chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 33.0
Sex: M
Vaccine: FLUX
Symptoms: Dizziness, Facial paresis, Palpitations
Clinical narrative: Racing heart beat, face felt funny as if harder to move facial muscles. Also lightheaded but not quite dizzy.  It subsided after a few hours on its own. Did not go to a doctor or report it at the time but it was the second time it happened. First was in 2009 with similar symptoms and results. Got the flu shot in the intervening years and had no issues.
Age: 70.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth
Clinical narrative: Hot, red, swollen arm at injection site. Pt came into pharmacy on 9/19/2015 @3p with un relieved symptoms even after taking hydrocodone, otc pain relievers and applying an ice pack.
Age: 26.0
Sex: F
Vaccine: TDAP
Symptoms: Syncope
Clinical narrative: Pt fainted after receiving the Boostrix (Tdap) immunization, recovered immediately after we laid her on floor, she did not want to call 911, she stated that she had not eaten since noon and had just had an energy drink, watched pt for awhile and called her mother to come pick up.
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Adverse event includes red, warm and itchy around the injection site of Prevnar 13.
Age: 51.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site warmth
Clinical narrative: Patient noticed a red spot that was painful a few inches from where she got the shot.  Noted that it is warm to the touch.
Age: 56.0
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: PATIENT COMPLAINING OF SORENESS AND REDNESS AT INJECTION SITE WHICH EXPANDED TO COVER HIS DELTOID AND UPPER BICEP.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Injection site bruising, Injection site discolouration
Clinical narrative: Pt had bruising to arm where shot was given.  It had turned a blueish yellow color.  She also had bruising at an injection site in other arm where she had blood drawn recently also.
Age: 67.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Rash
Clinical narrative: Rash below injection sites on upper arm.
Age: 50.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Arm swollen and painful.
Age: 20.0
Sex: F
Vaccine: FLU3
Symptoms: Blood glucose decreased, Eye disorder, Injection site pain, Throat tightness
Clinical narrative: Pt complained of sparklings in her eyes then later complained of little tightness in her throat and feeling fire at the injection site.
Age: 51.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Chest pain, Erythema, Impaired work ability, Injection site erythema, Migraine
Clinical narrative: Redness, pain, fever, nausea, muscle aches, pain, cramping, rash, severe migraine, redness and swelling at vaccine site and redness and severe pain on chest on same side of vaccine, cannot move arm without servere pain. Migraine scale over 10, vaccine and chest pain 5 if not moving. This lasted from Wednesday evening and Saturday (today)first day no fever and actually out of bed. Called DR on Friday told if still running fever Saturday go to Urgent care, broke fever 1:30 this am. Missed 2 entire days of work and am still in pain, still have redness, swelling, rash and pain. Migraine comes and goes.
Age: 51.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Muscle spasms, Myalgia, Nausea, Pain, Pain in extremity
Clinical narrative: Redness, pain, fever, nausea, muscle aches, pain, cramping, rash, severe migraine, redness and swelling at vaccine site and redness and severe pain on chest on same side of vaccine, cannot move arm without servere pain. Migraine scale over 10, vaccine and chest pain 5 if not moving. This lasted from Wednesday evening and Saturday (today)first day no fever and actually out of bed. Called DR on Friday told if still running fever Saturday go to Urgent care, broke fever 1:30 this am. Missed 2 entire days of work and am still in pain, still have redness, swelling, rash and pain. Migraine comes and goes.
Age: 51.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Pyrexia, Rash, Vaccination site pain, Vaccination site swelling
Clinical narrative: Redness, pain, fever, nausea, muscle aches, pain, cramping, rash, severe migraine, redness and swelling at vaccine site and redness and severe pain on chest on same side of vaccine, cannot move arm without servere pain. Migraine scale over 10, vaccine and chest pain 5 if not moving. This lasted from Wednesday evening and Saturday (today)first day no fever and actually out of bed. Called DR on Friday told if still running fever Saturday go to Urgent care, broke fever 1:30 this am. Missed 2 entire days of work and am still in pain, still have redness, swelling, rash and pain. Migraine comes and goes.
Age: 46.0
Sex: F
Vaccine: FLUX
Symptoms: Chills, Headache, Pain, Pyrexia
Clinical narrative: Fever, headache, body aches, chills.
Age: 3.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Left deltoid is swollen, red and sl tender to touch, warm to touch, started on Sat am, got on Thursdat given by MA.
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Urticaria
Clinical narrative: Pt developed hives treated with BENADRYL and prednisone full recovery.
Age: 90.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Discomfort, Hypoaesthesia, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Shortly after receiving vaccine she developed numbness/tingling in hands that lasted 3-4 days. One week post vaccine developed pain, redness and swelling at injection site. All discomfort has resolved 2 wks post vaccination.
