chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 88.0
Sex: M
Vaccine: FLU3, PNC13, FLU3, PNC13
Symptoms: Sensory loss, Urinary incontinence
Clinical narrative: Received vaccines (2) on Oct. 2, 2014, no symptoms until Thanksgiving Day Nov. 27th (patient was wobbly). Friday patient fell, brought to MD (Dr. on Monday) took MRI with normal results, following Tuesday patient fell again taken to ED (no strength in arms/hands/feet). Admitted for 5 days incontinent, now in nursing home for rehab fell numerous times since vaccine. Slow rehab currently - can sit/ambulate slowly, very tired, diagnosed with Guillain-Barre Syndrome.
Age: 88.0
Sex: M
Vaccine: FLU3, PNC13, FLU3, PNC13
Symptoms: Asthenia, Balance disorder, Fall, Fatigue, Guillain-Barre syndrome
Clinical narrative: Received vaccines (2) on Oct. 2, 2014, no symptoms until Thanksgiving Day Nov. 27th (patient was wobbly). Friday patient fell, brought to MD (Dr. on Monday) took MRI with normal results, following Tuesday patient fell again taken to ED (no strength in arms/hands/feet). Admitted for 5 days incontinent, now in nursing home for rehab fell numerous times since vaccine. Slow rehab currently - can sit/ambulate slowly, very tired, diagnosed with Guillain-Barre Syndrome.
Age: 88.0
Sex: M
Vaccine: FLU3, PNC13, FLU3, PNC13
Symptoms: Incontinence, Nuclear magnetic resonance imaging normal
Clinical narrative: Received vaccines (2) on Oct. 2, 2014, no symptoms until Thanksgiving Day Nov. 27th (patient was wobbly). Friday patient fell, brought to MD (Dr. on Monday) took MRI with normal results, following Tuesday patient fell again taken to ED (no strength in arms/hands/feet). Admitted for 5 days incontinent, now in nursing home for rehab fell numerous times since vaccine. Slow rehab currently - can sit/ambulate slowly, very tired, diagnosed with Guillain-Barre Syndrome.
Age: 25.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Chills, Headache, Myalgia, Oropharyngeal pain
Clinical narrative: Started with the chills and sore throat progressed to a fever with muscle aches, head ache, running nose joint pain.
Age: 25.0
Sex: M
Vaccine: FLU3
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: Started with the chills and sore throat progressed to a fever with muscle aches, head ache, running nose joint pain.
Age: 47.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site erythema, Injection site inflammation, Injection site pain, Injection site pruritus, Injection site reaction
Clinical narrative: A large, round, red inflamed area around the Afluria 2014-2015 infection site.  Very warm to the touch with an itching and burning sensation and the formation of dozens of tiny fluid filled blisters which cracked open upon scratching and then become crusty.
Age: 47.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Injection site vesicles, Injection site warmth, Scab
Clinical narrative: A large, round, red inflamed area around the Afluria 2014-2015 infection site.  Very warm to the touch with an itching and burning sensation and the formation of dozens of tiny fluid filled blisters which cracked open upon scratching and then become crusty.
Age: 47.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Burning sensation, Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site reaction
Clinical narrative: A large, round, red inflamed area around the Afluria 2014-2015 infection site.  Very warm to the touch with an itching and burning sensation and the formation of dozens of tiny fluid filled blisters which cracked open upon scratching and then become crusty.
Age: 1.01
Sex: F
Vaccine: FLU3, HEPA, MMR, VARCEL
Symptoms: Hypersomnia
Clinical narrative: Excessive sleepiness. She slept for 11 hours which is very usual for her.
Age: 0.67
Sex: M
Vaccine: FLUX
Symptoms: Diarrhoea, Pyrexia
Clinical narrative: He threw up once at 7:00pm and then again at 8:30pm. He had a low grade fever, and has had diarrhea twice once last night and once this morning.
Age: 11.0
Sex: M
Vaccine: FLUX, MEN, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Redness, swelling, and pain over injection site and extending 4-5 centimeters out from injection site.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash erythematous
Clinical narrative: Wife came on 12/24/2014 and said he has a red rash from his spinal cord to the belly. She established that their MD was on vacation. I counseled her to go to emergency room if symptons persist.
Age: 25.0
Sex: F
Vaccine: DTAP, MMR
Symptoms: Arthralgia, Mobility decreased
Clinical narrative: Intense Arthritic pain in knees, fingers, ankles that I had never experienced before. Difficulty with mobility.
Age: 63.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Drug administered at inappropriate site, Injected limb mobility decreased, Injection site pain, Muscular weakness
Clinical narrative: Extreme pain in both shoulders (received injections in each; high up on the shoulder).  Immobility, weakness (could not raise arms).
