chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Pt. stated that she started feeling itchiness, pain, redness and swelling at the injection site the day after the administration.
Age: 22.0
Sex: F
Vaccine: HPV4
Symptoms: Blood glucose increased, Lymphadenopathy
Clinical narrative: This spontaneous report as received from a registered nurse via a company representative refers to a currently 22 year old female patient. After competing her 3rd GARDASIL (lot # unspecified) (dose, route and location unspecified) for vaccine, the patient experienced swollen lymph nodes. The patient went to an unspecified Primary Care HCP, who reached out to her physician, who then referred patient to an unspecified Infectious Disease HCP. The reporter reported that a blood test discovered the patient had "elevated sugar" on an unspecified date. The patient had sought medical attention via went to Primary Care HCP. At the time of report, the outcome of the swollen lymph nodes and elevated sugar was unknown. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age and gender. On 25-NOV-2013, the patient was inadvertently vaccinated with a dose of ROTATEQ, lot # H010688, expiration date 28-OCT-2013, 2 ml, oral. No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Measles antibody positive, Mumps antibody test positive, Rubella antibody negative
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age. On an unknown date the patient was vaccinated with MMR II (lot #, expiration date, dose, route and indication not reported). The pharmacist was reporting that the patient had negative titer for rubella and positive titer for measles and mumps possibly from either the past MMR II vaccination or natural disease; the reporter was not sure. The outcome of the events was unknown. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Limb discomfort
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and demographics. On 22-OCT-2013 the patient was vaccinated with PNEUMOVAX23, in the left deltoid and has experienced continued soreness and limited mobility which has gotten progressively worse. The pharmacist stated that the patient received this dose of PNEUMOVAX23 60 days ago and is still experiencing limited mobility (disability). Lot no was not provided. The outcome of limited mobility was reported as not recovered/not resolved. The outcome of continued soreness is unknown. Reporter causality was not provided. Additional information has been requested.
Age: 68.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Mobility decreased, Pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and demographics. On 22-OCT-2013 the patient was vaccinated with PNEUMOVAX23, in the left deltoid and has experienced continued soreness and limited mobility which has gotten progressively worse. The pharmacist stated that the patient received this dose of PNEUMOVAX23 60 days ago and is still experiencing limited mobility (disability). Lot no was not provided. The outcome of limited mobility was reported as not recovered/not resolved. The outcome of continued soreness is unknown. Reporter causality was not provided. Additional information has been requested.
Sex: U
Vaccine: PPV, PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Limb discomfort
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and demographics. On 22-OCT-2013 the patient was vaccinated with PNEUMOVAX23, in the left deltoid and has experienced continued soreness and limited mobility which has gotten progressively worse. The pharmacist stated that the patient received this dose of PNEUMOVAX23 60 days ago and is still experiencing limited mobility (disability). Lot no was not provided. The outcome of limited mobility was reported as not recovered/not resolved. The outcome of continued soreness is unknown. Reporter causality was not provided. Additional information has been requested.
Sex: U
Vaccine: PPV, PPV
Symptoms: Mobility decreased, Pain
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and demographics. On 22-OCT-2013 the patient was vaccinated with PNEUMOVAX23, in the left deltoid and has experienced continued soreness and limited mobility which has gotten progressively worse. The pharmacist stated that the patient received this dose of PNEUMOVAX23 60 days ago and is still experiencing limited mobility (disability). Lot no was not provided. The outcome of limited mobility was reported as not recovered/not resolved. The outcome of continued soreness is unknown. Reporter causality was not provided. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Activities of daily living impaired, Neuropathy peripheral
Clinical narrative: This spontaneous report as received from a physician, via company representative, refers to a female patient of unspecified age. On an unspecified date, patient started therapy with ZOSTAVAX, subcutaneous injection (dose and lot number not reported). Co-suspect or concomitant therapies were not reported. On an unspecified date, physician reported that the patient, that was also a physician, had received ZOSTAVAX at an unspecified pharmacy, and experienced a severe neuropathy in the injection arm. Reported stated that patient missed a lot of work because of this. At the time of the report, the patient was not recovered and the causality for the event was unknown. Severe neuropathy in the injection arm was considered as disability by the reporting physician. Additional information has been requested.
Age: 6.0
Sex: M
Vaccine: FLUN4
Symptoms: Gianotti-Crosti syndrome, Rash erythematous, Rash maculo-papular
Clinical narrative: FLUMIST given 11/7/13. Couple weeks later red maculopapular rash appeared. Dermatology diagnosed as Gianotti-Crosti. Steroid cream prescribed. Rash has improved. Following up with Dermatology.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from other health professional as part of a marketing research program, refers to a 62 or 63 year old female patient. On an unknown date approximately in 2012 (reported a 1 year ago) the patient was vaccinated with a dose of ZOSTAVAX (lot # and dosing regimen was not provided) administered once for herpes zoster vaccination. On an unknown date the patient developed shingles (mild) after receiving the vaccine. The patient recovered with sequelae from the event on an unknown date. Reporter's causality was not provided. Additional information has been requested.
