chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Local swelling, Pain, Pain in extremity, Skin tightness, Skin warm
Clinical narrative: Starting the afternoon of when the shot was given the patient had a very sharp pain in her arm, swollen, painful to touch, hot to touch arm felt like there was a tight band around it. In the course of the next 7 days she acquired Stevens Johnson syndrome in a burn unit.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Stevens-Johnson syndrome
Clinical narrative: Starting the afternoon of when the shot was given the patient had a very sharp pain in her arm, swollen, painful to touch, hot to touch arm felt like there was a tight band around it. In the course of the next 7 days she acquired Stevens Johnson syndrome in a burn unit.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Medication error, Wrong drug administered
Clinical narrative: This spontaneous report was received from a pharmacist concerning a 77 year old female patient with chronic lymphocytic leukemia (CLL). On 08-OCT-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot # J002968; expiration 14-JUNJ-2014) in the right arm. No other co-suspect therapy was reported. Concomitant medications were not provided. It was reported that on 08-OCT-2013, the patient wanted to get the tetanus, diphtheria and pertussis vaccine but there was a miscommunication and she requested ZOSTAVAX instead. She was not aware that ZOSTAVAX was for shingles. After ZOSTAVAX was administer, the patient realized that ZOSTAVAX was not what she wanted to get because of her history of CLL. Relevant laboratory data was unknown. The outcome of ZOSTAVAX administration in a patient with CLL was unknown. Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: Information was received from a nurse practitioner concerning a female patient. On 14-OCT-2013 the patient was vaccinated with her third dose of GARDASIL, intramuscular. The nurse reported that the patient had received her first two doses on a unspecified dates two years ago. No additional information available. No adverse effect was reported. Additional information is not expected.
Age: 59.0
Sex: U
Vaccine: VARZOS
Symptoms: Blood test, Cystoscopy, Discomfort, Pain, Swelling
Clinical narrative: This spontaneous report as received from an office manager refers to a 59 year old patient with cancer of prostate, hypertension and hyperlipidemia and no known drug allergies. In October 2013, about a week ago, the patient was vaccinated with ZOSTAVAX (Lot #, dose and route not provided). Concomitant therapies included LIPITOR, quinapril hydrochloride (manufacturer unknown) and hydrochlorothiazide (manufacturer unknown). Office manager stated that patient had a cystoscopy on 16-OCT-2013. On 17-OCT-2013, the patient visited office for pain and discomfort. The physician would like to prescribed MEDROL pack "steroids" to treat pain, swelling and discomfort but had not yet ordered. Last week patient underwent a physical exam which included blood work. The outcome of pain, swelling and discomfort was unknown. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to 18 patients who might have been vaccinated with doses of RECOMBIVAX HB (Lot # J000722, expiration date 17-SEP-2015) that were exposed to 31F for accumulative of 1 hour and 30 minutes between 04-OCT-2013 and 10-OCT-2013. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 79.0
Sex: M
Vaccine: PPV
Symptoms: Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a licensed practical nurse refers to a 79 year old male patient with joint pain, bursitis, hypertension and elbow pain. On 28-FEB-2013 the patient was vaccinated with a dose of PNEUMOVAX23 (lot # H017801, expiration date 08-JUL-2014, dose not reported) intramuscularly. It was reproted that within on e or two days of PNEUMOVAX23 administration, in March 2013, the patient experienced localized itching and swelling at the injection site in addition to heat in that area. The patient sought medical attention by calling the nurse. No treatment was given for the events. No lab diagnostics studies were performed. Within a week, in March 2013 these events resolved. The outcome of localized itching and swelling at the injection site in addition to heat in that area was reported as recovered/resolved.. The casual relationship between the PNEUMOVAS23 and the events was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as reported from a nurse practitioner refers to 18 patient who might have been vaccinated with doses of GARDASIL (Lot # H020910, expiration date 10-JUN-2015) that were exposed to 31F for accumulative of 1 hour and 30 minutes between 04-OCT-2013 and 06-OCT-2013. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain
Clinical narrative: Information was received from a 65 year old male consumer who was vaccinated with ZOSTAVAX one injection on 11-FEB-2010. On 30-SEP-2013, the patient came down with shingles. His doctor prescribed famciclovir 500 mg, 3 times a day; hydrocodone-acetaminophen (manufacturer unknown); and LYRICA 75 mg, 2-3 times daily. The patient reported that the pain stayed while the visible signs of shingles went away. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site pain
Clinical narrative: This spontaneous report as received from a physician refers to a female patient of unknown age. The patient has a history of nausea and vomiting after codeine use (manufacturer unspecified) on an unspecified date, and rash after penicillin use (manufacturer unspecified) on an unspecified date. The patient recovered on an  unspecified date. On 28-OCT-2013 the patient was vaccinated with a dose of ZOSTAVAX, intramuscular. Dose and lot number was not provided. There were no concomitant medications. The patient received ZOSTAVAX via the intramuscular route in error. On 29-OCT-2013, the patient developed pain at the site of the ZOSTAVAX injection. The patient went to see a physician. The patient was given ALEVE (manufacturer unspecified) for the pain on an unspecified date. No lab tests were performed. The patient had not recovered. No reporter causality was provided. Additional information has been requested.
Sex: M
Vaccine: VARZOS
Symptoms: Paraesthesia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a male patient of unknown age. It was reported that the patient had shingles on his ankles approximately 8 years before (on an unspecified date in October 2005). On 29-OCT-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiration date, dose were not reported). The patient stated that he had a tingling sensation in his ankles at the time of the report (on an unspecified date in October 2013). The outcome of tingling sensation in ankles was unknown. The patient sought medical attention, he contacted pharmacist. The relatedness between tingling sensation in ankles and ZOSTAVAX was not reported. Additional information has been requested.
Sex: U
Vaccine: HEPA
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unknown number of patients of unknown age and gender. It was reported that on unknown dates, the patients may have been vaccinated with doses of VAQTA (lot number, expiry date, dose and route unspecified) which was stored as low as 31 degrees Fahrenheit (F). No concomitant therapy was reported. No adverse effect was reported. This is one of the several reports from the same source. Additional information has been requested.
Age: 48.0
Sex: M
Vaccine: JEV1
Symptoms: Fatigue, Headache, Influenza like illness, Nausea, Vertigo
Clinical narrative: Flu like symptoms, fatigue, nausea, vomiting, vertigo, headaches.
Age: 48.0
Sex: M
Vaccine: JEV1
Symptoms: Vomiting
Clinical narrative: Flu like symptoms, fatigue, nausea, vomiting, vertigo, headaches.
Age: 61.0
Sex: F
Vaccine: PPV
Symptoms: Injection site mass, Pain in extremity
Clinical narrative: This spontaneous report was received from an approximately 61 year old female patient regarding herself. Current conditions of the patient included thyroid problems (unspecified), high cholesterol, atrial fibrillation (AFIB) and depression. There were no drug reactions or allergies. On 04-NOV-2013, the patient was vaccinated with 0.5 milliliter (ml) of PNEUMOVAX23 (lot number and expiry date unspecified), intramuscularly. Concomitant therapies included levothyroxine sodium, simvastatin, and venlafaxine hydrochloride. On 04-NOV-2013, within 2 hours of vaccination, her arm started hurting from her shoulder to her elbow. It ached like a bad tooth and she had an egg sized lump at the injection site. The following day (on 05-NOV-2013), the arm was still hurt but at the time of report (06-NOV-2013), the hurt was a lot less. Her concern was that the egg sized lump had moved from the injection site to her inner arm closer to the elbow. The patient sought medical attention (talked to the pharmacist). No treatment was given and no lab tests were performed. The patient was not recovered from the events at the time of report. The relatedness for the events was unknown for PNEUMOVAX23. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a certified medical assistant refers to a patient of unknown age and gender. On 01-NOV-2013 the patient was vaccinated with an expired dose of M-M-R II HSA, lot # 1405AA, exp. date 06-SEP-2013, subcutaneously, dose, strength, indication and site of administration not reported). No know adverse effects. Additional information has been requested.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Cellulitis
Clinical narrative: Patient experienced cellulitis type reaction approx 2 days after vaccination.
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Cough, Fatigue, Headache, Injection site erythema
Clinical narrative: 11/4/2013 - fatigue 11/05/2013 - fatigue, headache, red and warm-to-touch circle at point of injection 11/06/2013 - red and warm-to-touch circle at point of injection 11/07/2013 - severe pain in shoulder 11/08/2013 - severe pain in shoulder radiated up into left side of neck, back into shoulder blade and down into arm 11/09/2013 - severe pain in shoulder, weakness in left arm, tingling in left fingertips, on 7-8 on scale of 10 11/10/2013 - severe pain in shoulder, shoulder blade and neck continues, weakness in left arm, tingling in left fingertips 11/11/2013 - pain in shoulder decreased, fever, chills, congestion, coughing, sneezing, severe headache began early hours 11/12/2013 - continued discomfort in left shoulder, congestion decreased with medication, headache decreased in severity with medication
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Injection site joint discomfort, Injection site warmth, Muscular weakness, Musculoskeletal pain, Neck pain
Clinical narrative: 11/4/2013 - fatigue 11/05/2013 - fatigue, headache, red and warm-to-touch circle at point of injection 11/06/2013 - red and warm-to-touch circle at point of injection 11/07/2013 - severe pain in shoulder 11/08/2013 - severe pain in shoulder radiated up into left side of neck, back into shoulder blade and down into arm 11/09/2013 - severe pain in shoulder, weakness in left arm, tingling in left fingertips, on 7-8 on scale of 10 11/10/2013 - severe pain in shoulder, shoulder blade and neck continues, weakness in left arm, tingling in left fingertips 11/11/2013 - pain in shoulder decreased, fever, chills, congestion, coughing, sneezing, severe headache began early hours 11/12/2013 - continued discomfort in left shoulder, congestion decreased with medication, headache decreased in severity with medication
Age: 38.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity, Paraesthesia, Pyrexia, Respiratory tract infection, Sneezing
Clinical narrative: 11/4/2013 - fatigue 11/05/2013 - fatigue, headache, red and warm-to-touch circle at point of injection 11/06/2013 - red and warm-to-touch circle at point of injection 11/07/2013 - severe pain in shoulder 11/08/2013 - severe pain in shoulder radiated up into left side of neck, back into shoulder blade and down into arm 11/09/2013 - severe pain in shoulder, weakness in left arm, tingling in left fingertips, on 7-8 on scale of 10 11/10/2013 - severe pain in shoulder, shoulder blade and neck continues, weakness in left arm, tingling in left fingertips 11/11/2013 - pain in shoulder decreased, fever, chills, congestion, coughing, sneezing, severe headache began early hours 11/12/2013 - continued discomfort in left shoulder, congestion decreased with medication, headache decreased in severity with medication
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Autism, Autoimmune disorder, Irritability, Measles post vaccine, Rash
Clinical narrative: Measles rash on face, stomach and back; extreme fussiness; developed hives 8 days after measles rash began; diagnosed with autism 9 months after hives began; 1.5 years after vaccine, still has chronic autoimmune hives.