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Feeling hot, Paraesthesia
Clinical narrative: Face felt prickly and noticed face red and warm lasted about 30 minutes. Resolved on own, No treatment necessary No further problems.
Age: 9.0
Sex: F
Vaccine: FLUX, FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Swelling, Redness, Pain, Itching at injection site.
Age: 9.0
Sex: F
Vaccine: FLUX, FLU4
Symptoms: Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: Swelling, Redness, Pain, Itching at injection site.
Age: 9.0
Sex: F
Vaccine: FLUX, FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: Redness, bruising, and pain at injection site on upper outer left arm.
Age: 9.0
Sex: F
Vaccine: FLUX, FLU4
Symptoms: Injection site bruising, Injection site erythema, Injection site pain
Clinical narrative: Redness, bruising, and pain at injection site on upper outer left arm.
Age: 56.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Skin warm, Swelling, Tenderness
Clinical narrative: Tenderness noted at 0700 on 01/08/15 and then at 0700 on 01/09/15 area was noted to be swollen, red, and warm. Swelling noted to be 40 mm in diameter at 1430 on 01/09/15.
Age: 18.0
Sex: F
Vaccine: FLUN4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: No side effects have been reported, but Flumist was given to a pregnant patient.
Age: 1.64
Sex: F
Vaccine: FLU3
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Nausea, vomiting, diarrhea
Age: 1.5
Sex: F
Vaccine: DTAP, VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Chicken pox from the chicken pox vaccine.  May complicate her MCADD disease, but too early to tell..
Age: 48.0
Sex: F
Vaccine: FLUX
Symptoms: Diarrhoea, Myalgia, Oropharyngeal pain, Pyrexia
Clinical narrative: Severe muscle aches- particularly in neck and shoulders.  Slight fever, sore throat and diahrea.
Age: 3.0
Sex: F
Vaccine: VARCEL
Symptoms: Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Swelling at injection site; painful to touch; lump underneath injection site. Called nurse, they didn't even have injection site recorded properly.  Then doctor said it was probably a bug bite which is doubtful considering this is winter and my daughter wears pants all the time.  When I said that the doctor claimed in must be a scratch.  Really? A scratch that looks like a dot at the injection site???
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, Skin infection
Clinical narrative: Left arm was hurting just before bedtime on 01/07/15 but she didn't get up and look at it in the mirror. Next day couldn't get bp reading at dr office, nurse & doctor documented problem.
Age: 57.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle tightness, Pain in extremity
Clinical narrative: INITIAL ARM SORNESS PROGRESSIVE OVER A 2 WEEK PERIOD WITHOUT RESOLUTION, PATIENT REPORTS TIGHTNESS IN UPPER ARM RADIATING TO NECK AREA. NO SWELLING OR REDNESS AT INJECTION SITE UPON EVALUATUION ON 1/5/15.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling cold, Pyrexia, Tremor
Clinical narrative: Severe coldness and violent tremors for about two hours, and 100 deg. fever all that night.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Abdominal discomfort, Chills, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pain, swelling, redness at injection site.  Chills, fever, gastrointestinal discomfort.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Pyrexia
Clinical narrative: Pain, swelling, redness at injection site.  Chills, fever, gastrointestinal discomfort.
Age: 52.0
Sex: F
Vaccine: FLUX
Symptoms: Abdominal pain upper, Headache, Nausea
Clinical narrative: Nausea and stomach pain, in waves similar to food poisoning, but not as severe, and without vomiting. Also headache.
Age: 75.0
Sex: F
Vaccine: TDAP, VARZOS
Symptoms: Dyspnoea, Malaise
Clinical narrative: GENERAL UNWELL FEELING AND TROUBLE BREATHING.
Age: 54.0
Sex: M
Vaccine: ANTH
Symptoms: Pain, Spinal disorder, Spinal fusion surgery, Spinal laminectomy, Spinal operation
Clinical narrative: My lumbar spine has had 3 operations and 7 spinal injections. I feel the squalene agent that delivered the anthrax caused permanent damage to my spine.
Age: 10.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site induration
Clinical narrative: Left deltoid 4x4cm induration from flu.
Age: 48.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Swelling, Tenderness
Clinical narrative: Rec'd PREVNAR 12-18-14. 12-19-14 came to appt. Mild swelling, tenderness, mild redness.
Age: 0.54
Sex: U
Vaccine: DTAPHEPBIP, FLU3, HIBV, PNC13
Symptoms: Pyrexia, Rash, Rash maculo-papular
Clinical narrative: Maculopapular skin rash in face, scalp and trunk. No mucosal rash, no anaphylaxis, one day fever on 1/7/15.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: Patient broke out in a rash just on legs/thighs, not on immunization site. She is not sure if from shot. She never has had a reaction before. She has broken out into hives before due to cold weather. Patient taking ZYRTEC and BENADRYL.