Sex: M
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a male consumer of unknown age refers to himself. The consumer inquired about restarting his GARDASIL series after possibly receiving dose1, or 2 or both doses of GARDASIL (lot# and dosing regimen unspecified) that would have been given 10 years ago (approximately in 2003), no adverse event reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker referring to six patients of unknown demographics. No relevant medical history was reported. On an unknown date, the patients were vaccinated with PROQUAD (lot number J010597 and expiry date 28-FEB-2015) that was exposed to 41.58F for 446 hours throughout the month of November. No concomitant medications were reported. No adverse effects were reported. The reporter also stated that PROQUAD (lot number J006160 and expiry date 30-JAN-2014) was exposed to 41.58 for 510 hours. The vaccine with lot number J01597 and expiry date 28-FEB-2015 was only administered to six patients. Additional information has been requested
Sex: F
Vaccine: HPV4
Symptoms: Premature menopause
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient on her 20's. On an unknown date the patient was vaccinated with GARDASIL (dose, route and lot number not provided). On an unknown date the patient's mother called into a TV show to report her daughter experienced early menopause after administration of GARDASIL. The patient's outcome was unknown. The causal relationship was not provided. The mother stated her other experienced the same event (MARRS 1312USA010376). Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Premature menopause
Clinical narrative: This spontaneous report as received from a registered nurse refers to a female patient on her 20's. On an unknown date the patient was vaccinated with GARDASIL (dose, route and lot number not provided). On an unknown date the patient's mother called into a TV show to report her daughter experienced early menopause after administration of GARDASIL. The patient's outcome was unknown. The causal relationship was not provided. The mother stated her other experienced the same event (MARRS 1312USA010930). Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity
Clinical narrative: This spontaneous report as received from a female consumer refers to herself of unknown age. On an unknown date the patient was vaccinated with PNEUMOVAX 23 (lt/batch #, dose and route were unknown). The patient stated that she had an "unspecific allergic reaction" after receiving PNEUMOVAX 23. It was unknown if patient sought medical attention. At the time of reporting, the outcome of the event was unknown. Additional information has been requested.
Sex: F
Vaccine: HEPA
Symptoms: Incorrect dose administered, Needle issue, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with VAQTA (lot no J011712, Expiry date 21-SEP-2015) (dosing regimen and frequency unknown). On 16-DEC-2013 the patient was inadvertently administered an incomplete dose of VAQTA and the needle hub separated from the barrel of the pre filled VAQTA syringe, during administration, the needle hub separated from the barrel of the pre-filled VAQTA syringe. No adverse effects reported. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Local reaction
Clinical narrative: Local site reaction, redness 1 cm above injection site.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Dysuria, Muscle spasms, Nausea, Pain
Clinical narrative: At 10:00pm, patient reported high fever (but did not take his temp), chills, shivering, soreness, cramping (muscle) all over body, nausea, burning sensation on urination. Patient states he felt better 16 hrs., after the shot.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia
Clinical narrative: At 10:00pm, patient reported high fever (but did not take his temp), chills, shivering, soreness, cramping (muscle) all over body, nausea, burning sensation on urination. Patient states he felt better 16 hrs., after the shot.
Age: 0.15
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Crying
Clinical narrative: Unconsolable crying for at least 3 hours within the first 48 hrs shots are given. 2 month shots given 8/13/2013.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Contusion, Injection site pain, Pain
Clinical narrative: Pain radiating down left arm from site of injection upon certain movements. Bruise lasted 8-10 days then pain didn't get better.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Confusional state, Disorientation, Lumbar puncture abnormal, Memory impairment, Meningitis viral
Clinical narrative: On 9-23-13. Pt. received PNEUMOVAX approx. two weeks after Pt. noted to have become very forgetful. By Nov. 23 2013 Pt. noted to be very confused and disoriented.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Dyspnoea, Fatigue
Clinical narrative: Weakness and fatigue with shortness of breath 24 hours after influenza vaccine. In bed x 2 days, seen by PCP 10/30/13. Symptoms resolved after 2 1/2 weeks.
Age: 13.0
Sex: F
Vaccine: FLU4, HPV4
Symptoms: Pain, Pruritus, Rash, Urticaria
Clinical narrative: Hives, itching, sharp bumps, stinging. Treatment = BENADRYL, hydrocortisone cream. Notified our office on 12/17/13.
Age: 0.34
Sex: M
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Crying
Clinical narrative: Unconsolable cryhing for at least 3 hours within the first 48 hrs shots were given.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Pain in extremity, X-ray abnormal
Clinical narrative: Patient claims arm pain from rotator cuff down into fingers. Patient reported adverse event on 12-13-13 (9:30 AM approx).
