chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Pharyngeal inflammation, Throat tightness, Urticaria
Clinical narrative: Throat felt Constricted; Throat felt / inflamed; developed hives / "hives on the inside."; This case was reported by a consumer via call center representative and described the occurrence of throat constriction in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included multiple allergies.   On 13th September 2020, the patient received the 1st dose of Shingrix (intramuscular). In September 2020, less than 2 weeks after receiving Shingrix, the patient experienced throat constriction, pharyngeal inflammation and hives. The patient was treated with methylprednisolone sodium succinate (Solumedrol) and ambiguous medication nos (Epipen (Nos)). In September 2020, the outcome of the throat constriction, pharyngeal inflammation and hives were recovered/resolved.   It was unknown if the reporter considered the throat constriction, pharyngeal inflammation and hives to be related to Shingrix.  Additional details were reported as follows: The patient reported that after having Shingrix vaccine in left arm, she developed hives and her throat felt constricted and inflamed. She described the sensation as hives on the inside. She was given 2 shots of solumedrol and an Epipen. The symptoms were resolved. The reporter did not consent to follow-up.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Muscular weakness, Tremor
Clinical narrative: weakness in her hands; inability to control her hands or carry anything/shakiness; This case was reported by a consumer via call center representative and described the occurrence of hands weakness of in a 73-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th September 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On 18th September 2020, 2 hrs after receiving Shingrix, the patient experienced hands weakness of and tremor. On an unknown date, the outcome of the hands weakness of and tremor were not recovered/not resolved.   The reporter considered the hands weakness of and tremor to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix in left arm. Two hours after receiving vaccine, she began to experience multiple symptoms including inability to control her hands or carry anything, shakiness and weakness in her hands.  The patient provided with medical disclaimer and advised her to follow up with her healthcare professional.  The reporter consented to follow up.
Age: 88.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site pain, Insomnia, Pain, Pain in extremity
Clinical narrative: pain around the injection site / between a 3 to 4 on the pain scale; hurts when he raises his arm; pain in the arm / wakes him up / about 2 to 3 times a week (difficulty sleeping); This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 88-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included stroke (had a stroke a year ago on his right side).   On 6th August 2020, the patient received the 1st dose of Shingrix (intramuscular). In August 2020, 1 week after receiving Shingrix, the patient experienced pain in arm, pain upon movement and difficulty sleeping. On an unknown date, the outcome of the pain in arm and difficulty sleeping were not recovered/not resolved and the outcome of the pain upon movement was unknown.   It was unknown if the reporter considered the pain in arm, pain upon movement and difficulty sleeping to be related to Shingrix.  Additional details were reported as follows: The patient received Shingrix in the left arm and week after receiving the dose had pain around the injection site that occurs intermittently and was still ongoing at time of reporting. The patient reported the pain was between a 3 to 4 on the pain scale and hurts when he raised his arm. The patient reported the pain in the arm around the injection site woke him up from sleep about 2 to 3 times a week (difficulty sleeping) and this was still ongoing currently.  The reporter consented to follow up.
Age: 77.0
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Heart rate increased, Injection site erythema, Pain, Peripheral swelling
Clinical narrative: rapid heart beat; pink color around the area she had the injection; pain; arm swelling; tiredness; This case was reported by a consumer via call center representative and described the occurrence of heartbeats increased in a 77-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 23rd September 2020, the patient received the 1st dose of Shingrix. On 23rd September 2020, less than a day after receiving Shingrix, the patient experienced heartbeats increased, injection site erythema, pain, swelling arm and tiredness. On an unknown date, the outcome of the heartbeats increased, injection site erythema, pain, swelling arm and tiredness were not recovered/not resolved.   It was unknown if the reporter considered the heartbeats increased, injection site erythema, pain, swelling arm and tiredness to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient experienced a rapid heart beat, a pink color around the area she had the injection, tiredness, arm swelling, and pain.  The reporter wanted to know how long this would last, and if she should go to see her doctor. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Herpes zoster oticus, Rash
Clinical narrative: Shingles rash; rash; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 57-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In May 2020, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, 1 week after receiving Shingrix, the patient experienced shingles and rash. The patient was treated with antibiotics nos and steroids nos (Steroids). On 15th July 2020, the outcome of the shingles was recovered/resolved. On an unknown date, the outcome of the rash was recovered/resolved.   It was unknown if the reporter considered the shingles and rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. About a week after receiving the dose, she developed a shingles rash in her right ear that lasted amonth and a half.  The patient was treated with antibiotics and steroids. The patient received the injection in her right arm.  The reporter did not consent to follow up.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Eye irritation, Headache, Injection site pain, Pyrexia
Clinical narrative: Pain at Injection Site; Fever of 101.5; Chills; Shaking; Headache; Burning Eyes; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th September 2020, the patient received the 1st dose of Shingrix. On 24th September 2020, less than a day after receiving Shingrix, the patient experienced injection site pain, fever, chills, tremor, headache and burning in eyes. On 25th September 2020, the outcome of the injection site pain, fever, chills, tremor, headache and burning in eyes were recovered/resolved.   It was unknown if the reporter considered the injection site pain, fever, chills, tremor, headache and burning in eyes to be related to Shingrix.  Additional details were reported as follows: On 24th September 2020, less than a day after vaccination, patient experienced chills, shaking, fever of 101.5, pain at injection site, burning eyes, and a headache. Till the time of reporting, the patient had no symptoms and patient wanted to know if he should get the next injection. Reporter was provided with the Medical Disclaimer and was encouraged to see his physician and also provided the information in content, including the PI. The reporter consented to follow-up.
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Tremor
Clinical narrative: Pain at Injection Site; Fever of 101.5; Chills; Shaking; Headache; Burning Eyes; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 24th September 2020, the patient received the 1st dose of Shingrix. On 24th September 2020, less than a day after receiving Shingrix, the patient experienced injection site pain, fever, chills, tremor, headache and burning in eyes. On 25th September 2020, the outcome of the injection site pain, fever, chills, tremor, headache and burning in eyes were recovered/resolved.   It was unknown if the reporter considered the injection site pain, fever, chills, tremor, headache and burning in eyes to be related to Shingrix.  Additional details were reported as follows: On 24th September 2020, less than a day after vaccination, patient experienced chills, shaking, fever of 101.5, pain at injection site, burning eyes, and a headache. Till the time of reporting, the patient had no symptoms and patient wanted to know if he should get the next injection. Reporter was provided with the Medical Disclaimer and was encouraged to see his physician and also provided the information in content, including the PI. The reporter consented to follow-up.
Sex: F
Vaccine: FLUC3, VARZOS
Symptoms: Extra dose administered, Feeling hot, Headache, Hyperhidrosis, Myalgia
Clinical narrative: Sweating; Feeling warm; Arm soreness; Nausea; Vomiting; Headache; Muscle ache; Receiving a third Shingrix dose / received the two Shingrix doses last year.; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE (FLUCELVAX) for prophylaxis.   Previously administered products included Shingrix (1st dose and 2nd dose received in last year).   On 26th September 2020, the patient received the 3rd dose of Shingrix (intramuscular) .5 ml and FLUCELVAX (intramuscular). On 26th September 2020, unknown after receiving Shingrix, the patient experienced extra dose administered. On 27th September 2020, the patient experienced pain in arm, nausea, vomiting, headache and muscle pain. On 28th September 2020, the patient experienced sweating and feeling of warmth. On 28th September 2020, the outcome of the pain in arm, nausea and vomiting were recovered/resolved. On an unknown date, the outcome of the headache, muscle pain, sweating and feeling of warmth were not recovered/not resolved and the outcome of the extra dose administered was unknown.   It was unknown if the reporter considered the pain in arm, nausea, vomiting, headache, muscle pain, sweating and feeling of warmth to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. A Patient reports received 3rd dose of Shingrix, along with her Flu shot (FLUCELVAX), at her pharmacy 2 days ago from the date of reporting.  The patient informed the Pharmacist after the vaccination was administered, The patient experienced arm soreness, nausea and vomiting beginning 1 day after vaccination and lasting 24 hours.  The patient reported Muscle ache, headache, and sweating (warm feeling) beginning 24-48 hours after vaccination and not recovered.  Limited information available.  The reporter consented to follow up.
