chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 75.0
Sex: M
Vaccine: FLU3
Symptoms: Fungal skin infection, Injection site erythema, Injection site rash, Injection site warmth
Clinical narrative: Pt has red circle about size of dime in area of injection, was red and hot to touch per him,  he came in 10/18/19 to inform us of reaction.  He stated he went to doctor who stated it was a fungal issue in area, they gave clotrimazole cream to treat per his information, still ongoing rash in area
Age: 58.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Persistent left arm pain
Age: 57.0
Sex: F
Vaccine: FLUC4
Symptoms: Furuncle, Injection site discomfort, Injection site warmth, Skin lesion
Clinical narrative: Patient came into store and showed a raised lesion (she called it a boil) in the upper arm but NOT where the flu shot was administered  She said the warmth and discomfort radiated from the area of the flu administration site.
Age: 69.0
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Injection site pain, Injection site rash, Myalgia, Pyrexia
Clinical narrative: Dull pain and rash on arm in area of injection, starting the night of the injection, continuing through today [36 hours later]. On the day following the injection,  aching muscles, headache, feeling feverish [as if I was coming down with the flu]; these symptoms seem to be easing today.
Age: 64.0
Sex: M
Vaccine: FLUC4, VARZOS
Symptoms: Chills, Discomfort, Headache, Injection site pain, Injection site swelling
Clinical narrative: Fever, chills, shivering, headache, general discomfort, soreness and swelling at injection site
Age: 64.0
Sex: M
Vaccine: FLUC4, VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever, chills, shivering, headache, general discomfort, soreness and swelling at injection site
Age: 91.0
Sex: F
Vaccine: PPV
Symptoms: Blister, Erythema, Pain
Clinical narrative: blister on inner side halfway between shoulder and elbow about the size of a fifty cent piece appeared on 10/20/19, redness from shoulder to 2 inches from elbow appeared on 10/18/19, painful since 10/18/19
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Chills, Hyperhidrosis, Loss of personal independence in daily activities, Myalgia
Clinical narrative: Muscle aches first 12 hours, then chills, kept me from normal activity.  Acetaminophen taken for aches, chills for upward of 6 hours.  Profuse sweating for an hour after chills.  Stayed on Acetaminophen.  The side effects were much more than I expected.  Debilitating for 36 hours.
Age: 82.0
Sex: F
Vaccine: FLU3, UNK
Symptoms: Asthenia, Fatigue, Myalgia, Vomiting
Clinical narrative: Received shot Sat. morning--then woke up around 1;00 am that night vomiting.  I vomited on the floor beside the bed and then again on the bathroom floor before I could make it to the toilet.  I went back to bed--woke up around 4:00 am realizing I was too weak to clean the mess and called for my son on the floor below.  I spent the day taking my pain meds and trying to take in enough fluid to not be dangerously dehydrated.  I did not go to the Emergency Room or a walk in clinic because I was afraid they would admit me to the hospital which would only make me worse.  My son stays with me and gives me better care.   I developed muscle pain like I have never felt.  It was not a body ache--it was muscle pain.  It hurt to sit or to lie down. Any movement at all cause extreme hurting in the muscles.   I could pinch my arm, legs, or back and feel PAIN not just a pinch.  I could tell Monday morning that I was no longer getting worse and felt too tired to get out to the doctors office so did not call him.  I continued to gradually feel better, and by Wednesday I was weak but better.  Writing this I see how foolish I was to not call the doctor and will give my son instructions to call him if I seem sick and do not call the doctor myself.  My not going was based in knowing I was given a killed virus--I would have gone to the emergency room if I had not felt I knew the cause of my sickness.  I ask myself how I would resist the live flu unless this was a faulty batch of vaccine which is why I am reporting the incident.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Hyperaesthesia, Influenza like illness, Injection site pain
Clinical narrative: severe soreness at injection site (still exists, going on 48 hours) joint aches, 19 hours to  31 hours chills, off and on, 19 hours to 31 hours skin sensitivity (all over like flu), off and on, 19 hours to 31 hours these symptoms/signs were helped by ibuprofen (which is why they were on and off)
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Pain in extremity
Clinical narrative: Patient came into the Pharmacy on 10/19/19 and said that her arm was still hurting after receiving the Prevnar on 9/30/19.  She stated that her right arm was very sore after 2 weeks and that it was painful to lift her arm.  She could move her arm around but that it was very sore and had been sore since receiving the Prevnar.  She also stated that it was getting better but wondered how much longer it would last.
Age: 11.0
Sex: M
Vaccine: FLU4
Symptoms: Dizziness, Fall, Loss of consciousness, Syncope
Clinical narrative: Patient was at home, felt dizzy and fainted, fell to the floor,  woke up a few minutes later and was fine.
Age: 9.0
Sex: M
Vaccine: FLU4
Symptoms: Abdominal pain upper, Dizziness, Fall, Syncope
Clinical narrative: Patient had s pain in their stomach,  felt dizzy and then fainted.  Patient fell to floor but was unharmed.  Pt recovered without injury quickly without injury.
Age: 71.0
Sex: F
Vaccine: FLUA3
Symptoms: Injection site pain, Pain, Pain in extremity
Clinical narrative: patient indicated that arm was sore for a couple of days after injection, got better than began hurting again. indicated that hurt in muscle on left deltoid and it is painful for her to lift arm up
Age: 76.0
Sex: F
Vaccine: FLU3, PPV, VARZOS, FLU3, PPV, VARZOS
Symptoms: Erythema, Peripheral swelling, Skin warm
Clinical narrative: PT's right arm became swollen, red and warm to the touch. The swelling reached the elbow and according the the pt was spreading.
