chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 68.0
Sex: F
Vaccine: PPV, PPV
Symptoms: Paraesthesia, Peroneal nerve palsy
Clinical narrative: radiculoneuropathy; she started to experience "tingling in the right leg"/she started to experience "weakness of the right leg"/patient began to "start tripping and falling"/patient was diagnosed with "foot drop"; radiculoneuropathy; This spontaneous report was received from a consumer and his 68-year-old wife, who was also the patient. The patient had no pertinent medical history nor allergies. Concomitant therapies included rosuvastatin calcium (CRESTOR).  On an unknown day in August 2017, the patient was vaccinated with a first dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) injection, administered in the left arm, lot number N010106, with an expiration date on 15-NOV-2018, for prophylaxis (route of administration was not reported).  On an unknown day in 2017 (also reported as: "two weeks after administration"), the patient started to experience "tingling in the right leg", then, four months after that, she started to experience "weakness of the right leg", and afterward, she began "tripping and falling, thus, the patient was diagnosed with "foot drop" (peroneal nerve palsy). Approximately in January 2018, the patient started physical therapy and in approximately December 2018, she started to see a neurologist. The patient had immune globulin infusions (reported as "IVIG infusions)" starting in March 2019, to rule out "radiculoneuropathy" (radiculopathy/neuropathy peripheral). In May 2019, the patient was done a spinal tap (results not provided). In September 2019, the patient finished immune globulin infusions.  It was reported that all throughout 2019, magnetic resonance imaging (MRI) from brain to feet were performed (results not reported) and on unspecified dates, multiple blood works, and four electromyography (EMG) tests were done, showing fine results except for weakness in the right leg.   At reporting time (reported as "currently"), she had not recovered from the events as she still experienced "decreased limb mobility" and had still physical therapy. The causality assessment between the adverse events and the suspect therapy was not provided.  Upon internal review, the event neuropathy peripheral was considered to be medically significant.
Age: 53.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: I received my first Shingrix shot on Dec 30, 2019, and a few adys later started getting hives across my whole body.   The itching, and size of the hives, was not getting better, and I went to the doctors office after about 3 weeks later.  I was told it is unliekly that the Shingrix caused the hives (I was seen by Dr.), and to take OTC antihistamines.  I started taking approximately 1 Benadryl pill/day, and the hives were getting progressively better.  I received my 2nd dose this morning, and the hives have flared up significatly.  Both vacciens were administeted in my left arm.
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Somnolence
Clinical narrative: Tired; Sleepy; This case was reported by a pharmacist via other manufacturer and described the occurrence of tiredness in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 27th January 2020, the patient received Shingrix. In January 2020, less than a week after receiving Shingrix, the patient experienced tiredness and sleepiness. On 30th January 2020, the outcome of the tiredness and sleepiness were recovered/resolved.   It was unknown if the reporter considered the tiredness and sleepiness to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received SHINGRIX and experienced tired and sleepy for the next few days. No further information was provided.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Pain
Clinical narrative: dull headache; left arm where she received her injection was sore; feeling of a little ache the day after the injection; This case was reported by a other health professional via sales rep and described the occurrence of injection site pain in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2019, the patient received the 1st dose of Shingrix. In 2019, 1 day after receiving Shingrix, the patient experienced injection site pain and general body pain. On an unknown date, the patient experienced headache. On an unknown date, the outcome of the injection site pain, general body pain and headache were unknown.   It was unknown if the reporter considered the injection site pain, general body pain and headache to be related to Shingrix.  Additional information was provided as follows: This case was reported by patient herself and she was an orthodontic employee. The age at vaccination was not reported. The patient was an orthodontic employee. The patient had the feeling of a little ache the day after the injection with a dull headache. The patient's left arm where she received her injection was sore. For drug tolerance of 2nd dose, refer case US2020AMR024903.
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash on the face; This case was reported by a pharmacist via call center representative and described the occurrence of rash in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th February 2020, the patient received the 1st dose of Shingrix. On 11th February 2020, 1 days after receiving Shingrix, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient experienced rash on face one day after receiving the dose of Shingrix. The reporter consented to follow up. No vaccine's data provided.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Malaise
Clinical narrative: Headache and malaise. Lasted 24 hours. Took ibuprofen.
Age: 56.0
Sex: M
Vaccine: VARZOS
Symptoms: Computerised tomogram head normal, Facial paralysis, Magnetic resonance imaging normal, Paralysis
Clinical narrative: Bell's palsy with complete paralysis of all muscles invovled. Slight improvement in the last week .
