chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Full blood count normal, Lymphadenopathy, Metabolic function test normal, Mononucleosis heterophile test negative, Parotid gland enlargement
Clinical narrative: Extreme swelling of lymph nodes and parotid glands in the neck and jaw area extending into the lower face and below the ears.  Also swelling in the upper center chest directly below the neck.  Scratchy throat, itchy eyes, dry mouth and some trouble swallowing in the morning when awakening.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Swelling, Throat irritation
Clinical narrative: Extreme swelling of lymph nodes and parotid glands in the neck and jaw area extending into the lower face and below the ears.  Also swelling in the upper center chest directly below the neck.  Scratchy throat, itchy eyes, dry mouth and some trouble swallowing in the morning when awakening.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Blood test, Dry mouth, Lymphadenopathy, Oesophageal discomfort, Swelling
Clinical narrative: Extreme swelling of lymph nodes and parotid glands in the neck and jaw area extending into the lower face and below the ears.  Also swelling in the upper center chest directly below the neck.  Scratchy throat, itchy eyes, dry mouth and some trouble swallowing in the morning when awakening.
Age: 60.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Swelling face
Clinical narrative: Extreme swelling of lymph nodes and parotid glands in the neck and jaw area extending into the lower face and below the ears.  Also swelling in the upper center chest directly below the neck.  Scratchy throat, itchy eyes, dry mouth and some trouble swallowing in the morning when awakening.
Age: 0.17
Sex: M
Vaccine: RV1
Symptoms: Abdominal pain, Culture stool, Diarrhoea, Pyrexia, Ultrasound scan
Clinical narrative: Abdominal pain diarrhea fever
Age: 0.17
Sex: M
Vaccine: RV1
Symptoms: X-ray
Clinical narrative: Abdominal pain diarrhea fever
Age: 34.0
Sex: F
Vaccine: UNK
Symptoms: Blood test, Pyrexia
Clinical narrative: Fever
Age: 50.0
Sex: F
Vaccine: FLUC4
Symptoms: Urticaria
Clinical narrative: Hives on legs, stomach, and back beginning a few hours after vaccination, ongoing today
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: Patient described a hive like reaction that required her to go to urgent care. She did not disclose the treatment she received.
Age: 50.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Patient said 2 days after receiving the vaccine it was swollen under his arm. He said his arm still hurt. Felt better in about a week.
Age: 11.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Blood culture positive, Erythema, Fasciitis, Hypersensitivity, Magnetic resonance imaging abnormal
Clinical narrative: Patient and Mom both presented at pharmacy stating rheumatologist (Dr) reccommended pneumonia and flu vaccines for patient based on immuno-compromised state. In the evening following vaccination, patient developed high fever 103 degree +, and right arm pain/redness. Mom could not get fever to break with Tylenol and Motrin, so took patient into hospital.  Hospital testing revealed possible cellulitis and sepsis, pt started on Vancomycin therapy to treat, but then symptoms did not resolve.  Patient ended up needing dose of Solumedrol in hospital as well to have relief from symptoms and mom stated patient in patient at hospital for 7 nights and was discharged on steroid and antibiotic therapy (precautionary) and believe patient may have underlying immune disorder that created intensified allergic reaction to vaccine.
Age: 11.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Myositis, Pain in extremity, Pyrexia
Clinical narrative: Patient and Mom both presented at pharmacy stating rheumatologist (Dr) reccommended pneumonia and flu vaccines for patient based on immuno-compromised state. In the evening following vaccination, patient developed high fever 103 degree +, and right arm pain/redness. Mom could not get fever to break with Tylenol and Motrin, so took patient into hospital.  Hospital testing revealed possible cellulitis and sepsis, pt started on Vancomycin therapy to treat, but then symptoms did not resolve.  Patient ended up needing dose of Solumedrol in hospital as well to have relief from symptoms and mom stated patient in patient at hospital for 7 nights and was discharged on steroid and antibiotic therapy (precautionary) and believe patient may have underlying immune disorder that created intensified allergic reaction to vaccine.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Dyspnoea, Fatigue, Headache
Clinical narrative: Rash on feet (went away after 10 days).  Severe headaches. Rash at injection site. Went away in 3 days.  Weakness, difficulty breathing, shivering, fatigue - ongoing after 12 days.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Influenza virus test negative, Injection site rash, Rash
Clinical narrative: Rash on feet (went away after 10 days).  Severe headaches. Rash at injection site. Went away in 3 days.  Weakness, difficulty breathing, shivering, fatigue - ongoing after 12 days.
Age: 64.0
Sex: F
Vaccine: PPV
Symptoms: Peripheral swelling
Clinical narrative: arm swollen from shot
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Myalgia, Pain
Clinical narrative: Extreme muscle ache, headache, fatigue, pain level 7
Age: 82.0
Sex: F
Vaccine: VARZOS
Symptoms: Dizziness, Headache, Nausea, Pain in extremity, Pyrexia
Clinical narrative: SORE ARM,, Next morning woke up very dizzy, stood up and got nauseous, later in day had headache and fever of 100.1
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Inflammation, Pain in extremity, Peripheral swelling, Rash erythematous, Skin warm
Clinical narrative: Patient's Right arm is warm to touch and swollen.  It's very painful for the first 3-5 days.  Patient also experiences some small red dots for the first 3 days but it went away after 1 week.  Advise patient to take some Ibuprofen to help with inflammation and pain but patient declined.
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Borrelia test negative, Disorientation, Encephalitis viral, Influenza like illness, Malaise
Clinical narrative: Low fever and malaise (flu-like) began late 11/13 and continued next day, worsening to disorientation and loss of mental clarity. Hospitalized 11/15/2019 -11/25/2019 for urgent treatment of viral encephalitis.
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Mental disorder, Pyrexia, Viral test negative, West Nile virus test negative
Clinical narrative: Low fever and malaise (flu-like) began late 11/13 and continued next day, worsening to disorientation and loss of mental clarity. Hospitalized 11/15/2019 -11/25/2019 for urgent treatment of viral encephalitis.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue
Clinical narrative: shivers from approximately 9:00 PM until 1:00 AM. it did not seem like a fever as I did not sweat. I felt run down and tired the following day. Felt normal two days following vaccine
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Balance disorder, Chills, Decreased appetite, Feeling cold, Injection site pain
Clinical narrative: Moderate  pain at the injection site. Approximately 10 hours after vaccination I experienced profound shivering. This lasted from about 1-5 AM. Sometimes I felt very cold, but not always during this time. I was also very unsteady on my feet. The latter has persisted through Day 2. I did not experience nausea. I did not take any OTC pain relievers but did continue taking my usual medications. It is now the end of Day 2 and the arm pain is fading. I?m still a bit unsteady on my feet. Appetite has also recovered. BTW I experienced exactly the same issues after receiving the first dose of Shingrix on 9/11/2019.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Vaccine positive rechallenge
Clinical narrative: Moderate  pain at the injection site. Approximately 10 hours after vaccination I experienced profound shivering. This lasted from about 1-5 AM. Sometimes I felt very cold, but not always during this time. I was also very unsteady on my feet. The latter has persisted through Day 2. I did not experience nausea. I did not take any OTC pain relievers but did continue taking my usual medications. It is now the end of Day 2 and the arm pain is fading. I?m still a bit unsteady on my feet. Appetite has also recovered. BTW I experienced exactly the same issues after receiving the first dose of Shingrix on 9/11/2019.
Age: 80.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Hypersensitivity
Clinical narrative: PATIENT'S DAUGHTER REPORTED PATIENT WAS HOSPITALIZED WITH SEVERE ALLERGIC REACTION, DAY AFTER VACCINE ADMINISTRATION
Age: 81.0
Sex: F
Vaccine: FLU3
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Soreness of the left arm that started a few days after the vaccine.  No issues right after the vaccine.  Then about one week after the vaccine, patient experience pain the arm and she cannot move the arm too high.  Will see the MD on 12-31-19 but will try to see the MD sooner.
Age: 6.0
Sex: F
Vaccine: FLUC4
Symptoms: Loss of consciousness, Syncope, Urinary incontinence
Clinical narrative: Pt had a reported history of feeling dizzy and vomiting after vaccination.  The patient was nervous and anxious for the vaccination and was being held by her father.  After the vaccine was given the pt experienced vasovagal syncope and briefly lost consciousness in her fathers arms and urinated. The pt quickly regained consciousness. the pt was observed for approximately 5 min. and it was suggested she stay for 15 minutes but she appeared to be fine and the parents decided against staying.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Injection site erythema, Injection site pain, Injection site swelling, Neck pain
Clinical narrative: Patient experienced a tender, red swallen area around the injection site and also noticed her neck hurt several days after the vaccine and she felt weak.
Age: 62.0
Sex: M
Vaccine: VARZOS
Symptoms: Lethargy, Myalgia, Pyrexia
Clinical narrative: Systemic muscle aches, fever, lethargy
Age: 58.0
Sex: M
Vaccine: FLU4
Symptoms: Guillain-Barre syndrome, Immunoglobulin therapy, Mechanical ventilation, Paralysis
Clinical narrative: Patient diagnosed with Guillain-Barré syndrome, paralyzed from the neck down, unable to breath on his own.  Patient started having symptoms about a week before full paralysis on 11/18/2019.  Patient was on vacation and is now hospitalized.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Joint stiffness, Tendon disorder
Clinical narrative: Patient stated received 2nd Shingrix dose and day after the 2nd dose was administered, patient had "tightness" in knee that he had replaced this summer. The tightness then moved to his achilles tendon and is still there. Patient also stated that he received vaccination in left arm (verified) and this occurred in left knee (same knee that was replaced) and left achilles tendon only. Patient stated received first shingrix while in a recovery home after knee replacement. Patient stated he asked his physician about this "reaction" and Dr said he had not heard of it and would have to look it up and patient hadn't heard anything from physician.
Age: 80.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pain, Swelling
Clinical narrative: Severe soreness, mild/moderate redness, and swelling
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Influenza like illness, Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Patient states that post immunization, he experienced flu like symptoms, but no fever. Then two days later he said his right arm became sore from the shoulder blade down to his tricep. He said by the third day, it felt like his whole arm was paralyzed and he could not move it up and down. There is swelling at the tricep and a red rash. Patient went to an urgent care where they prescribed Prednisone 20mg 5 days of therapy and Clindamycin 300mg  with 10 days of therapy.
Age: 71.0
Sex: M
Vaccine: FLU3
Symptoms: Injection site swelling
Clinical narrative: Patient states that post immunization, he experienced flu like symptoms, but no fever. Then two days later he said his right arm became sore from the shoulder blade down to his tricep. He said by the third day, it felt like his whole arm was paralyzed and he could not move it up and down. There is swelling at the tricep and a red rash. Patient went to an urgent care where they prescribed Prednisone 20mg 5 days of therapy and Clindamycin 300mg  with 10 days of therapy.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Anxiety, Autoimmune thyroiditis, Bacterial infection, Barium swallow, Bedridden
Clinical narrative: I spent the first 24 years of my life totally healthy! I lived a very active,  healthy and full life with my husband and 2 dogs.  My health started to decline after my first and second gardasil vaccination but I never questioned that the vaccination caused my problems, I just thought it was a coincidence that the time lines matched up.  I developed Celiac Disease, Hashimotos Disease, severe stomach problems, motility issues, heart burn, anxiety, and neurological problems like neuropathy and parethesia.  After my third and final vaccination I woke up the next morning and had a severe profound fatigue that left me bed bound.  That fatigue never went away.  This time I new it was indeed the vaccination. It has been almost 1.5 years since my last vaccination and my life is completely ruined.  I quit my job, quit school, and spend 90% of my time in bed too tired to even watch TV.  My immune system has been completely ruined and now I have several other bacterial and viral infections I live with.  The gardasil vaccination ruined my, I would give anything to go back in time and undo it.  I think it is also worth noting that when I was 17 years old I had the first and second round of the gardasil vaccination, but I never went back to receive the third.  Then, 7 years later I was told I should restart and get all 3 vaccinations in the 6 months timeline that is recommended.  So I have actually had 5 gardasil vaccinations.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Blood test, Coeliac disease, Colonoscopy, Dyspepsia, Endoscopy
Clinical narrative: I spent the first 24 years of my life totally healthy! I lived a very active,  healthy and full life with my husband and 2 dogs.  My health started to decline after my first and second gardasil vaccination but I never questioned that the vaccination caused my problems, I just thought it was a coincidence that the time lines matched up.  I developed Celiac Disease, Hashimotos Disease, severe stomach problems, motility issues, heart burn, anxiety, and neurological problems like neuropathy and parethesia.  After my third and final vaccination I woke up the next morning and had a severe profound fatigue that left me bed bound.  That fatigue never went away.  This time I new it was indeed the vaccination. It has been almost 1.5 years since my last vaccination and my life is completely ruined.  I quit my job, quit school, and spend 90% of my time in bed too tired to even watch TV.  My immune system has been completely ruined and now I have several other bacterial and viral infections I live with.  The gardasil vaccination ruined my, I would give anything to go back in time and undo it.  I think it is also worth noting that when I was 17 years old I had the first and second round of the gardasil vaccination, but I never went back to receive the third.  Then, 7 years later I was told I should restart and get all 3 vaccinations in the 6 months timeline that is recommended.  So I have actually had 5 gardasil vaccinations.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Fatigue, Gastric disorder, Gastric emptying study, Gastrointestinal motility disorder, Immune system disorder
Clinical narrative: I spent the first 24 years of my life totally healthy! I lived a very active,  healthy and full life with my husband and 2 dogs.  My health started to decline after my first and second gardasil vaccination but I never questioned that the vaccination caused my problems, I just thought it was a coincidence that the time lines matched up.  I developed Celiac Disease, Hashimotos Disease, severe stomach problems, motility issues, heart burn, anxiety, and neurological problems like neuropathy and parethesia.  After my third and final vaccination I woke up the next morning and had a severe profound fatigue that left me bed bound.  That fatigue never went away.  This time I new it was indeed the vaccination. It has been almost 1.5 years since my last vaccination and my life is completely ruined.  I quit my job, quit school, and spend 90% of my time in bed too tired to even watch TV.  My immune system has been completely ruined and now I have several other bacterial and viral infections I live with.  The gardasil vaccination ruined my, I would give anything to go back in time and undo it.  I think it is also worth noting that when I was 17 years old I had the first and second round of the gardasil vaccination, but I never went back to receive the third.  Then, 7 years later I was told I should restart and get all 3 vaccinations in the 6 months timeline that is recommended.  So I have actually had 5 gardasil vaccinations.
Age: 25.0
Sex: F
Vaccine: HPV9
Symptoms: Loss of personal independence in daily activities, Neurological symptom, Neuropathy peripheral, Paraesthesia, Viral infection
Clinical narrative: I spent the first 24 years of my life totally healthy! I lived a very active,  healthy and full life with my husband and 2 dogs.  My health started to decline after my first and second gardasil vaccination but I never questioned that the vaccination caused my problems, I just thought it was a coincidence that the time lines matched up.  I developed Celiac Disease, Hashimotos Disease, severe stomach problems, motility issues, heart burn, anxiety, and neurological problems like neuropathy and parethesia.  After my third and final vaccination I woke up the next morning and had a severe profound fatigue that left me bed bound.  That fatigue never went away.  This time I new it was indeed the vaccination. It has been almost 1.5 years since my last vaccination and my life is completely ruined.  I quit my job, quit school, and spend 90% of my time in bed too tired to even watch TV.  My immune system has been completely ruined and now I have several other bacterial and viral infections I live with.  The gardasil vaccination ruined my, I would give anything to go back in time and undo it.  I think it is also worth noting that when I was 17 years old I had the first and second round of the gardasil vaccination, but I never went back to receive the third.  Then, 7 years later I was told I should restart and get all 3 vaccinations in the 6 months timeline that is recommended.  So I have actually had 5 gardasil vaccinations.
Age: 55.0
Sex: M
Vaccine: FLUC4
Symptoms: Erythema, Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: patient says cant move arm, painful, swelling, no redness
Age: 41.0
Sex: F
Vaccine: TDAP
Symptoms: Injection site nerve damage, Injection site pain, Neck pain, Pain, Pain in extremity
Clinical narrative: While receiving the Adacel IMZ the patient said she felt the needle hit her nerve. She said after that she has pain from her arm to the back of her neck on the right side above the shoulder. She states that is hurts when she sweeps the floor. Patient stated that she has not seen her doctor about the pain. She said it is slowly getting better.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site cellulitis, Injection site erythema, Injection site induration, Injection site pain, Injection site swelling
Clinical narrative: Induration, pain, spreading erythema around the injection site up to around 8 cm in diameter.  Seen in clinic 2 days later, and clinically appeared to be cellulitis. Started on cephalexin, and the pain/redness/swelling was markedly improved the following day per mother's report on 12/7/19
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Muscular weakness, Nausea
Clinical narrative: Flu-like symptoms within 10 hours - chills, nausea, muscle weakness
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Cough, Fatigue, Injection site erythema, Injection site pain
Clinical narrative: 8PM-cough, throat tight, "lump" in throat, throat red/streaked. Used cough drop. 8:23PM Benadryl 25mg. ~9PM throat "opens up", fell asleep. 10PM chills, shaking, teeth chatter, muscle spasms in arms, legs, & neck. No fever. 10:40PM Tylenol 500mg. 10:40PM "hear pulse", "achy", awake every 1-2 hours all night. 11PM decrease in spasms, fell asleep. 11/30 8AM awaken exhausted, shower. 8:30-9AM vomit (fluid) X4. 9-11AM sleep. 11AM decrease Nausea. 11/30 &12/1 able to be up but extremely tired. 12/2 "back to normal". Mild soreness/redness at injection site (no streaks or rash). No Headache. No Fever. No Issues since. First time receiving High-Dose. No Issues with any other flu shot in the past. Patient did notify physician.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Muscle spasms, Nausea, Pain, Pharyngeal erythema, Sensation of foreign body
Clinical narrative: 8PM-cough, throat tight, "lump" in throat, throat red/streaked. Used cough drop. 8:23PM Benadryl 25mg. ~9PM throat "opens up", fell asleep. 10PM chills, shaking, teeth chatter, muscle spasms in arms, legs, & neck. No fever. 10:40PM Tylenol 500mg. 10:40PM "hear pulse", "achy", awake every 1-2 hours all night. 11PM decrease in spasms, fell asleep. 11/30 8AM awaken exhausted, shower. 8:30-9AM vomit (fluid) X4. 9-11AM sleep. 11AM decrease Nausea. 11/30 &12/1 able to be up but extremely tired. 12/2 "back to normal". Mild soreness/redness at injection site (no streaks or rash). No Headache. No Fever. No Issues since. First time receiving High-Dose. No Issues with any other flu shot in the past. Patient did notify physician.
Age: 65.0
Sex: F
Vaccine: FLU3
Symptoms: Throat tightness, Tremor, Vomiting
Clinical narrative: 8PM-cough, throat tight, "lump" in throat, throat red/streaked. Used cough drop. 8:23PM Benadryl 25mg. ~9PM throat "opens up", fell asleep. 10PM chills, shaking, teeth chatter, muscle spasms in arms, legs, & neck. No fever. 10:40PM Tylenol 500mg. 10:40PM "hear pulse", "achy", awake every 1-2 hours all night. 11PM decrease in spasms, fell asleep. 11/30 8AM awaken exhausted, shower. 8:30-9AM vomit (fluid) X4. 9-11AM sleep. 11AM decrease Nausea. 11/30 &12/1 able to be up but extremely tired. 12/2 "back to normal". Mild soreness/redness at injection site (no streaks or rash). No Headache. No Fever. No Issues since. First time receiving High-Dose. No Issues with any other flu shot in the past. Patient did notify physician.
Age: 39.0
Sex: M
Vaccine: FLU4
Symptoms: Anaphylactic reaction
Clinical narrative: Anaphylaxis occurring approximately 3 hours after vaccine administration. Patient reported to emergency room.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Guillain-Barre syndrome, Immunoglobulin therapy, Intensive care, Pain in extremity, Paralysis
Clinical narrative: RECEIVED FLUZONE HD ON 9/25/19. PATIENT FELT ARM SORENESS FOR 2-3 DAYS AFTER IMMUNIZATION. AROUND 2 & 1/2 WEEKS LATER FELT "WOBBLY" AND WENT TO ER NEXT DAY. PARALYSIS ORIGINATING AT FEET AND PROGRESSED TO RESPIRATORY ISSUES. DIAGNOSED WITH GUILLAN-BARRE SECONDARY TO FLU SHOT. PATIENT RECEIVED IVIG, IN ICU FOR 2 WEEKS, ACUTE NURSING FOR 4 WEEKS, CURRENT UNDER CARE TO GET OFF TRACHEA ASSISTANCE AND TO WALK UNASSISTED. VAR FORM CORRECTLY FILLED OUT AND THE VIS SHEET WAS DOCUMENTED AS GIVEN TO PATIENT. HUSBAND REPORTED ADVERSE EVENT TO PHARMACY FOR THE 1ST TIME ON 12/07/19.
Age: 69.0
Sex: F
Vaccine: FLU3
Symptoms: Respiratory disorder, Tracheostomy, Walking aid user
Clinical narrative: RECEIVED FLUZONE HD ON 9/25/19. PATIENT FELT ARM SORENESS FOR 2-3 DAYS AFTER IMMUNIZATION. AROUND 2 & 1/2 WEEKS LATER FELT "WOBBLY" AND WENT TO ER NEXT DAY. PARALYSIS ORIGINATING AT FEET AND PROGRESSED TO RESPIRATORY ISSUES. DIAGNOSED WITH GUILLAN-BARRE SECONDARY TO FLU SHOT. PATIENT RECEIVED IVIG, IN ICU FOR 2 WEEKS, ACUTE NURSING FOR 4 WEEKS, CURRENT UNDER CARE TO GET OFF TRACHEA ASSISTANCE AND TO WALK UNASSISTED. VAR FORM CORRECTLY FILLED OUT AND THE VIS SHEET WAS DOCUMENTED AS GIVEN TO PATIENT. HUSBAND REPORTED ADVERSE EVENT TO PHARMACY FOR THE 1ST TIME ON 12/07/19.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Cerebral haemorrhage, Clavicle fracture, Syncope
Clinical narrative: Within 20-30 minutes after receiving this injection I lost consciousness and fell fracturing my scull in two places and my left clavicle. I required acute hospitalization including transfer to two different  hospitals with intensive care and rehabilitation.  I have never lost consciousness  before.
Age: 72.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Clavicle fracture, Fall, Intensive care, Loss of consciousness, Skull fracture
Clinical narrative: Within 20-30 minutes after receiving this injection I lost consciousness and fell fracturing my scull in two places and my left clavicle. I required acute hospitalization including transfer to two different  hospitals with intensive care and rehabilitation.  I have never lost consciousness  before.
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Chest pain, Differential white blood cell count, Dizziness, Dysgeusia
Clinical narrative: Metalic taste in the mouth, numbness of the mouth and throat, pain in throat and chest, lightheaded, feeling of high pressure in the head, high blood pressure, nausea, body weakness, pallor. Treatment: taken to ER, given IV medication and IV fluids Outcome: Discharged home after 4 to 5 hours after reaction
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Electrocardiogram normal, Full blood count, Head discomfort, Hypertension, Hypoaesthesia oral
Clinical narrative: Metalic taste in the mouth, numbness of the mouth and throat, pain in throat and chest, lightheaded, feeling of high pressure in the head, high blood pressure, nausea, body weakness, pallor. Treatment: taken to ER, given IV medication and IV fluids Outcome: Discharged home after 4 to 5 hours after reaction
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Oropharyngeal pain, Pallor, Pharyngeal hypoaesthesia
Clinical narrative: Metalic taste in the mouth, numbness of the mouth and throat, pain in throat and chest, lightheaded, feeling of high pressure in the head, high blood pressure, nausea, body weakness, pallor. Treatment: taken to ER, given IV medication and IV fluids Outcome: Discharged home after 4 to 5 hours after reaction
Age: 53.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth, Pain
Clinical narrative: all body hurts injection side redness and tender and hot swollen arm
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Nausea
Clinical narrative: 12/1/2019 9:50 am nausea. Continued until 12/2/2019 noon 11/30/2019 6:30 pm pain in the injection site. Ended 12/6/2019 in evening
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site erythema, Injection site pain, Pyrexia
Clinical narrative: Fever and chills - starting at 1:00 a.m. on 12/1/19 continuing through 12/2/19 until end of day Fatigue- same start time  as fever and chills and extended through 6 a.m. on 12/3/19 Redness at injection site noted initially on 12/2/19 extending through 12/5/2019 Soreness at injection site through 12/6/2019
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Genital rash, Herpes zoster, Hypoaesthesia, Post herpetic neuralgia, Rash
Clinical narrative: Slightly less than 3 months after receiving the second Shringrix injection, I came down with Shingles. The rash location was pubic/pelvic/buttocks--right side--and about 4 weeks after onset of initial symptoms I developed PHN: numbness on right buttock, running down right leg and especially affecting foot. Left foot also developed some sympathetic numbness. About 4-5 weeks after onset of PHN, it began to recede.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Feeling cold, Nervousness, Peripheral swelling, Skin warm
Clinical narrative: PATIENT HAD A REACTION LATER DURING THE DAY, HAD HER ARM RED AND WARM TO TOUCH,  SHE  WAS FEELING SHAKY AND HAD A COLD FEELING. NEXT DAY, HER ARM STARTED SWELLING, MORE REDNESS AND THE SWELLING STARTED  TO SPREAD
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash on opposite shoulder than shot given and between breasts
Age: 27.0
Sex: M
Vaccine: FLU4
Symptoms: Erythema, Flushing
Clinical narrative: Feeling flushed, red skin neck and face
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Headache, Injection site reaction, Injection site swelling, Pain in extremity, Peripheral swelling
Clinical narrative: Red rash and swelled at place were they gave the shot . Really bad head ache. Arm swelled and sore 19 days laters
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Rash erythematous
Clinical narrative: Red rash and swelled at place were they gave the shot . Really bad head ache. Arm swelled and sore 19 days laters
Age: 4.0
Sex: F
Vaccine: MMRV
Symptoms: Injection site cellulitis
Clinical narrative: Patient developed symptoms consistent with cellulitis on R thigh, treated with Cephalexin.
Age: 72.0
Sex: M
Vaccine: PPV
Symptoms: Urticaria
Clinical narrative: Patient developed hives 5 hours after vaccination.  He went to see a physician assistant who prescribed and administered a steroid shot.
Age: 64.0
Sex: F
Vaccine: FLUC4
Symptoms: Inflammation
Clinical narrative: PATIENT REPORTED CONTINUED INFLAMATION 15 DAYS POST VACCINATION
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site rash, Injection site swelling, Musculoskeletal pain, Neck pain
Clinical narrative: redness, swelling, rash on arm of injection. pain in arm up through shoulder and neck. patient went to hospital the morning after shot. patient stated she was given a couple shots and received an antibiotic. Called patient the evening after seeing the doctor and she said she was feeling better. She stated she wasn't sure if she was allergic or if there was an infection.
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: redness, swelling, rash on arm of injection. pain in arm up through shoulder and neck. patient went to hospital the morning after shot. patient stated she was given a couple shots and received an antibiotic. Called patient the evening after seeing the doctor and she said she was feeling better. She stated she wasn't sure if she was allergic or if there was an infection.
Age: 61.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Influenza, Myalgia
Clinical narrative: flu systems:  muscle aches, fatigue
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Chills, Injected limb mobility decreased, Injection site warmth, Loss of personal independence in daily activities, Musculoskeletal stiffness
Clinical narrative: about five hours after  arm stiffened up ,fingers tingled, then i couldn't move it.Knew it would be sore at area given but my whole arm was affected.Call daughter in law ( nurse) said it's common.This was not.When I went to bed around 10PM I had the chills ,thought maybe because I had to put ice on it (site) was very warm.Had slight fever when I went to bed, sweated most of the night.Morning(dec.7th threw up breakfast and had slight fever of 99.8.(took Acetaminophen 1cap)Can Now raise my arm from elbow down but still having hard time raising arm, cant use left arm to even brush hair.I move it(left) with rt hand to get muscle moving.I'm still struggling with it today.Hope tomorrow will get even better.
Age: 68.0
Sex: F
Vaccine: PPV
Symptoms: Night sweats, Paraesthesia, Pyrexia, Vomiting
Clinical narrative: about five hours after  arm stiffened up ,fingers tingled, then i couldn't move it.Knew it would be sore at area given but my whole arm was affected.Call daughter in law ( nurse) said it's common.This was not.When I went to bed around 10PM I had the chills ,thought maybe because I had to put ice on it (site) was very warm.Had slight fever when I went to bed, sweated most of the night.Morning(dec.7th threw up breakfast and had slight fever of 99.8.(took Acetaminophen 1cap)Can Now raise my arm from elbow down but still having hard time raising arm, cant use left arm to even brush hair.I move it(left) with rt hand to get muscle moving.I'm still struggling with it today.Hope tomorrow will get even better.
Age: 9.0
Sex: F
Vaccine: FLUC4
Symptoms: Pallor, Syncope, Unresponsive to stimuli
Clinical narrative: PATIENT WAS GIVEN VACCINATION IN LEFT ARM. MOVED TO SIT ON BENCH TO WAIT FOR MOTHER AND SHE BECAME PALE AND SHE FAINTED. THIS HAPPENED WITHIN 5 MINUTES OF THE VACCINATION. SHE WAS ASSISTED TO THE FLOOR WHERE SHE WAS UNRESPONSIVE FOR APPROXIMATELY 1 MINUTE. SHE THEN  OPENED HER EYE AND RESPONDED TO VERBAL QUESTIONS ABOUT HOW SHE WAS FEELING. SHE WAS THEN EVALUATED BY PARAMEDICS AND GIVEN THE OK TO LEAVE THE FACILITY.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Diarrhoea, Vomiting
Clinical narrative: Patient states that she started having diarrhea and vomiting on 12/8/2019 at 10:00AM. This was about a day after receiving the vaccine. Counseled patient to start drink Gatorade and Imodium to replenish her electrolytes and to stop the diarrhea. Currently monitoring patient, will follow up with patient on 12/9/2019.
Age: 55.0
Sex: F
Vaccine: FLU4
Symptoms: Contusion, Pain
Clinical narrative: BRUISING--STILL THE SIZE A LITTLE LARGER THAN QUARTER, AND VERY SORE TO THE TOUCH NO SIGNS OF SWELLING
Age: 23.0
Sex: M
Vaccine: TDAP
Symptoms: Lymphadenopathy, Nodule, Oedema peripheral, Skin discolouration, Tenderness
Clinical narrative: Donor noticed swollen lymph node in R axilla as well as blue, blotchy color, possible bruise, near swollen lymph node the day following the immunization (12/6/19) at approximately 10 am. Swelling in axilla has reduced and blue discoloration has resolved according to donor. Small, mobile, mildly tender, symmetrical nodule approx. 1-2 mm in size noted today (12/8/19) on palpation of R anterior axilla. No blue discoloration noted in R axilla. Donor denies any other symptoms.
Age: 32.0
Sex: M
Vaccine: PPV
Symptoms: Mobility decreased, Pain in extremity, Peripheral swelling
Clinical narrative: Patient stated today she was having a lot of swelling and pain in her arm. She was having difficulty raising her arm and was unable to raise her arm over her head.
Age: 14.0
Sex: F
Vaccine: HPV9
Symptoms: Presyncope
Clinical narrative: Vasovagal
Age: 0.83
Sex: F
Vaccine: UNK
Symptoms: Urticaria
Clinical narrative: Hives developed two hours after. Still getting hives 4 days later  Flu shit unknown which kind. Second shot. Did fine with first shot
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Malaise, Nausea, Pain in extremity
Clinical narrative: Chills, nausea, headache, sore arm, malaise
Age: 55.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site pain, Sleep disorder
Clinical narrative: Left Deltoid is still sore. IM injection was given correctly, but my arm still hurts enough I need to take Tylenol for the discomfort and the pain wakes me up at night.
Age: 31.0
Sex: F
Vaccine: TDAP
Symptoms: Joint range of motion decreased, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: Patient called 1 week after getting vaccine--explaining that her arm still hurt to the point where it was difficult to get dressed--also said she had lost some range of motion--asked what to do and wanted to make us aware of the situation--told patient if not feeling better may want to contact primary doctor go to a Urgent Care or Emergency room. I would document situation and contact her again.
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL, HEPA, MMR, PNC13, VARCEL
Symptoms: Pyrexia, Seizure
Clinical narrative: Child had a simple febrile seizure   about 10 hours after receiving 1 y vaccines.   On   11/26/19, she was seen for  eval by neurology at Hosp and it was felt that this child likely had seizure related to fever due to vaccination.  No further  eval was recommended, only follow up in 3 months
Age: 1.0
Sex: F
Vaccine: HEPA, MMR, PNC13, VARCEL, HEPA, MMR, PNC13, VARCEL
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Child had a simple febrile seizure   about 10 hours after receiving 1 y vaccines.   On   11/26/19, she was seen for  eval by neurology at Hosp and it was felt that this child likely had seizure related to fever due to vaccination.  No further  eval was recommended, only follow up in 3 months
Age: 39.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Dystonia, Muscle contractions involuntary
Clinical narrative: Patient stated he experienced severe neck pain and numbness following Anthrax vaccine
Age: 39.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Condition aggravated, Hypoaesthesia, Neck pain
Clinical narrative: Patient stated he experienced severe neck pain and numbness following Anthrax vaccine
Age: 48.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Mobility decreased
Clinical narrative: After I got flu shot on Oct 21st, I was ok. But I got pain and could not move my arm because of pain after few days. It has been more than one month now. I met doctor today. She asked me to report it.
Age: 48.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Mobility decreased, Pain, Pain in extremity
Clinical narrative: After I got flu shot on Oct 21st, I was ok. But I got pain and could not move my arm because of pain after few days. It has been more than one month now. I met doctor today. She asked me to report it.
Sex: F
Vaccine: HPV9
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: No adverse effects reported at this time.; The patient was inadvertently administered one dose of GARDASlL 9 while she was 27 weeks and 5 days gestation.; The patient was inadvertently administered one dose of GARDASlL 9 while she was 27 weeks and 5 days gestation.; The patient was inadvertently administered one dose of GARDASlL 9 while she was 27 weeks and 5 days gestation.; This spontaneous prospective pregnancy report was received from a physician referring to a female patient of unknown age with factor v leiden mutation and pregnancy with advanced maternal age. The patient's medical history included depression, anxiety, and cholestasis with previous pregnancies. The patient has a history of 2 previous pregnancies and 1 live birth(s), and drug allergy to Temazepam. Concomitant therapies included fluoxetine hydrochloride(PROZAC) and buspirone hydrochloride.  The patient became pregnant with last mentrual period of 28-APR-2019 and an estimated date of conception of 12-MAY-2019 and estimated date of delivery (EDD) of 02-FEB-2020.   On 04-NOV-2019, the patient was inadvertently administered one dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast)(GARDASIL 9) (strength, route, dose, frequency, anatomical location, lot # and expiration date were unknown) for prophylaxis, while she was 27 weeks and 5 days gestation (maternal exposure during pregnancy, contraindicated product). This pregnancy was previously complicated by intrauterine growth
Age: 18.0
Sex: F
Vaccine: ANTH, FLU4, JEV1, SMALL
Symptoms: Exposure during pregnancy, Human chorionic gonadotropin positive
Clinical narrative: On 7 December, 2019, PT discovered that she was pregnant after testing positive after taking three separate pregnancy tests. 2 of the tests were taken 7 December, 2019; the other was taken 8 December, 2019. All three were tested positive. PT's blood was drawn for HCG testing on 09 December, 2019. Results came back positive for pregnancy. PT expressed she thinks she became pregnant on the 22 November, 2019.
Age: 57.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Pruritus, Urticaria
Clinical narrative: Large raised hives around front and sides of abdomen with burning and itching
Age: 11.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema multiforme, Pyrexia, Rash, Rash pruritic
Clinical narrative: 11/19/19: Fever (100.4 PO) and rash onset in the afternoon following flu vaccine administration earlier that morning.  Per parent fever (to touch) x 2 days.  Slightly pruritic non-urticarial rash progress to trunk (chest/abdomen, back) and arms the morning following vaccination.  It then progressed to b/l lower extremities  and the trunk cleared by 11/22/19.  Face, genital region spared.  Pt evaluated on 11/22/19 - afebrile, felt well except for concern about the appearance of rash.  Dx: Erythema Multiforme rash b/l lower extremities, buttocks, R palm and b/l upper extremities.   Loratadine with positive effect.  Pt re-evaluated 11/25/19 - rash nearly resolved, pt feeling well.
Age: 33.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Joint range of motion decreased
Clinical narrative: Minor  "frozen shoulder" like symptoms in my surgically repaired left shoulder. Significantly limited range of motion (at the worst only about 20 degrees of movement) and joint pain (6/10 left shoulder). Symptoms persisted for approximately 10 days with improvement each day following onset. I used physical therapy exercises previously used in should rehabilitation. I was able to find some anecdotal evidence for this sort of reaction. Had problems persisted longer or gotten worse I would have sought medical treatment. I wanted to add my report as collateral information for possible future research into this sort of reaction.
Sex: U
Vaccine: MMR, VARCEL
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; administerd vaccines experienced temperature excursion; This spontaneous report was received from a registered nurse referring to a 33 year old patient of unknown gender. There was no information about the patient's concurrent conditions, concomitant therapies or medical history provided.  On 25-OCT-2019, the patient was vaccinated with an improperly stored dose of  measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) lot R036582 expiring on 02-JAN-2021, for prophylaxis  (dose, route of administration, lot number and expiration date were not reported).   The administered dose of measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live(M-M-R II) experienced temperature excursion of unknown degrees Celsius for a total of 96hours, as recorded by a data logger, on several days between 28-SEP-2019-19-OCT-2019.   On 06-NOV-2019, the patient was vaccinated with an improperly stored dose of  varicella virus vaccine live (oka/merck)(VARIVAX) lot # S000132 expiring on 17-DEC-2020, for prophylaxis  (dose, route of administration, lot number and expiration date were not reported).   The administered dose of varicella virus vaccine live (oka/merck)(VARIVAX) experienced temperature excursion of unknown degrees Celsius for a total of 192hours, as recorded by a data logger, on several days between 28-SEP-2019-03-NOV-2019.   The vaccines had not had any previous temperature excursions.  There was no adverse effect reported. No product quality complaint was involved.
Age: 1.5
Sex: F
Vaccine: HEPA, MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse effect reported; a female patient received improperly stored VAQTA; Expiration date: 25-MAY-2019; This spontaneous report was received from a medical assistant referring to a 18 month old female patient. No information was provided regarding the patient's medical history, concurrent conditions, concomitant medications, drug reactions and allergies.  On 04-NOV-2019, the patient received an improperly stored hepatitis a vaccine, inactivated (VAQTA)25/0.5 (units not reported) (Lot No. S009562 has been verified to be a valid lot number for hepatitis a vaccine, inactivated, expiration date reported as 26-JUL-2020, but upon internal validation established as 25-MAY-2019) (expired product administered) for prophylaxis (dose, dose number, route of administration and anatomical injection site were not reported).     It was reported that on an unknown date, the vaccine was exposed to a temperature excursion above 47 Fahrenheit (F) degrees (52.09 F degrees) for 1.39 hours. There was a previous temperature excursion above 47 F degrees (64.83 F degrees) for 13.35 hours. The call was placed because of a Digital Data logger report. No adverse effects were reported.
Age: 4.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional adverse events; a patient was administered an improperly stored VARIVAX; This spontaneous report was received from a medical assistant referring to a 4 year old patient of unknown gender. The patient's medical history, concurrent conditions and concomitant medications were not reported.   On 02-DEC-2019, the patient was vaccinated with an improperly stored dose of varicella virus vaccine live (oka/merck)(VARIVAX) following lot numbers were reported but it was not specified which one was administered to the patient: lot # S020464 and expiration date: 21-JUL-2019 and lot # S021928 and expiration date: 15-JUL-2021 (dose, frequency, route and anatomical location were not provided) for prophylaxis. The administered doses of the vaccines were stored at the following temperatures: from 15 degrees Fahrenheit to 46 degrees Fahrenheit (mainly at 35.7 degrees Fahrenheit) for 2 hours. The vaccine was reconstituted with sterile diluent, which was properly stored. There was no digital data logger involved and there was no previous temperature excursion.
Sex: M
Vaccine: PPV
Symptoms: Body temperature increased, Injection site pain
Clinical narrative: he experience soreness at the injection site as well as a temperature of 101; he experience soreness at the injection site as well as a temperature of 101; This spontaneous report as received from a consumer referring to her husband a male patient of unknown age. The patient's concurrent conditions, past medical history and concomitant medications were not reported.  On 03-DEC-2019, the patient was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) 1 shot (dose, frequency, route and anatomical location were not provided) for prophylaxis. On 04-DEC-2019, the patient experienced soreness at the injection site (injection site pain) as well as temperature of 101 (body temperature abnormal), as treatment he received acetaminophen (TYLENOL) and he did not sought medical attention. The outcome of injection site pain and body temperature abnormal was reported as not recovered.  The causality assessment between the events and pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) was not reported.
Sex: U
Vaccine: PPV
Symptoms: Injection site pain, Injection site swelling
Clinical narrative: pain and swelling at the injection site; pain and swelling at the injection site; This spontaneous report was received from a field employee referring to an unspecified number of unknown patients. The patients' pertinent medical history, concurrent conditions, concomitant medications, previous drug reactions or allergies were unknown by the reporter.  On unknown dates in November 2019 (also reported as "within the past month"), the patients were vaccinated with pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) intramuscularly (strength, dose and anatomical site of vaccination were not reported; lot number and expiration date were unknown by the reporter) as routine immunization.  On unspecified dates in November 2019,  the patients experienced pain and swelling at the injection site (vaccination site pain and vaccination site swelling). It was unknown by the reporter if any treatment was given for the adverse events or if any laboratories or studies were performed.  The outcome of vaccination site swelling and vaccination site pain was reported as recovered. The causality assessment between pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) and the aforementioned events, was not reported.  This case has been considered as non-valid due to the lack of patient's identifiers.