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chest discomfort, Dyspnoea, Fatigue, Headache
Clinical narrative: Patient received ZOSTAVAX on 12/9/13 - later that evening started a headache. On 12/10/13 complained of tightness of chest and difficulty in breathing (middle of night) thereafter experiences fatigue.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased, Muscle atrophy, Nerve injury, Pain in extremity
Clinical narrative: By that night I had pain and limited use of my left arm. Have had physical therapy for 6 weeks. The doctor said it impacted a nerve and caused some muscles to atrophy - it is getting better.
Age: 0.62
Sex: F
Vaccine: DTAPHEPBIP, FLU3, HEPA, HIBV, PNC13
Symptoms: Incorrect dose administered
Clinical narrative: None.
Age: 34.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Back pain, Chills, Fatigue, Malaise, Pain
Clinical narrative: Pt describes feeling sick, run down afternoon of 12/11/13, later evening fever, chills, body ache, pain/ache worst in back. Pt sick 12/12/13, 12/13/13, 12/14/13, 12/15/13.
Age: 34.0
Sex: F
Vaccine: FLU3, TDAP
Symptoms: Pyrexia
Clinical narrative: Pt describes feeling sick, run down afternoon of 12/11/13, later evening fever, chills, body ache, pain/ache worst in back. Pt sick 12/12/13, 12/13/13, 12/14/13, 12/15/13.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Injection site pain, Musculoskeletal stiffness, Nodule, Pain in extremity
Clinical narrative: Pt got PNEUMOVAX 23 on 11-11-13 and said that night she had neck stiffness, her arm has sore above site of injection and below injection site then felt a knot. Symptoms went away next morning.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle spasms, VIIth nerve paralysis
Clinical narrative: Spasms in face, legs, and arms.
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain, Back pain, Bladder disorder, Condition aggravated, Functional gastrointestinal disorder
Clinical narrative: On May 24, 2011, one day after administration of Hep. B shot, foot became numb followed by right leg numbness, which continued to travel up leg. Pain in abdomen and back as numbness became worse. Went to the emergency room. An MRI was administered and patient was immediately placed on steroids. A one-week hospital stay was required while numerous tests were ran. Complete numbness of right side of lower back down right leg. Numbness exists on left side with no feeling on particular part of left foot. Moderate to severe sensitivity. Lower right extremities exhibit coldness on a consistent basis. Bladder and bowel issues as numbness exists around these areas. Medication consists of: (a) Gabapentin; (b) CYMBALTA; and (c) Baclofen. Symptoms tend to flare when stressed and attempt physical activity. Physical therapy for past two years and is ongoing.
Age: 45.0
Sex: F
Vaccine: HEP
Symptoms: Hypoaesthesia, Laboratory test, Nuclear magnetic resonance imaging, Peripheral coldness
Clinical narrative: On May 24, 2011, one day after administration of Hep. B shot, foot became numb followed by right leg numbness, which continued to travel up leg. Pain in abdomen and back as numbness became worse. Went to the emergency room. An MRI was administered and patient was immediately placed on steroids. A one-week hospital stay was required while numerous tests were ran. Complete numbness of right side of lower back down right leg. Numbness exists on left side with no feeling on particular part of left foot. Moderate to severe sensitivity. Lower right extremities exhibit coldness on a consistent basis. Bladder and bowel issues as numbness exists around these areas. Medication consists of: (a) Gabapentin; (b) CYMBALTA; and (c) Baclofen. Symptoms tend to flare when stressed and attempt physical activity. Physical therapy for past two years and is ongoing.
Age: 53.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Injection site pain, Pain
Clinical narrative: Public health nurse received call from patient on 12/4/13 that still having pain at site where flu vaccine given (L deltoid). Shot was given on 11/6/13 at clinic. Area still sore to touch or with arm movements. Denies fever or swelling. Referred to PCP - patient saw on 12/4/13 and doctor thinks shot may have been given too high and went into joint or tendon. Recommend to take ibuprofen and follow-up if still bothering patient.
Age: 60.0
Sex: U
Vaccine: VARZOS
Symptoms: Injection site reaction, Injection site swelling, Rash erythematous
Clinical narrative: Pt received ZOSTAVAX on Dec. 12 - 11 - 13 or Fri 12 - 13 - 13 he says he developed a 5 cm, red, swollen rash at injection site, on left deltoid. He immediately began taking, dicloxacillin. The rash resolved. He believes it was an injection.
Sex: U
Vaccine: FLU3
Symptoms: Erythema, Local swelling
Clinical narrative: Arm red and swollen. Question cellulitis and put on antibiotics. Lt arm.
Age: 19.0
Sex: M
Vaccine: HEP
Symptoms: Cough, Throat irritation
Clinical narrative: Pt. requested flu vaccine. Is allergic to eggs, within 15-20 min of receiving the vaccine he c/o urticaria. BENADRYL 50 mg given STAT. Coughing - Albuterol 90mcg/puff - 2 puffs STAT - had "itchy throat" - cont. tried to clear. Within 20 min of tx all symptoms resolved. Pt. released to home.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Vaccination site swelling
Clinical narrative: Vaccinated 12/17/13. Morning of 12/18/13 noticed swelling at site of vaccination, about 1 1/2 inches round. Morning of 12/19/13 spot was more swollen, about 2" x 3", red color, itchy, sore to touch.