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Abnormal sensation in eye, Arthralgia, Asthenia, Chills, Decreased appetite
Clinical narrative: started with a change in mood then severe headache. then progressed into pain in the deltoid much worse than it seemed it should be - and worse than previous flu shot. i had not eaten all day and the thought of food was disgusting. started shivering and chattering teeth, worse than the worst flu i have had. covered with many blankets, fever rose above 101 started to feel extremely nausea, fainted for one second then sat up quickly to vomit. vomitted everything in me and then back to blankets and chattering, fell asleep woke up very very hot, did not take temp but it was high, laid uncovered to try to bring temp down. woke up at 5am still unwell, dizzy, pain in all joints and muscles fell back asleep until 8, now, feel better but still weak, headache, some muscle joint pain, eyes feel hot, still mild fever under 101.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Feeling cold, Feeling hot, Headache, Malaise
Clinical narrative: started with a change in mood then severe headache. then progressed into pain in the deltoid much worse than it seemed it should be - and worse than previous flu shot. i had not eaten all day and the thought of food was disgusting. started shivering and chattering teeth, worse than the worst flu i have had. covered with many blankets, fever rose above 101 started to feel extremely nausea, fainted for one second then sat up quickly to vomit. vomitted everything in me and then back to blankets and chattering, fell asleep woke up very very hot, did not take temp but it was high, laid uncovered to try to bring temp down. woke up at 5am still unwell, dizzy, pain in all joints and muscles fell back asleep until 8, now, feel better but still weak, headache, some muscle joint pain, eyes feel hot, still mild fever under 101.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Mood altered, Myalgia, Nausea, Pain in extremity, Pyrexia
Clinical narrative: started with a change in mood then severe headache. then progressed into pain in the deltoid much worse than it seemed it should be - and worse than previous flu shot. i had not eaten all day and the thought of food was disgusting. started shivering and chattering teeth, worse than the worst flu i have had. covered with many blankets, fever rose above 101 started to feel extremely nausea, fainted for one second then sat up quickly to vomit. vomitted everything in me and then back to blankets and chattering, fell asleep woke up very very hot, did not take temp but it was high, laid uncovered to try to bring temp down. woke up at 5am still unwell, dizzy, pain in all joints and muscles fell back asleep until 8, now, feel better but still weak, headache, some muscle joint pain, eyes feel hot, still mild fever under 101.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope, Vomiting
Clinical narrative: started with a change in mood then severe headache. then progressed into pain in the deltoid much worse than it seemed it should be - and worse than previous flu shot. i had not eaten all day and the thought of food was disgusting. started shivering and chattering teeth, worse than the worst flu i have had. covered with many blankets, fever rose above 101 started to feel extremely nausea, fainted for one second then sat up quickly to vomit. vomitted everything in me and then back to blankets and chattering, fell asleep woke up very very hot, did not take temp but it was high, laid uncovered to try to bring temp down. woke up at 5am still unwell, dizzy, pain in all joints and muscles fell back asleep until 8, now, feel better but still weak, headache, some muscle joint pain, eyes feel hot, still mild fever under 101.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Borrelia test negative, CSF protein increased, CSF red blood cell count positive, Guillain-Barre syndrome, Hypoaesthesia
Clinical narrative: Patient was admitted due to progressive lower extremity weakness.  He also reported developing numbness in his fingers.  He was diagnosed with Guillian-Barre syndrome secondary to influenza vaccine.  He received an influenza vaccine on 11/8/19 (Sanofi Pasteur Lot:  UJ285AB).  Neurology was consulted.  They did not recommend any specific treatment, but rather supportive care.  He was discharged with instructions to follow up with neurology if his symptoms did not resolve within a month.
Age: 72.0
Sex: M
Vaccine: FLU3
Symptoms: Lumbar puncture, Magnetic resonance imaging spinal, Muscular weakness
Clinical narrative: Patient was admitted due to progressive lower extremity weakness.  He also reported developing numbness in his fingers.  He was diagnosed with Guillian-Barre syndrome secondary to influenza vaccine.  He received an influenza vaccine on 11/8/19 (Sanofi Pasteur Lot:  UJ285AB).  Neurology was consulted.  They did not recommend any specific treatment, but rather supportive care.  He was discharged with instructions to follow up with neurology if his symptoms did not resolve within a month.
Sex: M
Vaccine: VARZOS
Symptoms: Chronic obstructive pulmonary disease, Cough, Dyspnoea, Pneumonia, Pyrexia
Clinical narrative: chronic obstructive pulmonary disease with acute exacerbation; acute on chronic hypoxic respiratory failure; Pneumonia; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a male patient of unknown age. His concurrent conditions, medical history and concomitant medications were not reported. In or around 22-JAN-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, lot #, expiration date, dosage, injection anatomical location or route of administration were not provided) as routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after vaccination, the patient suffered shortness of breath, cough and fever requiring multiple hospitalizations. He has been diagnosed with chronic obstructive pulmonary disease with acute exacerbation, acute on chronic hypoxic respiratory failure (respiratory failure) and pneumonia. As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX), his symptoms had resulted in physical limitations not present prior to vaccination. He also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of vaccination, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, he suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  The chronic obstructive pulmonary disease, respiratory failure and pneumonia were considered disabling events.  Upon internal review, the respiratory failure and pneumonia were medically significant events.
