chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 31.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Unusually stiff and sore at injection site (left shoulder) shortly after injection; felt like shoulder had received a very strong punch unlike other years' flu injections. The stiffness and soreness then spread to the forearm (left) and hand starting at 4:30 pm (90 minutes after injection.) Thirty minutes later, stiffness and soreness spread to left leg (top). Was difficult and very uncomfortable to fully raise left arm overhead. Noted that I was not able to do so until some time later that evening. Stiffness/soreness in mentioned sites continued eight hours later until I went to sleep at midnight. Soreness/stiffness had lessened some by morning, but remained noticeable at all sites mentioned. Soreness did not abate until later that day. Injection site remains lightly sore at touch today, five days later.
Age: 78.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site vesicles
Clinical narrative: Patient's upper arm, near injection site, became swollen, red , and sore. The redness covered the upper arm. The reaction occurred the evening of receiving the immunization.  A water blister appeared at the site of the injection. The patient reported the reactions 2 days following the injection and stated the redness and soreness have reduced.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Discomfort, Injection site swelling, Mobility decreased
Clinical narrative: 9/12/2020 The patient's wife called around 5pm to report that patient was having severe shoulder/arm pain and shivering following his second dose of Shingrix earlier that day  She stated he had iced the area and taken half a tablet of pain medication he had on hand, as well as an anti-inflammatory medication, but was still quite uncomfortable.   Discussed potential adverse effects of vaccination and that some effects will resolve in 2 to 3 days, but if his discomfort continued or became worse he should consider following up with an urgent care or his family practitioner.  Upon follow up an hour and a half after her initial call she reported he had some improvement in his pain following taking the second half of the pain medication.  She said his shivering had subsided.  She stated he didn't feel applying ice provided any comfort, but he applied heat and it helped some.   9/13/2020 - The patient's wife stated he had some improvement and his pain was being managed with ibuprofen.   9/15-2020 - placed f/u call to wife. She stated pt. is still in pain, but has not taken any medication for it. She statesethat he is having trouble "barely raising his arm."  They scheduled an appointment with their primary care doctor that evening .  9/17/2020 f/u with wife - family doctor did a physical exam and said his upper arm was very swollen and mentioned the injection might have been given too high on the arm - he prescribed a seven day course of a steroid.  Too soon to determine if steroid will result in total recovery.
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: 9/12/2020 The patient's wife called around 5pm to report that patient was having severe shoulder/arm pain and shivering following his second dose of Shingrix earlier that day  She stated he had iced the area and taken half a tablet of pain medication he had on hand, as well as an anti-inflammatory medication, but was still quite uncomfortable.   Discussed potential adverse effects of vaccination and that some effects will resolve in 2 to 3 days, but if his discomfort continued or became worse he should consider following up with an urgent care or his family practitioner.  Upon follow up an hour and a half after her initial call she reported he had some improvement in his pain following taking the second half of the pain medication.  She said his shivering had subsided.  She stated he didn't feel applying ice provided any comfort, but he applied heat and it helped some.   9/13/2020 - The patient's wife stated he had some improvement and his pain was being managed with ibuprofen.   9/15-2020 - placed f/u call to wife. She stated pt. is still in pain, but has not taken any medication for it. She statesethat he is having trouble "barely raising his arm."  They scheduled an appointment with their primary care doctor that evening .  9/17/2020 f/u with wife - family doctor did a physical exam and said his upper arm was very swollen and mentioned the injection might have been given too high on the arm - he prescribed a seven day course of a steroid.  Too soon to determine if steroid will result in total recovery.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Dermatitis, Hypersensitivity, Pruritus, Pustule, Skin irritation
Clinical narrative: Within hours, possibly 1 day, of receiving the injection, I started to experience a skin reaction on the lower L arm. Over a few days, I had the same symptoms (pox raised, inflamed, itchy areas) on both arms and both legs. The L calf and lower leg have several such affecte areas, the L thigh has one large area, and the lower R leg has several patches. The symptoms peaked about 9-10 days after the injection and have been slowly abating. It is now 16 days after the injection. All affected skin areas still have visible marks and raised sections, but only a few areas have mild irritation. All areas appear to be healing resolving. I had a video call with Dr. today. She assessed the skin reaction as an allergic reaction.
Age: 50.0
Sex: M
Vaccine: VARZOS
Symptoms: Skin reaction
Clinical narrative: Within hours, possibly 1 day, of receiving the injection, I started to experience a skin reaction on the lower L arm. Over a few days, I had the same symptoms (pox raised, inflamed, itchy areas) on both arms and both legs. The L calf and lower leg have several such affecte areas, the L thigh has one large area, and the lower R leg has several patches. The symptoms peaked about 9-10 days after the injection and have been slowly abating. It is now 16 days after the injection. All affected skin areas still have visible marks and raised sections, but only a few areas have mild irritation. All areas appear to be healing resolving. I had a video call with Dr. today. She assessed the skin reaction as an allergic reaction.
Age: 64.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia
Clinical narrative: Aching of knuckle joints of left hand on awakening (next morning about 13.5 after vaccine.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Lip swelling, Oral pain, Swelling face, Throat tightness
Clinical narrative: Patient states that shortly after vaccination she had facial and lip swelling, she felt like she was swallowing marbles or that her throat was closing, and that her oral mucosa still feels sore. She took Benadryl, and it helped some, but then got worse. She states she did not go to the ER, and that she treated herself at home.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Muscular weakness
Clinical narrative: Patient returned 10 minutes after flu shot reporting weak legs.  No other symptoms. She had eaten recently but not a lot. BP 135/93 and HR 73. Patient (a nurse) agreed this BP was ok for her. Looked over Fluzone side effects with her but she said it wasn't those but just weak legs.  She refused 911 and waited 15 more minutes.  Then she said she was going to get her mom to pick her up.  We called assistant manager who walked her to her car to wait for mom.  called pt but not but couldn't get her.
Age: 76.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Incorrect route of product administration, Peripheral swelling, Wrong technique in product usage process
Clinical narrative: Patient's arm swelled the morning following immunization.  She visited her PCP who told her the injection was given "too fast" and ended up in the "fat".
Age: 88.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Patient had pain at the injection site and in her shoulder.  She said she could not lift her arm.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Disturbance in attention, Influenza like illness, Pyrexia, Vaccination complication
Clinical narrative: PT EXPERIENCING NORMAL VACCINE REACTION. FLU LIKE SYMPTOMS/FEVER/CHILLS FOR 2 NIGHTS. INABILITY TO CONCENTRATE
Age: 1.08
Sex: M
Vaccine: MMR, PNC13
Symptoms: Cyanosis, Influenza virus test negative, Lethargy, Pallor, Pyrexia
Clinical narrative: Child was unresponsive, stopped breathing. For 3 minutes. Child turned blue and was gray. 911 was called and was evaluated and taken into emergency room where tests were done child was gray and lethargic . Child had a fever of 99.2. Child behave more responsive two hours after the ordeal.
Age: 1.08
Sex: M
Vaccine: MMR, PNC13
Symptoms: Respiratory arrest, Streptococcus test negative, Unresponsive to stimuli
Clinical narrative: Child was unresponsive, stopped breathing. For 3 minutes. Child turned blue and was gray. 911 was called and was evaluated and taken into emergency room where tests were done child was gray and lethargic . Child had a fever of 99.2. Child behave more responsive two hours after the ordeal.
Age: 73.0
Sex: M
Vaccine: FLU4
Symptoms: Computerised tomogram, Delirium, Influenza like illness, Klebsiella sepsis, Klebsiella test positive
Clinical narrative: PT EXPERIENCED FLU LIKE SYMPTOMS THE NIGHT OF THE VACCINATION (WEDNESDAY). HE FELT OK UNTIL SUNDAY THE 13TH WHEN HAD A HIGH FEVER AND WAS DELIRIOUS. AMBULANCE WAS CALLED AND PATIENT WAS ADMITTED ON MONDAY 9/14/20 WITH SEPSIS. CULTURED KLEBSIELLA. AT THIS POINT HOSPITAL CAN NOT FIND SOURCE OF INFECTION.
Age: 73.0
Sex: M
Vaccine: FLU4
Symptoms: Pyrexia
Clinical narrative: PT EXPERIENCED FLU LIKE SYMPTOMS THE NIGHT OF THE VACCINATION (WEDNESDAY). HE FELT OK UNTIL SUNDAY THE 13TH WHEN HAD A HIGH FEVER AND WAS DELIRIOUS. AMBULANCE WAS CALLED AND PATIENT WAS ADMITTED ON MONDAY 9/14/20 WITH SEPSIS. CULTURED KLEBSIELLA. AT THIS POINT HOSPITAL CAN NOT FIND SOURCE OF INFECTION.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity, Rash erythematous, Skin warm, Tenderness
Clinical narrative: Patient presented to pharmacy one day after receiving Pneumovax-23 with a topical red rash on her bicep-area of the left arm.  No topical rash or any visible reaction within the area of the deltoid muscle, where the immunization was administered.  Patient verbally confirmed to pharmacist that the deltoid area of her arm where the immunization was administered did not hurt and was entirely unaffected.  She said that her bicep area was somewhat warm to touch and painful/tender.   Pharmacist advised that the patient closely monitor the site for any worsening of symptoms and to contact her primary-care physician for further evaluation/follow-up.  Pharmacist advised the patient to apply a cold compress to the site, keep the site elevated, and take an oral analgesic & antihistamine to help relieve pain and inflammation/rash.
Age: 83.0
Sex: M
Vaccine: FLUA4
Symptoms: Injection site bruising
Clinical narrative: Bruising at injection site lasting one week. Beginning to resolve. Patient wanted to report because he had never had such severe bruising from a vaccination previously
Age: 84.0
Sex: M
Vaccine: FLUA4
Symptoms: Arthralgia, Mobility decreased, Pain, Pain in extremity
Clinical narrative: PAIN IN ARM, UNABLE TO MAKE A FIST, LEFT SIDE SORENESS, LEFT ANKLE SORE, DIFFICULT TO MOVE LEFT SIDE OF BODY
Age: 30.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: patient fainted in store approx. 4-5 minutes after receiving vaccination
Age: 7.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: no adverse event as of yet, pt received flublock and not fluzone.  Flubloc is not indicated for pts under 18
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Pain, Pyrexia, SARS-CoV-2 test negative
Clinical narrative: Woke up early morning, 4am on 14 Aug 2020- Fever, 100.9, headache, body aches, fatigue. Fever continued to fluctuate throughout the day and evening, 99.7- 101.  Symptoms lasted 3 days but were milder.
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: The patient came in and showed that her  upper right arm (bicep area) was red and warm to the touch, Said that it started at the injection site and has gotten worse
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Injection site erythema, Injection site swelling, Skin warm
Clinical narrative: The wife called  and said about 2 days after the vaccine, he experienced swelling about 2-3 inches below the injection site.  It was red and warm and about 3-4 inches in diameter.  At the site of injection there was a quarter size red spot.  No other symptoms were experienced.  They iced the swelling and it went away in 4 days.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: Patient called the pharmacy because she was concerned about feeling dizzy and nauseous  after taking her regular dose of maintenance medicine of metformin. She was  advice to take some milk or fruit juice. She did tried some milk and she throw everything up. The dizziness and nausea continued till later part of the day 5:00pm. She was called again at 7:00 pm, the feeling of dizziness and nausea had not completely resolved
Age: 67.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Abdominal discomfort, Decreased appetite, Fatigue, Feeling abnormal, Feeling cold
Clinical narrative: Extreme fatigue, swollen sore arm,  very cold. loss of appetite  and upset stomach. Iced my arm and slept  the entire next day .   Vaccines were administered on Wednesday and  I didn?t feel normal again until  Saturday.
Age: 67.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Hypersomnia, Peripheral swelling
Clinical narrative: Extreme fatigue, swollen sore arm,  very cold. loss of appetite  and upset stomach. Iced my arm and slept  the entire next day .   Vaccines were administered on Wednesday and  I didn?t feel normal again until  Saturday.
Age: 75.0
Sex: M
Vaccine: FLUA3, PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: right arm swelling and redness
Age: 77.0
Sex: F
Vaccine: FLUA3
Symptoms: Asthenia, Dizziness, Injection site bruising, Pyrexia
Clinical narrative: Flu vaccine for the 20-21 season was administered on 08/25/20.  the patient was notifed by her husband that she has a bruise on the triceps area of the right arm.  The bruise got worse with time and extended to the elbow region. in addition, the patient reports general weakness.   The patient tried to contact the doctor but was unable to be seen due to COVID-19.  The site of administrtion is clear of any bruising or injury. Also the patient reports taking Eliquis and she mentioned that she had a few incedence of bruising in the past. I instructed the patient to see her PCP because she also mentioned she had a few days with fever and dizziness since she got the flu vaccine.
Age: 16.0
Sex: F
Vaccine: HPV9, MNQ
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Mild swelling, redness at injection site. Not warm to touch. Full ROM of arm. Reaction typical of Meningitis vaccine
Age: 71.0
Sex: F
Vaccine: FLUA4
Symptoms: Mobility decreased, Weight bearing difficulty
Clinical narrative: Pt described dificulty moving arm + lifting objects  Pt advised by her daughter to take Ibuprofen (daughter is a doctor)
Age: 78.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Areflexia, Asthenia, Atrial fibrillation, Bedridden, Bilevel positive airway pressure
Clinical narrative: -See attached chart notes for neuromuscular weakness & resultant intubation, hospitalization. 9/11/2020. Patient is a 78 y.o. female on whom I have been asked to consult for evaluation and treatment of probable GBS. She did yard work on 9/8/20 which made her tired. That afternoon she began noticing numbness and tingling of her fingers and toes. That evening she could not get off the toilet; she was too weak in the legs. She needed to use a medical alert device to get help. Normally she used a walker. She notified EMS, who transported her to the hospital. In the ED she was found to hypertensive (190s), O2 sats 87%, urine with possible infection, and CXR with possible pneumonia vs aspiration but normal procalcitonin. She has required bipap. Admitted 9/9/20. Yesterday she reported improved sensation in her limbs. On exam for hospitalist, she was areflexic and weak. She had LP, which showed Prot 75. Decision was last night to delay IVIG to see how she looks today. She reports numbness now rising up to her lower abdomen. She is still requiring bipap and has air hunger when it is turned off. Of note, she had a VZV vaccine on or about 9/1/20. 9/16/2020. Unfortunate 78-year-old lady with morbid obesity, chronic obstructive pulmonary disease, recently vaccinated for varicella zoster virus who developed a rapidly progressive Guillain-Barre on 09/10. Currently intubated. She is status post a completed dose of IVIG. NIF remains low and she has no muscular function in her lower extremities. Neurology is recommending pain control for the neuropathy and no further therapies for the Galbraith. Time and physical therapy may allow for recovery. She will likely need a protracted vent wean. We will put her on 10/5 pressure support today. She also need protracted rehab but she is now bedbound until she potentially regains functional status. We will therefore try to have her placed in LTAC to assist with both the ventilator weaning and rehabilitation from yellow-gray syndrome. Regarding other active medical issues she is still slightly hypervolemic we will continue Lasix and Diamox. Regarding her A. fib this is well controlled with her current dose of diltiazem. She is on anticoagulation for this. Regarding her pneumonia she is completed a course of antibiotics. She is still has MRSA in his sputum culture. This may be colonized endotracheal tubes there is no convincing signs of bacterial pneumonia on chest x-ray imaging or clinical exam (no white count no fever etc.). We will continue to monitor and have low threshold to institute anti-MRSA coverage should she develop worsened respiratory failure but for now she is off antibiotics.
Age: 78.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: CSF protein increased, Chest X-ray normal, Dyspnoea, Endotracheal intubation, Fatigue
Clinical narrative: -See attached chart notes for neuromuscular weakness & resultant intubation, hospitalization. 9/11/2020. Patient is a 78 y.o. female on whom I have been asked to consult for evaluation and treatment of probable GBS. She did yard work on 9/8/20 which made her tired. That afternoon she began noticing numbness and tingling of her fingers and toes. That evening she could not get off the toilet; she was too weak in the legs. She needed to use a medical alert device to get help. Normally she used a walker. She notified EMS, who transported her to the hospital. In the ED she was found to hypertensive (190s), O2 sats 87%, urine with possible infection, and CXR with possible pneumonia vs aspiration but normal procalcitonin. She has required bipap. Admitted 9/9/20. Yesterday she reported improved sensation in her limbs. On exam for hospitalist, she was areflexic and weak. She had LP, which showed Prot 75. Decision was last night to delay IVIG to see how she looks today. She reports numbness now rising up to her lower abdomen. She is still requiring bipap and has air hunger when it is turned off. Of note, she had a VZV vaccine on or about 9/1/20. 9/16/2020. Unfortunate 78-year-old lady with morbid obesity, chronic obstructive pulmonary disease, recently vaccinated for varicella zoster virus who developed a rapidly progressive Guillain-Barre on 09/10. Currently intubated. She is status post a completed dose of IVIG. NIF remains low and she has no muscular function in her lower extremities. Neurology is recommending pain control for the neuropathy and no further therapies for the Galbraith. Time and physical therapy may allow for recovery. She will likely need a protracted vent wean. We will put her on 10/5 pressure support today. She also need protracted rehab but she is now bedbound until she potentially regains functional status. We will therefore try to have her placed in LTAC to assist with both the ventilator weaning and rehabilitation from yellow-gray syndrome. Regarding other active medical issues she is still slightly hypervolemic we will continue Lasix and Diamox. Regarding her A. fib this is well controlled with her current dose of diltiazem. She is on anticoagulation for this. Regarding her pneumonia she is completed a course of antibiotics. She is still has MRSA in his sputum culture. This may be colonized endotracheal tubes there is no convincing signs of bacterial pneumonia on chest x-ray imaging or clinical exam (no white count no fever etc.). We will continue to monitor and have low threshold to institute anti-MRSA coverage should she develop worsened respiratory failure but for now she is off antibiotics.
Age: 78.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Guillain-Barre syndrome, Hypertension, Hypervolaemia, Hypoaesthesia, Immunoglobulin therapy
Clinical narrative: -See attached chart notes for neuromuscular weakness & resultant intubation, hospitalization. 9/11/2020. Patient is a 78 y.o. female on whom I have been asked to consult for evaluation and treatment of probable GBS. She did yard work on 9/8/20 which made her tired. That afternoon she began noticing numbness and tingling of her fingers and toes. That evening she could not get off the toilet; she was too weak in the legs. She needed to use a medical alert device to get help. Normally she used a walker. She notified EMS, who transported her to the hospital. In the ED she was found to hypertensive (190s), O2 sats 87%, urine with possible infection, and CXR with possible pneumonia vs aspiration but normal procalcitonin. She has required bipap. Admitted 9/9/20. Yesterday she reported improved sensation in her limbs. On exam for hospitalist, she was areflexic and weak. She had LP, which showed Prot 75. Decision was last night to delay IVIG to see how she looks today. She reports numbness now rising up to her lower abdomen. She is still requiring bipap and has air hunger when it is turned off. Of note, she had a VZV vaccine on or about 9/1/20. 9/16/2020. Unfortunate 78-year-old lady with morbid obesity, chronic obstructive pulmonary disease, recently vaccinated for varicella zoster virus who developed a rapidly progressive Guillain-Barre on 09/10. Currently intubated. She is status post a completed dose of IVIG. NIF remains low and she has no muscular function in her lower extremities. Neurology is recommending pain control for the neuropathy and no further therapies for the Galbraith. Time and physical therapy may allow for recovery. She will likely need a protracted vent wean. We will put her on 10/5 pressure support today. She also need protracted rehab but she is now bedbound until she potentially regains functional status. We will therefore try to have her placed in LTAC to assist with both the ventilator weaning and rehabilitation from yellow-gray syndrome. Regarding other active medical issues she is still slightly hypervolemic we will continue Lasix and Diamox. Regarding her A. fib this is well controlled with her current dose of diltiazem. She is on anticoagulation for this. Regarding her pneumonia she is completed a course of antibiotics. She is still has MRSA in his sputum culture. This may be colonized endotracheal tubes there is no convincing signs of bacterial pneumonia on chest x-ray imaging or clinical exam (no white count no fever etc.). We will continue to monitor and have low threshold to institute anti-MRSA coverage should she develop worsened respiratory failure but for now she is off antibiotics.
Age: 78.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Lumbar puncture, Mechanical ventilation, Muscle disorder, Muscular weakness, Musculoskeletal disorder
Clinical narrative: -See attached chart notes for neuromuscular weakness & resultant intubation, hospitalization. 9/11/2020. Patient is a 78 y.o. female on whom I have been asked to consult for evaluation and treatment of probable GBS. She did yard work on 9/8/20 which made her tired. That afternoon she began noticing numbness and tingling of her fingers and toes. That evening she could not get off the toilet; she was too weak in the legs. She needed to use a medical alert device to get help. Normally she used a walker. She notified EMS, who transported her to the hospital. In the ED she was found to hypertensive (190s), O2 sats 87%, urine with possible infection, and CXR with possible pneumonia vs aspiration but normal procalcitonin. She has required bipap. Admitted 9/9/20. Yesterday she reported improved sensation in her limbs. On exam for hospitalist, she was areflexic and weak. She had LP, which showed Prot 75. Decision was last night to delay IVIG to see how she looks today. She reports numbness now rising up to her lower abdomen. She is still requiring bipap and has air hunger when it is turned off. Of note, she had a VZV vaccine on or about 9/1/20. 9/16/2020. Unfortunate 78-year-old lady with morbid obesity, chronic obstructive pulmonary disease, recently vaccinated for varicella zoster virus who developed a rapidly progressive Guillain-Barre on 09/10. Currently intubated. She is status post a completed dose of IVIG. NIF remains low and she has no muscular function in her lower extremities. Neurology is recommending pain control for the neuropathy and no further therapies for the Galbraith. Time and physical therapy may allow for recovery. She will likely need a protracted vent wean. We will put her on 10/5 pressure support today. She also need protracted rehab but she is now bedbound until she potentially regains functional status. We will therefore try to have her placed in LTAC to assist with both the ventilator weaning and rehabilitation from yellow-gray syndrome. Regarding other active medical issues she is still slightly hypervolemic we will continue Lasix and Diamox. Regarding her A. fib this is well controlled with her current dose of diltiazem. She is on anticoagulation for this. Regarding her pneumonia she is completed a course of antibiotics. She is still has MRSA in his sputum culture. This may be colonized endotracheal tubes there is no convincing signs of bacterial pneumonia on chest x-ray imaging or clinical exam (no white count no fever etc.). We will continue to monitor and have low threshold to institute anti-MRSA coverage should she develop worsened respiratory failure but for now she is off antibiotics.
Age: 78.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Neuropathy peripheral, Paraesthesia, Pneumonia, Procalcitonin normal, Sensory disturbance
Clinical narrative: -See attached chart notes for neuromuscular weakness & resultant intubation, hospitalization. 9/11/2020. Patient is a 78 y.o. female on whom I have been asked to consult for evaluation and treatment of probable GBS. She did yard work on 9/8/20 which made her tired. That afternoon she began noticing numbness and tingling of her fingers and toes. That evening she could not get off the toilet; she was too weak in the legs. She needed to use a medical alert device to get help. Normally she used a walker. She notified EMS, who transported her to the hospital. In the ED she was found to hypertensive (190s), O2 sats 87%, urine with possible infection, and CXR with possible pneumonia vs aspiration but normal procalcitonin. She has required bipap. Admitted 9/9/20. Yesterday she reported improved sensation in her limbs. On exam for hospitalist, she was areflexic and weak. She had LP, which showed Prot 75. Decision was last night to delay IVIG to see how she looks today. She reports numbness now rising up to her lower abdomen. She is still requiring bipap and has air hunger when it is turned off. Of note, she had a VZV vaccine on or about 9/1/20. 9/16/2020. Unfortunate 78-year-old lady with morbid obesity, chronic obstructive pulmonary disease, recently vaccinated for varicella zoster virus who developed a rapidly progressive Guillain-Barre on 09/10. Currently intubated. She is status post a completed dose of IVIG. NIF remains low and she has no muscular function in her lower extremities. Neurology is recommending pain control for the neuropathy and no further therapies for the Galbraith. Time and physical therapy may allow for recovery. She will likely need a protracted vent wean. We will put her on 10/5 pressure support today. She also need protracted rehab but she is now bedbound until she potentially regains functional status. We will therefore try to have her placed in LTAC to assist with both the ventilator weaning and rehabilitation from yellow-gray syndrome. Regarding other active medical issues she is still slightly hypervolemic we will continue Lasix and Diamox. Regarding her A. fib this is well controlled with her current dose of diltiazem. She is on anticoagulation for this. Regarding her pneumonia she is completed a course of antibiotics. She is still has MRSA in his sputum culture. This may be colonized endotracheal tubes there is no convincing signs of bacterial pneumonia on chest x-ray imaging or clinical exam (no white count no fever etc.). We will continue to monitor and have low threshold to institute anti-MRSA coverage should she develop worsened respiratory failure but for now she is off antibiotics.
Age: 78.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Sputum culture positive, Staphylococcal infection, Staphylococcus test positive, Urine analysis
Clinical narrative: -See attached chart notes for neuromuscular weakness & resultant intubation, hospitalization. 9/11/2020. Patient is a 78 y.o. female on whom I have been asked to consult for evaluation and treatment of probable GBS. She did yard work on 9/8/20 which made her tired. That afternoon she began noticing numbness and tingling of her fingers and toes. That evening she could not get off the toilet; she was too weak in the legs. She needed to use a medical alert device to get help. Normally she used a walker. She notified EMS, who transported her to the hospital. In the ED she was found to hypertensive (190s), O2 sats 87%, urine with possible infection, and CXR with possible pneumonia vs aspiration but normal procalcitonin. She has required bipap. Admitted 9/9/20. Yesterday she reported improved sensation in her limbs. On exam for hospitalist, she was areflexic and weak. She had LP, which showed Prot 75. Decision was last night to delay IVIG to see how she looks today. She reports numbness now rising up to her lower abdomen. She is still requiring bipap and has air hunger when it is turned off. Of note, she had a VZV vaccine on or about 9/1/20. 9/16/2020. Unfortunate 78-year-old lady with morbid obesity, chronic obstructive pulmonary disease, recently vaccinated for varicella zoster virus who developed a rapidly progressive Guillain-Barre on 09/10. Currently intubated. She is status post a completed dose of IVIG. NIF remains low and she has no muscular function in her lower extremities. Neurology is recommending pain control for the neuropathy and no further therapies for the Galbraith. Time and physical therapy may allow for recovery. She will likely need a protracted vent wean. We will put her on 10/5 pressure support today. She also need protracted rehab but she is now bedbound until she potentially regains functional status. We will therefore try to have her placed in LTAC to assist with both the ventilator weaning and rehabilitation from yellow-gray syndrome. Regarding other active medical issues she is still slightly hypervolemic we will continue Lasix and Diamox. Regarding her A. fib this is well controlled with her current dose of diltiazem. She is on anticoagulation for this. Regarding her pneumonia she is completed a course of antibiotics. She is still has MRSA in his sputum culture. This may be colonized endotracheal tubes there is no convincing signs of bacterial pneumonia on chest x-ray imaging or clinical exam (no white count no fever etc.). We will continue to monitor and have low threshold to institute anti-MRSA coverage should she develop worsened respiratory failure but for now she is off antibiotics.
Age: 69.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pruritus, Vaccination site warmth
Clinical narrative: Patient called 9/17/20, to report large warm, red band around the vaccination site and arm. She reported extreme itching in that area that started the day after receiving the High-Dose influenza vaccination. RPH recommended ice packs, antihistamine oral and topical.
Age: 83.0
Sex: F
Vaccine: FLUA4
Symptoms: Chest pain, Muscle spasms, Pain
Clinical narrative: Pt received immunization. Returned approximately 5 minutes later reporting symptoms of back spasms. Pt experienced chest pain radiating. Pt was instructed to sit down and rested. Pt was monitored by pharmacy staff. Pt condition improved and was instructed to contact PCP. Pt ambulatory.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Paraesthesia, Rash
Clinical narrative: numbness, tingling left arm and left side of neck  Rash
Age: 57.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Hypoaesthesia, Ocular hyperaemia, Paraesthesia, Pharyngeal swelling
Clinical narrative: Patient experienced redness of eyes, swelling of the throat, numbness and tingling of the fingers. Patient took 2 tables of diphenhydramine 25mg (50mg total) and is Feeling better. Patient denies having a rash.
Age: 56.0
Sex: M
Vaccine: FLU4, FLU4, FLU4
Symptoms: Exposure via eye contact, Exposure via skin contact, Eye irrigation
Clinical narrative: leaking was believed to be between the syringe and the needle at the leur lock, no AE; during administration the vaccine spilled on the arm, clothing, and the left eye, no AE; patient did not receive a full dose, no AE; during administration the vaccine spilled on the arm, clothing, and the left eye, no AE; Initial information received on 08-Sep-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 56 year old male patient for whom it was reported that during administration of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT], vaccine spilled on the arm, clothing, and the left eye (Exposure via eye contact, Exposure via skin contact) and the patient did not receive a full dose (underdose) as leaking was believed to be between the syringe and the needle at the leur lock (syringe issue).  Medical history, past medical treatment, vaccination, family history and concomitant medication were not provided.   On 08-Sep-2020, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UJ471AB and expiry date: 30-Jun-2021) via an intramuscular route in the left arm for prophylactic vaccination.  It was actual medication error case due to Vaccine underdose and exposure via eye contact, exposure via eye contact and Syringe issue (latency same day).  The pharmacist reported that after the event the needle was checked and was tight; there was no damage noted to the syringe on inspection after the event. The syringe had been disposed of at the time of this report. Pharmacist stated that needle was injected into the arm and the vaccine was being administered and patient did not receive a full dose, however patient reported that the needle never penetrated his arm or that the injection was not in all the way. The patient was a physician. The patient was asked to see the syringe prior to the injection and syringe was handed to the patient and then it was handed back to the pharmacist for the injection. There was no more medication left in the syringe.   At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 56.0
Sex: M
Vaccine: FLU4, FLU4, FLU4
Symptoms: Accidental exposure to product, Exposure via eye contact, Exposure via skin contact, Eye irritation
Clinical narrative: leaking was believed to be between the syringe and the needle at the leur lock, no AE; during administration the vaccine spilled on the arm, clothing, and the left eye, no AE; patient did not receive a full dose, no AE; during administration the vaccine spilled on the arm, clothing, and the left eye, no AE; Initial information received on 08-Sep-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 56 year old male patient for whom it was reported that during administration of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT], vaccine spilled on the arm, clothing, and the left eye (Exposure via eye contact, Exposure via skin contact) and the patient did not receive a full dose (underdose) as leaking was believed to be between the syringe and the needle at the leur lock (syringe issue).  Medical history, past medical treatment, vaccination, family history and concomitant medication were not provided.   On 08-Sep-2020, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UJ471AB and expiry date: 30-Jun-2021) via an intramuscular route in the left arm for prophylactic vaccination.  It was actual medication error case due to Vaccine underdose and exposure via eye contact, exposure via eye contact and Syringe issue (latency same day).  The pharmacist reported that after the event the needle was checked and was tight; there was no damage noted to the syringe on inspection after the event. The syringe had been disposed of at the time of this report. Pharmacist stated that needle was injected into the arm and the vaccine was being administered and patient did not receive a full dose, however patient reported that the needle never penetrated his arm or that the injection was not in all the way. The patient was a physician. The patient was asked to see the syringe prior to the injection and syringe was handed to the patient and then it was handed back to the pharmacist for the injection. There was no more medication left in the syringe.   At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 56.0
Sex: M
Vaccine: FLU4, FLU4, FLU4
Symptoms: Exposure via eye contact, Exposure via skin contact, Needle issue, Syringe issue, Underdose
Clinical narrative: leaking was believed to be between the syringe and the needle at the leur lock, no AE; during administration the vaccine spilled on the arm, clothing, and the left eye, no AE; patient did not receive a full dose, no AE; during administration the vaccine spilled on the arm, clothing, and the left eye, no AE; Initial information received on 08-Sep-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 56 year old male patient for whom it was reported that during administration of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT], vaccine spilled on the arm, clothing, and the left eye (Exposure via eye contact, Exposure via skin contact) and the patient did not receive a full dose (underdose) as leaking was believed to be between the syringe and the needle at the leur lock (syringe issue).  Medical history, past medical treatment, vaccination, family history and concomitant medication were not provided.   On 08-Sep-2020, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UJ471AB and expiry date: 30-Jun-2021) via an intramuscular route in the left arm for prophylactic vaccination.  It was actual medication error case due to Vaccine underdose and exposure via eye contact, exposure via eye contact and Syringe issue (latency same day).  The pharmacist reported that after the event the needle was checked and was tight; there was no damage noted to the syringe on inspection after the event. The syringe had been disposed of at the time of this report. Pharmacist stated that needle was injected into the arm and the vaccine was being administered and patient did not receive a full dose, however patient reported that the needle never penetrated his arm or that the injection was not in all the way. The patient was a physician. The patient was asked to see the syringe prior to the injection and syringe was handed to the patient and then it was handed back to the pharmacist for the injection. There was no more medication left in the syringe.   At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 36.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Flushing, Urticaria
Clinical narrative: facial flushing, feeling hot, puffy face.
Age: 36.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Feeling hot, Flushing, Swelling face
Clinical narrative: facial flushing, feeling hot, puffy face.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Eye discharge, Haemoglobin normal, Lacrimation increased, Lymphadenopathy, Lymphocyte percentage increased
Clinical narrative: Patient presents with fever for __1__ days with  Tmax of ___103.4___. Parents gave antipyretic with improvement in fever.  Last  ibuprofen    _1____ hours ago. Associated symptoms include: _Y__ watery eyes* _Y__ body aches* (excessive crying/fussiness) _N__ Sore throat _?__ Headache* _N__ Vomiting _N__ Diarrhea _N__ congestion of the nose _N__ cough** _N__ wheezing**    _No__ recent travel   _No known__ sick contacts   PE shows 101.5 fever in child whose exam is remarkable for posterior cervical and posterior occipital lymphadenopathy bilaterally without meningismus and some scleral injection with watery eye discharge and rhinorrhea. No rash and otherwise normal exam.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Monocyte percentage increased, Neutrophil percentage decreased, Pain, Platelet count normal, Pyrexia
Clinical narrative: Patient presents with fever for __1__ days with  Tmax of ___103.4___. Parents gave antipyretic with improvement in fever.  Last  ibuprofen    _1____ hours ago. Associated symptoms include: _Y__ watery eyes* _Y__ body aches* (excessive crying/fussiness) _N__ Sore throat _?__ Headache* _N__ Vomiting _N__ Diarrhea _N__ congestion of the nose _N__ cough** _N__ wheezing**    _No__ recent travel   _No known__ sick contacts   PE shows 101.5 fever in child whose exam is remarkable for posterior cervical and posterior occipital lymphadenopathy bilaterally without meningismus and some scleral injection with watery eye discharge and rhinorrhea. No rash and otherwise normal exam.
Age: 1.0
Sex: M
Vaccine: HEPA, MMR, VARCEL
Symptoms: Rhinorrhoea, White blood cell count decreased
Clinical narrative: Patient presents with fever for __1__ days with  Tmax of ___103.4___. Parents gave antipyretic with improvement in fever.  Last  ibuprofen    _1____ hours ago. Associated symptoms include: _Y__ watery eyes* _Y__ body aches* (excessive crying/fussiness) _N__ Sore throat _?__ Headache* _N__ Vomiting _N__ Diarrhea _N__ congestion of the nose _N__ cough** _N__ wheezing**    _No__ recent travel   _No known__ sick contacts   PE shows 101.5 fever in child whose exam is remarkable for posterior cervical and posterior occipital lymphadenopathy bilaterally without meningismus and some scleral injection with watery eye discharge and rhinorrhea. No rash and otherwise normal exam.
Age: 14.0
Sex: F
Vaccine: MNQ
Symptoms: Injection site reaction, Pruritus, Urticaria
Clinical narrative: Itching, hives, and welts on arm including the injection site
Sex: U
Vaccine: HPV9
Symptoms: Expired product administered
Clinical narrative: they accidentally gave an expired GARDASIL-9 vaccine to a patient; This spontaneous report was received from a pharmacist and refers to a patient of unknown age and gender. Information regarding the patient's medical history, concurrent conditions and concomitant medications was not provided. On 09-SEP-2020 the patient was vaccinated with an expired dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) lot # N019103, with expiration date of 03-FEB-2020, for prophylaxis(once, vaccine). The product did not undergo a temperature excursion prior to administration. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; manufacturername: Merck Sharp & Dohme Corp; manufactureraddress: manufacturercity: manufacturerstate:  manufacturercountry: devicelotnumber: N019103; expirationdate: 03-FEB-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: F
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: the patient was administered improperly stored VARIVAX; This spontaneous report as received from a medical assistant referring to a 1-year-old female patient. The patient's pertinent medical history, concomitant medications, and previous drug allergies or reactions were not reported.  On 24-AUG-2020, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck) (VARIVAX) injection (INJ) subcutaneously for "well check" (prophylaxis) (dose, vaccination scheme frequency, anatomical location and anatomical location were not reported; lot number: S032355 with expiration date of 14-OCT-2021). The administered dose of the vaccine experienced multiple temperature excursions which went from -14 degrees Celsius (C) to -10 C for 116 hours; and from -9 C to 8 C for 13 hours, as recorded by a data logger (product storage error).; Sender's Comments:  US-009507513-2009USA005503: