chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 2.0
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse events; patient was administered an improperly stored PROQUAD; This spontaneous report was received from a medical assistant concerning to a 24-month-old patient of unknown gender. No information was provided regarding the patients' medical history, concurrent conditions or concomitant medications.  On 04-DEC-2019, the patient was vaccinated with an improperly stored dose of Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live (PROQUAD) lot number S008575 with expiration date on 16-SEP-2020 (dosage schedule, route and anatomical location were not reported) for prophylaxis.  Administered doses of vaccine experienced one temperature excursion of -9 to 8 degrees Celsius (C) (-6.9 C) and another one of -9 to 8 C (-0.2 C), both excursions were ongoing. There was no previous temperature excursion. No digital data logger was involved. No adverse effects were reported.
Sex: M
Vaccine: TD
Symptoms: No adverse event, Product storage error
Clinical narrative: tenivac was administered to patient which was exposed to room temperature (72F) for 4-5 days (96-120) due to fridge wasn't working, with no ae; Initial information received on 06-Nov-2019 regarding an unsolicited valid non-serious case received from a other health professional.   This case is linked to case 2019SA311273.  This case involves an unknown age male patient who received unknown dose of DIPHTHERIA-2/TETANUS-5 ADSORBED TOXOIDS NO PRESERVATIVE ADULT [TENIVAC] (Lot no: U6265AA expiry date: 19-APR-2021) via unknown route on unknown date.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  It was an actual medication error due to the Product storage error. It was reported that tenivac was administered to patient which was exposed to room temperature (72F) for 4-5 days (96-120) due to fridge wasn't working, with no ae.  At the time of reporting, the patient had no adverse event.  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.
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Underdose
Clinical narrative: a patient received the Fluzone Quadrivalent 0.25 mL for their first dose and second dose 0.5 ml / no AE; Initial information received on 22-Nov-2019 regarding an unsolicited valid non-serious case received from a nurse.  This case involves a 3 years and 10 months old female patient who was vaccinated with 0.25 ml first dose of suspect INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] lot UT6647JA (Expiry date 30-Jun-2020) via intramuscular route in the thigh nos on 14-Oct-2019 and 0.5 ml second dose of suspect INFLUENZA QUADRIVAL A-B VACCINE lot UJ2578C (Expiry date 30-Jun-2020) via intramuscular route in the thigh nos on 11-Nov-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was an actual medication error case due to vaccine underdose.  At the time of reporting no adverse reaction 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.
Sex: U
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a child under 18 years of age may have been received the Flublok Quadrivalent but she is not sure, no AE.; Initial information received on 27-Nov-2019 regarding an unsolicited valid non-serious case received from a physician.  This case involves a child who is under 18 years of age and may have been received the INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number, expiration date and other dosing details not reported) on an unknown date but the reporter is not sure.  The patient's medical history and concomitant medications were not reported.  It was an actual medication error case due to inappropriate age at vaccine administration.  No adverse event reported at the time of reporting.  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.  Information on the batch number was requested.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling hot, Headache, Musculoskeletal pain, Musculoskeletal stiffness
Clinical narrative: Intense shoulder pain and stiffness.  Alternating chills and hot spells.  Intense all over body ache.  Sharp headache left temple.  Symptoms peaked 12-24 hrs after shot.  All symptoms gone by 48 hrs, except shoulder pain/stiffness which is now tolerable without pain medication.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Intense shoulder pain and stiffness.  Alternating chills and hot spells.  Intense all over body ache.  Sharp headache left temple.  Symptoms peaked 12-24 hrs after shot.  All symptoms gone by 48 hrs, except shoulder pain/stiffness which is now tolerable without pain medication.
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Facial paralysis
Clinical narrative: pt had left sided bell's palsy after receiving shingrix on 7/29/2019
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Abdominal pain upper, Arthralgia, Asthenia, Burning sensation, Chills
Clinical narrative: Received Fluzone HD vaccine on 11/18/19. Two days later, migraine-like headache with change in eyesight, nausea, weakness, followed on 11/21/19 by chills, diarrhea (initially bloody), stomach pain, stuffy nose, bleeding/burning shoulder cyst, rectal burning requiring Anusol suppositories, achy joints, fatigue - all continuing through 11/27/19.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Cyst, Diarrhoea, Diarrhoea haemorrhagic, Fatigue, Haemorrhage
Clinical narrative: Received Fluzone HD vaccine on 11/18/19. Two days later, migraine-like headache with change in eyesight, nausea, weakness, followed on 11/21/19 by chills, diarrhea (initially bloody), stomach pain, stuffy nose, bleeding/burning shoulder cyst, rectal burning requiring Anusol suppositories, achy joints, fatigue - all continuing through 11/27/19.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Migraine, Nasal congestion, Nausea, Visual impairment
Clinical narrative: Received Fluzone HD vaccine on 11/18/19. Two days later, migraine-like headache with change in eyesight, nausea, weakness, followed on 11/21/19 by chills, diarrhea (initially bloody), stomach pain, stuffy nose, bleeding/burning shoulder cyst, rectal burning requiring Anusol suppositories, achy joints, fatigue - all continuing through 11/27/19.