Sex: M
Vaccine: VARZOS
Symptoms: Respiratory failure
Clinical narrative: chronic obstructive pulmonary disease with acute exacerbation; acute on chronic hypoxic respiratory failure; Pneumonia; This spontaneous report has been received from a lawyer regarding a case in litigation, concerning a male patient of unknown age. His concurrent conditions, medical history and concomitant medications were not reported. In or around 22-JAN-2015, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, lot #, expiration date, dosage, injection anatomical location or route of administration were not provided) as routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after vaccination, the patient suffered shortness of breath, cough and fever requiring multiple hospitalizations. He has been diagnosed with chronic obstructive pulmonary disease with acute exacerbation, acute on chronic hypoxic respiratory failure (respiratory failure) and pneumonia. As a direct and proximate result of defective zoster vaccine live (ZOSTAVAX), his symptoms had resulted in physical limitations not present prior to vaccination. He also experienced mental and emotional distress due to resulting physical limitations and seriousness of his condition. As a result of vaccination, the patient sustained severe and permanent personal injuries. Further, as a tragic consequence, he suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result, the patient had suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages.  The chronic obstructive pulmonary disease, respiratory failure and pneumonia were considered disabling events.  Upon internal review, the respiratory failure and pneumonia were medically significant events.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Lethargy, Lymph node pain, Lymphadenopathy, Pain
Clinical narrative: slight fever, lethargy, headache, body ache, lymph node under left arm was swollen and painful
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: slight fever, lethargy, headache, body ache, lymph node under left arm was swollen and painful
Age: 34.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site pain, Loss of personal independence in daily activities
Clinical narrative: Patient received flu vaccine on November 2, 2019 and phoned Regulatory Authority on 2/24/20 to c/o moderately severe pain in left shoulder after receiving flu vaccine. Denies numbness/tingling. Reports the pain interferes with ADL's. He has used OTC Ibuprofen for the pain since then, but not on a consistent basis. Unknown if he has sought evaluation for the pain.
Age: 27.0
Sex: F
Vaccine: TDAP
Symptoms: Blood glucose, Dizziness, Syncope, Tooth infection
Clinical narrative: Shortly after administering vaccine Tdap (Boostrix) at around 4:30 P.M patient felt ok, but was stating she felt a little dizzy. She was monitored for a few minutes and when she walked up front she felt dizzy again and fainted. She was worked up by MD with stable blood pressure and sugar levels. She was taken to hospital for further check up. followed up with patients parents on 3-3-2020 at 8:40 A.M and was told she was home doing well. Patient was worked up and found tooth infection and is being treated for infection all other exams were normal per conversation.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Injection site reaction, Injection site vesicles, Rash, Rash papular
Clinical narrative: Shingles in right upper arm (just seems to be a strange coincidence that it was the exact location of the vaccine.) symptoms are: painful, pruritic rash right upper arm. Lesions are cluster of  6-7 erythematous papules and vesicles.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash pruritic
Clinical narrative: Shingles in right upper arm (just seems to be a strange coincidence that it was the exact location of the vaccine.) symptoms are: painful, pruritic rash right upper arm. Lesions are cluster of  6-7 erythematous papules and vesicles.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Hyperhidrosis, Myalgia
Clinical narrative: Chills, 100 degree temperature, down to 98.8 after 8 hours, sweating, muscle soreness
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient received an expired dose of VARIVAX; No known adverse effects.; This spontaneous report was received from a nurse, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, and drug reactions/allergies were not reported. Concomitant therapies included sterile diluent.  On 27-FEB-2020, the patient was vaccinated with an expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) (lot number R002056, expiration date 22-JAN-2020) as prophylaxis (strength, dose number, frequency, route of administration, and anatomical vaccination site were not provided). No known adverse events were reported.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Papule
Clinical narrative: punctalz reddened aras on the hard palate. Papule (L) upper arm
Age: 17.0
Sex: F
Vaccine: HEPA, HPV4, MENB
Symptoms: Cellulitis, Erythema, Swelling
Clinical narrative: redness swelling Cellulitis given Bactrim; Zyrtec
Age: 37.0
Sex: M
Vaccine: FLU4
Symptoms: Chills, Myalgia, Pyrexia, Rash
Clinical narrative: SEVERE FEVERS, CHILLS & MUSCLE PAIN X 16 HOURS REPORTED RASH PREVIOUS YEAR AFTER TAKING VACCINE
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Body temperature increased, Chills, Dizziness, Ear discomfort
Clinical narrative: Uncontrollable shivering early in the morning (6:00 - 6:30 am), slightly elevated temp (99.9 at 7:00 am, down to 99.6 at 8:30 am, dizziness when moving my head as if ears are plugged, upset stomach.
Age: 6.0
Sex: M
Vaccine: MMR
Symptoms: Abdominal pain upper, Chest X-ray, Decreased appetite, Pneumonia, Respiratory tract congestion
Clinical narrative: stomach pain, congestion, loss of appetite, pneumonia
Age: 69.0
Sex: M
Vaccine: UNK
Symptoms: Blood test, Chills, Disorientation, Dizziness, Fatigue
Clinical narrative: On Tuesday 02/24/2020 I went to bed with severe chills. Woke up at @3am and while walking to the bathroom I was disoriented and then passed out TEMPORARILY and hit my backside and head on the floor. My wife came to my aide and I was profusely sweating and felt drained and light headed. I made my way back to my bed and my wife administered cold compresses to my head. Within @ 15 minutes I started to feel a bit better, but very tired. I fell asleep and woke the next day feeling like I had the Flu. We drove to the medical center Hospital and went to the Emergency Room where I was seen by Doctors. All vitals were taken and I had a fever of 101.2 and a low blood pressure. Blood and urine was taken and I was put on an IV DRIP. I was released after @ 5 hours and went home. That evening my temp spiked to 104. I took Iboprophen and after a couple of hours it started to come down. Now after 1 week from the vaccines my symptoms are very Flu like.
