chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 26.0
Sex: F
Vaccine: FLUR4
Symptoms: Exposure during pregnancy, No adverse event
Clinical narrative: a patient who was 9 weeks pregnant received Flublok Quadrivalent pre-filled syringe; Initial information received on 28-Oct-2019 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 26 years old female patient who was exposed to vaccine influenza quadrivalent recombinant vaccine [Flublok QIV]. Data regarding this pregnancy were received prospectively, i.e. before pregnancy outcome was known. The reported a patient who was 9 weeks pregnant received Flublok Quadrivalent pre-filled syringe occurred at unknown gestation period.  The date of last menstrual period was not reported.  The estimated due date was not reported.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient had previous pregnancy was unknown.   On 25-Oct-2019, the patient received a dose influenza quadrivalent recombinant vaccine (Lot: QFAA1934 and Expiry date: 30-Jun-2020) via unknown route in the left deltoid.  On an unknown date (latency: unknown), after the administration of influenza quadrivalent recombinant vaccine therapy, it was reported that the patient did know she was pregnant at the time. Patient received no other vaccines concomitantly. Reporter stated that, as far as she was aware, the patient had experienced no adverse symptoms.  It was not reported if the patient received any corrective treatment.  Event outcome was not applicable.  No further relevant information was reported.
Age: 59.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 58 years old and received the Fluzone High Dose, no AE; 59 years old and received the Fluzone High Dose, no AE; Initial information received on 29-Oct-2019 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves a 59 years old female patient who received 0.5 ml dose INFLUENZA USP TRIVAL A-B HIGH DOSE SUBVIRION VACCINE [FLUZONE HIGH DOSE] (lot number:UJ274AA and expiry date:26-May-2020) via unknown route in the right deltoid on 28-Oct-2019.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   It was a case of actual medication error due to overdose and inappropriate age at vaccine administration.  It was reported that there were no side effects observed.  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: 16.0
Sex: U
Vaccine: FLUR4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: a 16 year old patient received a dose of Fluzone QIV / No adverse event; Initial information regarding an unsolicited valid non-serious case received from a pharmacist via nurse on 24-Oct-2019.  This case is linked to cases 2019SA304580, 2019SA304587, 2019SA304588, 2019SA304589, 2019SA304590, 2019SA304591 and 2019SA304592.  This case involves a 16-year-old patient (unknown gender) who received QUADRIVALENT RECOMBINANT INFLUENZA VACCINE [Flublok QIV]) (Batch No: QFAA1938, Expiry date: 30-Jun-2020) (Product administered to patient of inappropriate age).  The patient's past medical history, medical treatments, vaccinations and family history were not provided.  It was an actual medication error due to the inappropriate age at vaccine administration.  It was not reported whether the patient experienced any 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: U
Vaccine: HIBV, TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 14 year old was scheduled for Adacel vaccination but ActHIB was given instead/no AE; The Hib portion was given to a 14 yo inadvertently/no AE; Initial information received on 31-Oct-2019 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 14 years old patient who was supposed to be given DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] vaccination instead HIB (PRP/T) VACCINE [ACT-HIB] was given.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included MENINGOCOCCAL VACCINE B (MENB) for Immunisation; and HPV VACCINE (HPV VACCINE) for Immunisation.  On an unknown date, the patient received a dose of suspect HIB (PRP/T) VACCINE lot UJ157AA, via intramuscular route in the deltoid nos.  This is a case of actual medication error due to Wrong vaccine administered and Inappropriate age at vaccine administration.   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: 53.0
Sex: M
Vaccine: FLU4
Symptoms: Blood pressure increased, Blood test, Chest X-ray, Chest pain, Electrocardiogram
Clinical narrative: Eyes color changed to red; Pain in my legs muscles, chest and jaw; Pain in my legs muscles, chest and jaw; Acute allergic reaction to flu vaccine; Pain in my legs muscles, chest and jaw; Blood pressure was around 160; This is a spontaneous case, reported by other non-health professional to agency [reference number: SEQ19-06089] and initially received on 04-Nov-2019, concerning a 53-year-old, male patient.   The patient's relevant medical history included flu vaccination with other brands for more than 10 years with no adverse events. The patient was not taking any concomitant medication.  On 04-Oct-2019 at 4:30 pm, the patient was administered Afluria Quadrivalent [influenza vaccine, NDC: 33332-419-11; dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: P10011060 and expiration date: 15-May-2020] for prevention of seasonal influenza.  On the same day, an hour after vaccination, the patient experienced pain in leg muscles, chest and jaw, and the patient's eyes colour changed to red.  On the same day, the patient went to hospital emergency room and underwent electrocardiogram (EKG), chest X-ray and had blood tests done, however, results were not provided. The patient's blood pressure was around 160, units were not specified. It was reported that the patient was diagnosed with acute allergic reaction to flu vaccine. The patient received treatment medicine prednisone at a dose of 20 mg, administered once per day, for 5 days (5 tablets).  On 05-Oct-2019, the patient's blood pressure went to normal, and the patient was discharged home.  At the time of the initial reporting, the outcome for the events of pain in legs, chest pain, pain in jaw, red eyes and acute allergic reaction was not reported.  The case was assessed as serious.   The reporter assessed the events to be related to Afluria Quadrivalent.  This case is linked to cases 201905876, 201905877 and 201905878 (same reporter).  Company comment: The patient experienced pain in jaw, blood pressure increased, ocular hyperaemia, chest pain, pain in extremity and hypersensitivity an hour after vaccination with the suspect product Afluria Quadrivalent. Chronology is plausible. No diagnostic findings and concomitant medications were provided. Considering all the above mentioned, causality between suspect product and the events is assessed as possibly related.; Reporter's Comments: They recognized this is acute allergic reaction to flu vaccine.; Sender's Comments: The patient experienced pain in jaw, blood pressure increased, ocular hyperaemia, chest pain, pain in extremity and hypersensitivity an hour after vaccination with the suspect product Afluria Quadrivalent. Chronology is plausible. No diagnostic findings and concomitant medications were provided. Considering all the above mentioned, causality between suspect product and the events is assessed as possibly related.
Age: 53.0
Sex: M
Vaccine: FLU4
Symptoms: Hypersensitivity, Myalgia, Ocular hyperaemia, Pain in jaw
Clinical narrative: Eyes color changed to red; Pain in my legs muscles, chest and jaw; Pain in my legs muscles, chest and jaw; Acute allergic reaction to flu vaccine; Pain in my legs muscles, chest and jaw; Blood pressure was around 160; This is a spontaneous case, reported by other non-health professional to agency [reference number: SEQ19-06089] and initially received on 04-Nov-2019, concerning a 53-year-old, male patient.   The patient's relevant medical history included flu vaccination with other brands for more than 10 years with no adverse events. The patient was not taking any concomitant medication.  On 04-Oct-2019 at 4:30 pm, the patient was administered Afluria Quadrivalent [influenza vaccine, NDC: 33332-419-11; dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: P10011060 and expiration date: 15-May-2020] for prevention of seasonal influenza.  On the same day, an hour after vaccination, the patient experienced pain in leg muscles, chest and jaw, and the patient's eyes colour changed to red.  On the same day, the patient went to hospital emergency room and underwent electrocardiogram (EKG), chest X-ray and had blood tests done, however, results were not provided. The patient's blood pressure was around 160, units were not specified. It was reported that the patient was diagnosed with acute allergic reaction to flu vaccine. The patient received treatment medicine prednisone at a dose of 20 mg, administered once per day, for 5 days (5 tablets).  On 05-Oct-2019, the patient's blood pressure went to normal, and the patient was discharged home.  At the time of the initial reporting, the outcome for the events of pain in legs, chest pain, pain in jaw, red eyes and acute allergic reaction was not reported.  The case was assessed as serious.   The reporter assessed the events to be related to Afluria Quadrivalent.  This case is linked to cases 201905876, 201905877 and 201905878 (same reporter).  Company comment: The patient experienced pain in jaw, blood pressure increased, ocular hyperaemia, chest pain, pain in extremity and hypersensitivity an hour after vaccination with the suspect product Afluria Quadrivalent. Chronology is plausible. No diagnostic findings and concomitant medications were provided. Considering all the above mentioned, causality between suspect product and the events is assessed as possibly related.; Reporter's Comments: They recognized this is acute allergic reaction to flu vaccine.; Sender's Comments: The patient experienced pain in jaw, blood pressure increased, ocular hyperaemia, chest pain, pain in extremity and hypersensitivity an hour after vaccination with the suspect product Afluria Quadrivalent. Chronology is plausible. No diagnostic findings and concomitant medications were provided. Considering all the above mentioned, causality between suspect product and the events is assessed as possibly related.
Sex: M
Vaccine: FLUX
Symptoms: Blood glucose increased, Pancreatitis
Clinical narrative: Pancreatitis; Blood sugar spiked very high; This is a spontaneous case, initially received from consumer via agency (reference number: SEQ19-06147) on 04-Nov-2019, concerning a 68-year-old, male patient.   The patient's medical history was not reported.  The patient's concomitant medications included Keprom (ketoprofen) and levetiracetam, both for an unknown indication.  On an unspecified date in 2018, the patient was administered INN Flu Vaccine [influenza vaccine, dose, route of administration, batch number, expiration date and anatomical location: not reported] for unknown indication.   On an unspecified date in 2018, after vaccination, the patient's blood sugar spiked very high and he developed pancreatitis.  On an unspecified date in 2018, the patient was recovered from the events of pancreatitis and 'blood sugar increased'.  The reporter assessed the case as serious but did not provide causality assessment.  The case was linked with 201905879 (due to same patient).  Company comment: The patient experienced pancreatitis and blood glucose increased after vaccination with INN flu vaccine. Chronology is plausible. No medical history and diagnostic findings were provided. Causality was also confounded by therapy with concomitant medications, Keprom (ketoprofen) and levetiracetam. Considering all the above mentioned, causality between suspect product and the events is assessed as possibly related.; Sender's Comments: The patient experienced pancreatitis and blood glucose increased after vaccination with INN flu vaccine. Chronology is plausible. No medical history and diagnostic findings were provided. Causality was also confounded by therapy with concomitant medications, Keprom (ketoprofen) and levetiracetam. Considering all the above mentioned, causality between suspect product and the events is assessed as possibly related.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Patient experienced soreness and aches and pains. Also a slight fever
Age: 85.0
Sex: M
Vaccine: FLUC4
Symptoms: Asthenia, Cough, Decreased appetite, Pulmonary function test, Respiratory tract congestion
Clinical narrative: atarted coughing 10/28/19 around 8:30pm c/o ongoing coughing, wheezing, congested, weakness not eating.. tx 10/31/19 depo medrol, abluterol aerosol, antibiotic, cough med
Age: 85.0
Sex: M
Vaccine: FLUC4
Symptoms: Wheezing
Clinical narrative: atarted coughing 10/28/19 around 8:30pm c/o ongoing coughing, wheezing, congested, weakness not eating.. tx 10/31/19 depo medrol, abluterol aerosol, antibiotic, cough med
Age: 71.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Chills, Feeling abnormal, Headache, Insomnia, Pain
Clinical narrative: Thur 11/7 pt felt achyness, chills Fri 11/8  8am pt develop  headache, did not feel good; left arm from flu vaccine was warm to touch, red & itchy.  Sun 11/10  pt's left arm still red, warm to touch & itchy Mon 11/11 pt called nurse  & possibility due to  reaction from ingredients in flu vaccine.   patient started to apply ice which helps, but was not able to sleep Tues 11/12  Redness is no longer as warm as it was before. Patient will continue icing & will take benadry tonight
Age: 71.0
Sex: F
Vaccine: FLUA3, PPV
Symptoms: Pruritus, Skin reaction, Skin warm
Clinical narrative: Thur 11/7 pt felt achyness, chills Fri 11/8  8am pt develop  headache, did not feel good; left arm from flu vaccine was warm to touch, red & itchy.  Sun 11/10  pt's left arm still red, warm to touch & itchy Mon 11/11 pt called nurse  & possibility due to  reaction from ingredients in flu vaccine.   patient started to apply ice which helps, but was not able to sleep Tues 11/12  Redness is no longer as warm as it was before. Patient will continue icing & will take benadry tonight
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal discomfort, Anal incontinence, Arthralgia, Fatigue, Loss of personal independence in daily activities
Clinical narrative: About 12-18 hours after vaccination, I experienced severe arthralgia, myalgia, and GI distress to the point of involuntary defacation multiple times.  I was unable to get out of bed all day Saturday aside from using the restroom due to all-over body pain.  I did not go to work Monday and I am going in late to work today due to stomach issues and lack of proper sleep.  Sunday, mid-day, possibly later in the evening, the pain started to lessen and the GI issues were not as prominent.  Monday was mostly exhaustion and mild GI distress, while today compromises of being tired and GI disturbances.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Mobility decreased, Myalgia
Clinical narrative: About 12-18 hours after vaccination, I experienced severe arthralgia, myalgia, and GI distress to the point of involuntary defacation multiple times.  I was unable to get out of bed all day Saturday aside from using the restroom due to all-over body pain.  I did not go to work Monday and I am going in late to work today due to stomach issues and lack of proper sleep.  Sunday, mid-day, possibly later in the evening, the pain started to lessen and the GI issues were not as prominent.  Monday was mostly exhaustion and mild GI distress, while today compromises of being tired and GI disturbances.
Age: 37.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pruritus, Pruritus
Clinical narrative: Severe itching to chest, neck, chin, both shoulders and left arm
Age: 4.0
Sex: F
Vaccine: DTAPIPVHIB, FLU4, PNC13
Symptoms: No adverse event, Wrong patient received product
Clinical narrative: The patient was scheduled for a well-child visit along with two other siblings 9 months and 2 y.o. Vaccines drawn up correctly for the patient and double-checked for accuracy with a second RN. At the time of administration the immunizations intended for 9 mo female sibling were administered to the patient. Patient received 0.5 ml Pentacel, 0.5 ml Pneumococcal-13 and 0.25 ml Influenza.   No adverse reaction noted at time of administration. Error immediately reported to the nurse practitioner examining the patients, who then spoke with the mother of the child/patient.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pain
Clinical narrative: Patient's wife described her husband's symptoms at her vaccination:  Quite tender to touch and very red at and around the injection site.
Age: 35.0
Sex: F
Vaccine: HEP
Symptoms: Chills, Fatigue, Malaise, Paraesthesia, Pyrexia
Clinical narrative: Several hours after receiving immunization employee reported having chills, fever , extreme fatigue, malaise, tingling in left arm.  Employee took Ibuprofen 400 mg, went to bed; symptoms were gone when she got up the next morning.
Age: 41.0
Sex: F
Vaccine: FLU4, PPV
Symptoms: Injection site bruising, Injection site pain, Pain
Clinical narrative: Patient reports having severe pain in her left upper arm for four days following administration of Fluzone and Pneumovax 23. Pt states she was not able to even put on clothing without severe pain radiating in her arm, and that she had bruising following administration as well.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Injection site pain, Pain in extremity, Peripheral swelling, Skin warm
Clinical narrative: The medication was very painful. I could feel the fluid in my arm causing severe pain.  I called my doctor on 10/3 & she suggested an ice pack with Ibruphrophen every 4 hours/24 hours.   I went to a Med Center on 10/15 because it was still painful, swollen, warm to the touch, & red. They prescribed Benedryl & a daytime allergy med.   on 10/18 I went to my doctor?s office & saw Dr who prescribed physical therapy which I?ve been to 4 times. On 11/10 my doctor prescribed Lidocaine patches which I am using. Also on 11/11 I had an Ultrasound ?. O blood clots found.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Ultrasound scan normal
Clinical narrative: The medication was very painful. I could feel the fluid in my arm causing severe pain.  I called my doctor on 10/3 & she suggested an ice pack with Ibruphrophen every 4 hours/24 hours.   I went to a Med Center on 10/15 because it was still painful, swollen, warm to the touch, & red. They prescribed Benedryl & a daytime allergy med.   on 10/18 I went to my doctor?s office & saw Dr who prescribed physical therapy which I?ve been to 4 times. On 11/10 my doctor prescribed Lidocaine patches which I am using. Also on 11/11 I had an Ultrasound ?. O blood clots found.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Erythema, Mobility decreased, Muscular weakness, Musculoskeletal stiffness, Pain
Clinical narrative: The medication was very painful. I could feel the fluid in my arm causing severe pain.  I called my doctor on 10/3 & she suggested an ice pack with Ibruphrophen every 4 hours/24 hours.   I went to a Med Center on 10/15 because it was still painful, swollen, warm to the touch, & red. They prescribed Benedryl & a daytime allergy med.   on 10/18 I went to my doctor?s office & saw Dr who prescribed physical therapy which I?ve been to 4 times. On 11/10 my doctor prescribed Lidocaine patches which I am using. Also on 11/11 I had an Ultrasound ?. O blood clots found.
Age: 73.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Skin warm, Swelling
Clinical narrative: The medication was very painful. I could feel the fluid in my arm causing severe pain.  I called my doctor on 10/3 & she suggested an ice pack with Ibruphrophen every 4 hours/24 hours.   I went to a Med Center on 10/15 because it was still painful, swollen, warm to the touch, & red. They prescribed Benedryl & a daytime allergy med.   on 10/18 I went to my doctor?s office & saw Dr who prescribed physical therapy which I?ve been to 4 times. On 11/10 my doctor prescribed Lidocaine patches which I am using. Also on 11/11 I had an Ultrasound ?. O blood clots found.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site cellulitis, Injection site erythema, Injection site pain
Clinical narrative: Patient reported redness, pain, tenderness over entire upper right arm after vaccination. Diagnosed by walk-in care MD as cellulitis.
Age: 0.08
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No Adverse reactions at this time.  Patient is a 7 week old given the flu vaccine by mistake.
Age: 12.0
Sex: U
Vaccine: HPV9
Symptoms: No adverse event, Product storage error
Clinical narrative: No adverse effect; patients who received improperly stored GARDASIL 9 since 8/13/2019; This spontaneous report as received from a phlebotomist refers to a 12-year-old patient of unknown gender. No information regarding the patient's pertinent medical history, concomitant medications, drug reactions and allergies was provided.  On an unknown date in 2019 (reported as since 13-AUG-2019), the patient was vaccinated with incorrect stored dose of hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection, lot # 1602281, expiration date 21-JUL-2021 (dose and route of administration were not reported) for prophylaxis. The temperature excursion occurred on 13-AUG-2019. The vaccine was stored in temperature 30.60 degrees Fahrenheit for 41 minutes and in temperature 56.80 degrees Fahrenheit for 4 hours 30 minutes. There was no previous temperature excursion. The digital data logger was involved. No adverse effects were reported.; Sender's Comments:  US-009507513-1909USA004622:
Age: 0.17
Sex: F
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Apnoea, Crying, Cyanosis, Hypotonia, Irritability
Clinical narrative: Had increased fussiness in the afternoon/evening after immunizations.  Patient was crying inconsolably at the time.  Mother states she stopped breathing for 20-30 seconds, went limp and face turned blue.  Had given a single dose of Tylenol @ 19:15.  Called 911 and went to hospital.
Age: 61.0
Sex: F
Vaccine: FLU3
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: No adverse reaction, however patient incorrectly got High Dose Flu in place of regular Flu Dose.
Age: 69.0
Sex: M
Vaccine: FLU3
Symptoms: Hypoaesthesia
Clinical narrative: Patient reported numbness in left arm that lasted approximately 24 hours.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Blister, Pruritus, Rash
Clinical narrative: Blisters/Rash across shoulder and back started to occur about 1 week after immunization.  Symptoms slowly improved.  Mainly experienced itching as a symptom of rash/blisters.
Age: 31.0
Sex: M
Vaccine: FLU4
Symptoms: Facial paralysis
Clinical narrative: left sided bell's palsy, severe.
Age: 75.0
Sex: F
Vaccine: PPV
Symptoms: Injected limb mobility decreased, Injection site erythema, Injection site swelling
Clinical narrative: Patient returned to the pharmacy on 11/12/19 two days after vaccination. Patient presented her left arm and it was red and swollen from the should down to the elbow. Patient described that she did not experience symptoms until she was about to go to bed on 11/10/19, she stated that the next day she was unable to lift her arm more than a 30 degree angle.  She used ice packs to keep the swelling down. She explained and presented that it is no longer as bad and she is able to lift her arm up now. I asked if she experienced any fever or other side effects and she denied that she has.
Age: 40.0
Sex: F
Vaccine: PPV
Symptoms: Injection site oedema, Injection site pain, Ultrasound scan abnormal
Clinical narrative: injection side severe edema and pain treated to Ketorolac  injection, and hydroncotison cream topically.
Age: 62.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site discolouration
Clinical narrative: patient claims that she has an ashen color around the injection site that has been there since the injection but no pain or any other reactions
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Myalgia, Pain
Clinical narrative: EXTREME MUSCLE PAIN FROM 9/20/2019 TO PRESENT TIME. UNABLE TO LEFT ARM OVER HEAD WITHOUT MUSCLE PAIN
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Cough, Fatigue, Headache, Influenza like illness
Clinical narrative: Flu like symptoms: Tiredness, headache, cough, chills, nausea, soreness at injection site
Age: 71.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Nausea
Clinical narrative: Flu like symptoms: Tiredness, headache, cough, chills, nausea, soreness at injection site
Age: 7.0
Sex: M
Vaccine: PPV
Symptoms: Erythema, Peripheral swelling
Clinical narrative: Developed redness and swelling in left arm beginning the day after vaccination. Mom took child to the Emergency Department on 11/6/19 and was instructed to apply cold compresses alternating with warm compresses, give ibuprofen and consult primary physician if not improving. Mom called us 11/7/19 because redness and swelling now extended to his hand, he c/o discomfort and was having difficulty moving his arm. The primary physician was not available this day so directed her to go back to the ER. Spoke with mom today and she reports ER advised her to continue treatment and notify them if no improvement by 11/11/19. She reports today that symptoms are much improved.
Age: 79.0
Sex: F
Vaccine: FLU3, PPV
Symptoms: Chills, Hyperhidrosis, Insomnia, Pain, Pain in extremity
Clinical narrative: Started feeling achy around 4pm, By 8pm was having  shivering and sweats.  By 9pm her arm was in severe pain. Was up all night with pain of 15 on a scale of 1-10 .   Used a sling the next day and pain started subsiding around 12pm and continued to get better over the next few days.
Age: 1.0
Sex: M
Vaccine: MMRV
Symptoms: Unevaluable event
Clinical narrative: NO ADVERSE REACTION NOTED
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Altered state of consciousness, Blindness, Chills, Headache, Tremor
Clinical narrative: Without warning/hint got feeling of going to pass out, went blind, without any warning vomited, got shakes/shivers, got headache. Note that I felt fine until the first notion that I was going to pass out. I didn't feel dizzy or lightheaded, but felt something that I never experienced before. Was not sick to my stomach prior to vomiting (haven't vomited in 30, 40 or more years)Sight came back after vomiting. The next day I felt fine, i.e,, I was back to "normal."
Age: 79.0
Sex: M
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: Without warning/hint got feeling of going to pass out, went blind, without any warning vomited, got shakes/shivers, got headache. Note that I felt fine until the first notion that I was going to pass out. I didn't feel dizzy or lightheaded, but felt something that I never experienced before. Was not sick to my stomach prior to vomiting (haven't vomited in 30, 40 or more years)Sight came back after vomiting. The next day I felt fine, i.e,, I was back to "normal."
Age: 12.0
Sex: F
Vaccine: FLU4, HPV9, TDAP, UNK
Symptoms: Presyncope, Vomiting
Clinical narrative: patient near fainted post vaccine , she was evaluated and was breathing , no signs of cyanosis or labored breathing , abc evaluated and was stable and rr and heart rate 90 , rr 20 , speaking in full sentences  was constantly observed stayed at office for 2 hrs after vaccine , she had vomiting few times and at time of leaving office she was doing well no signs of distress no labored breathing vitals were stable , walked alone from office  we did offer to go to emergency room if needed  and mom said she will observe and go to er if needed
Age: 67.0
Sex: F
Vaccine: FLU3, HEPA, PPV
Symptoms: Mobility decreased, Pain in extremity
Clinical narrative: Patient came in on 11-12-19 and said she was having arm pain and trouble lifting it up high. She was wondering if it would have correlation with her vaccines she received on 10-14-19. Suggested she take Tylenol and contact her provider or go in to urgent care if this continues in the next day or two.
Sex: F
Vaccine: DTAPIPVHIB, PNC13, RV1
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 10 DAY OLD INFANT ADMINISTERED 2 MONTH VACCINES IN ERROR
Age: 18.0
Sex: M
Vaccine: MNQ
Symptoms: Syncope
Clinical narrative: Unwitnessed syncope approximately 15 minutes after injection administration. No headache, chest pain or palpitations. Initial BP 90/58. Monitored patient for 20 minutes. Color improved. BP up to 100/62. Patient discharged home by self.
Age: 71.0
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Rash
Clinical narrative: Patient completed his second dose of Shingrix and developed a rash on his lower abdomen approximately two weeks afterward. MD diagnosed patient with Shingles.
Age: 35.0
Sex: F
Vaccine: FLU4
Symptoms: Fibrin D dimer normal, Full blood count normal, Pain in extremity
Clinical narrative: RIGHT POSTERIOR LOWER LEG PAIN, PAIN FELT LIKE SHOOTING PAIN GOING DOWN LEG , SEVERY OF PAIN WAS 5,  NO RECENT TRAUMA , PAIN INCREASES WHEN STANDING .
Age: 73.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site rash, Pruritus
Clinical narrative: PATIENT EXPERIENCED PRURITUS AND DEVELOPED A RASH THAT WAS 5-INCH BY 2-INCH WHERE THE VACCINE WAS ADMINISTERED. PATIENT REPORTED A.E. 3 DAYS AFTER ADMINISTRATION.
Age: 67.0
Sex: F
Vaccine: FLU3
Symptoms: Contusion, Erythema, Peripheral swelling, Skin warm
Clinical narrative: Patient came in with her left arm swollen, red, and bruised. Patient states reaction started day after having gotten her flu shot. Left arm is red and hot to the touch.
Age: 73.0
Sex: M
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: PATIENT EXPERIENCED A NON-ITCHY RASH ON THE NECK, ABOUT 5-INCHES BY 1.5-INCHES
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Burning sensation, Immediate post-injection reaction, Joint range of motion decreased, Musculoskeletal pain, Pain in extremity
Clinical narrative: Patient experienced immediate burning sensation upon insertion of needle and injection of vaccine. Since injection has been experiencing sever upper arm/shoulder pain and limited ROM.
Age: 52.0
Sex: F
Vaccine: FLU4
Symptoms: Shoulder injury related to vaccine administration
Clinical narrative: Patient experienced immediate burning sensation upon insertion of needle and injection of vaccine. Since injection has been experiencing sever upper arm/shoulder pain and limited ROM.
Age: 4.0
Sex: M
Vaccine: DTAPIPV, FLU4, MMRV
Symptoms: Injection site reaction, Rash vesicular, Varicella virus test negative
Clinical narrative: varicella-like rash affecting left lower extremity primarily (injection site) without constitutional symptoms
Age: 62.0
Sex: M
Vaccine: FLU4
Symptoms: Dyspnoea, Headache, Lip swelling, Malaise, Swelling
Clinical narrative: Pt reports malaise, swelling of lips and nostrils, headache, and slight difficulty breathing (lungs were "tight" per pt).  Symptoms began around 24 hours after vaccination and mostly resolved by 3 days later.  Pt did not seek medical care for reaction.
Age: 61.0
Sex: M
Vaccine: FLUC4
Symptoms: Lethargy, Mobility decreased, Muscular weakness, Weight decreased
Clinical narrative: lost 19 pounds over the past 2 weeks, lethargic, unable to move muscle weakness of whole body for a week
Age: 46.0
Sex: F
Vaccine: FLU4
Symptoms: Immediate post-injection reaction, Injected limb mobility decreased, Injection site pain, Shoulder injury related to vaccine administration
Clinical narrative: Patient experienced immediate burning sensation upon insertion of needle and injection of vaccine. Since injection has been experiencing sever upper arm/shoulder pain and limited ROM.
Age: 1.25
Sex: F
Vaccine: DTAP
Symptoms: Cellulitis
Clinical narrative: Cellulitis
Age: 21.0
Sex: M
Vaccine: FLU4, TDAP
Symptoms: Injection site pruritus, Pruritus, Skin warm
Clinical narrative: PATIENT STATED REACTION STARTED WITH LIGHT ITCHING AT INJECTION SITE WHERE FLU SHOT WAS ADMINISTERED (RIGHT ARM). BUT HAS PROGRESSED TO THE WHOLE ARM ITCHING AND IS WARM TO THE TOUCH. PATIENT TOOK BENADRYL AND STATES IT IS HELPING A LITTLE.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Blood test, Chronic inflammatory demyelinating polyradiculoneuropathy, Erythema, Headache, Hypersensitivity
Clinical narrative: Acute allergic reaction within 12 hours of injection, covering my entire upper half of my body, profuse redness, swelling, hot, itchy, painful, headache.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Hypoaesthesia, Nerve conduction studies abnormal, Pain, Pain in extremity, Paraesthesia
Clinical narrative: Acute allergic reaction within 12 hours of injection, covering my entire upper half of my body, profuse redness, swelling, hot, itchy, painful, headache.
Age: 62.0
Sex: F
Vaccine: PPV
Symptoms: Pruritus, Skin warm, Swelling
Clinical narrative: Acute allergic reaction within 12 hours of injection, covering my entire upper half of my body, profuse redness, swelling, hot, itchy, painful, headache.
Age: 72.0
Sex: F
Vaccine: FLUA3, PNC13
Symptoms: Injected limb mobility decreased, Injection site inflammation, Injection site pain
Clinical narrative: Left upper arm was very painful, and a bit inflamed, for about 24 - 36 hours after injections.  At the same time, I couldn't lift my left arm any higher than a 5 o'clock position without upper arm pain (in approx the same area as injections). I was told that the pain would probably disappear over time, but it has now been over a year and the pain upon raising my left arm above the 5 o'clock position remains; just as intense as ever. No treatment received.
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Arthralgia, Full blood count normal, Laboratory test normal, Metabolic function test normal, Muscle spasms
Clinical narrative: PAIN IN BOTH LEGS POSTERIOR AND PRTICULARLY CALVES, STARTED 2 DAYS AFTER THE FLU SHOT GIVEN, WOKE UP WITH CRAMPS FROM DISTAL GLUTEUS AREA TO HER ANKLES ,  WENT TO ER ON 11/8/19   ALL LABS AND ULTRASOUND WAS NORMAL.   CONT TO C/O MUSCLE TWITCHING AND PAIN OF BOTH LEGS AND IS MORE COMFORTABLE STANDING THAN SITTING TODAY AT HER APPT.     PAIN FROM BUTTOCKS DOWN TO ANKLES BILATERAL
Age: 41.0
Sex: F
Vaccine: FLU4
Symptoms: Muscle twitching, Musculoskeletal pain, Pain in extremity, Ultrasound scan normal
Clinical narrative: PAIN IN BOTH LEGS POSTERIOR AND PRTICULARLY CALVES, STARTED 2 DAYS AFTER THE FLU SHOT GIVEN, WOKE UP WITH CRAMPS FROM DISTAL GLUTEUS AREA TO HER ANKLES ,  WENT TO ER ON 11/8/19   ALL LABS AND ULTRASOUND WAS NORMAL.   CONT TO C/O MUSCLE TWITCHING AND PAIN OF BOTH LEGS AND IS MORE COMFORTABLE STANDING THAN SITTING TODAY AT HER APPT.     PAIN FROM BUTTOCKS DOWN TO ANKLES BILATERAL
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Feeling abnormal, Injection site pain, Pyrexia
Clinical narrative: Ran fever and felt bad with the first injection...but about 24 hours after the 2nd in the series I developed a fever of 103.2..injection site looks good..slightly tender but no redness, swelling etc.
Age: 41.0
Sex: M
Vaccine: FLU4
Symptoms: Biopsy skin, Exfoliative rash, Full blood count normal, Hepatic enzyme increased, Ophthalmological examination
Clinical narrative: Developed rash on body extending from chest down to ankles two days after vaccination, along with body ache and low fever. Rash is scaly, moderately itchy and is in round patches. Initial diagnosis from dermatologist is pityriasis rosea for some areas of the rash. Skin biopsy performed on 11/07/2019. Differentials ordered were to rule out tinea, PLEVA, ID (autoimmune eczema), and psoriasis. Biopsy results will be available to reporter on 11/15/2019.
Age: 41.0
Sex: M
Vaccine: FLU4
Symptoms: Pain, Pityriasis rosea, Pyrexia, Rash, Rash pruritic
Clinical narrative: Developed rash on body extending from chest down to ankles two days after vaccination, along with body ache and low fever. Rash is scaly, moderately itchy and is in round patches. Initial diagnosis from dermatologist is pityriasis rosea for some areas of the rash. Skin biopsy performed on 11/07/2019. Differentials ordered were to rule out tinea, PLEVA, ID (autoimmune eczema), and psoriasis. Biopsy results will be available to reporter on 11/15/2019.
Age: 41.0
Sex: M
Vaccine: FLU4
Symptoms: Red blood cell sedimentation rate normal
Clinical narrative: Developed rash on body extending from chest down to ankles two days after vaccination, along with body ache and low fever. Rash is scaly, moderately itchy and is in round patches. Initial diagnosis from dermatologist is pityriasis rosea for some areas of the rash. Skin biopsy performed on 11/07/2019. Differentials ordered were to rule out tinea, PLEVA, ID (autoimmune eczema), and psoriasis. Biopsy results will be available to reporter on 11/15/2019.
Age: 28.0
Sex: F
Vaccine: PNC13
Symptoms: Erythema, Immediate post-injection reaction, Injection site cellulitis, Injection site pain, Mobility decreased
Clinical narrative: Patient experienced burning upon administration but thought was normal.  By end of day pain was fairly extreme and had trouble lifting arm.  Next day pain was extreme and arm was red. Went to hospital, was told vaccine administered too high and patient had cellulitis at administration site.  Went home with pain meds and antibiotics but when issue worsened, patient went back to hospital and was admitted.
Age: 28.0
Sex: F
Vaccine: PNC13
Symptoms: Pain, Product administered at inappropriate site
Clinical narrative: Patient experienced burning upon administration but thought was normal.  By end of day pain was fairly extreme and had trouble lifting arm.  Next day pain was extreme and arm was red. Went to hospital, was told vaccine administered too high and patient had cellulitis at administration site.  Went home with pain meds and antibiotics but when issue worsened, patient went back to hospital and was admitted.
Age: 0.75
Sex: F
Vaccine: DTAPIPV, MMR, VARCEL
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Pt was administered 4yr old shots early. Pt was accidentally mixed with sibling. Parent informed staff. Verified that patient wasn't having any kind of reaction. Per immunization tool kit, pt shouldn't have any adverse reactions.  Explained adverse reaction symptoms, ER protocol if needed. MOP was informed that she should follow up with pt's pcm as needed. Pt had no reaction in the clinic. A note was placed in pt's IMR.  Technician is aware of the mix up, and has been briefed on protocols/operating instructions.  It will not happen again.
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Dehydration, Diarrhoea, Full blood count, Laboratory test abnormal, Pyrexia
Clinical narrative: After 5 hours she developed a high fever 103, then she had diarrhea and vomiting. Which caused her to become dehydrated. I called her dr and he said take her to the ER because that is not a normal reaction. This exact same thing happened at the 4 month vaccines which were the exact same. She had diarrhea for 1 week after the fever broke. The fever started 5/6 hours after receiving the 2nd doses.  She did not receive 6 or 12 month vaccinations. I got a new pediatrician who said we can start back with vaccines but to do them separate to see if a specific one was causing the symptoms. She did not get the 3rd and final dose of ROTATEQ but she received DTaP and had no fever but did have a small amount of diarrhea which she had with all the vaccines once we split them up. No fever. She received MMR at 17 months she had fever of 101 and diarrhea. She received varicella 2-3 months later and had no reaction at all. She is completed on the varicella.
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Vomiting
Clinical narrative: After 5 hours she developed a high fever 103, then she had diarrhea and vomiting. Which caused her to become dehydrated. I called her dr and he said take her to the ER because that is not a normal reaction. This exact same thing happened at the 4 month vaccines which were the exact same. She had diarrhea for 1 week after the fever broke. The fever started 5/6 hours after receiving the 2nd doses.  She did not receive 6 or 12 month vaccinations. I got a new pediatrician who said we can start back with vaccines but to do them separate to see if a specific one was causing the symptoms. She did not get the 3rd and final dose of ROTATEQ but she received DTaP and had no fever but did have a small amount of diarrhea which she had with all the vaccines once we split them up. No fever. She received MMR at 17 months she had fever of 101 and diarrhea. She received varicella 2-3 months later and had no reaction at all. She is completed on the varicella.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Dizziness, Fall, Feeling abnormal, Heart rate increased, Hyperhidrosis
Clinical narrative: Received vaccine on 10/30 or 10/31. Patient has never had problems with flu vaccine in the past and has never received the high dose before.  The reaction was the same as with the TB skin test.  Within the hour after the vaccination started feeling faint. Patient was walking to couch and fell down.  Patient reports sweating, rapid heart rate, rapid pulse, ringing in the ears and high blood pressure (~190).  After episode laid on couch for 1 day and half.  Patient felt lousy; symptoms continued.  Patient contacted pharmacist but not sure, if doctor was contacted since was so out of it. Patient's nurse comes every other Tuesday and housekeep comes every day.  Symptoms continue but not as bad.
Age: 76.0
Sex: F
Vaccine: FLU3
Symptoms: Hypertension, Tinnitus
Clinical narrative: Received vaccine on 10/30 or 10/31. Patient has never had problems with flu vaccine in the past and has never received the high dose before.  The reaction was the same as with the TB skin test.  Within the hour after the vaccination started feeling faint. Patient was walking to couch and fell down.  Patient reports sweating, rapid heart rate, rapid pulse, ringing in the ears and high blood pressure (~190).  After episode laid on couch for 1 day and half.  Patient felt lousy; symptoms continued.  Patient contacted pharmacist but not sure, if doctor was contacted since was so out of it. Patient's nurse comes every other Tuesday and housekeep comes every day.  Symptoms continue but not as bad.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Confusional state, Disorientation, Erythema, Fall
Clinical narrative: Patient describes extreme redness and swelling onset shortly after vaccination on her drive home.  Her joints were achy shortly thereafter.  That night she describes the feeling of losing all muscle control and falling to the floor.  She thought that she lost control of her bladder, but did not urinate.  Her husband had to carry her to the bedroom where she slept and felt confused and disoriented for 18 hours.  She says that her joints are still achy at this time, but have improved.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling
Clinical narrative: Patient describes extreme redness and swelling onset shortly after vaccination on her drive home.  Her joints were achy shortly thereafter.  That night she describes the feeling of losing all muscle control and falling to the floor.  She thought that she lost control of her bladder, but did not urinate.  Her husband had to carry her to the bedroom where she slept and felt confused and disoriented for 18 hours.  She says that her joints are still achy at this time, but have improved.
Age: 0.33
Sex: F
Vaccine: HIBV, PNC13
Symptoms: Irritability, Pyrexia
Clinical narrative: Fevers started the night of the vaccines 11/11/19 into the next morning. Patient was extra fussy through the night and next morning
Age: 41.0
Sex: F
Vaccine: FLUC4
Symptoms: Cough, Feeling abnormal, Feeling cold, Feeling hot, Hyperhidrosis
Clinical narrative: Around 5-6pm patient started to get hot, sweaty, and throat started to swell up.   Patient was sweating through dinner and did not feel good at all.  Later, started to feel cold so took shower and Tylenol. On Sunday, symptoms worsen and started alternating Tylenol and Ibuprofen alternating; had diarrhea after hot/cold flashes.  On Monday patient rested, symptoms continued, and coughing started. Yesterday patient felt better but still was sweating profusely.  Patient has overall body aches and hot/cold flashes.  Patient could not get in touch in PCP so yesterday went to ER.    Patient tested for Flu A/B and strepresults were negative. Doctor specified symptoms were probably related to the vaccine.  Patient given Afrin, Tylenol, Ibuprofen, Mucinex D, throat lozenges.  Patient noted her children received the vaccine the same day with no problems. Patient feels a little better today.    Patient has only received Flu vaccine the last 7 years; has not experienced any problems.
Age: 41.0
Sex: F
Vaccine: FLUC4
Symptoms: Influenza A virus test negative, Influenza B virus test, Influenza virus test negative, Pain, Pharyngeal swelling
Clinical narrative: Around 5-6pm patient started to get hot, sweaty, and throat started to swell up.   Patient was sweating through dinner and did not feel good at all.  Later, started to feel cold so took shower and Tylenol. On Sunday, symptoms worsen and started alternating Tylenol and Ibuprofen alternating; had diarrhea after hot/cold flashes.  On Monday patient rested, symptoms continued, and coughing started. Yesterday patient felt better but still was sweating profusely.  Patient has overall body aches and hot/cold flashes.  Patient could not get in touch in PCP so yesterday went to ER.    Patient tested for Flu A/B and strepresults were negative. Doctor specified symptoms were probably related to the vaccine.  Patient given Afrin, Tylenol, Ibuprofen, Mucinex D, throat lozenges.  Patient noted her children received the vaccine the same day with no problems. Patient feels a little better today.    Patient has only received Flu vaccine the last 7 years; has not experienced any problems.