chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report was received from a pharmacist refers to a female patient of unknown age. The patient current conditions included high blood pressure and depression. On 03-JUN-2013 the patient was vaccinated with ZOSTAVAX (dose and frequency was not reported) lot # J000430 (Expiry: 10-APR-2014), subcutaneous. Concomitant therapies included SERTRALINE HYDROCHLORIDE, WARFARIN SODIUM and METOPROLOL. ON an unknown date, the patient experienced shingles on the neck. The patient sought medical attention and went to the physician office. On 11-FEB-2014, the patient was prescribed with hydrocodone/acetaminophen and VALTREX. It was reported that the patient has not yet started with these medications. The outcome of the event shingles on the neck was reported as not recovered. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
Sex: F
Vaccine: FLU3
Symptoms: Influenza A virus test positive
Clinical narrative: This initial case was received from a nurse on 04 February 2014. Of note, the nurse also reported another patient with confirmed influenza following vaccination with FLUZONE; that event is captured in case 2014SA015528. A female patient in her "30's" (exact age not reported), with no reported concomitant medications or relevant medical history, received an injection of FLUZONE (lot number UH906AC) in October 2013. Approximately three months post-vaccination, during the week of 27 January 2014, the patient tested positive for A strain influenza, using rapid flu test "Alere BionixNOW Influenza A and B". The outcome was reported to be resolved. Additional documents held by sender: None.
Age: 1.11
Sex: M
Vaccine: HEPA, MMRV, PNC13
Symptoms: Varicella post vaccine
Clinical narrative: Chickenpox
Sex: F
Vaccine: FLU3
Symptoms: Influenza A virus test positive
Clinical narrative: This initial case was received from a nurse on 04 February 2014. Of note, the nurse also reported another patient with confirmed influenza following vaccination with FLUZONE; that event is captured in case 2014SA015529. A female patient in her "50's" (exact age not reported), with no reported concomitant medications or relevant medical history, received an injection of FLUZONE (lot number UH906AC) in October 2013. Approximately three months post-vaccination, during the week of 27 January 2014, the patient tested positive for A strain influenza, using rapid flu test "Alere BionixNOW Influenza A and B". The outcome was reported to be resolved. Additional documents held by sender: None.
Sex: U
Vaccine: MMR
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a pharmacist refers to a unspecified patients of unknown age. Medical history and drug reactions/allergies were not reported. On an unknown date, the unspecified patients were vaccinated with improperly stored M-M-R II (lot, dose and route not reported). Concomitant medication was not reported. Additional information has been requested.
Age: 55.0
Sex: M
Vaccine: HEP, MMR
Symptoms: Blood test normal, Electromyogram normal, Nuclear magnetic resonance imaging spinal normal, Unevaluable event
Clinical narrative: Received mandatory vaccinations days later I woke up with intense.
Age: 8.0
Sex: F
Vaccine: HEP, IPV, TDAP
Symptoms: Syncope
Clinical narrative: Vasovagal syncope following multi-vaccine administration.
Age: 6.0
Sex: F
Vaccine: FLU3, MMR
Symptoms: Crying, Dry skin, Pallor, Syncope, Unresponsive to stimuli
Clinical narrative: Child was noted to have very brief syncopal episode in office. Aprox 5mins after vaccine administration was complete the child became quiet and slid down off her chair her eyes were open but she did not respond when called the first time. I called her name again while proceeding to place her in prone position her face was pale, and her skin was dry. She immediately began crying at that time asking me what I was doing and why. Her mom stated that this had never happened before but did report that child had not yet had any breakfast and also that her father always has syncopal episodes every time he gets any type of injection.
Age: 40.0
Sex: F
Vaccine: DTAP
Symptoms: Erythema, Nausea, Swelling
Clinical narrative: Golf ball sized swelling, redness and nausea.
Age: 35.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Cellulitis, Pain, Pain in extremity
Clinical narrative: BODYACHES, ARM PAIN, CELLULITIS.
Age: 35.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Cellulitis, Pain, Pain in extremity
Clinical narrative: Bodyaches, cellulitis, arm pain.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Urticaria
Clinical narrative: Hives all over, took Benadryl.
Age: 13.0
Sex: M
Vaccine: FLUC3
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: None reported.
Sex: U
Vaccine: PPV
Symptoms: Drug dose omission, Product container issue, Product quality issue
Clinical narrative: This spontaneous report as received from a health care student refers to a patient of unknown age and gender. Pertinent medical history and drug reactions/allergies were not reported. On an unknown date, the patient was vaccinated with PNEUMOVAX23 (lot # H013394, expiration date 05-MAR-2014) (dose and route were not reported). Concomitant therapy was not reported. On an unknown date, 4 unspecified patients received doses of PNEUMOVAX23 from a vial that was initially intact but when withdrawing the 5th (last) dose the vial leaked from around the sides between crimp and stopper. No leaking occurred when withdrawing the first 4 doses. The patient was unable to receive a dose of PNEUMOVAX23 because of this product quality issue. No adverse effect reported. The rubber stopper was present. The stopper was present, it appeared normal. The crimp on tightly and properly. No evidence of cracks(s) breakage on the vial. No pressure was noticed when inserting a syringe needle such as product spraying out of the vial. The product leak out. It was not from the needle insertion site or IV connection site. It was from around the sides between crimp and stopper. It was not from under the crimp. The Product dripped out of the vial. Air was injected into the vial, 0.5 ml. It was not upon removing vial from carton. The flip cap was not removing. Liquid product withdrawing. The syringe needle was not inserting while injecting air. The syringe needle was inside of the vial when the leaking was noted. The patient missed the dose. No retrival mococcal vaccine, PNEUMOVAX23 vial had been discarded. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Rash erythematous
Clinical narrative: 4 days after immunization patient got 4-5 large red spots on body. Since that time the rash has spread over chest, arms, and back but the spots are smaller. The large spots were small blisters, but the smaller ones do not have blisters. Patient going to try BENADRYL, hydrocortisone cream and call the MD.
Sex: U
Vaccine: HEP
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to a pediatric patient of unknown age. On an unknown date the pediatric patient was inadvertently vaccinated with an expired third dose of RECOMBIVAX HB lot # 1259AA (Expiry: 19-DEC-2013) 0.5 ml, intramuscular. No adverse effects reported. No further information reported. Additional information has been requested.
Age: 1.25
Sex: M
Vaccine: DTAP, VARCEL
Symptoms: Rash vesicular, Varicella, Varicella post vaccine
Clinical narrative: Generalized chicken pox rash about 12 lesions from head to groin.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event
Clinical narrative: This spontaneous report was received from a pharmacist refers to a adult patient of unknown demography. On an unknown date, the patient who was intended to vaccinate with M-M-R II was inadvertently vaccinated with PROQUAD (dose, route and frequency was not reported). No adverse effects reported. Additional information is not expected.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Dysphonia, Neck pain, Tension headache, Tinnitus, Wheezing
Clinical narrative: Patient received Tdap vaccine at 1015 AM on 2/11/14. Patient reported to nurse at 1200, patient reported 20-25 minutes after injection that symptoms of tightness in head (front), ringing in both ears and generalized neck pain had began. As patient was talking, voice begin to change to raspy voice and audible wheezing. Wheezing was noted upon auscultation at 1225. PO BENADRYL 25mg administered at 1227. EMS called at 1230, report called to medical director. RN at ED.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pruritus, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Area of erythema, swelling, itching, and increased warmth of L upper arm where vaccine administered measuring 9.5cm x 17cm.
Age: 4.0
Sex: F
Vaccine: FLUN4
Symptoms: Gait disturbance, Pain in extremity
Clinical narrative: My daughter woke up in the morning complaining of leg pain. She was having difficulty walking as well. I contacted the pediatrician who sent her to see a neurosurgeon since symptoms were not improving. After several hours we arrived at hospital to only be seen by ER physician as symptoms were improving. This is the second year in a row that my daughter has had issues with her lower extremities following the nasal mist flu vaccine.
Age: 74.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Heart rate increased, Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: This is about a pneumonia shot I received from my Dr. and NOT at my request. I never get sick and I sure regret 100% getting that shot in my right arm biceps area 6 inchs below the injection site became so swollen it was like 2 baseballs inside my arm. It was swollen clear around my arm above the elbow. One hour later the arm above the elbow turned bright red in color and extremely hot to the touch. The redness spread over to the middle of my chest and under the right arm pit. I could not bend my arm. the pain was horrific. My heart rate was so fast I was unable to sleep at all that Saturday night. Being the weekend there was no one at Drs. office to report this to so I suffered it out until Monday a.m. when I drove to Dr.'s office to prove to them what had occurred. I did take pictures.  if there is a class action suite going on over these pneumonia shots I need to know where to sign up. my Dr. recommended an antibiotic med. but now I am afraid to take any that contains penicillin or sulfa. NEVER have I been allergic to anything ever, now thanks to that injection I am at risk. HERE IT IS 2 WEEKS LATER AND MY INJECTION SITE STILL BURNS AND IS SNSITIVE TO TOUCH.  I HATE IT.
Age: 74.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site swelling, Injection site warmth, Insomnia
Clinical narrative: This is about a pneumonia shot I received from my Dr. and NOT at my request. I never get sick and I sure regret 100% getting that shot in my right arm biceps area 6 inchs below the injection site became so swollen it was like 2 baseballs inside my arm. It was swollen clear around my arm above the elbow. One hour later the arm above the elbow turned bright red in color and extremely hot to the touch. The redness spread over to the middle of my chest and under the right arm pit. I could not bend my arm. the pain was horrific. My heart rate was so fast I was unable to sleep at all that Saturday night. Being the weekend there was no one at Drs. office to report this to so I suffered it out until Monday a.m. when I drove to Dr.'s office to prove to them what had occurred. I did take pictures.  if there is a class action suite going on over these pneumonia shots I need to know where to sign up. my Dr. recommended an antibiotic med. but now I am afraid to take any that contains penicillin or sulfa. NEVER have I been allergic to anything ever, now thanks to that injection I am at risk. HERE IT IS 2 WEEKS LATER AND MY INJECTION SITE STILL BURNS AND IS SNSITIVE TO TOUCH.  I HATE IT.