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Immediate post-injection reaction, Injection site joint movement impairment, Injection site pain, Rotator cuff syndrome
Clinical narrative: The patient is experiencing limited range of motion and pain in left shoulder - onset of symptoms immediately after vaccination on 11/25/2014. Rotator cuff tendonitis - receiving physical therapy with slow improvement.
Age: 3.0
Sex: F
Vaccine: FLU3, VARCEL
Symptoms: Injection site reaction, Urticaria
Clinical narrative: After approx 15 minutes, 1/2 dollar size welt at injection site, ice applied and decrease to quarter size within 10 minutes - no SOB, rash or other assoc symptoms.
Age: 11.0
Sex: M
Vaccine: MNQ, MNQ
Symptoms: Cellulitis, Erythema, Peripheral swelling
Clinical narrative: (R) arm, red, swelling. Dx: cellulitis: tx: Cefdinir x 10 days.
Age: 12.0
Sex: M
Vaccine: HEPA, HPV4, MNQ
Symptoms: Ear pain, Facial paresis, Hypoaesthesia, VIIth nerve paralysis
Clinical narrative: Developed ear pain on right 6-7 days after vaccines then 2 days later R-sided facial numbness and weakness (Bell's palsy). Treated with prednisone burst and taper x 10 days. Symptoms are gradually improving still with some deficits (mild) on 12/23/14.
Age: 1.2
Sex: F
Vaccine: DTAP, HEPA, MMRV, PNC13
Symptoms: Pyrexia, Rash
Clinical narrative: Fever and rash on day 9 after vaccination with PROQUAD.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Dyskinesia, Muscle contractions involuntary, Musculoskeletal stiffness, Seizure, Unresponsive to stimuli
Clinical narrative: Tdap given at 3:20 then titers drawn, during 2nd and third vial of titers client unresponsive, body stiff and jerking, eyes closed and mouth drawn in, hands, arms and legs/feet tight and drawn inward while needle in right hand, needle removed and client positioned on mat on floor with legs up. 911 called. 3:45 unresponsive - seizure about 4 minute, EMS on site at 3:50 pm.
Age: 21.0
Sex: F
Vaccine: TDAP
Symptoms: Viral titre
Clinical narrative: Tdap given at 3:20 then titers drawn, during 2nd and third vial of titers client unresponsive, body stiff and jerking, eyes closed and mouth drawn in, hands, arms and legs/feet tight and drawn inward while needle in right hand, needle removed and client positioned on mat on floor with legs up. 911 called. 3:45 unresponsive - seizure about 4 minute, EMS on site at 3:50 pm.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Angioedema, Eye swelling
Clinical narrative: Angioedema of eyes. Eye (L) started swelling 3 hrs after flu vaccine. Both eyes swollen by morning - (no redness and no discharge).
Age: 17.0
Sex: M
Vaccine: FLU3, HEPA, HPV4
Symptoms: Pallor, Syncope, Tension
Clinical narrative: Patient became pale and had an episode of syncope for 5 sec. Then patient tensed up and arms shook for 5 seconds. Patient then became alert and layed on table until stable enough to sit up. Patient was observed for 20 min before leaving the office.
Age: 4.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Local reaction, Vaccination complication
Clinical narrative: 12/28/14 - 24 hrs after FLUZONE administration, pt developed a 10 cm area of erythema around the flu vaccine administration site as described to Dr ER. Pt treated Kw/ KEFLEX but thought to have local reaction to flu vaccine.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Axillary pain, Influenza virus test, Injection site erythema, Injection site inflammation, Injection site pain
Clinical narrative: Pt. was seen in E.R. when flu immunization was given. Then seen 2 days later with approx. 9 cm circle reddened, inflamed area on site of injection. Pt. describes pain from area and going into armpit same arm.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Streptococcus test
Clinical narrative: Pt. was seen in E.R. when flu immunization was given. Then seen 2 days later with approx. 9 cm circle reddened, inflamed area on site of injection. Pt. describes pain from area and going into armpit same arm.
Age: 67.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Musculoskeletal disorder, Musculoskeletal pain, Pain in extremity
Clinical narrative: Patient states pain in shoulder and upper arm severe enough that it inhibits her ability to use arm. Immunization given on 12-22-14 reported to pharmacy on 1-9-15.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Acoustic stimulation tests abnormal, Deafness unilateral, Sudden hearing loss
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 70 year old female (additional information was received directly from the patient who was also an Audiologist). The patient's pertinent medical history and drug reactions or allergies were unspecified. On 20-DEC-2014, the patient was vaccinated with ZOSTAVAX (lot # reported as J49842, expiration date: 31-MAR-2016) 0.65 ml, subcutaneous. Concomitant medications were unspecified. On 26-DEC-2014, the patient experienced sudden hearing loss, 40% in her right ear after receiving ZOSTAVAX. On 27-DEC-2014, the patient tested her hearing herself. The patient sought medical attention by visiting otolaryngologist (ENT physician). The patient was treated with ten, two hour, hyperbaric chamber treatments, with steroid therapy and FAMVIR. It was also reported that, at the time of report, the patient was still on steroid therapy that would be completed on 13-JAN-2015. The patient would have two more hearing tests completed on an unspecified dates. At the time of the report the outcome of the events was reported as recovering. The relatedness between the event and the therapy with ZOSTAVAX was not provided. Upon internal review the event of sudden hearing loss in right ear was considered to be medically significant. Lot number J49842 is an invalid lot number for ZOSTAVAX. Additional information has been requested.
