chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: TD
Symptoms: Adverse reaction
Clinical narrative: Initial information for this unsolicited case was received on 23 February 2015 from a healthcare professional via another manufacturer. An unidentified patient, gender, age and date of birth were not reported was vaccinated on an unreported date with DIPHTHERIA/TETANUS ADSORBED TOXOIDS, manufacturer, batch, route and site of administration were not reported. On an unreported date, the patient experienced a serious reaction. The patient's medical history and concomitant medications were not reported. Laboratory tests were not reported. The patient outcome was not reported. Documents held by sender: None Based on information received on 23-FEB-2015, the following information suspect product was coded via generic name N/A DIPHTHERIA AND TETANUS TOXOIDS have been amended.; Sender's Comments: This is a poorly documented case of an unidentified patient with an unknown medical history who was vaccinated with DIPHTHERIA/TETANUS ADSORBED TOXOIDS vaccine, manufacturer unknown and at an unspecified time experienced a severe adverse reaction. Information about concomitant medications, diagnosis and laboratory tests to support the potential diagnosis are required. In the absence of this information, no final conclusion can be drawn.
Age: 49.0
Sex: M
Vaccine: TDAP
Symptoms: Injected limb mobility decreased, Injection site pain
Clinical narrative: Initial unsolicited report received from a health professional on 17-Jan-2018. This case involves a 59 years old male patient who was vaccinated with a 0.5 ml injection of ADACEL (batch number: U5798AB, expiration date and dose in series were not reported), via intramuscular route in left deltoid on 05-JAN-2018. The patient medical history and concomitant medications were not reported. On 16-Jan-2018, 11 days after the vaccination, the patient experienced pain and limited range of motion of the left shoulder area. Laboratory data and corrective treatment were not reported. The outcome of the event was unknown at the time of reporting. List of documents held by sender: none.
Sex: M
Vaccine: TDAP
Symptoms: Hepatitis C antibody negative, Lichen planus
Clinical narrative: Initial unsolicited report received from literature on 16-Jan-2018. Abstract: Lichen planus is an inflammatory dermatosis with a prevalence of approximately 1%. Recent meta-analyses show that patients with hepatitis C virus have a 2.5 - to 4.5 - fold increased risk of developing Lichen planus. Lichen planus has also followed vaccinations and has specifically been attributed to the hepatitis B vaccine, the influenza vaccine, and the tetanus-diphtheria-acellular pertussis vaccine. We describe a case of Lichen planus in a hepatitis C virus-infected male occurring in temporal association with the administration of the tetanus-diphtheria-acellular pertussis vaccine. The patient's presentation was clinically consistent with Lichen planus and confirmed by biopsy. It is likely that many cases of vaccine induced Lichen planus have gone unpublished or unrecognized. In areas with high prevalence of hepatitis C virus infection, we may expect to see more cases of vaccine-induced Lichen planus especially in light of the updated Centers for Disease Control and Prevention tetanus-diphtheria-acellular pertussis vaccination recommendations. This case serves to educate healthcare providers about vaccine-induced Lichen planus and, in particular, the need to counsel hepatitis C virus-infected patients about a potential risk of developing Lichen planus following vaccination. We also reflect on current theories suggesting the T-cell-mediated pathogenesis of Lichen planus and the role that hepatitis C virus and toxoid or protein vaccines may play in initiating the disease. This case involves 34-year-old male patient who was vaccinated with single dose of ADACEL (Batch number, expiration date, dose, route and site of administration was not reported) on an unspecified date. The patient's medical history and concomitant medications was not reported. On an unspecified date, four week following the vaccination, the patient experienced eruption of Lichen planus. Lab serology was negative for HCV antibodies. Corrective treatment was not reported. The patient's event outcome was not reported. List of documents held by sender: none.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Hypoaesthesia, Joint range of motion decreased, Pain in extremity
Clinical narrative: Initial unsolicited report received from a consumer (patient herself) on 18-Jan-2018. This case involves a 47-year-old female patient who was vaccinated with a 0.5 ml single dose of FLU SHOT (Batch number, expiry date and dose in series were not reported) via intramuscular route in the right deltoid on 26-Sep-2017 for immunization and also vaccinated with a dose of PNEUMOCOCCAL VACCINE (PNEUMONIA VACCINE) (Batch number, expiry date, dose, dose in series, route and site of administration were not reported) on an unspecified date. The patient's medical history and concomitant medications were not reported. On an unknown date, following the vaccination, the patient developed symptoms of right arm pain, limited range of motion (ROM) and numbness of fingers of right hand which continued to persist. It was reported that the patient was being evaluated by a neurologist in February. Laboratory investigations and corrective treatment were not reported. The outcome of all the events was reported as not recovered. List of documents held by sender: none.
Age: 63.0
Sex: F
Vaccine: FLU3
Symptoms: Injection site pain
Clinical narrative: Pt. states that she had soreness in her muscle where her flu shot was administered since the date she receive the vaccine.
Age: 10.0
Sex: M
Vaccine: FLUC4
Symptoms: Ear congestion, Fall, Loss of consciousness
Clinical narrative: Pt received her vaccination first, stood up and waited while mother and sister received theirs. While on way out, patient passed out. Did not hit head or hurts self in fall. Pt said his ears felt full right before fainting. Fire dept came. Checked pulse, O2 sat and blood sugar, all ok. Pt left w/mom. Checked on him Sunday. Mom said he was ok.