Age: 69.0
Sex: M
Vaccine: UNK
Symptoms: Hyperhidrosis, Hypotension, Loss of consciousness, Pyrexia, Urine analysis
Clinical narrative: On Tuesday 02/24/2020 I went to bed with severe chills. Woke up at @3am and while walking to the bathroom I was disoriented and then passed out TEMPORARILY and hit my backside and head on the floor. My wife came to my aide and I was profusely sweating and felt drained and light headed. I made my way back to my bed and my wife administered cold compresses to my head. Within @ 15 minutes I started to feel a bit better, but very tired. I fell asleep and woke the next day feeling like I had the Flu. We drove to the medical center Hospital and went to the Emergency Room where I was seen by Doctors. All vitals were taken and I had a fever of 101.2 and a low blood pressure. Blood and urine was taken and I was put on an IV DRIP. I was released after @ 5 hours and went home. That evening my temp spiked to 104. I took Iboprophen and after a couple of hours it started to come down. Now after 1 week from the vaccines my symptoms are very Flu like.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Erythema, Headache, Heart rate increased, Rash
Clinical narrative: rash to chest, redness, fast heart rate, headache
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, IPV, MMRV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given Kinrix which contains IPV and IPV on the same day . This gave her 2 doses at once and 5 doses of IPV all together. No adverse reactions have been noted or reported.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Musculoskeletal pain, Nausea
Clinical narrative: Nausea fever chills sore arm shoulder. Bad fatique 10 days later and headache
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity, Pyrexia
Clinical narrative: Nausea fever chills sore arm shoulder. Bad fatique 10 days later and headache
Age: 22.0
Sex: F
Vaccine: ANTH
Symptoms: Injection site erythema
Clinical narrative: Patient reports local, redness in injection site
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Cellulitis, Dizziness, Ear pain, Ear swelling
Clinical narrative: Patient developed Ramsay Hunt syndrome ~3 days after receiving the first shot of Shingrix.  He had a headache that day from the vaccine which has persisted.  By Tuesday Feb 25th he started feeling pain in his right ear.  On Wednesday his right ear became very swollen, bright red, and very painful.  He saw his doctor and was diagnosed with cellulitis and started on Keflex 500 mg every 6 hours with minimal to no improvement over the next two days.  He was also using a warm compress and taking Advil 400 mg every 8 hours for pain.  Beginning Friday evening, Feb 28, 2020 he started having facial paralysis, more intense pain that included headaches and pain behind and in front of his year, as well as swelling in those areas.  The facial paralysis progressed over that weekend on March 2 and March 3 with dizziness in the mornings upon waking, inability to completely close his right eye, and drooping right side of his mouth (inability to form a smile, whistle, or completely form a seal when drinking from a glass).  He also had some difficulty with speech and had some blistering with sores on his right external ear.  On Monday he was diagnosed with Ramsay Hunt syndrome from the Shingrix vaccine and started on valacyclovir 1 gm orally every 8 hours for 7 days and prednisone 20 mg tablets to take 3 tablets (60 mg) by mouth for 3 days, then 2 tablets (40 mg) for 3 days, then 1 tablet (20 mg) for 3 days.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Eyelid function disorder, Facial paralysis, Headache, Herpes zoster oticus
Clinical narrative: Patient developed Ramsay Hunt syndrome ~3 days after receiving the first shot of Shingrix.  He had a headache that day from the vaccine which has persisted.  By Tuesday Feb 25th he started feeling pain in his right ear.  On Wednesday his right ear became very swollen, bright red, and very painful.  He saw his doctor and was diagnosed with cellulitis and started on Keflex 500 mg every 6 hours with minimal to no improvement over the next two days.  He was also using a warm compress and taking Advil 400 mg every 8 hours for pain.  Beginning Friday evening, Feb 28, 2020 he started having facial paralysis, more intense pain that included headaches and pain behind and in front of his year, as well as swelling in those areas.  The facial paralysis progressed over that weekend on March 2 and March 3 with dizziness in the mornings upon waking, inability to completely close his right eye, and drooping right side of his mouth (inability to form a smile, whistle, or completely form a seal when drinking from a glass).  He also had some difficulty with speech and had some blistering with sores on his right external ear.  On Monday he was diagnosed with Ramsay Hunt syndrome from the Shingrix vaccine and started on valacyclovir 1 gm orally every 8 hours for 7 days and prednisone 20 mg tablets to take 3 tablets (60 mg) by mouth for 3 days, then 2 tablets (40 mg) for 3 days, then 1 tablet (20 mg) for 3 days.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Skin ulcer, Speech disorder
Clinical narrative: Patient developed Ramsay Hunt syndrome ~3 days after receiving the first shot of Shingrix.  He had a headache that day from the vaccine which has persisted.  By Tuesday Feb 25th he started feeling pain in his right ear.  On Wednesday his right ear became very swollen, bright red, and very painful.  He saw his doctor and was diagnosed with cellulitis and started on Keflex 500 mg every 6 hours with minimal to no improvement over the next two days.  He was also using a warm compress and taking Advil 400 mg every 8 hours for pain.  Beginning Friday evening, Feb 28, 2020 he started having facial paralysis, more intense pain that included headaches and pain behind and in front of his year, as well as swelling in those areas.  The facial paralysis progressed over that weekend on March 2 and March 3 with dizziness in the mornings upon waking, inability to completely close his right eye, and drooping right side of his mouth (inability to form a smile, whistle, or completely form a seal when drinking from a glass).  He also had some difficulty with speech and had some blistering with sores on his right external ear.  On Monday he was diagnosed with Ramsay Hunt syndrome from the Shingrix vaccine and started on valacyclovir 1 gm orally every 8 hours for 7 days and prednisone 20 mg tablets to take 3 tablets (60 mg) by mouth for 3 days, then 2 tablets (40 mg) for 3 days, then 1 tablet (20 mg) for 3 days.
Age: 6.0
Sex: M
Vaccine: HEPA
Symptoms: Hyperhidrosis, Hypopnoea, Hypotonia, Pallor, Respiratory rate increased
Clinical narrative: Patient  became very pale, limp, diaphoretic, had rapid shallow breathing, and would respond by nodding but did not speak (child normally speaks), about 15-20 minutes after the vaccine was given. Patient was laid down, feet were elevated, he drank juice and over the next 15-20 minutes symptoms slowly resolved. Vitals were taken and returned to normal.
Age: 67.0
Sex: M
Vaccine: FLU3, VARZOS
Symptoms: Influenza like illness, Nausea, Pain, Pyrexia, Vomiting
Clinical narrative: Patient started having severe nausea, resulted in vomiting which he rarely does. Low grade fever, body aches, and flu-like symptoms that lasted 72 hours. Patient stated he went to the emergency room after 48 hours of symptoms afraid he had caught something while in store. They gave him phenergan which helped with the nausea.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: During a 1/23/20 nursing appointment, the patient report that he developed a rash after taking the Shingrix vaccine on 6/20/2019. The patient did not elaborate on how severe the rash was, when it resolved, or if he took anything to help the rash resolve.  SkinRash
Age: 66.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: about 18hrs. after shot (L) arm became red & swollen, & sore (normal w/shot pain) (nothing serious) went from deltoid to elbow - only on inside of arm was red & swollen. Patient took advil and rash was clear within 2 days.
Age: 39.0
Sex: F
Vaccine: PPV
Symptoms: Rash
Clinical narrative: Rash
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Nausea, Vomiting
Clinical narrative: After receiving the Shingrix shot on 7/10/2019, the patient reported nausea/vomiting and erythema around the injection site for the next 3 days. After the 3 days, the symptoms resolved. The patient requested to not receive the second shot of the series.
Age: 54.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Decreased appetite, Myalgia, Poor quality sleep, Pyrexia
Clinical narrative: Joint pain and muscles aches beginning within 2-3 hours of vaccination which persisted 24+ hours.  Overnight fever developed (highest recorded 100.7 F but not checked until early morning). Poor sleep due to fever and muscle/joint pain. Decreased appetite.
Age: 0.83
Sex: F
Vaccine: FLUA3
Symptoms: Condition aggravated, Generalised tonic-clonic seizure, Partial seizures, Respiratory rate decreased, Seizure
Clinical narrative: responsive seizure within 24 hours of the vaccine. Has had another response in seizure at 6 months of age to vaccine Dtap & Flu shot that has caused body to react in seizure and not fever. Seizure at 6 months was hypotonic episode in which daughter was non-responsive, body limp and eyes rolled back. The seizure at this time was grand mal seizure with convulsions and very slowed breathing. Daughter has now had 3 grand mal seizures and 8 focal seizures following the grand mal ones. 2 of the 3 were within 24 hrs of vaccination.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Blister, Injection site erythema, Pain, Pruritus
Clinical narrative: That night right upper arm started turning a little red around injection site of DTaP/IPV.  Yesterday redness spread rapidly - mom drew line around area.  This morning redness spread outside of line and large blister has erupted in the middle of the redness with more smaller blisters appearing.  Very itchy and painful.   Plan:  CEPHALEXIN 250 MG/5ML PO RECON SUSP - 500 mg (10 mL) by mouth twice a day for 5 days and PREDNISOLONE SODIUM PHOSPHATE 15 MG/5ML PO SOLUTION - 22.2 mg (7.4 mL) by mouth twice a day for 3 days.  Keflex x 5 days Orapred to dampen blistering RTC if not improving
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Pustule, Rash, Rash pruritic
Clinical narrative: Possible Shingles rash on right anterolator/posteior shoulder. Erythema, with multiple small pustules present. Patient states rash as more painful than itchy.