Age: 0.2
Sex: M
Vaccine: RV5
Symptoms: Diarrhoea, Mucous stools
Clinical narrative: This spontaneous report as received from the patient's mother refers to her 2 months old male child. Pertinent medical history was unknown. No allergies were reported. On an unknown date July 2014 the patient was vaccinated with ROTATEQ (2 ml, oral). Concomitant medications included other unspecified vaccines. On an unknown date in July 2014 the patient experienced diarrhea and mucous in the stools. The reporter states that she is a breastfeeding mother and she did not know whether the patient was developing some sort of sensitivity. On an unknown date in September 2014, the patient was vaccinated with another dose of ROTATEQ and also other unspecified vaccines. On an unknown date in September 2014 the patient again experienced diarrhea. The reporter said that mucous in stools was still present and did not resolved since July 2014. The reporter states that she did call her son's physician (details unspecified) and was told to monitor him and make sure her son got lot of fluids. No treatment was given for the events. No diagnostics studies were performed. The outcome of the events was reported as recovered/resolved. The reporter considered mucous in the stools to be related to ROTATEQ. The reporter considered diarrhea to be related to ROTATEQ. The causal relationship between some sort of sensitivity and ROTATEQ was unknown. Additional information is not expected as the reporter is not willing to be contacted.
Age: 26.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Pain in extremity
Clinical narrative: Arm soreness 1 month after vaccine administered.
Age: 55.0
Sex: F
Vaccine: PPV
Symptoms: Limb discomfort, Pain, Pain in extremity
Clinical narrative: Pain and throb on left upper arm. Taking ADVIL for a regular basis. Constant discomfort.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a licensed vocational nurse (LVN) refers to a 67 patients of unknown age and gender. Patient's medical histories and concurrent conditions were not provided. On unspecified dates between August 2014 and October 2014, 67 patients were vaccinated with improperly stored doses of ROTATEQ oral (dose, lot number and expiry date were not reported). ROTATEQ, Oral was found to be unsupported excursions with in-house stability data. No adverse symptoms reported. Product quality complaint (PQC) was not involved. The outcome of the event was unknown. This is one of several reports received from the same reporter. Follow up information has been received on 06-JAN-2015 from the nurse concerning 60 unspecified patients of unknown age and gender vaccinated with improperly stored doses of ROTATEQ between August 2014 and October 2014. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown gender and age. No relevant medical history of the patients was reported. On unknown dates the patients were vaccinated with doses of improperly stored ROTATEQ orally (lot number, strength, dose and frequency were not reported). There were no concomitant medications reported. No adverse effect was reported. It was unspecified if the patients had sought any medical attention. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: FLU3
Symptoms: Adverse reaction
Clinical narrative: This case was reported by a other health professional and described the occurrence of adverse reaction in a patient who received Seasonal trivalent Influenza vaccine. On an unknown date, the patient received Seasonal trivalent Influenza vaccine (unknown). On an unknown date, unknown after receiving Seasonal trivalent Influenza vaccine, the patient experienced adverse reaction. On an unknown date, the outcome of the adverse reaction was unknown. It was unknown if the reporter considered the adverse reaction to be related to Seasonal trivalent Influenza vaccine. Additional information received on 16 October 2014: The patient had a reaction after a Flu vaccine. The caller was not sure that it was FLULAVAL. The medical fellows thought it was due to Thimerosal.