Age: 2.0
Sex: M
Vaccine: MMR
Symptoms: Urticaria
Clinical narrative: Measles rash on face, stomach and back; extreme fussiness; developed hives 8 days after measles rash began; diagnosed with autism 9 months after hives began; 1.5 years after vaccine, still has chronic autoimmune hives.
Age: 68.0
Sex: F
Vaccine: HEPA
Symptoms: Dizziness, Dysstasia, Gait disturbance, Hypertension, Nausea
Clinical narrative: Dizziness in bed during the night- Complete vertigo in the morning- unable to stand or walk unassisted- nausea- went to doctor- had high blood pressure and was sent to Medical Center.
Age: 68.0
Sex: F
Vaccine: HEPA
Symptoms: Vertigo
Clinical narrative: Dizziness in bed during the night- Complete vertigo in the morning- unable to stand or walk unassisted- nausea- went to doctor- had high blood pressure and was sent to Medical Center.
Age: 12.0
Sex: F
Vaccine: HPV4, TDAP
Symptoms: Blindness, Deafness, Pallor
Clinical narrative: Had Tdap shot with no problem. As soon as she was given the HPV shot she became pale and complained she cannot see or hear. BP was 61/45 PR 56 and SO2 was 73. Given Benadryl 2 tsp and cold water to drink. Applied cold compress to the face. BP went up to 75/50 and SO22 99. No loss of consciousness or difficulty bresthing. Call 911. She was fine when they arrive and mother refuse to take her to hospital.Parents brought child home and decided sahe was well and did not go the the hospital for follow up
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Sensation of heaviness
Clinical narrative: Sore, aching arm.  Feeling of heaviness in arm.
Age: 5.0
Sex: M
Vaccine: FLUX
Symptoms: Injection site rash
Clinical narrative: Rash at administration site.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Injected limb mobility decreased, Injection site swelling, Pain in extremity, Skin warm
Clinical narrative: Severe pain in left arm, radiating to left side of chest; Extreme swelling in upper left arm; Inability to lift left arm; Extreme warmth in Left arm.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Ageusia, Balance disorder, Headache, Myalgia, Nausea
Clinical narrative: Vertigo, headache, loss sense of balance, taste, nauseating, and muscle ache.  Can't smell anything other than continuously smell strong odor of exhausted fume. The most severe reaction last for a week and still suffering from the smell of exhausted fume odor and nauseating from time to time.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Parosmia, Vertigo
Clinical narrative: Vertigo, headache, loss sense of balance, taste, nauseating, and muscle ache.  Can't smell anything other than continuously smell strong odor of exhausted fume. The most severe reaction last for a week and still suffering from the smell of exhausted fume odor and nauseating from time to time.
Age: 32.0
Sex: F
Vaccine: FLUX
Symptoms: Asthenia, Pain in extremity
Clinical narrative: Injection was given at the very top of the left arm. I told the nurse it felt like she hit my bone, "I would have felt that" was her response. I have NEVER had a shot that far up on my arm before. I'm still having pain in my arm and almost feels like strength loss.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Erythema, Inflammation, Injection site reaction, Localised oedema
Clinical narrative: Pt had initial reaction to vaccine at site of injection. Staff monitored erythema and localized edema. Pt c/o pain at inflamed area. No f/c, n/v, ha, sob, doe, n/t, los. She had localized pain at point of inflammation that traveled down to mid forearm, and involved elbow. She described distant 'staph infection' and a hx of cysts and 'boils' when she was in a hot tub years ago. Ink lines where erythema and swelling has traveled showed migrating pattern. TTP at flexion of elbow and lateral upper arm. Moderate localized edema. No nodularity, skin was pinkish red with no borders of demarcation. No involvement of wrist distally. Grip strong, FROM at shoulder, PROM at elbow limited by pain.  This appeared to be an infective process with no clear external cellulitis, caused by a pneumoccocal vaccine administered upon admission.  Keflex QID and Bactrim BID was given to cover most concerns.
Age: 42.0
Sex: F
Vaccine: PPV
Symptoms: Pain, Pain in extremity, Staphylococcal infection, Swelling
Clinical narrative: Pt had initial reaction to vaccine at site of injection. Staff monitored erythema and localized edema. Pt c/o pain at inflamed area. No f/c, n/v, ha, sob, doe, n/t, los. She had localized pain at point of inflammation that traveled down to mid forearm, and involved elbow. She described distant 'staph infection' and a hx of cysts and 'boils' when she was in a hot tub years ago. Ink lines where erythema and swelling has traveled showed migrating pattern. TTP at flexion of elbow and lateral upper arm. Moderate localized edema. No nodularity, skin was pinkish red with no borders of demarcation. No involvement of wrist distally. Grip strong, FROM at shoulder, PROM at elbow limited by pain.  This appeared to be an infective process with no clear external cellulitis, caused by a pneumoccocal vaccine administered upon admission.  Keflex QID and Bactrim BID was given to cover most concerns.
