chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 62.0
Sex: F
Vaccine: FLUX
Symptoms: Erythema of eyelid, Eyelid oedema, Eyelid pain, Hordeolum, Purulent discharge
Clinical narrative: Pain in lower right eyelid which developed to stye-like infection oozing pus. Treated with steroid & antibiotic eye ointment which I had from similar occurrence two years ago, again right after a flu shot. Had not connected the two at that time. Now a month later, there is still redness and some swelling in the lid, but it has improved with treatment.
Age: 12.0
Sex: M
Vaccine: FLUN4
Symptoms: Loss of consciousness, Nausea, Presyncope, Retching
Clinical narrative: Vasovagal reaction with some associated nausea and retching following intranasal influenza vaccine. Per parent's report, patient "passed out" while at the grocery store. No confirmed loss of consciousness. Symptoms resolved after a bowel movement.
Age: 17.0
Sex: M
Vaccine: FLU3, HEPA, MNQ
Symptoms: Off label use
Clinical narrative: Inadvertent administration of adult Hepatitis A to a 17 year old young man.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Injection site erythema, Injection site papule, Injection site vesicles, Local reaction
Clinical narrative: Local reaction: 26 x 20 cm erythematous, raised, well-circumscribed papule centered on the injection site.  Central vesicle 3 x 3 cm.  Systemic symptoms of fever (101.4F), myalgia and fatigue.  Seen in my office today 12/1/2014.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pyrexia
Clinical narrative: Local reaction: 26 x 20 cm erythematous, raised, well-circumscribed papule centered on the injection site.  Central vesicle 3 x 3 cm.  Systemic symptoms of fever (101.4F), myalgia and fatigue.  Seen in my office today 12/1/2014.
Age: 57.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth
Clinical narrative: Patient received vaccine Friday afternoon and was unmarked until Sunday morning and then noticed a swollen, red, warm mark about 4x6 inches in size around the injection site and she stated it was itchy.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Abdominal pain upper, Chills, Diarrhoea, Dizziness, Dyskinesia
Clinical narrative: Getting ready for bed, she told me that she felt dizzy and nauseated. She then said that she felt weird "all over." Her legs began to shake and then her whole body was shaking with chills. She jerked REALLY HARD and said that it felt like she had just fallen off of a building. I start to feel her legs and can immediately tell that she was running fever. While taking her temperature, under the arm, I can feel her heart "racing" hard and fast. She then starts to complain of a tummy ache. We go to the emergency room. When we get there I notice that her top lip and under her left eye started to swell. While laying in the hospital bed she says that her it was tight under her bra strap and it was getting kind of hard to breathe. Continued with 102.6 fever and vomiting and one episode of diarrhea. For the past couple of months she has complained of sensitive teeth.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Dyspnoea, Eyelid oedema, Feeling abnormal, Influenza, Lip swelling
Clinical narrative: Getting ready for bed, she told me that she felt dizzy and nauseated. She then said that she felt weird "all over." Her legs began to shake and then her whole body was shaking with chills. She jerked REALLY HARD and said that it felt like she had just fallen off of a building. I start to feel her legs and can immediately tell that she was running fever. While taking her temperature, under the arm, I can feel her heart "racing" hard and fast. She then starts to complain of a tummy ache. We go to the emergency room. When we get there I notice that her top lip and under her left eye started to swell. While laying in the hospital bed she says that her it was tight under her bra strap and it was getting kind of hard to breathe. Continued with 102.6 fever and vomiting and one episode of diarrhea. For the past couple of months she has complained of sensitive teeth.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Nausea, Palpitations, Pyrexia, Sensitivity of teeth, Tremor
Clinical narrative: Getting ready for bed, she told me that she felt dizzy and nauseated. She then said that she felt weird "all over." Her legs began to shake and then her whole body was shaking with chills. She jerked REALLY HARD and said that it felt like she had just fallen off of a building. I start to feel her legs and can immediately tell that she was running fever. While taking her temperature, under the arm, I can feel her heart "racing" hard and fast. She then starts to complain of a tummy ache. We go to the emergency room. When we get there I notice that her top lip and under her left eye started to swell. While laying in the hospital bed she says that her it was tight under her bra strap and it was getting kind of hard to breathe. Continued with 102.6 fever and vomiting and one episode of diarrhea. For the past couple of months she has complained of sensitive teeth.
Age: 13.0
Sex: F
Vaccine: HPV4
Symptoms: Vomiting
Clinical narrative: Getting ready for bed, she told me that she felt dizzy and nauseated. She then said that she felt weird "all over." Her legs began to shake and then her whole body was shaking with chills. She jerked REALLY HARD and said that it felt like she had just fallen off of a building. I start to feel her legs and can immediately tell that she was running fever. While taking her temperature, under the arm, I can feel her heart "racing" hard and fast. She then starts to complain of a tummy ache. We go to the emergency room. When we get there I notice that her top lip and under her left eye started to swell. While laying in the hospital bed she says that her it was tight under her bra strap and it was getting kind of hard to breathe. Continued with 102.6 fever and vomiting and one episode of diarrhea. For the past couple of months she has complained of sensitive teeth.