Age: 62.0
Sex: M
Vaccine: HEP, PPV
Symptoms: Expired product administered, Malaise
Clinical narrative: This case was reported by a pharmacist and described the occurrence of feeling unwell in a 62-year-old male patient who received ENGERIX B adult (batch number AHBVC148AB, expiry date 6th September 2014). Co-suspect products included PNEUMOVAX VACCINE. On 27th October 2014, the patient received the 1st dose of ENGERIX B adult and PNEUMOVAX VACCINE. On 27th October 2014, an unknown time after receiving ENGERIX B adult, the patient experienced feeling unwell and expired vaccine used. On an unknown date, the outcome of the feeling unwell and expired vaccine used were unknown. It was not reported if the reporter considered the feeling unwell to be related to ENGERIX B adult.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: This spontaneous report was received from a pharmacist via company representative. The pharmacist was reporting on himself. The patient's medical history, concurrent conditions, drug reactions and allergies were not reported. On an unknown date, the patient was vaccinated with ZOSTAVAX (dose, route of administration, anatomical location, lot# and exp. date were not reported) for shingles prevention. No concomitant therapy was reported. On an unknown date, reported as "about two weeks or more ago", the patient experienced post vaccination shingles. The patient had a rash on his temple and leg and stated that it was very painful. The patient did not seek for medical attention, did not visit the physician and indicated that was going to self-treat himself. The patient did not recover from the event. The relatedness between ZOSTAVAX and the event was not reported. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown gender and age. No relevant medical history of the patients was reported. On unknown dates the patients were vaccinated with doses of improperly stored LIQUID PEDVAXHIB (lot number, strength, dose, frequency and route of administration were not reported). There were no concomitant medications reported. No adverse effect was reported. It was unspecified if the patients had sought any medical attention. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a state immunization official who is a health worker refers to seven patients of unknown age and gender. No medical history and concomitant medication was reported. On an unspecified dates seven patients were inadvertently vaccinated with (Oka/Merck) VARIVAX lot # J000152 (Strength, Dose, Route were not reported) that had been improperly stored. No adverse effects reported. No product quality complaint was involved. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown gender and age. No relevant medical history of the patients was reported. On unknown dates the patients were vaccinated with doses of improperly stored PNEUMOVAX 23 (lot number, strength, dose, frequency and route of administration were not reported). There were no concomitant medications reported. No adverse effect was reported. It was unspecified if the patients had sought any medical attention. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received on 04-DEC-2014 from a health professional at a physician's office via a company representative. On 02-DEC-2014, the RECOMBIVAX HB (Lot # K012933) at this physician's office had been exposed to temperatures outside of the required temperature range and the efficacy of the RECOMBIVAX HB outside of the temperature range has not been established. The health professional reported that RECOMBIVAX HB (Lot # K012933) was administered to several patients (both male and female, no other patient information provided). No further information has been provided. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a 67 year old female patient. In 2009, the patient was vaccinated with ZOSTAVAX dose 1 (dose, route, anatomical location, lot #, expiration date were not reported). On 31-DEC-2014, the patient was subcutaneously vaccinated with ZOSTAVAX lot # K015308 dose 2, 0.65 ml, in the right deltoid. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. Information about concurrent conditions and medical history was not provided. On 26-DEC 2014 the patient was vaccinated with GARDASIL, (strength, lot#, frequency, series dosage number unspecified and expiration date not reported) dose 0.5 ml, intramuscular. The product had undergone an unsupported temperature excursion. No adverse experience reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to an unspecified number of patients of unknown gender and age. No relevant medical history of the patients was reported. On unknown dates the patients were vaccinated with doses of improperly stored GARDASIL (lot number, strength, dose, frequency and route of administration were not reported). There were no concomitant medications reported. No adverse effect was reported. It was unspecified if the patients had sought any medical attention. There was no product quality complaint (PQC) involved. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 1.05
Sex: F
Vaccine: HEPA, MMR, PNC, VARCEL
Symptoms: Pyrexia
Clinical narrative: This spontaneous report as received from a Nurse Practitioner refers to a 12 month old female patient developmentally delayed. The patient's medical history included left sided weakness and constipation. Nurse practitioner confirmed that all medical history developed on unspecified dates prior to receiving M-M-R II, VAQTA, VARIVAX (Merck) and PREVNAR (manufacturer unknown). None drug reactions/allergies were reported. On 05-JAN-2015, the patient was vaccinated with a dose of M-M-R II, 0.5 ml, subcutaneous, lot # K001997, expiry date 10-FEB-2016. Other suspect therapies included dose of VAQTA 0.5 ml, intramuscular, lot # K005958, expiry date 09-FEB-2017, dose of VARIVAX (Merck) 0.5 ml, subcutaneous, lot number K009757 and expiry date 09-JUL-2016 and a dose of PREVNAR (manufacturer unknown) dose, route, lot number and expiry date were not reported. None concomitant medication provided. The nurse practitioner stated that the patient developed a fever of 103.3f and a heart rate of 189 "within 20 hours" of receiving M-M-R II, VAQTA, VARIVAX (Merck) and PREVNAR (manufacturer) on 05-JAN-2015. The nurse practitioner reported that she saw the patient in the office "this morning" (on 06-JAN-2015) and the patient's temperature was 101/3 F and her heart rate was 178. The nurse practitioner stated that she referred the patient today to an unspecified hospital to have "routine lab work drawn", a chest x-ray, and an electrocardiogram (EKG). The nurse practitioner reported that the patient was in route to the hospital at this time to have the above tests done. The patient had not been admitted to the hospital yet. On 07-JAN-2015, the Nurse practitioner reported that the patient was still in an unspecified emergency room since yesterday but has not been admitted yet. At the time of the report the patient did not receive any treatment. The outcome of patient developed a fever of 103.3 F was reported as not recovered. Relatedness between the therapy with M-M-R II, VAQTA and VARIVAX (Merck) and the event: fever of 103.3 F was not reported. Additional information has been requested.