Age: 76.0
Sex: F
Vaccine: FLU3, PPV, VARZOS, FLU3, PPV, VARZOS
Symptoms: Swelling
Clinical narrative: PT's right arm became swollen, red and warm to the touch. The swelling reached the elbow and according the the pt was spreading.
Age: 24.0
Sex: M
Vaccine: FLU4
Symptoms: Loss of consciousness, Syncope, Urinary incontinence
Clinical narrative: Patient fainted while walking away after flu shot, immediately regained consciousness, was helped to bench where he passed out again about 1 minute after first incident. Patient was unconscious for about 15 seconds second time, even with physical jostling/stimulus & talking loudly to him. Patient urinated himself then woke up. Once patient was unconscious second time, pharmacy called 911 who instructed us to keep patient here with no foods or liquids. We talked to patient and kept him on bench- patient said he had passed out before during other vaccinations but didn't tell us since the "flu shot is not as serious". Paramedics arrived within 5 minutes and pharmacy staff reported what happened then gave them privacy. Patient refused service to hospital but paramedics recommended he go and get checked out on own still. Paramedics say patient passed out third time while they were here. Patient was with girlfriend who drove him home.  Pharmacy will follow up with patient next day.
Age: 71.0
Sex: F
Vaccine: UNK
Symptoms: Abdominal pain upper, Arthralgia, Fatigue, Hyperhidrosis, Pyrexia
Clinical narrative: Three degrees of fever that afternoon, joint pain, stomach pain, sweating, shakiness, fatigue. I still have some fever two days later.
Age: 71.0
Sex: F
Vaccine: UNK
Symptoms: Tremor
Clinical narrative: Three degrees of fever that afternoon, joint pain, stomach pain, sweating, shakiness, fatigue. I still have some fever two days later.
Age: 68.0
Sex: F
Vaccine: FLU3
Symptoms: Pain, Pain in extremity
Clinical narrative: PATIENT REPORTED PAIN IN HER ARM 15 DAYS AFTER HER FLU SHOT.  SHE SAID IT HURTS WHEN SHE ROTATES HER SHOULDER.
Age: 54.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Asthenia, Fatigue, Headache, Nausea, Poor quality sleep
Clinical narrative: nausea, mild headache, shaky, weak, fatigue; lasted approximately 5 a.m. (12 hours after shot) until about 3 p.m. (might have started earlier but was in bed; tossed and turned all night, not sure if related). I assume this is a result of the Shingrix because I've never had a reaction to the influenza vaccine or any other besides the normal sore/warm arm at point of injection.
Age: 54.0
Sex: F
Vaccine: UNK, VARZOS
Symptoms: Tremor
Clinical narrative: nausea, mild headache, shaky, weak, fatigue; lasted approximately 5 a.m. (12 hours after shot) until about 3 p.m. (might have started earlier but was in bed; tossed and turned all night, not sure if related). I assume this is a result of the Shingrix because I've never had a reaction to the influenza vaccine or any other besides the normal sore/warm arm at point of injection.
Age: 49.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injected limb mobility decreased, Injection site bruising, Injection site nodule, Injection site pain
Clinical narrative: Severe pain at the time of injection. Persistent pain for next four days (present day) with 1.5 cm bruise and underlying palpable knot. Difficulty abducting and rotating arm. No numbness or weakness of arm.
Age: 49.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Contusion, Nodule, Pain, Swelling
Clinical narrative: Severe pain at the time of injection. Persistent pain for next four days (present day) with 1.5 cm bruise and underlying palpable knot. Difficulty abducting and rotating arm. No numbness or weakness of arm.
Age: 66.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Erythema, Immediate post-injection reaction, Pain, Pain in extremity, Swelling
Clinical narrative: On 10/14/2019 after i received the vaccine , immediately once it was administered i could feel a lot of pain . Then that evening the right arm felt sore and although i slept throughout the night i knew there was something wrong as it was sore to lie onto the right arm. The next morning the swelling and redness began to above the elbow . That was 10/15 /2019 . The same day i reported it to the pharmacist on duty. Then on 10/16/2019 the soreness , swelling redness became more distinct and below the elbow. So i went to pharmacy and showed the right arm to the lady pharmacist who was standing in only. I started with Benadryl but stopped after 3 doses . On 10/17/2019 the redness and swelling spread to my hand tuimb and little finger , that night i visited Dr who appeared alarmed and gave me an anti biotic injection plus some antibiotic pills to take for some 10 days . On 10/18/2019 i again visited pharmacy to show the right arm yet again and ask for the information to report the event which was announced to me on the 10/15./2019 by pharmacist but no information was immediately given to me , only on  my asking on 10/18/2019 with the pharmacist. I also requested a copy of the RX of the vaccine which i got .My arm today 10/20/2019 is no longer swollen however ot still feels sore above and below the elbow as i place it to write this e mail on the desk and also when i am asleep i avoid to lie on the right side.
Age: 66.0
Sex: M
Vaccine: PPV, PPV
Symptoms: Myalgia, Peripheral swelling
Clinical narrative: On 10/14/2019 after i received the vaccine , immediately once it was administered i could feel a lot of pain . Then that evening the right arm felt sore and although i slept throughout the night i knew there was something wrong as it was sore to lie onto the right arm. The next morning the swelling and redness began to above the elbow . That was 10/15 /2019 . The same day i reported it to the pharmacist on duty. Then on 10/16/2019 the soreness , swelling redness became more distinct and below the elbow. So i went to pharmacy and showed the right arm to the lady pharmacist who was standing in only. I started with Benadryl but stopped after 3 doses . On 10/17/2019 the redness and swelling spread to my hand tuimb and little finger , that night i visited Dr who appeared alarmed and gave me an anti biotic injection plus some antibiotic pills to take for some 10 days . On 10/18/2019 i again visited pharmacy to show the right arm yet again and ask for the information to report the event which was announced to me on the 10/15./2019 by pharmacist but no information was immediately given to me , only on  my asking on 10/18/2019 with the pharmacist. I also requested a copy of the RX of the vaccine which i got .My arm today 10/20/2019 is no longer swollen however ot still feels sore above and below the elbow as i place it to write this e mail on the desk and also when i am asleep i avoid to lie on the right side.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Myalgia
Clinical narrative: Muscular pain, weakness and fatigue lasting  approximately none24 hours.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pruritus, Rash
Clinical narrative: Patient reports that the morning following administration of the vaccine that he had chills and spots/bumps that began to appear in random places on the body. Specifically the right side of his body. They are very itchy but not painful. He states they last about 24 hours then disappear but new ones appear in other random places.  Patient stated that if the symptoms continued he would follow up with primary care physician on Monday 10/21/19.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Fall
Clinical narrative: After receiving the flu vaccine and leaving the pharmacy, patient's mom called to report that she became dizzy and fell over at home. Patient did not lose consciousness.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site urticaria
Clinical narrative: patient got immunization on 10/17, came to pharmacy with large erythematous welt where vaccine was administered. suggested hydrocortisone ointment along with benadryl and to follow up with physician
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site inflammation, Injection site pain
Clinical narrative: Approximately 18 hours after injection employee noticed bruising in her left inner upper arm 3 " from injection site in deltoid. Area was noted to be tender and inflamed. Area of bruising increased over the next 24 hr and continued to be tender and inflamed over bruised area NOT at injection site
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Chills, Erythema, Eye swelling, Hypersensitivity, Pyrexia
Clinical narrative: patient complained of her eyes swelling and turning red, as well as the feeling that her throat was closing up.  She took a benadryl which helped.  Appeared to be some type of allergic reaction.  Overnight she experienced symptoms of fever such as chills.  By the next morning she was feeling better.
Age: 66.0
Sex: F
Vaccine: FLU3
Symptoms: Throat tightness
Clinical narrative: patient complained of her eyes swelling and turning red, as well as the feeling that her throat was closing up.  She took a benadryl which helped.  Appeared to be some type of allergic reaction.  Overnight she experienced symptoms of fever such as chills.  By the next morning she was feeling better.
Age: 77.0
Sex: M
Vaccine: FLUA3, PPV
Symptoms: Neck pain
Clinical narrative: Pt states on 10/20/19 that they are experiencing a sore neck beginning on Friday. Pt reports no other symptoms. Pt reports uncertainty if it is related to the 2 vaccinations that they received.
Age: 80.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain, Injection site swelling, Injection site warmth, Pyrexia
Clinical narrative: pain in left arm at injection site from time left pharmacy to present (three weeks), warm to touch, swollen, low-grade fever
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain, Pyrexia, Somnolence
Clinical narrative: Fever, aches, chills, overwhelming tiredness (slept just like when sick with flu)
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Injection site rash, Malaise, Muscle spasms, Musculoskeletal stiffness
Clinical narrative: Patient began to feel ill about 4 hours after the shot.  Symptoms started as head to toe muscle pain, severe headache, leg spasms, nausea, and unable to bend fingers.  Symptoms persisted for 3 days.  Rash at injection site appeared 4 days post immunization and disappeared within 48 hours.
Age: 60.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Myalgia, Nausea
Clinical narrative: Patient began to feel ill about 4 hours after the shot.  Symptoms started as head to toe muscle pain, severe headache, leg spasms, nausea, and unable to bend fingers.  Symptoms persisted for 3 days.  Rash at injection site appeared 4 days post immunization and disappeared within 48 hours.
Age: 71.0
Sex: M
Vaccine: PNC13
Symptoms: Erythema, Influenza like illness, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: Patient had painful, large, red swollen left arm and flu like symptoms with fever ( 101 degrees F at one point) for 3 weeks. Afterwards, pt made full recovery.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: Patient reports having sharp shooting/stabbing pain down left arm since receiving flu shot
Age: 69.0
Sex: F
Vaccine: PPV
Symptoms: Hyperhidrosis, Mobility decreased, Pyrexia, Vertigo
Clinical narrative: Patient describes waking up at 2 am, sweaty with a fever.  Her head is spinning and she can't life her arm.  She states she feels the shot was given correctly, that it must've been something in the vaccine.
Age: 63.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Peripheral swelling, Pruritus, Skin warm
Clinical narrative: Pt's arm is red, swollen, warm to the touch, and itchy.
Age: 67.0
Sex: F
Vaccine: PPV
Symptoms: Hypersensitivity, Injection site pain, Injection site swelling
Clinical narrative: Patient had pain and swelling on a large area of left shoulder and upper arm on 9/17/19, went to the emergency room on 9/18/19 per patient.  ER physician diagnosed allergic reaction with possible cellulitis.
