection site pain
Clinical narrative: This spontaneous report was received from a 66 year old male patient. On 24-FEB-2013 the patient was vaccinated with ZOSTAVAX in the left arm. The patient's route of administration was not reported. On 26-FEB-2013, 3 days after onset of therapy the patient experienced injection site pain and joint pain to the point that he went to the emergency room. He was prescribed 600 mg MOTRIN (frequency not specified) and 50 mg Tramadol (frequency not specified) and sent home the same day. The outcome of injection site pain and joint pain was reported as not recovered/not resolved. The reporter did not provide causality for these events. Additional information is not expected.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Muscular weakness, Myalgia, Pain in extremity
Clinical narrative: This spontaneous report was received from a 66 year old male patient. On 24-FEB-2013 the patient was vaccinated with ZOSTAVAX in the left arm. The patient's route of administration was not reported. On 26-FEB-2013, 3 days after onset of therapy the patient experienced injection site pain and joint pain to the point that he went to the emergency room. He was prescribed 600 mg MOTRIN (frequency not specified) and 50 mg Tramadol (frequency not specified) and sent home the same day. The outcome of injection site pain and joint pain was reported as not recovered/not resolved. The reporter did not provide causality for these events. Additional information is not expected.
Age: 66.0
Sex: M
Vaccine: VARZOS, VARZOS, VARZOS
Symptoms: Arthralgia, Feeling cold, Lethargy, Myalgia
Clinical narrative: This spontaneous report was received from a 66 year old male patient. On 24-FEB-2013 the patient was vaccinated with ZOSTAVAX in the left arm. The patient's route of administration was not reported. On 26-FEB-2013, 3 days after onset of therapy the patient experienced injection site pain and joint pain to the point that he went to the emergency room. He was prescribed 600 mg MOTRIN (frequency not specified) and 50 mg Tramadol (frequency not specified) and sent home the same day. The outcome of injection site pain and joint pain was reported as not recovered/not resolved. The reporter did not provide causality for these events. Additional information is not expected.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Pain in extremity, Rotator cuff syndrome, Tenderness
Clinical narrative: Persistent pain in (L) mid upper arm 6 months after injection. Tender. Subsequently developed impingement syndrome of shoulder, but tenderness out of proportion to expected referred pain.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Abnormal labour, Exposure during pregnancy, Injection site pruritus, Peripartum haemorrhage, Vaccination site swelling
Clinical narrative: Initial case was received from a consumer on 28 February 2013. An adult female patient (age not reported) received dose one an intradermal injection of FLUZONE intradermal, sanofi pasteur Inc., lot number UT4464AA (site and side not reported) on 25 January 2013. The patient was determined to be 37 weeks gestation at the time of vaccination. The patient's current pregnancy history included kidney stones before the vaccine. She had no treatment for infertility. Date of last menstrual period was reported as 09 May 2012 and estimated date of delivery was reported as 21 February 2013 (did not follow DD/MM/YYYY). On an unspecified date, the patient experienced labor excessive bleeding (reported as current pregnancy history). The patient experienced vaccine insertion site slightly swollen and itchy on unspecified date. Laboratory or diagnostic tests and treatments were not reported. The patient's outcome and pregnancy outcome were not reported. Documents held by sender: None.
Age: 12.0
Sex: M
Vaccine: FLU3, HPV4, TDAP
Symptoms: Anxiety, Disturbance in attention, Dyskinesia, Energy increased, Initial insomnia
Clinical narrative: "Approx 45 min after vaccination" felt anxious. "Arms felt twitchy" lasted for 2 hrs. in all, felt he couldn't focus on a task & increased energy - ran in place to relieve feelings. Felt at times he couldn't control his movements. This satisfied his increased anxiety per mother. Difficulty falling asleep. Did attend school as usual 1/10/13. No medical follow up. Called nurse practitioner in AM & was not concerned. Mth stated this helped her to feel better.
