chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 67.0
Sex: F
Vaccine: PPV, VARZOS
Symptoms: Erythema, Extensive swelling of vaccinated limb, Feeling hot, Injection site pain
Clinical narrative: arm swelling; Injection site pain; redness; heat to the touch from her elbow to her shoulder; This case was reported by a consumer via call center representative and described the occurrence of extensive swelling of vaccinated limb in a 67-year-old female patient who received Herpes zoster (SHINGRIX) for prophylaxis.   Co-suspect products included PNEUMONIA VACCINE for prophylaxis.   On 28th July 2020, the patient received the 1st dose of SHINGRIX and PNEUMONIA VACCINE. On 28th July 2020, less than an hour after receiving SHINGRIX, the patient experienced extensive swelling of vaccinated limb, injection site pain, erythema and feeling hot. The patient was treated with ibuprofen and non-drug therapy (Cold Compress). On 30th July 2020, the outcome of the extensive swelling of vaccinated limb, injection site pain, erythema and feeling hot were recovered/resolved.   It was unknown if the reporter considered the extensive swelling of vaccinated limb, injection site pain, erythema and feeling hot to be related to SHINGRIX.  Additional details were reported as follows: The patient received a dose of SHINGRIX and pneumonia vaccine in her left arm on the same day. She stated that she developed injection site pain, arm swelling, redness and heat to the touch from her elbow to her shoulder within one hour of receiving these vaccines.  The symptoms resolved two days later after she treated herself with ibuprofen and cold compresses.  The reporter had no information for the pneumonia vaccine. The reporter consented to follow up.
Age: 14.0
Sex: F
Vaccine: DTAP, TDAP
Symptoms: No adverse event, Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 14 year old patient was given Infanrix instead of Adacel/ NO AE; Initial information received on 21-Sep-2020 regarding an unsolicited valid non-serious case from a other health professional .  This case involves a 14-years-old female patient who received once dose of DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR 3-COMPONENT, TETANUS VACCINE TOXOID [INFANRIX] (lot number: G5BE3, expiry date: 25-May-2021, via an unknown route in the left deltoid instead of DIPHTHERIA-2/TETANUS/5 AC PERTUSSIS VACCINE [ADACEL] (lot number, expiry date not reported) (wrong product administered) on 16-Sep-2020 for prophylactic vaccination.  The patient's medical history, past medical treatment, and family history were not provided. There was no history of vaccination prior to this dose.  No concomitant medications or no other vaccines were used.  It was an actual medication error case due to wrong vaccine administered.(latency: same day)  At the time of reporting, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 17.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 17 year old received Flublok vaccine with no adverse event; Initial information received on 29-Sep-2020 regarding an unsolicited valid non-serious case received from a pharmacist.  This case involves a 17 years old female patient who received 0.5 ml once INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (lot number: QFAA2028, expiry date: 30-Jun-2021) via un unknown route on left arm on 24-Sep-2020 for prophylactic vaccination (product administered to patient of inappropriate age).  The patient's medical history, medical treatments, concomitant therapy, vaccinations and family history were not provided. No other vaccines were administered.  It was an actual medication error case due to Inappropriate age at vaccine administration. (latency: same day)  At the time of report, no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 77.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Rash pruritic
Clinical narrative: LARGE ITCHY RASH COVERING LARGE PORTION OF ARM, SAW DR. WHO GAVE HER CEPHALEXIN ON 9/24/20 AS PRECAUTION/SHE STATES THE RASH IS WITH NO FUTHER ISSUES.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity, Pyrexia
Clinical narrative: sore arm, fever aches
Age: 14.0
Sex: F
Vaccine: FLU4
Symptoms: Dizziness, Loss of consciousness, Nausea, Syncope
Clinical narrative: Fainted the next morning after doing yoga. Was dizzy and nauseous.  Woke up laying  on floor. Passed  out
Age: 65.0
Sex: M
Vaccine: VARZOS
Symptoms: Nerve conduction studies, Neuropathy peripheral, Ultrasound Doppler
Clinical narrative: Terrible neuropathy in both feet that has not gone away. Have had bloodflow and nerve tests.  The neuropathy is definitely nerve-related.  Am taking 3600 mg of gabapentin to try to sleep.  I did not have anything before this!  Unfortunately it is not abating.