Age: 11.0
Sex: M
Vaccine: MNQ, TDAP
Symptoms: Injection site erythema, Injection site swelling, Injection site warmth, Local reaction, Tenderness
Clinical narrative: His left thigh started with a small local reaction and now 2/3 of his thigh is red, swollen and warm to the touch.    Per PCP, these reactions are self- limited and are generally treated with cold or warm compresses, symptomatic treatment with antihistamines if itching, and corticosteroid topically to reduce warmth, erythema and tenderness, particularly if the reaction progressed over several days. Oral steriod was prescribed. Outcome unknown at this time.
Age: 13.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Blood glucose, Syncope
Clinical narrative: Patient in exam room with mother and older brother post immunizations. Other staff member called for help after finding patient had fainted on exam room floor. Patient was assessed by pediatricians, vital signs obtained, and blood glucose checked. At this time patient was conscious.  Patient was given water and crackers. Patient remained in exam room with mother and brother for approximately 45 minutes for observation.
Age: 60.0
Sex: F
Vaccine: FLUX
Symptoms: Diarrhoea, Malaise, Nausea, Vomiting
Clinical narrative: Nausea, diarehha, throwing up Have felt sick ever since That will be the last flu shot I ever get.
Age: 27.0
Sex: M
Vaccine: HPV4
Symptoms: Burning sensation, Pruritus
Clinical narrative: & burning, itching
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Rash, Rash pruritic, Urticaria
Clinical narrative: Rash, UrticariaPruritus & arm and body rash that itched 4 days after shingrix,
Age: 72.0
Sex: M
Vaccine: FLUC4
Symptoms: Urticaria
Clinical narrative: Pt visited ED 6 days after vaccination w/ urticarial rash that started 1 day after receiving the influenza vaccination.
Age: 70.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pain, Swelling, Tenderness
Clinical narrative: Redness, Swelling, Pain and Tenderness
Age: 40.0
Sex: F
Vaccine: HEP
Symptoms: Abdominal pain upper, Nausea, Pyrexia, Vomiting
Clinical narrative: 2/24/20 onset of nausea, vomiting, stomach pain, low grade fever 99.5, 99.9 degrees F, continuously including today 3/3/20 Temperature 100.0 degree F,
Age: 69.0
Sex: M
Vaccine: PPV
Symptoms: Injection site erythema, Injection site warmth, Nausea
Clinical narrative: Redness at site warmth at site nausea
Age: 59.0
Sex: M
Vaccine: TDAP
Symptoms: Pain
Clinical narrative: Prolonged pain with abduction of the left arm for three months post-vaccine.
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Cellulitis, Erythema, Pyrexia, Rash
Clinical narrative: diagnosed with cellulitis-fever-red circle with spots around it
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Laboratory test, Peripheral swelling, Rash
Clinical narrative: On February 28th, she got a rash all over her legs and her feet were very swollen. She went to the emergency room on February 29th and they told her she possibly has vasculitis and it caused a full rash on both legs. she is doing further testing.
Age: 46.0
Sex: M
Vaccine: MMR
Symptoms: Dizziness, Fatigue, Headache, Loss of consciousness, Tinnitus
Clinical narrative: 10 minutes after the MMR vaccine injection I fell unconscious for a couple minutes. After I had ringing/buzzing in my ears for 30 minutes, then felt dizzy for the next 5-6 hours. The rest of the evening I felt fatigued and had a head ache. The next morning I felt fine. No other adverse reactions since.
Age: 17.0
Sex: M
Vaccine: FLU4, HEP, MMR, TDAP
Symptoms: Ear pain, Fatigue, Otitis media acute, Pain, Pyrexia
Clinical narrative: The patient was previously un-vaccinated and was diagnosed with pertussis in December along with several siblings. He received his first immunizations on 2/14/20. Patient presented to urgent care on 2/15/20 with right ear pain and was diagnosed with right otitis media and prescribed amoxicillin-clavulanate 875-125 mg/tab (take 1 tablet by mouth two times a day for 7 days).  Patient then presented for evaluation on 2/26/20 with sudden onset of itchy rash on his hands, wrists, face, chest, back and abdomen. For the 2 days previous (2/24/20 & 2/25/20) he was running fevers and feeling achy and tired. Did not feel unwell on 2/26/20. The patient had taken 2 benadryl before arriving on 2/26/20 and it was starting to help. Patient was also discharged with a prescription of hydroxyzine HCL 25 mg tablet (take 25 mg by mouth every 6 hours, as needed for itching). Provider expected improvement in 24-48 hours.