Age: 12.0
Sex: M
Vaccine: FLU3, HPV4, TDAP
Symptoms: Muscle twitching
Clinical narrative: "Approx 45 min after vaccination" felt anxious. "Arms felt twitchy" lasted for 2 hrs. in all, felt he couldn't focus on a task & increased energy - ran in place to relieve feelings. Felt at times he couldn't control his movements. This satisfied his increased anxiety per mother. Difficulty falling asleep. Did attend school as usual 1/10/13. No medical follow up. Called nurse practitioner in AM & was not concerned. Mth stated this helped her to feel better.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy student refers to an unspecified number of patients. On an unknown date, an unspecified number of patiens may have been administered (Merck) VARIVAX (lotnumber and route of administration was not reported) that was exposed to an unsupported temperature excursion (stored between 6F and 10F for an unspecified period of time and the average overall temperature may not have been at 5F or below). No adverse effect was reported. No further information was available. There was not relatedness reported for (Merck) VARIVAX. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. On 23-OCT-2012 ZOSTAVAX (lot# H0111048 / expiry date 09-MAY-2013) was reconstituted with expired sterile diluent (lot #E010687 / expiry date February 2012)(subcutaneous) and administered to the patient. Dose and dose number were  not reported. No adverse symptoms were reported. This case is linked to cases MARRS#: 1302USA008550, 1303USA003573, 1303USA003574 and 1303USA003575 (same reporter link). Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a registered nurse refers to a female patient (age unknown). On an unknown date, the patient was vaccinated with PNEUMOVAX23 (dose, route, lot number not provided). Concomitant medication was not reported. On an unknown date, the patient was administered PNEUMOVAX23 and developed a pink swollen ring like area where she was vaccinated. At the time of the report, the outcome of pink swollen ring like area where she was vaccinated was unknown. Pink swollen ring like area where she was vaccinated was unknown related to PNEUMOVAX23. Additional information has been requested.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMRV
Symptoms: Burning sensation, Injection site erythema, Injection site rash
Clinical narrative: Pink rash with burning sensation. Treatment included ATARAX, Cephalexin, ORAPRED ODT. Rash on left thigh.
Sex: U
Vaccine: PPV
Symptoms: Blood immunoglobulin G decreased, Blood test abnormal, Computerised tomogram head abnormal, Unevaluable event
Clinical narrative: Introduction: Chronic sinusitis causes significant morbidity. Atopy and immunodeficiency are known predisposing risk factors to chronic sinusitis. Recently, multiple studies have shown a linkage between patients with chronic sinusitis who do not meet diagnostic criteria with cystic fibrosis (CF) and a single cystic fibrosis gene mutation. The CF gene was discovered years ago, its role in CF syndrome is still unclear. In these patients, intravenous immunoglobulin (IVIg) has been used for immune replacement and immunomodulation. We describe our experience using IVIg in 2 patients with full CF mutation and 6 patients with a single mutation. Clinical Data: Our 8 patients ranged in age from 3 to 56 years with various CF mutations. The gene mutations included F508CF in 2 patients; single copy of F505CF in 4 patients; W1282X in 1 patient; and R117H in 1 patient. All patients were diagnosed with chronic sinus disease and had received repeated courses of antibiotic therapy. All had positive CT scans for the sinuses. An immune work-up was performed: all patients had low borderline lgG levels (450 plus or minus 56); 4 patients had an lgG3 subclass deficiency; 2 patients had low lgA; and 1 patient had low lgM. All patients had low isohemagglutinin levels. All patients had no response to pneumococcal vaccine (manufacturer unknown), and 4 had a low response to tetanus, polio and Haemophilus influenzae type B vaccines. Results: All patients were treated with IVIg (600-800 mg/Kg body weight) and recorded major improvement in the incidence of acute sinusitis with no further sinus surgeries recorded. A decreased use of antibiotic therapy was noted. Patients and caregivers reported that quality of life of energy levels had increased an average of 4 steps on a scale of 1-10. The full CF mutation patients were able to preserve their lung function and no hospitalizations were recorded after therapy was instituted. Discussion: The CF mutation combined with an aberrant immune system can lead to chronic sinus infections in single mutations, as well as lung destruction in full CF mutation, from various infectious and inflammatory pathways. IVIg therapy can benefit these patients by reducing the number of infections. IVIg can benefit patients with CF mutation: - In single mutation as immune replacement in preventing chronic sinus infection. - In full CF mutation as an immunomodulatory agent and to reduce post-infectious inflammatory changes. Additional information has been requested.