Age: 4.0
Sex: M
Vaccine: HEPA
Symptoms: Wrong drug administered
Clinical narrative: Gave patient wrong vaccine; was suppose to give patient Hep B not Hep A.
Age: 1.07
Sex: M
Vaccine: FLU3, HIBV, MMRV, PNC13
Symptoms: Erythema, Genital rash, Rash maculo-papular, Rash vesicular, Scab
Clinical narrative: In genital area is a vesicular rash thin roofed with some crusted (older) lesions and some erythematous mac/papules now consistent with mild varicella.
Age: 1.07
Sex: M
Vaccine: FLU3, HIBV, MMRV, PNC13
Symptoms: Varicella post vaccine
Clinical narrative: In genital area is a vesicular rash thin roofed with some crusted (older) lesions and some erythematous mac/papules now consistent with mild varicella.
Age: 46.0
Sex: F
Vaccine: FLUC3
Symptoms: Altered visual depth perception, Colour blindness acquired, Hypoaesthesia, Laboratory test normal, Muscular weakness
Clinical narrative: vaccine administered approximately 0715 am 12 Nov ...that same day by late afternoon and evening member felt onset body aches, torso itching that evening......13 Nov 13, member tried tylenol ES with minimal relief of body aches .....myalgia increased along with fever and paresthesias and numbness of both feet by that evening....went to ER and was admitted
Age: 46.0
Sex: F
Vaccine: FLUC3
Symptoms: Myalgia, Pain, Paraesthesia, Pruritus, Pyrexia
Clinical narrative: vaccine administered approximately 0715 am 12 Nov ...that same day by late afternoon and evening member felt onset body aches, torso itching that evening......13 Nov 13, member tried tylenol ES with minimal relief of body aches .....myalgia increased along with fever and paresthesias and numbness of both feet by that evening....went to ER and was admitted
Age: 51.0
Sex: F
Vaccine: FLUC3
Symptoms: Drug administered at inappropriate site, Mobility decreased, Pain, Paraesthesia
Clinical narrative: Inability to raise arm, tingling to fingers, constant pain.  Injection was given very high in joint area. Have taken ibuprofen and iced and exercised. Continued pain and immobility almost three weeks after injection.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Asthenia, Diarrhoea, Fatigue, Malaise, Nausea
Clinical narrative: Following lasted over 3 weeks: fever, night sweats, nausea, diarrhea, weakness, fatigue, malaise.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Night sweats, Pyrexia, Red blood cell sedimentation rate increased
Clinical narrative: Following lasted over 3 weeks: fever, night sweats, nausea, diarrhea, weakness, fatigue, malaise.
Age: 11.0
Sex: M
Vaccine: FLUN3, MNQ, TDAP
Symptoms: Injection site erythema, Injection site warmth, Local reaction
Clinical narrative: PATIENT SEEN ON 11/22/2013 11:00 AM WITH A LARGE LOCAL REACTION ON RIGHT UPPER ARM FROM MENACTRA. AREA WARM, RED, AREA MEASURED 20 BY 12 CMS
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Immediate post-injection reaction, Injected limb mobility decreased, Injection site bruising, Injection site pain
Clinical narrative: Patient reports pain at injection site at the time of vaccination and since.  She reports pain has worsened since the vaccination date where she has difficulty using her left arm and experiences discomfort and pain when lifting the arm. She describes the pain to be at 10 on the pain scale of 10.  She has been icing the area and taking ibuprofen and acetaminophen for pain relief.  She has not seeked medical attention as of yet but intends to.  She reports there was slight bruising at the injection site which is no longer visible.
Age: 40.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Patient reports pain at injection site at the time of vaccination and since.  She reports pain has worsened since the vaccination date where she has difficulty using her left arm and experiences discomfort and pain when lifting the arm. She describes the pain to be at 10 on the pain scale of 10.  She has been icing the area and taking ibuprofen and acetaminophen for pain relief.  She has not seeked medical attention as of yet but intends to.  She reports there was slight bruising at the injection site which is no longer visible.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Cellulitis, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: 12/8 itching, pain at site, warm to touch, 8" x 6". 12/9 larger area - very sore. 12/10 seen doctor cellulitis.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Musculoskeletal pain
Clinical narrative: Patient stating he is still having severe pain in his shoulder more than one month post vaccination.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, pain at location of injection. Spreading redness and swelling over 3 days. Patient saw doctor after 3 days. Was given a course of antibiotics. At 5 days after vaccine given, patient reports decreased redness and swelling.
Age: 27.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Arthralgia, Fatigue, Injection site pain, Injection site swelling, Insomnia
Clinical narrative: 6/17/08 9p: achy enough to take MOTRIN (L) arm w/ Tdap. 6/18/08 7am: unable to move arm/achy joints, took MOTRIN. Noon: fever; fatigue; pain; sleeplessness. 4p: severe pain and swelling at site. Very achy joints. 9p: worse yet. Lasted until Fri morning.
Age: 27.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Mobility decreased, Pain, Pyrexia
Clinical narrative: 6/17/08 9p: achy enough to take MOTRIN (L) arm w/ Tdap. 6/18/08 7am: unable to move arm/achy joints, took MOTRIN. Noon: fever; fatigue; pain; sleeplessness. 4p: severe pain and swelling at site. Very achy joints. 9p: worse yet. Lasted until Fri morning.
Age: 39.0
Sex: M
Vaccine: ANTH
Symptoms: Faecal incontinence, Presyncope, Unresponsive to stimuli, Urinary incontinence
Clinical narrative: Donor had vaso-vagal response following anthrax vaccination - Prior to vaccination donor donated 900 mls plasma - Donor states he did not eat prior to donation. During reaction donor unresponsive < 30 seconds - Donor incontinent bowel and bladder. Donor treated per protocol, he was laid supine, Oxygen admin 6 l prn via nasal cannula, normal saline admin 500 ml. Initial vitals during and after event. 4:26 pm BP 80/p pulse 120+. At 4:35 pm BP 101/62 Pulse 84. At 455 pm BP 110/70 Pulse at 90. After treatment - donor recovered well, oral fluids given along with granola bar, donor left center without incident. Donor was contacted the following day and stated he had no adverse problems from incident and was feeling well. Medical director requested VAER's due to reaction occurred quickly after vaccination. VAERS completed due to uncertainty of cause of reaction.
Age: 11.0
Sex: F
Vaccine: MNQ, TDAP
Symptoms: Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Painful, warm swelling at vaccine site.
Age: 65.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Chills, Joint lock, Pain in extremity, Tremor
Clinical narrative: Received PNEUMOVAX 12-17-13. That evening stated her right arm became very painful and hurt down to fingertips. She felt as though her joints were locking up. She also had chills and was tremorous all over. On 18th felt better.
Age: 62.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site nodule, Injection site pain, Injection site reaction, Myalgia
Clinical narrative: Small knot and soreness at site of injection - still evident at end of October. (Soreness at injection site remains.) Severe upper left arm muscle pain for appx. 1 month. Called and spoke w/nurse 9/25/2013 - advised to use warm compresses.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Injection site was, red, tender, swollen, itching and painful. Treated w/ibuprofen and BENADRYL, prednisone added.
Age: 26.0
Sex: F
Vaccine: FLU3
Symptoms: Rash generalised
Clinical narrative: Rash in whole body.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Activities of daily living impaired, Balance disorder, Dizziness, Dysstasia, Gait disturbance
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 15 year old female patient. Patient was not pregnant. The patient had no pertinent medical history. Drug reactions/allergies were none. On 26-JUL-2013 the patient was vaccinated with GARDASIL, intramuscular (dose, dosage, lot not reported). Concomitant therapies included YAZ. On an unknown date of August-2013 the patient experienced headache, nausea, heart palpitations, dizziness and trouble with balance after receiving the vaccine. The patient has had difficulty standing (disability) and trouble walking (disability) and because of this has been out of school for 2 months. The patient saw the physician and sought medical attention. It was also reported that the patient will not continue with the series. The outcomes of the reported events were unknown at the time of the report. The events difficulty standing and trouble walking were considered to be serious due to disability. Additional information has been requested.
Age: 15.0
Sex: F
Vaccine: HPV4
Symptoms: Headache, Nausea, Palpitations
Clinical narrative: This spontaneous report as received from a physician via a company representative refers to a 15 year old female patient. Patient was not pregnant. The patient had no pertinent medical history. Drug reactions/allergies were none. On 26-JUL-2013 the patient was vaccinated with GARDASIL, intramuscular (dose, dosage, lot not reported). Concomitant therapies included YAZ. On an unknown date of August-2013 the patient experienced headache, nausea, heart palpitations, dizziness and trouble with balance after receiving the vaccine. The patient has had difficulty standing (disability) and trouble walking (disability) and because of this has been out of school for 2 months. The patient saw the physician and sought medical attention. It was also reported that the patient will not continue with the series. The outcomes of the reported events were unknown at the time of the report. The events difficulty standing and trouble walking were considered to be serious due to disability. Additional information has been requested.
Age: 0.53
Sex: F
Vaccine: DTAP, FLU3, HEP, HIBV, PNC13, RV5
Symptoms: Laboratory test, Respiratory syncytial virus test negative, Unevaluable event, Urine analysis normal
Clinical narrative: Received 6 months immunization DTaP, flu, hib, PREVNAR, ROTATEQ and hepatatis B.
Age: 45.0
Sex: F
Vaccine: TTOX
Symptoms: Discomfort, Erythema, Fatigue, Headache, Induration
Clinical narrative: Donor noticed swelling, redness about the size of a baseball.  There was hardness, hot.  Donor had headache and was tired. Donor stated did not have temperature but took Ibuprofen for discomfort and headache.  Feeling better today 12/24/13 and most of redness gone but still has hard lump in arm.
Age: 45.0
Sex: F
Vaccine: TTOX
Symptoms: Skin warm, Swelling, Upper extremity mass
Clinical narrative: Donor noticed swelling, redness about the size of a baseball.  There was hardness, hot.  Donor had headache and was tired. Donor stated did not have temperature but took Ibuprofen for discomfort and headache.  Feeling better today 12/24/13 and most of redness gone but still has hard lump in arm.
Age: 68.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Unknown exact onset time of adverse event. Patient said he had severe injection arm pain in the middle of the night. Said he had to go to the ER. Said he was given an Epipen shot on 10/29/2013.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Arthralgia, Diarrhoea, Nausea, Vomiting
Clinical narrative: Nausea, vomiting, diarrhea.  Joint pain.
Age: 19.0
Sex: F
Vaccine: PPV
Symptoms: Blood culture negative, Computerised tomogram thorax abnormal, Induration, Influenza virus test negative, Lobar pneumonia
Clinical narrative: Localized induration over the Left shoulder deltoid muscle.  Patient also had very high grade fevers to 103 for 48 hours, but she has had serious prior episodes of fevers in the past.
Age: 19.0
Sex: F
Vaccine: PPV
Symptoms: Lung infiltration, Polymerase chain reaction, Pyrexia
Clinical narrative: Localized induration over the Left shoulder deltoid muscle.  Patient also had very high grade fevers to 103 for 48 hours, but she has had serious prior episodes of fevers in the past.
Age: 2.0
Sex: M
Vaccine: UNK
Symptoms: Abnormal behaviour, Decreased appetite, Irritability, Pyrexia
Clinical narrative: Fever 101.5 on Fri; fever 104.2 Sat-Sun; No appetite Sat-Mon; Irritable/clingy Sat-Tue.
Age: 75.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Erythema, Feeling hot, Pruritus, Tenderness
Clinical narrative: Tdap received 12/17/2013. On 12/23/2013 developed erythema, warmth, tenderness, itching. Treated for cellulitis, rec antihistamine (19 x 8 cm area).
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: The patient's arm became drastically red and started at her shoulder and went to her elbow.
Age: 77.0
Sex: F
Vaccine: FLU3
Symptoms: Blood pressure increased, Hyporesponsive to stimuli, Pyrexia, Somnolence
Clinical narrative: Pt reported feeling fine after waiting 10 minutes after getting vaccine. They showed up at other pharmacy, curled up in a chair, wasn't very responsive and looked like she was falling asleep. Paramedics were called and it was determined that she had a fever of approximately 103.9 and elevated BP - 130.
Age: 56.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Pain
Clinical narrative: Patient noticed soreness on upper arm (left). Patient still has soreness and lifting arm is painful. He spoke to his PCP I advise him to recheck and schedule appt with his MD to check if this could be related to immunization.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Blepharospasm, Lip swelling
Clinical narrative: Pt states his eye has been twitching and lips have been swollen. Onset started shortly after administration of flu vaccine according to pt. He denies use of any new medications or ingestion of dietary substances that may have caused an allergic rxn.
Sex: F
Vaccine: PPV
Symptoms: Swelling
Clinical narrative: This spontaneous report as received from a female patient of unknown age. On 18-DEC-2013 the patient was vaccinated with PNEUMOVAX23 vaccine. On December 2013 (reported as unspecified the patient developed a reaction (unspecified amount of hours after vaccine administration) and swelling on her shoulder the size of a football. The outcome of both events were unknown. The patient did not seek any medical attention. Additional information is not expected.
Age: 54.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 50 year old male patient. On 18-DEC-2013 the patient was vaccinated with ZOSTAVAX lot # J006155 expiry 30-AUG-2014, .65 ml, subcutaneously for prevention of shingles. The patient had no drug allergies. The pharmacist reported that the patient received ZOSTAVAX and experienced injection site reactions of hardness, redness (a quarter in size) and a mass (2 inches in diameter) the next day on 19-DEC-2013. The patient did not recover from the events. The patient sought medical attention since he contacted the pharmacy. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Dizziness
Clinical narrative: This spontaneous report as received from a health care worker refers to an unspecified number of patients of unknown demographics. No relevant medical history was reported. On an unknown date, unspecified number patients were vaccinated with a dose of GARDASIL from a recalled lot (lot # J007354 and expiry date 20-FEB-2016). No concomitant medication was reported. On an unknown date, some patients administered with a dose of recalled GARDASIL (lot number J007354 and expiry date 20-FEB-2016) experienced dizziness. The outcome of the event was unknown. Additional information has been requested.
Age: 0.25
Sex: M
Vaccine: RV5
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a 2 month old male patient with no medical history and  no drug reaction/allergies. Nurse stated that the patient received a dose of oral ROTATEQ, (lot # 0283AE, 2 ml orally on 11-DEC-2013 which was expired on 24-OCT-2013. Concomitant therapy included POLY-VI-SOL. No adverse event was reported. No treatment was given. No lab diagnostics study was performed. The patient did not seek medical attention. Additional information has been requested.
Age: 30.0
Sex: F
Vaccine: HEP
Symptoms: Hepatitis B surface antibody negative
Clinical narrative: This spontaneous report was received from a physician refers to herself as a 30 year old female patient. On an unknown date in 1993, the patient was vaccinated with 3-dose of RECOMBIVAX HB intramuscular (dose and frequency was not reported) for residency required. On an unknown date in January 1994, the patient received the results for a blood test that was performed on an unspecified date and the results showed as negative immunity to hepatitis B. On an unknown date in 1994, the patient received 4th dose of RECOMBIVAX HB and he was sure that his antibodies tested positive after the 4th dose. The physician stated she had blood work completed on 17-DEC-2013 and the results stated she again had negative immunity for Hepatitis B. No further information was provided. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: TYP
Symptoms: Diarrhoea
Clinical narrative: Within two (?) to eight hours after the first two doses of the vaccine (AM)- evacuative diarrhea (nothing left to come out); after last two doses of vaccine (AM) - milder diarrhea within two (?) to eight hours of taking the pills.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Blepharospasm, Excessive eye blinking, Fatigue, Lip swelling, Pain
Clinical narrative: Red blotches on her face developed and her lips swelled.  She complained of feeling generally tired achy and she developed an eye blinking tick.  Benadryl was administered that evening which had minimal effect on the facial rash and swelling and no effect on the eye twitching.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Rash, Rash macular, Swelling face
Clinical narrative: Red blotches on her face developed and her lips swelled.  She complained of feeling generally tired achy and she developed an eye blinking tick.  Benadryl was administered that evening which had minimal effect on the facial rash and swelling and no effect on the eye twitching.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Brain injury, Cardiac arrest, Laboratory test, Laboratory test normal, Respiratory arrest
Clinical narrative: Suddenly stopped breathing and cardiac arrest, was given CPR, suffered brain damage.
Age: 0.5
Sex: F
Vaccine: DTAPIPVHIB, PNC13
Symptoms: Resuscitation
Clinical narrative: Suddenly stopped breathing and cardiac arrest, was given CPR, suffered brain damage.
Age: 45.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Discomfort, Pain
Clinical narrative: Pt received both immunizations in left arm (about 4 inches apart). Reports pain and discomfort x 2 days. Came into clinic and reports being transferred to MC. In hospital for weekend where she was treated. Discharged home w/ discomfort after the weekend. Pt report being treated w/ Atbx and pain medications.
Sex: M
Vaccine: VARZOS
Symptoms: Hyperaesthesia, Injection site erythema, Injection site pain, Pain of skin
Clinical narrative: This spontaneous report as received from a consumer who is a male patient of unknown age. The patient's medical history included shingles on his scalp in July 2012. In February 2012, patient had undergone unspecified steroid treatment in a nebulizer for months due to a respiratory infection and no allergies were reported. On 10-DEC-2013 the patient was vaccinated with ZOSTAVAX (strength, dose and frequency unknown). Concomitant therapies included atorvastatin (manufacture unknown) and trazodone hydrochloride (manufacture unknown). On 10-DEC-2013, he first had brief redness or soreness at injection site which quickly disappeared. However, after 24 hours the vaccination patient began to experience extreme sensitivity of the skin and torso. This skin sensitivity flared late over the next days, and has intensified, with a painful sensitivity stretching from back to torso as of 17-DEC-2013. The patient has no rash, redness, lesions or itching. Patient sought medical attention and has not received any treatment. No laboratory tests were performed. The outcome of redness or soreness at injection site was reported as recovered/resolved. The outcome of extreme sensitivity of the skin on torso, skin sensitivity flared over the next days and has intensified with a painful sensitivity stretching from back to torso was unknown. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Rash generalised, Varicella post vaccine, Varicella virus test positive
Clinical narrative: This spontaneous report was received from an other health professional refers to a female infant patient of unknown age. On an unknown date, the infant mother was vaccinated with VARIVAX (Merck) (dose, route and frequency was not reported). On an unknown date, 45 days after infant mother received VARIVAX (Merck), the infant contracted chickenpox. The patient was sought medical attention and saw the physician. On an unknown date, the infant had a generalized rash, no fever and no complications. The infant had no known exposure of wild type varicella and mother did not exhibit any signs of a rash. On an unknown date cultured a vesicle and identified varicella virus. The outcome of the event chickenpox and generalized rash was unknown. The reporter did not provide the causality between the event and the suspect drug. Additional information has been requested.
Sex: U
Vaccine: HPV4, PPV, RV5, VARZOS
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from an other health professional refers to unspecified number of patients of unknown demography. On an unknown date, the patients were vaccinated with ZOSTAVAX (dose, route and frequency was not reported) which was exposed to -5C for 14 days. The patients were also vaccinated with GARDASIL (dose, route and frequency was not reported), ROTATEQ (dose, route and frequency was not reported) and PNEUMOVAX23 (dose, route and frequency was not reported) which was exposed to -5c for 30 days. No adverse effects reported. Additional information is not expected.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 62 year old male patient. Patient had no known allergies. On 16-DEC-2013 the patient was vaccinated with ZOSTAVAX vial (strength, dose and frequency unknown) lot # J006157 and expiry date 30-AUG-2014 subcutaneously. On 18-DEC-2013, patient experienced injection site reaction described as a red, swollen, warm knot like area at the injection site of the ZOSTAVAX vaccination that was 6 inches by 3 to 4 inches, without pain or itching. It was reported that patient sought pharmacist and was instructed to use ALEVE or Ibuprofen for swelling, but unspecified if patient took any ALEVE or Ibuprofen. No laboratory tests were performed. The outcome of event was reported as not recovered/not resolved. This case # 1312USA009925 is linked to case # 1312USA011095 via same reporter link. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Injection site reaction
Clinical narrative: This spontaneous report as received from a pharmacist refers to multiple patients of unknown age. On an unknown date the patient was vaccinated with ZOSTAVAX, (strength, dose and frequency unknown) subcutaneous. On an unknown date the patient experienced injection site reactions following ZOSTAVAX vaccination, but smaller in size (half to silver dollar in size). The outcome of injection site reactions following ZOSTAVAX vaccination, but smaller in size (half to silver dollar in size) was unknown). No further information has been reported. This case # 1312USA011095 is linked to case # 1312USA009925 via same reporter link. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site papule
Clinical narrative: This spontaneous report as received from a pharmacist via company representative refers to a female patient in her 60's. On an unknown date reportedly couple of years ago the patient was vaccinated with a dose of ZOSTAVAX (lot# and dosing regimen unspecified). The pharmacist reported that the patient developed papules at the injection site after administration of ZOSTAVAX a couple of years ago. The patient sought medical attention (contacted pharmacy via phone). The outcome of the event was unknown. Reporter's causality was not provided. Additional information is not expected.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: This spontaneous report as received from a nurse refers to a 60 year old female patient with no medical history.  On 06-DEC-2013 the patient was vaccinated with a dose of ZOSTAVAX (lot # J006832, exp date: 14-SEP-2014) subcutaneous. Concomitant therapies included verapamil, aspirin, NASONEX and triamcinolone. The nurse was reporting that a patient developed redness, swelling, and itching at the injection site after receiving a dose of ZOSTAVAX (in approximately December 2013). The nurse also mentioned that the patient developed glaucoma while taking amitriptyline in the past (captured in MARRS# 1312USA011131). There was no laboratory studies performed. Patient sought medical attention by calling the office and was given no treatment for AE. The outcome of events was reported as not recovered/not resolved. Additional information has been requested.
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Headache, Hyperhidrosis, Pain, Swelling
Clinical narrative: Case number PHHY2013US000638, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 473728) website on 02 Jan 2013, with the follow-up received from Quality Assurance Department (reference number: 209068) on 18 Dec 2013: This report refers to a 41-year-old female patient. Concomitant medication included propranolol. Current condition of this patient include high blood pressure. She was vaccinated with FLUVIRIN (batch number: 1204601, Expiry date: 31 May 2013) to left arm on 27 Oct 2012. On 29 Oct 2012 morning, the patient presented with aching, swelling and redness (not rash). The patient also experienced sweating and headache. Patient went to hospital and was diagnosed with viral infection. Laboratory data showed white blood cells were high. Chest X-ray was negative. Outcome of the events were reported as condition unchanged. Seriousness and causality were not reported. Based on the investigation performed, QA department stated that, the FLUVIRIN (batch number: 1204601) was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (reference number: 209068) on 18 Dec 2013: Updated batch review report.
Sex: F
Vaccine: FLU3
Symptoms: Viral infection, White blood cell count increased
Clinical narrative: Case number PHHY2013US000638, is an initial spontaneous report received from the Vaccine Adverse Event Reporting System (VAERS reference number: 473728) website on 02 Jan 2013, with the follow-up received from Quality Assurance Department (reference number: 209068) on 18 Dec 2013: This report refers to a 41-year-old female patient. Concomitant medication included propranolol. Current condition of this patient include high blood pressure. She was vaccinated with FLUVIRIN (batch number: 1204601, Expiry date: 31 May 2013) to left arm on 27 Oct 2012. On 29 Oct 2012 morning, the patient presented with aching, swelling and redness (not rash). The patient also experienced sweating and headache. Patient went to hospital and was diagnosed with viral infection. Laboratory data showed white blood cells were high. Chest X-ray was negative. Outcome of the events were reported as condition unchanged. Seriousness and causality were not reported. Based on the investigation performed, QA department stated that, the FLUVIRIN (batch number: 1204601) was manufactured in accordance with the approved internal procedures and it is in compliance with the cGMP requirements. Follow-up received from Quality Assurance Department (reference number: 209068) on 18 Dec 2013: Updated batch review report.