Sex: M
Vaccine: FLUC4
Symptoms: Dizziness
Clinical narrative: Pt. felt light headed after vaccine. Placed pt. on floor for short time.
Age: 55.0
Sex: F
Vaccine: YF
Symptoms: Diarrhoea, Dizziness, Influenza virus test negative, Neck pain, Pain
Clinical narrative: 1/23/18-began symptoms: achy legs, spine and neck aches, general body aches, fever up to 102 degrees which did respond to ALEVE-bedridden on 1/23/18-monitoring for worsening symptoms. 1/29/18-fever resolved, body aches diminished, out of bed, newly developed dizziness, diarrhea-treatment recommend hydration.
Age: 55.0
Sex: F
Vaccine: YF
Symptoms: Pain in extremity, Pyrexia, Spinal pain
Clinical narrative: 1/23/18-began symptoms: achy legs, spine and neck aches, general body aches, fever up to 102 degrees which did respond to ALEVE-bedridden on 1/23/18-monitoring for worsening symptoms. 1/29/18-fever resolved, body aches diminished, out of bed, newly developed dizziness, diarrhea-treatment recommend hydration.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Dysphagia, Dyspnoea, Feeling cold, Foreign body sensation in eyes, Ocular hyperaemia
Clinical narrative: Patient called 1-28-18 starting around 5pm on 1/27/18 his throat was swelling (he could breath and swallow a little) and his eyes became blood shot/sandy feeling in eye. Around 7pm he reports cold chills and feeling sleepy fever approximately 99.5. When he woke up in morning he was feeling a little better but eyes still feel same and throat swollen some.
Age: 70.0
Sex: M
Vaccine: FLU3
Symptoms: Pharyngeal oedema, Pyrexia, Somnolence
Clinical narrative: Patient called 1-28-18 starting around 5pm on 1/27/18 his throat was swelling (he could breath and swallow a little) and his eyes became blood shot/sandy feeling in eye. Around 7pm he reports cold chills and feeling sleepy fever approximately 99.5. When he woke up in morning he was feeling a little better but eyes still feel same and throat swollen some.
Age: 17.0
Sex: M
Vaccine: FLU4, HEPA, HPV9, MNQ, VARCEL
Symptoms: Syncope
Clinical narrative: Pt. received Hep A, Flu, HPV 9, MCV 4 and VAR. After vaccine administration pt. had a period of syncope lasting 20-30 sec. Head was put between his knees and he came to.
Sex: M
Vaccine: HPV9
Symptoms: Extra dose administered
Clinical narrative: Information was received from the mother of a 23 year old male patient. The patient's medical history, concurrent conditions, and concomitant therapies were not reported. On unspecified dates, reported as "between his 16th and 17th birthday", the patient was vaccinated with GARDASIL. On 16-JAN-2018, the patient was vaccinated with GARDASIL 9 injection (lot # and expiration date were not reported) for prophylaxis. The outcome of drug administered to patient of inappropriate age was unknown.
Age: 44.0
Sex: F
Vaccine: HPV9
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: This spontaneous report was received from an office manager, referring to a 44 year old female patient. No information was provided regarding the patient's medical history, concurrent conditions or concomitant medications. On 15-JAN-2018, the patient received a dose of GARDASIL 9, intramuscular injection for prophylaxis (drug administered to patient of inappropriate age). The dose, frequency, anatomical location, lot number and expiration date were not reported. The reporter stated that there were no adverse effects reported in the patient.
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event
Clinical narrative: This spontaneous report was received from a registered nurse referring to a patient of unknown age and gender. The patient's pertinent medical history, concurrent conditions, concomitant therapies and past drug reactions/allergies were not reported. On 02-JAN-2018, the patient was vaccinated with a dose of M-M-R II (strength, dose, route, anatomical location, lot #, expiration date and therapy type were not reported) for prophylaxis; and on 10-JAN-2018, the patient was vaccinated with a dose of VARIVAX one vial, subcutaneously, once, lot # N014630, expiration date: 11-MAY-2019 (strength, anatomical location) for prophylaxis. Other suspect therapies included sterile diluent (MERCK) subcutaneously, once, lot # M039200, expiration date: 03-MAY-2019 (strength, anatomical location) for prophylaxis. No adverse effects were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Decreased immune responsiveness, Herpes zoster, Pain, Rash vesicular
Clinical narrative: Information has been received from a lawyer regarding a case in litigation concerning a male patient of unknown age. No information was received regarding the patient's past medical history, concurrent conditions, or concomitant medication. The patient was inoculated with ZOSTAVAX on or about 16-MAY-2011 at a health department, as recommended for routine adult health maintenance and for the prevention of shingles. ZOSTAVAX did not prevent shingles as intended, but rather caused the patient to contract a persistent strain of herpes zoster. On or about 17-APR-2017, the patient was treated by a physician for the onset of a severe vesicular rash accompanied by weakened immune symptoms, which was diagnosed as severe herpes zoster, or shingles. The patient was prescribed BACTROBAN, valacyclovir, and prednisone for management of his persistent and painful symptoms. The outcome of the events is unknown. As a direct and proximate result of these malfunctions, the patient suffered painful injuries and damages, and required extensive medical care and treatment. As a further proximate result, the patient has suffered and will continue to suffer significant medical expenses, and pain and suffering, and other damages. Additional information has been requested.
Age: 5.0
Sex: M
Vaccine: DTAP
Symptoms: Erythema, Injection site erythema, Injection site warmth
Clinical narrative: Mom said the area where the vaccine was administered with a little red this morning 2/6/2018. Around 11 AM she noticed that it was much bigger redness and felt warm. She also found a picture of his previous reaction to DTaP and displays this on her phone to me which shows macular erythema. Mom did take a picture of the current reaction. He denies any pain. Mom says he still using the arm without hesitancy. Mom says he was so excited and he was "skipping in here" to clinic happy to come. No fever. He slept fine last night without fussiness or any other problems. No wheezing, cough, swelling of the lips or tongue, shortness of breath, vomiting or diarrhea.
Age: 38.0
Sex: M
Vaccine: MMR, MNQ
Symptoms: No adverse event, Wrong drug administered
Clinical narrative: I gave MENACTRA instead of giving second dose MMR. Patient did not have any adverse effects after receiving both immunizations.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Fatigue, Headache, Injection site pain, Myalgia
Clinical narrative: Headache, Fever, Muscle Aches, pain where shot was given, tired, weak.
Age: 57.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Headache, Fever, Muscle Aches, pain where shot was given, tired, weak.
Age: 0.58
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV5
Symptoms: Cranial nerve paralysis
Clinical narrative: Left 6th cranial nerve palsy. Patient's mother called into the office for advice/input, and was put on the schedule to be seen. After Dr. (PCP) assessed the patient, he was then referred to Dr. (Pediatric Ophthalmology), as well as Dr. (Pediatric Neurology).
Age: 68.0
Sex: M
Vaccine: PNC13
Symptoms: Rash pruritic
Clinical narrative: Itchy rash developed day following vaccination. Patient reports itching only, no pain reported.
Age: 50.0
Sex: F
Vaccine: FLUX
Symptoms: Crying, Pain, Pain in extremity
Clinical narrative: My left arm continues to throb on a daily basis ever since my flu vaccination. Sometimes the pain is so severe, it stops me dead in my tracks and the tears stream down my face because I can't find any relief for same. PLEASE HELP ME!!!!!!!!!!!!!!!!!!!!!!!!!!!
Sex: U
Vaccine: VARCEL
Symptoms: No adverse event, Underdose
Clinical narrative: This spontaneous report was received from a nurse, concerning a patient of unknown age and gender. The patient's medical history, concurrent conditions, drug reactions, allergies and concomitant medications were not reported. The nurse informed that on 18-JAN-2018, the patient was vaccinated with the first dose of VARIVAX injection, subcutaneously, 0.5 ml once, for prophylaxis, lot #N022856 and expiration date 23-AUG-2018, which was reconstituted with sterile diluent (MERCK) (strength, dose, lot number and expiration date were not reported). It was reported that some of the vaccine was not injected, but discharged onto the patient's arm, resulting on a dose that may have been too small. No adverse effects were reported.
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Dysstasia, Guillain-Barre syndrome, Muscular weakness, Pyrexia
Clinical narrative: On 11-02-17 patient's grandmother told me that after the 4 month vaccinations that the patient had a three day history of fever of 102+. The patient had "jello legs" and was unable to stand for perhaps as long as three weeks after the immunizations. Family did not notify anyone. "There's nothing you can do anyway," she says. Now problem resolved. Grandmother stated the family wanted to only administer one vaccine at a time. Today she described the event as "Guillain-Barre Syndrome".
Age: 0.5
Sex: M
Vaccine: PNC13
Symptoms: Injection site erythema, Injection site induration, Injection site nodule, Injection site oedema, Injection site swelling
Clinical narrative: Right leg redness and swelling/firmness across entire thigh x 2 days. After- redness and edema at injection site-knot felt upon exam, no tenderness to touch or drainage.
Age: 76.0
Sex: F
Vaccine: FLUA3
Symptoms: Erythema, Injection site discharge
Clinical narrative: Patient's husband reported on 2-1-18 that patient had a colored drainage from the injection site of her flu shot which was administered 10-19-2017. Husband stated her arm had a red area since 10-19-2017.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, RV5
Symptoms: Decreased eye contact, Depressed level of consciousness, Eye movement disorder, Poor feeding infant, Somnolence
Clinical narrative: Parents note pt became "unresponsive" later in the day after the vaccine, and that her "eyes rolled back."  Parents could not get her to look at them. She would not feed well. They became worried and called our office at approx. 10:30 pm. Our triage nurse documented the patient being more sleepy than usual and difficult to feed. She urged parents to wake pt for feeds and to call back if pt would not take the next feed. Parents state by 2am patient was more awake and fed better. She gradually returned to baseline by the next morning. Parents state her decreased arousal lasted just under 24h.
Age: 0.17
Sex: F
Vaccine: DTAPHEPBIP, RV5
Symptoms: Unresponsive to stimuli
Clinical narrative: Parents note pt became "unresponsive" later in the day after the vaccine, and that her "eyes rolled back."  Parents could not get her to look at them. She would not feed well. They became worried and called our office at approx. 10:30 pm. Our triage nurse documented the patient being more sleepy than usual and difficult to feed. She urged parents to wake pt for feeds and to call back if pt would not take the next feed. Parents state by 2am patient was more awake and fed better. She gradually returned to baseline by the next morning. Parents state her decreased arousal lasted just under 24h.
Age: 0.33
Sex: M
Vaccine: RV5
Symptoms: Vomiting
Clinical narrative: Vomiting.
Age: 65.0
Sex: M
Vaccine: PNC13
Symptoms: Arthralgia, Mobility decreased
Clinical narrative: Severe pain in right knee and hip. Increasing in severity as the day has progressed. At the time of his report to the pharmacist (4:00pm), he cannot bend his right leg.
Age: 0.08
Sex: M
Vaccine: DTAPHEPBIP, RV5
Symptoms: Respiratory arrest, Somnolence, Vomiting
Clinical narrative: Drowsy, throwing up, stopped breathing. We called 911.
Age: 37.0
Sex: F
Vaccine: PPV
Symptoms: Injection site bruising, Injection site infection, Injection site swelling
Clinical narrative: Swelling and bruising at the injection site, and subsequent infection.
Age: 65.0
Sex: M
Vaccine: FLUA3, FLUA3
Symptoms: Arthralgia, Asthenia, Cough, Dyspnoea, Headache
Clinical narrative: Pain at injection site (More severe than previous vaccines taken years ago). Weakness and muscle/joint pain appearing next morning. Shortness of breath(trying to inhale deeply results in dry cough). Slight headache. All symptoms are still present over 24 hrs since injection but seem to be lessening.
Age: 65.0
Sex: M
Vaccine: FLUA3, FLUA3
Symptoms: Injection site pain, Myalgia
Clinical narrative: Pain at injection site (More severe than previous vaccines taken years ago). Weakness and muscle/joint pain appearing next morning. Shortness of breath(trying to inhale deeply results in dry cough). Slight headache. All symptoms are still present over 24 hrs since injection but seem to be lessening.
Age: 0.17
Sex: M
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV1
Symptoms: Apnoea, Cyanosis, Skin discolouration
Clinical narrative: Stopped breathing on several occasions and turned blue then gray in color.
Age: 1.0
Sex: M
Vaccine: DTAPHEPBIP, HEPA, HIBV, MMR, PNC13, VARCEL
Symptoms: Flushing, Oedema peripheral, Urticaria
Clinical narrative: Patient developed sudden onset flushing and edema of extremities in addition to hives on his lower back. Event occurred several minutes after administration of vaccines. He received 12.5 mg of Benadryl and had improvement in symptoms.
Age: 66.0
Sex: F
Vaccine: PNC13
Symptoms: Pain in extremity
Clinical narrative: Vaccine was administered to patient on 01/22/2018. On 2/6/2018, patient called pharmacy to report that she has been experiencing pain in the left arm. Describes the pain as getting worse over the last week. Arm is not red, swollen, or warm to touch. In the first few days after vaccine, she said it felt like normal soreness from an IM injection but has since gotten worse. She has seen her MD for annual check up not related to vaccine and mentioned it to him. He did not seem concerned and said some patients experience soreness for a longer period of time. At this time, the patient is still experiencing soreness. I advised her to follow up with us or MD if this persists longer than a few more days.
Age: 70.0
Sex: F
Vaccine: FLUR4
Symptoms: Cough, Decreased appetite, Eye swelling, Fatigue, Heart rate increased
Clinical narrative: Adverse reactions started on 01/30/18 at approximately 6:00 p.m.; eyes and face started to swell;  profuse sweating and rapid heart rate. These reactions lasted approximately 20 minutes. The following day extreme fatigue, nausea and body aches; loss of appetite; poor sleep pattern that night. Unable to work on Feb. 1st and Feb. 2nd due to extreme fatigue, unable to sleep due to coughing for hours during the night.
Age: 70.0
Sex: F
Vaccine: FLUR4
Symptoms: Hyperhidrosis, Hypertension, Impaired work ability, Influenza virus test negative, Insomnia
Clinical narrative: Adverse reactions started on 01/30/18 at approximately 6:00 p.m.; eyes and face started to swell;  profuse sweating and rapid heart rate. These reactions lasted approximately 20 minutes. The following day extreme fatigue, nausea and body aches; loss of appetite; poor sleep pattern that night. Unable to work on Feb. 1st and Feb. 2nd due to extreme fatigue, unable to sleep due to coughing for hours during the night.
Age: 70.0
Sex: F
Vaccine: FLUR4
Symptoms: Nausea, Pain, Sleep disorder, Swelling face
Clinical narrative: Adverse reactions started on 01/30/18 at approximately 6:00 p.m.; eyes and face started to swell;  profuse sweating and rapid heart rate. These reactions lasted approximately 20 minutes. The following day extreme fatigue, nausea and body aches; loss of appetite; poor sleep pattern that night. Unable to work on Feb. 1st and Feb. 2nd due to extreme fatigue, unable to sleep due to coughing for hours during the night.
Age: 4.0
Sex: F
Vaccine: DTAPIPV, MMRV
Symptoms: Injection site erythema, Injection site induration, Injection site swelling, Injection site warmth, Vaccination complication
Clinical narrative: Mom reports redness, swelling, and hot to touch at injection site. Started the evening of the day the vaccines were given, got progressively worse. Mom called PCP's office the next day to report. Also stated the site was very hard. Advised mom bring child in to be evaluated by MD. MD evaluated and measured a 5cm x 5cm area of redness and warm skin surrounding the injection site. Diagnoses of "adverse reaction to vaccine" given. No treatment prescribed.