Age: 5.0
Sex: F
Vaccine: MMRV
Symptoms: Neck mass, Urticaria
Clinical narrative: Lump under left check on neck, hives face, neck, ears, chest arms etc. going on a week
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dyspnoea, Hypersensitivity, Nasal congestion, Pharyngeal swelling
Clinical narrative: Severe allergic reaction - swollen face, neck, nose, throat.  Had trouble breathing around 1 am. She felt like her nose was stuffy. She developed chills and started gasping for breath. Patient waited until 4 am and contact daughter. Daughter took her to emergency room at 4 am and she was sent home at 8:30am. She was treated for an allergic reaction in the emergency room with IV benadryl, epinephrine, and prednisone.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling, Swelling face
Clinical narrative: Severe allergic reaction - swollen face, neck, nose, throat.  Had trouble breathing around 1 am. She felt like her nose was stuffy. She developed chills and started gasping for breath. Patient waited until 4 am and contact daughter. Daughter took her to emergency room at 4 am and she was sent home at 8:30am. She was treated for an allergic reaction in the emergency room with IV benadryl, epinephrine, and prednisone.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Abdominal pain, Cataract, Cataract operation, Cholecystectomy, Cough
Clinical narrative: cataract surgery on right eye; shingles out break in; chronic cough and throat issue; Throat issue; swallowing issues; gall bladder disorder; shingles outbreak / at the instrument insertion site /  in her eye following that surgery; chronic abdominal pain; shingles outbreak  in October of 2019 / shingles out break in her eye; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (diagnosed in 2003 and had shingles outbreaks since then every 2-3 months). Concurrent medical conditions included drug allergy (patient was allergic to many different medications).   In April 2019, the patient received the 1st dose of Shingrix. In September 2019, the patient received the 2nd dose of Shingrix. In October 2019, between 5 and 7 months after receiving Shingrix and less than 2 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and chronic abdominal pain. On an unknown date, the patient experienced cataract (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant), chronic cough, throat discomfort, swallowing difficult and gallbladder disorder. On an unknown date, the outcome of the vaccination failure, cataract, ophthalmic herpes zoster, shingles, chronic abdominal pain, chronic cough, throat discomfort, swallowing difficult and gallbladder disorder were unknown.   It was unknown if the reporter considered the vaccination failure, cataract, ophthalmic herpes zoster, shingles, chronic abdominal pain, chronic cough, throat discomfort, swallowing difficult and gallbladder disorder to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient had a medical history of shingles, diagnosed in 2003, and had shingles outbreaks since then every 2-3 months.  The patient received dose 1 of Shingrix in April of 2019.  With the dose 1 of Shingrix she developed a large rash at the injection site two days after receiving the vaccine, and this rash lasted for 4 days and resolved.  The patient received dose 2 of Shingrix in September 2019 and in October 2019 she had gall bladder removal surgery and had chronic abdominal pain of unknown origin since October of 2019. She stated that she had a shingles outbreak in October of 2019 at the instrument insertion site for her gall bladder surgery.  The patient underwent cataract surgery on her right eye 24th June 2020 and had a shingles out break in her eye following that surgery. The patient stated she had a chronic cough and throat issue following a surgical procedure, unknown date of this procedure.  The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020193845:same patient, same reporter, different dose
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Oropharyngeal discomfort, Vaccination failure
Clinical narrative: cataract surgery on right eye; shingles out break in; chronic cough and throat issue; Throat issue; swallowing issues; gall bladder disorder; shingles outbreak / at the instrument insertion site /  in her eye following that surgery; chronic abdominal pain; shingles outbreak  in October of 2019 / shingles out break in her eye; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (diagnosed in 2003 and had shingles outbreaks since then every 2-3 months). Concurrent medical conditions included drug allergy (patient was allergic to many different medications).   In April 2019, the patient received the 1st dose of Shingrix. In September 2019, the patient received the 2nd dose of Shingrix. In October 2019, between 5 and 7 months after receiving Shingrix and less than 2 months after receiving Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and chronic abdominal pain. On an unknown date, the patient experienced cataract (serious criteria GSK medically significant), ophthalmic herpes zoster (serious criteria GSK medically significant), chronic cough, throat discomfort, swallowing difficult and gallbladder disorder. On an unknown date, the outcome of the vaccination failure, cataract, ophthalmic herpes zoster, shingles, chronic abdominal pain, chronic cough, throat discomfort, swallowing difficult and gallbladder disorder were unknown.   It was unknown if the reporter considered the vaccination failure, cataract, ophthalmic herpes zoster, shingles, chronic abdominal pain, chronic cough, throat discomfort, swallowing difficult and gallbladder disorder to be related to Shingrix and Shingrix.  Additional details were provided as follows: The patient had a medical history of shingles, diagnosed in 2003, and had shingles outbreaks since then every 2-3 months.  The patient received dose 1 of Shingrix in April of 2019.  With the dose 1 of Shingrix she developed a large rash at the injection site two days after receiving the vaccine, and this rash lasted for 4 days and resolved.  The patient received dose 2 of Shingrix in September 2019 and in October 2019 she had gall bladder removal surgery and had chronic abdominal pain of unknown origin since October of 2019. She stated that she had a shingles outbreak in October of 2019 at the instrument insertion site for her gall bladder surgery.  The patient underwent cataract surgery on her right eye 24th June 2020 and had a shingles out break in her eye following that surgery. The patient stated she had a chronic cough and throat issue following a surgical procedure, unknown date of this procedure.  The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020193845:same patient, same reporter, different dose
Sex: U
Vaccine: FLUX
Symptoms: Illness
Clinical narrative: got sooooo sick; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received the 1st dose of Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced sickness. On an unknown date, the outcome of the sickness was unknown.   It was unknown if the reporter considered the sickness to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The age at vaccination was not reported. The reporter stated that only time he or she took the flu shot and he or she got sick.
Sex: F
Vaccine: VARZOS
Symptoms: Injection site haemorrhage
Clinical narrative: began to bleed from the injection site; This case was reported by a pharmacist via call center representative and described the occurrence of injection site hemorrhage in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number Y7JL5, expiry date 13th May 2022) for prophylaxis.   On 26th September 2020, the patient received the 1st dose of Shingrix (intramuscular). On 26th September 2020, immediately after receiving Shingrix, the patient experienced injection site hemorrhage. On 26th September 2020, the outcome of the injection site hemorrhage was recovered/resolved.   It was unknown if the reporter considered the injection site hemorrhage to be related to Shingrix.  Additional details were reported as follows: The age at vaccination was not reported. The patient received dose of Shingrix via intramuscular in the left deltoid. Immediately after the needle was withdrawn the patient began to bleed from the injections site, a band aid was applied and the bleeding had stopped by the time the patient returned to home. The reporter did not consent to follow up.
Age: 84.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Fever/fever of 99.0 F; Pain/Soreness; This case was reported by a consumer via call center representative and described the occurrence of fever in a 84-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th September 2020, the patient received the 1st dose of Shingrix (intramuscular). On 28th September 2020, less than a day after receiving Shingrix, the patient experienced fever and pain. The patient was treated with paracetamol (Tylenol). On an unknown date, the outcome of the fever was not recovered/not resolved and the outcome of the pain was unknown.   It was unknown if the reporter considered the fever and pain to be related to Shingrix.  Additional details were provided as follows:  The patient experienced pain and fever after first Shingrix vaccine. The reporter stated, the soreness started after receiving the injection. On 29th September 2020, the patient experienced fever of 99.0 degree F The patient has taken Tylenol, but the fever has not disappeared. All information was not available. The reporter did not consent to follow-up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Fatigue, Headache, Injection site pain, Injection site ulcer
Clinical narrative: ulcer developed at injection site; ulcer developed at injection site which is painful to the touch; Blisters; fatigue; muscle pain; headache; This case was reported by a other health professional via call center representative and described the occurrence of injection site ulcer in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th September 2020, the patient received the 2nd dose of Shingrix. In September 2020, less than a week after receiving Shingrix, the patient experienced injection site ulcer, injection site pain, blister, fatigue, muscle pain and headache. The patient was treated with valaciclovir (Valacyclovir) and dermatologicals nos (Ointment). On an unknown date, the outcome of the injection site ulcer, injection site pain, blister, fatigue, muscle pain and headache were unknown.   It was unknown if the reporter considered the injection site ulcer, injection site pain, blister, fatigue, muscle pain and headache to be related to Shingrix.  Additional details were provided as follows:  The patient had blisters after shingrix shot. The patient experienced ulcer developed at injection site which was painful to the touch, fatigue, headache and muscle pain. The patient received treatment Valcyclovir and (unknown) ointment. When asked for batch number, expiration date, number of dose and date of vaccination the health care professional stated she was not aware of this details. The reporter consented to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: ulcer developed at injection site; ulcer developed at injection site which is painful to the touch; Blisters; fatigue; muscle pain; headache; This case was reported by a other health professional via call center representative and described the occurrence of injection site ulcer in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th September 2020, the patient received the 2nd dose of Shingrix. In September 2020, less than a week after receiving Shingrix, the patient experienced injection site ulcer, injection site pain, blister, fatigue, muscle pain and headache. The patient was treated with valaciclovir (Valacyclovir) and dermatologicals nos (Ointment). On an unknown date, the outcome of the injection site ulcer, injection site pain, blister, fatigue, muscle pain and headache were unknown.   It was unknown if the reporter considered the injection site ulcer, injection site pain, blister, fatigue, muscle pain and headache to be related to Shingrix.  Additional details were provided as follows:  The patient had blisters after shingrix shot. The patient experienced ulcer developed at injection site which was painful to the touch, fatigue, headache and muscle pain. The patient received treatment Valcyclovir and (unknown) ointment. When asked for batch number, expiration date, number of dose and date of vaccination the health care professional stated she was not aware of this details. The reporter consented to follow up.
Age: 72.0
Sex: F
Vaccine: FLUX
Symptoms: Insomnia, Pain, Pain in extremity
Clinical narrative: It was a flu shot. Left arm was sore the next day, pain traveled up the arm into the shoulder and neck.  Pain worsened, and now I have shooting pain when raising the arm and have difficulting sleeping or turning over in bed due to the pain.
Age: 67.0
Sex: M
Vaccine: FLUA4
Symptoms: Extra dose administered, No adverse event
Clinical narrative: Patient was given a second flu shot at a flu clinic that was conducted by pharmacist at a pharmacy at a school Patient asked for flu and shingles shot and was explained by pharmacist that flu would go in left and shingles in right and after administering flu in left arm patient told pharmacist that he already got his flu shot 2 months ago. pharmacist verified after getting back to store that patient had his flu shot 2 weeks before at another store.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Gait disturbance, Injection site induration, Injection site swelling
Clinical narrative: Patient received the flu vaccination on 10/3/2020 and called doctor on 10/4/2020 about swelling on the upper left leg, thigh felt hard, no redness, limping on the left leg 2 hours after received vaccine. Patient was seen in the office on 10/5/20 with swelling on the left thigh and limping on the left leg still.
Age: 20.0
Sex: F
Vaccine: DTAPIPVHIB
Symptoms: No adverse event, Vaccination error
Clinical narrative: No adverse reaction reported after injection.  Vaccine given in error
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: Fever (99.5), chills, aches
Age: 53.0
Sex: F
Vaccine: FLUC4, VARZOS
Symptoms: Asthenia, Headache, Myalgia, Nausea, Somnolence
Clinical narrative: Horrible headache, nausea, sleepy/weakness and muscle aches.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous, Rash pruritic, Rash vesicular
Clinical narrative: 3 DAYS POST VACCINATION PATIENT BROKE OUT INTO A CHICKEN POX LIKE RASH ALL OVER TRUNK AND EXTREMITIES SUPER ITCHY RED BUMPS, WAS NOT EXPOSED TO ANYTHING ELSE, NOR HAD IT BEFORE. NO OTHER ALLERGENS OR IRRITANT EXPOSURE
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Dizziness, Hypotonia, Immediate post-injection reaction, Loss of consciousness, Nausea
Clinical narrative: Immediately after receiving his 4th shot, Gardasil 9, patient went unconscious, closed his eyes and began to drift backward.  He went limp and began to slide off the table.  His father and I held him and he began to shake.  We placed him in a chair.  After 30 seconds, he regained consciousness and asked what happened.  He then turned white and vomited on the floor.  He continued to have nausea and lightheadedness for 10 minutes until he recovered.   The order of vaccine administration was Menactra first, Fluzone second, both in right arm, then Adacel third and Gardasil last, in left arm.  He was fine after the first 3 shots.
Age: 11.0
Sex: M
Vaccine: FLU4, HPV9, MNQ, TDAP
Symptoms: Pallor, Tremor, Vomiting
Clinical narrative: Immediately after receiving his 4th shot, Gardasil 9, patient went unconscious, closed his eyes and began to drift backward.  He went limp and began to slide off the table.  His father and I held him and he began to shake.  We placed him in a chair.  After 30 seconds, he regained consciousness and asked what happened.  He then turned white and vomited on the floor.  He continued to have nausea and lightheadedness for 10 minutes until he recovered.   The order of vaccine administration was Menactra first, Fluzone second, both in right arm, then Adacel third and Gardasil last, in left arm.  He was fine after the first 3 shots.
Age: 34.0
Sex: F
Vaccine: FLU4
Symptoms: Lethargy, Somnolence
Clinical narrative: Lethargy (unable to wake up for more than 10-15 minutes) for 48 hours
Age: 6.0
Sex: M
Vaccine: FLU4
Symptoms: Vaccination site swelling
Clinical narrative: excessive swelling at vaccine site. Mother states she didn't look at it last night, but noticed it this morning. Mom states is is about 2.5 to 3 inches in circumference and about 1/2 inch raised. No discoloration and minor soreness described. Mom called their family practice provider and was instructed to put ice on. Patient has not complain of pain or discomfort.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Erythema, Haematoma, Immediate post-injection reaction, Injection site erythema, Injection site swelling
Clinical narrative: Within seconds of administration Left full arm redness/significant swelling/ warm to touch extending to the full length and circumference of the arm, throat scratching. Administered Zantac/Benedryl/Ibuprofen/?steroids immediately and continued for 4-5 days. Swelling improved over the course of the week, leaving several large hematomas to the L arm from all of the swelling for several weeks to follow.