Age: 90.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Paraesthesia
Clinical narrative: Shortly after receiving vaccine she developed numbness/tingling in hands that lasted 3-4 days. One week post vaccine developed pain, redness and swelling at injection site. All discomfort has resolved 2 wks post vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a pharmacist referring to three patients of unknown age and gender. On unknown dates the patients was vaccinated with improper stored ZOSTAVAX (lot # reported as L017138, expiration date 13-AUG-2016, dose and route were not reported). The vaccine was exposed to 20F for 8 hours. No adverse effects were reported. Additional information has been requested.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: This spontaneous report as received from a pharmacist via field representative refers to a 62 year old female patient. The patient's pertinent medical history included Sjogren's syndrome. On an unknown date, the patient was mistakenly vaccinated with ZOSTAVAX 0.65 ml, subcutaneously instead of PNEUMOVAX 23. The patient asked for PNEUMOVAX 23 but was given ZOSTAVAX by mistake. No adverse effects were reported. Additional information has been requested.
Age: 11.0
Sex: M
Vaccine: HPV4
Symptoms: Injection site pain
Clinical narrative: Information has been received from a consumer referring to her son, an 11 year old male patient. The patient's relevant medical history and concurrent conditions were unknown. On 15-SEP-2105 at 16:00 the patient was vaccinated with a dose of GARDASIL (dose, lot# and expiration date not reported; route reported as "injection") in the right arm. Information regarding concomitant medications was unknown. On 15-SEP-2015 at 20:30 the patient began to feel a stabbing pain in his arm at the injection site. He was treated with an unknown pain medication a little while ago. It was unknown if there was any relevant laboratory data. At the time of this report, it was unknown if the patient would continue to get the GARDASIL and the outcome of the event was not recovered. Additional information has been requested.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a female nurse of unknown age referring to herself. On an unknown date the patient was vaccinated with an improperly stored dose of ZOSTAVAX (lot #, dose and route were not reported). No adverse effect reported. Additional information is not expected since the reporter does not want to be contacted.
Age: 53.0
Sex: M
Vaccine: FLUX
Symptoms: Eye swelling, Peripheral swelling, Pruritus, Urticaria
Clinical narrative: Itchy hands, swollen fingers, hives first day increasing. Itchy hands and feet, larger hives second day. Swollen eyes, larger hives and itchy hands and feet third day. First day 20 mg of prednisone was given along with Benadryl taken every 6 hours. Third day went back to stat health and they increased the dose of prednisone to 60mg and continue taking Benadryl. Instructed to go to hospital if breathing problems arise.
Age: 0.34
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV5
Symptoms: Muscle twitching, Neurological symptom, Seizure
Clinical narrative: Twitching, neurological symptoms, mild seizures.
Age: 69.0
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Fatigue, Muscular weakness, Myalgia
Clinical narrative: Muscle pain, muscle weakness, extreme fatigue.
Age: 45.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Pruritus, Rash pruritic
Clinical narrative: Started out with some small itchy bumps on my left arm (same arm as injection). Bumps have continued to spread all up and down arm and I am starting to get patches on right arm and jaw bone line. Very itchy!!
Age: 22.0
Sex: F
Vaccine: FLU3
Symptoms: Immediate post-injection reaction, Injection site erythema, Rash erythematous
Clinical narrative: Patient had immediate redness at site of injection.  Within 5 Minutes redness spread to chest area.  Patient was given 50mg of Benadryl.  Patient did not experience any trouble breathing.  Benadryl helped the red rash with 15 minutes of administration.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Gait disturbance, Injection site haematoma, Myalgia
Clinical narrative: Increasing leg muscle pain as day progressed.  Pain very bad.  Walking was diffcult.
Age: 56.0
Sex: F
Vaccine: TD
Symptoms: Arthralgia, Injection site pain, Rheumatoid arthritis
Clinical narrative: After initial soreness at shot sight wore off, pain in shoulder and elbow began to increase.  It seems to be a rheumatoid arthritis flare up (or something like it) that had NEVER occurred before.  It has now been 15 days of pain.
Age: 72.0
Sex: M
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Injection site reaction, Insomnia, Myalgia, Pain
Clinical narrative: Upper arm muscles at site of injection sore.  Could not lift affected arm above shoulder level or move arm behind back.  Could not sleep on left side because of pain.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site swelling, Insomnia
Clinical narrative: PT complaining of redness, warmth and inflammation at site of vaccination (he says it's so swollen his skin stretch to the point its shiny). Painful at touch, unable to use arm or sleep on that side. States that reaction occurred the night after vaccination, reported 09/19/15 and has not shown much improvement. PT encouraged to seek urgent care/ER.
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Vaccination site inflammation, Vaccination site warmth
Clinical narrative: PT complaining of redness, warmth and inflammation at site of vaccination (he says it's so swollen his skin stretch to the point its shiny). Painful at touch, unable to use arm or sleep on that side. States that reaction occurred the night after vaccination, reported 09/19/15 and has not shown much improvement. PT encouraged to seek urgent care/ER.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Chest pain, Dyspnoea
Clinical narrative: LEFT SIDE CHEST PAIN, SHORTNESS OF BREATH. SELF-RESOLVED WITH NO EMERGENCY ROOM VISIT SUNDAY MORNING 9/20/2015 AM.
Age: 66.0
Sex: M
Vaccine: FLU3, PNC13, VARZOS
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Redness and swelling at injection site.
Age: 67.0
Sex: F
Vaccine: FLUX, PNC13
Symptoms: Chills, Erythema, Fatigue, Pain, Swelling
Clinical narrative: 9/17 Extreme fatigue, chills pain on first day. 9/18:  redness and sweilling in patches covering approx 5 cm long area. 9/19 Redness & swelling grew to 8 cm x 7cm. 9/20 Redness spread to 11 cm long, but no swelling. The red area is not at the direct site of the injection, it's towards the inside of the arm. I have a picture of the area taken 9/19.
