chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 18.0
Sex: F
Vaccine: HPV4
Symptoms: Syncope, Tonic clonic movements, Unresponsive to stimuli
Clinical narrative: Patient received HPV, then went down to lab for blood work.  After blood work she went to waiting room were she had an episode of  syncope followed by brief tonic clonic movements which were witnessed by her parent.   Nurses were called to evaluate and she was pale and unresponsive but was breathing.  Mom stated that pt had history of syncope after medical procedures including ear piercing and blood draws. Patient was given NS 1L IV bolus. EKG was done and was normal. Stat Chem 7 was normal.  Urine pregnancy test was negative. Patient was observed for two hours.  At the end of this time she was awake, alert and cooperative.  VS were stable. Patient was sent home with parent with instructions to return if any further syncope.
Age: 0.28
Sex: M
Vaccine: PPV
Symptoms: Crying, Decreased appetite, Gastrooesophageal reflux disease, Insomnia, Irritability
Clinical narrative: Started with increased fussiness, lack of sleep, and crying on date of vaccination. By morning of 1/1/2013, infant had small hive like bumps extending from abdomen and core to upper legs, arms, neck, face, and behind ears. Symptoms have continued and have also included increased reflux with decreased appetite. All symptoms including rash/hives have not subsided as of 1/4/2013.
Age: 0.28
Sex: M
Vaccine: PPV
Symptoms: Rash generalised, Urticaria
Clinical narrative: Started with increased fussiness, lack of sleep, and crying on date of vaccination. By morning of 1/1/2013, infant had small hive like bumps extending from abdomen and core to upper legs, arms, neck, face, and behind ears. Symptoms have continued and have also included increased reflux with decreased appetite. All symptoms including rash/hives have not subsided as of 1/4/2013.
Age: 67.0
Sex: M
Vaccine: PPV
Symptoms: Cardiac monitoring normal, Musculoskeletal pain, Pallor, Syncope, White blood cell count increased
Clinical narrative: Sore shoulder. Then fainted. Very pale. Visited Emergency Room.
Age: 1.53
Sex: M
Vaccine: DTAP, FLU3
Symptoms: Injection site erythema, Injection site induration, Injection site warmth
Clinical narrative: Red, warm, induration at injection site.
Age: 31.0
Sex: F
Vaccine: HEPAB
Symptoms: Pain in extremity
Clinical narrative: Pain in left arm, no swelling, redness, or palpable masses.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Computerised tomogram head normal, Cyanosis, Diagnostic procedure, Dyspnoea, Gastrooesophageal reflux disease
Clinical narrative: Happy, healthy 2 month old had vaccines at 1:30 pm.  Went home, ate a bottle, and was laid down for a nap.  Began gasping for air, turned blue, eyes rolled back of head, and CPR began.  Taken to hospital and stayed for 2-3 days.  CT head, lumbar puncture, and all work-up was normal.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Gaze palsy, Laboratory test normal, Lumbar puncture normal, Resuscitation
Clinical narrative: Happy, healthy 2 month old had vaccines at 1:30 pm.  Went home, ate a bottle, and was laid down for a nap.  Began gasping for air, turned blue, eyes rolled back of head, and CPR began.  Taken to hospital and stayed for 2-3 days.  CT head, lumbar puncture, and all work-up was normal.
Age: 12.0
Sex: F
Vaccine: FLUN3, HEPA, HPV4, MNQ, TDAP, VARCEL
Symptoms: Fall, Feeling abnormal, Loss of consciousness, Syncope
Clinical narrative: Client received Var, HPV and Tdap vaccines in her left arm and continued talking with me. After receiving Menactra and Hep A vaccines in the right she fainted. She was sitting and drooped to side, I caught her by the shoulders to keep her from hitting her head on the table. After a couple of seconds she regained consciousness and said she felt funny. I asked her to place her head on her knees and talked to her several minutes until she felt she could sit up. She remained sitting for about 10 minutes before feeling better and ready to leave.
Age: 22.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dizziness, Face injury, Hyperhidrosis, Laceration, Loss of consciousness
Clinical narrative: Patient was sitting down at a blood pressure machine and passed out. She hit her face on the edge of the machine when she passed out and had a small cut on her face. She was lain down on the floor and paramedics were called in. Patient had no difficulty breathing, or any signs or symptoms of anaphylaxis after passing out. She did feel dizzy and was sweating.
Age: 22.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood test, Computerised tomogram head, Dizziness, Face injury, Fall
Clinical narrative: Patient was sitting down at a blood pressure machine and passed out. She hit her face on the edge of the machine when she passed out and had a small cut on her face. She was lain down on the floor and paramedics were called in. Patient had no difficulty breathing, or any signs or symptoms of anaphylaxis after passing out. She did feel dizzy and was sweating.
Age: 22.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Heart rate increased, Hypotension, Loss of consciousness
Clinical narrative: Patient was sitting down at a blood pressure machine and passed out. She hit her face on the edge of the machine when she passed out and had a small cut on her face. She was lain down on the floor and paramedics were called in. Patient had no difficulty breathing, or any signs or symptoms of anaphylaxis after passing out. She did feel dizzy and was sweating.
Age: 8.0
Sex: M
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Vomiting.
Age: 43.0
Sex: M
Vaccine: HEP
Symptoms: Activities of daily living impaired, Dizziness, Dizziness postural, Fall, Muscular weakness
Clinical narrative: Consistent dizzy spells when standing up and weakness in arm that vaccine was administered. The muscle weakness is most concerning. It has now been 2 months since my 1st vaccine.  At the gym, I cannot raise a weight with my left arm.  Not even 10 lbs! Tried to do curls, and couldn't lift hardly any weight.  I can curl 40 lbs with my right arm.  No pain in the vaccinated arm, maybe very little soreness.  Dizzy spells still happening every time I stand up from sitting or lying down. A few days ago, I completely fell from being so dizzy. This all started after my vaccine.
Age: 43.0
Sex: M
Vaccine: HEP
Symptoms: Pain in extremity
Clinical narrative: Consistent dizzy spells when standing up and weakness in arm that vaccine was administered. The muscle weakness is most concerning. It has now been 2 months since my 1st vaccine.  At the gym, I cannot raise a weight with my left arm.  Not even 10 lbs! Tried to do curls, and couldn't lift hardly any weight.  I can curl 40 lbs with my right arm.  No pain in the vaccinated arm, maybe very little soreness.  Dizzy spells still happening every time I stand up from sitting or lying down. A few days ago, I completely fell from being so dizzy. This all started after my vaccine.
Age: 1.01
Sex: F
Vaccine: FLU3, HEPA, HIBV, MMR, PPV, VARCEL
Symptoms: Incorrect dose administered, No adverse event, Wrong drug administered
Clinical narrative: Patient was given the adult dose of PNEUMOVAX 23, instead of PREVNAR 13, on 12/11/12. Family reports no reaction.
Age: 51.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia, Injection site pain, Nuclear magnetic resonance imaging, Pain in extremity
Clinical narrative: Pain in arm evening of shot; Nov. 24th went to family doctor w/ pain radiating from vaccine location down arm - numbness in index finger & thumb - received steroids. After a week, went back for physical therapy - made worse. So went to orthopedic clinic. MRI - Dec 26 - results showed pocket at area of shot - fluid at surface of bone.
Age: 2.0
Sex: F
Vaccine: TYP
Symptoms: Eczema herpeticum, Eye swelling, Immunology test normal, Pruritus, Pyrexia
Clinical narrative: Vaccine adm 07/12/12. No allergic reaction or any acute event in clinic. 07/13/12 - Fever up to 102 degrees F. 7/14/12 - Fever & rash on face and hands - beginning to peel. 07/16/12 - office visit - no fever. Dry red papules over pre-existing eczema patches elbows, knees, eyes & face. Also noted 2-3 patches on throat. Ref'd to Dermatology. Differential Dx = Herpes 'Eczema herpeticum' - Coxsackie disease. DFA fine lesion by Derm 'negative' for Herpes Simplex. Parents left for another country same week with child. Mother states it took 2 weeks for rash to resolve and she remained 'very itchy' during this period. Approximately 1 week after arriving in another country her 'eyes were swollen' -> take child to ER where she received IV steroid and ATARAX by mouth. Eye swelling took 4 days to resolve. Mother is concerned that above sequence of events may be related to Typhoid vaccination.
Age: 2.0
Sex: F
Vaccine: TYP
Symptoms: Rash, Rash papular, Skin exfoliation
Clinical narrative: Vaccine adm 07/12/12. No allergic reaction or any acute event in clinic. 07/13/12 - Fever up to 102 degrees F. 7/14/12 - Fever & rash on face and hands - beginning to peel. 07/16/12 - office visit - no fever. Dry red papules over pre-existing eczema patches elbows, knees, eyes & face. Also noted 2-3 patches on throat. Ref'd to Dermatology. Differential Dx = Herpes 'Eczema herpeticum' - Coxsackie disease. DFA fine lesion by Derm 'negative' for Herpes Simplex. Parents left for another country same week with child. Mother states it took 2 weeks for rash to resolve and she remained 'very itchy' during this period. Approximately 1 week after arriving in another country her 'eyes were swollen' -> take child to ER where she received IV steroid and ATARAX by mouth. Eye swelling took 4 days to resolve. Mother is concerned that above sequence of events may be related to Typhoid vaccination.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Local reaction, Local swelling, Malaise, Nausea
Clinical narrative: Local redness & swelling - same day, persistent nausea, achiness, malaise - started after 2-3 days.
Age: 60.0
Sex: F
Vaccine: FLU3
Symptoms: Pain
Clinical narrative: Local redness & swelling - same day, persistent nausea, achiness, malaise - started after 2-3 days.
Age: 24.0
Sex: F
Vaccine: TDAP
Symptoms: Rash generalised, Rash pruritic
Clinical narrative: Patient received the Tdap on 1/2/13 and developed an itchy rash all over her body, which improved with BENADRYL short term but persisted. Patient saw a doctor on 1/4/13 and was prescribed methylprednisone and an anti-itch cream.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Erythema, Oedema peripheral, Pain in extremity, Skin reaction
Clinical narrative: Left shoulder -> elbow turned red that night & next morning swollen & pain.
Age: 42.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site swelling, Swelling
Clinical narrative: Patient called on Jan 3 2013 for unrelated matter she related developing an "egg" at site of injection and later, "swelling from above my collarbone and up the side of my neck" on 12/30/12. As of Jan 3 2013 all symptoms resolved per patient.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 years old female patient. The patient did not have any drug reactions/allergies. The patient was vaccinated with ZOSTAVAX (0.65 ml, subcutaneous, left arm, lot # was reported as H098038, expiration date was in January 2014) on 31-DEC-2012. No other co-suspects were reported. No concomitant medications were reported. The patient developed a headache three hours later after vaccinated ZOSTAVAX on 31-DEC-2012. No treatment information was reported. The patient sought medical attention via calling pharmacy. The outcome of headache was reported as not recovered/not resolved. The relatedness for headache is unknown for ZOSTAVAX. Additional information is not expected.
Age: 5.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Wrong drug administered
Clinical narrative: This spontaneous report as received from a consumer refers to his ex foster daughter of 5 years old who on 17-DEC-2012, had gone a check up and inadvertently received ZOSTAVAX (dose, route, anatomical location and lot number not provided) instead of another unnamed vaccine she was schedule to get, it was reported that the patient had a high fever (In December approximately).Sought medical attention was reported as Yes, by talking to health professional (HCP). At the time of the report, the patient had no recovered from high fever. The relatedness for high fever was unknown for ZOSTAVAX. A legal issue was involved. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect storage of drug
Clinical narrative: This spontaneous report as received from a Registered Nurse refers to an unknown number of patients who were vaccinated with nonviable VARIVAX (Merck) (injection) (lot #, dose and route not reported) due to cold chain failure. The failure date was unknown. The provider needed to revaccinate the patients. Additional information has been requested.
Age: 4.0
Sex: U
Vaccine: MMR
Symptoms: Expired drug administered, No adverse event
Clinical narrative: This spontaneous report as received from a medical assistant refers to a 4 years old patient. On 10-DEC-2012, the patient was vaccinated with an expired dose of M-M-R II, 0.5 ml, intramuscular (lot # 667962/1596Z, expiration date 18-NOV-2012). No other co-suspects were reported. No concomitant medications were reported. No adverse reactions were noted. Additional information has been requested.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 69 years old male patient. No medical history or concurrent conditions were reported. On 28-DEC-2012, the patient was vaccinated with 0.65 ml ZOSTAVAX subcutaneously in the left deltoid. Lot number was reported as H013014 with an expiration date of 03-OCT-2013. No other co-suspects were reported. Concomitant medications included unspecified cholesterol and blood pressure medication. After the patient was administered with the vaccine, he reported that he felt dizzy. The patient's episode of dizziness resolved "within about 2 minutes, and the he felt fine". The injection site did not demonstrate any redness or swelling. The pharmacist states that he will follow-up with the patient later "today" to verify that he has recovered, but at the present time, the pharmacist stated that he believes the patient is fully recovered. The reporter relatedness for felt dizzy is unknown for ZOSTAVAX. No additional information is currently available. Additional information has been requested.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site rash, Injection site swelling, Pyrexia
Clinical narrative: This spontaneous report as received from a pharmacist refers to a 60 years old female patient. The patient was vaccinated subcutaneously with a dose of 0.65 ml (once) ZOSTAVAX (lot number reported as H017447, exp.: 20-DEC-2013) on 06-DEC-2012. No other co-suspects were reported. Concomitant medications included sertraline hydrochloride, metoprolol, torsemide, CRESTOR, EFFIENT, losartan potassium (manufacturer unknown) and NIASPAN. The patient's relevant medical history was unknown. The patient's relevant past drug history was unknown. On 07-DEC-2012 the patient experienced swelling and rash at the injection site and a low-grade fever. Her relevant laboratory data was unknown. No treatment information was reported. It was reported that as of 09-DEC-2012, the patient had discontinued to take ZOSTAVAX and continued to experience swelling and rash at the injection site and a low-grade fever. The relatedness for the events were unknown for ZOSTAVAX. Additional information is not expected.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster
Clinical narrative: This spontaneous report as received from a 74 years old female patient regarding herself with no drug reactions/allergies. On an unknown date (reported as more than 15 years ago) the patient had outbreak of shingles. The patients current conditions included blood pressure and asthma. Approximately on an unknown date in 2007, the patient was vaccinated with a dose of ZOSTAVAX (lot number, expiry date, route and dose were not reported)as told by her HCP(health care professional). Concomitant medications included losartan potassium (reported as losartan 100) and fluticasone propionate, ADVAIR (reported as ADVAIR DISCUS 150). Approximately on an unknown date in October 2012 (reported as end of October), the patient had another outbreak of shingles and does not feel that this was a milder case of shingles as told by her HCP. A culture of the shingles was taken. The patient sought medical attention (details unspecified). The outcome of the event was unknown. Additional information has been requested.
Age: 0.6
Sex: U
Vaccine: VARZOS
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received from a physician refers to a 7 months old patient. It was reported that the patient was 7 months old when the patient was vaccinated with ZOSTAVAX 6 months ago in approximately June 2012. Lot# and route were unspecified. The patient was not experiencing any known symptoms. Additional information has been requested.
Age: 91.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash pustular
Clinical narrative: This spontaneous report as received from a pharmacist referred to a 91 years old female patient with no Pertinent Medical History and no Drug Reactions/Allergies. The patient was vaccinated with a dose of ZOSTAVAX (lot # reported as H018799, exp date 15-Jan-2014, subcutaneous, dose unspecified) on 21-DEC-2012. Concomitant medications included MEGACE, trimethoprim and levothyroxine sodium (manufacturer unspecified). On 31-DEC-2012 (today) the patient had a single fluid-filled pustule in middle of her back with a flat, two-inch-by-four-inch rash surrounding it. Patient had sought unspecified medical attention. No Lab Diagnostics Studies Performed. No treatment was given for the events. The outcome was reported as not recovered/not resolved. The causality between adverse event and ZOSTAVAX was unknown. Additional information has been requested.