Age: 36.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site warmth, Peripheral swelling, Skin warm, Throat irritation
Clinical narrative: Within seconds of administration Left full arm redness/significant swelling/ warm to touch extending to the full length and circumference of the arm, throat scratching. Administered Zantac/Benedryl/Ibuprofen/?steroids immediately and continued for 4-5 days. Swelling improved over the course of the week, leaving several large hematomas to the L arm from all of the swelling for several weeks to follow.
Age: 22.0
Sex: F
Vaccine: FLU4
Symptoms: Injection site pain, Injection site reaction, Musculoskeletal stiffness, Pain, Pain in extremity
Clinical narrative: Phone call with patient on 10/06/2020. called in with complaint of sore left arm. She states initial administration of vaccine felt "normal", but noticed soreness in left arm "a few hours later". She states feeling is characterized as stiff, dull pain on "side" of arm approximated with the center of the lateral deltoid muscle. She specifically states that pain is not at the "top" of shoulder, but is localized approximately 2 to 3 inches "down" from peak of shoulder girdle. She states pain is worsened upon movement, particularly when raising arm above head. She states she initially took ibuprofen approximately 09/28/2020, but only took once as she characterizes herself as a "tough it out" person. She states she also sleeps on her left side and regularly lifts and carries a heavy backpack for school, which she believes may be contributing to the continuation of soreness. I recommended rest of afflicted arm, cool/warm therapy, and NSAID therapy if NSAIDs are approved by her primary care doctor.  states she plans to make an appointment with Dr. at Hospital to have left arm evaluated.  During follow-up phone call on 10/06/2020  states that she was previously vaccinated with flu vaccine at primary care doctor's office at  Hospital in January 2020 after returning home from studying abroad. She states that the medical professional who gave the vaccine seemed "unsure" of how to administer vaccine, and states that during and shortly after vaccination in January 2020 her left arm "didn't feel right", but at the time did not have any unusual pain or soreness in arm other than "any other vaccine."
Age: 91.0
Sex: F
Vaccine: FLU4
Symptoms: Abnormal behaviour, Confusional state, Feeling hot, Pain
Clinical narrative: Patient's son called and said she was achy, hot, and "loopy" the afternoon of the immunization.  She seemed confused; she prepared 6 cups of coffee instead of her normal one.  She was fine the next morning.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Headache, Nausea, Pain, Pain in extremity
Clinical narrative: Headache, general arm soreness, body soreness, fatigue, nausea
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Chills, Cough, Headache, Hyperhidrosis
Clinical narrative: Tightness in my chest, wheezing and coughing. Soar throat and itchy feeling. Head and body aches, chills and sweats. Extreme Nausea. This lasted for 12 hours.
Age: 31.0
Sex: F
Vaccine: FLU4
Symptoms: Nausea, Oropharyngeal pain, Pain, Pruritus, Wheezing
Clinical narrative: Tightness in my chest, wheezing and coughing. Soar throat and itchy feeling. Head and body aches, chills and sweats. Extreme Nausea. This lasted for 12 hours.
Age: 0.25
Sex: M
Vaccine: DTAPIPVHIB, HEP, PNC13, RV1
Symptoms: Incomplete course of vaccination, Product preparation issue
Clinical narrative: Registry assessed. Child due for 2 month immunizations. I chose Pentacel combination vaccine for Dtap/IPV/Hib. However, I did not reconstitute and administed only DTaP and IPV. Child had no immediate adverse reaction. However, I acknowledge that this is a vaccine administration error. Child needs to be immunized for Hib. Supervisor notified of error.