Age: 24.0
Sex: F
Vaccine: DTAP
Symptoms: Dizziness, Headache, Injection site pain, Nausea, Pyrexia
Clinical narrative: Sore and pain on arm of injection, headache and faint feeling, nausea, red rash covering arm, fever.
Age: 24.0
Sex: F
Vaccine: DTAP
Symptoms: Rash erythematous
Clinical narrative: Sore and pain on arm of injection, headache and faint feeling, nausea, red rash covering arm, fever.
Age: 69.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Erythema, Pain in extremity, Peripheral swelling
Clinical narrative: Red, swollen, painful, down to 2 days, (same arm that pt was recently treated for cancer in his elbow), took APAP, symptoms reduced, currently gone.
Age: 59.0
Sex: M
Vaccine: FLUX
Symptoms: Eye disorder, Photopsia
Clinical narrative: EYE PROBLEMS SHOOTING LIGHTS MORE INTENSE IN A DARKER ROOM.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity, Peripheral swelling, Vomiting
Clinical narrative: Per pt, 9/17 arm swelling with pain, vomiting. Pt did not inform pharmacy until 9/20 at 3pm. Stated she takes Benadryl for sleep, but that had not helped with swelling. Stated she will see doctor 9/21.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Decreased appetite, Enema administration, Explorative laparotomy, Haematochezia, Intussusception
Clinical narrative: Grey skin tone, lethargic, no desire to eat, bloody stool. After sleeping in very late and looking grey, his mother took him to his doctor's office who advised to call with any new symptoms. Imediately following the visit, patient had a bloody stool. Dr. recommended the emergency department at hospital. Patient had an ultra sound and x-ray that confirmed Intussusception. The first treatment was an air enema which was unsuccessful after numerous attempts, he then went into surgery where laproscopic and exploratory surgery was performed by Dr. The exploratory surgery was successful at correcting the prolem. Patient was on morphine and Tylenol for two to three days and allowed to eat gradually 2 days after surgery.
Age: 0.33
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Lethargy, Skin discolouration, Somnolence, Ultrasound abdomen abnormal, X-ray gastrointestinal tract abnormal
Clinical narrative: Grey skin tone, lethargic, no desire to eat, bloody stool. After sleeping in very late and looking grey, his mother took him to his doctor's office who advised to call with any new symptoms. Imediately following the visit, patient had a bloody stool. Dr. recommended the emergency department at hospital. Patient had an ultra sound and x-ray that confirmed Intussusception. The first treatment was an air enema which was unsuccessful after numerous attempts, he then went into surgery where laproscopic and exploratory surgery was performed by Dr. The exploratory surgery was successful at correcting the prolem. Patient was on morphine and Tylenol for two to three days and allowed to eat gradually 2 days after surgery.
Age: 74.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: A couple hours after administration, patient claims the injection site and surrounding area became red and itchy. Area covered about a two inch diameter around injection site.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Infection, Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: PATIENT REPORTED THAT SHE HAD A BUMP AT THE INJECTION SITE, SORENESS AND BRUISING. SHE PRESENTED ON 9/19 AT THE EMERGENCY ROOM WITH REDNESS AND WARMTH EXTENDING DOWN FROM THE INJECTION SITE TOWARDS THE ELBOW. SHE WAS GIVEN MEDICATION FOR INFECTION.
Age: 65.0
Sex: F
Vaccine: PPV
Symptoms: Injection site warmth
Clinical narrative: PATIENT REPORTED THAT SHE HAD A BUMP AT THE INJECTION SITE, SORENESS AND BRUISING. SHE PRESENTED ON 9/19 AT THE EMERGENCY ROOM WITH REDNESS AND WARMTH EXTENDING DOWN FROM THE INJECTION SITE TOWARDS THE ELBOW. SHE WAS GIVEN MEDICATION FOR INFECTION.
Age: 72.0
Sex: M
Vaccine: FLUX
Symptoms: Headache, Nausea, Oropharyngeal pain, Pain, Pyrexia
Clinical narrative: Sore throat, fever, naseau, aching, headache.
