chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 87.0
Sex: M
Vaccine: FLU4
Symptoms: Myocardial necrosis marker increased, Tremor
Clinical narrative: Per Son of patient - he mentioned that many hours after patient received vaccine that he called and reported shaking uncontrollably. The patient was taken to the hospital by the son and it was reported that a cardiac enzyme was elevated and patient was treated in ER for 6 hours. Son states that MD was not sure if it was a reaction to the vaccine but stated it was possible. Patient had no prior history of allergy to flu vaccine or components. Patient had a regularly scheduled appt with primary care MD on the following week and it was recommended to also let MD know to put note in chart. Per the son, not further issues or adverse reacts have come about since patient got home from hospital
Age: 66.0
Sex: M
Vaccine: FLU4
Symptoms: Computerised tomogram, Dizziness, Electrocardiogram, Neuritis, Vertigo
Clinical narrative: Severe Vestibular Neuritis; Serious dizziness, vomiting, vertigo.
Age: 66.0
Sex: M
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Severe Vestibular Neuritis; Serious dizziness, vomiting, vertigo.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Urticaria, Vaccination complication
Clinical narrative: Patient came to clinic for Hives but had no none hives on her body during the examine, she them needed to get her 4 year old vaccines, after they were administered mother brought pt back to clinic because Pt was having a reaction, Pt was taken back to a room immediately and a provider was notified immediately, she was evaluated by the provider and was given Benadryl here in clinic, Pt did break out in Hives on her face and arms. Provider explained to mom to give Benadryl at home if needed, Pt did not have difficulty breathing and was sent home after giving medication to help with the reaction.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Pain in extremity
Clinical narrative: pain in the right arm, patient complaining that she cannot move arm
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Peripheral swelling, Rash macular, Rash pruritic, Skin warm
Clinical narrative: "Itchy rash started on friday x 5 days 3 hours after I received a Shingles  shot. On the 2nd day, it was also on both his L leg blotches. L arm was swollen  & little warm, went to pharmacy & told me to take Benadryl which cleared the  rash up. But the next day, rash showed up again & it went away after I took  couple Benadryl & that's it. The rash has NOT come back since."
Age: 76.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Injection site erythema, Injection site oedema, Oedema peripheral
Clinical narrative: Patient presented for evaluation for erythema and edema that started at site of injection, then seemed to travel down the arm away from vaccination site.  Not painful.
Age: 41.0
Sex: M
Vaccine: FLU4, HEPA
Symptoms: Extra dose administered
Clinical narrative: Patient was supposed to get 1 flu vaccine in left arm and 1 Hep A vaccine in right arm. However, by error the patient recieved 2 flu vaccine instead in right and left arms. The patient still recieved Hep A vaccine in right arm thereafter.
Age: 51.0
Sex: F
Vaccine: FLU4
Symptoms: Axillary pain, Swelling
Clinical narrative: Day after vaccine administered left under arm/pit swollen, painful to touch. Swelling and pain reduced after 3 days with Aleve.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Biopsy skin abnormal, Erythema, Papule, Pruritus, SARS-CoV-2 test negative
Clinical narrative: Two days after immunization, patient developed pruritic erythematous papules on the trunk that subsequently generalized to the upper and lower extremities.  Remained afebrile with no associated symptoms. COVID testing was negative. Biopsy showed :  Right lower abdomen, punch of skin:  Vacuolar interface change with perivascular lymphocytes and a few eosinophils.  See note.  Note: This mid to upper dermal predominantly perivascular infiltrate also reveals a few scattered interstitial inflammatory cells. On balance, the findings are suggestive of an adverse drug reaction (including vaccination) or viral exanthem.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Viral rash
Clinical narrative: Two days after immunization, patient developed pruritic erythematous papules on the trunk that subsequently generalized to the upper and lower extremities.  Remained afebrile with no associated symptoms. COVID testing was negative. Biopsy showed :  Right lower abdomen, punch of skin:  Vacuolar interface change with perivascular lymphocytes and a few eosinophils.  See note.  Note: This mid to upper dermal predominantly perivascular infiltrate also reveals a few scattered interstitial inflammatory cells. On balance, the findings are suggestive of an adverse drug reaction (including vaccination) or viral exanthem.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Arthritis, Blister, Burning sensation, Chills
Clinical narrative: Starting at 9pm day of shot, fever of 100.6 to 99.8 for four days accompanied by chills.  Fever finally subsided the Sunday evening after shot but came back Monday evening to 99.8.  Also experienced inflamed joints, intestines and bladder.  Bodily functions felt like I was eliminating broken glass.  Severe abdominal crapping occurred as well. Small water blisters that were itchy and burning emerged randomly on all parts of my body.  These were not clusters or a swath of redness.  Injection site still raised and hot 5 days afterwards, but not showing signs of infection or pus. Have not sought medical care because worst of it is over (I hope).
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Cystitis noninfective, Erythema, Feeling abnormal, Gastrointestinal inflammation, Injection site swelling
Clinical narrative: Starting at 9pm day of shot, fever of 100.6 to 99.8 for four days accompanied by chills.  Fever finally subsided the Sunday evening after shot but came back Monday evening to 99.8.  Also experienced inflamed joints, intestines and bladder.  Bodily functions felt like I was eliminating broken glass.  Severe abdominal crapping occurred as well. Small water blisters that were itchy and burning emerged randomly on all parts of my body.  These were not clusters or a swath of redness.  Injection site still raised and hot 5 days afterwards, but not showing signs of infection or pus. Have not sought medical care because worst of it is over (I hope).
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site warmth, Pruritus, Pyrexia
Clinical narrative: Starting at 9pm day of shot, fever of 100.6 to 99.8 for four days accompanied by chills.  Fever finally subsided the Sunday evening after shot but came back Monday evening to 99.8.  Also experienced inflamed joints, intestines and bladder.  Bodily functions felt like I was eliminating broken glass.  Severe abdominal crapping occurred as well. Small water blisters that were itchy and burning emerged randomly on all parts of my body.  These were not clusters or a swath of redness.  Injection site still raised and hot 5 days afterwards, but not showing signs of infection or pus. Have not sought medical care because worst of it is over (I hope).
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site swelling, Injection site warmth, Pruritus
Clinical narrative: sit reaction. swelling, and heat at site of injection, using Zyrtec for itch as well as topically cortisone
Age: 70.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Insomnia, Neck pain, Pain in extremity, Skeletal injury
Clinical narrative: Pharmacist told me he hit my bone with needle injection and my arm would be sore longer    I have not contacted anyone  It has been a week today.   Normal vaccine pain started about 1-2 hours after injection.  Pain continued to get worse. Could not sleep that evening. . Throbbing pain In Left arm going to shoulder and neck.   My arm is still sore at injection site. Throbbing pain is on and off with pain in shoulder and neck
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema
Clinical narrative: red arm, not in the deltoid
Age: 18.0
Sex: M
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Upon receiving 2nd injection (flu vaccine), Pt had a syncopal event that lasted approximately 5 seconds.  Pt was A/ox4 post event, pt placed in right lateral recovery position, ice packs placed on head and neck with vs stable (see documentation).  Pt denies any palpitations, chest pain, dizziness, shortness of breath, headache, nausea or other discomfort.  Pt discharged home with mother after 10 minutes of rest on his own recognizance and without any complaints.  Pt given instructions to go to the immediate care or emergency department if he has further symptoms or has a syncopal episode again. Pt verbalized understanding.
Age: 0.75
Sex: M
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site nodule
Clinical narrative: Erythematous nodule at site of injection within 12 hours (hypersensitivity reaction) - redness has cleared within 2 weeks, but nodule is still the size of a nickel
Age: 13.0
Sex: M
Vaccine: FLUR4
Symptoms: Feeling abnormal, Product administered to patient of inappropriate age
Clinical narrative: This is actually an administration error. Typing up patient's flu shot on 9/15/20 i realized that I had given patient a egg free flu shot (flublok)(on 9/14/20 clinic) due to his discovered allergy to eggs at the clinic when i asked him even though his sheet stated he wasnt. Flublok was chosen to minimize his reaction to the flu shot due to his potential egg allergy. When entering in his RX on 9/15 I noticed that Flublok is only indicated for ages 18+. upon doing research, newer studies show that Flublok is actually just as safe and efficacious as fluarix in ages 7-17 so there was minimal need for concern. I spoke with patient's mom on 9/15/20 at 5:00 PM and explained the situation and asked how patient was doing. Both of her sons had gotten the flu shot that day and both were feeling a little under the weather but besides that they were fine. She was understanding of the situation and thanked me for explaining and telling her what i had discovered. I told her that I would let the provider know as well since the vaccine was technically off label for his age group still. I called Dr's office on 9/15/20 at 5:08 pm and spoke with his nurse and explained the entire situation again. The nurse was ok with what had happened and told me she would pass on the information to Dr as well so that he could be made aware and document this as well. I will make a dispensing error report and VAERS form tonight just to cover what happened and keep this documented. 9/15/20 at 5:19pm
Age: 57.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Pyrexia
Clinical narrative: fever of around 101, steadily declined over 48 hours.  Fatigue, gone after 4 days
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pyrexia
Clinical narrative: Fever, shiver
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Eye irritation, Eye pruritus, Oropharyngeal pain
Clinical narrative: Patient went home and after 2 hours had a very severe sore throat and itchy burning sensation in her eyes.
Age: 4.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Injection site bruising, Injection site nodule, Injection site swelling
Clinical narrative: Pt called office next day after vaccines were given .Mom stated the next day after vaccines were given pt's injection site got swollen and bruised. Mom also stated the following day pt's arm got a knot.
Age: 69.0
Sex: M
Vaccine: FLU4
Symptoms: Pruritus, Rash
Clinical narrative: itchiness all over body evening of the next day. Whole body rash the following morning. Resolved after 1 week
Age: 59.0
Sex: F
Vaccine: FLU4
Symptoms: Chest pain, Headache, Pain
Clinical narrative: Patient was given fluzone before lunch today. Everything was fine, we got a call saying that she went to the hospital after 1 hour and 15 minutes . After she left her work as she was driving she got pain in the sternum and shooting pain wrapping around that went to her head. Patients daughter said md does not believe it is from the immunization. They asked for ingredients from shot , we said please have them followup with us. It is still not clear if this reaction came from immunization.
Age: 55.0
Sex: M
Vaccine: VARZOS
Symptoms: Bone pain, Grip strength decreased, Pain
Clinical narrative: Pain feels like it's in the bone. Losing control of arm. Has constant ache all the time. Has problems holding things in hand. Knows it's not right since having the shot.
Age: 12.0
Sex: F
Vaccine: HEP, HEPA, HPV9, MNQ, TDAP
Symptoms: Dizziness, Nausea, Vomiting
Clinical narrative: After receiving the vaccines, patient complained of dizziness and nausea, gave apple juice and let her lay down for a few minutes until she reported feeling better, Per patient, she did not eat her breakfast and dinner last night,  discharged patient but on her way outside of the clinic together with her dad,  a care assistant called the staff and reported that the patient vomited, brought her back to the clinic and VS were taken, no distress noted and referred to the pediatrician for further evaluation and management.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Chills, Headache
Clinical narrative: li also had a flu shot today but don't know which one. flu shot was in left arm. Shingles vaccine right arm. within 2 hours my right shoulder became very painful, to the point where i cannot use it.   i took tylenol at 1:00 ans starting icing it.  it hasn't helped.     it is now 7:00pm and i have a head ache and shivers, no fever at this time.
Age: 16.0
Sex: M
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Patient was given Flublox which is recommended for 18 years and up. This patient is 16 years old.
Age: 40.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient received a flu shot on 8-18-20. She returned to the pharmacy 4 weeks (9-15-20) later complaining that she cannot lift her arm more than 90 degrees. She has had pain and movement issues in her arm since receiving the vaccination.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient reported that symptoms began Monday morning which included redness and swelling at the injection site accompanied with pain. No pustule/broken skin present. slightly warm to the touch
Age: 91.0
Sex: F
Vaccine: FLUA4
Symptoms: Rash
Clinical narrative: Patient stated that she woke up with a rash over her entire body.
Age: 72.0
Sex: M
Vaccine: VARZOS
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient received 3 doses of Shingrix (11/19/2019, 2/3/2020, 6/25/2020). Patient did not remember he received his 1st dose back in 2019. Patient received 1 extra dose of Shingrix. However, patient has not reported any adverse events and doing well as of now.
Age: 65.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Candida infection, Myalgia, Rash
Clinical narrative: pt reports that she had muscle pain, joint pain, thrush and a rash on her bilateral arms
Age: 61.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Skin warm, Swelling
Clinical narrative: day after shot given, patient developed swelling, and redness about 2 inches below injection site.   this continued for next two days and progressively got warmer to the touch as well.    Patient was advised to visit physician unknown diagnosis/ treatment/ outcome
Age: 51.0
Sex: M
Vaccine: FLU4
Symptoms: Chest pain
Clinical narrative: Patient's wife came into pharmacy asking about him as he had his flu shot earlier in the day and was now experiencing chest pains. Patient took 2 aspirin with no relief. Advised patient to go to urgent care for treatment of chest pain weather or not related to flu vaccine.
Age: 68.0
Sex: M
Vaccine: SMALL
Symptoms: Blood culture, Blood lactic acid, C-reactive protein, Chills, Differential white blood cell count
Clinical narrative: 8.6.2020 68 yrs old male presents to Urgent Care with vaccine site reaction. He got vaccine yesterday at about 5 pm, noted swelling and redness after about 3 hours. He said he has myalgia and chills. Has been using Tylenol. Denies any fever, hives, shortness of breath and chest pain   Review of Systems  Constitutional: Negative for fatigue and fever.  Respiratory: Negative for cough and shortness of breath.   Cardiovascular: Negative for chest pain.  Gastrointestinal: Negative for abdominal pain, nausea and vomiting.  Genitourinary: Negative.   Musculoskeletal:       Left arm swelling and redness  Neurological: Negative for dizziness and headaches.
Age: 68.0
Sex: M
Vaccine: SMALL
Symptoms: Erythema, Full blood count, Metabolic function test, Myalgia, Swelling
Clinical narrative: 8.6.2020 68 yrs old male presents to Urgent Care with vaccine site reaction. He got vaccine yesterday at about 5 pm, noted swelling and redness after about 3 hours. He said he has myalgia and chills. Has been using Tylenol. Denies any fever, hives, shortness of breath and chest pain   Review of Systems  Constitutional: Negative for fatigue and fever.  Respiratory: Negative for cough and shortness of breath.   Cardiovascular: Negative for chest pain.  Gastrointestinal: Negative for abdominal pain, nausea and vomiting.  Genitourinary: Negative.   Musculoskeletal:       Left arm swelling and redness  Neurological: Negative for dizziness and headaches.
Age: 68.0
Sex: M
Vaccine: SMALL
Symptoms: Vaccination site reaction
Clinical narrative: 8.6.2020 68 yrs old male presents to Urgent Care with vaccine site reaction. He got vaccine yesterday at about 5 pm, noted swelling and redness after about 3 hours. He said he has myalgia and chills. Has been using Tylenol. Denies any fever, hives, shortness of breath and chest pain   Review of Systems  Constitutional: Negative for fatigue and fever.  Respiratory: Negative for cough and shortness of breath.   Cardiovascular: Negative for chest pain.  Gastrointestinal: Negative for abdominal pain, nausea and vomiting.  Genitourinary: Negative.   Musculoskeletal:       Left arm swelling and redness  Neurological: Negative for dizziness and headaches.
Age: 60.0
Sex: F
Vaccine: FLU4
Symptoms: Chest pain, Documented hypersensitivity to administered product, Dyspnoea, Fatigue
Clinical narrative: patient with history prior adverse reaction to flu vaccine flu vaccine given in error subsequently developed shortness of breath & chest pain & fatigue symptoms improving with steroids referred to allergist for ongoing management
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Pain, Pyrexia, Tremor
Clinical narrative: woke up with shaking chills, body aches, fatigue, developed fever of approx 101.5 fever lasted < 10 hours fatigue lasted about 2 days
Age: 0.25
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13
Symptoms: Cardiac arrest, Death, Resuscitation, Sudden infant death syndrome
Clinical narrative: Pt had a well child physical in the office with immunizations on 9/1/2020 On 9/3 experienced cardiac arrest and taken to hospital ER - unable to resuscitate and pt expired. Suspected SIDS- no autopsy results at this time. Pt died on 9/3/2020
Age: 5.0
Sex: M
Vaccine: FLU4
Symptoms: Joint stiffness, Joint swelling
Clinical narrative: Right tight and knee swollen 2 days after shot Symptoms are improving
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain, Arthralgia, Back pain, Breast pain, Headache
Clinical narrative: Skin itches mildly, repeatedly. Shoulders arms breasts back abdomen hurt.  Ibuprophen  is not helping enough.  Now, 34 hours after shot, I feel the worst so far. Headache., joints hurt, abdomen hurts, shoulders hurt, knee ache, back is  sore,  unable to sleep  due to  aches.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Insomnia, Pain in extremity, Pruritus
Clinical narrative: Skin itches mildly, repeatedly. Shoulders arms breasts back abdomen hurt.  Ibuprophen  is not helping enough.  Now, 34 hours after shot, I feel the worst so far. Headache., joints hurt, abdomen hurts, shoulders hurt, knee ache, back is  sore,  unable to sleep  due to  aches.
Age: 75.0
Sex: M
Vaccine: FLUA3
Symptoms: Peripheral swelling, Rash, Rash erythematous
Clinical narrative: patient had fluad on 9/8/20, he came back to pharmacy on 9/10/20 and showed pharmacist his arm. it had a large "band" of red rash, slightly swollen. he said it started day after he received vaccination. he said it was not warm to touch or sensitive. I told him to watch it and if he still has it after a few more days to contact doctor. he did not seem too concerned about the reaction and said it was the first time he has had a flu shot.
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Hyperhidrosis, Immediate post-injection reaction, Nausea
Clinical narrative: I received the shingles vaccine in lthe left shoulder  and flu in the right shoulder.  I immediately felt nauseous and started sweating.  I had to sit there for a few minutes, drank some water.  I bought some cookies on my way out the door and ate 4 in the car, and started to feel better.  The rest of this afternoon I've felt exhausted.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Oral herpes, Oral pain
Clinical narrative: Pt reports getting dental work 1 week after getting her second Shingrix dose and getting shingles in her mouth as a result. Symptoms of intense pain in the mouth existed for about 2-3 weeks before resolution.
Age: 36.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Flushing, Urticaria
Clinical narrative: Pt c/o symptoms including urticaria and flushing. Presented to the clinic post shot exercise. Provider administered diphenhydramine 50mg, 2 tabs, po. Prescribed at diphenhydramine 1-2 tabs TID PRN. Monitored for 45 minutes. RTC instructions provided if symptoms return.
Age: 36.0
Sex: M
Vaccine: ANTH, ANTH
Symptoms: Feeling hot, Flushing, Swelling face
Clinical narrative: Pt c/o symptoms including urticaria and flushing. Presented to the clinic post shot exercise. Provider administered diphenhydramine 50mg, 2 tabs, po. Prescribed at diphenhydramine 1-2 tabs TID PRN. Monitored for 45 minutes. RTC instructions provided if symptoms return.
Age: 76.0
Sex: M
Vaccine: FLUA4
Symptoms: Chest pain, Chills, Cough, Malaise, Pain
Clinical narrative: per patient's daughter, he did not feel well after the flu vaccine.  he had fever (highest @ 100.5F), chills, body aches, cough and chest pain due to excessive coughing.  Symptoms persisted for 3-4 days and the cough lasted longer (up to 9 days) so patient was brought to emergency room where he was given benzonatate 100mg tid, albuterol inhaler (2 pfs q 4 to 6 hours), pulse oximeter and an aerochamber.
Age: 76.0
Sex: M
Vaccine: FLUA4
Symptoms: Pyrexia
Clinical narrative: per patient's daughter, he did not feel well after the flu vaccine.  he had fever (highest @ 100.5F), chills, body aches, cough and chest pain due to excessive coughing.  Symptoms persisted for 3-4 days and the cough lasted longer (up to 9 days) so patient was brought to emergency room where he was given benzonatate 100mg tid, albuterol inhaler (2 pfs q 4 to 6 hours), pulse oximeter and an aerochamber.
Age: 28.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Headache, Myalgia, Oropharyngeal pain
Clinical narrative: Sore throat Fatigue Headache  Muscle aches
Age: 72.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Neck pain
Clinical narrative: entire shoulder and neck pain treated with ibuprofen
Age: 79.0
Sex: F
Vaccine: FLU4
Symptoms: Pain, Swelling
Clinical narrative: Pain and swelling
Age: 4.0
Sex: M
Vaccine: VARCEL
Symptoms: Rash, Rash papular
Clinical narrative: Pt had vaccine 9/11/20, 9/12/20 pt had a red papular rash all over body. Mom sent a picture to Dr & gave Benadryl.
Age: 7.0
Sex: M
Vaccine: FLUC4
Symptoms: Disorientation, Emotional disorder, Fall, Headache, Pallor
Clinical narrative: Patient Received his vaccination first and was fine While waiting for Mom and Sister to get their vaccination he was standing behind me and then fell forward on my arm and then fell to the gRound. Patient's father who is a physician and was waiting in the waiting area outside the immunization Room Came in and Revived the patient. The patient was Somewhat disoriented and very pale. I then went out and got the child a bottle of water while his dad held him and made Sure he was Responsive, coherent and ok. Patient was a little emotional and complained that his head hurt. They Sat outside the immunizing Room for about 10-15 minutes and then left. I called Mom later on in the afternoon to check on the patient. Mom said he had a Slight headache but otherwise was feeling ok, doing much better and playing outside.
Age: 26.0
Sex: M
Vaccine: FLU4
Symptoms: Syncope
Clinical narrative: Shortly after administration patient fainted.
Age: 35.0
Sex: M
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Patient says his arm hurts really bad. He called on 9/4 stating it still hurts even after taking Motrin/Tylenol. His vaccine was administered on 8/27 we refered him to his PCP. His PCP referred him to Orthopedic/Physical therapy. Pt is now in PT as of 9/15.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Alopecia, Tachycardia
Clinical narrative: Self resolved tachycardia 100-130 6pm x 48 hours, subsequent focal hair loss
Age: 64.0
Sex: F
Vaccine: TDAP
Symptoms: Medication error, No adverse event, Product storage error
Clinical narrative: Adacel was administered after it underwent a temperature excursion of 30 degrees Fahrenheit, no AE; Initial information was received on 03-Sep-2020 regarding an unsolicited valid non-serious case from other healthcare professional.  This case was linked to cases 2020SA241277, 2020SA241248, 2020SA241279, 2020SA241280, 2020SA241281, 2020SA241282, 2020SA241283, 2020SA241284, 2020SA241285, 2020SA241286 and 2020SA241287 (same reporter).  This case involves a 64-year-old female patient who was administered with DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] which underwent a temperature excursion of 30 degrees Fahrenheit (product storage error).  Medical history, past medical treatments, vaccination, concomitant medications and family history were not provided.  On 17-Aug-2020, the patient received a dose of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot C5667AA, Expiry date 26-SEP-2021) via unknown route in unknown administration site for prophylactic vaccination   This was an actual medication error case due to product storage error temperature too low (latency: same day).  At the time of reporting no adverse event was reported.  Laboratory data, corrective treatment and outcome: not applicable.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 78.0
Sex: M
Vaccine: TDAP
Symptoms: Medication error, No adverse event, Product administered to patient of inappropriate age, Product storage error
Clinical narrative: Adacel was administered to 78 years old patient/No AE; Adacel was administered to the patient which underwent a temperature excursion of 30 degrees F/No AE; Initial information was received on 03-Sep-2020 regarding an unsolicited valid non-serious case from the other health care professional.  This case is linked to cases 2020SA241277, 2020SA241278, 2020SA241279, 2020SA241280, 2020SA241281, 2020SA241282, 2020SA241283, 2020SA241248, 2020SA241285, 2020SA241286 and 2020SA241287 (same reporter).  This case involves a 78 years old male patient who received DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] after it underwent a temperature excursion of 30 degrees Fahrenheit (product storage error and product administered to patient of inappropriate age).  Medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.  On 24-Aug-2020, the patient received a dose of suspect DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE (lot C5667AA, expiry date: 26-Sep-2021) via unknown route in unknown administration site for prophylactic vaccination.   It was a case of an actual medication error due to product storage error temperature too low and inappropriate age at vaccine administration.  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Anxiety, Crying, Dyspnoea, Feeling abnormal, Headache
Clinical narrative: anxiety; fainted; nausea; headaches; We had difficulty getting her to become conscious; shortness; severe crying; she just felt foggy for months; having panic attacks; She did not act the same for months; This spontaneous report has been received from the patient's parent/ guardian/ caregiver via Food And Drug Administration (agency # 836044) on 04-SEP-2020 referring to a 13 years old female patient who was not pregnant. Prescriptions, over-the-counter medications, dietary supplements, or herbal remedies being taken at the time of vaccination were reported as: levocetirizine dihydrochloride (XYZAL) OTC allergy medication. Allergies to medications, food, or other products was not reported. Other illnesses at the time of vaccination and up to one month prior was not reported. Chronic or long-standing health conditions was not reported. The patient had a not specified vaccine on 01-MAY-2020.  On 01-MAY-2018 16:30, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose 1; dose, lot# and expiration date were not reported) via intramuscular in arm for prophylaxis.   The patient's parent reported the patient fainted 15 minutes after the vaccination as they were checking out at the doctor's office. They had difficulty getting the patient to become conscious, it took over 30 minutes before the parent could even get the patient to the car and then the nurse used a wheelchair. The patient slept for hours after that incident and felt foggy. She did not act the same for months after and began having panic attacks within 48 hours of the vaccine, which she had never experienced before. The patient would experience shortness of breath, severe crying, nausea, headaches, and said she just felt foggy for months. The patient began therapy after as she could not walk into or talk about going to a doctor's office without having a panic attack. She still, in 2019 (reported as over a year later), experienced anxiety and panic attacks. The patient had doctor or other healthcare professional office/clinic visit. The patient was disability or permanent damage due to the events. None lab was suggested by her physician. Outcome of all events was not recovered.  The causality assessment between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.  Additional information has been received on 14-SEP-2020. The receptionist stated that without the patient's name or date of birth she would not be able to assist with any information. Additional information is not expected.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Hypersomnia, Loss of consciousness, Nausea, Panic attack, Syncope
Clinical narrative: anxiety; fainted; nausea; headaches; We had difficulty getting her to become conscious; shortness; severe crying; she just felt foggy for months; having panic attacks; She did not act the same for months; This spontaneous report has been received from the patient's parent/ guardian/ caregiver via Food And Drug Administration (agency # 836044) on 04-SEP-2020 referring to a 13 years old female patient who was not pregnant. Prescriptions, over-the-counter medications, dietary supplements, or herbal remedies being taken at the time of vaccination were reported as: levocetirizine dihydrochloride (XYZAL) OTC allergy medication. Allergies to medications, food, or other products was not reported. Other illnesses at the time of vaccination and up to one month prior was not reported. Chronic or long-standing health conditions was not reported. The patient had a not specified vaccine on 01-MAY-2020.  On 01-MAY-2018 16:30, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (dose 1; dose, lot# and expiration date were not reported) via intramuscular in arm for prophylaxis.   The patient's parent reported the patient fainted 15 minutes after the vaccination as they were checking out at the doctor's office. They had difficulty getting the patient to become conscious, it took over 30 minutes before the parent could even get the patient to the car and then the nurse used a wheelchair. The patient slept for hours after that incident and felt foggy. She did not act the same for months after and began having panic attacks within 48 hours of the vaccine, which she had never experienced before. The patient would experience shortness of breath, severe crying, nausea, headaches, and said she just felt foggy for months. The patient began therapy after as she could not walk into or talk about going to a doctor's office without having a panic attack. She still, in 2019 (reported as over a year later), experienced anxiety and panic attacks. The patient had doctor or other healthcare professional office/clinic visit. The patient was disability or permanent damage due to the events. None lab was suggested by her physician. Outcome of all events was not recovered.  The causality assessment between the events and hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.  Additional information has been received on 14-SEP-2020. The receptionist stated that without the patient's name or date of birth she would not be able to assist with any information. Additional information is not expected.
Age: 10.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Hallucination, auditory, Hallucination, visual
Clinical narrative: GARDASIL 9 administered 08/29/2019/2nd dose of GARDASIL 9 was held due to previous symptoms; after administration consumer reported hallucinations and tremors that evening; after administration consumer reported hallucinations and tremors that evening; This spontaneous report was received from a physician via company representative, referring to a 10 years old female patient. The patient's concurrent conditions included asthma and allergies. Information about historical conditions and concomitant medications was unknown.  On 29-AUG-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1602284, expiration date 26-SEP-2021; strength, dose and route were unknown) for prophylaxis.  On the same date, after administration, the patient experienced hallucinations and tremors that evening. The patient was recovered on 30-AUG-2019 (reported as the next day). The second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was held due to previous symptoms (inappropriate schedule of product administration). It was unknown whether any treatment was given for the events. It was unknown whether any lab diagnostics/studies was performed. The causality assessments between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the events were unknown.  Upon internal review, hallucinations was determined to be medically significant. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: 1602284; expirationdate: 26-SEP-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
Age: 10.0
Sex: F
Vaccine: HPV9, HPV9
Symptoms: Hallucination, Inappropriate schedule of product administration, Tremor
Clinical narrative: GARDASIL 9 administered 08/29/2019/2nd dose of GARDASIL 9 was held due to previous symptoms; after administration consumer reported hallucinations and tremors that evening; after administration consumer reported hallucinations and tremors that evening; This spontaneous report was received from a physician via company representative, referring to a 10 years old female patient. The patient's concurrent conditions included asthma and allergies. Information about historical conditions and concomitant medications was unknown.  On 29-AUG-2019, the patient was vaccinated with hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) (lot # 1602284, expiration date 26-SEP-2021; strength, dose and route were unknown) for prophylaxis.  On the same date, after administration, the patient experienced hallucinations and tremors that evening. The patient was recovered on 30-AUG-2019 (reported as the next day). The second dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was held due to previous symptoms (inappropriate schedule of product administration). It was unknown whether any treatment was given for the events. It was unknown whether any lab diagnostics/studies was performed. The causality assessments between hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) and the events were unknown.  Upon internal review, hallucinations was determined to be medically significant. combinationproductreport: Yes; brandname: GARDASIL 9 SYRINGE (DEVICE); commondevicename: HPV rL1 6 11 16 18 31 33 45 52 58 VLP vaccine (yeast); productcode: FMF; devicetype: SYRINGE, PISTON (FMF); manufacturername: Merck Sharp & Dohme Corp.; manufactureraddress:; manufacturercity:; manufacturerstate:; manufacturercountry:; devicelotnumber: 1602284; expirationdate: 26-SEP-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
Age: 76.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Injection site pain, Rash erythematous, Rash pruritic
Clinical narrative: woke up with red splotches and itching on torso and arm; woke up with red splotches and itching on torso and arm; Initial information was received on 04-Sep-2020 regarding an unsolicited valid non-serious case received from a consumer/ non-healthcare professional.  This case involves a 76 years old female patient who woke up with red splotches and itching on torso and arm (rash macular and pruritus), while she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medications were not provided.   On 28-Aug-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date not reported) via unknown route in the left arm for prophylactic vaccination.  On 29-Aug-2020, the patient developed a non-serious adverse event as woke up with red splotches and itching on torso and arm (rash macular and pruritus) one day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Case details: Patient stated that she received a Fluzone high dose vaccine on Friday and on saturday morning she woke up adverse event. She stated that she was prescribed prednisone and some cream for the itching but, it was still there and the problem was still ongoing.   Details of laboratory data were not reported.  The patient was treated with Prednisone [Prednisone Acetate] and some cream for localised itching.  At the time of report, the patient was not recovered from the events.  There will be no information available on the batch number for this case.
Age: 76.0
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Pruritus, Rash macular
Clinical narrative: woke up with red splotches and itching on torso and arm; woke up with red splotches and itching on torso and arm; Initial information was received on 04-Sep-2020 regarding an unsolicited valid non-serious case received from a consumer/ non-healthcare professional.  This case involves a 76 years old female patient who woke up with red splotches and itching on torso and arm (rash macular and pruritus), while she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medications were not provided.   On 28-Aug-2020, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number and expiry date not reported) via unknown route in the left arm for prophylactic vaccination.  On 29-Aug-2020, the patient developed a non-serious adverse event as woke up with red splotches and itching on torso and arm (rash macular and pruritus) one day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Case details: Patient stated that she received a Fluzone high dose vaccine on Friday and on saturday morning she woke up adverse event. She stated that she was prescribed prednisone and some cream for the itching but, it was still there and the problem was still ongoing.   Details of laboratory data were not reported.  The patient was treated with Prednisone [Prednisone Acetate] and some cream for localised itching.  At the time of report, the patient was not recovered from the events.  There will be no information available on the batch number for this case.
Age: 66.0
Sex: M
Vaccine: FLU4, FLU4, PPV
Symptoms: Body temperature increased, Chills, Feeling hot, Injection site erythema, Injection site pain
Clinical narrative: fever, severe chills, joint pain, severe redness and swelling at injection site
Age: 66.0
Sex: M
Vaccine: FLU4, FLU4, PPV
Symptoms: Pain
Clinical narrative: fever, severe chills, joint pain, severe redness and swelling at injection site
Age: 66.0
Sex: M
Vaccine: FLU4, FLU4, PPV
Symptoms: Arthralgia, Chills, Injection site erythema, Injection site swelling, Pyrexia
Clinical narrative: fever, severe chills, joint pain, severe redness and swelling at injection site
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Chills, Decreased appetite, Full blood count normal, Lymphadenopathy, Malaise
Clinical narrative: patient experienced a temperature that has ranged up to 103.8 and then 100.6; enlarged lymph nodes in her neck; frontal headache; extreme tiredness; sore throat; Initial information received on 08-Sep-2020 regarding an unsolicited valid non-serious case from a consumer or non-healthcare professional.  This case involves a 70 years old female patient who experienced patient experienced a sore throat (oropharyngeal pain), temperature that has ranged up to 103.8 and then 100.6 (body temperature increased), enlarged lymph nodes in her neck (lymphadenopathy), frontal headache (headache) and extreme tiredness (fatigue), while she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On 25-Aug-2020, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number, expiry date not reported) not reported via an unknown route at an unknown administration site for prophylactic vaccination.  On 29-Aug-2020, the patient developed a non-serious sore throat (oropharyngeal pain) four days following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  On 30-Aug-2020, the patient developed a non-serious patient experienced a temperature that has ranged up to 103.8 and then 100.6 (body temperature increased), enlarged lymph nodes in her neck (lymphadenopathy), frontal headache (headache) and extreme tiredness (fatigue) five days following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Relevant laboratory test results included:  On 30-Aug-2020: Body temperature: 103.8 and on an unknown date: 100.6.  On an unknown date: Full blood count: [normal]  On an unknown date: Metabolic function test: [normal]  It was not reported if the patient received a corrective treatment.  At the time of this report, outcome of the oropharyngeal pain were not recovered.  The event outcome was unknown for body temperature increased, lymphadenopathy, headache and fatigue.  There will be no information available on the batch number for this case.
Sex: F
Vaccine: FLU4, FLU4
Symptoms: Metabolic function test normal, Oropharyngeal pain, Pyrexia, SARS-CoV-2 test negative, Weight decreased
Clinical narrative: patient experienced a temperature that has ranged up to 103.8 and then 100.6; enlarged lymph nodes in her neck; frontal headache; extreme tiredness; sore throat; Initial information received on 08-Sep-2020 regarding an unsolicited valid non-serious case from a consumer or non-healthcare professional.  This case involves a 70 years old female patient who experienced patient experienced a sore throat (oropharyngeal pain), temperature that has ranged up to 103.8 and then 100.6 (body temperature increased), enlarged lymph nodes in her neck (lymphadenopathy), frontal headache (headache) and extreme tiredness (fatigue), while she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's medical history, past medical treatment, vaccination, concomitant medication and family history were not provided.   On 25-Aug-2020, the patient received a 0.7 mL dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot number, expiry date not reported) not reported via an unknown route at an unknown administration site for prophylactic vaccination.  On 29-Aug-2020, the patient developed a non-serious sore throat (oropharyngeal pain) four days following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  On 30-Aug-2020, the patient developed a non-serious patient experienced a temperature that has ranged up to 103.8 and then 100.6 (body temperature increased), enlarged lymph nodes in her neck (lymphadenopathy), frontal headache (headache) and extreme tiredness (fatigue) five days following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Relevant laboratory test results included:  On 30-Aug-2020: Body temperature: 103.8 and on an unknown date: 100.6.  On an unknown date: Full blood count: [normal]  On an unknown date: Metabolic function test: [normal]  It was not reported if the patient received a corrective treatment.  At the time of this report, outcome of the oropharyngeal pain were not recovered.  The event outcome was unknown for body temperature increased, lymphadenopathy, headache and fatigue.  There will be no information available on the batch number for this case.