Sex: F
Vaccine: FLUC3, VARZOS
Symptoms: Nausea, Pain in extremity, Vomiting
Clinical narrative: Sweating; Feeling warm; Arm soreness; Nausea; Vomiting; Headache; Muscle ache; Receiving a third Shingrix dose / received the two Shingrix doses last year.; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included INFLUENZA VACCINE (FLUCELVAX) for prophylaxis.   Previously administered products included Shingrix (1st dose and 2nd dose received in last year).   On 26th September 2020, the patient received the 3rd dose of Shingrix (intramuscular) .5 ml and FLUCELVAX (intramuscular). On 26th September 2020, unknown after receiving Shingrix, the patient experienced extra dose administered. On 27th September 2020, the patient experienced pain in arm, nausea, vomiting, headache and muscle pain. On 28th September 2020, the patient experienced sweating and feeling of warmth. On 28th September 2020, the outcome of the pain in arm, nausea and vomiting were recovered/resolved. On an unknown date, the outcome of the headache, muscle pain, sweating and feeling of warmth were not recovered/not resolved and the outcome of the extra dose administered was unknown.   It was unknown if the reporter considered the pain in arm, nausea, vomiting, headache, muscle pain, sweating and feeling of warmth to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. A Patient reports received 3rd dose of Shingrix, along with her Flu shot (FLUCELVAX), at her pharmacy 2 days ago from the date of reporting.  The patient informed the Pharmacist after the vaccination was administered, The patient experienced arm soreness, nausea and vomiting beginning 1 day after vaccination and lasting 24 hours.  The patient reported Muscle ache, headache, and sweating (warm feeling) beginning 24-48 hours after vaccination and not recovered.  Limited information available.  The reporter consented to follow up.
Age: 79.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site rash, Pain in extremity
Clinical narrative: left arm pain; red rash with itching around the injection; red rash itching around the injection site; itching around the injection site; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 79-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10th August 2020, the patient received the 1st dose of Shingrix. On 10th August 2020, less than a week after receiving Shingrix, the patient experienced pain in arm, injection site rash, injection site erythema and injection site itching. On an unknown date, the outcome of the pain in arm was unknown and the outcome of the injection site rash, injection site erythema and injection site itching were recovered/resolved.   It was unknown if the reporter considered the pain in arm, injection site rash, injection site erythema and injection site itching to be related to Shingrix.  Additional details were provided as follows: The patient received 1st dose of Shingrix in left deltoid. On the same of vaccination or the next day, the patient had left arm pain and also red rash with itching around the injection site, which took about 1 week to resolve. The reporter consented to follow up.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Dizziness, Fatigue, Injection site pain, Nausea
Clinical narrative: Fever, severe chills, nausea, dizziness, body aches, VERY sore at site; very fatigued.
Age: 56.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Fever, severe chills, nausea, dizziness, body aches, VERY sore at site; very fatigued.