Age: 18.0
Sex: M
Vaccine: FLUN4, HEPA, HPV4, TDAP
Symptoms: Loss of consciousness, Presyncope, Syncope, Tremor, Urinary incontinence
Clinical narrative: Pt received required vaccines; fainted approximately 5 minutes after vaccine administration.  Sx of vasovagal response included; LOC, loss of bladder control; body shaking.  Patient braced in chair to prevent injury; regained consciousness w/o ammonia capsule.  Given juice, ice pack, allowed to lie down with feet elevated for 20-30 minutes.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Body temperature increased, Injection site erythema, Injection site induration, Injection site oedema, Injection site pain
Clinical narrative: Pt c/o pain in right deltoid area where Pneumovax vaccine was administered rated 10/10. Temp = 100.1 tympanic, 99.0 Temporal. Area was hard, slightly swollen and redden. Very tender to touch. Area was circled by staff. Pt offered ice but refused. Tylenol, Ibuprofen and Vistaril provided. Later that afternoon, the area on right shoulder much improved. It was dime sized with mild redness and some edema.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Injection site swelling
Clinical narrative: Pt c/o pain in right deltoid area where Pneumovax vaccine was administered rated 10/10. Temp = 100.1 tympanic, 99.0 Temporal. Area was hard, slightly swollen and redden. Very tender to touch. Area was circled by staff. Pt offered ice but refused. Tylenol, Ibuprofen and Vistaril provided. Later that afternoon, the area on right shoulder much improved. It was dime sized with mild redness and some edema.
Age: 1.52
Sex: F
Vaccine: HEPA
Symptoms: Nausea, Vomiting
Clinical narrative: Patient was nauseated and vomited one time at 3 AM this morning.
Age: 24.0
Sex: M
Vaccine: SMALL
Symptoms: Back pain, Chills, Dyspnoea, Fatigue, Headache
Clinical narrative: Head ache, back pain, shortness of breath, chills and fatigue. Patient given Tylenol at ER.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Back pain, Mobility decreased, Pain in extremity
Clinical narrative: Shortly after the vaccine was administered (pneumococcal 23 lot number J005067), the patient experienced a sharp ache throughout her back and up and down her entire arm. She is using Tylenol alternating with aspirin to control the extreme pain which is still lingering 4 days later. She also states she has a "dead arm" in which she can barely lift and move. She is now questioning whether she will need therapy to rehabilitate.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3, IPV, MMRV
Symptoms: Injection site erythema, Injection site mass, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Huge red bump at injection site, size of a plum, red, hurts, itchy. Lump started small and got bigger overnight.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Decreased appetite, Dizziness, Hyperhidrosis, Malaise
Clinical narrative: Sudden dizziness, profuse sweating, nausea. Had to lay down with eyes closed and could not move his head w/o feeling like he would vomit. Persistent dizziness, malaise and low appetite since.
Age: 36.0
Sex: M
Vaccine: FLU3
Symptoms: Nausea
Clinical narrative: Sudden dizziness, profuse sweating, nausea. Had to lay down with eyes closed and could not move his head w/o feeling like he would vomit. Persistent dizziness, malaise and low appetite since.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Dyspnoea, Feeling abnormal, Nausea, Vomiting
Clinical narrative: Acute sob and difficulty breathing the evening after she rec'd her flu shot. Used the albuterol inhaler, which helped alot, but states she would have had to go to the ER if she hadn't had the inhaler. SOB resolved, but pt had nausea and vomiting that entire night, felt miserable. No hx of egg allergy. Has done well with flu shots in the past.
Age: 37.0
Sex: M
Vaccine: JEV1
Symptoms: Urticaria
Clinical narrative: Hives urticaria.
Age: 44.0
Sex: F
Vaccine: FLU3
Symptoms: Chest discomfort, Hypoaesthesia, Injection site induration, Sensation of heaviness
Clinical narrative: Numbness, heaviness in left arm, tightness in chest. Induration at injection site.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site discomfort, Paraesthesia
Clinical narrative: Left shoulder discomfort, tingling in 4th and 5th digits on left hand.  Dr. prescribed Mobic 15mg due to employee havingt symptoms for three weeks.
Age: 51.0
Sex: F
Vaccine: FLUX
Symptoms: Headache, Injection site pain
Clinical narrative: Severe headache and soreness at injection site.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain upper, Diarrhoea, Fatigue, Headache, Nausea
Clinical narrative: Stomach cramping, diarrhea, nausea, vomiting, headache, and fatigue.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Stomach cramping, diarrhea, nausea, vomiting, headache, and fatigue.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Diarrhoea, Dizziness, Nausea, Pyrexia
Clinical narrative: Dizzy, nausea, diarrhea, weakness, fever. Did not seek treatment until seeing Dr. 7 days later.