Age: 90.0
Sex: M
Vaccine: PNC13
Symptoms: Dry skin, Erythema, Pruritus generalised, Scab, Skin discolouration
Clinical narrative: Patient came into the pharmacy about three weeks after vaccination to consult about his reaction he believes was due to the vaccine. Patient said he started to notice a reaction within the next couple of days of redness, discoloration, dry loose skin and peeling, scabbing, and severe itchiness all over his body. Patient is still having issues with his skin even within.
Age: 90.0
Sex: M
Vaccine: PNC13
Symptoms: Skin disorder, Skin exfoliation
Clinical narrative: Patient came into the pharmacy about three weeks after vaccination to consult about his reaction he believes was due to the vaccine. Patient said he started to notice a reaction within the next couple of days of redness, discoloration, dry loose skin and peeling, scabbing, and severe itchiness all over his body. Patient is still having issues with his skin even within.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: No adverse event, Product preparation error
Clinical narrative: Incorrect diluent was used to reconstitute the SHINGRIX vaccine. Instead of using the adjuvant suspension component on the package, the sterile diluent for ZOSTAVAX vaccine was used instead. The CDC recommends redoing the first dose of the vaccine to the customer after 4 weeks. The patient and her primary care doctor's office was informed of the this incident and to come back sometimes after February 21st 2018 to redo the first dose. Patient had no adverse reaction to this error.
Age: 51.0
Sex: F
Vaccine: FLUC4, FLUX
Symptoms: Erythema, Pain, Skin warm, Swelling
Clinical narrative: Red, raised area approx 2.5x1.5, painful and very warm to the touch. Sought medical advice and was advised to ice the area and take anti-inflammatory meds for pain and swelling relief.
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Abdominal pain, Allergy test negative, Arthralgia, Autoimmune disorder, Burning sensation
Clinical narrative: Severe neurological and autoimmune symptoms. Initially, swelling, burning and pain in feet and ankles. Severe, debilitating headaches, strong bounding pulse on left side of head, sensation of something dripping left side of head, unable to tolerate light, joint pain, abdominal pain, nausea, chest pain, left hip and arm/neck/shoulder pain. Increased sensation to touch & heat of fingers. Muscle twitching, spasms and jerking (especially lower extremities but also all over).
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Chest pain, Cortisol normal, Dyskinesia, Headache, Hepatobiliary scan normal
Clinical narrative: Severe neurological and autoimmune symptoms. Initially, swelling, burning and pain in feet and ankles. Severe, debilitating headaches, strong bounding pulse on left side of head, sensation of something dripping left side of head, unable to tolerate light, joint pain, abdominal pain, nausea, chest pain, left hip and arm/neck/shoulder pain. Increased sensation to touch & heat of fingers. Muscle twitching, spasms and jerking (especially lower extremities but also all over).
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Hyperaesthesia, Immunology test normal, Joint swelling, Mononucleosis heterophile test negative, Muscle spasms
Clinical narrative: Severe neurological and autoimmune symptoms. Initially, swelling, burning and pain in feet and ankles. Severe, debilitating headaches, strong bounding pulse on left side of head, sensation of something dripping left side of head, unable to tolerate light, joint pain, abdominal pain, nausea, chest pain, left hip and arm/neck/shoulder pain. Increased sensation to touch & heat of fingers. Muscle twitching, spasms and jerking (especially lower extremities but also all over).
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Muscle twitching, Musculoskeletal pain, Nausea, Neck pain, Neurological examination normal
Clinical narrative: Severe neurological and autoimmune symptoms. Initially, swelling, burning and pain in feet and ankles. Severe, debilitating headaches, strong bounding pulse on left side of head, sensation of something dripping left side of head, unable to tolerate light, joint pain, abdominal pain, nausea, chest pain, left hip and arm/neck/shoulder pain. Increased sensation to touch & heat of fingers. Muscle twitching, spasms and jerking (especially lower extremities but also all over).
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Neurological symptom, Nuclear magnetic resonance imaging brain normal, Nuclear magnetic resonance imaging spinal normal, Ophthalmological examination normal, Pain in extremity
Clinical narrative: Severe neurological and autoimmune symptoms. Initially, swelling, burning and pain in feet and ankles. Severe, debilitating headaches, strong bounding pulse on left side of head, sensation of something dripping left side of head, unable to tolerate light, joint pain, abdominal pain, nausea, chest pain, left hip and arm/neck/shoulder pain. Increased sensation to touch & heat of fingers. Muscle twitching, spasms and jerking (especially lower extremities but also all over).
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Peripheral swelling, Photophobia, Pulse abnormal, Sensory disturbance, Skin warm
Clinical narrative: Severe neurological and autoimmune symptoms. Initially, swelling, burning and pain in feet and ankles. Severe, debilitating headaches, strong bounding pulse on left side of head, sensation of something dripping left side of head, unable to tolerate light, joint pain, abdominal pain, nausea, chest pain, left hip and arm/neck/shoulder pain. Increased sensation to touch & heat of fingers. Muscle twitching, spasms and jerking (especially lower extremities but also all over).
Age: 45.0
Sex: F
Vaccine: FLU4
Symptoms: Small fibre neuropathy, Ultrasound biliary tract normal, Viral test negative
Clinical narrative: Severe neurological and autoimmune symptoms. Initially, swelling, burning and pain in feet and ankles. Severe, debilitating headaches, strong bounding pulse on left side of head, sensation of something dripping left side of head, unable to tolerate light, joint pain, abdominal pain, nausea, chest pain, left hip and arm/neck/shoulder pain. Increased sensation to touch & heat of fingers. Muscle twitching, spasms and jerking (especially lower extremities but also all over).