Age: 74.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Aphagia, Burning sensation, Cough, Erythema, Local swelling
Clinical narrative: This is about a pneumonia shot I received from my Dr. and NOT at my request. I never get sick and I sure regret 100% getting that shot in my right arm biceps area 6 inchs below the injection site became so swollen it was like 2 baseballs inside my arm. It was swollen clear around my arm above the elbow. One hour later the arm above the elbow turned bright red in color and extremely hot to the touch. The redness spread over to the middle of my chest and under the right arm pit. I could not bend my arm. the pain was horrific. My heart rate was so fast I was unable to sleep at all that Saturday night. Being the weekend there was no one at Drs. office to report this to so I suffered it out until Monday a.m. when I drove to Dr.'s office to prove to them what had occurred. I did take pictures.  if there is a class action suite going on over these pneumonia shots I need to know where to sign up. my Dr. recommended an antibiotic med. but now I am afraid to take any that contains penicillin or sulfa. NEVER have I been allergic to anything ever, now thanks to that injection I am at risk. HERE IT IS 2 WEEKS LATER AND MY INJECTION SITE STILL BURNS AND IS SNSITIVE TO TOUCH.  I HATE IT.
Age: 74.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Musculoskeletal disorder, Nasopharyngitis, Nausea, Pain in extremity, Pruritus
Clinical narrative: This is about a pneumonia shot I received from my Dr. and NOT at my request. I never get sick and I sure regret 100% getting that shot in my right arm biceps area 6 inchs below the injection site became so swollen it was like 2 baseballs inside my arm. It was swollen clear around my arm above the elbow. One hour later the arm above the elbow turned bright red in color and extremely hot to the touch. The redness spread over to the middle of my chest and under the right arm pit. I could not bend my arm. the pain was horrific. My heart rate was so fast I was unable to sleep at all that Saturday night. Being the weekend there was no one at Drs. office to report this to so I suffered it out until Monday a.m. when I drove to Dr.'s office to prove to them what had occurred. I did take pictures.  if there is a class action suite going on over these pneumonia shots I need to know where to sign up. my Dr. recommended an antibiotic med. but now I am afraid to take any that contains penicillin or sulfa. NEVER have I been allergic to anything ever, now thanks to that injection I am at risk. HERE IT IS 2 WEEKS LATER AND MY INJECTION SITE STILL BURNS AND IS SNSITIVE TO TOUCH.  I HATE IT.
Age: 74.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pyrexia, Skin warm, Vomiting
Clinical narrative: This is about a pneumonia shot I received from my Dr. and NOT at my request. I never get sick and I sure regret 100% getting that shot in my right arm biceps area 6 inchs below the injection site became so swollen it was like 2 baseballs inside my arm. It was swollen clear around my arm above the elbow. One hour later the arm above the elbow turned bright red in color and extremely hot to the touch. The redness spread over to the middle of my chest and under the right arm pit. I could not bend my arm. the pain was horrific. My heart rate was so fast I was unable to sleep at all that Saturday night. Being the weekend there was no one at Drs. office to report this to so I suffered it out until Monday a.m. when I drove to Dr.'s office to prove to them what had occurred. I did take pictures.  if there is a class action suite going on over these pneumonia shots I need to know where to sign up. my Dr. recommended an antibiotic med. but now I am afraid to take any that contains penicillin or sulfa. NEVER have I been allergic to anything ever, now thanks to that injection I am at risk. HERE IT IS 2 WEEKS LATER AND MY INJECTION SITE STILL BURNS AND IS SNSITIVE TO TOUCH.  I HATE IT.
Age: 4.0
Sex: F
Vaccine: FLU3, HEPA, VARCEL
Symptoms: Cellulitis, Induration, Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Vaccines given 2/7/14-- left thigh received Hep A (lot 55PZ4, Glaxosmithkline) and VZV (lot J006108, Merck); developed increasing tenderness, redness, and warmth around injection site on left thigh; by day 2 after the vaccine (2/9/14) pt was seen in urgent care and was noted to have cellulitis (large area of redness 4-5cm diameter, with induration and tenderness); improved within 24hrs on cephalexin.  Unclear of local reaction vs true cellulitis.
Age: 4.0
Sex: F
Vaccine: FLU3, HEPA, VARCEL
Symptoms: Local reaction, Tenderness
Clinical narrative: Vaccines given 2/7/14-- left thigh received Hep A (lot 55PZ4, Glaxosmithkline) and VZV (lot J006108, Merck); developed increasing tenderness, redness, and warmth around injection site on left thigh; by day 2 after the vaccine (2/9/14) pt was seen in urgent care and was noted to have cellulitis (large area of redness 4-5cm diameter, with induration and tenderness); improved within 24hrs on cephalexin.  Unclear of local reaction vs true cellulitis.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Injection site pain, Injection site pruritus, Skin swelling
Clinical narrative: Swelling of skin this morniing 2/14/14 no fever; itching and pain on pressure (L) arm at site of varicella and milder reaction at site of KINRIX.
Age: 1.33
Sex: M
Vaccine: FLU3, MMR, VARCEL
Symptoms: Blister
Clinical narrative: Patient developed 3 - 5 vesicular lesions on torso 2/8/14.
Age: 54.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain
Clinical narrative: Patient received FLUVIRIN vaccination on 11/22/13. She is complaining of shoulder pain after receiving vaccination. According to patient, has not taken any pain med. to help but still in pain (shoulder).
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Crying, Drooling, Head injury, Pallor
Clinical narrative: After immunizations were given patient was crying and upset. About 5-10 seconds after that patient started drooling was leaning back and hit head on mirror. Turned pale. had a partially chewed tootsie roll in her mouth, easily removed. Dr checked patient. P 108 Sao2 97% BP 90/58. Patient was kept for 20 min for observation. Dr said patient was feeling better and could go home.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to 3 patients of unknown demographics. The patient's current conditions or medical history were not reported. ON an unknown date, the patients might have been vaccinated with improperly stored ZOSTAVAX lot # J000432 exp. 10-APR-2014, (dose and route were not provided). No adverse effects were reported. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report was received from a consumer (patient mother) refers to a female patient of unknown age. On 31-JUL-2008, the patient was vaccinated with the first dose of GARDASIL (dose, route and frequency was not reported). On 02-OCT-2008, the patient was vaccinated with the second dose of GARDASIL (dose, route and frequency was not reported). On 01-DEC-2008, the patient was vaccinated with the third dose of GARDASIL (dose, route and frequency was not reported). No AE reported. No further information ws provided. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site rash
Clinical narrative: This spontaneous report as received from a physician via company representative refers to an unspecified number of patients (patients demographics were unspecified). These Patients medical history and allergies were unspecified. On an unknown date, unspecified number of patients were vaccinated with PNEUMOVAX 23 injection, (dosage, frequency, route of administration and lot number were unspecified). Concomitant medications were unspecified. On an unknown date, unspecified number of patients developed large rash around the injection site after receiving PNEUMOVAX. No product quality complaint was involved. The outcome of event large rash around the injection site after receiving PNEUMOVAX was unknown. Also reported as the rash took around two to four weeks to go away. The reporter causality assessment for the event with the therapy of PNEUMOVAX 23 was not reported. No further information was provided. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Swelling
Clinical narrative: Redness and swelling developed around injection site. Large areas of swelling.
Age: 0.33
Sex: F
Vaccine: HEPA, PPV, VARCEL
Symptoms: Rash
Clinical narrative: Rash on L arm, chest and back.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Fatigue, Headache, Joint swelling
Clinical narrative: Joints swollen and painful, severe headache, fatigue.
Age: 18.0
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Local reaction, Rash, Rash pruritic
Clinical narrative: Patient received varicella vaccine and flu vaccine; had local reaction and that night developed rash behind right knee that was itchy.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Pain of skin, Tenderness
Clinical narrative: For a few days (7-10) I had pain in my scalp.  It was bothering me for days, aching, sore, tender to the touch, it really hurt.  Parting my hair it looked red on the left side of my head.  Eventually it went away.  Didn't realize it could have been a side effect of the Shingles Vaccine.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Blood test, Computerised tomogram, Guillain-Barre syndrome, Lumbar puncture, Nuclear magnetic resonance imaging
Clinical narrative: Guillain Barre Syndrome, AIDP.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Ultrasound scan, X-ray
Clinical narrative: Guillain Barre Syndrome, AIDP.
Age: 31.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Pt was only 61 years old at time of vaccination, package insert indicated patient age should be over 65.
Age: 49.0
Sex: F
Vaccine: DTAP, HEPA, IPV, JEVX, TYP
Symptoms: Joint range of motion decreased, Musculoskeletal pain, Periarthritis
Clinical narrative: Lasting shoulder pain bilateral and reduced range of motion in the bilateral arms, worse in left arm (adhesive capsulitis).
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Dysphonia, Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling, redness, soreness, itchy at injection site, hoarseness, wheezing, treated with Benadryl and Albuterol.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Wheezing
Clinical narrative: Swelling, redness, soreness, itchy at injection site, hoarseness, wheezing, treated with Benadryl and Albuterol.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Patient came in to get advise of swollen red injection site on left arm 2 days post-vaccination.
Age: 31.0
Sex: M
Vaccine: FLUC3, FLUC3
Symptoms: Pain, Pain in extremity, Tenderness
Clinical narrative: Pt complains of sore arm lasting 1+ month following immunization.  Sore with movement and to touch.
Age: 53.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site rash, Rash
Clinical narrative: Rash on arm (upper and lower) in which FLUVIRIN PF vaccine administered. Persisted several days to my knowledge.
Age: 74.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Erythema, Heart rate increased, Injected limb mobility decreased, Injection site erythema, Injection site pain
Clinical narrative: Sir; this is the second filing of my reaction to the pneumonia shot. The first report to you I made an error on the injection site. I received the shot in my left upper arm not the right arm as I stated. Your time limit to report problems is absurd. Its pressure to hurry. The reaction to the pneumonia shot was extremely bad. It has been two weeks and my arm still aches and burns and itches. I have never been allergic to any thing. Either I received an outdated or spoiled or to much of the serum.  My left arm was so swollen I could not use it for 3 days it was hot to the touch and bright red. I developed a fever with nausea and vomiting. I couldn't eat for 2 days. Since it happened on a Sat. no one was at Dr. office until mon. When I drove there and showed the Dr. she said she had never seen anyone that had a reaction to the shot. I didn't ask for it it was recommended that I have it.  The redness spread from my inner left arm over to the middle of my chest..I took pictures.  After 3 days I developed a head cold with coughing the Dr. recommended antihistamine and an antibiotic, of which I refuse to take due to a  possible reaction like the pneumonia shot. Now what do I do now. I want an explanation.
Age: 74.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Injection site swelling, Injection site warmth, Insomnia
Clinical narrative: Sir; this is the second filing of my reaction to the pneumonia shot. The first report to you I made an error on the injection site. I received the shot in my left upper arm not the right arm as I stated. Your time limit to report problems is absurd. Its pressure to hurry. The reaction to the pneumonia shot was extremely bad. It has been two weeks and my arm still aches and burns and itches. I have never been allergic to any thing. Either I received an outdated or spoiled or to much of the serum.  My left arm was so swollen I could not use it for 3 days it was hot to the touch and bright red. I developed a fever with nausea and vomiting. I couldn't eat for 2 days. Since it happened on a Sat. no one was at Dr. office until mon. When I drove there and showed the Dr. she said she had never seen anyone that had a reaction to the shot. I didn't ask for it it was recommended that I have it.  The redness spread from my inner left arm over to the middle of my chest..I took pictures.  After 3 days I developed a head cold with coughing the Dr. recommended antihistamine and an antibiotic, of which I refuse to take due to a  possible reaction like the pneumonia shot. Now what do I do now. I want an explanation.
Age: 74.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Aphagia, Burning sensation, Cough, Erythema, Local swelling
Clinical narrative: Sir; this is the second filing of my reaction to the pneumonia shot. The first report to you I made an error on the injection site. I received the shot in my left upper arm not the right arm as I stated. Your time limit to report problems is absurd. Its pressure to hurry. The reaction to the pneumonia shot was extremely bad. It has been two weeks and my arm still aches and burns and itches. I have never been allergic to any thing. Either I received an outdated or spoiled or to much of the serum.  My left arm was so swollen I could not use it for 3 days it was hot to the touch and bright red. I developed a fever with nausea and vomiting. I couldn't eat for 2 days. Since it happened on a Sat. no one was at Dr. office until mon. When I drove there and showed the Dr. she said she had never seen anyone that had a reaction to the shot. I didn't ask for it it was recommended that I have it.  The redness spread from my inner left arm over to the middle of my chest..I took pictures.  After 3 days I developed a head cold with coughing the Dr. recommended antihistamine and an antibiotic, of which I refuse to take due to a  possible reaction like the pneumonia shot. Now what do I do now. I want an explanation.
Age: 74.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Musculoskeletal disorder, Nasopharyngitis, Nausea, Pain in extremity, Pruritus
Clinical narrative: Sir; this is the second filing of my reaction to the pneumonia shot. The first report to you I made an error on the injection site. I received the shot in my left upper arm not the right arm as I stated. Your time limit to report problems is absurd. Its pressure to hurry. The reaction to the pneumonia shot was extremely bad. It has been two weeks and my arm still aches and burns and itches. I have never been allergic to any thing. Either I received an outdated or spoiled or to much of the serum.  My left arm was so swollen I could not use it for 3 days it was hot to the touch and bright red. I developed a fever with nausea and vomiting. I couldn't eat for 2 days. Since it happened on a Sat. no one was at Dr. office until mon. When I drove there and showed the Dr. she said she had never seen anyone that had a reaction to the shot. I didn't ask for it it was recommended that I have it.  The redness spread from my inner left arm over to the middle of my chest..I took pictures.  After 3 days I developed a head cold with coughing the Dr. recommended antihistamine and an antibiotic, of which I refuse to take due to a  possible reaction like the pneumonia shot. Now what do I do now. I want an explanation.
Age: 74.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Pyrexia, Skin warm, Vomiting
Clinical narrative: Sir; this is the second filing of my reaction to the pneumonia shot. The first report to you I made an error on the injection site. I received the shot in my left upper arm not the right arm as I stated. Your time limit to report problems is absurd. Its pressure to hurry. The reaction to the pneumonia shot was extremely bad. It has been two weeks and my arm still aches and burns and itches. I have never been allergic to any thing. Either I received an outdated or spoiled or to much of the serum.  My left arm was so swollen I could not use it for 3 days it was hot to the touch and bright red. I developed a fever with nausea and vomiting. I couldn't eat for 2 days. Since it happened on a Sat. no one was at Dr. office until mon. When I drove there and showed the Dr. she said she had never seen anyone that had a reaction to the shot. I didn't ask for it it was recommended that I have it.  The redness spread from my inner left arm over to the middle of my chest..I took pictures.  After 3 days I developed a head cold with coughing the Dr. recommended antihistamine and an antibiotic, of which I refuse to take due to a  possible reaction like the pneumonia shot. Now what do I do now. I want an explanation.
Age: 51.0
Sex: F
Vaccine: UNK
Symptoms: Chills, Diarrhoea, Pyrexia, Urticaria, Vomiting
Clinical narrative: Vomiting, dirrhrea, hives, fever, chills.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Fatigue, Headache, Oropharyngeal pain, Pain
Clinical narrative: Sore throat, headache, coughing, achy, tired.
Age: 29.0
Sex: M
Vaccine: HEP
Symptoms: Musculoskeletal stiffness, Nausea
Clinical narrative: EMPLOYEE CALLED CENTER ON 2/16/14 TO REPORT SYMPTOMS FOLLOWING THE VACCINATION OF HEPATITIS B ON 2-15-14. HE REPORTED THAT A COUPLE OF HOURS AFTER RECEIVING THE IMMUNIZATION HE FELT NAUSEOUS AND HAD STIFFNESS TO HIS LEFT ARM. EMPLOYEE STATED THAT HE WENT TO SLEEP FOR SEVERAL HOURS AND UPON WAKING UP AROUND 9:00PM HIS SYMPTOMS REMAINED.  HE WENT BACK TO BED FOR THE NIGHT AND HIS SYMPTOMS WERE STILL PRESENT UPON CALLING CENTER IN THE MORNING.
Age: 54.0
Sex: M
Vaccine: DTAP
Symptoms: Dizziness, Nausea, Vertigo
Clinical narrative: Dizziness and nausea. Had to sit without moving head until 2:00PM when symptoms ceased. Just movement of head caused room to spin.
Age: 28.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site pain
Clinical narrative: Its been almost a month and still have reoccuring pain only in the arm and area where the shot was given.  Tolerable pain however its enough to be concerned.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Chest discomfort, Dizziness, Dyspnoea, Hypoaesthesia
Clinical narrative: Within a few minutes of injection in left arm, arm went numb all the way to fingertips. Then I had a tingling sensation and dizziness then breathing difficulty.  Could not catch my breath, very heavy feeling in chest and chest tightness and wheezing.  I work in an intensive care and was observed closely. I took Benadryl within 20 min. of event and continued to take Benadryl Q 4-6 hours x next 3 days.  Chest tightness, intermittent dizziness, and overall weak feeling lasted 3-4 days.
Age: 50.0
Sex: F
Vaccine: FLU4
Symptoms: Paraesthesia, Wheezing
Clinical narrative: Within a few minutes of injection in left arm, arm went numb all the way to fingertips. Then I had a tingling sensation and dizziness then breathing difficulty.  Could not catch my breath, very heavy feeling in chest and chest tightness and wheezing.  I work in an intensive care and was observed closely. I took Benadryl within 20 min. of event and continued to take Benadryl Q 4-6 hours x next 3 days.  Chest tightness, intermittent dizziness, and overall weak feeling lasted 3-4 days.
Age: 37.0
Sex: F
Vaccine: FLUX, PPV, TDAP
Symptoms: Axillary pain, Chills, Confusional state, Dizziness, Heart rate increased
Clinical narrative: Severe soreness in arm by 9:30 AM, fever, chills, body pain so that I couldn't get up, stabbing pain under arm of injection, lightheaded, dizzy, rapid heart beat, confusion, plugged nose and drainage even after 800 mg Motrin and full dose of Benadryl. Until 02/15/14. Then itchy rash broke out on upper stomach and arms and legs during the night of 02/15/14 I still have the rash.
Age: 37.0
Sex: F
Vaccine: FLUX, PPV, TDAP
Symptoms: Nasal congestion, Pain, Pain in extremity, Pyrexia, Rash pruritic
Clinical narrative: Severe soreness in arm by 9:30 AM, fever, chills, body pain so that I couldn't get up, stabbing pain under arm of injection, lightheaded, dizzy, rapid heart beat, confusion, plugged nose and drainage even after 800 mg Motrin and full dose of Benadryl. Until 02/15/14. Then itchy rash broke out on upper stomach and arms and legs during the night of 02/15/14 I still have the rash.
Age: 37.0
Sex: F
Vaccine: FLUX, PPV, TDAP
Symptoms: Rhinorrhoea
Clinical narrative: Severe soreness in arm by 9:30 AM, fever, chills, body pain so that I couldn't get up, stabbing pain under arm of injection, lightheaded, dizzy, rapid heart beat, confusion, plugged nose and drainage even after 800 mg Motrin and full dose of Benadryl. Until 02/15/14. Then itchy rash broke out on upper stomach and arms and legs during the night of 02/15/14 I still have the rash.
Age: 38.0
Sex: F
Vaccine: PPV
Symptoms: Blood test, Pain, Pruritus, Swelling
Clinical narrative: Swelling, pain, itching, later extreme swelling and pain.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: Patient received high dose Fluzone under the age of 65.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered to patient of inappropriate age
Clinical narrative: None.
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Decreased appetite, Extensive swelling of vaccinated limb, Eye pain, Local swelling, Lymphadenopathy
Clinical narrative: Legs and all extremities are all swollen up excessively, tongue swollen, lymph nodes feel swollen, pain behind left eye, no appetite, rash on thighs. The symptoms are continuing as of 2/16/2014.
Age: 36.0
Sex: F
Vaccine: FLUX
Symptoms: Rash, Swollen tongue
Clinical narrative: Legs and all extremities are all swollen up excessively, tongue swollen, lymph nodes feel swollen, pain behind left eye, no appetite, rash on thighs. The symptoms are continuing as of 2/16/2014.
Age: 38.0
Sex: F
Vaccine: FLU3
Symptoms: Defaecation urgency, Hypoaesthesia, Laboratory test normal, Paraesthesia, Presyncope
Clinical narrative: Left foot went numb. Prickly numbness creeping up neck and around ears in waves causing near syncope. Also having simultaneous waves of tingling throughout buttocks to anus making the feeling of the need to move bowels. Short, frequent waves followed by short resolution and then it happened again for about 14 hours. Left foot numbness continues to be intermittent. On 11/14/13 the left hand went numb and continues to do so intermittently. Also have multiple areas of intermittent fasciculations, vibrations, muscles spasm to all areas of the body.
Sex: F
Vaccine: PPV
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age. On 07-FEB-2014 the patient was vaccinated with an expired dose of PNEUMOVAX 23 (lot # H010661, expiration date 02-FEB-2014) (dose unknown) via intramuscular route. No known adverse effects. Additional information is not expected.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a physician through email via healthcare worker refers to a patient of unknown demography. On an unknown date the patient was vaccinated with PNEUMOVAX 23 lot # J009833 (Expiry: 25-JAN-2015) (dose, route and frequency was not reported). On an unknown date the patient experienced significant pain, redness and swelling at the injection site. The outcome of the event significant pain, redness and swelling at the injection site was unknown. The reporter did not provide the causality between the event of significant pain, redness and swelling at the injection site and the suspect drug. The case is linked to the case 1402USA007454, 1402USA007455 and 1402USA007456 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a physician through email via healthcare worker refers to a patient of unknown demography. On an unknown date the patient was vaccinated with PNEUMOVAX 23 lot # J009833 (Expiry: 25-JAN-2015) (dose, route and frequency was not reported). On an unknown date the patient experienced significant pain, redness and swelling at the injection site. The outcome of the event significant pain, redness and swelling at the injection site was unknown. the reporter did not provide the causality between the event of significant pain, redness and swelling at the injection site and the suspect drug. This case is linked to case 1402USA006209, 1402USA007455 and 1402USA007456. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a physician through email via healthcare worker refers to a patient of unknown demography. On an unknown date the patient was vaccinated with PNEUMOVAX 23 lot # J009833 (Expiry: 25-JAN-2015) (dose, route and frequency was not reported). On an unknown date the patient experienced significant pain, redness and swelling at the injection site. The outcome of the event significant pain, redness and swelling at the injection site was unknown. The reporter did not provide the causality between the event of significant pain, redness and swelling at the injection site and the suspect drug. The case is linked to the case 1402USA006209, 1402USA007454 and 1402USA007456 (same reporter link). Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a physician through email via healthcare worker refers to a patient of unknown demography. On an unknown date the patient was vaccinated with PNEUMOVAX 23 lot # J009833 (Expiry: 25-JAN-2015) (dose, route and frequency was not reported). On an unknown date the patient experienced significant pain, redness and swelling at the injection site. The outcome of the event significant pain, redness and swelling at the injection site was unknown. The reporter did not provide the causality between the event of significant pain, redness and swelling at the injection site and the suspect drug. The case is linked to the case 1402USA006209, 1402USA007454 and 1402USA007455 (same reporter link). Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Rash
Clinical narrative: This spontaneous report as received from an administering pharmacist via a field employee refers to a female patient of unknown age. On 16-JAN-2014, the patient was vaccinated with a dose of ZOSTAVAX (lot # and expiry not reported), single dose, injection in the arm for shingles prevention. On 16-JAN-2014, for two weeks following administration, the patient experienced "an aggravating rash" which went away after two weeks (on 30-JAN-2014). The patient was left, however, with severe pain in the arm in which she had been injected. The patient was aggravated by movement. The patient did not seek medical attention. No treatment was given for adverse events. It was not reintroduced. The outcome of "severe pain in the arm" and "pain was aggravated by movement" was not recovered. Additional information has been requested.
Age: 16.0
Sex: F
Vaccine: FLUX, HPV4, MNQ
Symptoms: Syncope
Clinical narrative: This spontaneous report as received form a physician refers to a 16 year old female patient with no pertinent medical history or drug reactions/allergies. On 07-FEB-2014 the patient was vaccinated with the first dose of GARDASIL (lot # J009788, expiration date 17-MAR-2016). Other suspect therapies included flu vaccine (manufacturer unknown). Concomitant therapies included MENACTRA. The patient fainted after receiving GARDASIL. The patient was fasting prior to being vaccinated. The patient sought medical attention via office visit. There was no treatment was given for the AE. No lab diagnostics studies were performed. The physician had the patient lie down with her feet elevated and the patient recovered quickly on the same day. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Headache, Incomplete course of vaccination
Clinical narrative: This spontaneous report as received from clinical medical assistant via company representative refers to a male patient of unknown age concerning her son. On an unknown date the patient was vaccinated with GARDASIL, first dose (dose unit, lot# and expiry date unknown). On an unknown date the patient experienced headache after receiving the first dose of GARDASIL. No information was available on the severity or duration of the headache. Patient did not continue the GARDASIL series as a result of the headache. On an unknown date headache was recovered. Therapy with GARDASIL was discontinued. The outcome of headache was reported as recovered/resolved. No further information reported. Additional information is not expected.
Age: 25.0
Sex: F
Vaccine: FLU3
Symptoms: Injected limb mobility decreased, Pain, Sleep disorder, Vaccination site pain, Weight bearing difficulty
Clinical narrative: Case number PHHY2013US000945, is an initial spontaneous report received from Vaccine Adverse Event Reporting System (VAERS reference number: 472897) web site on 02 Jan 2013 and a follow up information was received from the quality assurance department on 11 Feb 2014. This report refers to 25-year-old female patient. Her medical history included allergy to penicillin. Concomitant medication included prenatal vitamins. She was vaccinated with FLUVIRIN (batch number: unknown) intramuscularly into the right arm on 05 Sep 2012. On the same day, the patient developed severe pain and immobility. During day one to five after vaccination, the patient experienced complete immobility of right arm and shoulder and inability to sleep due to the stabbing pains in the arm. Mobility of the arm returned to about 85% and pain receded to a bearable state during day 6 to 19. The patient again experienced complete immobility and severe pain on day 20 after vaccination. There were no signs of amnesia. Mobility again returned to about 85% and the patient's pain receded to a bearable state and then mobility returned to about 90-95% by day 31-60. Pain present during movements at a certain angle and with extra weight on the arm. Pain varied each day, but was on a bearable level. Visit to a physician was postponed due to a 2.5 month trip abroad. He was about to visit a physician on 18 Nov 2012. Long-term and permanent damage was expected. The final outcome of the event was condition unchanged. The reporter assessed the event as serious (disability) and causality assessment was not reported. Upon follow up received on 11 Feb 2014, quality assurance department confirmed that the initially reported batch number 1223SP is invalid and hence batch review records (QA investigations) were cancelled. Follow up information was received from the quality assurance department (QA reference number: 208894) on 11 Feb 2014: It was confirmed that the initially reported batch number 1223SP is invalid and hence batch review records (QA investigations) were cancelled.
Age: 60.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Ophthalmic herpes zoster, Oral herpes, Vaccination site swelling
Clinical narrative: Case number PHHY2013US140261 is an initial spontaneous report received via vaccine adverse event reporting system (VAERS reference number: 504361) on 03 Dec 2013, with the follow-up received from Quality Assurance Department (reference number: 269289) on 12 Feb 2014: This report refers to a 60 years-old female patient. Her medical history included allergy to ciprofloxacin, codeine and methocarbamol and concomitant medications were amlodipine, PREMPRO, levothyroxine, CYMBALTA and sertraline. She was vaccinated with FLUVIRIN (batch number: 1307601, Expiry date: 31 Mar 2014) intramuscularly in the left arm and ZOSTAVAX (other manufacturer, batch number: J003796) subcutaneously in the right arm on 13 Sep 2013. On 26 Sep 2013, she had a swollen bar at the vaccination site, fever blisters in nostrils and shingles in the eye. She went to emergency room. The outcome was reported as condition unchanged. Based on the investigation performed, QA department stated that, the FLUVIRIN (batch number: 1307601) was manufactured in accordance with the approved internal procedures and it was in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (reference number: 269289) on 12 Feb 2014: Updated batch review report.
Age: 60.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Delusion, Disorientation, Pyrexia, Tremor
Clinical narrative: Case number PHHY2013US140354 is an initial spontaneous report received via vaccine adverse event reporting system (VAERS reference number: 504457) on 03 Dec 2013 and a follow up report from the QA department (QA reference number: 269576) received on 12 Feb 2014. This report refers to a 60 years-old female patient. Her medical history was not reported. Her concomitant medications included morphine, furosemide, levothyroxine, gabapentin, lamotrigine; VESICARE and ARAVA. She was vaccinated with FLUVIRIN (batch number: 1307601, expiry date: 31 Mar 2014) and PNEUMOVAX (other manufacturer, batch number: 1947AA); both vaccines administered intramuscularly in the right arm on 19 Sep 2013. On the same day evening after vaccination, she had fever, shaking, disorientation and delusions. She was taken to emergency room by her husband. She was treated with BENADRYL. The outcome was reported as complete recovery. Seriousness and causality were not reported. Batch review report (reference number: 269576) received from quality assurance department on 12 Feb 2014: Based on the document review, it was stated that the concerned FLUVIRIN batch number 1307601 was manufactured in accordance with approved internal procedures and it was in compliance with the current good manufacturing practices (cGMP) requirements. Follow up report from the QA department (QA reference number: 269576) received on 12 Feb 2014: Batch review report was updated.