chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 50.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Back pain, Gait disturbance, Headache, Injection site pain, Mobility decreased
Clinical narrative: I noticed severe lower back pain a few days after the vaccine, but couldn't figure out what had caused it until I also noticed a chicken pox like rash about four to five  days after the vaccine.  I called the doctor's office and they said these symptoms are extremely rare and they would only last a few days.   The rash, which was worst on my upper legs and upper arms, as well as scattered on my back and chest, was itchy and somewhat raised.  Some places were blotchy and raised on the back of my arm close to my armpit.  Most of them were just spread-out red spots.  The rash almost completely disappeared after three weeks, but the back pain has continued, but decreased in severity.  The first week was extremely painful and I could hardly walk or move due to the back  pain.  Moving the wrong way would shoot pain in my back.  This happened for a few weeks and now it's just sore for the most part.   I had experienced pain at the injection site on my shoulder since receiving the vaccine and it was painful for about a week.  I had also had the flu vaccine the same day in the other shoulder, but it only mildly hurt for about a day or two.  I also experienced bad headaches, but they are not entirely abnormal for me so I didn't think much about them.   The biggest concern for me is that my back pain is still not recovered entirely.
Age: 50.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Pain, Rash, Rash macular, Rash papular, Rash pruritic
Clinical narrative: I noticed severe lower back pain a few days after the vaccine, but couldn't figure out what had caused it until I also noticed a chicken pox like rash about four to five  days after the vaccine.  I called the doctor's office and they said these symptoms are extremely rare and they would only last a few days.   The rash, which was worst on my upper legs and upper arms, as well as scattered on my back and chest, was itchy and somewhat raised.  Some places were blotchy and raised on the back of my arm close to my armpit.  Most of them were just spread-out red spots.  The rash almost completely disappeared after three weeks, but the back pain has continued, but decreased in severity.  The first week was extremely painful and I could hardly walk or move due to the back  pain.  Moving the wrong way would shoot pain in my back.  This happened for a few weeks and now it's just sore for the most part.   I had experienced pain at the injection site on my shoulder since receiving the vaccine and it was painful for about a week.  I had also had the flu vaccine the same day in the other shoulder, but it only mildly hurt for about a day or two.  I also experienced bad headaches, but they are not entirely abnormal for me so I didn't think much about them.   The biggest concern for me is that my back pain is still not recovered entirely.
Age: 16.0
Sex: M
Vaccine: FLU4
Symptoms: Head injury, Hypotension, Loss of consciousness
Clinical narrative: after vaccination, put pressure at the injection site for 30 seconds then after 2 minutes upright, patient passed out on the floor and hit their head on the dry wall.  blood pressure was low so taken to the hospital for further evaluation.
Age: 1.0
Sex: F
Vaccine: MMRV
Symptoms: Erythema, Skin warm, Swelling, Tenderness
Clinical narrative: Red, swollen, quarter size in diameter, tender to touch, warm
Age: 69.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Red, swollen arm
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain
Clinical narrative: Chills, aches and extreme headache for of the 24 hours following vaccination
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Cold sweat, Dysphagia, Eye irritation, Glassy eyes, Nausea
Clinical narrative: vaccine administered at 11:38AM at the off site clinic on 10-22-20. approx 11:55am she started to complain of her eyes burning, feeling hard to swallow, clammy, itching, and she was shaking (which is a normal body function). I asked many questions and she stated she has had the flu shot many times with no issues only to the tetnus vaccine. I placed a cool cloth on her neck and tried to get her to relax as she was responsive but the itching continued as I advised about an Epi-pen but she can't have them she stated. The other collegues in the office at the time had benadryl so she took one 25mg tablet at 12:10 as the itching is what bothered her. She sat and relaxed, went to the bathroom as she felt nauseous but did not vomit. It seemed to get better than about 1:00pm her eyes were burning again/appeared glassy and she felt very clammy so I called paramedics. They arrived on scene, took vitals, listened to lungs and were clear. Advised they could take her to the ER, it seemed the bendryl was helping but the delayed reaction one is not able to tell the severity of it. She delined the ER. I advised before leaving to keep the benadryl at home but should anything develop further she needed to go to ER, she agreed. I called her MD office and disclosed the incident per the MA he was going to follow up with her as well.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Pruritus, Tremor
Clinical narrative: vaccine administered at 11:38AM at the off site clinic on 10-22-20. approx 11:55am she started to complain of her eyes burning, feeling hard to swallow, clammy, itching, and she was shaking (which is a normal body function). I asked many questions and she stated she has had the flu shot many times with no issues only to the tetnus vaccine. I placed a cool cloth on her neck and tried to get her to relax as she was responsive but the itching continued as I advised about an Epi-pen but she can't have them she stated. The other collegues in the office at the time had benadryl so she took one 25mg tablet at 12:10 as the itching is what bothered her. She sat and relaxed, went to the bathroom as she felt nauseous but did not vomit. It seemed to get better than about 1:00pm her eyes were burning again/appeared glassy and she felt very clammy so I called paramedics. They arrived on scene, took vitals, listened to lungs and were clear. Advised they could take her to the ER, it seemed the bendryl was helping but the delayed reaction one is not able to tell the severity of it. She delined the ER. I advised before leaving to keep the benadryl at home but should anything develop further she needed to go to ER, she agreed. I called her MD office and disclosed the incident per the MA he was going to follow up with her as well.
Age: 23.0
Sex: F
Vaccine: FLUR4
Symptoms: Dysphagia, Throat tightness
Clinical narrative: Pt reported noticing onset of symptoms - tightness in throat and difficulty swallowing. Took Benadryl with no relief. Then took a dose of her own EpiPen 2:10pm. Arrived at ER at 2:30pm.
Age: 76.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site inflammation, Injection site pruritus, Injection site rash
Clinical narrative: Patient was given vaccine around 3pm on the 21st. She states that later that night, her arm start to itch and there was some redness at the injection site. As it progressed, the rash traveled further down her arm and covered the top portion of her arm. She states that it just itches. The area looked inflamed and very red. The skin was still intact.
Age: 12.0
Sex: F
Vaccine: UNK
Symptoms: Syncope
Clinical narrative: syncope  after receiving VZV and Flu vaccine
Age: 57.0
Sex: F
Vaccine: FLUC4
Symptoms: Chest pain, Confusional state, Nausea, Photopsia, Tremor
Clinical narrative: Nausea, vomiting, flashes of white lights, chest pains, shaking, confusion
Age: 57.0
Sex: F
Vaccine: FLUC4
Symptoms: Vomiting
Clinical narrative: Nausea, vomiting, flashes of white lights, chest pains, shaking, confusion
Age: 66.0
Sex: F
Vaccine: FLUA4
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Red swelling on the arm right below where the shot was given starting the day after the vaccine was given.
Age: 65.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Vaccination complication
Clinical narrative: PT. received  antibiotic clindamycin on 10/15/16 from urgent care, and then went to provider for second opinion and received bactrim DS on 10/16.  pt reported improvement on 10/16/20
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Headache, Injection site erythema, Injection site mass, Injection site swelling, Injection site warmth
Clinical narrative: Swollen lump at injection site. Hot to touch. Redness at injection site. Headache. bodyaches.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Pain
Clinical narrative: Swollen lump at injection site. Hot to touch. Redness at injection site. Headache. bodyaches.
Age: 61.0
Sex: F
Vaccine: FLUR4, VARZOS
Symptoms: Blister, Musculoskeletal stiffness
Clinical narrative: The weekend after receiving vaccinations, patient felt a stiffness in her neck that traveled down her spine to her lower back. Today October 22, 2020, the patient still experiencing the stiffness in her lower back along with a cluster of blisters.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site rash
Clinical narrative: Patient says the immunization was extremely painful, then within 3 hours, she had developed a quarter sized bruise and redness/light lacey rash about 2 inches wide going from the injection site to her elbow.  Today, which was 6 days later, the bruise and redness had not subsided,
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Pain, redness and swelling around injection began evening of the vaccine; continuing to increase in size.  At office visit of 10-22-20 at 4:20 pm area of redness, swelling, warmth was 10 inches by 5 inches.  Started on Keflex for possible cellulitis.
Age: 3.0
Sex: F
Vaccine: HEPA
Symptoms: Injection site swelling
Clinical narrative: Swollen area around the spot of vacination size 2.5 inches length wise/ wide by 1 inch high or long ways
Age: 66.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Pruritus, Rash, Urticaria
Clinical narrative: Had a rash, itchy hives
Age: 73.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Bacterial test negative, Blood creatinine increased, Body temperature increased, Chills, Dehydration
Clinical narrative: Had immunizations 10-2-2020, Friday at around 12:30PM. Friday evening patient had fever, chills, and swelling. He could not stand or get out of bed without help. He got out bed with help to throw up. He went to the ER at 9:00 am Saturday morning. He had a temperature on 101.7. The ER gave him an IV for rehydration with an antibiotic in the IV. He was in the ER for about 6 hours. Pt did not receive any medications upon discharge. It took the patient about one and a half weeks before he felt better.    Pt is feeling better now
Age: 73.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Mobility decreased, Pyrexia, SARS-CoV-2 test negative, Swelling, Vomiting
Clinical narrative: Had immunizations 10-2-2020, Friday at around 12:30PM. Friday evening patient had fever, chills, and swelling. He could not stand or get out of bed without help. He got out bed with help to throw up. He went to the ER at 9:00 am Saturday morning. He had a temperature on 101.7. The ER gave him an IV for rehydration with an antibiotic in the IV. He was in the ER for about 6 hours. Pt did not receive any medications upon discharge. It took the patient about one and a half weeks before he felt better.    Pt is feeling better now
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Body temperature increased, Chills, Dizziness, Headache, Tremor
Clinical narrative: patient experience dizziness, shaking, chills, high temperature and head ache
Age: 38.0
Sex: F
Vaccine: UNK
Symptoms: Hypoaesthesia
Clinical narrative: Persistent, chronic numbness on top of right foot after flu shot
Age: 25.0
Sex: M
Vaccine: FLU4
Symptoms: Rash, Rash erythematous, Rash papular, Rash pruritic
Clinical narrative: Patient came to the pharmacy on 10/22/2020 with a rash on both of his arms. It was a red in patches and had some raised pumps. Patient stated it started on Monday night and progressively got worse up to Wednesday. He said it did not get worse or better from Wednesday to Thursday. He stated it was very itchy so I recommended OTC benadryl and hydrocortisone cream. I counseled patient to watch for signs of it getting worse like trouble breathing and the rash spreading and recommended going to an urgent care if it gets worse.
Age: 67.0
Sex: F
Vaccine: FLUR4
Symptoms: Cellulitis
Clinical narrative: pt had cellulitus and went to the hospital.  Is ok now and called to report.  Pt mentioned she will be contacting her prescriber tomorrow when they are open
Age: 70.0
Sex: M
Vaccine: FLUA3, VARZOS
Symptoms: Dysphagia, Influenza like illness, Insomnia, Vision blurred
Clinical narrative: Patient called and reported that he has flu like symptoms since he received immunizations, difficult time with sleep, vision changes (blurred vision), and feels like difficult to swallow. Patient reported that he is started to feel a little better and planning to see prescriber for follow up.
Age: 81.0
Sex: M
Vaccine: FLU4
Symptoms: Blood pressure increased, Condition aggravated, Diplegia, Laboratory test normal, Lip swelling
Clinical narrative: Patient presented at pharmacy stating that he was just released from the hospital due to possible adverse reaction to his flu vaccine.  He experienced lip swelling, severely increased blood pressure, and became paralyzed from "the legs down."   He went to the hospital and stated that they thought he was having a stroke, but all tests came back negative.  He told the provider that he had the flu shot the day before and the provider seems to believe that he had a severe reaction to the flu vaccine. """
Age: 81.0
Sex: M
Vaccine: FLU4
Symptoms: Vaccination complication
Clinical narrative: Patient presented at pharmacy stating that he was just released from the hospital due to possible adverse reaction to his flu vaccine.  He experienced lip swelling, severely increased blood pressure, and became paralyzed from "the legs down."   He went to the hospital and stated that they thought he was having a stroke, but all tests came back negative.  He told the provider that he had the flu shot the day before and the provider seems to believe that he had a severe reaction to the flu vaccine. """
Age: 24.0
Sex: F
Vaccine: FLUC4
Symptoms: Ageusia, Dry eye, Eye pruritus, Eyelid function disorder, Facial paralysis
Clinical narrative: My first symptom started on Sunday October 11th.  The right side of my tongue went numb, and I could not feel or taste anything on the right side of my tongue.  I was eating calamari which is not apart of my normal diet, and therefore blamed the numbness on an allergic reaction.  However later in the week, on Thursday October 15th, I started to feel that my right eye was dry and itchy, and that I could not completely close my eye.  The next day, Friday the 16th, I could not move the right side of my face.  I could not smile, close my eye, move my lips, move my eyebrow, or use the right side of my face.  I could not get in to see my doctor until Monday October 19th, and I did not go to the ER because I was not experiencing any life threatening symptoms.  On Monday my doctor diagnosed me with Bell's Palsy which she said was related to an infection.  I spoke with a nurse at my doctors office that had worked for VAERS for many years, and she is the one who suggested that this was probably a vaccine reaction since there were not other evident causes of the Bell's Palsy, and because I started having problems just days after receiving the flu shot.  My doctor placed me on a high dose prednisone prescription with the hope that it would decrease the inflammation of the facial nerve, and start to restore facial function.  as of today, October 22nd, the only change in symptom I have is a decrease in the numbness on the right side of my tongue.
Age: 24.0
Sex: F
Vaccine: FLUC4
Symptoms: Hypoaesthesia oral, Neurological examination
Clinical narrative: My first symptom started on Sunday October 11th.  The right side of my tongue went numb, and I could not feel or taste anything on the right side of my tongue.  I was eating calamari which is not apart of my normal diet, and therefore blamed the numbness on an allergic reaction.  However later in the week, on Thursday October 15th, I started to feel that my right eye was dry and itchy, and that I could not completely close my eye.  The next day, Friday the 16th, I could not move the right side of my face.  I could not smile, close my eye, move my lips, move my eyebrow, or use the right side of my face.  I could not get in to see my doctor until Monday October 19th, and I did not go to the ER because I was not experiencing any life threatening symptoms.  On Monday my doctor diagnosed me with Bell's Palsy which she said was related to an infection.  I spoke with a nurse at my doctors office that had worked for VAERS for many years, and she is the one who suggested that this was probably a vaccine reaction since there were not other evident causes of the Bell's Palsy, and because I started having problems just days after receiving the flu shot.  My doctor placed me on a high dose prednisone prescription with the hope that it would decrease the inflammation of the facial nerve, and start to restore facial function.  as of today, October 22nd, the only change in symptom I have is a decrease in the numbness on the right side of my tongue.
Age: 62.0
Sex: F
Vaccine: FLUR4, PPV
Symptoms: Cellulitis, Erythema, Injected limb mobility decreased, Tenderness
Clinical narrative: Pt. stated she could not move her arms about 24 hours post injection ; stated they were red and tender to the touch. She went to urgent care and they said she had an infection , presumably cellulitis .
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site bruising, Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: bruising, red, swollen and warm to the touch sight area that is about the size of a baseball in circumference.   Very tender to the touch or with any movement of my left arm
Age: 19.0
Sex: F
Vaccine: FLUA4
Symptoms: Abdominal pain upper, Dizziness, Fall
Clinical narrative: No treatment was given except rest and oral fluids. Symptoms improved.
Age: 38.0
Sex: M
Vaccine: FLU4
Symptoms: Dyspnoea, Flushing, Rash, Urticaria
Clinical narrative: Vaccine Reaction- FLU-After approximately 4 day of the vaccines was administered to the patient, he starts developing short of breath, facial flushing, and a generalized rash with some hives.
Age: 91.0
Sex: F
Vaccine: FLU4, VARZOS
Symptoms: Urticaria
Clinical narrative: Patient's daughter called on the day after the vaccine was administered and reported that patient has hives on hands, stomach and hip.  Patient called doctor's office and left message.  Advised patient to try taking Benadryl.  Advised patient to call doctor if symptoms not improve or get worse.
Age: 35.0
Sex: F
Vaccine: UNK
Symptoms: Diarrhoea, Nausea, Vomiting
Clinical narrative: Vomiting Diarrhea  Nausea
Age: 9.0
Sex: F
Vaccine: UNK
Symptoms: Peripheral swelling, Urticaria
Clinical narrative: Flu vaccine caused swelling and inflated tissue in leg and hives.
Age: 17.0
Sex: F
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Fainting, Ems dispatched. She awoke and was transported for observation
Age: 79.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity, Wrong product administered
Clinical narrative: Pt received the incorrect vaccine. This was a second dose of Prevnar 13 instead of Pneumovax 23. Pt says her arm was extra sore, but reported no other adverse events
Age: 43.0
Sex: M
Vaccine: FLUX
Symptoms: Chills, Myalgia
Clinical narrative: Chills and muscle aches 3 hours post FLU vaccine. Treated with ADVIL, chills returned at 5pm, Treated with ADVIL and TYLENOL.
Age: 7.0
Sex: F
Vaccine: FLU4
Symptoms: Urticaria
Clinical narrative: Patient broke out into hives a day after the vaccine. Father of patient stated that she has had flu shots in past and never had this happened.
Age: 31.0
Sex: F
Vaccine: FLUR4
Symptoms: Discomfort, Injection site erythema, Lymphadenitis
Clinical narrative: Patient received Flublok vaccine on Tues 10/20/2020 aroung 6:15PM. Patient called to inform pharmacy of armpit swelling and minor discomfort on Thursday morning at 10:15 am 10/22/2020. There is very minor redness not very noticeable at actual injection site. This is the first time this has happened to patient. Patient was inform if condition worsens or does not resolve in 2 to 3 days to contact pharmacy and reach out to primary care as needed.
Age: 1.83
Sex: M
Vaccine: DTAP
Symptoms: Blood test normal, Febrile convulsion, Pyrexia, SARS-CoV-2 test negative, Urine analysis normal
Clinical narrative: Patient had a febrile seizure 7 days after the vaccine. He presented with a fever 6 days after the vaccine, we gave him infant ibuprofen beginning then, and on the 7th day had a seizure 5.5 hours after a dose. He was tested for COVID and infectious (via blood work and urine sample), which came back negative. He does not attend daycare so illnesses are rare for him.
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Dizziness, Headache, Nausea, Pain in extremity, Pyrexia
Clinical narrative: Aside from the pain in the arm, which is pretty normal,  I woke up at 3a.m. (12 hours after the injection) with a fever, dizziness, nausea, a splitting headache and I vomited. The headache lasted until  early Thursday morning,  and my fever finally broke on Wednesday afternoon (went up to 101.8) A rash started to appear below the injection site on Tuesday afternoon and is currently still on my body (as of 8pm PST on 10/22/2020).  The rash does not itch or burn but it is quite warm to the touch, as though it had its own little fever.  I took photos and sent them to my doctor today (10/22).  I did contact my doctor on  Wednesday and had a Telemed meeting with her.  I did forget to mention the rash until today; I simply overlooked it.   That?s why I sent a photo over, called her office to take a look at it and hope to hear from her by 10/23.   My physician had me call the pharmacy to see what dose of the flu vaccine I was given and it was the super one (ones given to the elderly).  My physician believes it was too strong for me and noted it on my chart.  I then contacted the pharmacy and had them note it as well.  Last of all, I did have this vaccine along with a PPSV23.  I have done the pneumonia and flu before in the past without any issues.