Age: 4.0
Sex: M
Vaccine: FLU4
Symptoms: Peripheral swelling
Clinical narrative: arm swelled from shoulder to elbow. Worsened greatly on October 2nd. Started getting better on October 3rd.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure / shingles in the vaginal area after receiving the second dose of Shingrix; vaginal shingles / shingles in the vaginal area; This case was reported by a other health professional via sales rep and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that female patient had vaginal shingles after administration of Shingrix. Occurred a week ago with no exact date informed. The reporter consented to follow up.  No patient's identifiers, batch number or vaccines expiration date. No vaccination date informed. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event, and laboratory confirmation were not provided. The case has been linked with the case US2020196134 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020196134:Same reporter
Sex: M
Vaccine: FLUX
Symptoms: Influenza, Malaise, Vaccination failure, Vaccine positive rechallenge
Clinical narrative: every year he got deathly ill from the flu/suspected vaccination failure; every year he got deathly ill from the flu; every year he got deathly ill from the flu; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, less than a year after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza and unwell. On an unknown date, the outcome of the vaccination failure, influenza and unwell were unknown.   It was unknown if the reporter considered the vaccination failure, influenza and unwell to be related to Influenza vaccine Quadrivalent unspecified season.  Additional details were reported as follows: The case was reported by patient's wife. The age at vaccination was not reported. The patient was forced to take a flu shot and every year he got deathly ill from the flu. When he retired he swore he would never take another shot and  after that he did not had the flu once.  This case was considered as suspected vaccination failure as details regarding vaccination schedule, time to onset for target disease and laboratory confirmation were unknown at the time of reporting. Seven separate cases were created according to seasons of flu vaccine however confirmation received from safety vac to consider only 1 case for same patient. Hence cases US2020AMR197708, US2020AMR197691, US2020AMR197692, US2020AMR197693, US2020AMR197694, US2020AMR197695 will be deleted (created in error) and all the future correspondence be add  in case US2020AMR197689 which will be retained in argus for this patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR197691:Same reporter US-GLAXOSMITHKLINE-US2020AMR197692:Same reporter US-GLAXOSMITHKLINE-US2020AMR197693:Same reporter US-GLAXOSMITHKLINE-US2020AMR197694:Same reporter US-GLAXOSMITHKLINE-US2020AMR197695:Same reporter US-GLAXOSMITHKLINE-US2020AMR197708:Same reporter
Sex: F
Vaccine: MEN
Symptoms: Loss of personal independence in daily activities, Mobility decreased, Seizure
Clinical narrative: Seizures; she could walk the 2nd night; she has been out of school all week; This case was reported by a consumer via interactive digital media and described the occurrence of seizure in a female patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced seizure (serious criteria GSK medically significant), mobility decreased and activities of daily living impaired. On an unknown date, the outcome of the seizure, mobility decreased and activities of daily living impaired were unknown.   It was unknown if the reporter considered the seizure, mobility decreased and activities of daily living impaired to be related to Meningococcal B vaccine.  Additional case details were reported as follows: The reporter was patient's parent. The age at vaccination was not reported. The patient was out of school all week because of vaccination and she could walk the 2nd night and her medications were not keeping her from having seizures. The follow up was not required.
Sex: F
Vaccine: FLUX
Symptoms: Death, Underdose
Clinical narrative: died; Underdose; This case was reported by a consumer via interactive digital media and described the occurrence of unknown cause of death in a female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced unknown cause of death (serious criteria death and GSK medically significant) and underdose. On an unknown date, the outcome of the unknown cause of death was fatal and the outcome of the underdose was unknown. The reported cause of death was unknown cause of death.   It was unknown if the reporter considered the unknown cause of death to be related to Flu vaccine.  Additional case details were reported as follows: The reporter was patient's grandchild. The age at vaccination was not reported. The patient received her first half flu shot, which led to underdose. On an unknown date patient was died. This was a medication error with harm. The follow up was not required.; Reported Cause(s) of Death: Unknown cause of death
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Groin pain, Inappropriate schedule of product administration, Injection site pain, Musculoskeletal pain
Clinical narrative: RA; pain presented in the hips,glutes, buttocks, hamstrings, thighs and groin areas. YOo It then spread to the left shoulder and neck.; she was in a wheelchair; 1st dose in October 2019 / second dose was administered on 8/17/2020; This case was reported by a consumer via call center representative and described the occurrence of rheumatoid arthritis in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number NZ4ZJ, expiry date 31st May 2022) for prophylaxis.   The patient's past medical history included rotator cuff repair. Previously administered products included Shingrix (1st dose received on 1st October 2019, No adverse reactions reported for this dose).   On 17th August 2020, the patient received the 2nd dose of Shingrix. On 17th August 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. In September 2020, the patient experienced neck pain (serious criteria hospitalization), pain in hip (serious criteria hospitalization), buttock pain (serious criteria hospitalization), pain in thigh (serious criteria hospitalization), groin pain (serious criteria hospitalization) and wheelchair user. On 23rd September 2020, the patient experienced rheumatoid arthritis (serious criteria hospitalization and GSK medically significant). The patient was treated with analgesic, nos (Pain Killer) and steroids nos (Steroids). On an unknown date, the outcome of the rheumatoid arthritis was not recovered/not resolved and the outcome of the neck pain, pain in hip, buttock pain, pain in thigh and groin pain were recovering/resolving and the outcome of the wheelchair user was recovered/resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the rheumatoid arthritis, neck pain, pain in hip, buttock pain, pain in thigh, groin pain and wheelchair user to be related to Shingrix.  Additional information was provided as follows: The patient received 2nd dose later than the recommended interval, which led to lengthening of vaccination schedule. In the beginning of September 2020, severe pain presented in the hips,glutes, buttocks, hamstrings, thighs and groin areas.  It then spread to the left shoulder and neck. The patient was treated in the ER several times.  The dates provided were 12th,13th 18th and 19th September 2020.  She received IV fluids, pain killers and steroids during those visits. She was admitted to the hospital for one overnight stay on 23rd September 2020 and was diagnosed with rheumatoid arthritis at that time. The pain was so extreme that she was in a wheelchair for a few weeks.  She said on a scale from 1 to 10, the pain was a 15.  The pain had improved.  She was currently on day 7 of 20mg of a steroid. The reporter consented to follow up. The batch number was updated from NZ4ZJ to NZ4ZJ as per sales data sheet.
Age: 60.0
Sex: F
Vaccine: VARZOS
Symptoms: Neck pain, Pain in extremity, Rheumatoid arthritis, Wheelchair user
Clinical narrative: RA; pain presented in the hips,glutes, buttocks, hamstrings, thighs and groin areas. YOo It then spread to the left shoulder and neck.; she was in a wheelchair; 1st dose in October 2019 / second dose was administered on 8/17/2020; This case was reported by a consumer via call center representative and described the occurrence of rheumatoid arthritis in a 60-year-old female patient who received Herpes zoster (Shingrix) (batch number NZ4ZJ, expiry date 31st May 2022) for prophylaxis.   The patient's past medical history included rotator cuff repair. Previously administered products included Shingrix (1st dose received on 1st October 2019, No adverse reactions reported for this dose).   On 17th August 2020, the patient received the 2nd dose of Shingrix. On 17th August 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. In September 2020, the patient experienced neck pain (serious criteria hospitalization), pain in hip (serious criteria hospitalization), buttock pain (serious criteria hospitalization), pain in thigh (serious criteria hospitalization), groin pain (serious criteria hospitalization) and wheelchair user. On 23rd September 2020, the patient experienced rheumatoid arthritis (serious criteria hospitalization and GSK medically significant). The patient was treated with analgesic, nos (Pain Killer) and steroids nos (Steroids). On an unknown date, the outcome of the rheumatoid arthritis was not recovered/not resolved and the outcome of the neck pain, pain in hip, buttock pain, pain in thigh and groin pain were recovering/resolving and the outcome of the wheelchair user was recovered/resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the rheumatoid arthritis, neck pain, pain in hip, buttock pain, pain in thigh, groin pain and wheelchair user to be related to Shingrix.  Additional information was provided as follows: The patient received 2nd dose later than the recommended interval, which led to lengthening of vaccination schedule. In the beginning of September 2020, severe pain presented in the hips,glutes, buttocks, hamstrings, thighs and groin areas.  It then spread to the left shoulder and neck. The patient was treated in the ER several times.  The dates provided were 12th,13th 18th and 19th September 2020.  She received IV fluids, pain killers and steroids during those visits. She was admitted to the hospital for one overnight stay on 23rd September 2020 and was diagnosed with rheumatoid arthritis at that time. The pain was so extreme that she was in a wheelchair for a few weeks.  She said on a scale from 1 to 10, the pain was a 15.  The pain had improved.  She was currently on day 7 of 20mg of a steroid. The reporter consented to follow up. The batch number was updated from NZ4ZJ to NZ4ZJ as per sales data sheet.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: suspected Vaccination failure / have shingles in the vaginal area after receiving the second dose of Shingrix; vaginal shingles / have shingles in the vaginal area; This case was reported by a other health professional via sales rep and described the occurrence of suspected vaccination failure in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. It was reported that female patient had vaginal shingles after administration of Shingrix occurred a week ago with no exact date informed. The reporter consented to follow up.  No patient's identifiers, batch number or vaccines expiration date. No vaccination date informed. This case was considered as suspected vaccination failure, since the details regarding the time to onset for event, and laboratory confirmation were not provided. The case has been linked with the case US2020AMR197665 reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR197665:Same reporter
Age: 76.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Urinary incontinence
Clinical narrative: Fever; urinary incontinence; This case was reported by a other health professional via call center representative and described the occurrence of fever in a 76-year-old female patient who received Herpes zoster (Shingrix) (batch number K735H, expiry date 13th September 2022) for prophylaxis.   On 28th September 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. In September 2020, less than a day after receiving Shingrix, the patient experienced urinary incontinence. On 28th September 2020, the patient experienced fever. On 30th September 2020, the outcome of the fever and urinary incontinence were recovered/resolved.   It was unknown if the reporter considered the fever and urinary incontinence to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. After receiving the vaccine later that night, she began to experience a fever. When she stood up to go to the bathroom, she had an episode of urinary incontinence. She also had a second episode of incontinence around 3 am the next morning.  As of 1st October 2020, her symptoms have resolved. The reporter did not consent to follow up.
Age: 32.0
Sex: F
Vaccine: MENB
Symptoms: Condition aggravated, Neuromyelitis optica spectrum disorder
Clinical narrative: Hospitalized for a neuromyelitis optica flareup; This case was reported by a consumer via call center representative and described the occurrence of neuromyelitis optica in a 32-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   The patient's past medical history included myelitis transverse. Concurrent medical conditions included neuromyelitis optica spectrum disorder and anti-aquaporin-4 antibody.   On 11th September 2020, the patient received the 1st dose of Bexsero. In September 2020, less than a week after receiving Bexsero, the patient experienced neuromyelitis optica (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the neuromyelitis optica was unknown.   It was unknown if the reporter considered the neuromyelitis optica to be related to Bexsero.  Additional case details were reported as follows: The patient reported case for herself. She stated that on Sunday, 13th September 2020, she was hospitalized for a neuromyelitis optica flareup. All information was not available. The reporter did not consent to follow up.
Sex: M
Vaccine: FLUX
Symptoms: Guillain-Barre syndrome, Paralysis
Clinical narrative: took a flu shot and got Guillen barre syndrome from it.; paralyzed from the neck down; This case was reported by a consumer via interactive digital media and described the occurrence of guillain barre syndrome in a male patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent unspecified season) for prophylaxis.   On an unknown date, the patient received Influenza vaccine Quadrivalent unspecified season. On an unknown date, unknown after receiving Influenza vaccine Quadrivalent unspecified season, the patient experienced guillain barre syndrome (serious criteria GSK medically significant) and paralysis (serious criteria GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome and paralysis were unknown.   It was unknown if the reporter considered the guillain barre syndrome and paralysis to be related to Influenza vaccine Quadrivalent unspecified season.  Additional case details were reported as follows: The case was reported by patient's daughter. The age at vaccination was not reported. The patient took a flu shot and got Guillen barre syndrome from it. He was paralyzed from the neck down. The physician told him never take another shot. The follow up was not required. This is 1 of the 9 link cases, reported by same reporter.
Age: 15.0
Sex: M
Vaccine: FLU4
Symptoms: Asthenia, Dizziness, Pallor
Clinical narrative: within minutes of receiving the vaccine patient started feeling weak and like he was going to pass out. His skin coloring visibly lightened. We took him outside, removed his mask, had him sit down. His parents authorized giving him 50mg of liquid Benadryl. Within a few more minutes his normal coloring returned and he started feeling better. His parents wanted to take him home. I advised they call his MD immediately. They did and had a telehealth visit. By the afternoon patient was completely back to normal.
Age: 39.0
Sex: F
Vaccine: FLU4
Symptoms: Rash, Swelling, Urticaria
Clinical narrative: Swelling , Rash, Hives
Age: 81.0
Sex: F
Vaccine: PPV
Symptoms: Rash
Clinical narrative: RASH SPREAD OVER ENTIRE LEFT ARM, SUBSIDED AFTER 2 DAYS
Age: 12.0
Sex: F
Vaccine: DTAP, MNQ
Symptoms: Pallor, Paraesthesia
Clinical narrative: pale, tingling in arms
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Impaired work ability, Injection site erythema, Injection site pain
Clinical narrative: Starting at midnight 11 hours after receiving immunization patient experienced 4 hours of uncontrollable chills/shaking (6 blankets didn't help), followed by intermittent shaking next 24 hours. Patient experienced grade 3 injection site redness >100mm, pain grade 3 severe lasting 72 hours, myalgia grade 3 prevented ADL 48 hour, fatigue grade 3 prevented ADL 72 hour, malaise grade 3 prevented ADL 72 hours. Patient missed work (RN) due to adverse effects and spent time in bed. Patient return to work 10/6/2020 with mild fatigue, mild injection site redness, mild injection site pain.