Age: 0.17
Sex: F
Vaccine: RV5
Symptoms: Culture stool positive, Differential white blood cell count abnormal, Full blood count abnormal, Haematochezia, Occult blood negative
Clinical narrative: lab confirmed hematochezia.  historically first on 9/28/2020.  lab + hemoccult 10/2/2020.  seen in office on 9/30/2020.  three neg hemoccult stool prior to the + one on 10/2/2020 and coinciding with grossly visible blood
Sex: F
Vaccine: VARZOS
Symptoms: Chemotherapy, Ovarian cancer stage IV, Surgery
Clinical narrative: diagnosed with stage 4 plus ovarian cancer in December 2018; This case was reported by a consumer via call center representative and described the occurrence of ovarian cancer in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   In September 2018, the patient received the 1st dose of Shingrix. In December 2018, between 2 and 4 months after receiving Shingrix, the patient experienced ovarian cancer (serious criteria GSK medically significant). The patient was treated with fluvastatin sodium (Vastin) and chemotherapy, nos (Chemotherapy). On an unknown date, the outcome of the ovarian cancer was not recovered/not resolved.   It was unknown if the reporter considered the ovarian cancer to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's husband. The reporter stated that his wife received first dose of Shingrix in September 2018 and was diagnosed with stage 4 plus ovarian cancer in December 2018. Second dose Shingrix was not yet received.  The patient underwent surgery and chemotherapy due to ovarian cancer. Currently, patient had been taking Vastin for over one year, and this drug inhibits future growth of tumors.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Ascites, Blood lactic acid decreased, Diarrhoea haemorrhagic, Gastrointestinal oedema, Gastrointestinal wall thickening
Clinical narrative: healthy 2 m.o. who presented 10/1 with emesis, fever, and bloody diarrhea.   had emesis of every bottle he had that was NBNB. He was seen by his PCP who gave a script for AUS and told mom to present to ED if course worsened. He was then febrile to Tmax 100.6 rectally and began having bloody diarrhea so mom took him to ED.   At  hopsital his workup was notable for rotavirus positive and an abdominal ultrasound showing RLQ intussusception. He was transferred to for further workup.  In the ED here, he remained afebrile. Lactate was 1.5. He was ordered for cefoxitin but this was discontinued before he received it. He received a lactated ringers bolus and was started on mIVF with d5 normal saline.  US intestines with thickening of the wall of the cecum and the terminal ileum and edema and thickening of the ileocecal valve are which in transverse plane resembles appearance of a small intussusception. There is no ileocolic intussusception at the time of the examination.  He transitioned off IV fluids and discharged home 10/3.
Age: 0.17
Sex: M
Vaccine: RV5
Symptoms: Intussusception, Pyrexia, Rotavirus test positive, Ultrasound abdomen abnormal, Vomiting
Clinical narrative: healthy 2 m.o. who presented 10/1 with emesis, fever, and bloody diarrhea.   had emesis of every bottle he had that was NBNB. He was seen by his PCP who gave a script for AUS and told mom to present to ED if course worsened. He was then febrile to Tmax 100.6 rectally and began having bloody diarrhea so mom took him to ED.   At  hopsital his workup was notable for rotavirus positive and an abdominal ultrasound showing RLQ intussusception. He was transferred to for further workup.  In the ED here, he remained afebrile. Lactate was 1.5. He was ordered for cefoxitin but this was discontinued before he received it. He received a lactated ringers bolus and was started on mIVF with d5 normal saline.  US intestines with thickening of the wall of the cecum and the terminal ileum and edema and thickening of the ileocecal valve are which in transverse plane resembles appearance of a small intussusception. There is no ileocolic intussusception at the time of the examination.  He transitioned off IV fluids and discharged home 10/3.
Age: 54.0
Sex: F
Vaccine: FLUX, VARZOS
Symptoms: Blindness, Condition aggravated, Headache, Visual impairment
Clinical narrative: lost of vision; history of vision issues / after receiving SHINGRIX make it worst; Head ache; This case was reported by a other health professional via call center representative and described the occurrence of loss of vision in a 54-year-old female patient who received SHINGRIX for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2020-2021 season) for prophylaxis.   Concurrent medical conditions included abnormal vision.   On 17th August 2020, the patient received the 1st dose of SHINGRIX and Influenza vaccine Quadrivalent 2020-2021 season. On an unknown date, less than 2 months after receiving SHINGRIX and Influenza vaccine Quadrivalent 2020-2021 season, the patient experienced loss of vision (serious criteria GSK medically significant), vision abnormal aggravated and headache. SHINGRIX was discontinued. On an unknown date, the outcome of the loss of vision and vision abnormal aggravated were unknown and the outcome of the headache was recovered/resolved.   It was unknown if the reporter considered the loss of vision, vision abnormal aggravated and headache to be related to SHINGRIX and Influenza vaccine Quadrivalent 2020-2021 season.  Additional details were provided as follows: The patient experienced head ache and lost of vision after vaccination. The patient had history of vision issues but after receiving SHINGRIX made it worst. The patient also received a dose of a Flu vaccine on the same day of SHINGRIX vaccination. The patient refused to receive the second dose of SHINGRIX. The reporter did not provided lot number and expiration date of the first dose of SHINGRIX. The reporter consented to follow-up.