Age: 72.0
Sex: F
Vaccine: PNC13
Symptoms: Chills, Erythema, Fatigue, Pruritus generalised
Clinical narrative: Itching, redness on arms, hands and trunk. Fatigue and chills for about 1 week.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ, MENB, MNQ, MENB, MNQ
Symptoms: Chest discomfort, Dyskinesia, Electroencephalogram normal, Eye movement disorder, Fall
Clinical narrative: Actual time of onset unknown. Per hospital H&P: pt was in usual state of health until 9/4/15 when she recived the wrong dose of the meningococcal vaccine and was called back to providers office for correct immunization, with the second shot she felt pressure going into her chest radiating from her arm the next morning she felt neck fully arching and felt like someone was pressing down on her chest and her arms were throbbing, she felt paralyzed from neck numbness and lots of full body pain this lasted 3-4 hours, pt then went via EMS to hospital in where she had a 10 day stay from 9/5-9/15 where her symptoms included sensitivity to touch, headache, throbbing at the back of the head. She had sensitivity to light for 5 days. She had tremors and random jerking. On the second day of admit she fell in the bathroom. On day 6 of admission she had head jurking with eye movements. She was discharged from hospital and admitted to a medical center in where she is now. Pt was admitted 9/16/15 with similar symptoms. Pt has had additional work up including and EEG which was noted on the report to be normal. It is recommeded that you obtain medical records from both hospitals.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ, MENB, MNQ, MENB, MNQ
Symptoms: Headache, Hyperaesthesia, Hypoaesthesia, Limb discomfort, Musculoskeletal discomfort
Clinical narrative: Actual time of onset unknown. Per hospital H&P: pt was in usual state of health until 9/4/15 when she recived the wrong dose of the meningococcal vaccine and was called back to providers office for correct immunization, with the second shot she felt pressure going into her chest radiating from her arm the next morning she felt neck fully arching and felt like someone was pressing down on her chest and her arms were throbbing, she felt paralyzed from neck numbness and lots of full body pain this lasted 3-4 hours, pt then went via EMS to hospital in where she had a 10 day stay from 9/5-9/15 where her symptoms included sensitivity to touch, headache, throbbing at the back of the head. She had sensitivity to light for 5 days. She had tremors and random jerking. On the second day of admit she fell in the bathroom. On day 6 of admission she had head jurking with eye movements. She was discharged from hospital and admitted to a medical center in where she is now. Pt was admitted 9/16/15 with similar symptoms. Pt has had additional work up including and EEG which was noted on the report to be normal. It is recommeded that you obtain medical records from both hospitals.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ, MENB, MNQ, MENB, MNQ
Symptoms: Pain, Pain in extremity, Paralysis, Photophobia, Tremor
Clinical narrative: Actual time of onset unknown. Per hospital H&P: pt was in usual state of health until 9/4/15 when she recived the wrong dose of the meningococcal vaccine and was called back to providers office for correct immunization, with the second shot she felt pressure going into her chest radiating from her arm the next morning she felt neck fully arching and felt like someone was pressing down on her chest and her arms were throbbing, she felt paralyzed from neck numbness and lots of full body pain this lasted 3-4 hours, pt then went via EMS to hospital in where she had a 10 day stay from 9/5-9/15 where her symptoms included sensitivity to touch, headache, throbbing at the back of the head. She had sensitivity to light for 5 days. She had tremors and random jerking. On the second day of admit she fell in the bathroom. On day 6 of admission she had head jurking with eye movements. She was discharged from hospital and admitted to a medical center in where she is now. Pt was admitted 9/16/15 with similar symptoms. Pt has had additional work up including and EEG which was noted on the report to be normal. It is recommeded that you obtain medical records from both hospitals.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ, MENB, MNQ, MENB, MNQ
Symptoms: Gait disturbance, Photosensitivity reaction, Psychogenic seizure
Clinical narrative: Actual time of onset unknown. Per hospital H&P: pt was in usual state of health until 9/4/15 when she recived the wrong dose of the meningococcal vaccine and was called back to providers office for correct immunization, with the second shot she felt pressure going into her chest radiating from her arm the next morning she felt neck fully arching and felt like someone was pressing down on her chest and her arms were throbbing, she felt paralyzed from neck numbness and lots of full body pain this lasted 3-4 hours, pt then went via EMS to hospital in where she had a 10 day stay from 9/5-9/15 where her symptoms included sensitivity to touch, headache, throbbing at the back of the head. She had sensitivity to light for 5 days. She had tremors and random jerking. On the second day of admit she fell in the bathroom. On day 6 of admission she had head jurking with eye movements. She was discharged from hospital and admitted to a medical center in where she is now. Pt was admitted 9/16/15 with similar symptoms. Pt has had additional work up including and EEG which was noted on the report to be normal. It is recommeded that you obtain medical records from both hospitals.
Age: 16.0
Sex: M
Vaccine: MENB, MNQ, MENB, MNQ, MENB, MNQ
Symptoms: Gait disturbance, Photosensitivity reaction, Seizure
Clinical narrative: Actual time of onset unknown. Per hospital H&P: pt was in usual state of health until 9/4/15 when she recived the wrong dose of the meningococcal vaccine and was called back to providers office for correct immunization, with the second shot she felt pressure going into her chest radiating from her arm the next morning she felt neck fully arching and felt like someone was pressing down on her chest and her arms were throbbing, she felt paralyzed from neck numbness and lots of full body pain this lasted 3-4 hours, pt then went via EMS to hospital in where she had a 10 day stay from 9/5-9/15 where her symptoms included sensitivity to touch, headache, throbbing at the back of the head. She had sensitivity to light for 5 days. She had tremors and random jerking. On the second day of admit she fell in the bathroom. On day 6 of admission she had head jurking with eye movements. She was discharged from hospital and admitted to a medical center in where she is now. Pt was admitted 9/16/15 with similar symptoms. Pt has had additional work up including and EEG which was noted on the report to be normal. It is recommeded that you obtain medical records from both hospitals.
Age: 68.0
Sex: M
Vaccine: PPV
Symptoms: HIV test, Hepatitis A virus test, Hepatitis B virus test, Hepatitis C virus test, Injury associated with device
Clinical narrative: NEEDLE STICK TO ADMINISTRATOR.