Age: 90.0
Sex: F
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: This spontaneous report as received from a physician refers to a 90 years old female patient. The patient was vaccinated with a dose of PNEUMOVAX23 on 20-DEC-2012. No other co-suspects were reported. No concomitant medications were reported. The physician stated that evening on 20-DEC-2012 the patient arm was really, really sore and she had difficulty moving it. The outcome of the events was unknown. It was unspecified if the patient sought medical attention. Additional information has been requested.
Age: 22.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Dizziness, Face injury, Hyperhidrosis, Laceration, Loss of consciousness
Clinical narrative: My daughter passed out within 5 minutes of receiving her vaccination. She fell off her seat, hitting her face on a cabinet and landed on the floor. Paramedics were called and she was transported to the ER her BP was very low and her pulse very high and she felt dizzy and faint.
Age: 22.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Blood test, Computerised tomogram head, Dizziness, Face injury, Fall
Clinical narrative: My daughter passed out within 5 minutes of receiving her vaccination. She fell off her seat, hitting her face on a cabinet and landed on the floor. Paramedics were called and she was transported to the ER her BP was very low and her pulse very high and she felt dizzy and faint.
Age: 22.0
Sex: F
Vaccine: FLU3, FLU3
Symptoms: Heart rate increased, Hypotension, Loss of consciousness
Clinical narrative: My daughter passed out within 5 minutes of receiving her vaccination. She fell off her seat, hitting her face on a cabinet and landed on the floor. Paramedics were called and she was transported to the ER her BP was very low and her pulse very high and she felt dizzy and faint.
Age: 1.52
Sex: F
Vaccine: DTAP, HEPA
Symptoms: Vomiting
Clinical narrative: Vomiting.
Age: 1.02
Sex: F
Vaccine: HEPA, MMR, PPV, VARCEL
Symptoms: Febrile convulsion, Pyrexia, Rash
Clinical narrative: Child experienced a febrile seizure lasting approximately five minutes. Child also experienced fevers for several days after shot administered, as well as rashes on the body.
Age: 49.0
Sex: F
Vaccine: FLUX
Symptoms: Urticaria
Clinical narrative: Hives.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Chills, Fatigue, Influenza like illness, Injection site erythema, Injection site swelling
Clinical narrative: Severe swelling at injection area, redness, warmth.  All eventually covered area from elbow to shoulder.  After two days, developed flu like symptoms of muscle aches, chills, fatigue.
Age: 65.0
Sex: M
Vaccine: PPV
Symptoms: Injection site warmth, Myalgia
Clinical narrative: Severe swelling at injection area, redness, warmth.  All eventually covered area from elbow to shoulder.  After two days, developed flu like symptoms of muscle aches, chills, fatigue.
Age: 21.0
Sex: F
Vaccine: FLUN3
Symptoms: Nasopharyngitis, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: High fever, sore throat, cold symptoms, body aches. Lasting 1+ week.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Pruritus generalised
Clinical narrative: Itching on my stomach area from above my navel to below my breast, stretching from one side of my body to the other.  This area became red and itchy all over. The redness/itchiness was gone when I awaken the next day.
Age: 43.0
Sex: F
Vaccine: FLUN3
Symptoms: Chills, Diarrhoea, Nausea, Pyrexia, Vomiting
Clinical narrative: Two hours of mild nausea followed by 7 hours of severe vomiting, diarrhea, and chills. The following morning the gastrointestinal symptoms were resolved but have a 100F fever. No treatment.
Age: 32.0
Sex: F
Vaccine: FLU3
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: Very sore and painful sholder and elbow.  Still occurring.  Seems worse.  Can't even sleep on that side.
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site reaction, Urticaria
Clinical narrative: Red welt size of a quarter at injection site.
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Dysstasia, Respiratory rate increased, Tremor
Clinical narrative: Pt became light headed and unable to stand upright. Increased respiratory rate and generalized shaking noted. No rales/stridor/wheezing noted.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Dizziness, Headache, Muscular weakness, Myalgia
Clinical narrative: Fever, muscle pain, stuffy head, headache, nausea, dizziness, chills, weakness in extremities.
Age: 54.0
Sex: F
Vaccine: FLUX
Symptoms: Nausea, Pyrexia, Upper respiratory tract congestion
Clinical narrative: Fever, muscle pain, stuffy head, headache, nausea, dizziness, chills, weakness in extremities.
Age: 64.0
Sex: M
Vaccine: FLUX
Symptoms: Dysphagia, Guillain-Barre syndrome, Hypoaesthesia, Intensive care, Pain
Clinical narrative: Numbness and tingling in hands and feet followed by severe pain. Symptoms then spreaded up both legs and arms and then to face. Trouble speaking and swallowing. Was admitted to hospital went to ICU for over 15 days. Diagnosed with ICU psychosis. Pneumonia.
Age: 64.0
Sex: M
Vaccine: FLUX
Symptoms: Paraesthesia, Pneumonia, Psychotic disorder, Speech disorder
Clinical narrative: Numbness and tingling in hands and feet followed by severe pain. Symptoms then spreaded up both legs and arms and then to face. Trouble speaking and swallowing. Was admitted to hospital went to ICU for over 15 days. Diagnosed with ICU psychosis. Pneumonia.
Sex: U
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a nurse practitioner refers to a patient of unknown age. The patient was vaccinated with the first dose of GARDASIL on 25-MAY-2011, and with the second dose on 27-NOV-2012 (doses, routes, lot numbers not reported). No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. It was unknown if the patient sought medical attention. Additional information has been requested.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Cough, Diarrhoea, Painful respiration, Pyrexia, Rhinorrhoea
Clinical narrative: Painful breathing, coughing, fever, excess mucus production, vomiting/diarrhea 10 hours later feeling much better.
Age: 66.0
Sex: M
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Painful breathing, coughing, fever, excess mucus production, vomiting/diarrhea 10 hours later feeling much better.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Flushing, Throat tightness
Clinical narrative: At 16:50 1/5/13 gave FLUVIRIN. At 16:55, patient complaining of flushing from her chest going up to her face and dizziness, throat tightening. I called 911 and had her lie down on floor. At 17:00 she said she felt better, but still tight. I administered one 0.3 mg EPIPEN into upper right thigh. At 17:05 paramedics came.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Eye pain
Clinical narrative: This spontaneous report as received from a consumer refers to her 79 years old sister. The patient was vaccinated with a dose of ZOSTAVAX (lot number, dose, route and indication not reported) on unspecified date in 2012. No other co-suspects were reported. No concomitant medications were reported. On 25-DEC-2012 the patient experienced eye pain and developed blisters around her eye and on her forehead. The patient sought unspecified medical attention and was given an unspecified treatment. The outcome of eye pain and blisters around her eye and on her forehead was reported as not recovered. The relatedness for eye pain and blisters around her eye on her forehead was not reported for ZOSTAVAX. Additional information is not expected.
Sex: U
Vaccine: RV5
Symptoms: Incorrect storage of drug, No adverse event
Clinical narrative: This spontaneous report as received from a pharmacy student refers to a patient of unknown age (gender not reported). On 11-DEC-2012, the patient was vaccinated with a dose of live, oral, ROTATEQ that was exposed to 17 C for 60 hours, lot number reported as "H010322", exp. date 30-NOV-2013 (dose, route were not reported). No other co-suspects were reported. No concomitant medications were reported. No adverse effect reported. The patient's outcome was unknown. Additional information has been requested.
Age: 50.0
Sex: M
Vaccine: FLUX
Symptoms: Joint range of motion decreased, Pain in extremity
Clinical narrative: Pain in upper arm, pain has increased and has effected range of motion, especially when getting dressed.
Age: 50.0
Sex: F
Vaccine: FLU3
Symptoms: Activities of daily living impaired, Immediate post-injection reaction, Injection site pain, Myalgia, Poor quality sleep
Clinical narrative: Arm hurt during and immediately after injection in left arm.  Seemed to be in muscle. Very painful to dress + undress, lift things, reach for seatbelt in car, put coat on. Sleep is poor due to extreme pain when lying down. Took Advil every 6 - 12 hours. Pain continues. Saw doctor 12/10/12 who prescribed I take methylprednisolone then followed by diclofenac sodium. Also prescribed physical therapy. Pain has diminished SLIGHTLY while on medication.
Age: 66.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Feeling cold, Oropharyngeal pain, Tremor
Clinical narrative: Bad sore throat and freezing.  Kept shaking and teeth chattering.  Lasted for approximately five hours.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Injection site mass, Injection site pain, Injection site swelling
Clinical narrative: Arm red, swollen, painful at injection site.  Lump 6cm X 7 cm at injection site.
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Activities of daily living impaired, Drug administered at inappropriate site, Headache, Injected limb mobility decreased, Musculoskeletal pain
Clinical narrative: Extreme pain in left arm and across shoulders, into neck and head; after three weeks, loss of mobility in arm and still have a lot of pain; injection given higher up on the arm than I've ever had done before - almost to shoulder; can't raise arm, reach across body, wash hair, etc.  Planning to see doctor soon.
Age: 58.0
Sex: F
Vaccine: FLUX
Symptoms: Neck pain, Pain in extremity
Clinical narrative: Extreme pain in left arm and across shoulders, into neck and head; after three weeks, loss of mobility in arm and still have a lot of pain; injection given higher up on the arm than I've ever had done before - almost to shoulder; can't raise arm, reach across body, wash hair, etc.  Planning to see doctor soon.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Fatigue, Hot flush, Hyperhidrosis, Injection site erythema, Injection site haematoma
Clinical narrative: Redness/swelling/hyperthermic/soreness/pain at/around site of injection. Very tired. Had hot-flashes, sweating. Bruising at/around injection site after previous symptoms diminished. Took naproxen orally and iced the injection site.
Age: 23.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Redness/swelling/hyperthermic/soreness/pain at/around site of injection. Very tired. Had hot-flashes, sweating. Bruising at/around injection site after previous symptoms diminished. Took naproxen orally and iced the injection site.
Age: 25.0
Sex: F
Vaccine: TTOX
Symptoms: Cough, Malaise, Pain in extremity, Respiratory tract congestion
Clinical narrative: Donor began feeling general malaise on 01/03/13, with congestion and cough. Generalized soreness in left extremities. Tetanus was given on 12/31/12. Donor felt fine upon leaving the center.
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Contusion, Full blood count abnormal, Idiopathic thrombocytopenic purpura, Petechiae, Platelet count decreased
Clinical narrative: Petechial rash spreading all over body, followed by purpura and bruising.  Patient diagnosed with ITP on Jan. 4, 2013 with a platelet count of 1,000.
Age: 5.0
Sex: F
Vaccine: FLUN3
Symptoms: Purpura, Rash generalised
Clinical narrative: Petechial rash spreading all over body, followed by purpura and bruising.  Patient diagnosed with ITP on Jan. 4, 2013 with a platelet count of 1,000.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Computerised tomogram, Electrocardiogram, Electroencephalogram, Grand mal convulsion, Nuclear magnetic resonance imaging
Clinical narrative: Grand mal seizure.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site pruritus, Injection site rash, Insomnia, Pain, Pruritus
Clinical narrative: Patient has had a swollen lymph node under his left arm (on trunk) for "many many months perhaps a year". The night after his FLUZONE HD shot (12/3) he noticed swelling and pain developed - it became sensitive to the touch and prevented him from sleeping. Dermatologist prescribed ZPAK on 12/10. A rash & itchiness developed from site over to chest. He was recovered by end of Dec.
Age: 74.0
Sex: M
Vaccine: FLU3
Symptoms: Swelling
Clinical narrative: Patient has had a swollen lymph node under his left arm (on trunk) for "many many months perhaps a year". The night after his FLUZONE HD shot (12/3) he noticed swelling and pain developed - it became sensitive to the touch and prevented him from sleeping. Dermatologist prescribed ZPAK on 12/10. A rash & itchiness developed from site over to chest. He was recovered by end of Dec.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pruritus
Clinical narrative: This spontaneous report as received from a 60 years old female registered nurse with drug allergy to cipro and allergy to shellfish refers to herself. The patient was vaccinated with ZOSTAVAX(lot# unknown) in MAY 2012. No other co-suspects were reported. Concomitant medications included: VALTREX. On 15-DEC-2012 the patient developed the shingles. She described her shingles as "full blown blisters" and mentioned she has "itching on her base of her neck going along to the left shoulder". There was no treatment information for the event. The patient had sought medical attention. Action taken on ZOSTAVAX wasn't reported. The outcome was reported as recovering. Additional information has been requested.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Burning sensation, Pain, Rash, Rash erythematous, Rash vesicular
Clinical narrative: This spontaneous report as received from a 74 years old male patient refers to himself. The patient's medical history included high cholesterol and loss of bone mass- osteoporosis. The patient did not have any drug reactions/allergies. The patient was vaccinated with ZOSTAVAX (1 injection on left upper arm subdermally, lot # unknown) on 30-OCT-2012. No other co-suspects were reported. Concomitant medications included FOSAMAX and SIMVASTIN. About a week or two after injection of ZOSTAVAX (also reported as since the end of October ) the patient had a rash that began on the back of his left thigh and had now it on his legs, back and shoulders as well. He said the rash was painful, and burns. He said it was similar to the Shingles, which had when he was in his 30's. He described them as red, little raised bumps not containing fluid. ZOSTAVAX was continued. No lab diagnostic studies performed. No treatment was given for adverse event. The outcome of shingles was unknown. Additional information has been requested.
Sex: F
Vaccine: FLU3
Symptoms: Hypersensitivity
Clinical narrative: Initial report was received from a consumer through another manufacturer on 26 December 2012. A female patient (age and date of birth not reported) had received an injection of FLUZONE SV 2012-2013, lot number reported as OH717AA (date, route and site of administration not reported) and an unspecified amount of time later experienced a severe allergic reaction. No additional information was provided. Outcome was not reported. Documents held by sender: None
Age: 72.0
Sex: F
Vaccine: PPV
Symptoms: Injection site rash, Pain
Clinical narrative: Pain after shot and rash around injection site. Went to the ED 12/15 evening and was given Benadryl and sent home. Patient had recovered by the 12/16.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes simplex, Simplex virus test positive, Vulvovaginal pain
Clinical narrative: This spontaneous report as received from a consumer refers to a 63 year old female patient with type 1 diabetes, otosclerosis, hypertension, and seasonal asthma (as stated by the reporter). Furthermore, the patient's medical history included allergy/adverse reaction to heparin, CIPRO, INDERAL and CELEBREX. On an unknown date, the patient was vaccinated with ZOSTAVAX for shingles (profylaxis). No other co-suspects were reported. Concomitant medications included LANTUS and clonidine. On an unknown date, after receiving ZOSTAVAX, the patient started having discomfort. Furthermore, she was in pain, it was keeping her awake and her skin looked like chicken pox. On an unknown date, she sought medical attention because of the events. No treatment information was reported. The patient's gynecologist did testing and she was HSV type 1 positive and HSV type 2 negative. Furthermore, three months before November 2012, a full panel lab test was performed (results were not specified). The outcome of the events is unknown. The relatedness for having discomfort, pain, keeping her awake and skin looked like chicken pox is unknown for ZOSTAVAX. Additional information has been requested.
Age: 63.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Discomfort, Insomnia, Pain, Rash vesicular, Simplex virus test positive
Clinical narrative: This spontaneous report as received from a consumer refers to a 63 year old female patient with type 1 diabetes, otosclerosis, hypertension, and seasonal asthma (as stated by the reporter). Furthermore, the patient's medical history included allergy/adverse reaction to heparin, CIPRO, INDERAL and CELEBREX. On an unknown date, the patient was vaccinated with ZOSTAVAX for shingles (profylaxis). No other co-suspects were reported. Concomitant medications included LANTUS and clonidine. On an unknown date, after receiving ZOSTAVAX, the patient started having discomfort. Furthermore, she was in pain, it was keeping her awake and her skin looked like chicken pox. On an unknown date, she sought medical attention because of the events. No treatment information was reported. The patient's gynecologist did testing and she was HSV type 1 positive and HSV type 2 negative. Furthermore, three months before November 2012, a full panel lab test was performed (results were not specified). The outcome of the events is unknown. The relatedness for having discomfort, pain, keeping her awake and skin looked like chicken pox is unknown for ZOSTAVAX. Additional information has been requested.
Age: 53.0
Sex: F
Vaccine: FLUX
Symptoms: Bacterial test, Death, Malaise, Pericardial haemorrhage, Viral test
Clinical narrative: According to son who was interrogated, decedent received flu vaccine 12/19 at hospital and was not feeling well after that; found dead at home 12/23, hemorrhagic pericarditis.
Age: 58.0
Sex: M
Vaccine: FLU3
Symptoms: Syncope
Clinical narrative: Pt fainted after administration, pt sat down & drank water and got up and left. We call 911 but pt refused further help. Called pt at 1pm & he was fine.
Age: 27.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Dyspnoea, Flushing, Loss of consciousness, Muscle rigidity, Musculoskeletal stiffness
Clinical narrative: Gave patient 2 vaccines in left arm (FLUVIRIN and ADACEL). Patient got up but then sat back down and passed out. Head rolled back and he became rigid and red. Patient's father and I laid him on ground and then I called 911. Patient was stiff for approximately 30 seconds then came to slowly breathing labored and slow. Did not administer any drugs like Epinephrine.
Age: 27.0
Sex: M
Vaccine: FLU3, TDAP
Symptoms: Posture abnormal, Respiratory rate decreased
Clinical narrative: Gave patient 2 vaccines in left arm (FLUVIRIN and ADACEL). Patient got up but then sat back down and passed out. Head rolled back and he became rigid and red. Patient's father and I laid him on ground and then I called 911. Patient was stiff for approximately 30 seconds then came to slowly breathing labored and slow. Did not administer any drugs like Epinephrine.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site pain, Pain
Clinical narrative: Hard, painful lump at PNEUMOVAX injection site. Fevers, body aches, redness at injection site. Induration at injection site.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pyrexia
Clinical narrative: Hard, painful lump at PNEUMOVAX injection site. Fevers, body aches, redness at injection site. Induration at injection site.
Age: 49.0
Sex: F
Vaccine: FLU3
Symptoms: Glossodynia, Oropharyngeal pain, Pain in extremity, Swollen tongue
Clinical narrative: Patient reports approximately 1 hour after receiving vaccine, tongue began to swell and had feeling of "white pepper" and burning on tongue with sore throat and severe pain in arm.
Age: 27.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Cough, Injection site erythema, Respiratory tract congestion, Vaccination site pain, Vaccination site swelling
Clinical narrative: Area where vaccine given is painful, red, swollen. Pt also c/o cough & congestion since vaccine admin. (left arm).
Age: 47.0
Sex: F
Vaccine: FLU3
Symptoms: Pigmentation disorder
Clinical narrative: Loss of pigmentation where the ID vaccine was given. Noticed 4 weeks after shot was given.
Age: 52.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: Initial report received from a healthcare professional on 25 September 2012. A 52-year-old female patient, whose medical history and concomitant medications were unknown, received a dose of FLUZONE (lot number: UH731AB) intramuscularly in the left arm on 12 September 2012. On 12 September 2012, the patient developed soreness that was radiating down her left arm since the vaccine given. Corrective medications and laboratory investigations were not reported. At the time of this report, the outcome of the event was unknown. Follow-up information was received from a healthcare professional on 26 December 2012. Based upon the new information, this case has been upgraded to serious. Treatment included diclofenac 75mg twice daily and cyclobenzaprine 10mg at bedtime. As of 21 December 2012, the issue was still not resolved. The patient stated it aches like a toothache all the time. Concomitant medications included calcium and aspirin. Outcome was not recovered. List of documents held by sender: none.
Sex: F
Vaccine: FLU3
Symptoms: Asthenia, Headache, Malaise, Myalgia, Pyrexia
Clinical narrative: Initial case was received from a consumer on 27 December 2012. A female patient (age not reported, birth date reported) received an injection of FLUZONE HIGH-DOSE, Sanofi Pasteur Inc., lot number unknown, (route, site, side and number of previous doses not reported) on an unknown date. That evening post vaccination (date unspecified), the patient became "really sick", was throwing up, had fever, and muscle aches. The next day, she became worse with vomiting, muscle aches, fever, and "no energy" and she went to her family doctor. The family doctor sent the patient to the emergency room, where she was admitted to the hospital for four days (dates unspecified), under the care of "heart specialist" (name unknown). Laboratory or diagnostic tests and treatments were not reported. The patient continued to have muscle aches, headache and no energy and was following up with family doctor. The patient's past medical history and concomitant medications were not reported. The patient's outcome was reported as not recovered. Documents held by sender: None.
Sex: F
Vaccine: FLU3
Symptoms: Vomiting
Clinical narrative: Initial case was received from a consumer on 27 December 2012. A female patient (age not reported, birth date reported) received an injection of FLUZONE HIGH-DOSE, Sanofi Pasteur Inc., lot number unknown, (route, site, side and number of previous doses not reported) on an unknown date. That evening post vaccination (date unspecified), the patient became "really sick", was throwing up, had fever, and muscle aches. The next day, she became worse with vomiting, muscle aches, fever, and "no energy" and she went to her family doctor. The family doctor sent the patient to the emergency room, where she was admitted to the hospital for four days (dates unspecified), under the care of "heart specialist" (name unknown). Laboratory or diagnostic tests and treatments were not reported. The patient continued to have muscle aches, headache and no energy and was following up with family doctor. The patient's past medical history and concomitant medications were not reported. The patient's outcome was reported as not recovered. Documents held by sender: None.
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Oedema peripheral
Clinical narrative: Patient called 2 days after receiving PNEUMOVAX arm was red and swollen. (Called on 12-19-12) Did see MD 12-21-12 for other reasons. He was not concerned about arm - no treatment for that. Spoke to patient 12-26-12 stated she was better.
Age: 33.0
Sex: F
Vaccine: TDAP
Symptoms: Gait disturbance, Muscle spasms, Myalgia
Clinical narrative: Vaccine administered 12/3/12 - F/U visit 12/13 pt reports - full body muscle pain - in leg so bad could barely walk - (R) arm & side of neck/scapula with persistent spasm - though better still then.
Age: 0.65
Sex: F
Vaccine: DTAP, HIBV, IPV, PNC13
Symptoms: Wrong drug administered
Clinical narrative: We were administering vaccines to both siblings in the exam room. Patient received the wrong vaccines that were supposed to be given to her sibling.
Age: 21.0
Sex: F
Vaccine: HPV4
Symptoms: Dizziness, Fall
Clinical narrative: Patient given GARDASIL #1 (L) deltoid. Patient remained sitting and was feeling fine. About 5 min later heard a loud sound and patient was found on floor. She said she felt dizzy and don't remember after that. No injuries from fall.
Age: 0.87
Sex: F
Vaccine: HEP
Symptoms: Accidental exposure to product
Clinical narrative: I administered a Hepatitis B vaccination to patient which was not ordered for her. The Hepatitis B vaccine was supposed to be given to her sibling.
Age: 72.0
Sex: F
Vaccine: HEPA
Symptoms: Burning sensation, Herpes zoster
Clinical narrative: 12/24/12 burning under skin, on back. No rash. On right hand side. 12/31/12 symptoms. 12/26/12 MD diagnosed patient with shingles. Symptoms are subsiding quickly.
Sex: F
Vaccine: HPV4
Symptoms: Inappropriate schedule of drug administration, No adverse event
Clinical narrative: This spontaneous report as received from a physician via company representative refers to a female patient of unknown age. On an unknown date in 2011, the patient was vaccinated with dose 1 of 0.5 milliliter (ml) of GARDASIL (lot number, expiry date were not reported) intramuscularly. No concomitant medications were reported. On 02-JAN-2013 (reported as today), the patient had just received her second dose of 0.5 milliliter (ml) of GARDASIL (lot number, expiry date were not reported) intramuscularly. No adverse reaction reported. 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 physician refers to an unspecified number of patients of unknown age or gender who administered the second dose of GARDASIL late. The dates of administration was unavailable. No adverse effect reported. It was unknown if the patients sought medical attention. At the time of report, the patients status was unknown. 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 registered nurse refers to a patient of unknown age. The patient was vaccinated with the first dose of GARDASIL (dose, route, lot number not reported) in December 2011. No other co-suspects were reported. No concomitant medications were reported. The nurse reported that the patient was in the office then (date of report 03-JAN-2013) to receive dose 2 of GARDASIL which would be late. No symptoms reported. It was unknown if the patient sought medical attention. Additional information has been requested.
Age: 14.0
Sex: F
Vaccine: HPV4
Symptoms: Arthralgia, Oedema peripheral, Rash, Swelling face
Clinical narrative: This spontaneous report as received from a healthcare worker refers to a 14 year old female patient. Patient had no relevant medical history and no known drug allergies. On 19 or 20 December 2012 the patient was vaccinated with, GARDASIL, 0.5 ml, vial, intramuscular for immunization. Lot number was not provided. No other co-suspects were reported. No concomitant medications were used. A few days after receiving GARDASIL the patient developed swelling of her hands, feet and face; joint pain in her fingers and knees; and rash on her back and arms. Patient's mother called physician's office. BENADRYL was given as treatment for the events. The outcome of the events was reported as recovering/resolving. The relatedness for swelling of hands and feet, swelling of face and joint pain in fingers and knees was not provided for GARDASIL. Additional information has been requested.
Age: 20.0
Sex: M
Vaccine: HPV4
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report as received form a consumer refers to her approximately 20 years old son, who was vaccinated with dose 1 GARDASIL (lot# and dose not reported) about a year ago, approximately in 2012. The consumer stated she was told her son only needed one "catch up shot" because of his age. No adverse event reported. The patient did not seek medical attention. Additional information has been requested.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site induration, Injection site pain, Oedema peripheral
Clinical narrative: (R) swollen arm w/ hardened area tender to touch at inj ste.