Age: 38.0
Sex: M
Vaccine: FLU4
Symptoms: Drug administered at inappropriate site, Immediate post-injection reaction, Injection site discomfort, Injection site nodule
Clinical narrative: Employee vaccinated as part of annual influenza campaign.  Felt that vaccine was administered too high and too far posterior on shoulder.  Had immediate discomfort which progressively worsened over the next several days / weeks.  He reported to Employee Health today for evaluation.  He has a soft tissue nodule in the area of the vaccine.  It appears to be in the subacromial space rather than the deltoid.
Age: 14.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Injection site erythema, Injection site swelling, Pyrexia, Vomiting
Clinical narrative: Grandmother called @ 3:00 p.m and that  states patient having "low grade fever" with slight swelling and redness at injection site and vomiting.  Vaccine given @ 9:15 AM 11/8/13. Adverse event began @ 1:30 PM 11/08/13.
Age: 14.0
Sex: F
Vaccine: TDAP, TDAP
Symptoms: Infectious mononucleosis, Injection site erythema, Injection site swelling, Pyrexia, Vomiting
Clinical narrative: Grandmother called @ 3:00 p.m and that  states patient having "low grade fever" with slight swelling and redness at injection site and vomiting.  Vaccine given @ 9:15 AM 11/8/13. Adverse event began @ 1:30 PM 11/08/13.
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Cough, Dyspnoea, Eye discharge, Eye swelling, Influenza like illness
Clinical narrative: **Premedicated 2 hours before vaccine with 50mg Benadryl (25mgx2).**  6:30 PM:"Eyes began to ooze, sore throat" 8:00 PM:"Felt like I had the flu, cough, runny nose, achy and feverish" 12:00 AM:"Middle of the night I woke up and my lips and eyes were swollen, I felt a little short of breath with sores in my mouth"   (This continued through the weekend, and she went to her doctor on Monday)
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Lip swelling, Oropharyngeal pain, Pain, Pyrexia, Rhinorrhoea
Clinical narrative: **Premedicated 2 hours before vaccine with 50mg Benadryl (25mgx2).**  6:30 PM:"Eyes began to ooze, sore throat" 8:00 PM:"Felt like I had the flu, cough, runny nose, achy and feverish" 12:00 AM:"Middle of the night I woke up and my lips and eyes were swollen, I felt a little short of breath with sores in my mouth"   (This continued through the weekend, and she went to her doctor on Monday)
Age: 37.0
Sex: F
Vaccine: FLU3
Symptoms: Stomatitis
Clinical narrative: **Premedicated 2 hours before vaccine with 50mg Benadryl (25mgx2).**  6:30 PM:"Eyes began to ooze, sore throat" 8:00 PM:"Felt like I had the flu, cough, runny nose, achy and feverish" 12:00 AM:"Middle of the night I woke up and my lips and eyes were swollen, I felt a little short of breath with sores in my mouth"   (This continued through the weekend, and she went to her doctor on Monday)
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Anaphylactoid reaction, Dyspnoea
Clinical narrative: I received a request by patient to get an influenza vaccination at around 11:40 AM on 11/12/2013. He said that he had never had a reaction to any vaccine in the past and had had the influenza vaccine in the past with no problems. He said he was feeling well today and noted that he had allergies to Motrin, Ibuprofen, Demerol, Norvasc and Altace. I administered the vaccine at 11:45 AM. At noon I received a call from his wife telling me he was having anaphylactic-like symptoms, with difficulty breathing and possible throat swelling. I asked her where the patient was and she said he was at store in downtown and that he was on his way to her. She told me he has had anaphylactic reactions in the past. I told her that she should call 911 if he indeed was having those symptoms. She stated she would call me back with an update.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Arthralgia, Bronchospasm, Chills, Dizziness, Headache
Clinical narrative: Patient stated s/s development "the next morning". Reported the following, "Got side effects from the T-Dap shot. Effects inclued lightheadedness, fever, chills, body shakes, headache, joint aches, nauseous, bronchial spasms."
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Impaired work ability, Nausea, Pyrexia, Tremor
Clinical narrative: Patient stated s/s development "the next morning". Reported the following, "Got side effects from the T-Dap shot. Effects inclued lightheadedness, fever, chills, body shakes, headache, joint aches, nauseous, bronchial spasms."
Age: 2.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site rash, Rash erythematous, Vaccination site swelling
Clinical narrative: Per parent pt developed red rash around vaccine site and some swelling, rash did not spread or become bigger, per parent apply ice on site.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Pain
Clinical narrative: Pt says she had a lot of pain immediately after her flu shot administration... she has had pain for last 5 days, to the point where she cannot lay on that arm at night.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Local swelling, Neck pain, Pain, Pain in extremity
Clinical narrative: Arm very sore to move, slight swelling. Went to the Dr on 10/31/2013 due to arm very sore to move and affecting my activities of daily living. Painful to use Deltoid muscle at all (9/10 on the pain scale). I was given steroids which didn't help at all. On 11/13/2013 I am going to the Dr again as there has been absolutely NO IMPROVEMENT in the pain, it is constant (5/10) and with movement, the pain shoots up my neck and down my arm (9/10). It's been 43 days since the vaccine.