Sex: U
Vaccine: FLU4
Symptoms: Arthralgia, Incorrect route of product administration
Clinical narrative: administered high on several patient's arm almost interarticular; shoulder soreness; This case was reported by a pharmacist via call center representative and described the occurrence of shoulder soreness in an unspecified number of patients who received Flu Seasonal QIV Quebec (FluLaval Tetra 2020-2021 season) for prophylaxis.   On 28th September 2020, the patient received FluLaval Tetra 2020-2021 season (intraarticular). In September 2020, less than a week after receiving FluLaval Tetra 2020-2021 season, the patient experienced shoulder soreness. On 28th September 2020, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the shoulder soreness and intramuscular formulation administered by other route were unknown.   It was unknown if the reporter considered the shoulder soreness to be related to FluLaval Tetra 2020-2021 season.  Additional details were reported as follows: The age at vaccination was not reported. The FluLaval was inadvertently administered high on several patient's arm almost intraarticularly instead of intramuscularly and as a result caused sore shoulders. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: outbreak after the first dose; This case was reported by a other health professional via call center representative and described the occurrence of shingles in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 30th July 2020, the patient received the 1st dose of Shingrix. On 24th September 2020, 56 days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not reported. The patient experienced an outbreak after the first dose of shingrix. The physician assistant needs information on Shingrix dosing schedule. The reporter consented to follow up.
Age: 80.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Incomplete course of vaccination
Clinical narrative: shingles; first dose of Shingrix on Feb, 2020 / did not receive the second dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 80-year-old female patient who received Herpes zoster (Shingrix) (batch number 3C37A, expiry date 30th April 2022) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In February 2020, the patient received the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, 5 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles and incomplete course of vaccination. On an unknown date, the outcome of the shingles and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was not applicable for 2nd dose. The patient experienced shingles after 1st dose of shingrix. Till the time of reporting, the patient did not receive the 2nd dose of the vaccine, which led to incomplete course of vaccination. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Ankylosing spondylitis
Clinical narrative: ankylosing spondylitis; This case was reported by a pharmacist via call center representative and described the occurrence of ankylosing spondylitis in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In July 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced ankylosing spondylitis (serious criteria GSK medically significant). The patient was treated with adalimumab (Humira). On an unknown date, the outcome of the ankylosing spondylitis was unknown.   It was unknown if the reporter considered the ankylosing spondylitis to be related to Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The reporter asked if a patient who was taking Humira for ankylosing spondylitis could receive 2nd dose of Shingrix. was it contraindicated. When asked if patient was already taking this medication before receiving 1st dose of Shingrix HCP stated she was not able to answer that question. The reporter consented to follow up. Only gender from patient was reported as HCP stated she did not have the information right now. No further details reported.
Sex: F
Vaccine: VARZOS
Symptoms: Illness, Joint swelling, Rash erythematous
Clinical narrative: red rash; shoulder became swollen; sick; This case was reported by a other health professional via call center representative and described the occurrence of red rash in a elderly female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 25th July 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 3 months after receiving Shingrix, the patient experienced red rash, swollen joints and sickness. On an unknown date, the outcome of the red rash, swollen joints and sickness were recovered/resolved.   It was unknown if the reporter considered the red rash, swollen joints and sickness to be related to Shingrix.  Additional details were provided as follows:  The age at vaccination was reported. The patient received 1st dose of shingrix and same shoulder became swollen, developed rash and became sick. The reporter mentioned that, the events resolved within 2 weeks. No further information provided. The reporter consented to follow up.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Arthritis, Back pain, Hepatic enzyme increased, Pancreatitis
Clinical narrative: elevated liver enzymes; pancreatitis; severe epigastric pain; severe pain in her lumbar and sacral region; inflammatory arthritis; This case was reported by a consumer via call center representative and described the occurrence of pancreatitis in a 61-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included amoxicillin trihydrate (Amoxicillin) unknown for sinus infection and tylenol #3 (nos) (Tylenol #3) for an unknown indication.   Concurrent medical conditions included herpes simplex and sinus infection. Concomitant products included valaciclovir hydrochloride (Valacyclovir).   On 4th February 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, the patient started Amoxicillin at an unknown dose and frequency and Tylenol #3 at an unknown dose and frequency. On 6th February 2020, 2 days after receiving Shingrix and not applicable after starting Amoxicillin, the patient experienced sacral pain and inflammatory arthritis. On an unknown date, the patient experienced pancreatitis (serious criteria hospitalization and GSK medically significant), elevated liver enzymes (serious criteria hospitalization) and epigastric pain. The patient was treated with ibuprofen (Advil). The action taken with Amoxicillin was unknown. The action taken with Tylenol #3 was unknown. On an unknown date, the outcome of the pancreatitis and inflammatory arthritis were recovered/resolved and the outcome of the elevated liver enzymes, sacral pain and epigastric pain were unknown.   It was unknown if the reporter considered the pancreatitis, elevated liver enzymes, sacral pain, inflammatory arthritis and epigastric pain to be related to Shingrix. It was unknown if the reporter considered the pancreatitis, elevated liver enzymes and epigastric pain to be related to Amoxicillin.  Additional details were reported as follows : The patient received Shingrix vaccine in her right deltoid intramuscularly and about two days later she had severe pain in her lumbar and sacral region, more towards the right compared to the left, and was diagnosed with inflammatory arthritis of the lumbar and sacral region by an orthopedic doctor. The patient was on Advil for her pain 600 mg every 6 hours. The orthopedic doctor prescribed Tylenol #3. The patient was having sinus infection and was on amoxicillin. So she took amoxicillin and one dose of Tylenol # 3 and after 2 hours customer started to experience severe epigastric pain and she was hospitalized with pancreatitis for 2 days with elevated liver enzymes and the pancreatitis resolved in 2 days. The inflammatory arthritis resolved in 3 days. The patient's had past medical history of herpes simplex and was on valacyclovir and did not know if she experienced the inflammatory arthritis because she had a diagnosis of herpes simplex. The patient did not receive second dose of the Shingrix vaccine yet. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: shingles; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 75-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, couple of days after receiving Shingrix, the patient experienced shingles. On an unknown date, the outcome of the shingles was recovered/resolved.   It was unknown if the reporter considered the shingles to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix vaccine three months ago and a few days later developed shingles.  The shingles had resolved, and he received his second dose the date before reporting. The reporter did not consent to follow up. MD follow up call declined provided information regarding shingles and Shingrix per FAQ.
Sex: F
Vaccine: FLU4
Symptoms: Chest discomfort, Cough, Eye irritation
Clinical narrative: Chest felt tight; Eyes were prickly; Cough; Initial information was received on 22-Sep-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional.  This case involves a female patient (age unspecified) had a cough, her chest felt tight (chest discomfort) and eyes were prickly (eye pruritus), while she received INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a 0.5 mL dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiry date not reported) via an unknown route and administration site for prophylactic vaccination.  On an unknown date, the patient had a cough, her chest felt tight (chest discomfort) and eyes were prickly (eye pruritus) (unknown latency, non-serious events) following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  No laboratory data was provided   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on lot number.
Sex: U
Vaccine: FLU4, UNK
Symptoms: Herpes zoster
Clinical narrative: Shingles; Initial information received on 25-Sep-2020 regarding an unsolicited valid non-serious case from a consumer/non-healthcare professional via non licensed partner Pfizer via social media.  This case involves a patient who experienced shingles (herpes zoster), while he/she received vaccines INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] and PNEUMOCOCCAL VACCINE POLYSACCH 23V.  The patient's past vaccination included VARICELLA VACCINE in JUN-2015. The patient's medical history, past medical treatment and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE and PNEUMOCOCCAL VACCINE POLYSACCH 23V not produced by Sanofi Pasteur (lot number not reported) via an unknown route at an unknown administration site as prophylactic vaccination.  On an unknown date, the patient developed a non-serious shingles (herpes zoster) (couple days later) following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE and PNEUMOCOCCAL VACCINE POLYSACCH 23V.  Laboratory details were not reported.  It was not reported if the patient received any corrective treatment.  The event outcome was reported as unknown for shingles.  There will be no information received on lot number for this case.
Sex: U
Vaccine: FLU4
Symptoms: Injection site urticaria
Clinical narrative: wheel and flare at vaccination site; Initial information was received on 28-Sep-2020 regarding an unsolicited valid non-serious case from a physician.  This case is linked to case 2020SA267990 (same reporter)  This case involves a patient (gender unspecified) who had a wheel and flare at injection site (vaccination site urticaria), when received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, medical treatment(s), vaccination(s), concomitant medication and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number not reported) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed a non-serious wheel and flare at injection site (vaccination site urticaria) within the last few weeks following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  No laboratory data was provided.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on lot number.
Sex: U
Vaccine: FLU4
Symptoms: Injection site swelling
Clinical narrative: more significant swelling near the injection site; Initial information was received on 28-Sep-2020 regarding an unsolicited valid non-serious case from a physician.  This case is linked to case 2020SA267987 (same reporter).  This case involves a patient (age and gender unspecified) who had more significant swelling near the injection site (vaccination site swelling), when received vaccine INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT].  Medical history, medical treatment(s), vaccination(s), concomitant medications and family history were not provided.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B VACCINE (lot number and expiry date not reported, form: pre-filled syringe) via unknown route in unknown administration site for prophylactic vaccination.  On an unknown date, the patient developed more significant swelling near the injection site (vaccination site swelling) within the last few weeks following the administration of INFLUENZA QUADRIVAL A-B VACCINE.  No laboratory data was reported.   It was not reported if the patient received a corrective treatment.  At the time of report, the outcome of event was unknown.  There will be no information available on lot number.
Age: 54.0
Sex: M
Vaccine: FLU4
Symptoms: Extra dose administered
Clinical narrative: 54 year old male received 2 doses of FLUZONE QUADRIVALENT/ no AE; Initial information was received on 17-Sep-2020 regarding an unsolicited valid non-serious case from a consumer/non-health care professional.  This case involves a 54 years old male patient who received two doses (0.5 mL) of suspect INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (Suspension for injection, lot UT7006JA, expiration date: 30-Jun-2021) first dose via intramuscular route in the right deltoid and second dose via intramuscular left deltoid for prophylactic vaccination (extra dose administered) on 16-Sep-2020.  Medical history, past medical treatments, past vaccination and family history were not provided.  No concomitant medications were given to the patient.  This was actual medication error due to extra dose administered (on same day).  It was not reported whether the patient experienced any adverse event.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 68.0
Sex: F
Vaccine: FLU4
Symptoms: Pain in extremity
Clinical narrative: Experiencing an achy feeling in the arm of the injection site/soreness of her arm; Initial information received on 17-Sep-2020 regarding an unsolicited valid non-serious case from a patient (retired nurse).  This case involved a 68 years old female patient who experienced an achy feeling in the arm of the injection site/ soreness of her arm (Pain in extremity), while she received vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  Relevant medical history included surgery of totally ripped the rotator cuff on the right arm. It was reported that she had surgery last year but still was getting physical therapy.  Past medical treatments and family history were not provided. No other vaccines were given.  Concomitant medications were not reported.   On 17-Sep-2020, the patient received a 0.7 mL once dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ488AA, expiration date: 30-Jun-2021) via unknown route in the left arm for prophylactic vaccination.  On 17-Sep-2020, the patient developed a non-serious achy feeling in the arm of the injection site/ soreness of her arm  (Pain in extremity), on same day following the administration of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE.  Detailed laboratory test was not reported.  It was not reported if the patient received any corrective treatment.  The patient was not recovered from the reported event at the time of reporting.