Age: 17.0
Sex: M
Vaccine: FLU4, HEP, MMR, TDAP
Symptoms: Rash, Rash pruritic
Clinical narrative: The patient was previously un-vaccinated and was diagnosed with pertussis in December along with several siblings. He received his first immunizations on 2/14/20. Patient presented to urgent care on 2/15/20 with right ear pain and was diagnosed with right otitis media and prescribed amoxicillin-clavulanate 875-125 mg/tab (take 1 tablet by mouth two times a day for 7 days).  Patient then presented for evaluation on 2/26/20 with sudden onset of itchy rash on his hands, wrists, face, chest, back and abdomen. For the 2 days previous (2/24/20 & 2/25/20) he was running fevers and feeling achy and tired. Did not feel unwell on 2/26/20. The patient had taken 2 benadryl before arriving on 2/26/20 and it was starting to help. Patient was also discharged with a prescription of hydroxyzine HCL 25 mg tablet (take 25 mg by mouth every 6 hours, as needed for itching). Provider expected improvement in 24-48 hours.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Injection site pain, Pyrexia
Clinical narrative: After 1 hour:  Muscle soreness to area of injection. After 7 hours:  chills After 12 hours:  tired, fever After 24 hours:  headache, continued
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Atrial fibrillation, Condition aggravated
Clinical narrative: Atrial Fibrilation (rapid heart beat)- she has not seen a physician yet.  She stated that she is taking medication that she has for this condition (did not state what it was) and she was waiting to see if it subsides on its own.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain in extremity, Rash
Clinical narrative: pt  complaints  about redness  , rash  all over the body and  sore arm
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: product storage error; No adverse event; This spontaneous report was received from a nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, drug reactions and allergies were unknown. Concomitant therapies included sterile diluent (lot # N031941, expiration date 03-AUG-2020). On 27-FEB-2020, the patient was vaccinated with measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant human albumin (rHA) (PROQUAD) with lot # S013715, expiration date 01-NOV-2020 (dose, frequency, anatomical location were unknown) via unspecified route for prophylaxis. The measles, mumps, rubella and varicella (oka-merck) virus vaccine live, recombinant human albumin (rHA) (PROQUAD) was reconstituted with properly stored sterile diluent at a temperature of 6 degrees Fahrenheit to 14 degrees Fahrenheit or minus 14 degree Celsius to minus 10 degree Celsius at minus 12.1 degree Celsius for a time frame of 4 hours. There was a previous temperature excursion. The temperature of 6 degrees Fahrenheit to 14 degrees Fahrenheit or minus 14 degree Celsius to minus 10 degree Celsius at minus 12.1 degree Celsius for a time frame of 6 hours 30 minutes. Digital data logger was involved. No adverse effects were reported. Product quality complaint (PQC) was not involved.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Myalgia, Pain
Clinical narrative: Pain, redness and swelling at injection site, generalized muscle aches and pain
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Painful rash at alternate site
Age: 53.0
Sex: F
Vaccine: TD, VARZOS
Symptoms: Borrelia test, Facial paralysis, Hypoaesthesia oral, Paraesthesia oral
Clinical narrative: Started developing tongue numbness and tingling 48 hours after the immunizations which then progressed to a slight right facial droop consistent with Bell's palsy. She was started on Prednisone and Valtrex
Age: 23.0
Sex: F
Vaccine: HPV9
Symptoms: Feeling abnormal, Hormone level abnormal, Pain in extremity, Polycystic ovaries, Syncope
Clinical narrative: Fainted within 5 minutes. Felt like my brain was robbed of oxygen forever. Was never warned the doctors never even put a note on file about it. My arm hurt for months. 9 months later I was diagnosed with ovarian issues polycystic ovarian syndrome
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site infection, Injection site pain, Injection site swelling
Clinical narrative: Patient's wife stated that the patient experience reddness, swelling, bruising (black and blue), pain, and site was hot to the touch. Pt went to doctor's office and was prescribed cephalexin since he was told it was infected. Script was filled on 3/2/20.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site warmth
Clinical narrative: Patient's wife stated that the patient experience reddness, swelling, bruising (black and blue), pain, and site was hot to the touch. Pt went to doctor's office and was prescribed cephalexin since he was told it was infected. Script was filled on 3/2/20.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site cellulitis, Injection site erythema
Clinical narrative: Patient has a large red area and cellulitis at center of red spot where injection was given.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Computerised tomogram, Dyskinesia, Nausea, Pain, Pain in extremity
Clinical narrative: patient had intractable pain from the right arm.  Nausea and vomiting and uncontrollable are movement.
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Vomiting, X-ray limb
Clinical narrative: patient had intractable pain from the right arm.  Nausea and vomiting and uncontrollable are movement.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: patient experienced rash over the upper 1/3 of her body she sought medical attention for it and it was diagnosed as shingles
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Erythema, Skin warm
Clinical narrative: Patient experienced redness and warmth on the arm below the injection site.
Age: 53.0
Sex: F
Vaccine: TDAP
Symptoms: Nodule, Pruritus
Clinical narrative: RAISED KNOT AND ITHCING THAT WENT AWAY
Age: 27.0
Sex: F
Vaccine: HPV9
Symptoms: Erythema, Rash, Urticaria
Clinical narrative: Rash- raised red wheals on forehead,under left eye, peri oral.
Age: 11.0
Sex: F
Vaccine: HPV9
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Per mother, pt. had large reddened, swollen area to site.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Insomnia
Clinical narrative: Red, swollen and hurt and the injection site for more than 3 days, then swollen traveled down to elbow.  Patient claimed it's hurtful and patient can't sleep.  Patient went to see doctor and was prescribed antibiotic for it for 10 days.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Feeling abnormal
Clinical narrative: Patient reported on 7/5/2019 that the Zoster vaccine he received on 3/15/19 had caused him to "feel terrible" six hours after the injection and for 2 days thereafter. The patient refused the second shot in the series.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: Patient reported having erythema during an 8/9/2019 primary care visit. The patient visited the vaccine back in October of 2018. The patient has already gotten both the vaccines in the series.  & Erythema
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pruritus, Rash erythematous, Rash pruritic
Clinical narrative: Pt called into the telephone triage service on 10/08/2019 stating that he had a pink, itchy rash for 3 days after receiving his dose of the Shingrix vaccine on 10/03/2019. The patient said during the call that the injection site area still itched, but his other symptoms resolved. The patient did not use any agent to relieve his symptoms.