Age: 66.0
Sex: F
Vaccine: UNK
Symptoms: Rash, Skin warm, Vomiting
Clinical narrative: Aside from the pain in the arm, which is pretty normal,  I woke up at 3a.m. (12 hours after the injection) with a fever, dizziness, nausea, a splitting headache and I vomited. The headache lasted until  early Thursday morning,  and my fever finally broke on Wednesday afternoon (went up to 101.8) A rash started to appear below the injection site on Tuesday afternoon and is currently still on my body (as of 8pm PST on 10/22/2020).  The rash does not itch or burn but it is quite warm to the touch, as though it had its own little fever.  I took photos and sent them to my doctor today (10/22).  I did contact my doctor on  Wednesday and had a Telemed meeting with her.  I did forget to mention the rash until today; I simply overlooked it.   That?s why I sent a photo over, called her office to take a look at it and hope to hear from her by 10/23.   My physician had me call the pharmacy to see what dose of the flu vaccine I was given and it was the super one (ones given to the elderly).  My physician believes it was too strong for me and noted it on my chart.  I then contacted the pharmacy and had them note it as well.  Last of all, I did have this vaccine along with a PPSV23.  I have done the pneumonia and flu before in the past without any issues.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site erythema, Injection site warmth
Clinical narrative: Vaccine injection site was red, hot to touch, softball size red area. Vaccines given 10/20/2020 and noticed first reaction sign 10/21/2020. 10/22/2020 site was a lot more red and large. Was seen by PA-C and Pt was given decadron by mouth 0.7ml. Told to take motrin and cold compress, benadryl as needed
Age: 37.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site haematoma, Injection site haemorrhage, Injection site swelling
Clinical narrative: Swelling + bleeding at time of injection consistent with hematoma x 4cm (L) deltoid. Txt with antbx prophylactically
Age: 27.0
Sex: F
Vaccine: FLUC4
Symptoms: Hypersensitivity, Mobility decreased
Clinical narrative: pt was having difficulty raising arm. went to Urgent Care and diagnosed as allergic reaction
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea, Pyrexia, Vomiting
Clinical narrative: patient complained of severe fever, headache, chills, nausea and vomiting
Age: 0.25
Sex: F
Vaccine: RV5
Symptoms: Culture urine, Dehydration, Enema administration, Full blood count, Intussusception
Clinical narrative: Intussusception on 10/19/2020, bilious vomiting, fussiness, lethargic, dehydration. Admitted to Hospital 10/20/2020, air enema done and symptoms improved.
Age: 0.25
Sex: F
Vaccine: RV5
Symptoms: Irritability, Lethargy, Metabolic function test, Ultrasound abdomen, Urinary system X-ray
Clinical narrative: Intussusception on 10/19/2020, bilious vomiting, fussiness, lethargic, dehydration. Admitted to Hospital 10/20/2020, air enema done and symptoms improved.
Age: 0.25
Sex: F
Vaccine: RV5
Symptoms: Urine analysis, Vomiting
Clinical narrative: Intussusception on 10/19/2020, bilious vomiting, fussiness, lethargic, dehydration. Admitted to Hospital 10/20/2020, air enema done and symptoms improved.