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Muscular weakness, Musculoskeletal discomfort
Clinical narrative: Reports a  few hours after receiving the flu shot noted pain in the joint. Rated the pain at a level of 6 (six) on a scale of 1-10 where 10 is the worst pain. Took Tylenol and took Ibuprofen a few hours after that. Reported medication helped but reported she experienced more weakness in her arm. Reported has an appointment to see MD on 12/02/2014.  Reported pain comes and goes.  Reports disconfort in the joint - points to shoulder joint in upper arm. Reports sometimes experiences weakness in hand.
Age: 1.02
Sex: M
Vaccine: VARCEL
Symptoms: Herpes zoster, Polymerase chain reaction, Varicella virus test positive
Clinical narrative: Shingles in T1 dermatome on left side.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Injection site bruising, Injection site erythema, Injection site mass, Injection site pain
Clinical narrative: First noticed soreness, which progressed into signs of erythema with a lump above injection site with small bruise at injection site. Much redness with some swelling. Redness spread down the backside of the upper arm.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site swelling
Clinical narrative: First noticed soreness, which progressed into signs of erythema with a lump above injection site with small bruise at injection site. Much redness with some swelling. Redness spread down the backside of the upper arm.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site mass, Injection site nodule, Injection site reaction
Clinical narrative: First noticed soreness, which progressed into signs of erythema with a lump above injection site with small bruise at injection site. Much redness with some swelling. Redness spread down the backside of the upper arm.
Age: 61.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site warmth, Rash vesicular
Clinical narrative: First noticed soreness, which progressed into signs of erythema with a lump above injection site with small bruise at injection site. Much redness with some swelling. Redness spread down the backside of the upper arm.
Age: 0.61
Sex: F
Vaccine: DTAPHEPBIP, FLU4, PNC13, RV5
Symptoms: Electroencephalogram normal, Eye movement disorder, Nuclear magnetic resonance imaging normal, Posture abnormal, Tonic clonic movements
Clinical narrative: Patient abducted left arm up above head, turned head to left with eyes to left deviation, and start shaking in a tonic clonic fashion.  The entire episode lasted about 2 minutes.
Age: 55.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: No date or time onset for adverse reaction. Under-dose or possible second dose was given. Vaccination error.
Age: 43.0
Sex: F
Vaccine: FLUX
Symptoms: Injected limb mobility decreased, Injection site pain, Pain
Clinical narrative: Pain in left shoulder at injection site.  Pain with some movements of left arm limited some movements.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: No date or time onset for adverse reaction. Under-dose or possible second dose was given. Vaccination error.
Age: 35.0
Sex: F
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: No date or time onset for adverse reaction. Under-dose or possible second dose was given. Vaccination error.
Age: 44.0
Sex: M
Vaccine: FLU3
Symptoms: Unevaluable event
Clinical narrative: No date or time onset for adverse reaction. Under-dose or possible second dose was given. Vaccination error.
Age: 41.0
Sex: M
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Musculoskeletal pain
Clinical narrative: Soreness in upper shoulder.
Age: 65.0
Sex: M
Vaccine: PNC
Symptoms: Injection site pain, Injection site pustule, Injection site swelling, Injection site warmth
Clinical narrative: Noticed injection site sore, swollen about 3CM and raised in center.  By 12/01/2014 it looks like a smallpox vaccination with raised pustular area in center, but margins reduced to about 2cm.  No fever except at site.
Age: 59.0
Sex: M
Vaccine: PPV
Symptoms: Pain, Pyrexia
Clinical narrative: Body aches.  Moderate fever though out the night and next day.
Age: 64.0
Sex: M
Vaccine: TDAP
Symptoms: Headache
Clinical narrative: Donor states he developed a slight headache 45 minutes after vaccine. Headache resolved on its own in approximately 2 hours. Donor denies any other symptoms. Donor states it did not effect and daily activities.
Age: 77.0
Sex: M
Vaccine: FLUX
Symptoms: Joint swelling, Local swelling, Mobility decreased
Clinical narrative: Bilaterally swelling of ankle and subsequently the lower legs. This was accompanied by difficulty climbing stairs--for the first two steps, his foot doesn't begin the movement correctly, but once he gets going, he's fine. Also difficult to raise foot high (est. 45-60 deg. hip flexion). No prior episodes of this condition. Note that date of vaccine is approx., per patient "three weeks ago" on 12/01/2014. Accordingly, onset of adverse event is also approximate, per patient, "two days after flu shot," problem began.
Age: 1.28
Sex: M
Vaccine: DTAP, MMRV
Symptoms: Diarrhoea, Injection site erythema, Injection site swelling, Pyrexia, Rash
Clinical narrative: Fever, unknown temperature 11/28/14-11/30/14. Red bump size of pea on right leg beginning 11/28/14. Rash on abdomen described as little bumps starting 11/30/14. Loose stools beginning 12/1/14.