Age: 43.0
Sex: F
Vaccine: FLU3
Symptoms: Feeling cold, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Patient initially had some feelings of coldness and tingling that went away. The symptoms returned on 9/20/15 and intensified to the point of pains shooting up the forearm.
Age: 79.0
Sex: F
Vaccine: FLUX
Symptoms: Aphasia, Dysphagia, Eye swelling, Laboratory test, Peripheral swelling
Clinical narrative: Slightly swollen arm, itchy, moved to soft spots in both legs the next 2 days. Slightly swollen arm, swelling and itchiness moved down arm; next 2 days moved to soft spots in legs and buttocks; 4th day woke up with swollen eyes and cheeks. By evening swelling and itchiness moved to chin. Woke up at 2:30 AM with hugely swollen chin/throat and tongue. Couldn''t swallow or talk. Went to the ER.
Age: 79.0
Sex: F
Vaccine: FLUX
Symptoms: Pharyngeal oedema, Pruritus, Swelling face, Swollen tongue
Clinical narrative: Slightly swollen arm, itchy, moved to soft spots in both legs the next 2 days. Slightly swollen arm, swelling and itchiness moved down arm; next 2 days moved to soft spots in legs and buttocks; 4th day woke up with swollen eyes and cheeks. By evening swelling and itchiness moved to chin. Woke up at 2:30 AM with hugely swollen chin/throat and tongue. Couldn''t swallow or talk. Went to the ER.
Age: 50.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Mobility decreased, Myalgia
Clinical narrative: Couldn't move. Almost felt paralyzed. Muscle aches were so severe, I could hardly move. Spent the entire day in bed. No fever.
Age: 39.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Chills, Erythema, Local swelling, Pain, Pyrexia
Clinical narrative: Admin 9-18, pt returned to rx with localized redness, pain, swelling, previous fever and chills and vomiting. Advised ibuprofen and monitoring.
Age: 39.0
Sex: M
Vaccine: FLU3, PPV
Symptoms: Vomiting
Clinical narrative: Admin 9-18, pt returned to rx with localized redness, pain, swelling, previous fever and chills and vomiting. Advised ibuprofen and monitoring.
Age: 56.0
Sex: F
Vaccine: FLU3, PNC13
Symptoms: Asthenia, Fatigue, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: Swelling and redness at site of injection (left). Fever 101 degrees F. Lack of energy/fatigue. Pt. reported that will see MD 9/20/15. Pt reported feeling better 9/20/15 than Thursday 9/17/15.
Age: 56.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Mobility decreased, Pain, Tenderness
Clinical narrative: Upper arm tenderness radiating to neck and shoulder-difficulty lifting arm past elbow level for 4 days-hurts to lay on that side with pain when lifting.
Age: 66.0
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site cellulitis, Injection site discomfort, Injection site erythema, Injection site swelling
Clinical narrative: Information has been received from a pharmacist referring to a 66 year old female patient. The patient's medical history included gastritis and oesophagitis. The patient did not have drug reactions/allergies. On 08-SEP-2015 the patient was vaccinated with a dose of PNEUMOVAX 23 (lot # K012424, expiration date 05-JUN-2016, dose and route were unknown). Concomitant therapies included budesonide and an unspecified flu shot on 08-SEP-2015. On 09-SEP-2015, the patient developed redness, swelling and discomfort at the injection site of the PNEUMOVAX 23. The patient visited an unspecified physician on the same day and was diagnosed with cellulitis around the injection site of the PNEUMOVAX 23. None lab diagnostics studies were performed. The patient was prescribed an unspecified antibiotic and an unspecified medication for pain. The outcome of the event was reported as not recovered/not resolved. Causality was not provided. Additional information has been requested.
Sex: U
Vaccine: VARCEL
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of (Merck) VARIVAX (lot # K006138, expiration date 29-APR-2016, dose and route were unknown). No adverse effects reported. This is one of the two reports received from the same source. Additional information has been requested.
Age: 34.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site erythema, Injection site mass, Musculoskeletal stiffness, Myalgia
Clinical narrative: Lump and redness around injection site approximatekyl 1.2 inches in diameter. Muscle soreness and stiffness.
Sex: U
Vaccine: MMRV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse referring to an unspecified number of patients of unknown age and gender. On unknown dates, the patients were vaccinated with improperly stored doses of PROQUAD (lot # K011311, expiration date 14-FEB-2016, dose and route were unknown). No adverse effects reported. This is one of the two reports received from the same source. Additional information has been requested.
Sex: U
Vaccine: HIBV
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse practitioner referring to 3 patients of unknown age and gender. The patients' pertinent medical history and drug allergies were not reported. On 14-SEP-2015 the 3 patients were vaccinated with improperly stored LIQUID PEDVAXHIB (lot# L014426 with expiration date of 08-MAR-2018, dose, strength and route unknown). No adverse effects reported. Additional information has been requested.
Sex: U
Vaccine: VARCEL, VARZOS
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: Information was received from a registered nurse referring to a patient of unknown age and gender. The patient's medical history and concurrent condition were not reported. On 04-SEP-2015 the patient was supposed to receive a dose of ZOSTAVAX. Instead, the patient inadvertently received a dose of (Merck) VARIVAX (dose, strength and route unknown) (wrong drug administered). This occurred at an unspecified pharmacy. No symptom was reported. Additional information has been requested.
Sex: U
Vaccine: PPV
Symptoms: Hypersensitivity
Clinical narrative: This spontaneous report as received from an unknown reporter, as a part of a marketing research program conducted by a market research agency refers to some adult patients of unknown demography. The patient's concurrent conditions and medical history were not reported. On an unknown date, the patients were vaccinated with PNEUMOVAX23 (strength, dose, route and lot number or batch number unspecified). No concomitant medications were reported. On an unknown date, the patients were reported to have PNEUMOVAX23 allergies. It was also reported that T cell response was not robust than PNEUMOVAX23 and the hospital had decided to administer PREVNAR. The outcome of the event was unknown. The reporter's causality assessment was not provided. Additional information has been requested.
Sex: U
Vaccine: MMR
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a registered nurse concerning an unspecified number of patients of unknown age and gender. There was no pertinent medical history or drug reactions/allergies reported. On unknown dates the patients were vaccinated with doses of improperly stored M-M-R II (lot # L008684, expiration date: 13-MAR-2017, therapy type: rHA; dose and route unspecified). No adverse effects were reported. Additional information has been requested.
Sex: U
Vaccine: VARZOS
Symptoms: Parkinson's disease
Clinical narrative: Information has been received from an unspecified reporter referring to a patient of unknown age and gender without previously having chickenpox. There was no medical history or concurrent condition reported. On an unknown date the patient was vaccinated with a dose of ZOSTAVAX (dose, route and lot # were not reported). Later, on an unknown date the patient developed Parkinson's Disease. At the time of the report, the outcome of the event and the causality were not reported. Additional information is not expected as there was no contact information provided.
Age: 2.0
Sex: M
Vaccine: DTP, PNC
Symptoms: Feeding disorder of infancy or early childhood, Injection site swelling, Sensory integrative dysfunction, Speech disorder developmental, Therapy change
Clinical narrative: Additional information provided updated medical history, laboratory tests, additional events, event details and outcome. Information regarding PREVNAR was received form a healthcare professional regarding a 24 month old male patient who experienced swelling in both legs. The patient received a (booster dose number unspecified) dose on 05 Apr 2010. Medical history: The patient's concurrent illnesses include therapy regimen changed and physical examination ((at birth) head circumference 34.5 cm, length 20.5 inches). The patient's therapy regimen changed, as his past therapies included PREVNAR  given on an unspecified date. Patient delivered by Cesarean section, Mother had mild gestational diabetes. Indication for PREVNAR was immunization. Product was administered on 05 Apr 2010 (reported as a booster dose). Dose regimen was 1 dose 1 time per day (intramuscular). Additional suspect medication included DTaP. Concomitant medications were not reported. The patient experienced swelling in both legs (noted as 9x10 centimeters in the right leg an 5x10 centimeters in the left leg) on 06 Apr 2010. No treatment was reported. The patient's outcome was unknown. Additional on an unspecified date in May 2010, the patient experienced speech/language delay, feeding difficulty and sensory integration dysfunction. No treatment was reported. The outcome of the events was unknown. Physical examination (results: language/speech developmental milestones: sensory integration dysfunction with speech and language delays and feeding difficulty just occurred, emotional/social Developmental milestone, normal, cognitive thinking Developmental milestones normal, physical growth normal.) was done in 2010. No additional information was available at the time of this report.
Age: 0.81
Sex: F
Vaccine: DTAPIPVHIB, FLUX, HEP, PNC
Symptoms: Febrile convulsion
Clinical narrative: This is an initial spontaneous report from a Pfizer sales representative on behalf of a nurse who was reporting for a consumer. A 9-month-old female consumer (race unknown) received a second dose of PREVNAR (lot number 916599), intramuscularly, on 16Nov2011 along with first dose of PENTACEL (Lot number C381899) intramuscularly on 16Nov2011, a first dose of Influenza vaccine (lot number UT41199) intramuscularly on 16Nov2011 and a second dose of Hepatitis B vaccine (lot number 15172), intramuscularly on 16Nov2011. Relevant medical history and concomitant medications of the consumer were unknown. It was also noted the patient had no allergies or relevant family history. On 16Nov2011 the consumer experienced febrile seizure (several) after receiving PREVNAR, PENTACEL, influenza flu vaccine and hepatitis B vaccine, for which she was taken to the emergency room for evaluation. Treatment included TYLENOL. The relevant laboratory data of the consumer was unknown. Status of PREVNAR, PENTACEL, influenza flu vaccine and hepatitis B vaccine therapy was unknown at the time of report. Clinical outcome of the reported event was recovered without sequelae. The patient was evaluated on 17Nov2011 by the physician at a follow-up visit with no treatment. Follow-up (06Jan2012): Follow-up attempts completed. No further information expected. Follow-up (12Jan2012): New information reported from a contactable nurse includes: patient details, product details, lot numbers, medical history update, concomitant suspect vaccine update, event details resulting in a change in event from seizures to febrile seizure, treatment modalities and recovery status.
Age: 21.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Asthenia, Chills, Fatigue, Headache, Injection site pain
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. This 21-year-old female patient received a single dose of TRUMENBA via an unspecified route of administration on 03Mar2015 at 11 am as a meningococcal B outbreak was reported in the campus that the patient attended. No relevant medical history was present. Concomitant medications included on 100mg of ZOLOFT for generalised anxiety disorder from Mar2014 and ongoing. In the night of 03Mar2015 that patient experienced headache, fever, chills, pain at the site of injection, dizziness, with outcome recovered. Also the patient reported that she had some bruising from the vaccine and the bruises were not at the injection site, they were below on the arm. The discoloration was still there and it had been over 3 weeks since receiving the vaccine. No investigations were performed and no treatment was given for the reported events. Follow-up (24Mar2015): New information from a contactable consumer includes: new event bruising, outcome, concomitant medication, events nerve jerk pain and jaws achy were denied.
Age: 21.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Lymphadenopathy, Myalgia
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. This 21-year-old female patient received a single dose of TRUMENBA via an unspecified route of administration on 03Mar2015 at 11 am as a meningococcal B outbreak was reported in the campus that the patient attended. No relevant medical history was present. Concomitant medications included on 100mg of ZOLOFT for generalised anxiety disorder from Mar2014 and ongoing. In the night of 03Mar2015 that patient experienced headache, fever, chills, pain at the site of injection, dizziness, with outcome recovered. Also the patient reported that she had some bruising from the vaccine and the bruises were not at the injection site, they were below on the arm. The discoloration was still there and it had been over 3 weeks since receiving the vaccine. No investigations were performed and no treatment was given for the reported events. Follow-up (24Mar2015): New information from a contactable consumer includes: new event bruising, outcome, concomitant medication, events nerve jerk pain and jaws achy were denied.
Age: 21.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Chills, Contusion, Dizziness, Headache, Injection site pain
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. This 21-year-old female patient received a single dose of TRUMENBA via an unspecified route of administration on 03Mar2015 at 11 am as a meningococcal B outbreak was reported in the campus that the patient attended. No relevant medical history was present. Concomitant medications included on 100mg of ZOLOFT for generalised anxiety disorder from Mar2014 and ongoing. In the night of 03Mar2015 that patient experienced headache, fever, chills, pain at the site of injection, dizziness, with outcome recovered. Also the patient reported that she had some bruising from the vaccine and the bruises were not at the injection site, they were below on the arm. The discoloration was still there and it had been over 3 weeks since receiving the vaccine. No investigations were performed and no treatment was given for the reported events. Follow-up (24Mar2015): New information from a contactable consumer includes: new event bruising, outcome, concomitant medication, events nerve jerk pain and jaws achy were denied.
Age: 21.0
Sex: F
Vaccine: MENB, MENB
Symptoms: Pyrexia, Skin discolouration
Clinical narrative: This is a spontaneous report from a contactable consumer reporting for herself. This 21-year-old female patient received a single dose of TRUMENBA via an unspecified route of administration on 03Mar2015 at 11 am as a meningococcal B outbreak was reported in the campus that the patient attended. No relevant medical history was present. Concomitant medications included on 100mg of ZOLOFT for generalised anxiety disorder from Mar2014 and ongoing. In the night of 03Mar2015 that patient experienced headache, fever, chills, pain at the site of injection, dizziness, with outcome recovered. Also the patient reported that she had some bruising from the vaccine and the bruises were not at the injection site, they were below on the arm. The discoloration was still there and it had been over 3 weeks since receiving the vaccine. No investigations were performed and no treatment was given for the reported events. Follow-up (24Mar2015): New information from a contactable consumer includes: new event bruising, outcome, concomitant medication, events nerve jerk pain and jaws achy were denied.
Age: 28.0
Sex: F
Vaccine: UNK, MENB
Symptoms: Arthralgia, Blood culture negative, Chills, Fatigue, Full blood count normal
Clinical narrative: This is a spontaneous report from a non-clinical study program from a contactable physician assistant (other health care professional). A 28-year-old female patient received TRUMENBA, via an unspecified route of administration in the left deltoid, on 05Mar2015, at single dose. Relevant medical history included ongoing congenital bicornuate uterus, ongoing congenital absent R kidney, ongoing congential duplicate L ureter, ongoing asthma, ongoing bipolar disorder and ongoing migraines. Concomitant medications included NORCO from 05Mar2015 and 12Mar2015, for joint pain; TOPAMAX, from 05Mar2015, at 100 mg at bedtime; sumatriptan (unspecified trade name), from 05Mar2015, at 100 as needed; gabapentin (unspecified trade name), from 05Mar2015, at 300 mg 2x/day; CYMBALTA, from 05Mar2015, as needed; FLONASE, from 05Mar2015, as needed; PRO AIR, from 05Mar2015, as needed; IMPLANON IUD, from 05Mar2015. On unknown date the patient experienced pain at the site, fatigue, joint pain, fever, headache, chills, injection site pain, rash and rash turned out to be shingles. The outcome of the events was unknown. The reporter considered there was a reasonable possibility that the events were related to TRUMENBA, and mentioned that the patient will not receive the rest of series vaccinations with TRUMENBA. Follow-up (13Mar2015): New information received from the same contactable other health care professional includes: events updated. Follow-up (29Apr2015): new information received from a contactable other health care professional includes: events updated/added, indication updated, causality assessment, relevant medical history, concomitant medications.