Age: 31.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a physician refers to a 31 year old female patient. On 06-MAR-2013, the patient was inadvertently vaccinated with a dose of ZOSTAVAX (lot number and expiry date were not reported), 0.65 milligrams (ml), subcutaneously in the left arm instead of VARIVAX (Merck). It was the staff error. No adverse effects reported. Additional information is not expected.
Sex: U
Vaccine: VARZOS
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-JAN-2013 ZOSTAVAX (lot# H0111048 / expiry date 09-MAY-2013) was reconstituted with expired sterile diluent (lot# E010687 / expiry date February 2012)(subcutaneous) and administered to the patient. Dose and dose number were not reported. No adverse symptoms were reported. This case is linked to cases MARRS#: 1302USA008550, 1303USA003573; 1303USA003575 and 1303USA003576 (same reporter link). Additional information has been requested.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Influenza like illness, Oedema peripheral, Pain in extremity
Clinical narrative: Flu-like symptoms; significant arm swelling and soreness.
Age: 11.0
Sex: M
Vaccine: HPV4, MNQ
Symptoms: Syncope
Clinical narrative: Child had 1st fainting episode after receiving the HPV vaccine. Was given smelling salt (ammonia inhalant).  Recovered quickly, sat up after 10 minutes, then had 2nd fainting spell. Heart rate 100, given oxygen via nasal cannula, 2 liter flow rate for 15 minutes. Allowed to lay down for 15 min, then sit for 15 min.  Room was hot, per mom, patient did not not eat prior to immunization.  911 called initially, but mom refused.  Pt was able to walk out of clinic on his own after 30 minutes of observation.
Age: 53.0
Sex: M
Vaccine: PPV
Symptoms: Arthralgia, Injection site erythema, Injection site swelling
Clinical narrative: Pt had redness and swelling at the site that reportedly decreased in size since 2/26 (date of vaccination).  Pt also reported pain in joints which subsided in a few days.
Age: 39.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Condition aggravated, Hypothyroidism
Clinical narrative: Hypothyroidism NOS on 2013-03-01, clinician comment: The patient had long standing hypothyroidism before the vaccinations were given. This is not a reaction to a vaccine.
Sex: M
Vaccine: MMR, MMR
Symptoms: Communication disorder
Clinical narrative: Information has been received from a consumer (patient's mother) concerning a male patient of unknown age, who on unknown dates, was vaccinated with three doses of MMR II at 2, 6 and 17 months of age (doses, routes and lot #s not reported). It was reported that, on unspecified date, the patient developed subsequent various reactions. After the last dose of MMR II, the patient could no longer communicate. At the time of the report, the patient's outcome was unknown. Relatedness for the events was not reported for MMR II. Additional information has been requested.
Sex: M
Vaccine: MMR, MMR
Symptoms: Adverse reaction, Communication disorder, Dyspnoea, Nervous system disorder
Clinical narrative: Information has been received from a consumer (patient's mother) concerning a male patient of unknown age, who on unknown dates, was vaccinated with three doses of MMR II at 2, 6 and 17 months of age (doses, routes and lot #s not reported). It was reported that, on unspecified date, the patient developed subsequent various reactions. After the last dose of MMR II, the patient could no longer communicate. At the time of the report, the patient's outcome was unknown. Relatedness for the events was not reported for MMR II. Additional information has been requested.