Age: 34.0
Sex: F
Vaccine: FLUX
Symptoms: Blood test normal, Chest X-ray normal, Influenza virus test, Pain, Productive cough
Clinical narrative: High fever 103F Body aches Cough with junk in lungs Congested Symptoms lasted 3 days until Dr notified.  Urine test neg Blood test good Phenomena chest xray neg Flu test unknown
Age: 34.0
Sex: F
Vaccine: FLUX
Symptoms: Pyrexia, Respiratory tract congestion, Urine analysis normal
Clinical narrative: High fever 103F Body aches Cough with junk in lungs Congested Symptoms lasted 3 days until Dr notified.  Urine test neg Blood test good Phenomena chest xray neg Flu test unknown
Age: 68.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: Shivers, sore arm. Then, on 11/7/13 the patient had a fever of 105 degree F. He went to the hospital and was admitted for 4 days and received IV antibiotics.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal discomfort, Chills, Feeling cold, Tremor, Vomiting
Clinical narrative: Feeling suddenly cold, then severe chills where entire body is shaking.  Also stomach upset with vomiting. This lasting for a few hours. Felt fine by morning.
Age: 39.0
Sex: F
Vaccine: FLUX
Symptoms: Depressed mood, Depression, Mood altered
Clinical narrative: My mood dropped considerably.  I had been full of energy and very upbeat that evening.  It was a bit sudden.  I am sad and do not have the energy to smile - low depressive episode. It has continued to be very low, as I am writing this on 11/12/2013 at 5:00 PM  I know it will pass, but it was a peculiar onset.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Dysphagia, Hypersensitivity, Immediate post-injection reaction, Sneezing, Urticaria
Clinical narrative: Pt started sneezing right after immunizations given. Phone call later from mother who states about 15 minutes after they left office his hands and feet began to itch, he broke out in hives and started having trouble swallowing.  He was seen at ER immediately and was given Benadryl and steroids.  Diagnosis was acute allergic reaction.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unknown number of patients of unknown age and gender. It was reported that on an unknown dates, the patients may have been vaccinated with doses of RECOMBIVAX HB (lot number, expiry date, dose and route unspecified) which was stored as low as 31 degrees Fahrenheit (F). No concomitant therapy was reported. No adverse effect was reported. This is one of the several reports form the same source. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse concerning an unknown number of patients of unknown age and gender. It was reported that on unknown dates, the patients may have been vaccinated with doses of GARDASIL (lot number, expiry date, dose and route unspecified) which was stored as low as 31 degrees Fahrenheit (F). No concomitant therapy was reported. No adverse effect was reported. This is one of the several reports from the same source. Additional information has been requested.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Dyspnoea, Headache, Pain, Paralysis
Clinical narrative: Severe body aches, felt "like I was paralyzed" headache, fever, chills, SOB wheezing 3 hours after receiving flu vaccination.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Wheezing
Clinical narrative: Severe body aches, felt "like I was paralyzed" headache, fever, chills, SOB wheezing 3 hours after receiving flu vaccination.
Age: 11.0
Sex: F
Vaccine: HEPA, HPV4, MNQ, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Local reaction, Pruritus
Clinical narrative: Local swelling reaction, redness, and pain in left upper arm started 11/10/13. Itching. Father used OTC cream, pt seen by provider on 11/11/13. Provider prescribed Ibuprofen and Benadryl and cold compress.
Age: 4.0
Sex: M
Vaccine: FLUX
Symptoms: Pain, Pruritus, Pyrexia, Rash morbilliform
Clinical narrative: Patient developed a measles rash approx 10 days after receiving vaccine. This rash was accompanied by fever, aches and itching.
Age: 73.0
Sex: F
Vaccine: VARCEL
Symptoms: Headache, Injection site erythema, Injection site induration, Injection site urticaria, Injection site vesicles
Clinical narrative: Headache, red hard area around injection site with two blister like eruptions and hives at site.
Age: 40.0
Sex: M
Vaccine: FLU4
Symptoms: Pruritus, Urticaria
Clinical narrative: I had hives on my neck and head and upper back and this started on 11/08/2013 at 7:00 PM and I still have hives on my neck at this time 11/12/2013 at 4:30 PM and I have been taking Benadryl as treatment of hives and itching.
Age: 0.28
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Diarrhoea, Diarrhoea haemorrhagic, Stool analysis normal
Clinical narrative: Mother states diarrhea started one day after immunizations.  Started having bloody diarrhea, went to MD, stool was sent off for testing and results did not show anything.
Age: 40.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Dyspnoea, Paranasal sinus hypersecretion, Rhinorrhoea, Sinusitis
Clinical narrative: Sneezing, coughing, wheezing, shortness of breath, sinus drainage, infection in maxillary area of face and lobes and runny nose.
Age: 40.0
Sex: F
Vaccine: FLUX
Symptoms: Sneezing, Wheezing
Clinical narrative: Sneezing, coughing, wheezing, shortness of breath, sinus drainage, infection in maxillary area of face and lobes and runny nose.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Back pain, Cough, Dyspnoea, Fatigue
Clinical narrative: I started to cough uncontrollably and then felt a lump in my throat.  Breathing became difficult and I was wheezing. I took a Zyrtec and it calmed. The lump in my throat feeling went away and the cough was not as persistent. I then felt weak and got a fever.  From there, my fever got worse and I had severe back pain.  I also started to feel like something was crawling under my collarbone and then felt a sharp pain in localized areas of my back that slowly spread out.  My fever eventually went down to 99 and I went to bed. This morning, my entire body was sore and I felt drained.  I continue to feel drained and weak today. I probably should have gone to the doctors but hate going to emergency rooms. I do not feel like myself yet.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Formication, Pain, Pyrexia, Sensation of foreign body, Wheezing
Clinical narrative: I started to cough uncontrollably and then felt a lump in my throat.  Breathing became difficult and I was wheezing. I took a Zyrtec and it calmed. The lump in my throat feeling went away and the cough was not as persistent. I then felt weak and got a fever.  From there, my fever got worse and I had severe back pain.  I also started to feel like something was crawling under my collarbone and then felt a sharp pain in localized areas of my back that slowly spread out.  My fever eventually went down to 99 and I went to bed. This morning, my entire body was sore and I felt drained.  I continue to feel drained and weak today. I probably should have gone to the doctors but hate going to emergency rooms. I do not feel like myself yet.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Computerised tomogram head normal, Dysarthria, Electrocardiogram normal, Hypoaesthesia
Clinical narrative: She received flu shot in Lt. arm on 10/23/2013; approx 2 hours later her nose started running clear liquid, then Lt. hand and Lt. side of face became numb and her speech was slurred.  She declined to have ambulance called and was taken to local health unit by home health nurse.  B/P was 170/110 other vitals were wnl.  EMS was called approx 20 minutes after symptoms, B/P remained elevated at 182/110 and 180/110.  EMS arrived and transported pt to ER.  MD told her she may have experienced a TIA.  CT scan done at hospital did not reveal any findings and pt was allowed to go home.  Pt reported to work the next day to fill out workman's comp papers and reported symptoms had resolved.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Rhinorrhoea, Transient ischaemic attack
Clinical narrative: She received flu shot in Lt. arm on 10/23/2013; approx 2 hours later her nose started running clear liquid, then Lt. hand and Lt. side of face became numb and her speech was slurred.  She declined to have ambulance called and was taken to local health unit by home health nurse.  B/P was 170/110 other vitals were wnl.  EMS was called approx 20 minutes after symptoms, B/P remained elevated at 182/110 and 180/110.  EMS arrived and transported pt to ER.  MD told her she may have experienced a TIA.  CT scan done at hospital did not reveal any findings and pt was allowed to go home.  Pt reported to work the next day to fill out workman's comp papers and reported symptoms had resolved.
Age: 11.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: Received influenza injection at school clinic.  School nurse reported softball sized swelling at injection site. Child was given 25mg Benadryl and ice pack.  Mother was called.  Child remained at school.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Nausea
Clinical narrative: Nausea and headache.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Cough, Headache, Insomnia, Pain
Clinical narrative: SEVERE ACHES AND PAINS, HEADACHE, COUGH, SLEEPLESSNESS.
Age: 55.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Fatigue, Feeling abnormal, Nausea, Paraesthesia, Pharyngeal oedema
Clinical narrative: Within an hour of getting the vaccine, I started to feel nauseous and fatigued. Then my body started to tingle so I laid down. 2 hours later I awoke when the phone rang. Still drowsy, I was worried because my throat was swollen inside. Now 5 days later, I still feel poorly.
Age: 55.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Somnolence
Clinical narrative: Within an hour of getting the vaccine, I started to feel nauseous and fatigued. Then my body started to tingle so I laid down. 2 hours later I awoke when the phone rang. Still drowsy, I was worried because my throat was swollen inside. Now 5 days later, I still feel poorly.
Age: 55.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Diarrhoea, Nausea, Pharyngeal oedema
Clinical narrative: Within an hour of getting the vaccine, I started to feel nauseous and fatigued. Then my body started to tingle so I laid down. 2 hours later I awoke when the phone rang. Still drowsy, I was worried because my throat was swollen inside. Now 5 days later, I still feel poorly.
Age: 55.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Fatigue, Feeling abnormal, Nausea, Paraesthesia, Pharyngeal oedema
Clinical narrative: Patient states she started having nausea and diarrhea one hour after and swelling in throat about 2 hours after the administration.
Age: 55.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Somnolence
Clinical narrative: Patient states she started having nausea and diarrhea one hour after and swelling in throat about 2 hours after the administration.
Age: 55.0
Sex: F
Vaccine: FLUX, FLU3
Symptoms: Diarrhoea, Nausea, Pharyngeal oedema
Clinical narrative: Patient states she started having nausea and diarrhea one hour after and swelling in throat about 2 hours after the administration.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus, Rash
Clinical narrative: Rash on abdomen. Mild pruritis.
Age: 58.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site rash, Injection site swelling
Clinical narrative: Patient complained of tenderness, rash, swelling and pain that radiated 4-6 inches from the injection site down her left arm.
Age: 0.2
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC, RV5
Symptoms: Abdominal pain, Crying, Diarrhoea
Clinical narrative: Abdominal cramp, crying, massive diarrhea.  Gave as much fluids as possible and kept changing diaper.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Gait disturbance, Joint range of motion decreased, Paralysis
Clinical narrative: See above.
Age: 0.2
Sex: M
Vaccine: RV5
Symptoms: Expired drug administered, Respiratory disorder
Clinical narrative: This spontaneous report as received from a physician refers to a 2 month old male patient. The patient had no relevant medical history and past drug history was unknown. On an unknown date the patient was vaccinated with ROTATEQ (orally; dosage, frequency and lot number were not provided). The patient did not use any concomitant medication. On an unknown date in November 2013 the patient experienced respiratory issues and went to the hospital. IT was unknown if the patient was hospitalized. On 09-NOV-2013 the patient was vaccinated with a possibly second dose in the series of ROTATEQ (orally; dosage, frequency and lot number were not provided). The expiration date of this dose was October 2013. The patient was fine after the expired dose was given. On an unknown date in November 2013 the patient recovered from respiratory issues. The relatedness was not provided. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Discomfort, Muscle mass, Musculoskeletal pain, Rash, Rash vesicular
Clinical narrative: This spontaneous report was received from a 60 years old male consumer regarding himself with diabetes type II, coronary heart disease, peptic ulcer disease, osteoporosis, peripheral arterial disease and osteoarthritis. It was also reported a reaction to SULFA. On 04-OCT-2013 the patient was vaccinated with ZOSTAVAX for prevent shingles. Dose, lot # and route of administration were not reported. Concomitant therapies included TYLENOL. On 14-OCT-2013 the patient experienced severe pain on triangular shape on his shoulder after receiving the ZOSTAVAX. He felt like his muscle had created a knot. On 14-OCT-2013 consumer also noticed a rash on the back of the right shoulder which extended over the shoulder across to the sternum. The rash was raised and warm and had starting to develop white dots in the center of each vesicle. Patient established also he had discomfort coming from random points of pain that included his ear drum. The outcome of the adverse events was reported as not recovered. The relationship between adverse events and therapy with ZOSTAVAX was not reported. Additional information has been requested.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Skin warm
Clinical narrative: This spontaneous report was received from a 60 years old male consumer regarding himself with diabetes type II, coronary heart disease, peptic ulcer disease, osteoporosis, peripheral arterial disease and osteoarthritis. It was also reported a reaction to SULFA. On 04-OCT-2013 the patient was vaccinated with ZOSTAVAX for prevent shingles. Dose, lot # and route of administration were not reported. Concomitant therapies included TYLENOL. On 14-OCT-2013 the patient experienced severe pain on triangular shape on his shoulder after receiving the ZOSTAVAX. He felt like his muscle had created a knot. On 14-OCT-2013 consumer also noticed a rash on the back of the right shoulder which extended over the shoulder across to the sternum. The rash was raised and warm and had starting to develop white dots in the center of each vesicle. Patient established also he had discomfort coming from random points of pain that included his ear drum. The outcome of the adverse events was reported as not recovered. The relationship between adverse events and therapy with ZOSTAVAX was not reported. Additional information has been requested.
Age: 78.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain
Clinical narrative: This spontaneous report as received from a pharmacist  refers to a 78 year old female patient with high blood pressure, high cholesterol and GERD (gastro-esophageal reflux disease). On 10-OCT-2013, the patient was vaccinated with ZOSTAVAX lot # J002242 (administered subcutaneously). Concomitant therapies included simvastatin (manufacturer unknown), ATENOLOL, AVAPRO, and PRILOSEC. On 11-OCT-2013, the patient developed pain at the site of ZOSTAVAX injection. No therapy was given for the adverse event and no lab-tests were performed. The outcome of pain at the site of ZOSTAVAX injection was reported as not recovered/not resolved. A causality assessment was not provided by the reporter. Additional information has been requested.
Age: 80.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain
Clinical narrative: This spontaneous report was received from a registered pharmacist concerning an approximately 80 year old male patient. Current condition of the patient included lisinopril allergy. There was no pertinent medical history. On 18-JUL-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number and expiry date were reported as J002777 and 07JUN-2014 respectively, dose and route unspecified). Concomitant therapies included unspecified maintenance medication. On 18-JUL-2013, the patient developed pain at the injection site. There was no rash, redness or swelling at the injection site. The patient did not seek any medical attention. An unspecified over the counter medications were given for pain. No lab tests were performed. The patient was not recovered from pain at the injection site as the patient was still having pain (it still hurts). The relatedness for the event was unknown for ZOSTAVAX. Additional information has been requested.
Age: 80.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: This spontaneous report was received from a registered pharmacist concerning an approximately 80 year old male patient. Current condition of the patient included lisinopril allergy. There was no pertinent medical history. On 18-JUL-2013, the patient was vaccinated with a dose of ZOSTAVAX (lot number and expiry date were reported as J002777 and 07JUN-2014 respectively, dose and route unspecified). Concomitant therapies included unspecified maintenance medication. On 18-JUL-2013, the patient developed pain at the injection site. There was no rash, redness or swelling at the injection site. The patient did not seek any medical attention. An unspecified over the counter medications were given for pain. No lab tests were performed. The patient was not recovered from pain at the injection site as the patient was still having pain (it still hurts). The relatedness for the event was unknown for ZOSTAVAX. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to 18 patients who might have been vaccinated with doses of RECOMBIVAX HB (Lot # H011183, expiration date 31-JAN-2015) that were exposed to 31F for accumulative of 1 hour and 30 minutes between 04-OCT-2013 and 10-OCT-2013. No adverse effects were reported. This is one of several reports received from the same source. Additional information has been requested.
Age: 12.0
Sex: M
Vaccine: FLU3
Symptoms: Fatigue, Feeling hot, Speech disorder
Clinical narrative: Mom reported: 2 hrs. after receiving vaccine pt. felt warm, no temp taken. He then started talking funny not making sense - this lasted approx. 10 minutes. He later c/o feeling tired.