Age: 28.0
Sex: F
Vaccine: UNK, MENB
Symptoms: Headache, Herpes zoster, Injection site pain, Metabolic function test, Pain of skin
Clinical narrative: This is a spontaneous report from a non-clinical study program from a contactable physician assistant (other health care professional). A 28-year-old female patient received TRUMENBA, via an unspecified route of administration in the left deltoid, on 05Mar2015, at single dose. Relevant medical history included ongoing congenital bicornuate uterus, ongoing congenital absent R kidney, ongoing congential duplicate L ureter, ongoing asthma, ongoing bipolar disorder and ongoing migraines. Concomitant medications included NORCO from 05Mar2015 and 12Mar2015, for joint pain; TOPAMAX, from 05Mar2015, at 100 mg at bedtime; sumatriptan (unspecified trade name), from 05Mar2015, at 100 as needed; gabapentin (unspecified trade name), from 05Mar2015, at 300 mg 2x/day; CYMBALTA, from 05Mar2015, as needed; FLONASE, from 05Mar2015, as needed; PRO AIR, from 05Mar2015, as needed; IMPLANON IUD, from 05Mar2015. On unknown date the patient experienced pain at the site, fatigue, joint pain, fever, headache, chills, injection site pain, rash and rash turned out to be shingles. The outcome of the events was unknown. The reporter considered there was a reasonable possibility that the events were related to TRUMENBA, and mentioned that the patient will not receive the rest of series vaccinations with TRUMENBA. Follow-up (13Mar2015): New information received from the same contactable other health care professional includes: events updated. Follow-up (29Apr2015): new information received from a contactable other health care professional includes: events updated/added, indication updated, causality assessment, relevant medical history, concomitant medications.
Age: 28.0
Sex: F
Vaccine: UNK, MENB
Symptoms: Rash erythematous, Red blood cell sedimentation rate normal, Tenderness
Clinical narrative: This is a spontaneous report from a non-clinical study program from a contactable physician assistant (other health care professional). A 28-year-old female patient received TRUMENBA, via an unspecified route of administration in the left deltoid, on 05Mar2015, at single dose. Relevant medical history included ongoing congenital bicornuate uterus, ongoing congenital absent R kidney, ongoing congential duplicate L ureter, ongoing asthma, ongoing bipolar disorder and ongoing migraines. Concomitant medications included NORCO from 05Mar2015 and 12Mar2015, for joint pain; TOPAMAX, from 05Mar2015, at 100 mg at bedtime; sumatriptan (unspecified trade name), from 05Mar2015, at 100 as needed; gabapentin (unspecified trade name), from 05Mar2015, at 300 mg 2x/day; CYMBALTA, from 05Mar2015, as needed; FLONASE, from 05Mar2015, as needed; PRO AIR, from 05Mar2015, as needed; IMPLANON IUD, from 05Mar2015. On unknown date the patient experienced pain at the site, fatigue, joint pain, fever, headache, chills, injection site pain, rash and rash turned out to be shingles. The outcome of the events was unknown. The reporter considered there was a reasonable possibility that the events were related to TRUMENBA, and mentioned that the patient will not receive the rest of series vaccinations with TRUMENBA. Follow-up (13Mar2015): New information received from the same contactable other health care professional includes: events updated. Follow-up (29Apr2015): new information received from a contactable other health care professional includes: events updated/added, indication updated, causality assessment, relevant medical history, concomitant medications.
Age: 28.0
Sex: F
Vaccine: UNK, MENB
Symptoms: Arthralgia, Chills, Fatigue, Headache, Herpes zoster
Clinical narrative: This is a spontaneous report from a non-clinical study program from a contactable physician assistant (other health care professional). A 28-year-old female patient received TRUMENBA, via an unspecified route of administration in the left deltoid, on 05Mar2015, at single dose. Relevant medical history included ongoing congenital bicornuate uterus, ongoing congenital absent R kidney, ongoing congential duplicate L ureter, ongoing asthma, ongoing bipolar disorder and ongoing migraines. Concomitant medications included NORCO from 05Mar2015 and 12Mar2015, for joint pain; TOPAMAX, from 05Mar2015, at 100 mg at bedtime; sumatriptan (unspecified trade name), from 05Mar2015, at 100 as needed; gabapentin (unspecified trade name), from 05Mar2015, at 300 mg 2x/day; CYMBALTA, from 05Mar2015, as needed; FLONASE, from 05Mar2015, as needed; PRO AIR, from 05Mar2015, as needed; IMPLANON IUD, from 05Mar2015. On unknown date the patient experienced pain at the site, fatigue, joint pain, fever, headache, chills, injection site pain, rash and rash turned out to be shingles. The outcome of the events was unknown. The reporter considered there was a reasonable possibility that the events were related to TRUMENBA, and mentioned that the patient will not receive the rest of series vaccinations with TRUMENBA. Follow-up (13Mar2015): New information received from the same contactable other health care professional includes: events updated. Follow-up (29Apr2015): new information received from a contactable other health care professional includes: events updated/added, indication updated, causality assessment, relevant medical history, concomitant medications.