Sex: U
Vaccine: VARZOS
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 02-JAN-2013 ZOSTAVAX (lot # H0111048/expiry date 09-MAY-2013) was reconstituted with expired sterile diluent (lot # E010687/expiry date February 2012) (subcutaneous) and administered to the patient. Dose and dose number were not reported. No adverse symptoms were reported. This case is linked to cases MARRS#: 1302USA008550, 1303USA003573, 1303USA003574 and 1303USA003576 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On 06-MAR-2013, the patient was vaccinated with an expired 0.65 ml dose of ZOSTAVAX (Lot # 672428/1599AA, expiration date 13-JAN-2013) SQ. The patient was not experiencing any known symptoms. Additional information has been requested.
Sex: U
Vaccine: VARZOS
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 16-FEB-2013 ZOSTAVAX (lot # H0111048/expiry date 09-MAY-2013) was reconstituted with expired sterile diluent (lot # E010687/expiry date February 2012) (subcutaneous) and administered to the patient. Dose and dose number were not reported. No adverse symptoms were reported. This case is linked to cases MARRS#: 1303USA003573, 1303USA003574, 1303USA003575 and 1303USA003576 (same reporter link). Additional information has been requested.
Age: 18.0
Sex: F
Vaccine: HEPAB, MNQ, TDAP, VARCEL
Symptoms: Dysphagia, Dyspnoea
Clinical narrative: Difficulty breathing, difficulty swallowing, labor breathing. 0.3 epi and 25 mg of Benadryl given.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain
Clinical narrative: Big, round, swollen, larger than a half dollar, red, hot, and painful/sore on arm where shot was administered. Lasted for 2 weeks. Hurt to touch and move too much.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Pain of skin
Clinical narrative: Big, round, swollen, larger than a half dollar, red, hot, and painful/sore on arm where shot was administered. Lasted for 2 weeks. Hurt to touch and move too much.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Discomfort, Insomnia, Pain
Clinical narrative: Patient was given flu vaccine in the breathmobile on 1/16/2013. Called 1/17/2013 in the morning to report pain not relieved by Tylenol and sleeplessness due to discomfort. Stated there was no swelling. Never had a reaction to influenza in past.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Axillary pain, Injection site erythema, Oedema peripheral
Clinical narrative: The injection site became red and reached a size of 2.5 inches. There was some initial swelling and pain in the armpit.
Age: 4.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling to L deltoid.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV
Symptoms: Injection site erythema, Injection site rash
Clinical narrative: 5inch by 5inch red rash on left thigh surrounding injection site.
Age: 0.5
Sex: F
Vaccine: FLU3, PPV
Symptoms: Blood test, Hypoaesthesia, Injected limb mobility decreased, Injection site pain, Lumbar puncture
Clinical narrative: Severe pain when administered numbness in arm and hand. Could not raise arm at all.
Age: 0.5
Sex: F
Vaccine: FLU3, PPV
Symptoms: Nuclear magnetic resonance imaging
Clinical narrative: Severe pain when administered numbness in arm and hand. Could not raise arm at all.
Age: 36.0
Sex: F
Vaccine: VARCEL
Symptoms: Erythema, Oedema peripheral, Pruritus generalised, Tenderness
Clinical narrative: Arm became swollen, tender, and red circumferentially.  Generalized itching all over body, has lasted for 5 days and continues.
Age: 12.0
Sex: F
Vaccine: FLU3, HEPA, HPV4, MNQ, TDAP
Symptoms: Injection site bruising, Injection site erythema, Injection site nodule, Injection site pruritus, Nodule
Clinical narrative: Pt received vaccinations at Public Health Nursing on 11/05/2012. Three days after she noticed some redness and itching, and some bruising on the L upper arm where vaccinations were administered.  A month and a half ago a nodule appeared in the same place without redness or irritation.  Denies fever or chills or other s/s of infection.  2 cm bolus lesion with boggy/fluctuant exterior and underlying hard nodule no ecchymosis, erythema, not warm on palpation.
Age: 12.0
Sex: F
Vaccine: FLU3, HEPA, HPV4, MNQ, TDAP
Symptoms: Skin lesion
Clinical narrative: Pt received vaccinations at Public Health Nursing on 11/05/2012. Three days after she noticed some redness and itching, and some bruising on the L upper arm where vaccinations were administered.  A month and a half ago a nodule appeared in the same place without redness or irritation.  Denies fever or chills or other s/s of infection.  2 cm bolus lesion with boggy/fluctuant exterior and underlying hard nodule no ecchymosis, erythema, not warm on palpation.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Arthritis, Bone pain, Joint swelling
Clinical narrative: Experiencing bone pain throughout my body.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Headache, Injection site erythema, Pruritus
Clinical narrative: Red pin began to grow 1:52 PM 03/06/2013. 03/07/2013 4:49am Injection site redness grew to 1.5 inches. 03/08/2013 6:30AM Injection site redness grew to 2 inches. 03/08/2013 06:15 P< injection site redness grew to 4 inches, itching accompanied with headache.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Fall, Guillain-Barre syndrome, Immunoglobulin therapy, Knee arthroplasty, Loss of control of legs
Clinical narrative: While patient recouping from knee replacement surgery, he lost control of his legs, causing a fall. He was taken to Hospital. It was then determined that he has pneumonia. Over the following 24 hours, Guillain Barre Syndrome set in causing complete paralysis.  Intravenous immunoglobulin was administered at Hospital the following week. Patient has since been transferred to another hospital and is still under treatment.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Lumbar puncture, Paralysis, Pneumonia
Clinical narrative: While patient recouping from knee replacement surgery, he lost control of his legs, causing a fall. He was taken to Hospital. It was then determined that he has pneumonia. Over the following 24 hours, Guillain Barre Syndrome set in causing complete paralysis.  Intravenous immunoglobulin was administered at Hospital the following week. Patient has since been transferred to another hospital and is still under treatment.
Age: 2.0
Sex: F
Vaccine: HEPA
Symptoms: Drug administered at inappropriate site, Joint swelling, Skin discolouration
Clinical narrative: This case was reported by a pharmacist, the subject's mother and described the occurrence of bilateral ankle swelling in a 24-month-old female subject who was vaccinated with HAVRIX (GlaxoSmithKline). Concurrent vaccination included HAVRIX; GlaxoSmithKline; unknown; unknown given on an unspecified date. On 15 February 2013 at 10:30 the subject received 2nd dose of HAVRIX (unknown, left arm). On 25 February 2013, during vaccination with HAVRIX, the subject experienced vaccine administered at inappropriate site. On or about 25 February 2013, 10 days after vaccination with HAVRIX, the subject experienced discoloration of ankles and swelling of the right ankle and progressed to the left ankle a day later. The pharmacist, who is also the mother of the subject, reported her daughter experienced swelling and discoloration of the ankles approximately 10 days after vaccination with HAVRIX. The subject was hospitalized; infection, nephritic causes and a few other possible causes were ruled out. The actual diagnosis from the hospital was not clearly communicated from the mother. The mother noticed that vasculitis was reported in postmarketing section of the product insert (PI) and wanted more information on vasculitis, in effort to find a cause for her daughters' condition. None of the treating physicians suspected HAVRIX as a cause of the events that the subject experienced. The subject is no longer hospitalized. It was noted that the subject had no issues after the first dose of HAVRIX. At the time of reporting the bilateral ankle swelling resolved and discoloration of ankles was unresolved.
Age: 84.0
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Had shingles rash on side of arm and on leg with a lot of pain.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HEP, PNC13
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: No adverse reactions reported by patients mother. Patient received two doses of Hepatitis B at well child check on 3/7/2013. Advised patients mother to call office should any reactions occur.