Age: 7.0
Sex: F
Vaccine: IPV, MMR
Symptoms: Asthenia, Crying, Musculoskeletal stiffness, Pallor, Visual impairment
Clinical narrative: My daughter watched nurse give the shots (she always prefers to watch). She acted normal...stood up gave nurse a hug and picked out a sucker. We walked down the hallway to the waiting area where she started playing with her sister and the toys. I went over to the check-out window to make sure they had everything they needed and get the "what to look for sheets" for the MMR and Polio. I turned and told the girls it was time to go. Patient had a funny look on her face and sat down on the end table and started to sob quietly. I went over and put both hands on her shoulders and asked what was wrong. She quit sobbing and pushed back hard enough to make me off balance. I tried to pull her forwards, but she was stiff for a few seconds. I yelled, "We have a problem here!" The gals helped lay her on the floor. She was only out maybe 30 seconds. When she came to they gave her some lemonade. She was quite weak and it took about 15 minutes for her to regain color and energy. Patient said the first thing she noticed was her vision changing colors and that is why she sat down. Then she became very weak and her vision went black. This is her 4th polio immunization. We have not had anything else happen up to this time.
Age: 16.0
Sex: M
Vaccine: FLU4, MENB, MNQ
Symptoms: Headache, Pain in extremity, Pyrexia
Clinical narrative: Symptoms started occurring about 3 hours after the vaccines. It started with sore arms then lead to headache sore legs and fever.
Age: 65.0
Sex: F
Vaccine: PNC13
Symptoms: Injection site urticaria, Urticaria
Clinical narrative: Patient experiencing hives (localized at injection sight and systemic [legs, feet]) MD prescribed hydroxyzine and triamcinolone four days later.
Age: 64.0
Sex: M
Vaccine: HEPA, VARZOS
Symptoms: Product preparation error
Clinical narrative: Incorrect diluent was used to reconstitute the SHINGRIX vaccine. Instead of using the adjuvant suspension component in the package, the sterile diluent for ZOSTAVAX vaccine was used instead. The CDC recommends redoing the first dose of the vaccine to the customer in four weeks after the failed vaccine administration. Patient and prescriber office was contacted to have the vaccine done on February 6th.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Cold sweat, Diarrhoea, Headache, Injection site erythema
Clinical narrative: Patient experienced: GI side effects (diarrhea, nausea), pain in injection site, redness/swelling in injection site, headache, shivering, cold sweats. Event started a few hours after vaccination was given has continued until now (4 days later). Patient took ibuprofen to help with the pain. She reports symptoms getting better slowly.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site pain, Injection site swelling, Nausea
Clinical narrative: Patient experienced: GI side effects (diarrhea, nausea), pain in injection site, redness/swelling in injection site, headache, shivering, cold sweats. Event started a few hours after vaccination was given has continued until now (4 days later). Patient took ibuprofen to help with the pain. She reports symptoms getting better slowly.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal distension, Chills, Cold sweat, Diarrhoea, Headache
Clinical narrative: Patient experienced: GI side effects (diarrhea, nausea), pain in injection site, redness/swelling in injection site, headache, shivering, cold sweats. Event started a few hours after vaccination was given has continued until now (4 days later). Patient took ibuprofen to help with the pain. She reports symptoms getting better slowly.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Patient experienced: GI side effects (diarrhea, nausea), pain in injection site, redness/swelling in injection site, headache, shivering, cold sweats. Event started a few hours after vaccination was given has continued until now (4 days later). Patient took ibuprofen to help with the pain. She reports symptoms getting better slowly.
Age: 55.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Lethargy, Mobility decreased, Myalgia, Pain, Wrong drug administered
Clinical narrative: Patient experienced: GI side effects (diarrhea, nausea), pain in injection site, redness/swelling in injection site, headache, shivering, cold sweats. Event started a few hours after vaccination was given has continued until now (4 days later). Patient took ibuprofen to help with the pain. She reports symptoms getting better slowly.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Blood glucose normal, Cyanosis, Electroencephalogram abnormal, Epilepsy, Generalised tonic-clonic seizure
Clinical narrative: A few days after the vaccine, patient had a (non-febrile) tonic/clonic seizure, during which he became unresponsive/unconscious for 2-3 minutes, with twitching, and change in color (blueish). He was transported to the hospital via ambulance, during which he regained consciousness, and remained in a post-ictal state for about 30-40 minutes. The hospital did not perform any imaging or bloodwork, other than a blood sugar. Patient saw a neurologist later that week. Patient went on to develop daily seizure activity, and was diagnosed with Epilepsy, via EEG in January. At this time he is on 2 anti-convulsant medications to control his Grand mal seizures, and Myoclonic jerks.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Loss of consciousness, Muscle twitching, Myoclonus, Postictal state, Seizure
Clinical narrative: A few days after the vaccine, patient had a (non-febrile) tonic/clonic seizure, during which he became unresponsive/unconscious for 2-3 minutes, with twitching, and change in color (blueish). He was transported to the hospital via ambulance, during which he regained consciousness, and remained in a post-ictal state for about 30-40 minutes. The hospital did not perform any imaging or bloodwork, other than a blood sugar. Patient saw a neurologist later that week. Patient went on to develop daily seizure activity, and was diagnosed with Epilepsy, via EEG in January. At this time he is on 2 anti-convulsant medications to control his Grand mal seizures, and Myoclonic jerks.
Age: 3.0
Sex: F
Vaccine: FLU4
Symptoms: Unresponsive to stimuli
Clinical narrative: A few days after the vaccine, patient had a (non-febrile) tonic/clonic seizure, during which he became unresponsive/unconscious for 2-3 minutes, with twitching, and change in color (blueish). He was transported to the hospital via ambulance, during which he regained consciousness, and remained in a post-ictal state for about 30-40 minutes. The hospital did not perform any imaging or bloodwork, other than a blood sugar. Patient saw a neurologist later that week. Patient went on to develop daily seizure activity, and was diagnosed with Epilepsy, via EEG in January. At this time he is on 2 anti-convulsant medications to control his Grand mal seizures, and Myoclonic jerks.
Age: 95.0
Sex: M
Vaccine: FLU3
Symptoms: Chills, Pyrexia, Tremor
Clinical narrative: Chills, severe shaking, fever >100F for 2-3 days within 3-4 days after flu shot.
Age: 1.0
Sex: M
Vaccine: MMR
Symptoms: Febrile convulsion, Irritability, Pyrexia, Somnolence
Clinical narrative: On 10/07/17 around 5 am patient had a febrile seizure. His temperature read 104 immediately following his seizure. TYNELOL and MOTRIN were alternated throughout the day to keep his fever down. He was very drowsy and very fussy. He fell asleep on the floor and woke up approximately 30 minutes later. I picked him up and held him in my lap when he had another febrile seizure around 1:00pm. His temperature read 103.5 immediately following the seizure.
Age: 64.0
Sex: M
Vaccine: FLU4, PPV
Symptoms: Discomfort, Injection site erythema, Injection site pain
Clinical narrative: 2.5 - 3" diameter pink area over injection site, mildly tender to touch. 02/02/2018 14:19. Telephone Encounter note. Patient calls to report a "mild reaction" to the PPSV23 vaccine which was given L lower deltoid on 1/30/18. Patient states noting a 2.5-3 inch diameter pink area over the injection site, mildly tender to touch. Denies any difficulty breathing, angioedema or other s/s anaphylaxis. States "It's very minor, just doing what I was told and reporting any reaction." Advised to apply cold compress to alleviate discomfort and that it should resolve within a few days. Agrees to call triage with any worsening sx and to report to local ER or call 911 with my with any sx of anaphylaxis. Sx reviewed, patient verbalizes understanding. Will call writer back on Monday if not resolved. Verbally agrees to have reaction reported to VAERS.
Age: 18.0
Sex: M
Vaccine: HEP, HEPA, MMRV, TDAP
Symptoms: Drug administered to patient of inappropriate age, No adverse event
Clinical narrative: No adverse reaction. Was instructed to fill out since PROQUAD was administered to an 18 year old.
Sex: U
Vaccine: FLU3
Symptoms: Rash
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of rash in a patient who received FLUARIX. In August 2011, the patient received FLUARIX. On an unknown date, unknown after receiving FLUARIX, the patient experienced rash. On an unknown date, the outcome of the rash was unknown. It was unknown if the reporter considered the rash to be related to FLUARIX. Additional details were reported as follows: The age at vaccination was not reported. The patient ?returned to primary care physician (PCP), and told the healthcare professional (HCP) that, the patient had a rash. No other information was provided by the HCP. The HCP did not want to provide further details.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Feeling hot, Influenza, Injection site pain, Middle insomnia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shivering in a 65-year-old female patient who received SHINGRIX. Concurrent medical conditions included chickenpox, measles (twice as a child) and rash (diagnosed a couple of months ago). Concomitant products included Vitamin B12, vitamin D, vitamin E, aspirin, calcium, bupropion XL and nystatin. On 29th January 2018, the patient received the 1st dose of SHINGRIX. On 29th January 2018, less than a day after receiving SHINGRIX, the patient experienced shivering, tremor and nocturnal awakening. On 30th January 2018, the patient experienced feeling of warmth, muscle pain, flu symptoms, pain in arm, general body pain and injection site pain. In January 2018, the outcome of the tremor was recovered/resolved. On 29th January 2018, the outcome of the shivering was recovered/resolved. On an unknown date, the outcome of the feeling of warmth, muscle pain, flu symptoms and pain in arm were not recovered/not resolved and the outcome of the nocturnal awaking, general body pain and injection site pain were unknown. The reporter considered the shivering, feeling of warmth, muscle pain, flu symptoms, tremor and pain in arm to be related to SHINGRIX. It was unknown if the reporter considered the nocturnal awakening, general body pain and injection site pain to be related to SHINGRIX. Additional details were reported as follows: Yesterday at 1:48 PM, the patient received the first dose of SHINGRIX and woke up in the middle of the night and was shivering and shaking uncontrollably. One day after vaccination, the patient experienced feeling of warmth, muscle pain, flu symptoms, pain in arm, general body pain and injection site pain. The patient said that everything felt warm and the shaking and shivering lasted a good 45 minutes before it resolved. On 30th January 2018 the day of reporting, she had a sore right arm and aching all over which she described as flu like aching. The patient's muscles hurt and everything aches. She also experienced a sore right arm at the injection site. The reporter related the symptoms to the SHINGRIX vaccine. Reporter was surprised by her response because she only had two medications that did not agree with her which include Codeine and Lidocaine over the years.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia, Pain, Pain in extremity, Tremor
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of shivering in a 65-year-old female patient who received SHINGRIX. Concurrent medical conditions included chickenpox, measles (twice as a child) and rash (diagnosed a couple of months ago). Concomitant products included Vitamin B12, vitamin D, vitamin E, aspirin, calcium, bupropion XL and nystatin. On 29th January 2018, the patient received the 1st dose of SHINGRIX. On 29th January 2018, less than a day after receiving SHINGRIX, the patient experienced shivering, tremor and nocturnal awakening. On 30th January 2018, the patient experienced feeling of warmth, muscle pain, flu symptoms, pain in arm, general body pain and injection site pain. In January 2018, the outcome of the tremor was recovered/resolved. On 29th January 2018, the outcome of the shivering was recovered/resolved. On an unknown date, the outcome of the feeling of warmth, muscle pain, flu symptoms and pain in arm were not recovered/not resolved and the outcome of the nocturnal awaking, general body pain and injection site pain were unknown. The reporter considered the shivering, feeling of warmth, muscle pain, flu symptoms, tremor and pain in arm to be related to SHINGRIX. It was unknown if the reporter considered the nocturnal awakening, general body pain and injection site pain to be related to SHINGRIX. Additional details were reported as follows: Yesterday at 1:48 PM, the patient received the first dose of SHINGRIX and woke up in the middle of the night and was shivering and shaking uncontrollably. One day after vaccination, the patient experienced feeling of warmth, muscle pain, flu symptoms, pain in arm, general body pain and injection site pain. The patient said that everything felt warm and the shaking and shivering lasted a good 45 minutes before it resolved. On 30th January 2018 the day of reporting, she had a sore right arm and aching all over which she described as flu like aching. The patient's muscles hurt and everything aches. She also experienced a sore right arm at the injection site. The reporter related the symptoms to the SHINGRIX vaccine. Reporter was surprised by her response because she only had two medications that did not agree with her which include Codeine and Lidocaine over the years.
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Fall
Clinical narrative: After one minute of immunization administer patient was speaking and understanding conversation  he fell from exam table. Older brother picked him up screaming his name. I was thinking patient was having a seizure I asked for him to lay back down. Dr. came into room I stepped out to call EMS. EMS arrived and took him to ER.
Sex: F
Vaccine: VARZOS
Symptoms: Influenza like illness, Peripheral swelling
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of swelling arm in a adult female patient who received SHINGRIX. Concomitant products included atenolol, MUCINEX, naproxen, Omega 3, PEPCID, PERCOCET, SYNTHROID, ZOLOFT and Coq10. On 28th January 2018, the patient received SHINGRIX. On 29th January 2018, 1 days after receiving SHINGRIX, the patient experienced swelling arm and influenza-like symptoms. On an unknown date, the outcome of the swelling arm was not recovered/not resolved and the outcome of the influenza-like symptoms was recovered/resolved. The reporter considered the swelling arm and influenza-like symptoms to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient experienced a lot of swelling on her arm and the swelling had gotten bigger at approximately 4 inches in diameter.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect route of drug administration, Injection site rash, Product administered at inappropriate site
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of injection site rash in a 66-year-old female patient who received SHINGRIX (batch number 3Z4KL, expiry date unknown). On 31st January 2018, the patient received the 1st dose of SHINGRIX (subcutaneous). On 31st January 2018, unknown after receiving SHINGRIX, the patient experienced intramuscular formulation administered by other route and vaccine administered at inappropriate site. On an unknown date, the patient experienced injection site rash. On an unknown date, the outcome of the injection site rash, intramuscular formulation administered by other route and vaccine administered at inappropriate site were unknown. It was unknown if the reporter considered the injection site rash to be related to SHINGRIX. Additional details were provided as follows: The age at vaccination was not reported. A dose of SHINGRIX was inadvertently administered subcutaneously in the upper left arm of the patient, instead of the intended left deltoid, which led to inappropriate route of vaccination and vaccine administered at inappropriate site. In 2018, less than a week after receiving SHINGRIX, the patient developed a rash at the injection site. The expiration date was unknown. The patient did not require an emergency room visit or medical intervention. The healthcare professional did not believe the rash was life threatening, or disabling, and the patient did not require hospitalization.
Age: 77.0
Sex: M
Vaccine: VARZOS
Symptoms: Erythema, Skin warm, Tenderness
Clinical narrative: This case was reported by a dentist and described the occurrence of erythema of extremities in a patient who received SHINGRIX. On an unknown date, the patient received SHINGRIX at an unknown dose. On an unknown date, less than a week after receiving SHINGRIX, the patient experienced erythema of extremities, tenderness and skin warm. On an unknown date, the outcome of the erythema of extremities, tenderness and skin warm were unknown. It was unknown if the reporter considered the erythema of extremities, tenderness and skin warm to be related to SHINGRIX. Additional details were reported as follows: The age at vaccination was not reported. The patient received the shingles vaccine two days ago and now had a very large red area on the arm that was tender to touch and warm. The patient had no other problem from the injection. The reporter wanted to know was there a problem with taking the second dose after 8 weeks.