Sex: U
Vaccine: HPV2
Symptoms: Injection site pain
Clinical narrative: This case was reported by a healthcare professional (nurse) via Merck and described the occurrence of sore arm (injection site) in a subject of unspecified age and gender who was vaccinated with CERVARIX (GlaxoSmithKline). On an unspecified date in May 2010 the subject received 1st dose of CERVARIX (unknown). At an unspecified time after vaccination with CERVARIX, the subject experienced sore arm (injection site). The nurse reported a subject received a 1st dose of CERVARIX in May 2010 and developed a "sore arm that was not red". The sore arm was not specified as local or systemic reaction. At the time of reporting the outcome of the sore arm was unspecified. Follow up was received from the healthcare professional on 6 February 2014. The reporter stated that the subject was "one child that had an issue with CERVARIX." The reporter had no further information to provide at the time of reporting. Follow-up information was received on 19 February 2014 via nurse who reported "we do not use CERVARIX in our practice. Do no know who this refers to". The nurse did not provide any additional information.
Sex: U
Vaccine: HPV2
Symptoms: Injection site pain, Wrong technique in drug usage process
Clinical narrative: This case was reported by a healthcare professional (nurse) and described the occurrence of pain during injection in an unspecified number of subjects of unspecified ages and gender who were vaccinated with CERVARIX (GlaxoSmithKline). On unspecified dates the subjects received unspecified doses of CERVARIX (unknown) mixed with Lidocaine and experienced inappropriate preparation of medication. During vaccination with CERVARIX, the subjects experienced pain during injection. The nurse reported that it was brought to the attention of patient safety at the outpatient clinics that a physician was mixing Lidocaine with CERVARIX to reduce pain during administration (pain during injection). The nurse inquired if there were any contraindications to administering the vaccine with another medication. At the time of the reporting the outcome of the pain during injection was unspecified.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: This spontaneous report was received from a pharmacist who was informed by another unspecified pharmacist and refers to a female patient of unknown age. On 06-SEP-2014 the patient was vaccinated with ZOSTAVAX, 0.65 ml, subcutaneous. On an unknown date the patient experienced small red bump at the injection site which resolved within 1-2 days. No further information was provided. The outcome of small red bump at the injection site was reported as recovered/resolved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to the unspecified number of patients of unknown ages (reported as "about 5 patients but nurse could not be sure of exact number of patients"). On 16-OCT-2014, the nurse reported temperature excursion inquiry only and no adverse event was reported. On 06-JAN-2015, the nurse reported second temperature excursion for VARIVAX (Merck) doses and reported that improperly stored VARIVAX (Merck) (strength and lot# unknown, 0.5 ml, subcutaneous) doses had been administered to patients on unspecified dates since initial report of temperature excursion. Additional information has been requested.
Age: 35.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: This is a prospective pregnancy case. This 35-year-old female subject was enrolled in a study. The subject received the 1st dose of BOOSTRIX (intramuscular) 5 ml on 19th December 2014 16:00. On 19 December 2014, an unknown time after receiving BOOSTRIX the subject developed vaccine exposure during the pregnancy (Non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing.
Age: 29.0
Sex: F
Vaccine: TDAP
Symptoms: Exposure during pregnancy
Clinical narrative: This is a prospective pregnancy case. This 30-year-old female subject was enrolled in an open label study. The subject received BOOSTRIX (intramuscular) .5 ml on 6th January 2015. The subject's estimated date of delivery was 20th February 2015. The subject received BOOSTRIX at week 33 of the pregnancy and during the third trimester of pregnancy. On 6th January 2015, an unknown time after receiving BOOSTRIX the subject developed vaccine exposure during pregnancy (Non-serious). The outcome of vaccine exposure during pregnancy was unknown. The pregnancy was ongoing. Additional details provided: There was not known if adverse events had occurred.