Sex: U
Vaccine: VARZOS
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 07-FEB-2013 ZOSTAVAX (lot # H0111048/expiry date 09-MAY-2013) was reconstituted with expired sterile diluent (lot # E010687/expiry date February 2012) (subcutaneous) and administered to the patient. Dose and dose number were not reported. No adverse symptoms were reported. This case is linked to cases MARRS#: 1302USA008550, 1303USA003574, 1303USA003575 and 1303USA003576 (same reporter link). Additional information has been requested.
Age: 1.21
Sex: M
Vaccine: DTAP, HIBV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth
Clinical narrative: (L) side of thigh red and swollen since yesterday, no fever. 8cm x 8cm dia. warm to the touch & firm.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to an unspecified number of patients of unknown age and gender. The patients' medical history and concurrent conditions were not provided. During the time period of 03-FEB-2013 through 13-FEB-2013 the patients were vaccinated with a dose of PROQUAD. Dose, route and lot number were not provided. The nurse reported that the patients received improperly stored PROQUAD. No adverse event reported. Additional information has been requested.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site joint pain, Injection site pain
Clinical narrative: 3 months of shoulder pain in the (L) arm that was vaccinated. Began w/ intense burning at the site. It eventually went away.
Age: 30.0
Sex: M
Vaccine: MNQ, TYP
Symptoms: Body temperature increased, Pain in extremity
Clinical narrative: Temperature reported of 105 approximately 12 hours after vaccine. Significant pain in arm - (R) >> (L).
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Dizziness, Erythema, Headache, Muscular weakness
Clinical narrative: Got the Pneumococcal PPV 23 vaccine on March 6, 2013. On March 7 the pain became worse and redness is worse. That night pain was very intense whole body hurt. Had chills, fever, headache, nausea, dizziness, and muscle weakness. Came in to see doctor on March 8 going to take meds for pain & swelling.
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Nausea, Pain, Pyrexia, Swelling
Clinical narrative: Got the Pneumococcal PPV 23 vaccine on March 6, 2013. On March 7 the pain became worse and redness is worse. That night pain was very intense whole body hurt. Had chills, fever, headache, nausea, dizziness, and muscle weakness. Came in to see doctor on March 8 going to take meds for pain & swelling.
Age: 48.0
Sex: F
Vaccine: MMR
Symptoms: Urticaria
Clinical narrative: Started getting hives beginning 3/7/13 at 10:00 AM & progressed all day until she went to the ER at midnight. MD rx'd steroids & PEPCID. States sxs are decreasing today (3/8/13).
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Chest discomfort, Chest pain, Erythema, Oedema peripheral, Skin warm
Clinical narrative: (R) arm swollen, red & hot to touch chest pain, tight chest.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: Information has been received from a medical assistant concerning a patient, who on 04-MAR-2013 or 05-MAR-2013 was vaccinated with a dose of improperly stored GARDASIL (dose, route and lot # not reported), which had been drawn up into a plastic syringe on 02-MAR-2013. No adverse effect was reported. Additional information has been requested.
Age: 1.04
Sex: F
Vaccine: VARCEL
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Pyrexia
Clinical narrative: This spontaneous report as received from a other health professional refers to a 1 year old female patient. On 11-FEB-2013, the patient was vaccinated with the first dose of VARIVAX (merck) (LOT# H017243) subcutaneous (dose unspecified by reporter). No other co suspects were reported. No concomitant therapy was reported. On 24-FEB-2013 also reported as 10 days after the vaccination VARIVAX (merck), the patient experienced redness, swelling and rash at site of injection with fever of 102.6 F per 2 days. The outcome of redness, swelling, rash and fever was reported as recovered / resolved on 27-FEB-2013. Additional information is not expected.