Age: 62.0
Sex: M
Vaccine: PPV, VARZOS
Symptoms: Cellulitis
Clinical narrative: & cellulitis
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: & swelling
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: Patient was seen in the urgent care the day after she received the Shingrix vaccine. The patient experienced erythema and edema around the injection site. She did not require treatment for this issue to resolve.
Age: 86.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus
Clinical narrative: After receiving an injection of the recombinant herpes zoster (shingles) vaccine on 8/2/2019, the patient returned to the clinic with an area of pruritus and redness around the injection site approximately 4x6cm. The Zoster vaccine was discontinued thereafter (ie. the patient will not be getting the second shot in the series).
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Endoscopy abnormal, Oesophageal achalasia, Oesophageal dilatation, Oesophagogastroduodenoscopy abnormal, Productive cough
Clinical narrative: PER CHILD'S FATHER'S CONVERSATION WITH DR ON 11/25/2019 - AFTER 8/2/2016 VISIT WITH DR CHILD WAS TREMULOUS BUT THAT WENT AWAY. HE THEN STARTED WITH A WET COUGH THAT LASTED AN ENTIRE YEAR. FINALLY HE WAS DX WITH ACHALASIA PROBABLY COUGH WAS THE FIRST SIGN. DR INFORMED FATHER THAT BETWEEN 2016 & 2018 THAT HIS CHILD DID NOT COME TO US FOR CARE.
Age: 5.0
Sex: M
Vaccine: DTAP, IPV, MMR, VARCEL
Symptoms: Tremor
Clinical narrative: PER CHILD'S FATHER'S CONVERSATION WITH DR ON 11/25/2019 - AFTER 8/2/2016 VISIT WITH DR CHILD WAS TREMULOUS BUT THAT WENT AWAY. HE THEN STARTED WITH A WET COUGH THAT LASTED AN ENTIRE YEAR. FINALLY HE WAS DX WITH ACHALASIA PROBABLY COUGH WAS THE FIRST SIGN. DR INFORMED FATHER THAT BETWEEN 2016 & 2018 THAT HIS CHILD DID NOT COME TO US FOR CARE.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Diarrhoea, Headache, Influenza like illness, Myalgia
Clinical narrative: Flu like symptoms for 24 hrs including 101 fever, chills, vomiting, diarrhea muscle pain- Headache Received Shingrix shot - Had symptoms 1st shot but 2nd shot severe
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Vomiting
Clinical narrative: Flu like symptoms for 24 hrs including 101 fever, chills, vomiting, diarrhea muscle pain- Headache Received Shingrix shot - Had symptoms 1st shot but 2nd shot severe
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Hyperhidrosis, Loss of personal independence in daily activities, Myalgia
Clinical narrative: I received my second Zostavax vaccination. For the next 3 days, I had muscle pain all over but mostly in my lower back, which was not reduced by naproxen or acetaminophen; fever enough to soak me in sweat alternating with chills enough to wear and zip up my coat in a typical office setting; and fatigue nearly enough to fall asleep at my desk. I was able to push through with typical duties but for a reduced duration, like leaving work early.
Sex: M
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: I received my second Zostavax vaccination. For the next 3 days, I had muscle pain all over but mostly in my lower back, which was not reduced by naproxen or acetaminophen; fever enough to soak me in sweat alternating with chills enough to wear and zip up my coat in a typical office setting; and fatigue nearly enough to fall asleep at my desk. I was able to push through with typical duties but for a reduced duration, like leaving work early.
Age: 0.33
Sex: F
Vaccine: PNC13, RV5
Symptoms: Oral mucosal erythema, Soft tissue swelling
Clinical narrative: Patient developed severe swelling and redness of sublingual papilla 2 days after getting Rota Teq and Prevnar 13 immunizations.
Age: 18.0
Sex: F
Vaccine: HPV9
Symptoms: Peripheral swelling, Pruritus, Urticaria
Clinical narrative: Got the gardasil shot on a friday, sunday night my body was itchy. Monday I was covered in hives. Tuesday my foot and hand is swollen and still breaking out in hives.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Erythema, Herpes zoster, Injection site reaction, Pain
Clinical narrative: Develop an acute case of shingles at the site of Shingrix injection Received 1st Shingrix shot LT deltoid 2/3/2020, symptoms of redness, pain and swelling started 2/7/2020, followed the next day 2/8/20 with blisters, itchiness and more pain.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pruritus, Swelling, Varicella virus test positive
Clinical narrative: Develop an acute case of shingles at the site of Shingrix injection Received 1st Shingrix shot LT deltoid 2/3/2020, symptoms of redness, pain and swelling started 2/7/2020, followed the next day 2/8/20 with blisters, itchiness and more pain.