Age: 11.0
Sex: F
Vaccine: FLU4, FLUR4
Symptoms: Wrong product administered
Clinical narrative: a patient received a dose of Flublok instead of Fluzone Quadrivalent/ No AE; A 11 years old patient received a dose of FLUBLOK QUADRIVALENT vaccine/ No AE; Initial information was received on 18-Sep-2020 regarding an unsolicited valid non-serious case from nurse. This case is linked to cases 2020SA258133 and 2020SA258275.  This case involves an 11 years old female patient who accidentally was administrated with a 0.5 mL dose of suspect INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] (Lot UJ455AAA, expiration date: 17-Mar-2021) via unknown route in left deltoid on 17-Sep-2020 for prophylactic vaccination instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (wrong product administered & product administered to patient of inappropriate age).  Medical history, past medical treatments, past vaccinations and family history were not provided.  No concomitant vaccines was given to the patient.  This was an actual medication error case due to wrong vaccine administered and inappropriate age at vaccine administration.  At the time of report no adverse event was reported.  This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holders compliance with the requirements set out in Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 17.0
Sex: F
Vaccine: FLUR4
Symptoms: No adverse event, Wrong product administered
Clinical narrative: a patient received a dose of FLUBLOK QUADRIVALENT instead of FLUZONE QUADRIVALENT /No AE; A 17 years old female patient received a dose of FLUBLOK QUADRIVALENT /No AE; Initial information was received on 18-Sep-2020 regarding an unsolicited valid non-serious case from the other health care professional.  This case is linked to cases 2020SA258133 and 2020SA257773 (Same reporter).  This case involves a 17 years old female patient who received a 0.5 mL dose of INFLUENZA QUADRIVALENT RECOMBINANT VACCINE [FLUBLOK QIV] [lot number: UJ455AAA, expiry date: 17-May-2021] via an unknown route at the left deltoid for prophylactic vaccination instead of INFLUENZA QUADRIVAL A-B VACCINE [FLUZONE QUADRIVALENT] (wrong product administered and product administered to patient of inappropriate age) .   Medical history, medical treatment, vaccination and family history were not provided.   Patient did not received concomitant vaccines.  It was a case of actual medication error due to inappropriate age at vaccine administration and wrong vaccine administered (Latency: at the time of vaccination).  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: 76.0
Sex: F
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: The patient received a vaccine which was exposed to a low temperature of 30.9 degrees F for 2 hours, no AE; Initial information was received on 23-Sep-2020 regarding an unsolicited valid non-serious case from a other health professional.  This case involves a 76 year old female patient who received INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] which was exposed to a low temperature of 30.9 degrees F below the recommended range for 2 hours (product storage error).  Medical history, medical treatment(s), vaccination(s) and family history were not provided.  The patient received no other concomitant vaccines   On 22-Sep-2020, the patient received a 0.5 ml dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (lot UJ453AB, expiry date: 30-Jun-2021, form: prefilled syringe) once via intramuscular route in unknown administration site for prophylactic vaccination.  The vaccine was exposed to freezing temperature below the recommended range for 2 hours, reaching a low temperature of 30.9 degrees F, due to refrigerator malfunction.  It was a case of an actual medication error due to product storage error temperature too low.  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: 64.0
Sex: U
Vaccine: FLU4
Symptoms: Incorrect dose administered, No adverse event, Product administered to patient of inappropriate age
Clinical narrative: a 64.5 year old patient having received Fluzone High Dose, no AE; a 64.5 year old patient having received Fluzone High Dose, no AE; Initial information was received on 28-Sep-2020 regarding an unsolicited valid non-serious case from a nurse via phone.  This case involves a 64.5-year-old patient (gender was not reported) who was vaccinated with a 0.7 ml once dose of INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT] (prefilled syringe, batch number and dosing details were not reported) on an unknown date for prophylactic vaccination.  The patient's medical history, past medical treatment(s), vaccination(s), family history and concomitant medication were not provided.   This was an actual medication error case due to inappropriate age at vaccine administration and overdose (latency was same day).  No adverse event reported at the time of reporting.  The nurse wanted to know is it dangerous if a under 65 year old patient received Fluzone High Dose.  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.  There will be no information available on the batch number for this case