Age: 18.0
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age. On 16-SEP-2011, the patient was vaccinated with the first 0.5 ml dose of GARDASIL (Lot # not reported) intramuscularly, on 13-MAR-2012, the patient was vaccinated with the second 0.5 ml dose of GARDASIL (Lot # not reported) intramuscularly and on 26-DEC-2012, the patient received the third 0.5 ml dose of GARDASIL (Lot # not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a patient of unknown age. On an unknown date, the patient was vaccinated with an expired dose of ZOSTAVAX (route and lot # not reported). No adverse effect was reported. 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 pharmacist refers to a patient of unknown age and gender. 4 years ago in 2009, the patient was vaccinated with the first dose of GARDASIL (dose, route and lot not reported). Pharmacist reported that the patient who was at the time of the phone call in the pharmacy to receive dose 2 of GARDASIL which woul dbe late. Dose 1 was administered 4 years ago. No symptoms reported. The outcome of the event was unknown. The reporter considered the event to be not related to GARDASIL. Additional information is not expected.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Herpes zoster, Insomnia, Pain, Rash
Clinical narrative: This spontaneous report was received from an 82 year old female patient concerning herself. The patient had a lumpectomy on an unspecified date 12 years ago and completed radiation therapy on an unspecified date 12 years ago, patient recently had a mastectomy in May 2012, with no treatment given after the mastectomy. Two years ago in 2011, the patient was vaccinated with ZOSTAVAX, (dose and lot not reported) subcutaneous. The patient states that at the time of the phone call she had shingles. The patient stated that the actual disease started 5 weeks ago on 14-FEB-2013. Initially the patient thought she had pulled a muscle in her rib cage as the developing zoster virus started with the pain. "Then a couple of days went by and a half dollar rash developed with multiple pustules." The rash was no longer evident however there was still a red discoloration were the rash was, without any raised rash. The patient stated that there was residual pain in the right front of her rib cage that leads around to the back on the same side. She was having great difficulty sleeping because of the pain. The patient reported that one day the pain would be gone and then the pain comes back. The patient went for a routine visit to her physician when she initially experienced the pain, for what she thought was a pulled muscle in her side, on 14-FEB-2013. On 15-FEB-2013, she went back to her physician because she had developed the shingles rash. The patient was prescribed acyclovir and hydrocodone as treatment for the shingles. The patient also stated she gets an upset stomach when she takes any narcotics, including the hydrocodone. The outcome of the even was unknown. The relatedness between the event and ZOSTAVAX was unknown. Additional information is not expected.
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pustular
Clinical narrative: This spontaneous report was received from an 82 year old female patient concerning herself. The patient had a lumpectomy on an unspecified date 12 years ago and completed radiation therapy on an unspecified date 12 years ago, patient recently had a mastectomy in May 2012, with no treatment given after the mastectomy. Two years ago in 2011, the patient was vaccinated with ZOSTAVAX, (dose and lot not reported) subcutaneous. The patient states that at the time of the phone call she had shingles. The patient stated that the actual disease started 5 weeks ago on 14-FEB-2013. Initially the patient thought she had pulled a muscle in her rib cage as the developing zoster virus started with the pain. "Then a couple of days went by and a half dollar rash developed with multiple pustules." The rash was no longer evident however there was still a red discoloration were the rash was, without any raised rash. The patient stated that there was residual pain in the right front of her rib cage that leads around to the back on the same side. She was having great difficulty sleeping because of the pain. The patient reported that one day the pain would be gone and then the pain comes back. The patient went for a routine visit to her physician when she initially experienced the pain, for what she thought was a pulled muscle in her side, on 14-FEB-2013. On 15-FEB-2013, she went back to her physician because she had developed the shingles rash. The patient was prescribed acyclovir and hydrocodone as treatment for the shingles. The patient also stated she gets an upset stomach when she takes any narcotics, including the hydrocodone. The outcome of the even was unknown. The relatedness between the event and ZOSTAVAX was unknown. Additional information is not expected.