Age: 83.0
Sex: M
Vaccine: VARZOS
Symptoms: Bundle branch block right, Cardiac pacemaker insertion, Dyspnoea, Fall, Loss of consciousness
Clinical narrative: Became short of breath on both Saturday and Sunday.  On Monday, 11/24/2014, blacked-out and fell.  Sent to hospital by ambulance where it was eventually determined that I had Right Bundle Branch Block, and a Pacemaker was installed.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthropathy, Cough, Headache, Neck pain, Nuclear magnetic resonance imaging brain
Clinical narrative: Extreme & Acute Head & Neck Pain. Thumb knuckle would not perform properly (continuous pain and swelling). A lot of very deep coughing. All beginning within 2 days of side effect onset.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Peripheral swelling, X-ray limb
Clinical narrative: Extreme & Acute Head & Neck Pain. Thumb knuckle would not perform properly (continuous pain and swelling). A lot of very deep coughing. All beginning within 2 days of side effect onset.
Age: 64.0
Sex: F
Vaccine: FLU3, VARZOS
Symptoms: Arthralgia, Dermatitis acneiform, Pelvic pain
Clinical narrative: Patient state experience rash and pain on from hip to pelvic area.  Patient state she visited her physician and the doctor put her on Acyclovir 1 gram three times daily to treat the symptoms.
Age: 47.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Left index finger pain, persistent.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Diarrhoea, Fatigue, Influenza like illness, Oropharyngeal pain, Pain
Clinical narrative: Sore throat; sneezing; tiredness; aching; diarrhea - all the symptoms of influenza. Symptoms are still ongoing.
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Sneezing
Clinical narrative: Sore throat; sneezing; tiredness; aching; diarrhea - all the symptoms of influenza. Symptoms are still ongoing.
Age: 50.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis, Injection site erythema, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: Patient developed low grade fever and swelling, erythema and warmth at the injection site. Swelling progressed to about 12 cm area, then began decreasing in size.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Activities of daily living impaired, Chills, Diarrhoea, Malaise, Nasal congestion
Clinical narrative: Local swelling in right upper extremity at site of vaccination.  Pt had associated nasal drainage/congestion, chills, fever and malaise.  Reported diarrhea also.  She missed work due to symptoms.  Did not feel otherwise like she had another illness prior to vaccination.
Age: 51.0
Sex: F
Vaccine: TDAP
Symptoms: Pyrexia, Rhinorrhoea, Vaccination site swelling
Clinical narrative: Local swelling in right upper extremity at site of vaccination.  Pt had associated nasal drainage/congestion, chills, fever and malaise.  Reported diarrhea also.  She missed work due to symptoms.  Did not feel otherwise like she had another illness prior to vaccination.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Immediate post-injection reaction, Injected limb mobility decreased, Injection site inflammation, Injection site pain
Clinical narrative: The vaccination with Prevnar 13 was administered by the Pharmacist.  I do not know her name.  The vaccination was painful at the site of injection immediately.  The deltoid muscles was inflamed at the site of the injection.  Waking up the next day I stated to my wife that my entire left shoulder hurt.  Movement of the left glenohumeral joint and left rotator cuff elicited sharp arthritic-type pains deep in the shoulder joint.  As time progressed over the few days and then weeks the I was unable to move my left arm with experiencing sharp pains radiating from the joint down my arm along the radius and ulna muscle mass.  Any movement of my left shoulder continues to be quite painful.  Pain also remains at the site of injection and has never lessened.  I have taken non-steroidal anti-inflammatory drugs to combat the shoulder pain and stiffness.  They have not lessened the pain or stiffness.
Age: 69.0
Sex: M
Vaccine: PNC13
Symptoms: Muscle mass, Musculoskeletal pain, Musculoskeletal stiffness, Pain
Clinical narrative: The vaccination with Prevnar 13 was administered by the Pharmacist.  I do not know her name.  The vaccination was painful at the site of injection immediately.  The deltoid muscles was inflamed at the site of the injection.  Waking up the next day I stated to my wife that my entire left shoulder hurt.  Movement of the left glenohumeral joint and left rotator cuff elicited sharp arthritic-type pains deep in the shoulder joint.  As time progressed over the few days and then weeks the I was unable to move my left arm with experiencing sharp pains radiating from the joint down my arm along the radius and ulna muscle mass.  Any movement of my left shoulder continues to be quite painful.  Pain also remains at the site of injection and has never lessened.  I have taken non-steroidal anti-inflammatory drugs to combat the shoulder pain and stiffness.  They have not lessened the pain or stiffness.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Headache, Injection site erythema, Injection site inflammation
Clinical narrative: Pain in joints, pain in muscles, headache, tired, continued for five days, then on 11/24/2014, the sixth day after, the injection site became inflamed with itching and swelling.  The injection site problems are just now easing somewhat on 12/01/2014, but it is still red, swollen and itching.  This area on my left arm is about two inches by three inches.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pruritus, Injection site swelling, Myalgia
Clinical narrative: Pain in joints, pain in muscles, headache, tired, continued for five days, then on 11/24/2014, the sixth day after, the injection site became inflamed with itching and swelling.  The injection site problems are just now easing somewhat on 12/01/2014, but it is still red, swollen and itching.  This area on my left arm is about two inches by three inches.
Age: 10.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Chest X-ray, Convulsion, Drug screen, Fatigue, Full blood count
Clinical narrative: Patient had a seizure lasted for about 30 seconds in the waiting room about 3-5 minutes after getting Fluvirin flu shot. No Epipen was required. Was lucid (was able to tell location and time) about 1 minutes afterwards, was tired. Paramedics came about 6:05 PM. Paramedics, pt, and family left about 6:20 PM for hospital observations. Per mom, patient was discharged that same Saturday night.
Age: 10.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Urine analysis
Clinical narrative: Patient had a seizure lasted for about 30 seconds in the waiting room about 3-5 minutes after getting Fluvirin flu shot. No Epipen was required. Was lucid (was able to tell location and time) about 1 minutes afterwards, was tired. Paramedics came about 6:05 PM. Paramedics, pt, and family left about 6:20 PM for hospital observations. Per mom, patient was discharged that same Saturday night.
Age: 10.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Blood test, Grand mal convulsion, Headache, Injection site pain, Pain in extremity
Clinical narrative: Patient had a seizure lasted for about 30 seconds in the waiting room about 3-5 minutes after getting Fluvirin flu shot. No Epipen was required. Was lucid (was able to tell location and time) about 1 minutes afterwards, was tired. Paramedics came about 6:05 PM. Paramedics, pt, and family left about 6:20 PM for hospital observations. Per mom, patient was discharged that same Saturday night.
Age: 10.0
Sex: M
Vaccine: FLU3, FLU3
Symptoms: Pyrexia
Clinical narrative: Patient had a seizure lasted for about 30 seconds in the waiting room about 3-5 minutes after getting Fluvirin flu shot. No Epipen was required. Was lucid (was able to tell location and time) about 1 minutes afterwards, was tired. Paramedics came about 6:05 PM. Paramedics, pt, and family left about 6:20 PM for hospital observations. Per mom, patient was discharged that same Saturday night.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Generalised erythema, Pruritus generalised, Rash, Rash erythematous, Rash pruritic
Clinical narrative: Case number PHEH2014US022857 is a combined initial and follow up spontaneous report received from the health care professional (also the patient) on 13 Nov 2014 and on 18 Nov 2014. This report refers to a 55-year-old female patient. She was allergic to many things, including sulfites, tannins and nitrates. She was vaccinated with FLUVIRIN (batch number: not reported) via subcutaneous route on 12 Nov 2014 around 01:00 pm. On the same date, within an hour her nose started draining and this continued all day and evening and was still running. At 09:00 pm, she had itching on her underarms and upon examination, the area was red. By 11 pm, the redness and itching had expanded from the underarm to the chest, to the groin area and wrists, which were also itching and it expanded to her neck and to her waist. She put cortisone cream on all the red skin and took 3 ADVIL, Albuterol and also CLARITIN 24 hour. All the red areas were very hot. By 01:00 am, most of her torso was red, swollen and itchy and it spread to her back anywhere, there was restrictive clothing and her necklace. She stayed awake because she was very concerned because of the itchiness and burning. She forgot to add the patches for itching, and redness also showed up on the bends of her elbows and the top of her ankles. By 03:00 am, all the red spot had increased to a very deep red and very hot. Her torso was very hot. She applied even more cortisone cream to all the red areas and even to unaffected skin because it kept spreading. She used an entire one ounce tube of cortisone cream. Some of the heat had gone away so she went to sleep. Then she woke up at 06:00 am, the redness, heat and swelling on the torso and neck had disappeared but there were red skin and bumps on her upper thighs, button and back of thighs. On 13 Nov 2014, she took Albuterol inhaler because she was so congested. The rash resolved on the same date, but she experienced another episode of rash after dinner. It was even worse than the day before with hives all over her body. She did not experience any respiratory symptoms either time. She had not seen a doctor and was planning to make an appointment with an allergist. The outcome of the events hives and pruritic rash were not reported. The outcome of the other events reported as improving. The events reported as non-serious. The causality of the events was not reported. Seriousness assessment of the event (hives all over the body) was upgraded based on the available information in the source document.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Respiratory tract congestion, Rhinorrhoea, Skin burning sensation, Skin warm, Sleep disorder
Clinical narrative: Case number PHEH2014US022857 is a combined initial and follow up spontaneous report received from the health care professional (also the patient) on 13 Nov 2014 and on 18 Nov 2014. This report refers to a 55-year-old female patient. She was allergic to many things, including sulfites, tannins and nitrates. She was vaccinated with FLUVIRIN (batch number: not reported) via subcutaneous route on 12 Nov 2014 around 01:00 pm. On the same date, within an hour her nose started draining and this continued all day and evening and was still running. At 09:00 pm, she had itching on her underarms and upon examination, the area was red. By 11 pm, the redness and itching had expanded from the underarm to the chest, to the groin area and wrists, which were also itching and it expanded to her neck and to her waist. She put cortisone cream on all the red skin and took 3 ADVIL, Albuterol and also CLARITIN 24 hour. All the red areas were very hot. By 01:00 am, most of her torso was red, swollen and itchy and it spread to her back anywhere, there was restrictive clothing and her necklace. She stayed awake because she was very concerned because of the itchiness and burning. She forgot to add the patches for itching, and redness also showed up on the bends of her elbows and the top of her ankles. By 03:00 am, all the red spot had increased to a very deep red and very hot. Her torso was very hot. She applied even more cortisone cream to all the red areas and even to unaffected skin because it kept spreading. She used an entire one ounce tube of cortisone cream. Some of the heat had gone away so she went to sleep. Then she woke up at 06:00 am, the redness, heat and swelling on the torso and neck had disappeared but there were red skin and bumps on her upper thighs, button and back of thighs. On 13 Nov 2014, she took Albuterol inhaler because she was so congested. The rash resolved on the same date, but she experienced another episode of rash after dinner. It was even worse than the day before with hives all over her body. She did not experience any respiratory symptoms either time. She had not seen a doctor and was planning to make an appointment with an allergist. The outcome of the events hives and pruritic rash were not reported. The outcome of the other events reported as improving. The events reported as non-serious. The causality of the events was not reported. Seriousness assessment of the event (hives all over the body) was upgraded based on the available information in the source document.
Age: 55.0
Sex: F
Vaccine: FLU3
Symptoms: Swelling, Urticaria
Clinical narrative: Case number PHEH2014US022857 is a combined initial and follow up spontaneous report received from the health care professional (also the patient) on 13 Nov 2014 and on 18 Nov 2014. This report refers to a 55-year-old female patient. She was allergic to many things, including sulfites, tannins and nitrates. She was vaccinated with FLUVIRIN (batch number: not reported) via subcutaneous route on 12 Nov 2014 around 01:00 pm. On the same date, within an hour her nose started draining and this continued all day and evening and was still running. At 09:00 pm, she had itching on her underarms and upon examination, the area was red. By 11 pm, the redness and itching had expanded from the underarm to the chest, to the groin area and wrists, which were also itching and it expanded to her neck and to her waist. She put cortisone cream on all the red skin and took 3 ADVIL, Albuterol and also CLARITIN 24 hour. All the red areas were very hot. By 01:00 am, most of her torso was red, swollen and itchy and it spread to her back anywhere, there was restrictive clothing and her necklace. She stayed awake because she was very concerned because of the itchiness and burning. She forgot to add the patches for itching, and redness also showed up on the bends of her elbows and the top of her ankles. By 03:00 am, all the red spot had increased to a very deep red and very hot. Her torso was very hot. She applied even more cortisone cream to all the red areas and even to unaffected skin because it kept spreading. She used an entire one ounce tube of cortisone cream. Some of the heat had gone away so she went to sleep. Then she woke up at 06:00 am, the redness, heat and swelling on the torso and neck had disappeared but there were red skin and bumps on her upper thighs, button and back of thighs. On 13 Nov 2014, she took Albuterol inhaler because she was so congested. The rash resolved on the same date, but she experienced another episode of rash after dinner. It was even worse than the day before with hives all over her body. She did not experience any respiratory symptoms either time. She had not seen a doctor and was planning to make an appointment with an allergist. The outcome of the events hives and pruritic rash were not reported. The outcome of the other events reported as improving. The events reported as non-serious. The causality of the events was not reported. Seriousness assessment of the event (hives all over the body) was upgraded based on the available information in the source document.
Age: 36.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Case number PHEH2014US023177, is an initial spontaneous report received from a physician assistant on 17 Nov 2014. This report refers to 36 year old female patient. Her medical history and concomitant medication was not reported. She was vaccinated with FLUVIRIN (batch number: 14511P) intramuscular on 03 Nov 2014. On the same day post vaccination later that evening she developed pain in the arm at the injection site. Pain fluctuating in intensity (sometimes severe) and was persisted since that time. She described the pain as a level 10 pain at times. Outcome of the event was unknown. Seriousness and causality assessment was not reported. Seriousness assessment of pain at the site was upgraded based on information available in the source documents.
Age: 1.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13
Symptoms: Autopsy, Death, Inappropriate schedule of drug administration
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of death in sleep in a 18-month-old female patient who received PEDIARIX. Co-suspect products included PEDVAXHIB and PREVNAR. Previously administered products included PEDIARIX (at age of 2 months, which went uncomplicated) and PEDIARIX (at age of 4 months, which went uncomplicated). On 18th November 2014, the patient received the 3rd dose of PEDIARIX .5 ml, PEDVAXHIB and PREVNAR. On 18th November 2014, less than a day after receiving PEDIARIX, the patient experienced death in sleep (serious criteria death and GSK medically significant). On an unknown date, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the death in sleep was fatal and the outcome of the drug dose administration interval too long was unknown. The patient died on 18th November 2014. An autopsy was performed. It was unknown if the reporter considered the death in sleep to be related to PEDIARIX. Additional details were provided: It was unknown if the patient had concomitant medication or relevant medical history. All previous vaccinations went uncomplicated. It was unknown if the subject was hospitalized. The patient died at home. On 18 November 2014, the patient was vaccinated during the office hours, that evening she died and never woke up from a nap. The physician was waiting for an autopsy report which has not yet been completed. The physician reported that the parents requested a delayed dosing schedule: the 3rd dose be given at 18 months, rather than 6 months. The physician was available to contact.
Age: 1.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13
Symptoms: Autopsy, Death
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of death in sleep in a 18-month-old female patient who received PEDIARIX. Co-suspect products included PEDVAXHIB and PREVNAR. Previously administered products included PEDIARIX (at age of 2 months, which went uncomplicated) and PEDIARIX (at age of 4 months, which went uncomplicated). On 18th November 2014, the patient received the 3rd dose of PEDIARIX .5 ml, PEDVAXHIB and PREVNAR. On 18th November 2014, less than a day after receiving PEDIARIX, the patient experienced death in sleep (serious criteria death and GSK medically significant). On an unknown date, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the death in sleep was fatal and the outcome of the drug dose administration interval too long was unknown. The patient died on 18th November 2014. An autopsy was performed. It was unknown if the reporter considered the death in sleep to be related to PEDIARIX. Additional details were provided: It was unknown if the patient had concomitant medication or relevant medical history. All previous vaccinations went uncomplicated. It was unknown if the subject was hospitalized. The patient died at home. On 18 November 2014, the patient was vaccinated during the office hours, that evening she died and never woke up from a nap. The physician was waiting for an autopsy report which has not yet been completed. The physician reported that the parents requested a delayed dosing schedule: the 3rd dose be given at 18 months, rather than 6 months. The physician was available to contact.
Age: 1.5
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13
Symptoms: Death
Clinical narrative: This case was reported by a physician via call center representative and described the occurrence of death in sleep in a 18-month-old female patient who received PEDIARIX. Co-suspect products included PEDVAXHIB and PREVNAR. Previously administered products included PEDIARIX (at age of 2 months, which went uncomplicated) and PEDIARIX (at age of 4 months, which went uncomplicated). On 18th November 2014, the patient received the 3rd dose of PEDIARIX .5 ml, PEDVAXHIB and PREVNAR. On 18th November 2014, less than a day after receiving PEDIARIX, the patient experienced death in sleep (serious criteria death and GSK medically significant). On an unknown date, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the death in sleep was fatal and the outcome of the drug dose administration interval too long was unknown. The patient died on 18th November 2014. An autopsy was performed. It was unknown if the reporter considered the death in sleep to be related to PEDIARIX. Additional details were provided: It was unknown if the patient had concomitant medication or relevant medical history. All previous vaccinations went uncomplicated. It was unknown if the subject was hospitalized. The patient died at home. On 18 November 2014, the patient was vaccinated during the office hours, that evening she died and never woke up from a nap. The physician was waiting for an autopsy report which has not yet been completed. The physician reported that the parents requested a delayed dosing schedule: the 3rd dose be given at 18 months, rather than 6 months. The physician was available to contact.
Age: 1.31
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13
Symptoms: Autopsy, Death, Inappropriate schedule of drug administration
Clinical narrative: Patient deceased.
Age: 1.31
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13
Symptoms: Autopsy, Death
Clinical narrative: Patient deceased.
Age: 1.31
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13, DTAPHEPBIP, HIBV, PNC13
Symptoms: Death
Clinical narrative: Patient deceased.
Sex: M
Vaccine: VARZOS
Symptoms: Cerebrovascular accident, Cerebrovascular disorder, Death
Clinical narrative: This 73-year-old male subject was enrolled in a study. On 9th December 2013, the subject received the 2nd dose of Zoster VZV-gE-AS01B(intramuscular). On 8th October 2013, the subject received the 1st dose of Flu Seasonal QIV Dresden (intramuscular). The subject's past medical history included hyperlipidemia and hypertension. Concomitant products included Aspirin, atorvastatin, lisinopril and hydrochlorothiazide and metoprolol. On 10th March 2014, 91 days after receiving Zoster VZV-gE-AS01B and 153 days after receiving Flu Seasonal QIV Dresden the subject developed severe - grade 3 cerebrovascular event. Serious criteria included death. The outcome of cerebrovascular event was fatal on 10th March 2014. The subject died on 10th March 2014. The reported cause of death was cerebrovascular disorder. An autopsy was not performed. The investigator considered that there was a reasonable possibility that the cerebrovascular event may have been caused by Zoster VZV-gE-AS01B and Flu Seasonal QIV Dresden. Investigator comments: Hospital medical records requested. Death certificate indicates immediate cause of death to be cerebrovascular accident occurring on 10/MAR/2014 with no specific time indicated (under 1 day) due to or as a consequence of hypertension. No autopsy was performed. Patient has history of hypertension and hyperlipidemia since 2000 and was receiving therapy for both conditions.
Age: 16.0
Sex: M
Vaccine: HEPA
Symptoms: Cardiac disorder, Chest pain, Inappropriate schedule of drug administration, Malaise, Pericarditis
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of pain in chest in a 16-year-old male patient who received HAVRIX (batch number A7HC5, expiry date 13th August 2016). Previously administered products included GARDASIL with an associated reaction of influenza like illness (and a bad virus afterwards) and HAVRIX (1st dose, lot number N434L, expiry date 19 February 2016). Concurrent medical conditions included asthma, attention deficit disorder, diabetes and overweight. Concomitant products included NOVOLOG, ADDERALL, albuterol and LEVEMIR. On 21st August 2014, the patient received the 2nd dose of HAVRIX .5 ml. On 21st August 2014, an unknown time after receiving HAVRIX, the patient experienced drug dose administration interval too short. On 1st September 2014, the patient experienced pain in chest (serious criteria hospitalization and life threatening), heart issue (serious criteria hospitalization) and felt sick. On 5th September 2014, the patient experienced pericarditis (serious criteria hospitalization and GSK medically significant). The patient was treated with steroids nos. On an unknown date, the outcome of the pain in chest, pericarditis and felt sick were recovered/resolved and the outcome of the heart issue and drug dose administration interval too short were unknown. It was not reported if the reporter considered the pain in chest, pericarditis, heart issue and felt sick to be related to HAVRIX. Additional details were provided: The patient received medical attention at Inpatient hospital. The patient had a family medical history of heart problems and the patient's brother has diabetes too.
Age: 65.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Influenza like illness, Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Flu-like symptoms for 48h after vaccination. Arm pain at site of injection with erythema and swelling. Remains painful to touch at 6d after injections. Flu and PNEUMOVAX given concurrently.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Drug administered at inappropriate site, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: Arm felt stiff and immobile after the shot. Patient tried TYLENOL and Ibuprofen. Still not able to move arm after 2 weeks. She felt as though the shot was given too high up near the shoulder.
Age: 71.0
Sex: M
Vaccine: FLUC3
Symptoms: Infective tenosynovitis
Clinical narrative: Customer states that a tendon became infected, resulting in cortisone injections.
Age: 0.53
Sex: M
Vaccine: FLU3, HIBV, RV5
Symptoms: Inappropriate schedule of drug administration
Clinical narrative: None.
Age: 0.49
Sex: U
Vaccine: RV5, HEP
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse concerning a 5 months old patient of unknown gender who on 22-OCT-2014 was vaccinated with ROTATEQ (lot # J014868, expiration date 13-OCT-2015), oral (dose not reported). The vaccine was reported to have temperature excursions from 10-SEP-2014 to 12-SEP-2014. No adverse reports. This is one of several reports from the same source. Additional information is not expected because all follow ups requested to complete the case were received.
Age: 0.17
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse concerning a 8 weeks old patient of unknown gender who on 07-OCT-2014 was vaccinated with ROTATEQ (lot # J014868, expiration date 13-OCT-2015), oral (dose not reported). The vaccine was reported to have temperature excursions from 10-SEP-2014 to 12-SEP-2014. No adverse reports. This is one of several reports from the same source. Additional information is not expected because all follow ups requested to complete the case were received.
Sex: U
Vaccine: HPV4, PPV, RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a nurse concerning unspecified patients (age and gender not provided). The nurse reported that since 25SEP2014 improperly stored PNEUMOVAX, ROTATEQ and GARDASIL were administered to unspecified patients. No adverse effects were noted. No additional information was provided. Additional information is expected.
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: This spontaneous report was received from a nurse refers to an unspecified number of patients of unknown age and gender. Medical history was not reported. On an unknown date in November 2014 the patients were vaccinated with doses of ROTATEQ (strength, dosage, route, lot number and expiration date were not reported), that were exposed to a supported temperature excursion since 05-NOV-2014. No adverse effects were reported. This is one of several cases received from the same reporter. Additional information has been requested.
Age: 0.51
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse concerning a 6 months old patient of unknown gender who on 20-OCT-2014 was vaccinated with ROTATEQ (lot # J014868, expiration date 13-OCT-2015), oral (dose not reported). The vaccine was reported to have temperature excursions from 10-SEP-2014 to 12-SEP-2014. No adverse reports. This is one of several reports from the same source. Additional information is not expected because all follow ups requested to complete the case were received.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Blood creatine phosphokinase normal, Full blood count normal, Induration, Injection site pain, Injection site swelling
Clinical narrative: Received flu vacc on 9-8-2014. (First ever) soon after had swelling and severe pain in the (L) deltoid triceps muscle at injection site. Indurated soft tissue is still tender and worsening severe pain. Referred to P.T.
Age: 34.0
Sex: F
Vaccine: FLU3
Symptoms: Laboratory test, Nuclear magnetic resonance imaging abnormal, Red blood cell sedimentation rate normal, Tenderness
Clinical narrative: Received flu vacc on 9-8-2014. (First ever) soon after had swelling and severe pain in the (L) deltoid triceps muscle at injection site. Indurated soft tissue is still tender and worsening severe pain. Referred to P.T.
Age: 78.0
Sex: M
Vaccine: FLU3
Symptoms: Abasia, Swelling
Clinical narrative: Swelling in the area, also cannot walk, after 2 weeks of vaccine.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Borrelia test negative, Chest X-ray normal, Chest pain, Dizziness, Fatigue
Clinical narrative: Evening of flu vaccine - stuffy nose. Next day nasal congestion, overall body aches, tired, lightheaded. Approx 1 week later noted left sided chest pain. 11/20 saw Occupational Med MD - numerous tests including CXR. 11/25 follow up appt at Occ Med - to follow up and have Echo stress tests scheduled for 12/12/14.