Age: 17.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Seizure
Clinical narrative: Had seizure (for about 30 secs) / felt light headed about 2 minutes after influenza vaccination
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Patient was given Proquad & Kinrix on same day in (L) forearm. Swelling & pain & redness 2 x 4inches at the site of injection of Kinrix. Seen pt in office on 10/14/2020 - given ibuprofen & -Benadryl, condition improved
Age: 2.0
Sex: F
Vaccine: DTAPHEPBIP, FLU4
Symptoms: Febrile convulsion, Pyrexia
Clinical narrative: Patient was given 2 shots: Fluzone #1 + Pediarix #2 on 9/30/20 Developing high Fever on Saturday + was seen in ER for simple Febrile Seizure - Rechecked in office on 10/2/20/20 + 10/8/2020. Documented in ER as otitis media but Rechecked in office no concerns of infection. Condition improved
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Pt. notified me on 10-10-20 that the eveing of 10-09-20 she started running a fever and has body aches. These symptoms continued through Saturday. She reported to me again on Sunday that fever exceeded 102 degrees on Saturday evening. Sunday morning was better. I instructed her to follow up with PCP on Monday if not better but checked in on Monday and she was better.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Neuropathy peripheral, Post herpetic neuralgia
Clinical narrative: neuropathy; shingles; post-herpetic neuralgia; Information has been received from a lawyer referring to a patient of unknown age and gender. Information about concurrent condition, history condition and concomitant medication was not reported. On or about 12-OCT-2017, the patient was vaccinated with zoster vaccine live (ZOSTAVAX) (strength, dose, route, lot# and expiration date unknown) for routine health maintenance and for its intended purpose: the prevention of shingles (herpes zoster). Shortly after receiving zoster vaccine live (ZOSTAVAX), the patient suffered an outbreak of shingles, post-herpetic neuralgia and neuropathy. As a result of these symptoms, the patient was seen and treated by medical providers and was still under their care. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient's symptoms have resulted in physical limitations not present prior to using the vaccine. The patient also experiences mental and emotional distress due to resulting physical limitations and seriousness of the patient's condition. As a result of the manufacture, marketing, advertising, promotion, distribution and/or sale of zoster vaccine live (ZOSTAVAX), the patient sustained severe and permanent personal injuries. Further, as a tragic consequence of zoster vaccine live (ZOSTAVAX), the patient suffered serious, progressive, permanent, and incurable injuries, as well as significant conscious pain and suffering, mental anguish, emotional distress, loss of enjoyment of life, physical impairment and injury. As a direct and proximate result of zoster vaccine live (ZOSTAVAX), the patient has suffered and incurred damages, including medical expenses; the loss of accumulations; and other economic and non-economic damages. The outcome of the events shingles, post-herpetic neuralgia and neuropathy was considered to be not recovered and causal relationship was assessed as related.    The lawyer considered the events shingles, post-herpetic neuralgia and neuropathy to be disability.   Upon internal review, neuropathy was determined to be medically significant.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash vesicular
Clinical narrative: shingles; varicella type rash; other zoster related injuries; This initial spontaneous report was received from a lawyer regarding a case in litigation and refers to a patient of unknown age and gender. No information was provided regarding medical history, concurrent conditions, or concomitant medications. On or about 21-SEP-2009, the patient was vaccinated (inoculated) with zoster vaccine live (ZOSTAVAX) (lot#, expiration date, dose, dose# and route not specified)  by a healthcare provider for routine long-term prevention of shingles and zoster related conditions (prophylaxis). Subsequently, the patient was treated by physician's for the following injuries resulting from the patient's zoster vaccine live (ZOSTAVAX) use: shingles, varicella type rash, and other zoster related injuries. The outcome of the events was not provided. Therefore, the causality for the events was related to zoster vaccine live (ZOSTAVAX).
Age: 1.08
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Death, Influenza virus test negative, SARS-CoV-2 test negative
Clinical narrative: patient was given the Fluzone Quad vaccination and was dead the next day, No reason of death has been determined/ (Death NOS); Initial information received on 19-Oct-2020 regarding an unsolicited valid serious case from Nurse.  This case involves a 13 months old male patient who died the next day (Death) after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant medications were reported.  On 14-Oct-2020, the patient received a 0.5ml once dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7081JA and expiration date 30-Jun-2021) via intramuscular route in the left vastus lateralis for prophylactic vaccination.  On 15-Oct-2020, the patient died (death), 1 day following the vaccination of INFLUENZA QUADRIVAL A-B VACCINE. This event was assessed as medically significant. No other illness and symptoms were reported. The child was found the next morning lifeless.   No laboratory data reported.  It was not reported if the patient was receiving any corrective treatment.  It was unknown at the time of reporting if an autopsy was done and the cause of death was not known, as no reason of death was determined.; Sender's Comments: This case involves a 13 months old male patient who died the next day (Death) after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT]. Time to onset is compatible. Additional information regarding patient's relevant medical history, health condition at time of vaccination and Laboratory tests, autopsy results for cause of death is needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: patient was given the Fluzone Quad vaccination and was dead the next day, No reason of death has been determined (Death NOS)
Age: 1.08
Sex: M
Vaccine: FLU4, FLU4
Symptoms: Death
Clinical narrative: patient was given the Fluzone Quad vaccination and was dead the next day, No reason of death has been determined/ (Death NOS); Initial information received on 19-Oct-2020 regarding an unsolicited valid serious case from Nurse.  This case involves a 13 months old male patient who died the next day (Death) after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  No concomitant medications were reported.  On 14-Oct-2020, the patient received a 0.5ml once dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot UT7081JA and expiration date 30-Jun-2021) via intramuscular route in the left vastus lateralis for prophylactic vaccination.  On 15-Oct-2020, the patient died (death), 1 day following the vaccination of INFLUENZA QUADRIVAL A-B VACCINE. This event was assessed as medically significant. No other illness and symptoms were reported. The child was found the next morning lifeless.   No laboratory data reported.  It was not reported if the patient was receiving any corrective treatment.  It was unknown at the time of reporting if an autopsy was done and the cause of death was not known, as no reason of death was determined.; Sender's Comments: This case involves a 13 months old male patient who died the next day (Death) after receiving INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT]. Time to onset is compatible. Additional information regarding patient's relevant medical history, health condition at time of vaccination and Laboratory tests, autopsy results for cause of death is needed for complete assessment of the case. Based upon the reported information, the role of the vaccine cannot be assessed.; Reported Cause(s) of Death: patient was given the Fluzone Quad vaccination and was dead the next day, No reason of death has been determined (Death NOS)
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Asthenia, Blood glucose increased, Breath odour, Confusional state, Diabetic ketoacidosis
Clinical narrative: Developed signs of hyperglycemia (high blood sugar): Frequent urination, Increased thirst, Fatigue, Fruity-smelling breath, Nausea, Shortness of breath,  Weakness, Confusion resulting in diabetic ketoacidosis with a diagnosis of Type 1 Diabetes Mellitus.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Dyspnoea, Fatigue, Hyperglycaemia, Nausea, Pollakiuria
Clinical narrative: Developed signs of hyperglycemia (high blood sugar): Frequent urination, Increased thirst, Fatigue, Fruity-smelling breath, Nausea, Shortness of breath,  Weakness, Confusion resulting in diabetic ketoacidosis with a diagnosis of Type 1 Diabetes Mellitus.
Age: 1.0
Sex: F
Vaccine: MMR
Symptoms: Thirst, Type 1 diabetes mellitus
Clinical narrative: Developed signs of hyperglycemia (high blood sugar): Frequent urination, Increased thirst, Fatigue, Fruity-smelling breath, Nausea, Shortness of breath,  Weakness, Confusion resulting in diabetic ketoacidosis with a diagnosis of Type 1 Diabetes Mellitus.
Age: 55.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Headache, Hot flush, Impaired work ability, Nausea, Pain
Clinical narrative: started out with heat flashes and stomach nausea progressed into dry heaves with severe body aching in upper torso and massive headache for 2 days straight no fever. GlaxoSmith kline poisened my body as far as I am concerned. This shit almost killed me and I will be writing a letter to the manufacturer expressing my concerns and seeking 2 days worth of lost wages and for unknown damage to my body at this time.
Age: 55.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Retching
Clinical narrative: started out with heat flashes and stomach nausea progressed into dry heaves with severe body aching in upper torso and massive headache for 2 days straight no fever. GlaxoSmith kline poisened my body as far as I am concerned. This shit almost killed me and I will be writing a letter to the manufacturer expressing my concerns and seeking 2 days worth of lost wages and for unknown damage to my body at this time.
Age: 55.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain, Chills, Hot flush, Nausea, Retching
Clinical narrative: started out with heat flashes and stomach nausea progressed into dry heaves with severe body aching in upper torso and massive headache for 2 days straight no fever. GlaxoSmith kline poisened my body as far as I am concerned. This shit almost killed me and I will be writing a letter to the manufacturer expressing my concerns and seeking 2 days worth of lost wages and for unknown damage to my body at this time.
Sex: M
Vaccine: PPV
Symptoms: Vaccination site pain, Vaccination site swelling, Vaccination site warmth
Clinical narrative: The area feels hot; Injection site reaction of pain and swelling; Injection site reaction of pain and swelling; This spontaneous report was received from a pharmacist referring to an elderly reported as "over 65 years old" male patient. Information regarding the patient's medical history,  drug allergies, or reactions was reported as none. Patient historical vaccines included pneumococcal 4 6B 9V 14 18C 19F 23F conj vaccine (CRM197) (PREVENAR) and concomitant vaccines, an unspecified influenza virus vaccine inactivated.       On 29-SEP-2020, the patient was vaccinated with the first dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX 23), 0.5 milligrams once, intramuscularly in the deltoid for prophylaxis (strength, lot number and expiration date were not provided).    On 30-SEP-2020, the patient experienced vaccination site pain and vaccination site swelling. The patient was told to take acetaminophen (TYLENOL) and used iced.  On 01-OCT-2020, the patient was contacted, and he reported that the swelling was extended down to the elbow, and the area feels hot (vaccination site warmth) in addition to being painful. The patient was advised to contact the physician.    The outcome of vaccination site pain, vaccination site warmth, and vaccination site swelling was reported as not resolved.     The reporter did not assess the causal relationship between the events and  pneumococcal Vaccine, Polyvalent (23-valent)(PNEUMOVAX23 ). combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not suggest a causal association with the device or device constituent
Age: 60.0
Sex: U
Vaccine: PPV
Symptoms: Product storage error
Clinical narrative: Improperly stored vaccine administered; This spontaneous report as received from a nurse and refers to a 60-year-old patient. The patient's medical history, historical drugs, previous drug reactions, allergies, concurrent conditions, and concomitant therapies were not reported.      On 09-OCT-2020, the patient was vaccinated with an improperly stored dose of pneumococcal vaccine, polyvalent (23-valent) (PNEUMOVAX23) 0.5 milliliter lot # S024808, expiration date on 02-JUN-2021 as prophylaxis (strength,  frequency, route of administration, and anatomical location were not reported). The administered dose of vaccine experienced the temperature excursion below 2 degrees Celsius (minus 17 degrees Celsius) for 63 hours and 45 minutes. There was no previous temperature of excursion. Data logger was not involved. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S024808; expirationdate: 02-JUN-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability
Sex: U
Vaccine: HEP, HEP
Symptoms: Product storage error
Clinical narrative: No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 21-SEP-2020, the patient was vaccinated with an improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB), 1 injection, lot # S022584, expiration date: 31-OCT-2021 (injection site and route of administration were not provided) for prophylaxis.  On 04-AUG-2020, the administered dose experienced the temperature excursion of below 2 degrees Celsius (C) (1.1 C) for 27 hours and 45 minutes and above 9 degrees Celsius (9 C) for 1 hour and 15 minutes. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. No further adverse events (AE) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022584; expirationdate: 31-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Sex: U
Vaccine: HEP, HEP
Symptoms: Product storage error, Product temperature excursion issue
Clinical narrative: No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 23-SEP-2020, the patient was vaccinated with an improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB), 1 injection, lot # S022584, expiration date: 31-OCT-2021 (injection site and route of administration were not provided) for prophylaxis.  On 04-AUG-2020, the administered dose experienced the temperature excursion of below 2 degrees Celsius (C) (1.1 C) for 27 hours and 45 minutes and above 9 degrees Celsius (9 C) for 1 hour and 15 minutes. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. No further adverse events (AE) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022584; expirationdate: 31-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Sex: U
Vaccine: HEP, HEP
Symptoms: Product storage error, Product temperature excursion issue
Clinical narrative: No further AE; temperature excursion involving multiple lot numbers for GARDASIL 9, MMR II, ROTATEQ, and RECOMBIV AX. Many of the vaccines have been administered to patients; This spontaneous report was received from a practice manager and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant therapies was provided.  On 25-SEP-2020, the patient was vaccinated with an improperly stored dose of hepatitis b vaccine (recombinant) (RECOMBIVAX HB), 1 injection, lot # S022584, expiration date: 31-OCT-2021 (injection site and route of administration were not provided) for prophylaxis.  On 04-AUG-2020, the administered dose experienced the temperature excursion of below 2 degrees Celsius (C) (1.1 C) for 27 hours and 45 minutes and above 9 degrees Celsius (9 C) for 1 hour and 15 minutes. The digital data logger was involved in recording the temperature excursion details. No previous temperature excursion had occurred. No further adverse events (AE) were reported.  This is one of multiple reports received from the same reporter. combinationproductreport: Yes; brandname: RECOMBIVAX HB SYRINGE (DEVICE); commondevicename: Hepatitis B Vaccine (Recombinant); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S022584; expirationdate: 31-OCT-2021; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA001083:Same Reporter
Sex: U
Vaccine: RV5
Symptoms: No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: No other adverse events reported.; patient received Rotateq after it bad been stored outside of the recommended storage range; This spontaneous report was received from a medical assistant, referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, previous drug reactions, allergies, or concomitant medications were not reported.   On 01-SEP-2020, the patient was vaccinated with an improperly stored rotavirus vaccine, live, oral, pentavalent (ROTATEQ) orally administered (lot number 1661000 which has been verified to be valid, expiration date reported and validated as 13-MAY-2021) (dose and frequency were unknown by the reporter; vaccination scheme was not reported) as prophylaxis. The administered dose of the vaccine was stored at a temperature of 47.1 degrees Fahrenheit, during a time frame of 30 minutes, as recorded by a digital data logger. There was no previous temperature excursion. No other adverse events were reported in the patient.  This is one of several reports received from the same reporter.; Sender's Comments:  US-009507513-2010USA006671: US-009507513-2010USA006870:
Sex: U
Vaccine: PPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No other AE reported; Expired vaccine used; This spontaneous report, as received from a pharmacist, refers to a patient of unknown age and gender. Information regarding the patient's medical history, concomitant medications, drug allergies, or reactions was not provided.     On 15-OCT-2020, the patient was vaccinated with an expired dose of pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) 0.5 milliliter, intramuscular for prophylaxis(lot # S026366, has been verified to be a valid lot number for pneumococcal vaccine, polyvalent (23-valent), expiration date reported as 17-SET-2020) (expired product administered). No other adverse event was reported. combinationproductreport: Yes; brandname: PNEUMOVAX23 SYRINGE (DEVICE); commondevicename: Pneumococcal Vaccine, Polyvalent (23-valent); productcode: FMF; manufacturername: Merck Sharp & Dohme Corp.; devicelotnumber: S026366; expirationdate: 17-SEP-2020; deviceage and unit: 0 ; malfunction: Unknown; deviceusage: Initial; evaluatedbymfr: Not returned to manufacturer; reasonfornoneval: 81 Other; labeledsingleusedevice: No; mdcpreportability: No; mdcpreprationale: Case information does not meet the criteria for Reportability; Sender's Comments:  US-009507513-2010USA006884: