chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Immediate post-injection reaction, Lethargy, Pain, Pyrexia, Screaming
Clinical narrative: She screamed during vaccinations. Hours later she was lethargic, hot, and flushed in the face and body. She just wanted to sleep. The next day (about 26 hours later from immunizations) same symptoms however had a 103.0 rectal temperature. Doctor on-call said to bring her to the ER at the hospital. She constantly wanted to be held, just slept, seemed drowsy, lethargic, had a abnormal cry that sounded like she was in pain. She was not her normal self. Also didn't want to eat. Hospital said to continue administering infants Tylenol for the fever. She resumed to normal after 3 full days after the immunizations.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Somnolence
Clinical narrative: She screamed during vaccinations. Hours later she was lethargic, hot, and flushed in the face and body. She just wanted to sleep. The next day (about 26 hours later from immunizations) same symptoms however had a 103.0 rectal temperature. Doctor on-call said to bring her to the ER at the hospital. She constantly wanted to be held, just slept, seemed drowsy, lethargic, had a abnormal cry that sounded like she was in pain. She was not her normal self. Also didn't want to eat. Hospital said to continue administering infants Tylenol for the fever. She resumed to normal after 3 full days after the immunizations.
Age: 13.0
Sex: F
Vaccine: FLUN3, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Fall, Head injury, Pallor
Clinical narrative: Vaccine was given then weight was obtained by standing scale, pt then walked to waiting room (front of building) with other 2 sister who rec'd vaccinations as well. She fell backwards and hit her head on the floor. When front staff got to her, her eyes were closed. By the time RN's got up front she was awake, responsive, and pale. Cool wash cloth placed on head. BP checked 104/74, pulse was strong. Stayed on floor with knees up for approximately 5-10 mins. Able to walk out with family.
Age: 66.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Fatigue, Injection site erythema, Injection site pain, Myalgia, Pyrexia
Clinical narrative: Muscle aches, low grade fever starting on 11/29 increasing to 101 by that night. Also redness on left arm from shoulder to almost the elbow, tender to the touch and warm. Also very tired 11/19 and 11/30 and slept a good portion of the day.  No fever on Saturday and started feeling better by Sunday.  The rash did last until Monday but decreased a little at a time.  Took Tylenol.
Age: 66.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Rash, Somnolence
Clinical narrative: Muscle aches, low grade fever starting on 11/29 increasing to 101 by that night. Also redness on left arm from shoulder to almost the elbow, tender to the touch and warm. Also very tired 11/19 and 11/30 and slept a good portion of the day.  No fever on Saturday and started feeling better by Sunday.  The rash did last until Monday but decreased a little at a time.  Took Tylenol.
Age: 45.0
Sex: F
Vaccine: FLU3
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Arm is sore with decrease overhead ROM.
Age: 22.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Fever (Tmax 102), pain at site of injection, erythema at site of injection.
Age: 32.0
Sex: F
Vaccine: HPV4, MNQ, TDAP
Symptoms: Dizziness, Loss of consciousness, Unresponsive to stimuli
Clinical narrative: Pt given 1st Gardasil, when checking out pt c/o of dizziness to mom.  Pt passed out and was unresponsive for 2-3 min.  Pt came to and taken back to room and examined by Dr., who sent pt to hospital for outpt observation.
Age: 30.0
Sex: M
Vaccine: HEPAB, HPV4
Symptoms: Chills, Dizziness, Pain, Tremor
Clinical narrative: Shaking chills noted, today (12/4/2012 2:00 PM) some vague body ache without HA and light-headed feeling noted.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Local swelling, Pruritus generalised
Clinical narrative: Within 5 minutes of injection, generalized itching and localized swelling and redness described as the size between a quarter and silver dollar. BENADRYL liquid 50mg given, pt. waited 15 minutes before leaving with no further progression of symptoms. Patient contacted later and no problems.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Infection, Skin warm, Swelling
Clinical narrative: Swelling, infection/fever in the arm/might be forming pus in arm.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Skin warm
Clinical narrative: Redness on back of arm at injection site. Hot to touch - per patient via telephone conversation. Her physician concurred with recommendation to use hydrocortisone Cr and BENADRYL.
Age: 28.0
Sex: F
Vaccine: ANTH, TYP, YF
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling
Clinical narrative: Swollen, red, hard, itchy at the injection site.  Affected area is 5 1/4" by 2 3/4" of redness and swelling of the right arm. Reported to medical and received Benadryl capsules.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Headache, Pain, Pyrexia, Urine analysis normal
Clinical narrative: Aching, fever, headache.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Hypoaesthesia, VIIth nerve paralysis
Clinical narrative: Numbness on side of face. Diagnosed as Bell's Palsy by Dr.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Audiogram, Deafness unilateral, Ear discomfort, Nuclear magnetic resonance imaging, Tinnitus
Clinical narrative: Woke to loud ringing in right ear and fullness and inability to hear out of right ear.  Saw primary physican, started steroiods, went to ENT continued steroids and had injections into ear.
Age: 0.18
Sex: F
Vaccine: 6VAX-F, HEP, RV1
Symptoms: Crying, Oedema peripheral, Pyrexia, Screaming
Clinical narrative: High pitch screaming for 6hrs, Fever of 101F and at 11pm check on baby while sleeping and her arms from the elbows down were swollen double in size.
Age: 25.0
Sex: F
Vaccine: HEP, TDAP
Symptoms: Decreased appetite, Fatigue, Nausea, Pain
Clinical narrative: Around 3pm yesterday, 12/4/12, she started experiencing body aches, fatigue, loss of appetite, and nausea when trying to eat.  She took Tylenol and ibuprofen last night but continues to feel the same today.  She took Tylenol again today but it has not helped with the body aches.  She states she will go to the doctor if she doesn't feel better by tomorrow 12/6/12.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Fatigue, Muscular weakness, Stress, Tremor
Clinical narrative: On 11/7/12 reported to this RN that had onset of periodic tremors and weakness in right arm within 1-2 days of injection.  Evening of 11/7 had additional tremors of face.  Advised physician care.   Continues to experience some symptoms though to lesser degree as of 12/5.  Worsen with fatigue/stress. Neurology refer made by primary care physician; appt pending this month.  No clear association ID'd by primary physician.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Hypoaesthesia, Injection site pain, Muscular weakness, Pain in extremity
Clinical narrative: Severe pain 7 on 1-10 scale in entire L arm. Lack of strengh, numbness, aching & tingling down through fingers & in palm of hand.   Aleve, Tylenol & local massage to arm helped but still have weakness & tingling, especially L hand hours later.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: Paraesthesia
Clinical narrative: Severe pain 7 on 1-10 scale in entire L arm. Lack of strengh, numbness, aching & tingling down through fingers & in palm of hand.   Aleve, Tylenol & local massage to arm helped but still have weakness & tingling, especially L hand hours later.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Back pain
Clinical narrative: PATIENT IS EXPERIENCING LOWER BACK PAIN STARTING TODAY.
Age: 68.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Approximately 9 hours after receiving vaccine patient began to complain of pain and burning at site of vaccine injection in left deltoid.  The site became progressively red, slightly swollen, and warm to touch for the rest of the day and next day.  The patient states the pain starting subsiding the morning of 12/05/2012.  By 12/05/2012 at 1600, the redness spread from approximately 4 inches below top of shoulder down to bend in elbow and covered 2/3 of circumference of upper left arm; Skin remains intact at this time with no blistering.  Patient also spiked a max fever of 100.9 F on 12/05/2012 at 0300 am.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Condition aggravated, Convulsion
Clinical narrative: Treatment sought in the Emergency Department after seizure activity during the PM hours after receiving the flu shot; Evalauted by neurologist and he states that the vaccine lowered the seizure threshold.
Age: 59.0
Sex: M
Vaccine: FLU3
Symptoms: Chest discomfort, Eye pruritus, Insomnia, Ocular hyperaemia, Pulmonary congestion
Clinical narrative: The symptoms began at home about 2 hours after the inoculation at 2:45PM. It started as a slight tightness in his chest and progressed with congestion in his lungs, possibly stimulated from lingering symptoms of the asthma that he was diagnosed with 15 years ago. He has not been on any asthma medication however for over 4 years now. His eyes began to redden and itch to the point of constantly having to rub them to ease the discomfort. He did not get much sleep that night. This reaction occurred this year and 2 years ago as well, but not last year.
Age: 33.0
Sex: M
Vaccine: FLUX
Symptoms: Headache, Nausea, Pallor
Clinical narrative: Nausea, Pale Skin, Headache. Pt was taken to facility and given anti-nausea and anti-diarrhea medicine and released.  He was told to come back if the problem continue after 2 days.
Age: 25.0
Sex: F
Vaccine: FLUX
Symptoms: Dizziness, Injection site erythema, Nausea, Sinus disorder, Vertigo
Clinical narrative: Dizziness leading to nausea all day. Redness around injection site.  Doctor guessed the injection inflamed sinuses, leading to vertigo.
Age: 4.0
Sex: M
Vaccine: FLU3, IPV, MMR, VARCEL
Symptoms: Erythema, Injection site swelling
Clinical narrative: Right upper arm swollen from axilla to below elbow. Mother states redness has decreased after Ibuprofen administered and cool compresses applied. No history of reaction.
Age: 59.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Chills, fever (101.5), aches - until 12:00 or so. I have had these same symptoms the last to times I have had a flu shot, the next day I feel drained but have no chills, aches, etc.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Acne, Erythema, Oedema peripheral, Pruritus, Skin warm
Clinical narrative: Patient is complaining of a large red lump on her arm.  She says it is itchy and warm to the touch. She says her arm is swollen and red with a few small pimples.  Patient was instructed in the afternoon to take a Claritin to help with the itchiness by the pharmacist who had given her the shot. She called back later in the evening stating that it did not help so I instructed her to contact her doctor. After that she said that it wasn't that bad that she should bother the doctor tonight so she will call the doctor in the morning.
Age: 82.0
Sex: F
Vaccine: PPV
Symptoms: Upper extremity mass
Clinical narrative: Patient is complaining of a large red lump on her arm.  She says it is itchy and warm to the touch. She says her arm is swollen and red with a few small pimples.  Patient was instructed in the afternoon to take a Claritin to help with the itchiness by the pharmacist who had given her the shot. She called back later in the evening stating that it did not help so I instructed her to contact her doctor. After that she said that it wasn't that bad that she should bother the doctor tonight so she will call the doctor in the morning.
Age: 67.0
Sex: M
Vaccine: FLUX, VARZOS
Symptoms: Injection site pain
Clinical narrative: Pain in R shoulder where the vaccine was administered. Administered in the Deltoid area.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Arthralgia, Headache, Hyperacusis, Myalgia, Photophobia
Clinical narrative: Woke up with deeply sore neck muscles, aching joints, headache, light and sound discomfort. Treated with NSAID.
Age: 63.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Diarrhoea, Erythema, Myalgia, Nausea, Oedema peripheral
Clinical narrative: After getting a pneumonia shot over 5 years after the last one, I had a fever from 101 to 103 for 5 days, muscle aches, redness & swelling of entire upper arm, nausea 5 days, then diarrhea 5 days.  Also got my annual flu shot at the same time.
Age: 63.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pyrexia
Clinical narrative: After getting a pneumonia shot over 5 years after the last one, I had a fever from 101 to 103 for 5 days, muscle aches, redness & swelling of entire upper arm, nausea 5 days, then diarrhea 5 days.  Also got my annual flu shot at the same time.
Age: 49.0
Sex: M
Vaccine: FLUX
Symptoms: Autopsy, Death, Glioblastoma multiforme, Immunoglobulin therapy, Motor dysfunction
Clinical narrative: This case was reported in a literature article and described the occurrence of glioblastoma multiforme in a 49-year-old male subject who was vaccinated with influenza vaccine unspecified (manufacturer unspecified). On an unspecified date the subject received unspecified dose of Influenza vaccine unspecified (unknown route, unknown lot number). At an unspecified time after vaccination with Influenza vaccine unspecified, the subject presented with a 2-week history of bilateral lower extremity weakness and paresthesia starting at the level of the axilla. The subject had a recent history of viral infection status post flu vaccination. He was evaluated by Neurology and initially diagnosed with transverse myelitis. He underwent intravenous immunoglobulin and steroid treatment without improvement. The subject's physical examination revealed 3/5 proximal and 5/5 distal muscle strength in the lower extremities, deep tendon reflexes were 2/4 with no upper motor neuron signs visualized. He was medically stabilized and transferred to our inpatient rehabilitation facility. Ten days post admission, the subject experienced acute motor loss (0/5) in bilateral lower extremities and worsening paresthesia, now involving bilateral upper extremities. At 10 days post admission, imaging revealed C7 to T2 diffuse cord expansion and an oval-shaped focus of intramedullary enhancement. Prior to the completion of his medical work-up the subject passed away due to unclear causes. The subject died from glioblastoma multiforme and respiratory failure. Post mortem autopsy results showed histopathological diagnosis of primary glioblastoma multiforme of the spinal cord.
Age: 49.0
Sex: M
Vaccine: FLUX
Symptoms: Muscular weakness, Neurological examination abnormal, Paraesthesia, Respiratory failure, Viral infection
Clinical narrative: This case was reported in a literature article and described the occurrence of glioblastoma multiforme in a 49-year-old male subject who was vaccinated with influenza vaccine unspecified (manufacturer unspecified). On an unspecified date the subject received unspecified dose of Influenza vaccine unspecified (unknown route, unknown lot number). At an unspecified time after vaccination with Influenza vaccine unspecified, the subject presented with a 2-week history of bilateral lower extremity weakness and paresthesia starting at the level of the axilla. The subject had a recent history of viral infection status post flu vaccination. He was evaluated by Neurology and initially diagnosed with transverse myelitis. He underwent intravenous immunoglobulin and steroid treatment without improvement. The subject's physical examination revealed 3/5 proximal and 5/5 distal muscle strength in the lower extremities, deep tendon reflexes were 2/4 with no upper motor neuron signs visualized. He was medically stabilized and transferred to our inpatient rehabilitation facility. Ten days post admission, the subject experienced acute motor loss (0/5) in bilateral lower extremities and worsening paresthesia, now involving bilateral upper extremities. At 10 days post admission, imaging revealed C7 to T2 diffuse cord expansion and an oval-shaped focus of intramedullary enhancement. Prior to the completion of his medical work-up the subject passed away due to unclear causes. The subject died from glioblastoma multiforme and respiratory failure. Post mortem autopsy results showed histopathological diagnosis of primary glioblastoma multiforme of the spinal cord.
Age: 11.0
Sex: F
Vaccine: FLU3, MNQ, TDAP
Symptoms: Oedema peripheral, Rash generalised
Clinical narrative: Patient was given 3 immunization 10/17/2012 she had MCV4 and Tdap in left deltoid. She came in 10/19/2012 with arm swollen and rash all over her body. Patient was placed on Prednisone. Patient did recover.
Age: 21.0
Sex: F
Vaccine: HPV2
Symptoms: Abortion induced, Maternal exposure during pregnancy, Pregnancy test positive
Clinical narrative: This retrospective pregnancy case was reported by a pharmacist and described the occurrence of vaccine exposure during pregnancy in a 21-year-old female subject who was vaccinated with CERVARIX (GlaxoSmithKline) during pregnancy. The subject's medical history included previous pregnancies include two full term. On 26 September 2012 the subject received 3rd dose of CERVARIX (.5 ml, intramuscular, unknown). Her last menstrual period was on 18 August 2012 and estimated date of delivery was not provided. The subject used no contraception and the pregnancy was by normal conception. On 26 September 2012, at the time of vaccination with CERVARIX, the subject experienced vaccine exposure during pregnancy. The subject received her 3rd dose of CERVARIX on 26 September 2012. Later that same day, the subject received a positive pregnancy test. The subject decided to terminate the pregnancy for reasons unrelated to CERVARIX vaccination [elective aborted pregnancy]. At the time of the report no additional information was available. The outcome of the pregnancy was elective termination with no apparent congenital abnormality.
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Rash
Clinical narrative: Patient described a rash that runs down her arm. Itches, but not painful.
Age: 19.0
Sex: F
Vaccine: FLU3
Symptoms: Fall, Laceration, Lip injury, Syncope
Clinical narrative: Patient fainted 30 minutes after shot and fell. Pt fell on card rack and cut lip & nose.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Induration, Pain in extremity, Pruritus, Skin warm
Clinical narrative: Patient reports arm was sore and achy evening of flu shot. Continued to be more sore over next few days. 2 days after vaccine - arm was red and hot. Patient also says it feels hard & itchy. Patient considering seeing MD for possible cellulitis.
Age: 55.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Left deltoid at injection site, swelling, erythema, warm to touch, pain. Tx. BENADRYL 25mg 2 tabs Q6 hours for 48 hours. ALEVE 2 tablets BID up to one week.
Age: 45.0
Sex: M
Vaccine: FLU3
Symptoms: Erythema, Urticaria
Clinical narrative: Large hive and redness the width (quarter size) of the arm.
Age: 71.0
Sex: F
Vaccine: FLU3
Symptoms: Back pain, Gait disturbance, Muscular weakness, Myalgia, Pain in extremity
Clinical narrative: 71 yo female who developed sudden onset of lower extremity weakness, LBP, foot pain, generalized myalgias, difficulty walking. Started within 2d of receiving this vaccine. She had called pharmacist who said it was not related.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Chills, Dysphagia, Headache, Malaise
Clinical narrative: First 24 hours pt. had severe sore throat, could not swallow, no rash or hives experienced. After 8-10 hours symptoms improved. Pt. also experienced chest pains, chills, nausea, headache & malaise.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Nausea, Oropharyngeal pain
Clinical narrative: First 24 hours pt. had severe sore throat, could not swallow, no rash or hives experienced. After 8-10 hours symptoms improved. Pt. also experienced chest pains, chills, nausea, headache & malaise.
Age: 42.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain
Clinical narrative: Shoulder pain/soreness since injection refer to ortho, shoulder x-ray.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant (also reported as a healthcare worker) who administered vaccines refers to a patient of unknown age. The patient was vaccinated with the first two doses of GARDASIL (lot # and route unknown) on 11-NOV-2010 and 29-DEC-2011 respectively. No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was unknown that if the patient had sought medical attention. Additional information has been requested.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse refers to two patients of unknown age (gender unspecified). On 20-NOV-2012, the two patients were vaccinated with a dose of PROQUAD (merck), (lot number, expiration date and route not reported) which was improperly stored. No concomitant medications were reported. No symptoms were reported. Additional information is not expected.
Age: 10.0
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a Medical Assistant refers to a patient of unknown age. The patient was vaccinated with dose 1 GARDASIL on 02-FEB-2011 and on 11-NOV-2011 the patient was vaccinated with the second dose. No other co-suspects were reported. No concomitant medications were reported. No adverse event reported. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report refers to a patient of unknown age. The patient was vaccinated with dose 1 GARDASIL on APR-2011. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced inappropriate schedule of drug administration. No treatment information was reported. The outcome of inappropriate schedule of drug administration is unknown. Inappropriate schedule of drug administration is not related to GARDASIL. Nurse called regarding GARDASIL and delay in administering to patient between first and second dose. First dose given 04/2011 and second dose given 10/2012. Nurse asked if the 3 dose series had to be started over. No adverse effect reported. No further information available. 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 other health professional refers to a patient of unknown age. The patient was vaccinated with dose 1, .5 ml GARDASIL on 20-NOV-2010. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced inappropriate schedule of drug administration. No treatment information was reported. The outcome of inappropriate schedule of drug administration is unknown. Inappropriate schedule of drug administration is not related to GARDASIL. Per nurse, patient received a first dose of GARDASIL on 11/20/2010, second dose of GARDASIL on 11/07/2011 and third dose on 11/28/2012. No adverse effect reported. No further information is available. Additional information has been requested.
Sex: U
Vaccine: HPV4
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age. On unknown date the patients were vaccinated with a dose of GARDASIL (lot number not provided). Route was not reported. The patient received a dose of GARDASIL that had been stored improperly. The nurse could not provide more detailed information. This is 1 of 3 reports from the same source (other case numbers 1212USA001482 and 1212USA001483). Additional information has been requested.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a female patient of unknown age. The patient was vaccinated subcutaneously with her first dose of GARDASIL (lot number not reported) in October 2011 and the second dose in September 2012. No other co-suspects were reported. No concomitant medications were reported. The patient had not yet received the third dose. No adverse effects reported. It was unspecified if the patient had sought medical attention. Additional information has been requested.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Skin lesion
Clinical narrative: This spontaneous report as received from a pharmacy student refers to a 81 years old female patient. The patient was vaccinated with ZOSTAVAX (dose, route and lot # were unknown) in April 2010. No other co-suspects were reported. No concomitant medications were reported. The patient developed "a few lesions on her neck about 2 weeks ago" approximately on 07-NOV-2012. The patient sought medical attention by office visiting and was evaluated by her unspecified physician and was diagnosed with shingles. Valacyclovir hydrochloride was prescribed and the patient completed therapy on 20-NOV-2012. The outcome of shingles was reported as recovered/resolved on 20-NOV-2012. No lab diagnosis studies performed. Additional information has been requested.
Age: 25.0
Sex: F
Vaccine: VARCEL
Symptoms: Rash vesicular
Clinical narrative: This spontaneous report as received from a physician refers to a 25 years old female patient with no drug allergy. The patient was vaccinated with VARIVAX (Merck) (lot # reported as G007690, exp date 05-AUG-2013, route unknown) on 05-NOV-2012. No other co-suspects were reported. Concomitant medications included multivitamin (unspecified), vitamin D (unspecified) and progesterone pill. On 26-NOV-2012 the patient experienced broken out in varicella rash about 3 weeks after received VARIVAX (Merck). The treatment information was reported as acyclovir. The patient had sought medical attention via office visit. The outcome of broken out in varicella rash was unknown. Additional information has been requested.
Sex: F
Vaccine: HEP
Symptoms: Herpes zoster
Clinical narrative: The primary reporter is a forensic psychologist, patient, who declined to provide her contact information. She reports that "over 20 years ago", when she received the first of a series of 3 doses of Hepatitis B vaccine, she "developed shingles". She is certain that this occurrence was reported as an AE, since she received it at a state hospital. She states that the hospital called the manufacturer of the vaccine and was told by the manufacturer that it is possible for a person to develop shingles after receiving a Hepatitis B vaccine. She did not receive the additional two doses of the series. NO additional information available. Additional information is not expected.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Fatigue, Injection site rash, Injection site warmth, Malaise
Clinical narrative: Pharmacist reports that the patient, who received her third lifetime dose of PNEUMOVAX on 27November2012, returned to the pharmacy on 29Nov2012 complaining of rash and warmth at the injection site and of "fatigue and not feeling well." No further information is available. Not recovered. Additional information is expected.
Sex: U
Vaccine: HEP
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a other refers to a patient of unknown age. The patient was vaccinated with, .5 ml RECOMBIVAX HB on 29-NOV-2012. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced incorrect storage of drug. No treatment information was reported. The outcome of incorrect storage of drug is unknown. Incorrect storage of drug is not related to RECOMBIVAX HB. Patient was given RECOMBIVAX that was stored in a plastic syringe in the refrigerator. No AE reported. No further AE information is available. {Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a other health professional refers to a patient of unknown age. The patient was vaccinated with VARIVAX (merck) She is reporting that about 501 patients over the period of 08/27/2012 to 09/24/2012 have received VARIVAX doses that were exposed to unknown temperatures because the shipping duration took 5 days to the practice. No AE reported. No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced incorrect storage of drug. No treatment information was reported. The outcome of incorrect storage of drug is unknown. Incorrect storage of drug is not related to VARIVAX (Merck). Additional information has been requested.
Age: 0.2
Sex: U
Vaccine: HBHEPB, HEP
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a healthcare worker refers to three infants. The patient were vaccinated with a first dose of RECOMBIVAX HB (lot #, dose and route not reported) at birth on unspecified dates. The patients also received doses 2 and 3 of either RECOMBIVAX HB (lot #, dose and route not reported) or COMVAX (lot #, dose and route not reported at 2 months of age and then at 4 months of age. No adverse effect was reported. Additional information has been requested.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity, Rash
Clinical narrative: Initial information has been received from the patient's family member concerning an approximately 62 or 63 years old male patient with an unspecified pertinent medical history or drug reactions/allergies, who last year, in approximately 2011, was vaccinated with ZOSTAVAX (dose, route, indication and lot were not reported). No other co-suspects were reported. No concomitant medications were reported. It was reported that 2 or 3 weeks ago, approximately in October 2012 the patient developed a painful rash on his legs that feels similar to poison oak. No treatment information was reported. The patient's outcome was unknown. Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Influenza like illness, Rash
Clinical narrative: This spontaneous report as received from a registered nurse (R.N.) refers to a patient of unknown age in her area (not from her office). On an unknown date patient was vaccinated with PNEUMOVAX 23 (lot # not reported). The nurse heard that the patient developed flu like symptoms, rash and cellulitis after receiving PNEUMOVAX23. It was unspecified whether the patient sought for medical attention. The nurse had no information on the patient. The outcome was unknown. This is one of several reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age. On an unknown date the patients were vaccinated with a dose of live, oral, ROTATEQ (lot number not provided). Route was not reported. The patients received a dose of live, oral ROTATEQ that had been stored improperly. The nurse could not provide more details information. This is 1 of 3 reports from the same source (other case numbers 1212USA000912 and 1212USA001483). Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a nurse refers to an unspecified number of patients of unknown age. On an unknown date the patients were vaccinated with a dose of PEDVAXHIB (lot number not provided). Route was not reported. The patients received a dose of PEDVAXHIB that had been stored improperly. The nurse could not provide more detailed information. This is 1 of 3 reports from the same source (other case numbers 1212USA000912 and 1212USA001482). Additional information has been requested,
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 58 years old female patient. The patient's pertinent medical history included hypertension and diabetes. The patient's current conditions included allergy to sulfonamides, fluoroquinolones and tetracycline. On 19-NOV-2012, the patient was vaccinated with a single dose of ZOSTAVAX (dose was not reported)subcutaneously to the left arm. Lot number was reported as H013943 and expiry date was 25-OCT-2013. Concomitant medications included lisinopril and metformin. Approximately on an unknown date in November 2012, the patient experienced redness, swelling and warmth at injection site. The patient had called the pharmacy on 21-NOV-2012 and described the area of reaction as measuring 3 inches by 4 inches. The patient sought medical attention (called the pharmacy) and no treatment was given. No laboratory diagnostics studies were performed. The outcome of redness, swelling and warmth at injection site was not recovered. Additional information is not expected.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a 70 years old male patient. Approximately on November 2010 (reported as two years ago from the reported date), the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, dose and route were not reported). No concomitant medications were reported. On an unknown date, the patient saw his physician as he experienced symptoms consistent with "precursors of shingles". The patient sought medical attention (saw his physician) and treatment information was unspecified. The outcome of symptoms consistent with "precursors of shingles" was reported as not recovered. Additional information is not expected.
Age: 2.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: This spontaneous report as received from a pharmacist refers to a female patient of unknown age with vaccination. The patient was vaccinated with VARIVAX (Merck) on 1995 (17 years ago). No other co-suspects were reported. No concomitant medications were reported. On an unknown date the patient experienced varicella, 6 itchy chickenpox lesions on her face 17 years ago after receiving a dose of VARIVAX. The lesions were gone in couple of days. No treatment information was reported. The relatedness for varicella in unknown for VARIVAX (Merck). Additional information has been requested.
Sex: F
Vaccine: PPV
Symptoms: Arthralgia, Fatigue, Injection site pain
Clinical narrative: This spontaneous report as received from a registered pharmacist refers to a elderly female patient of unknown age. The patient was vaccinated intramuscularly with a dose of PNEUMOVAX23 (lot # H013399; exp date 07-MAR-2012) on 13-OCT-2012. No other co-suspects were reported. No concomitant medications were reported. The pharmacist reported that on 13-OCT-2012, the patient developed arthralgia, fatigue and pain at the injection site after receiving PNEUMOVAX23. The patient sought unspecified medical attention and was given unspecified antibiotics and antihistamines as treatment. On an unspecified date in 2012,the events arthralgia, fatigue and pain at the injection site was resolved. This is one of the two reports received from the same reporter (MARRS# 1210USA008578). Additional information is not expected.
Sex: U
Vaccine: MMR, PPV, RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a registered nurse refers to unknown number of patients. The patients were vaccinated with M-M-R II (lot number unspecified), PNEUMOVAX 23 (lot number unspecified) and ROTATEQ (lot number unspecified) in the year 2010 that were exposed to 47 F for 72 hours. No concomitant medications were reported. The patients were not experiencing any known symptoms. It was unspecified if the patients had sought medical attention. Attempts are being made to obtain additional identifying information to distinguish the individual patients mentioned in this report. Additional information will be provided if available.
Age: 74.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pruritus, Injection site warmth
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 74 years old female patient with no drug allergies. The patient current condition included high cholesterol and benign prostatic hyperplasia. On 24-NOV-2012, the patient was vaccinated with a dose of ZOSTAVAX (lot number was 673029/0616AE, expiry date was 28-JUN-2013 and dose was not provided) subcutaneously. Concomitant medications included atorvastatin and finasteride (manufacturer unknown). On 25-NOV-2012, the patient developed injection site reaction which included localized itching, redness, warmth and induration. There was no rash. The patient sought medical attention (contacted pharmacist) and no treatment was given. No laboratory diagnostics were performed. The outcome of injection site reaction which included localized itching, redness, warmth and induration was reported as not recovered. Additional information is not expected.
Age: 67.0
Sex: F
Vaccine: TDAP, PPV, PPV, TDAP
Symptoms: Influenza like illness, Pain, Somnolence
Clinical narrative: This spontaneous report as received from a registered nurse (R.N.) refers to a 67 years old female patient with hypertension, hyperlipidemia, gastroesophageal reflux disease (GERD), diverticulitis, interstitial cystitis and insomnia. The patient had drug allergy to codeine derivatives and MACROBID, reported as MACROBID. On 28-NOV-2012 the patient was vaccinated intramuscularly with 0.5 ml PNEUMOVAX23 (lot # reported as H014283, expiry date reported as 17-APR-2014). Concomitant medications included aspirin, lisinopril, simvastatin, sertraline and pantoprazole. The patient developed "flu like symptoms", including achiness and feeling "sleepy" after receiving PNEUMOVAX23. The patient sought for medical attention via a follow-up outbound call which was made from office to patient. No treatment was given. Lab diagnostics studies performed were reported as none. The outcome was unknown. It was also reported by the nurse that they had heard that there might be a problem with one or more of the lot numbers of PNEUMOVAX23. The nurse was requesting a lot check for PNEUMOVAX23 lot # H014283 with expiry date 17-APR-2014. This is one of several reports received from the same source. Additional information has been requested.
Age: 67.0
Sex: F
Vaccine: TDAP, PPV, PPV, TDAP
Symptoms: Abnormal behaviour, Pain, Somnolence
Clinical narrative: This spontaneous report as received from a registered nurse (R.N.) refers to a 67 years old female patient with hypertension, hyperlipidemia, gastroesophageal reflux disease (GERD), diverticulitis, interstitial cystitis and insomnia. The patient had drug allergy to codeine derivatives and MACROBID, reported as MACROBID. On 28-NOV-2012 the patient was vaccinated intramuscularly with 0.5 ml PNEUMOVAX23 (lot # reported as H014283, expiry date reported as 17-APR-2014). Concomitant medications included aspirin, lisinopril, simvastatin, sertraline and pantoprazole. The patient developed "flu like symptoms", including achiness and feeling "sleepy" after receiving PNEUMOVAX23. The patient sought for medical attention via a follow-up outbound call which was made from office to patient. No treatment was given. Lab diagnostics studies performed were reported as none. The outcome was unknown. It was also reported by the nurse that they had heard that there might be a problem with one or more of the lot numbers of PNEUMOVAX23. The nurse was requesting a lot check for PNEUMOVAX23 lot # H014283 with expiry date 17-APR-2014. This is one of several reports received from the same source. Additional information has been requested.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Arthralgia, Drug administered at inappropriate site, Pain
Clinical narrative: Patient received vaccine 12/3 and called us 12/5 to report pain in the shoulder joint of the left arm.
Age: 44.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Arthralgia
Clinical narrative: Patient received vaccine 12/3 and called us 12/5 to report pain in the shoulder joint of the left arm.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Chills, Diarrhoea, Dizziness, Pyrexia, Vomiting
Clinical narrative: Chills, vomiting, loose stool, high temperature, dizziness.
Age: 66.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Diarrhoea, Dizziness, Dyspnoea, Pyrexia, Vomiting
Clinical narrative: Chills, vomiting, loose stool, high temperature, dizziness.
Age: 61.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pain, Injection site rash, Injection site reaction, Urticaria
Clinical narrative: Rash, pain in area of shot.  Resulting in welt and redness in area of shot and additional rash approximately one inch above shot area.  Soreness less on 12/06/2012, but rashes are more pronounced.
Age: 43.0
Sex: M
Vaccine: FLU3
Symptoms: Chest discomfort, Cough, Ocular hyperaemia, Oropharyngeal pain
Clinical narrative: Patient reports slight sore throat, dry cough, chest tightness & bloodshot eyes (redness) starting after work around 6 p.m. Patient didn't report to doctor until next morning.
Age: 11.0
Sex: F
Vaccine: FLUX, HPV4, MNQ, TDAP
Symptoms: Anxiety, Crying, Dizziness, Pallor
Clinical narrative: This spontaneous report as received from a physician assistant refers to a 11 years old female patient. The patient was vaccinated with the first dose of GARDASIL (lot # 673256/0629AE) 0.5 ml intramuscularly on 10-NOV-2012. Secondary suspect therapy included a dose of unspecified flu vaccine (manufacture unknown) given intramuscularly on 10-NOV-2012. Concomitant therapies included MENACTRA and TDaP given along with GARDASIL on 10-NOV-2012. Within a minute, the patient felt dizzy and had a feeling of impending doom. She appeared pale and was crying. She laid down and after a few minutes she started pacing. After about 30 minutes, the reporter was comfortable with her leaving because she seemed more calm. The reporter hadn't heard back from the patient since the adverse event happened, so he was assuming that she had recovered, but could not verify this. No lab tests were performed. No treatment was given. The patient had sought unspecified medical attention. Additional information has been requested.
Age: 37.0
Sex: M
Vaccine: FLU3, HEP
Symptoms: Arthralgia, Body temperature increased, Pain, Pain in extremity, Visual impairment
Clinical narrative: 11/27/12 Started feeling achy over entire body & some sharp pains shooting to hands, ankles. T 100.1. Felt vision was "off" as he mixed up the paint at work, normal by 11/28/12.
Age: 64.0
Sex: F
Vaccine: FLU3
Symptoms: Pruritus
Clinical narrative: Itching for about 2 days.
Age: 73.0
Sex: F
Vaccine: FLUX
Symptoms: Pain in extremity
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 73 years old female patient. The patient was vaccinated with AFLURIA. Other suspect therapies included PNEUMOVAX23. No concomitant medications were reported. On an unknown date the patient experienced pain in unspecified arm after an unspecified inactivated influenza vaccine (unknown if AFLURIA specifically, brand name and manufacturer unspecified) was administered on an unspecified date. Pharmacist also reports that a dose of PNEUMOVAX-23 was administered "approximately 3 weeks prior" to the influenza vaccination, in the patient's same arm. No treatment information was reported. The outcome of pain in arm is unknown. The relatedness for pain in arm is unknown for AFLURIA. Additional information has been requested.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: At site of injection had 50 cent size redness & raised area, and itching. Sx started day after injection. On 12/4/12 called clinic & instructed per Dr. ZYRTEC 10mg nightly for several days. Pt notified had taken a CLARITIN that day & it had helped.
Age: 79.0
Sex: M
Vaccine: FLU3
Symptoms: Chills
Clinical narrative: 9/3/12 - Chills 4.20am - 4.50am. 9/3/12 - Chills 5.30pm - 5.45pm. 12/3/12 - Chills 9.00pm - 9.30pm. 12/5/12 - Chills 6.00am - 6.30am.
Age: 66.0
Sex: F
Vaccine: PPV, TDAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: (Rt) upper arm swollen 6" x 5" - pink- per pt site was larger & red-states swelling down same-warm to touch/tender. Warm moist pad to site-TYLENOL-RTC PRN.
Age: 27.0
Sex: F
Vaccine: FLU3
Symptoms: Dysphagia, Injection site pain, Injection site swelling, Injection site warmth, Pharyngeal oedema
Clinical narrative: 1500 Noted (R) upper arm swelling, hot, aching, location upper arm to elbow - iced area, ibuprofen, no temp. 1630 Noted throat feeling swollen & had difficulty swallowing, denies difficulty breathing. On daily med for seasonal allergies / asthma - loratadine - used albuterol inhaler without change symptoms, no wheezing. On 12-4-12 difficulty swallowing subsided 12-5-12 slight swelling (R) upper arm & less pain today.
Age: 4.0
Sex: M
Vaccine: DTAP, FLU3
Symptoms: Injection site erythema, Injection site swelling, Musculoskeletal pain, Skin warm
Clinical narrative: (L) upper arm redness & swelling extending onto shoulder blade & down across elbow positive tense positive hot nontender negative itch positive redness.
Age: 62.0
Sex: M
Vaccine: VARCEL
Symptoms: Wrong drug administered
Clinical narrative: Misadministration-VARIVAX given instead of ZOSTAVAX. Dr notified & discussed with patient. Pt is getting ZOSTAVAX in 4 wks.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain, Chills, Diarrhoea, Dizziness, Eye irritation
Clinical narrative: Pt developed a headache. Had a glass of wine and took aspirin. Injection site pain, dizziness, nausea. Drank ginger ale. Vomited x 4 hours. Eye itching, burning, watery. Abdominal cramping and diarrhea. Fever, chills.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Eye pruritus, Headache, Injection site pain, Lacrimation increased, Nausea
Clinical narrative: Pt developed a headache. Had a glass of wine and took aspirin. Injection site pain, dizziness, nausea. Drank ginger ale. Vomited x 4 hours. Eye itching, burning, watery. Abdominal cramping and diarrhea. Fever, chills.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Pyrexia, Vomiting
Clinical narrative: Pt developed a headache. Had a glass of wine and took aspirin. Injection site pain, dizziness, nausea. Drank ginger ale. Vomited x 4 hours. Eye itching, burning, watery. Abdominal cramping and diarrhea. Fever, chills.