Sex: U
Vaccine: HEP
Symptoms: Incorrect product storage
Clinical narrative: Information has been received on 04-DEC-2014 from a health professional at a physician's office via a company representative. On 02-DEC-2014, the RECOMBIVAX HB (Lot # K011957) at this physician's office had been exposed to temperatures outside of the required temperature range and the efficacy of the RECOMBIVAX HB outside of the temperature range has not been established. The health professional reported that RECOMBIVAX HB (Lot # K011957) was administered to several patients (both male and female, no other patient information provided). No further information has been provided. Additional information has been requested.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: This spontaneous report was received from a consumer who refers to herself, a 50-year-old female patient. On 09-DEC-2014 the patient was vaccinated with ZOSTAVAX. On 09-DEC-2014 after getting the ZOSTAVAX the patient experienced minor swelling and pain "next to the injection site". The outcome of minor swelling and pain "next to the injection site" is unknown. No further information was provided and no contact details were provided. Additional information is not expected.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist refers to a female patient of unknown age with allergy to penicillin. No concomitant medications were reported. On 04-DEC-2014 the patient was vaccinated with ZOSTAVAX lot # K012924, subcutaneous in the right arm. In DEC-2014 the patient experienced headaches, large painful area of redness, warmth, and swelling at injection site after administration of ZOSTAVAX on 04-DEC-2014. The outcome of headaches and large painful area of redness, warmth, and swelling at injection site was reported as not recovered/not resolved. The patient sought medical attention by going to the pharmacy. No further information was provided. Additional information has been requested.
Sex: U
Vaccine: HIBV, HPV4
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with GARDASIL, 0.5 ml, intramuscular. Other suspect therapies included PEDVAXHIB. On an unknown date the nurse reported that the patients were administered with improperly stored GARDASIL and PEDVAXHIB. No adverse events were reported. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from medical assistant refers to a nine patients of unknown age and gender. On an unknown date, patients were vaccinated with doses of PROQUAD (Merck), .5 ml, subcutaneous (lot # and expiration date were not provided) that were improperly stored. The vaccines experienced a first temperature excursion on unknown date, the second temperature excursion was on 05-JAN-2015 and it was reported that improperly stored PROQUAD (Merck) were administered since the initial temperature excursion. Nine patients received improperly stored PROQUAD (Merck). No adverse effects reported. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Eyelid contusion, Eyelid irritation
Clinical narrative: This spontaneous report was received from a pharmacist reporting for a patient of her husband's. This report refers to a female patient of unknown age. On 02-DEC-2014 the patient was vaccinated with ZOSTAVAX, subcutaneous. On 02-DEC-2014, a few hours after administration of ZOSTAVAX, the patient experienced irritation and bruising of her eyelids. The outcome of irritation and bruising of her eyelids was reported as not recovered/not resolved. The patient sought medical attention via an office visit. No further information was provided. Additional information has been requested.
Age: 68.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: This spontaneous report was received from a pharmacist and refers to a 68 year old female patient who on 06-DEC-2014 was vaccinated with ZOSTAVAX, single dose vial, subcutaneous. No concomitant medications were reported. On 07-DEC-2014, the patient experienced injection site redness, injection site hardness and injection site warmth. The outcome of injection site redness, injection site hardness and injection site warmth was reported as not recovered/not resolved. The patient sought medical attention by going to the pharmacy. No further details were provided. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacist refers to a patient of unknown age and gender. Information regarding drug reactions or allergies and medical history was not reported. On 07-JAN-2015 the patient was inadvertently vaccinated with ZOSTAVAX (lot#, dose, route of administration, anatomical location were not reported) that expired on 19-DEC-2014. Concomitant therapies were not reported. No adverse effects were reported. Product quality complaint (PQC) was not involved. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to a patient of unknown age and gender. The reporter stated that on 26-JUN-2014, the patient received the first dose of GARDASIL (0.5 ml, intramuscular, anatomical location and lot number were not reported), on 13-NOV-2014 received the second dose of GARDASIL (0.5 ml, intramuscular, anatomical location and lot number were not reported) and on 08-JAN-2015 received the third dose of GARDASIL (0.5 ml, intramuscular, anatomical location and lot number were not reported). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Impaired gastric emptying
Clinical narrative: This spontaneous report as received from a registered nurse via a company representative refers to a patient of unknown age and gender. On an unknown date the patient was vaccinated with GARDASIL. On an unknown date the patients cousin reported that the patient developed gastroparesis on an unknown date after receiving GARDASIL. The outcome of developed gastroparesis on an unknown date after receiving GARDASIL is unknown. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Extra dose administered
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 66 year old female patient. The patient's medical history included hospitalization. The patient's past drug history was unknown. On 16-DEC-2014 the patient was vaccinated with dose 1 of PNEUMOVAX 23 (dose 1, 0.5 ml, intramuscular; lot number reported as K010465 EXP 23-MAR-2016) for inpatient status. On 17-DEC-2014 the patient was vaccinated with dose 2 of PNEUMOVAX 23 (dose 2, 0.5 ml, intramuscular; lot number reported as K010465 EXP 23-MAR-2016) for inpatient status. On 20-DEC-2014 the patient was vaccinated with dose 3 of PNEUMOVAX 23 (dose 3, 0.5 ml, intramuscular; lot number reported as KD19386) for inpatient status. Concomitant therapies included ANUSOL cream, ATIVAN "PRN", CARAFATE, CENTRUM, potassium 20 milliequivalent daily, MEGACE suspension 400 mg, NICODERM 21 g patch daily, PROMOD powder 7 g  three times a day, PROTONIX 40 mg daily, RESTORIL 15 mg at bedtime, thiamine, XANAX 0.25 mg every 6 hours "PRN", acetaminophen, PERCOCET 5/325 "PRN" and NOVOLOG sliding scale. The patient was vaccinated 3 times with PNEUMOVAX 23 in four day. No laboratory data was reported. It was unknown if the patient will continue to take PNEUMOVAX 23. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to 4 unspecified patients of unknown age and gender. On an unknown dates the patients were vaccinated with PROQUAD (Merck) 0.5 ml, subcutaneous (lot # not reported). On an unknown dates the patients received doses of PROQUAD (Merck) which had undergone a supported temperature excursion. No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a Licensed Practical Nurse refers to 8 unspecified patients of unknown age and gender. On an unknown dates the patients were vaccinated with VARIVAX (Merck) 0.5 ml, subcutaneous (lot # not reported). On an unknown dates the patients received doses of VARIVAX (Merck) which had undergone  supported temperature excursion. No adverse experiences were reported. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to a patient of unknown age and gender. On 08-JAN-2015 the patient was vaccinated with ZOSTAVAX subcutaneous, expiry date: 19-DEC-2014 (dose, lot # not reported). On 08-JAN-2015 the patient received an expired dose of ZOSTAVAX. There were no known adverse effects. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to multiple patients with unknown ages and genders. On unknown dates the multiple patients were vaccinated with (Oka/Merck) VARIVAX (lot # J008229, expiration date: 12-JUL-2015, 0.5 ml, subcutaneous) which involved in a supported temperature excursion. No adverse effects noted by any patients. It was not specified if the multiple patients sought for medical attention. Additional information has been requested.
Age: 20.0
Sex: F
Vaccine: VARCEL
Symptoms: Exposure during pregnancy, No adverse event, Pregnancy test urine positive
Clinical narrative: This spontaneous prospective pregnancy report as received from a registered nurse refers to a 20 year old female patient with no drug reactions/allergies. Patient's concurrent conditions included bipolar disorder. The patient became pregnant with last menstrual period (LMP) of 06-DEC-2014 and estimated date of delivery (EDD) of 12-SEP-2015. On 07-JAN-2015 the patient was inadvertently vaccinated with a dose of VARIVAX (Merck) dose: 0.5 ml, subcutaneously (lot # K006138, expiration date: 29-APR-2016). Concomitant therapies included ABILIFY (also reported as 'ABILFY'). Urine pregnancy test: positive on 07-JAN-2015. Initial exposure to VARIVAX (Merck) was at 4 weeks. The pregnancy outcome was outcome pending. The patient sought medical attention by visiting the office. No treatment was given for the event. No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: This spontaneous report as received from a nurse refers to a patient of unknown age. Patient medical history and current condition was not reported. On 05-JAN-2015 the patient was vaccinated with an expired dose of PNEUMOVAX 23 (dose reported as 0.5 ml via intramuscular route) (Lot # J004387 and expiry date 04-JAN-2015). No symptoms reported. The outcome of the event was unknown. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with PROQUAD (Merck). On an unknown date the patients received improperly stored PROQUAD (Merck) (20 doses) that were exposed to 32F for 12 hours. No adverse effects were reported. The outcome of the events were unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report as received from a consumer via a company representative refers to a female patient of unknown age (the consumer's daughter). In approximately 1999 the patient was vaccinated with VARIVAX (Merck) (dose, route, lot# and expiration date were not reported), the indication was reported as against "Barcelona". The patient contracted a mild varicella infection in 2004. The outcome of the event was not reported. The relatedness between the event and VARIVAX (Merck) was not reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with ZOSTAVAX. On an unknown date the patients received improperly stored ZOSTAVAX (approximately 10 doses) that were exposed to 32F for 12 hours. No adverse effects were reported. The outcome of the events were unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report as received from a health care worker refers to an unspecified number of patients of unknown age and gender. On an unknown date the patients were vaccinated with VARIVAX (Merck). On an unknown date the patients received improperly stored VARIVAX (Merck) (27 doses) that were exposed to 32F for 12 hours. No adverse effects were reported. The outcome of the events were unknown. This is one of several reports received from the same reporter. Additional information has been requested.
Age: 42.0
Sex: F
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Injection site pain, Pain in extremity, Tenderness
Clinical narrative: Feels like I was punched in the left arm. Unable to raise my arm at or above shoulder level. I'm unable to sleep on my left side without pain. Lots of pain in the deltoid muscle.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site swelling, Mobility decreased
Clinical narrative: Injection site swelled up the size of an egg. I could not move my arm for two days.