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Dermatitis, Rash, Rash erythematous, Rash pruritic, Skin abrasion
Clinical narrative: PT RECEIVED FIRST INJECTION AT WELL CHILD VISIT 10-7-2019 . SEEN IN URGENT CARE 10-12-2019 WITH SYMPTOMS OF RED, ITCHY RASH ON ABDOMEN, LEGS AND ARMS . SYMPTOMS GRADUALLY PRESENTED ON 10-8-2019 PER MOM. NO TREATMENT WAS GIVEN AT HOME PRIOR TO URGENT CARE VISIT.  URGENT CARE PHYSICIAN ASSISTANT NOTED ON SKIN EXAM: red round well demarcated lesion noted on the arms and legs as well as the abdomen ,buttocks, back and chest excoriations are noted it is Not hot or oozing no signs of infection are noted.  ASSESSMENT/PLAN:  Acute dermatitis - all over chest, back arms and legs L30.9: Dermatitis, unspecified triamcinolone acetonide 0.1 % topical cream - apply to affected to affected area twice daily for rash     Medrol (Pak) 4 mg tablets in a dose pack - Take 1 dose pk(s) by oral route.       Benadryl Allergy 25 mg tablet - Take 1 tab every 4-6 hours prn     Solu-Medrol (PF) 125 mg/2 mL solution for injection - Take 125 mg by injection route.     Quantity: 125 mg GIVEN AT TIME OF URGENT CARE VISIT 10-12-19
Age: 13.0
Sex: F
Vaccine: HPV9
Symptoms: Skin lesion
Clinical narrative: PT RECEIVED FIRST INJECTION AT WELL CHILD VISIT 10-7-2019 . SEEN IN URGENT CARE 10-12-2019 WITH SYMPTOMS OF RED, ITCHY RASH ON ABDOMEN, LEGS AND ARMS . SYMPTOMS GRADUALLY PRESENTED ON 10-8-2019 PER MOM. NO TREATMENT WAS GIVEN AT HOME PRIOR TO URGENT CARE VISIT.  URGENT CARE PHYSICIAN ASSISTANT NOTED ON SKIN EXAM: red round well demarcated lesion noted on the arms and legs as well as the abdomen ,buttocks, back and chest excoriations are noted it is Not hot or oozing no signs of infection are noted.  ASSESSMENT/PLAN:  Acute dermatitis - all over chest, back arms and legs L30.9: Dermatitis, unspecified triamcinolone acetonide 0.1 % topical cream - apply to affected to affected area twice daily for rash     Medrol (Pak) 4 mg tablets in a dose pack - Take 1 dose pk(s) by oral route.       Benadryl Allergy 25 mg tablet - Take 1 tab every 4-6 hours prn     Solu-Medrol (PF) 125 mg/2 mL solution for injection - Take 125 mg by injection route.     Quantity: 125 mg GIVEN AT TIME OF URGENT CARE VISIT 10-12-19
Age: 62.0
Sex: M
Vaccine: HEP, HEPA
Symptoms: Wrong product administered
Clinical narrative: Patient presented for Hepatitis B vaccination. Patient screened and ordered to receive HepB vaccination and was charted in chart and immunization registry to have received HepB vaccine. After completing vaccine inventory, it was found that nurse could have administered Hepatitis A vaccine instead and it narrowed between 2 patients in which the error could have occurred. Immunization branch contacted and as recommended, patient notified of error and encouraged to come in for re-vaccination.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: No adverse event, Wrong product administered
Clinical narrative: Medical Assistant gave Meningococcal (Menactra) per verbal order for PCP. Order was actually supposed to be Meningococcal B (Bexsero). MA misunderstood as she had never known of any other meningococcal vaccine. She called to Immunization Agency and spoke with someone there who said that it was fine. No contraindication.  Pt received a 3rd dose of the Menactra. No adverse event occurred.
Age: 74.0
Sex: M
Vaccine: HEPA
Symptoms: Aspartate aminotransferase increased, Metabolic function test
Clinical narrative: AST reading of 43
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Chills, Nausea, Pain, Pain in extremity
Clinical narrative: Both husband and myself had 2nd Shingrex Vaccine. Had no problem after the 1st. This one after 12 hours we had very severe shivers,shaking,body aches,nausea,stomach upset, low fever, tingling and pain in soles of feet. Took 2 days before we felt like ourselves again
Sex: F
Vaccine: VARZOS
Symptoms: Paraesthesia, Pyrexia, Tremor
Clinical narrative: Both husband and myself had 2nd Shingrex Vaccine. Had no problem after the 1st. This one after 12 hours we had very severe shivers,shaking,body aches,nausea,stomach upset, low fever, tingling and pain in soles of feet. Took 2 days before we felt like ourselves again
Sex: U
Vaccine: FLU3
Symptoms: Abdominal pain upper, Diarrhoea
Clinical narrative: Stomach cramping and diarrhea for 10 days following administration of a flu shot.
Age: 92.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Epistaxis, Haemoptysis, Immunoglobulin therapy, Platelet count decreased
Clinical narrative: Patient received flu immunization from pharmacy on October 4th, 2019. Patient was seen by outpatient clinic for warfarin management on 10/18/19 during which she complained of some blood in tissue after blowing nose and blood in sputum and some bruising. These symptoms continued through 10/26/2019 on which day patient was admitted to hospital for thrombocytopenia (i.e. platelet count of 1000/microliter). Patient received three transfusions and started on IVIG and methylprednisolone.
Age: 92.0
Sex: F
Vaccine: FLU3
Symptoms: Thrombocytopenia, Transfusion
Clinical narrative: Patient received flu immunization from pharmacy on October 4th, 2019. Patient was seen by outpatient clinic for warfarin management on 10/18/19 during which she complained of some blood in tissue after blowing nose and blood in sputum and some bruising. These symptoms continued through 10/26/2019 on which day patient was admitted to hospital for thrombocytopenia (i.e. platelet count of 1000/microliter). Patient received three transfusions and started on IVIG and methylprednisolone.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal distension, Basophil count increased, Blood test, Chest X-ray abnormal, Chest discomfort
Clinical narrative: Tuesday evening around 7 pm I received Afluria Qiv Flu vaccine within 15 minutes of receiving the shot I felt shortness of breath, my throat began to swell and my chest started to tighten. I called the pharmacist and spoke with him, he told me I might be able to treat at home but I should go in if I get worse, I then called the nurse advice line who told me I can treat at home with Benadryl. During this phone call my chest and neck broke out in hives, every step I took felt heavy, I felt dizzy, I had diarrhea, my arm started to swell, get hives and was hot to touch. My hands and arms started to feel tingly like pins and needles feeling. I had a friend rush me to the ER where and EKG, blood work and chest x-ray were done. I was given a very high dose of Benadryl through my IV which made the swelling in my throat go down but made me throw up after I sat up to get my x-ray, I was then given decadron and fluids, about half way through that I felt the tightness in my chest ease up however, I was still having some issues catching my breath, the x-ray showed I had a very high amount of air in my stomach which was swollen. before I was released I threw up and had my second bout of diarrhea. I was unable to go to work the next 3 day due to extreme exhaustion, feeling faint, headaches, tingly feeling in my hands, having trouble catching my breath, nausea and vomiting, I still had a rash on my chest and would become out of breath walking to the next room. My throat would feel like it was swelling and I took some Benadryl to help. Today (11/24) is the first day I am starting to feel not as weak. I have not vomited, felt faint, I feel like the hives on my chest are almost gone.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Diarrhoea, Discomfort, Dizziness, Dyspnoea, Electrocardiogram
Clinical narrative: Tuesday evening around 7 pm I received Afluria Qiv Flu vaccine within 15 minutes of receiving the shot I felt shortness of breath, my throat began to swell and my chest started to tighten. I called the pharmacist and spoke with him, he told me I might be able to treat at home but I should go in if I get worse, I then called the nurse advice line who told me I can treat at home with Benadryl. During this phone call my chest and neck broke out in hives, every step I took felt heavy, I felt dizzy, I had diarrhea, my arm started to swell, get hives and was hot to touch. My hands and arms started to feel tingly like pins and needles feeling. I had a friend rush me to the ER where and EKG, blood work and chest x-ray were done. I was given a very high dose of Benadryl through my IV which made the swelling in my throat go down but made me throw up after I sat up to get my x-ray, I was then given decadron and fluids, about half way through that I felt the tightness in my chest ease up however, I was still having some issues catching my breath, the x-ray showed I had a very high amount of air in my stomach which was swollen. before I was released I threw up and had my second bout of diarrhea. I was unable to go to work the next 3 day due to extreme exhaustion, feeling faint, headaches, tingly feeling in my hands, having trouble catching my breath, nausea and vomiting, I still had a rash on my chest and would become out of breath walking to the next room. My throat would feel like it was swelling and I took some Benadryl to help. Today (11/24) is the first day I am starting to feel not as weak. I have not vomited, felt faint, I feel like the hives on my chest are almost gone.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Fatigue, Feeling abnormal, Feeling hot, Headache, Monocyte count increased
Clinical narrative: Tuesday evening around 7 pm I received Afluria Qiv Flu vaccine within 15 minutes of receiving the shot I felt shortness of breath, my throat began to swell and my chest started to tighten. I called the pharmacist and spoke with him, he told me I might be able to treat at home but I should go in if I get worse, I then called the nurse advice line who told me I can treat at home with Benadryl. During this phone call my chest and neck broke out in hives, every step I took felt heavy, I felt dizzy, I had diarrhea, my arm started to swell, get hives and was hot to touch. My hands and arms started to feel tingly like pins and needles feeling. I had a friend rush me to the ER where and EKG, blood work and chest x-ray were done. I was given a very high dose of Benadryl through my IV which made the swelling in my throat go down but made me throw up after I sat up to get my x-ray, I was then given decadron and fluids, about half way through that I felt the tightness in my chest ease up however, I was still having some issues catching my breath, the x-ray showed I had a very high amount of air in my stomach which was swollen. before I was released I threw up and had my second bout of diarrhea. I was unable to go to work the next 3 day due to extreme exhaustion, feeling faint, headaches, tingly feeling in my hands, having trouble catching my breath, nausea and vomiting, I still had a rash on my chest and would become out of breath walking to the next room. My throat would feel like it was swelling and I took some Benadryl to help. Today (11/24) is the first day I am starting to feel not as weak. I have not vomited, felt faint, I feel like the hives on my chest are almost gone.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Paraesthesia, Peripheral swelling, Pharyngeal swelling, Urticaria
Clinical narrative: Tuesday evening around 7 pm I received Afluria Qiv Flu vaccine within 15 minutes of receiving the shot I felt shortness of breath, my throat began to swell and my chest started to tighten. I called the pharmacist and spoke with him, he told me I might be able to treat at home but I should go in if I get worse, I then called the nurse advice line who told me I can treat at home with Benadryl. During this phone call my chest and neck broke out in hives, every step I took felt heavy, I felt dizzy, I had diarrhea, my arm started to swell, get hives and was hot to touch. My hands and arms started to feel tingly like pins and needles feeling. I had a friend rush me to the ER where and EKG, blood work and chest x-ray were done. I was given a very high dose of Benadryl through my IV which made the swelling in my throat go down but made me throw up after I sat up to get my x-ray, I was then given decadron and fluids, about half way through that I felt the tightness in my chest ease up however, I was still having some issues catching my breath, the x-ray showed I had a very high amount of air in my stomach which was swollen. before I was released I threw up and had my second bout of diarrhea. I was unable to go to work the next 3 day due to extreme exhaustion, feeling faint, headaches, tingly feeling in my hands, having trouble catching my breath, nausea and vomiting, I still had a rash on my chest and would become out of breath walking to the next room. My throat would feel like it was swelling and I took some Benadryl to help. Today (11/24) is the first day I am starting to feel not as weak. I have not vomited, felt faint, I feel like the hives on my chest are almost gone.
Age: 33.0
Sex: F
Vaccine: FLU4
Symptoms: Vomiting
Clinical narrative: Tuesday evening around 7 pm I received Afluria Qiv Flu vaccine within 15 minutes of receiving the shot I felt shortness of breath, my throat began to swell and my chest started to tighten. I called the pharmacist and spoke with him, he told me I might be able to treat at home but I should go in if I get worse, I then called the nurse advice line who told me I can treat at home with Benadryl. During this phone call my chest and neck broke out in hives, every step I took felt heavy, I felt dizzy, I had diarrhea, my arm started to swell, get hives and was hot to touch. My hands and arms started to feel tingly like pins and needles feeling. I had a friend rush me to the ER where and EKG, blood work and chest x-ray were done. I was given a very high dose of Benadryl through my IV which made the swelling in my throat go down but made me throw up after I sat up to get my x-ray, I was then given decadron and fluids, about half way through that I felt the tightness in my chest ease up however, I was still having some issues catching my breath, the x-ray showed I had a very high amount of air in my stomach which was swollen. before I was released I threw up and had my second bout of diarrhea. I was unable to go to work the next 3 day due to extreme exhaustion, feeling faint, headaches, tingly feeling in my hands, having trouble catching my breath, nausea and vomiting, I still had a rash on my chest and would become out of breath walking to the next room. My throat would feel like it was swelling and I took some Benadryl to help. Today (11/24) is the first day I am starting to feel not as weak. I have not vomited, felt faint, I feel like the hives on my chest are almost gone.
Age: 32.0
Sex: F
Vaccine: PPV
Symptoms: Injection site erythema, Injection site pain, Injection site swelling
Clinical narrative: Pneumovac administered on Friday, 11/29. On Saturday 11/30 I had some pain and redness around injection site. By Sunday 12/1, redness had increased down the inside of my arm and now was raised, extremely painful. Area was marked and watched with improvement of pain/swelling with 1gram acetaminophen.
Age: 93.0
Sex: F
Vaccine: PNC13
Symptoms: Joint lock, Joint stiffness, Mobility decreased, Musculoskeletal stiffness
Clinical narrative: I am writing adding this to my comments page since it is sometimes hard to read my writing.  I have two devastating happenings. Each will be separate but you can see how close together they occurred.  In June my ophthalmologist referred me to Glaucoma specialties who examined my left eye. You can read the reports.  I had been on Travatan Z for my Right eye for several years without problem. Dr advised me to put it in both eyes .June 18 2019  Next visit after exam He added Combigan See date on file enclosed.  Next he added Dorzolamide HCL 2%eye drops. After today's I wanted to stay in bed.  I told him I couldn't take them. I still have all pills left for proof of number taken. I had my laser treatment (108 zaps in left eye) on August 29th/19 Tol to tay on Combigan but I noticed in less than a week I began it itch all over. Seemed to progress and in three nights I reported this and they suggested I not take them or 4 days. It seemed to halt further progression, but still became more and more prolific.  I called the doctor and He said He never heard of this and I had a skin decease.   I have gon to the Dermatologist who prescribed Fluocinolone 0.01% (11/4/19) in Cera ve cream. At this time I am slowly healing.  (2) Unfortunate decision to take a Pneumonia shot at pharmacy since I never had one. Wrong decision. I noticed and circled the Formaldehyde listed think it was just a generic listing. Wrong again I have been embalmed prematurely. Before this I never had an ache in my body AS I write I have to go to Dr, general Physician who say my change and said I should not have had any of these medications at my age. Sent to therapist, who said I look like a person 70 years of age. I am 93.5. I am not trying to find ways to detox. I decided to take as hot a shower as I can stand for as long as I can to loosen my shoulders  I can barely get out of bed in AM. all shoulders. hips and knees are stiff. I wish I could sue. But they have our hands tied there as well. Maybe if I'm dead one lawyer will star a class action suit. I am the keeper still working in my personal rentals keeping my sone who is buried] in Health insure obligations since he had a heart attack year ago at 45 and lot his good job.
Age: 58.0
Sex: M
Vaccine: FLUC4
Symptoms: Anti-GAD antibody, Anti-ganglioside antibody, Antibody test, Antinuclear antibody negative, Asthenia
Clinical narrative: Symptoms: Dizziness, myalgia, nausea vomiting & sudden onset of profound weakness Treatment: Globulin,immune 600ml IV daily x 4 days ML every day
Age: 58.0
Sex: M
Vaccine: FLUC4
Symptoms: Blood folate normal, Blood thyroid stimulating hormone normal, C-reactive protein normal, Computerised tomogram head normal, Cortisol normal
Clinical narrative: Symptoms: Dizziness, myalgia, nausea vomiting & sudden onset of profound weakness Treatment: Globulin,immune 600ml IV daily x 4 days ML every day
Age: 58.0
Sex: M
Vaccine: FLUC4
Symptoms: Dizziness, Electromyogram abnormal, Electrophoresis protein normal, Glycosylated haemoglobin normal, HIV test negative
Clinical narrative: Symptoms: Dizziness, myalgia, nausea vomiting & sudden onset of profound weakness Treatment: Globulin,immune 600ml IV daily x 4 days ML every day
Age: 58.0
Sex: M
Vaccine: FLUC4
Symptoms: Immunoglobulin therapy, Laboratory test abnormal, Myalgia, Nausea, Oesophagram
Clinical narrative: Symptoms: Dizziness, myalgia, nausea vomiting & sudden onset of profound weakness Treatment: Globulin,immune 600ml IV daily x 4 days ML every day
Age: 58.0
Sex: M
Vaccine: FLUC4
Symptoms: Red blood cell sedimentation rate normal, Scan normal, Vitamin B1, Vitamin B12 normal, Vitamin B6
Clinical narrative: Symptoms: Dizziness, myalgia, nausea vomiting & sudden onset of profound weakness Treatment: Globulin,immune 600ml IV daily x 4 days ML every day
Age: 58.0
Sex: M
Vaccine: FLUC4
Symptoms: Vitamin E, Vomiting
Clinical narrative: Symptoms: Dizziness, myalgia, nausea vomiting & sudden onset of profound weakness Treatment: Globulin,immune 600ml IV daily x 4 days ML every day
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Injection site erythema, Myalgia
Clinical narrative: Nearly uncontrollable shivering, redness at injection site, general muscle aches, tiredness
Age: 53.0
Sex: F
Vaccine: UNK
Symptoms: Pruritus, Rash
Clinical narrative: Rash and itching
Age: 54.0
Sex: F
Vaccine: FLU4
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: 10/22/2019 Pt in office complaint of waking up the morning after the injection and being unable to lift her arm over her head. The complaint was that her right arm was having this pain. The shot was documented to have been given in the left arm, I spoke with the MA that gave the shot and she confirmed that the patient refused the vaccine in her left arm and requested it be given in her Right  arm. C/O right arm hurting all through the biceps muscle and into the shoulder. At this time the patient was given a Triamcinalone 80/Dexamethasone 4 injection for the inflammation. Also started on Tylenol Arthritis 2 tabs 2 times per day.
Age: 8.0
Sex: F
Vaccine: FLUC4
Symptoms: Injection site erythema, Injection site urticaria, Injection site warmth, Malaise
Clinical narrative: Day after injection (<24 hours later) patient developed a erythematous patch approximately 3" x 3" around injection site. Patch was warm to the touch. Patient then developed diffuse urticaria only in the erythematous patch. Condition was resolved with OTC diphenhydramine. General malaise persisted (not of concern).
Age: 4.0
Sex: F
Vaccine: VARCEL
Symptoms: Varicella post vaccine
Clinical narrative: Patient now has Zoster virus.
Age: 9.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Took my 9 year old, daughter to pharmacy on Friday 12/06/2019 at 4:55 p.m. to get her annual flu shot.  At 5:17 p.m. I received a phone call from the pharmacist who explained that she accidently gave my daughter the Shingrix vaccination by mistake and was told that this shot was not intended for children and was designed for adults 50 year and older. We immediately called poison control where staff explained to us the possible side effects and to monitor her for the next 48 hours to make sure she doesn't have any major outbreaks or major fever spikes.    Friday evening patient ran a fever most of the evening which we were able to keep her comfortable w/ childrens ibuprofen.  She could barely lift her arm and the injection point on her left arm could not be touched without severe pain.  Arm was swollen at the point of injection and was very red.  Saturday, patient continued to run a fever and slept most of the day which was not like her at all.  She experienced the same level of pain in the arm and functionality was limited.  We again comforted her w/ childrens ibuprofen.  Swelling in the arm had gone down but had splotches of red around the point of injection about the size of the palm of her hand. Sunday evening, patient's fever began to calm down and she started to gain more mobility in her arm with less pain to the touch.  We monitored the red splotches to ensure they remained localized which they did. Monday morning, no fever and she has started to gain what appears to be full functionality in her arm.  Arm still a little red and splotches have not spread as of today.
Age: 9.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Rash macular, Somnolence, Wrong product administered
Clinical narrative: Took my 9 year old, daughter to pharmacy on Friday 12/06/2019 at 4:55 p.m. to get her annual flu shot.  At 5:17 p.m. I received a phone call from the pharmacist who explained that she accidently gave my daughter the Shingrix vaccination by mistake and was told that this shot was not intended for children and was designed for adults 50 year and older. We immediately called poison control where staff explained to us the possible side effects and to monitor her for the next 48 hours to make sure she doesn't have any major outbreaks or major fever spikes.    Friday evening patient ran a fever most of the evening which we were able to keep her comfortable w/ childrens ibuprofen.  She could barely lift her arm and the injection point on her left arm could not be touched without severe pain.  Arm was swollen at the point of injection and was very red.  Saturday, patient continued to run a fever and slept most of the day which was not like her at all.  She experienced the same level of pain in the arm and functionality was limited.  We again comforted her w/ childrens ibuprofen.  Swelling in the arm had gone down but had splotches of red around the point of injection about the size of the palm of her hand. Sunday evening, patient's fever began to calm down and she started to gain more mobility in her arm with less pain to the touch.  We monitored the red splotches to ensure they remained localized which they did. Monday morning, no fever and she has started to gain what appears to be full functionality in her arm.  Arm still a little red and splotches have not spread as of today.
Age: 9.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Took my 9 year old, daughter to pharmacy on Friday 12/06/2019 at 4:55 p.m. to get her annual flu shot.  At 5:17 p.m. I received a phone call from the pharmacist who explained that she accidently gave my daughter the Shingrix vaccination by mistake and was told that this shot was not intended for children and was designed for adults 50 year and older. We immediately called poison control where staff explained to us the possible side effects and to monitor her for the next 48 hours to make sure she doesn't have any major outbreaks or major fever spikes.    Friday evening patient ran a fever most of the evening which we were able to keep her comfortable w/ childrens ibuprofen.  She could barely lift her arm and the injection point on her left arm could not be touched without severe pain.  Arm was swollen at the point of injection and was very red.  Saturday, patient continued to run a fever and slept most of the day which was not like her at all.  She experienced the same level of pain in the arm and functionality was limited.  We again comforted her w/ childrens ibuprofen.  Swelling in the arm had gone down but had splotches of red around the point of injection about the size of the palm of her hand. Sunday evening, patient's fever began to calm down and she started to gain more mobility in her arm with less pain to the touch.  We monitored the red splotches to ensure they remained localized which they did. Monday morning, no fever and she has started to gain what appears to be full functionality in her arm.  Arm still a little red and splotches have not spread as of today.
Age: 10.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site pain, Injection site reaction, Injection site swelling
Clinical narrative: Pt received incorrect vaccine @ pharmacy. On 12/7/19 pt developed fever + pain @ inj site.
Age: 10.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia, Rash macular, Somnolence, Wrong product administered
Clinical narrative: Pt received incorrect vaccine @ pharmacy. On 12/7/19 pt developed fever + pain @ inj site.
Age: 10.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Pyrexia
Clinical narrative: Pt received incorrect vaccine @ pharmacy. On 12/7/19 pt developed fever + pain @ inj site.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Lip swelling, Paraesthesia oral, Swelling face
Clinical narrative: Lip tingling  within an hour of vaccination.  Woke up in the morning around 5:30am.  Upper lip was extremely swollen and bottom lip was moderately swollen.  Swelling was also present on left side of face from chin to left eye.  Medical Director was notified, MD and she advised to immediately take Benadryl and Zyrtec.  Medication taken at approximately 8am. The symptoms began to alleviate within the hour after taking the medication.
Age: 5.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered, No adverse event
Clinical narrative: ADULT DOSE INADVERTENTLY GIVEN TO CHILD.  MOTHER NOTIFIED 12/5/2019.   CALLED MOTHER 12/9/2019, STATES CHILD HAD NO FEVER OR SWELLING AT VACCINE SITE, NO ADVERSE REACTION NOTED.
Age: 38.0
Sex: M
Vaccine: FLUC4
Symptoms: Acoustic stimulation tests abnormal, Deafness unilateral, Tinnitus
Clinical narrative: PATIENT RETURNED TO THE CLINIC THE FOLLOWING DAY AFTER RECEIVING THE FLU VACCINE AND REPORTED HAVING RINGING IN HIS EARS AND NOT ABLE TO HEAR OTHERS FROM HIS LEFT EAR
Age: 1.33
Sex: M
Vaccine: DTAP, FLU4, PNC13
Symptoms: Injection site erythema, Injection site nodule, Injection site swelling
Clinical narrative: Vaccines were given on 12/02/2019. By evening of 12/02/2019; left thigh had two small bumps. skin toned. No bumps on right thigh. By evening of 12/03/2019, upper bump on left thigh became red. On morning of 12/04/2019, left upper bump was red and swollen. Swelling  "bigger then a quarter. " Patient came into office for an appointment on 12/04/2019. Amoxicillin 400mg/5ml 5 ml twice a day for 10 days and Hydrocortisone cream 1% apply to area twice a day for seven days was prescribed. Medicines started evening of 12/04/2019 per Mom. By morning of 12/05/2019; redness was gone. Area was still swollen but swelling was less. Today, 12/09/2019 left upper bump about size of pea. Mom can feel bump but can not see it.
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Erythema, Injection site erythema, Injection site warmth
Clinical narrative: 10/18/19 Nursing noted right upper extremity redness, hot to palpitation 10/19/19 redness continues to right deltoid and noted on abdomen below umbilicus referred to clinic for possible cellulitis 10/21/19 initial clinic visit PCP noted redness to right upper arm and left lower abdomen given hydrocortisone 1% topical TID and to follow-up in 2 days. 10/24/19 At follow-up erythema noted from top of right shoulder to the wrist no pain or itching reported given triamcinolone 0.1% BID x 5 days and diphenhydramine 25 mg TID x 5 days 10/25/19 At follow-up erythema noted on left and right arm as well as lower abdominal area however stated improving stop diphenhydramine and add hydrocortisone topical 11/1/19 left arm resolved right upper arm some improvement since previous visit continue hydrocortisone for 5 days
Age: 26.0
Sex: F
Vaccine: ANTH, FLU4
Symptoms: Injection site erythema
Clinical narrative: 26 year old female received influenza vaccination. Had some erythema in diffuse pattern to right upper arm extending from deltoid to 3-4 inches above her elbow. No SOB or wheezing. NKA. No PMHx for any significant medical concerns.
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Rash
Clinical narrative: Rash & RASH
Age: 53.0
Sex: F
Vaccine: DTP
Symptoms: Injection site erythema, Injection site oedema
Clinical narrative: erythema and edema around injection site
Age: 66.0
Sex: M
Vaccine: PPV
Symptoms: Pain in extremity
Clinical narrative: & Sore arm from injection Prednisone 40 mg once take two tablets by mouth now
Age: 5.0
Sex: M
Vaccine: HEP, IPV, MMR
Symptoms: Rash erythematous, Rash pruritic
Clinical narrative: Parents described a non-urticarial. Mildly pruritic rash in evening following vaccine administration on 9/18/19. Rash faint pink located below clavicle & sternal region, back & lower arms. Negative: fever, malaise, upper respiratory symptoms, GI complaints, cough, sign/symptoms respiratory distress. Loratadine as needed on 9/24/19. Symptomatic care at home. Parents reported at planned subsequent visit. Rash gradually resolved. On 9/25/19 faint pink rash remained on sternal region only.
Age: 76.0
Sex: M
Vaccine: FLU4
Symptoms: Rash, Urticaria
Clinical narrative: Skinrash & hives
Age: 4.0
Sex: F
Vaccine: DTAP
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Irritability, Pyrexia
Clinical narrative: Day 1 excessive fussiness, no fever Day 2 pain swelling, redness at injection site tactile fever -later in day. Increased swelling and diffuse hives. Faded over course of almost 2 weeks. Office visit and Urgent Care Patient fell believed on immunization...to emergency. She has had what sounds like Exaggerated immune response to vaccine in the past according to Mother. As of 12/7/19 the Mother states Patient's symptoms have resolved. She is scheduled to see a pediatric allergist/immunologist tomorrow. The plan is to catch Patient up on her immunizations if decided safe
Age: 89.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Peripheral swelling, Pruritus
Clinical narrative: Patient said she may have ignored issue, but she began to notice redness, swelling, and itchiness in left arm about 5 days after vaccination, and called to notify pharmacy 2 days later.  She notified pharmacy exactly 1 week post vaccination.
Age: 33.0
Sex: F
Vaccine: HPV9
Symptoms: Localised oedema, Pain
Clinical narrative: localized edema, pain
Age: 77.0
Sex: M
Vaccine: UNK
Symptoms: Gynaecomastia, Injection site erythema, Injection site swelling
Clinical narrative: Patient said he had more than usual amount of redness and swelling at the injection site. also had enlarging breasts that took more than 4 weeks to subside . Adverse reaction did subside on it own
Age: 11.0
Sex: M
Vaccine: HPV9
Symptoms: Syncope
Clinical narrative: syncope following vaccine administered in clinic; had also received Menveo and Tdap at same visit
Age: 52.0
Sex: U
Vaccine: VARZOS
Symptoms: Eye pain, Eye swelling, Hordeolum, Hypersensitivity, Ophthalmic herpes zoster
Clinical narrative: Feel like a have shingles in eye; feels like have sty; Swelled feels like have sty; Eye started to hurt; Forehead had bumpy rash; feel like I am having and allergy tingling; tingling; This case was reported by a consumer via call center representative and described the occurrence of ophthalmic herpes zoster in a 52-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included ophthalmic herpes zoster.   On 26th November 2019, the patient received the 1st dose of Shingrix. On 1st December 2019, 5 days after receiving Shingrix, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant), stye, eye swelling, eye pain, papular rash, allergic reaction and tingling. On an unknown date, the outcome of the ophthalmic herpes zoster, stye, eye swelling, eye pain, allergic reaction and tingling were unknown and the outcome of the papular rash was recovered/resolved.   It was unknown if the reporter considered the ophthalmic herpes zoster, stye, eye swelling, eye pain, papular rash, allergic reaction and tingling to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix in the left arm. In the night of 1st December 2019, the patient started having problem with the eye the patient had shingles in. There was swelling felt like the patient had stye. The patient's forehead had bumpy rash that came and went and the patient almost felt like he or she was having and allergy tingling etc. The patient felt fine on Saturday and most of Sunday till the patient's eye started to hurt. The patient felt like he or she had shingles in eye and other symptoms that went with it. The patient was wondering how long reactions occur after getting vaccinated.
Age: 52.0
Sex: U
Vaccine: VARZOS
Symptoms: Paraesthesia, Rash papular
Clinical narrative: Feel like a have shingles in eye; feels like have sty; Swelled feels like have sty; Eye started to hurt; Forehead had bumpy rash; feel like I am having and allergy tingling; tingling; This case was reported by a consumer via call center representative and described the occurrence of ophthalmic herpes zoster in a 52-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included ophthalmic herpes zoster.   On 26th November 2019, the patient received the 1st dose of Shingrix. On 1st December 2019, 5 days after receiving Shingrix, the patient experienced ophthalmic herpes zoster (serious criteria GSK medically significant), stye, eye swelling, eye pain, papular rash, allergic reaction and tingling. On an unknown date, the outcome of the ophthalmic herpes zoster, stye, eye swelling, eye pain, allergic reaction and tingling were unknown and the outcome of the papular rash was recovered/resolved.   It was unknown if the reporter considered the ophthalmic herpes zoster, stye, eye swelling, eye pain, papular rash, allergic reaction and tingling to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix in the left arm. In the night of 1st December 2019, the patient started having problem with the eye the patient had shingles in. There was swelling felt like the patient had stye. The patient's forehead had bumpy rash that came and went and the patient almost felt like he or she was having and allergy tingling etc. The patient felt fine on Saturday and most of Sunday till the patient's eye started to hurt. The patient felt like he or she had shingles in eye and other symptoms that went with it. The patient was wondering how long reactions occur after getting vaccinated.
Sex: F
Vaccine: PNC13
Symptoms: Arthralgia, Chills, Injection site pain, Injection site swelling, Injection site urticaria
Clinical narrative: Started developing some "swelling and pain" and "welt-like hives" at the injection site; Started developing some "swelling and pain" and "welt-like hives" at the injection site; Started developing some "swelling and pain" and "welt-like hives" at the injection site/welt-like hives were about "3 inches" in diameter; Hives appeared on her "wrist" as well; Joint and hip pain that was a sciatic feeling pain; Joint and hip pain that was a sciatic feeling pain; Chills; Inappropriate dose of vaccine administered; This is a spontaneous report based on the Information received by Pfizer from Merck & Co., Inc. (manufacturer reference number 01411624) from a contactable consumer reporting for herself. This female patient of unknown age received on 19Nov2019 second dose of pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) at single dose for immunization. Medical history and concomitant medications were not reported. About one year before this report (2018), she got vaccinated with the first dose of pneumococcal 13-val conj vac (dipht crm197 protein) with no reportable issues. On the same evening of vaccination, the patient started developing some "swelling and pain" and "welt-like hives" at the injection site and the hives appeared on her "wrist" as well. The patient also added the welt-like hives were about "3 inches" in diameter. The patient also said after getting the 2nd dose experienced "joint and hip pain that was a sciatic feeling pain" and she had the "chills" as well. The patient mentioned she took an unspecified antihistamine to treat her adverse reaction which helped because most of the symptoms "cleared up within 2 days" after getting the vaccination. Final outcome was unknown. No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: PNC13
Symptoms: Sciatica, Urticaria
Clinical narrative: Started developing some "swelling and pain" and "welt-like hives" at the injection site; Started developing some "swelling and pain" and "welt-like hives" at the injection site; Started developing some "swelling and pain" and "welt-like hives" at the injection site/welt-like hives were about "3 inches" in diameter; Hives appeared on her "wrist" as well; Joint and hip pain that was a sciatic feeling pain; Joint and hip pain that was a sciatic feeling pain; Chills; Inappropriate dose of vaccine administered; This is a spontaneous report based on the Information received by Pfizer from Merck & Co., Inc. (manufacturer reference number 01411624) from a contactable consumer reporting for herself. This female patient of unknown age received on 19Nov2019 second dose of pneumococcal 13-val conj vac (dipht crm197 protein) (PREVNAR 13) at single dose for immunization. Medical history and concomitant medications were not reported. About one year before this report (2018), she got vaccinated with the first dose of pneumococcal 13-val conj vac (dipht crm197 protein) with no reportable issues. On the same evening of vaccination, the patient started developing some "swelling and pain" and "welt-like hives" at the injection site and the hives appeared on her "wrist" as well. The patient also added the welt-like hives were about "3 inches" in diameter. The patient also said after getting the 2nd dose experienced "joint and hip pain that was a sciatic feeling pain" and she had the "chills" as well. The patient mentioned she took an unspecified antihistamine to treat her adverse reaction which helped because most of the symptoms "cleared up within 2 days" after getting the vaccination. Final outcome was unknown. No follow-up attempts are possible. No further information is expected.