Age: 47.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Bursitis, Joint range of motion decreased, Musculoskeletal pain, Product administered at inappropriate site
Clinical narrative: Extreme pain in shoulder. Loss of range of motion and strength. Primary care  doctor believes inflammation of bersa due to shot given too high up on arm near shoulder joint
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Nausea, Vertigo, Vomiting
Clinical narrative: vomit 12 hours, nausia gradually decreasing, vertigo gradually decreasing, both still ongoing after 9 days
Age: 71.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling, Pyrexia
Clinical narrative: pt experienced redness and swelling in right arm after vaccination. he also said he had a fever.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Headache, Loss of consciousness
Clinical narrative: Tired, muscle pain, headache, shivering, fever, nausea, dizziness and passing out.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Nausea, Pyrexia
Clinical narrative: Tired, muscle pain, headache, shivering, fever, nausea, dizziness and passing out.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Dysphagia, Ocular hyperaemia, Odynophagia, Oral pruritus, Oropharyngeal pain
Clinical narrative: About 7 hours following the vaccine, my throat started getting very sore.  It hurt a lot when I swallowed.  It felt like there was a big lump in my throat that i could not swollow.  I also noticed ulcers/bumps on the back of my throat.  Also, my mouth felt itchy/tingly.  My eyes got red, and i had a slight mucousy discharge from them.  I took Advil to try and relieve the throat pain and also took 2 Benadryl.  This isn't the first time this has happened to me.  This is the third time - it wasn't as severe as my first two episodes which I have several years ago.  Those two times involved vomiting, wheezing, the same throat problems, along with severe aching of my body.  I was sick for 3-4 days.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Paraesthesia oral, Pharyngeal ulceration, Secretion discharge, Sensation of foreign body
Clinical narrative: About 7 hours following the vaccine, my throat started getting very sore.  It hurt a lot when I swallowed.  It felt like there was a big lump in my throat that i could not swollow.  I also noticed ulcers/bumps on the back of my throat.  Also, my mouth felt itchy/tingly.  My eyes got red, and i had a slight mucousy discharge from them.  I took Advil to try and relieve the throat pain and also took 2 Benadryl.  This isn't the first time this has happened to me.  This is the third time - it wasn't as severe as my first two episodes which I have several years ago.  Those two times involved vomiting, wheezing, the same throat problems, along with severe aching of my body.  I was sick for 3-4 days.
Age: 56.0
Sex: F
Vaccine: FLU4
Symptoms: Vomiting, Wheezing
Clinical narrative: About 7 hours following the vaccine, my throat started getting very sore.  It hurt a lot when I swallowed.  It felt like there was a big lump in my throat that i could not swollow.  I also noticed ulcers/bumps on the back of my throat.  Also, my mouth felt itchy/tingly.  My eyes got red, and i had a slight mucousy discharge from them.  I took Advil to try and relieve the throat pain and also took 2 Benadryl.  This isn't the first time this has happened to me.  This is the third time - it wasn't as severe as my first two episodes which I have several years ago.  Those two times involved vomiting, wheezing, the same throat problems, along with severe aching of my body.  I was sick for 3-4 days.
Age: 19.0
Sex: F
Vaccine: FLUC4
Symptoms: Loss of consciousness, Syncope
Clinical narrative: Patient had flu shot at 11:38. After receiving shot, she and her boyfriend got up to stand in line for receipt and gift card. She had an episode of syncope and passed out at 11:40 while her boyfriend caught her. She was out for a very brief moment (few seconds, then came back to). Laid patient down to increase bloodflow and her blood pressure was 102/72 with pulse of 92 at 11:41; Patient remained stable so sat her up at 11:47 and her blood pressure dropped to 58/38 with a pulse of 83; had patient lie back down and blood pressure returned to normal at 111/62 with pulse of 60 at 11:49. Continued to monitor patient until EMS arrived at 12:14. Patient was stable with normal values of blood pressure and pulse. She declined to go to hospital.
Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Rash
Clinical narrative: pt noticed fine rash on arm used for immunization, slightly itchy, resolved within 24 hours
Age: 93.0
Sex: F
Vaccine: FLU3
Symptoms: Burning sensation, Erythema, Pruritus, Rash, Rash erythematous
Clinical narrative: Patient got rash over her body. has complained about burning sensation and itching.  Red spots over her boday including behind the neck and on back. The bandage plaster placed area was red to the marking of the bandage
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Blood creatine phosphokinase normal, Muscular weakness, Myalgia, Pain, Pain in extremity
Clinical narrative: onset 2-3 days after injection - no symptoms at injection site - pain and weakness limited from shoulder to elbow increased over a few days and remain unchanged over past 6 weeks - normal range of motion of arm - pain lifting objects and raising arm - muscles painful to pressure - NO rash, swelling, sensory loss or atrophy  outpatient doctor appointment scheduled
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Red blood cell sedimentation rate normal
Clinical narrative: onset 2-3 days after injection - no symptoms at injection site - pain and weakness limited from shoulder to elbow increased over a few days and remain unchanged over past 6 weeks - normal range of motion of arm - pain lifting objects and raising arm - muscles painful to pressure - NO rash, swelling, sensory loss or atrophy  outpatient doctor appointment scheduled
Age: 75.0
Sex: M
Vaccine: PNC13
Symptoms: No adverse event
Clinical narrative: Vaccine was administered to twin brother. Immunization was processed under patient's twin brothers name and profile. Both brothers wanted the vaccine and both received it. It was reported incorrectly, however. No true adverse effects.
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Bacterial test, Blood test, Body temperature increased, Chest X-ray, Crying
Clinical narrative: July 31, 2019:  My sons temperature rose to 100.5 at 651pm.  By 9pm, it was 102.5.  He still had a lacy rash all over his body and the back of his legs he had since after his early MMR  August 1, 2019: Temperature at 103.4 at 2am and crying/sleep disrupted.  Took him in to see his pediatrician about the temp and rash and baby all over feeling uncomfortable.  Dr. believed he was fighting something else and it was not a reaction to the immunizations.  The rash was presenting as viral exanthem.  Began alternating tylenol and motrin every 4-6 hours in recommended dosage  August 2: Temp was regulated around 99.9 with medication  August 3rd:  Temps: 7a = 100.2, 11a = 100.8, 3p = 101.8, 5p = 102.5 and baby began to become fussy and inconsolable from 5-7p.  We went to Urgent Care and the doctor believed he had an ear infection and prescribed antibiotics.  At 9p we gave 5ml amoxcillin and 1.875ml Motrin.  At 10p, his temp was 101.5 and we put his Owlet monitor on him for bed and his heart rate was 170 bpm (usually it is 115 bpm for sleep).  1a he woke up crying and  his temp hit 104 and we gave 2.5ml tylenol.  We called the after hours health line to get advice  August 4, 2019:  8a - 99.9, baby was playing but got sleepy fast.  10a fussy and wanted to sleep on me which is not normal for him - he always wants his bed.  At 2p he was fussy and warm and temp read 102.5 - I gave 2.5ml tylenol at this time.  220p he went back down for another nap on me.  By 430p, his temp was 99.8.  6p his temp was back up to 102.5 and he was fussy and crying non stop.  We gave 5ml amoxicillin.  At 7p his temo hit 102.1 and we gave 1.875 ml of motrin  August 5: 7a temp was 103.5 and baby had high pitch scream for an hour without stopping.  I took him back to his pediatrician office in the morning and he was checked by another doctor who believed he had Roseola and she determined he did NOT have an ear infection and to stop antibiotics - it was deemed viral and was told to keep up on tylenol/motrin.  By the time we got home from this appointment,  his temp reached 104 and continued to climb to 105 before we left the house to drive to the ER.  He began the high-pitch screaming again and we decided to go to the emergency room.  The ER ran multiple tests and determined it was likely viral or a reaction to vaccines.  Was told to keep him comfortable with the tylenol/motrin and keep fluids down.  By August 10th, he was back to his normal self with low grade fevers
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Discomfort, Emotional distress, Irritability, Rash, Skin warm
Clinical narrative: July 31, 2019:  My sons temperature rose to 100.5 at 651pm.  By 9pm, it was 102.5.  He still had a lacy rash all over his body and the back of his legs he had since after his early MMR  August 1, 2019: Temperature at 103.4 at 2am and crying/sleep disrupted.  Took him in to see his pediatrician about the temp and rash and baby all over feeling uncomfortable.  Dr. believed he was fighting something else and it was not a reaction to the immunizations.  The rash was presenting as viral exanthem.  Began alternating tylenol and motrin every 4-6 hours in recommended dosage  August 2: Temp was regulated around 99.9 with medication  August 3rd:  Temps: 7a = 100.2, 11a = 100.8, 3p = 101.8, 5p = 102.5 and baby began to become fussy and inconsolable from 5-7p.  We went to Urgent Care and the doctor believed he had an ear infection and prescribed antibiotics.  At 9p we gave 5ml amoxcillin and 1.875ml Motrin.  At 10p, his temp was 101.5 and we put his Owlet monitor on him for bed and his heart rate was 170 bpm (usually it is 115 bpm for sleep).  1a he woke up crying and  his temp hit 104 and we gave 2.5ml tylenol.  We called the after hours health line to get advice  August 4, 2019:  8a - 99.9, baby was playing but got sleepy fast.  10a fussy and wanted to sleep on me which is not normal for him - he always wants his bed.  At 2p he was fussy and warm and temp read 102.5 - I gave 2.5ml tylenol at this time.  220p he went back down for another nap on me.  By 430p, his temp was 99.8.  6p his temp was back up to 102.5 and he was fussy and crying non stop.  We gave 5ml amoxicillin.  At 7p his temo hit 102.1 and we gave 1.875 ml of motrin  August 5: 7a temp was 103.5 and baby had high pitch scream for an hour without stopping.  I took him back to his pediatrician office in the morning and he was checked by another doctor who believed he had Roseola and she determined he did NOT have an ear infection and to stop antibiotics - it was deemed viral and was told to keep up on tylenol/motrin.  By the time we got home from this appointment,  his temp reached 104 and continued to climb to 105 before we left the house to drive to the ER.  He began the high-pitch screaming again and we decided to go to the emergency room.  The ER ran multiple tests and determined it was likely viral or a reaction to vaccines.  Was told to keep him comfortable with the tylenol/motrin and keep fluids down.  By August 10th, he was back to his normal self with low grade fevers
Age: 1.0
Sex: M
Vaccine: MMR, VARCEL
Symptoms: Sleep disorder, Urine analysis, Vaccination complication, Viral infection, Viral rash
Clinical narrative: July 31, 2019:  My sons temperature rose to 100.5 at 651pm.  By 9pm, it was 102.5.  He still had a lacy rash all over his body and the back of his legs he had since after his early MMR  August 1, 2019: Temperature at 103.4 at 2am and crying/sleep disrupted.  Took him in to see his pediatrician about the temp and rash and baby all over feeling uncomfortable.  Dr. believed he was fighting something else and it was not a reaction to the immunizations.  The rash was presenting as viral exanthem.  Began alternating tylenol and motrin every 4-6 hours in recommended dosage  August 2: Temp was regulated around 99.9 with medication  August 3rd:  Temps: 7a = 100.2, 11a = 100.8, 3p = 101.8, 5p = 102.5 and baby began to become fussy and inconsolable from 5-7p.  We went to Urgent Care and the doctor believed he had an ear infection and prescribed antibiotics.  At 9p we gave 5ml amoxcillin and 1.875ml Motrin.  At 10p, his temp was 101.5 and we put his Owlet monitor on him for bed and his heart rate was 170 bpm (usually it is 115 bpm for sleep).  1a he woke up crying and  his temp hit 104 and we gave 2.5ml tylenol.  We called the after hours health line to get advice  August 4, 2019:  8a - 99.9, baby was playing but got sleepy fast.  10a fussy and wanted to sleep on me which is not normal for him - he always wants his bed.  At 2p he was fussy and warm and temp read 102.5 - I gave 2.5ml tylenol at this time.  220p he went back down for another nap on me.  By 430p, his temp was 99.8.  6p his temp was back up to 102.5 and he was fussy and crying non stop.  We gave 5ml amoxicillin.  At 7p his temo hit 102.1 and we gave 1.875 ml of motrin  August 5: 7a temp was 103.5 and baby had high pitch scream for an hour without stopping.  I took him back to his pediatrician office in the morning and he was checked by another doctor who believed he had Roseola and she determined he did NOT have an ear infection and to stop antibiotics - it was deemed viral and was told to keep up on tylenol/motrin.  By the time we got home from this appointment,  his temp reached 104 and continued to climb to 105 before we left the house to drive to the ER.  He began the high-pitch screaming again and we decided to go to the emergency room.  The ER ran multiple tests and determined it was likely viral or a reaction to vaccines.  Was told to keep him comfortable with the tylenol/motrin and keep fluids down.  By August 10th, he was back to his normal self with low grade fevers
Age: 16.0
Sex: M
Vaccine: FLUC4
Symptoms: Eye movement disorder, Seizure, Seizure like phenomena
Clinical narrative: The father said that on his drive back after the vaccination, patient experienced a seizure like experience, his arm was seizing and his eyes rolled back, but he came to normalcy on his own. Parent called his pediatrician and was advised that if it persists to contact ER. Father said that the patient was okay for the next few hours.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Blood pressure increased, Cough, Dyspnoea, Pyrexia
Clinical narrative: coughing, trouble breathing, fever, increased blood pressure. Patient taken by ambulance to emergency room.  no localized reaction at injection site.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Nerve compression, Pain, Pain in extremity, Peripheral swelling, Pyrexia
Clinical narrative: right arm a little swollen, arm pain, right arm hurt to move, felt like pinched nerve, could hardly lift anything.... achy body and also some feverishness. symptoms began later that evening, peaked Saturday, and patient said doing much better today (sunday, less than 48 hours later)
Age: 54.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site pain, Loss of personal independence in daily activities
Clinical narrative: Extreme pain in arm at injection site for 3 days. Unable to lift arm above head. Not able to do routine daily activities as pain was so bad. Increased Advil intake to 600-800mg every 6 hours and that helped dull the pain.
Age: 93.0
Sex: F
Vaccine: FLUR4
Symptoms: Contusion, Peripheral swelling
Clinical narrative: pt's arm was extremely swollen and bruised
Age: 68.0
Sex: F
Vaccine: TDAP
Symptoms: Cellulitis
Clinical narrative: cellulitis diagnosed and treated with antibiotics by md
Age: 17.0
Sex: M
Vaccine: MENB
Symptoms: Induration, Mass
Clinical narrative: Patient reports a little lump or induration under the skin of his left arm that has been there since the shot in September.  It has been slowly getting smaller.  Does not hurt and does not look infected.  Patient will monitor for any changes and massage the site to help work it out
Age: 66.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Red, swollen arm around the injection site.  Extended around the arm and about 3 inches long.  Warm to the touch.  Painful.  She called me at the pharmacy the day after getting the injection.  She said it had stopped hurting now but did mention previous pain.
Age: 65.0
Sex: M
Vaccine: FLU3
Symptoms: Pain in extremity
Clinical narrative: arm pain after the immunization and still has arm pain.  patient has been to the doctor for regular visit and was examined and told by the MD that it can happen from immunization.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site pruritus, Injection site swelling
Clinical narrative: PAIN, ITCHING, REDNESS, SWELLING, WARMTH AND INDURATION AT SITE  SITE OF INJECTION.  SHE HAS HAD NO RELIEF FROM REGULAR LISTED PAIN MEDICATION INCLUDING NORCO 5MG AND VOLTAREN XR 100MG.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site warmth
Clinical narrative: PAIN, ITCHING, REDNESS, SWELLING, WARMTH AND INDURATION AT SITE  SITE OF INJECTION.  SHE HAS HAD NO RELIEF FROM REGULAR LISTED PAIN MEDICATION INCLUDING NORCO 5MG AND VOLTAREN XR 100MG.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: Patient noticed a rash/redness that formed that had defined borders one week after vaccination.  Patient stated it was itchy.  Patient stated they have no done anything differently; no new detergents, etc.  Patient was told to take diphenhydramine and was told to seek medical treatment if the redness grew, started to throb, emitted heat or if the developed a fever.
Age: 59.0
Sex: M
Vaccine: VARZOS
Symptoms: Arrhythmia, Cardioversion, Condition aggravated, Rash
Clinical narrative: Patient had an arrhythmia 3 days after shot. Had to be shocked back to life. Also had a rash on hands. Patient is ok now
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Back pain, Diarrhoea, Fatigue, Headache, Nausea
Clinical narrative: Headache day 1. Aching sore body, severe back pain and fatigue for 7 days. Diarrhea and nausea on days 6 and 7 after vaccine.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Pain
Clinical narrative: Headache day 1. Aching sore body, severe back pain and fatigue for 7 days. Diarrhea and nausea on days 6 and 7 after vaccine.
Age: 3.0
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site urticaria, Pyrexia, Skin mass, Tenderness
Clinical narrative: 10/10/19 (7 days after vaccine) fever to 102.3 and red welt at the vaccine site. 10/13/19 (10 days after vaccine) tender nodule under skin, the redness and fever had passed 10/17/19 (14 days after vaccine) resolution of the nodule and tenderness
Age: 25.0
Sex: F
Vaccine: FLUC4
Symptoms: Erythema, Pain in extremity, Skin warm
Clinical narrative: on saturday, 2 days after vaccine was administered, patient noticed a red spot about 1 inch below injection site, as of today (sunday) red spot has grown and is roughly 2 inches x4 inches and is warm to the touch. patient states her arm is very sore and achey. Note : spot does not encompass the injection site, reaction top edge is about 1 inch below the injection site and continues down and forward on her left arm.
Age: 29.0
Sex: M
Vaccine: FLUC4
Symptoms: Disorientation, Eye movement disorder, Moaning
Clinical narrative: About one minute after vaccination patients wife yelled for me. pt was in chair with unfocused eyes, moaning slightly, unaware of surroundings. called 911, but within one minute pt was better and seemed to be more aware. He spoke with paramedics and said he was fine. He said he has a fear of needles and had a similar situation when giving blood. He thinks it was unrelated to the flu vaccine and more a response he has to needles.
Age: 9.0
Sex: F
Vaccine: FLUC4
Symptoms: Dehydration, Fall, Lip dry, Pallor, Scratch
Clinical narrative: patient was sitting down after the flu shot  and fell over in front of the chair. we called her name to see if she responded and held her up and set her in the chair with head down between her leg. she wanted water and was dehydrated ( lips dry and pale) so mom get her orange juice and was feeling fine. she has some scrapes so i put on bandages on her shoulder and knee.  she went home walking and was fine per mom. I called mom 2 times after and mom said she is home and resting, doing fine. i asked her to call me if any questions or concern.
Age: 52.0
Sex: M
Vaccine: FLU4
Symptoms: Arthralgia, Injection site pain, Pain, Pain in extremity, Tendonitis
Clinical narrative: shoulder pain within 2 hours pain to elbow and fingers hurts to extend arm on left side
Age: 23.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Pruritus, Swelling, Urticaria
Clinical narrative: extreme hives with itching, redness swelling, generalized throughout entire body for 2+ days
Age: 67.0
Sex: M
Vaccine: FLU3
Symptoms: Arthralgia, Headache, Hypersomnia, Musculoskeletal pain, Myalgia
Clinical narrative: Patient slept 4 hours more than Normal. Woke up with paiN iN hips, knees shoulders and muscles as well as a headache
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills
Clinical narrative: 8 Hours after administration of vaccine patient began to shiver uncontrollably. He proceeded to the ER & stayed for a few hours until shivering was over.
Age: 20.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Autoimmune disorder, Autoimmune thyroiditis, Fatigue, Laboratory test abnormal, Thyroid function test normal
Clinical narrative: At the age of 29 went to endocrinologist and was diagnosed with an autoimmune disorder called hashimotos; This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (ref# 802876) via an unspecified reporter, referring to a 22-year-old adult female patient. The patient's pertinent medical history, concurrent condition and concomitant medication were not reported. The patient was not pregnant at the time of vaccination. There were no known allergies to medications, food or other products. On 01-JUN-2008 at 14:00, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) in the arm (strength, dose, lot# and expiry date were not reported) route of administration reported as needle and syringe (not specified further-SYR) for prophylaxis. It was reported that within months, the patient started to feel tired and gained weight exponentially. The patient visited the gynecologist and underwent genetic lab work for thyroid with normal result (reported as numbers were normal). The patient still had symptoms and after years she visited a specialist. The patient underwent two rounds of unspecified lab works and on 01-JUN-2010, the patient went to an endocrinologist and was diagnosed with an autoimmune disorder Hashimotos (autoimmune thyroiditis) (reported as "at the age of 29 years"). There was no family history of thyroid problems. The patient visited a physician/healthcare professional clinic for the event. The outcome of the event was reported as not recovered. The causality assessment was not provided.  The Agency considered the event Hashimotos to be serious due to disability or permanent damage.  Follow up information has been received on 16-OCT-2019 and stated that there is not further information available.
Age: 20.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Weight increased
Clinical narrative: At the age of 29 went to endocrinologist and was diagnosed with an autoimmune disorder called hashimotos; This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (ref# 802876) via an unspecified reporter, referring to a 22-year-old adult female patient. The patient's pertinent medical history, concurrent condition and concomitant medication were not reported. The patient was not pregnant at the time of vaccination. There were no known allergies to medications, food or other products. On 01-JUN-2008 at 14:00, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) in the arm (strength, dose, lot# and expiry date were not reported) route of administration reported as needle and syringe (not specified further-SYR) for prophylaxis. It was reported that within months, the patient started to feel tired and gained weight exponentially. The patient visited the gynecologist and underwent genetic lab work for thyroid with normal result (reported as numbers were normal). The patient still had symptoms and after years she visited a specialist. The patient underwent two rounds of unspecified lab works and on 01-JUN-2010, the patient went to an endocrinologist and was diagnosed with an autoimmune disorder Hashimotos (autoimmune thyroiditis) (reported as "at the age of 29 years"). There was no family history of thyroid problems. The patient visited a physician/healthcare professional clinic for the event. The outcome of the event was reported as not recovered. The causality assessment was not provided.  The Agency considered the event Hashimotos to be serious due to disability or permanent damage.  Follow up information has been received on 16-OCT-2019 and stated that there is not further information available.
Age: 20.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Autoimmune thyroiditis, Fatigue, Laboratory test, Thyroid function test normal, Weight increased
Clinical narrative: At the age of 29 went to endocrinologist and was diagnosed with an autoimmune disorder called hashimotos; This report was identified from a line listing obtained on request by the Company from the FDA under the Freedom of Information Act (ref# 802876) via an unspecified reporter, referring to a 22-year-old adult female patient. The patient's pertinent medical history, concurrent condition and concomitant medication were not reported. The patient was not pregnant at the time of vaccination. There were no known allergies to medications, food or other products. On 01-JUN-2008 at 14:00, the patient was vaccinated with the third dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) in the arm (strength, dose, lot# and expiry date were not reported) route of administration reported as needle and syringe (not specified further-SYR) for prophylaxis. It was reported that within months, the patient started to feel tired and gained weight exponentially. The patient visited the gynecologist and underwent genetic lab work for thyroid with normal result (reported as numbers were normal). The patient still had symptoms and after years she visited a specialist. The patient underwent two rounds of unspecified lab works and on 01-JUN-2010, the patient went to an endocrinologist and was diagnosed with an autoimmune disorder Hashimotos (autoimmune thyroiditis) (reported as "at the age of 29 years"). There was no family history of thyroid problems. The patient visited a physician/healthcare professional clinic for the event. The outcome of the event was reported as not recovered. The causality assessment was not provided.  The Agency considered the event Hashimotos to be serious due to disability or permanent damage.  Follow up information has been received on 16-OCT-2019 and stated that there is not further information available.
Age: 75.0
Sex: F
Vaccine: VARZOS, FLU3, VARZOS
Symptoms: Chills, Condition aggravated, Fatigue, Glaucoma, Headache
Clinical narrative: Patient received her influenza and shingles vaccines on 09/20/2019 without incident. On 09/25/19, patient noticed a diffuse red rash that began on her neck, and left shoulder and progressed down to her left arm (deltoid/bicep/triceps area). She reported it to me a couple of days later and on presentation the rash was observed only on her left arm. She reported that she had gone to her dermatologist ( Dr), and psoriasis was ruled out and a determination that it was an adverse reaction to a vaccine was made. She was prescribed and completed 2 weeks of prednisone.
Age: 75.0
Sex: F
Vaccine: VARZOS, FLU3, VARZOS
Symptoms: Intraocular pressure increased, Nausea, Pain, Retching, Vaccination complication
Clinical narrative: Patient received her influenza and shingles vaccines on 09/20/2019 without incident. On 09/25/19, patient noticed a diffuse red rash that began on her neck, and left shoulder and progressed down to her left arm (deltoid/bicep/triceps area). She reported it to me a couple of days later and on presentation the rash was observed only on her left arm. She reported that she had gone to her dermatologist ( Dr), and psoriasis was ruled out and a determination that it was an adverse reaction to a vaccine was made. She was prescribed and completed 2 weeks of prednisone.
Age: 75.0
Sex: F
Vaccine: VARZOS, FLU3, VARZOS
Symptoms: Vomiting
Clinical narrative: Patient received her influenza and shingles vaccines on 09/20/2019 without incident. On 09/25/19, patient noticed a diffuse red rash that began on her neck, and left shoulder and progressed down to her left arm (deltoid/bicep/triceps area). She reported it to me a couple of days later and on presentation the rash was observed only on her left arm. She reported that she had gone to her dermatologist ( Dr), and psoriasis was ruled out and a determination that it was an adverse reaction to a vaccine was made. She was prescribed and completed 2 weeks of prednisone.
Age: 75.0
Sex: F
Vaccine: VARZOS, FLU3, VARZOS
Symptoms: Psoriasis, Rash erythematous
Clinical narrative: Patient received her influenza and shingles vaccines on 09/20/2019 without incident. On 09/25/19, patient noticed a diffuse red rash that began on her neck, and left shoulder and progressed down to her left arm (deltoid/bicep/triceps area). She reported it to me a couple of days later and on presentation the rash was observed only on her left arm. She reported that she had gone to her dermatologist ( Dr), and psoriasis was ruled out and a determination that it was an adverse reaction to a vaccine was made. She was prescribed and completed 2 weeks of prednisone.