Age: 51.0
Sex: F
Vaccine: FLU3
Symptoms: Full blood count normal, Hepatic enzyme, Nasal congestion, Pain
Clinical narrative: Evening of flu vaccine - stuffy nose. Next day nasal congestion, overall body aches, tired, lightheaded. Approx 1 week later noted left sided chest pain. 11/20 saw Occupational Med MD - numerous tests including CXR. 11/25 follow up appt at Occ Med - to follow up and have Echo stress tests scheduled for 12/12/14.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Insomnia, Mobility decreased, Pain in extremity, Paraesthesia
Clinical narrative: Immediate pain in arm. Still having pain, can not lift arm above shoulder level, tingling in hand. Pain from shoulder to elbow. Can't sleep at night from pain.
Age: 0.53
Sex: U
Vaccine: RV5
Symptoms: Incorrect product storage, No adverse event
Clinical narrative: Information has been received from a licensed practical nurse concerning a 6 months old patient of unknown gender who on 08-OCT-2014 was vaccinated with ROTATEQ (lot # J014868 expiration date 13-OCT-2015), oral (dose not reported). The vaccine was reported to have temperature excursions from 10-SEP-2014 to 12-SEP-2014. No adverse reports. This is one of several reports from the same source. Additional information is not expected because all follow ups requested to complete the case were received.
Age: 21.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Pain in extremity
Clinical narrative: Felt like vaccine hurt more than normal upon administration. Pinching (L) arm with movement continues. Pain varies from 3-6 on 1-10 scale. No redness/swelling or fever. Declines appointment in student health services.
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal pain, Pain in extremity
Clinical narrative: This case was reported by a other health professional and described the occurrence of pain in arm in a adult female patient who received FLUARIX QUADRIVALENT (batch number 7LE2S, expiry date 30th June 2015). On 4th September 2014 14:00, the patient received FLUARIX QUADRIVALENT. On an unknown date, less than a month after receiving FLUARIX QUADRIVALENT, the patient experienced pain in arm and pain in shoulder. On an unknown date, the outcome of the pain in arm and pain in shoulder were unknown. The reporter considered the pain in arm and pain in shoulder to be probably related to FLUARIX QUADRIVALENT. Additional information received on 06 October 2014: The caller was a nursing student. Her nursing class received FLUARIX QUADRIVALENT vaccine on the same day about a month ago. A few of them experienced side effects subsequent to the vaccine.
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal stiffness, Pain in extremity
Clinical narrative: This case was reported by a other health professional and described the occurrence of stiffness in arm in a adult female patient who received FLUARIX QUADRIVALENT (batch number 7LE2S, expiry date 30th June 2015). On 4th September 2014 14:00, the patient received FLUARIX QUADRIVALENT. On 4th September 2014, less than a day after receiving FLUARIX QUADRIVALENT, the patient experienced stiffness in arm and mild pain in injected limb. On an unknown date, the outcome of the stiffness in arm and mild pain in injected limb were recovered/resolved. The reporter considered the stiffness in arm and mild pain in injected limb to be probably related to FLUARIX QUADRIVALENT. Additional information received on 06 October 2014: The caller was a nursing student. Her nursing class received Flu Vaccines about a month ago. They received the vaccines on the same day. This patient experienced side effects (stiffness and mild pain in the affected arm) subsequent to the vaccine. The nursing student reported that this patient pain has alleviated quite a bit. When she first received the vaccine she had some pain, then the pain alleviated a bit for a few days, and then it got worse, and now the pain is mostly better about a week and a half later. The caller reported that this patient gave herself some physical therapy (moved her arm around a bit) and the patient reported to her that the pain went away after this self-therapy.
Age: 88.0
Sex: F
Vaccine: FLU3
Symptoms: Cold sweat, Drooling, Somnolence, Unresponsive to stimuli
Clinical narrative: Patient was drowsy, unresponsive but breathing, O2 sat 97-98% on r/a. Drooling. BP dropped from 140.86 to 90/60. Skin felt clammy. After about 10 mins-15 mins paramedics arrived. Patient was responsive and talking. BP went back up. Patient escorted to ER w/paramedics.
Age: 21.0
Sex: M
Vaccine: FLUX
Symptoms: Influenza
Clinical narrative: Initial unsolicited report was received from a consumer who is also the patient on 19 November 2014. A 21 year-old male patient had received on an unspecified date an Influenza vaccine (manufacturer, lot number and administration details not reported) and an unspecified amount of time later, experienced the flu and was in bed for two weeks. No further information was available at the time of the event. Outcome was unknown. Documents held by sender: none.
Age: 71.0
Sex: F
Vaccine: FLU4
Symptoms: Pain
Clinical narrative: Received vaccine on 10/30/14 in (R) deltoid. Began to experience significant pain 5 days later. Patient complains of significant pain when moving/using her (R) arm. Situation has not improved as of today's date.
Age: 48.0
Sex: U
Vaccine: FLU3
Symptoms: Arthralgia, C-reactive protein normal, Injection site induration, Injection site macule, Injection site warmth
Clinical narrative: 4.75 x 5 indurated, warm macule left deltoid on 11/4/14 after flu vacc on 11/3/14 in left deltoid. Went to ED 11/25/14 with severe arthralgias and dx'd with poss serum rxn, which improved with steroid taper.