chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Ocular discomfort, Pain, Pain in extremity, Periorbital swelling
Clinical narrative: fever; chills; achiness; sore arm; feeling swelling; pressure around her eyes; This case was reported by a consumer via call center representative and described the occurrence of fever in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 4ME42, expiry date 14th November 2021) for prophylaxis.  On 27th February 2020, the patient received the 1st dose of Shingrix (intramuscular). On 2nd March 2020, 4 days after receiving Shingrix, the patient experienced periocular swelling and sensation of pressure in eye. On an unknown date, the patient experienced fever, chills, pain and pain in arm. On an unknown date, the outcome of the fever, chills, pain, pain in arm, periocular swelling and sensation of pressure in eye were recovered/resolved.   It was unknown if the reporter considered the fever, chills, pain, pain in arm, periocular swelling and sensation of pressure in eye to be related to Shingrix.  Additional case details were reported as follows: This case was reported by patient herself. Less than 2 weeks after receiving Shingrix, the patient experienced fever, chills, achiness, and sore arm for a couple days. The patient also experienced feeling swelling and pressure around her eyes. The reporter consented to follow up.   Follow up information received from health care professional on 21st April 2020: The patient demographics details were updated. The batch details and expiry details of the suspect vaccine were updated. Generally healthy adult. Concurrent medical conditions included allergy to neomycin (rash), nickel sensitivity and allergy to metals. The patient had allergy of adhesive patches. The patient received the Shingrix 0.5ml. The patient did not report side effect to ours office. The VAERS details were updated.
Age: 61.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: fever; chills; achiness; sore arm; feeling swelling; pressure around her eyes; This case was reported by a consumer via call center representative and described the occurrence of fever in a 61-year-old female patient who received Herpes zoster (Shingrix) (batch number 4ME42, expiry date 14th November 2021) for prophylaxis.  On 27th February 2020, the patient received the 1st dose of Shingrix (intramuscular). On 2nd March 2020, 4 days after receiving Shingrix, the patient experienced periocular swelling and sensation of pressure in eye. On an unknown date, the patient experienced fever, chills, pain and pain in arm. On an unknown date, the outcome of the fever, chills, pain, pain in arm, periocular swelling and sensation of pressure in eye were recovered/resolved.   It was unknown if the reporter considered the fever, chills, pain, pain in arm, periocular swelling and sensation of pressure in eye to be related to Shingrix.  Additional case details were reported as follows: This case was reported by patient herself. Less than 2 weeks after receiving Shingrix, the patient experienced fever, chills, achiness, and sore arm for a couple days. The patient also experienced feeling swelling and pressure around her eyes. The reporter consented to follow up.   Follow up information received from health care professional on 21st April 2020: The patient demographics details were updated. The batch details and expiry details of the suspect vaccine were updated. Generally healthy adult. Concurrent medical conditions included allergy to neomycin (rash), nickel sensitivity and allergy to metals. The patient had allergy of adhesive patches. The patient received the Shingrix 0.5ml. The patient did not report side effect to ours office. The VAERS details were updated.
Age: 81.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain
Clinical narrative: Pain on her right side/She noted the pain was in her waist area/deep breathing and when lying down on; This case was reported by a pharmacist via call center representative and described the occurrence of pain in a 81-year-old female patient who received Herpes zoster (Shingrix) (batch number MY7JS, expiry date 30th April 2022) for prophylaxis.   On 8th April 2020, the patient received the 2nd dose of Shingrix. In April 2020, immediately after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.  Additional details were provided as follows: The patient received Shingrix and had complained of pain on her right side since.   She noted the pain was in her waist area and notices it with deep breathing and when lying down on her side.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Breast cancer female, Radiotherapy
Clinical narrative: Diagnosed with breast cancer; This case was reported by a pharmacist via call center representative and described the occurrence of breast cancer in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2019, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced breast cancer (serious criteria GSK medically significant). The patient was treated with tamoxifen and non-drug therapy (Radiation Therapy). On an unknown date, the outcome of the breast cancer was unknown.   It was unknown if the reporter considered the breast cancer to be related to Shingrix.  Additional information was received as follows: The patient received the first dose of Shingrix in November 2019, and was diagnosed with breast cancer after receiving dose one and received radiation therapy as a treatment. This patient was starting treatment with tamoxifen and has not received Shingrix dose two as of 23rd April 2020. The reporter did not consented for follow up.
Age: 18.0
Sex: M
Vaccine: MEN
Symptoms: Abnormal behaviour, Anxiety, Depression, Fatigue, Hypersomnia
Clinical narrative: He had the vaccine on the morning of Friday,  April 24.  That afternoon felt very tired.  Felt a little better the following day but still complaining of feeling tired.  But on the second day following the vaccine, Sunday April, the 26th, upon waking up, he looked and felt exhausted.  His eyes were really droopy.  Later into the afternoon and into the next day, April 27th, he was extremely fatigued with body aches and unusual behavior.  Very irritable and depressed. He has never displayed irritability and depression ever. He slept for 16 hours  each day the 26th, the 27th and the 28th.   Appeared a little better yesterday.  Did not exhibit as much anxiety, but still complaining of being extremely tired.  This is very unusual for him since he is used to competitive swimming and had not displayed this much fatigue even the month prior from being in quarantine from this Pandemic.
Age: 18.0
Sex: M
Vaccine: MEN
Symptoms: Irritability, Pain, Somnolence
Clinical narrative: He had the vaccine on the morning of Friday,  April 24.  That afternoon felt very tired.  Felt a little better the following day but still complaining of feeling tired.  But on the second day following the vaccine, Sunday April, the 26th, upon waking up, he looked and felt exhausted.  His eyes were really droopy.  Later into the afternoon and into the next day, April 27th, he was extremely fatigued with body aches and unusual behavior.  Very irritable and depressed. He has never displayed irritability and depression ever. He slept for 16 hours  each day the 26th, the 27th and the 28th.   Appeared a little better yesterday.  Did not exhibit as much anxiety, but still complaining of being extremely tired.  This is very unusual for him since he is used to competitive swimming and had not displayed this much fatigue even the month prior from being in quarantine from this Pandemic.
Sex: U
Vaccine: HEPA
Symptoms: No adverse event, Product storage error
Clinical narrative: No additional adverse event; patient was inadvertently administered a dose of VAQTA that had been improperly stored; This spontaneous report was received from a certified medical assistant and refers to a patient of unknown age and gender. No information regarding the patient's pertinent medical history, drug reactions or allergies and concomitant medications were provided. On 17-APR-2020, the patient was inadvertently vaccinated with a dose of hepatitis a vaccine, inactivated (VAQTA) (lot # S032056, expiration date of 09-NOV-2020; dose and route of administration were not reported) that had been improperly stored. The temperature of excursion was 47.7 Fahrenheit degrees and the time frame was 12 minutes. The vaccine underwent previous temperature excursion with the temperature of 58.3 Fahrenheit degrees for 14 hours. The call was because of a data logger. No additional adverse events were reported.
Sex: M
Vaccine: VARZOS
Symptoms: Pruritus, Urticaria
Clinical narrative: presented with hives across chest and on other arm / hives on arm of injection; itch; This case was reported by a nurse via sales rep and described the occurrence of hives in a adult male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix at an unknown dose. On an unknown date, less than a day after receiving Shingrix, the patient experienced hives. The patient was treated with prednisone. On an unknown date, the outcome of the hives was unknown.   It was unknown if the reporter considered the hives to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The age group of the patient was not reported, but selected as an adult as per vaccine indication. The patient received dose of Shingrix in the evening at around 7:30 to 8pm at local pharmacy. The reporter stated that, following morning (friday) after vaccination, the patient experiened hives on the arm  of injection, across chest, and on other arm and it was progresively worse. The patient had traveled 3 days prior to receiving Shingrix. The patient complained of the hives being mostly bothersome. The patient has not been seen back in the office and had no shortness of breath or tongue issues. The reporter consented to follow up.   Follow up information received from nurse on 23rd April 2020: The patient's demographic details were updated. The patient did not have any additional medical history. The patient had not perform laboratory testing. The patient received Prednisine 20 miligram, Benadryl 25 miligram, and Triamunoline cream as a treatment medication. The reporter stated that, the patient was recovering from hives. The reporter considered, the hives and itch was almost certain related to Shingrix. The reporter stated that, the patient received vaccine at pharmacy and not at office.
Sex: F
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash on the right arm; This case was reported by a other health professional via sales rep and described the occurrence of rash in a 72-year-old female patient who received Herpes zoster (Shingrix) (batch number JN25B, expiry date 9th November 2021) for prophylaxis.   The patient's past medical history included shingles (on right leg). Previously administered products included Shingrix (1st dose received on 27th March 2019).   On an unknown date, the patient received the 2nd dose of Shingrix .5 ml. On 18th April 2020, less than a year after receiving Shingrix, the patient experienced rash. The patient was treated with valaciclovir hydrochloride (Valtrex) and  (Triamscinalone ointment). On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the second dose from a pharmacy and the practice did not have the date when the 2nd dose was administered.  The patient began experiencing a rash on the right arm on Saturday April 18th and sought medical treatment from her physician office through a virtual visit on Monday April 20th. The patient was prescribed Valtrex and Triamscinalone ointment.  No further follow up or treatment done.
Age: 0.5
Sex: M
Vaccine: PNC13
Symptoms: Pyrexia
Clinical narrative: Fever 100.5  Pt also ran fever after dose given on 02/28/2020, but thought may have been due to Pentacel.  Tried to space out vaccines and start with PVC 13 on 4/29/2020, but ran fever later in evening following vaccine.
Age: 70.0
Sex: F
Vaccine: UNK, VARZOS, VARZOS
Symptoms: Rash, Sinusitis, Social problem
Clinical narrative: rash; sinus infection; got her first shot on 10/23/2019 and she plans on postponing her second dose (due to the Covid 19 pandemic situation; This case was reported by a nurse via call center representative and described the occurrence of rash in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis and Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Zostavax (received in an unknown date).   On 23rd October 2019, the patient received the 1st dose of Shingrix (intramuscular) and Influenza vaccine Quadrivalent 2019-2020 season. On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, less than a week after receiving Shingrix and Influenza vaccine Quadrivalent 2019-2020 season and not applicable after receiving Shingrix, the patient experienced rash, sinus infection and social problem. The patient was treated with antibiotics nos (Antibiotic (Details Unknown)). On an unknown date, the outcome of the rash and sinus infection were recovered/resolved and the outcome of the social problem was unknown.   It was unknown if the reporter considered the rash and sinus infection to be related to Shingrix and Influenza vaccine Quadrivalent 2019-2020 season.  Additional details were received as follows: The patient got her first shot on 23rd October 2019, and she plans on postponing her second dose due to the Covid 19 pandemic situation.   The patient was planning on getting the second shot of the series a few weeks ago but did not because she had a sinus infection.  The patient  had recovered from the sinus infection. She took antibiotics to treat it.   On 23rd October after vaccination with Shingrix and Influenza vaccine Quadrivalent 2019-2020 season developed a rash on the same arm where the Shingrix was injected. The rash was not at the injection site (deltoid) but it was down by her elbow. The patient consented to follow up. This case is 1 out of 3 cases reported by the same reporter.
Age: 13.0
Sex: M
Vaccine: FLU4, HPV9, MNQ
Symptoms: Dizziness, Eye movement disorder, Pallor
Clinical narrative: After patient received  vaccines informed patient to wait 20 minutes when patient was sitting patient informed me he felt like fainting and his eyes started turning back and his face tuned pale
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Nausea, Pyrexia, Skin burning sensation
Clinical narrative: Fever, Chills, Nausea, Skin Swelling, Skin burning, Head Ache, Fever lasted 36 hours and then returned the next evening
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Skin swelling
Clinical narrative: Fever, Chills, Nausea, Skin Swelling, Skin burning, Head Ache, Fever lasted 36 hours and then returned the next evening
Age: 0.33
Sex: F
Vaccine: DTAPHEPBIP, HIBV, PNC13, RV5
Symptoms: Cyanosis, Pyrexia, Tremor
Clinical narrative: Pt received vaccines in clinic 4/29/20. Mom called 4/30/20 reported pt evaluated at local er on evening of 4/29/20 for fever of 104, blue tint to lips and shaking. Mom states pt at home now with father and doing fine. States inst by er. had reaction to vaccines and to con't Tylenol. Pt is still running low grade fever but no other symptoms present per mom.
Sex: U
Vaccine: PPV
Symptoms: Extra dose administered, No adverse event
Clinical narrative: no additional effects reported; pateint was given 2 doses of Pneumovax on 02-APR-2020 and on 14-APR-2020; pateint was given 2 doses of Pneumovax on 02-APR-2020 and on 14-APR-2020; This initial spontaneous report as received from a pharmacist refers to an adult patient of unknown age and gender. No information regarding concurrent conditions, pertinent medical history, drug allergies and concomitant therapies were provided.   On 02-APR-2020, patient (resident in one of long term care facilities) was vaccinated with pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (dose, lot #, expiration date, route of administration were not reported) for prophylaxis. On 14-APR-2020, patient was given second dose of  pneumococcal vaccine, polyvalent (23-valent)(PNEUMOVAX23) (dose, lot #, expiration date, route of administration were not reported). He or she were given inadvertently  2 doses of the suspect vaccine. No additional effects reported.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Influenza, Pain
Clinical narrative: Like having the flu; Felt achy; This case was reported by a consumer via call center representative and described the occurrence of influenza in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced influenza and general body pain. On an unknown date, the outcome of the influenza and general body pain were recovered/resolved.   It was unknown if the reporter considered the influenza and general body pain to be related to Shingrix.  Additional information was received as follows: The age at vaccination was not reported. Thepatient received Shingrix and felt achy and like having the flu within 24 hours of the injection. The reporter consented for follow up. This case has been linked with US2020070100, for 2nd dose, same patient.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Haemorrhoids, Herpes zoster, Hordeolum, Influenza, Pain
Clinical narrative: Like having the flu; Felt achy; This case was reported by a consumer via call center representative and described the occurrence of influenza in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced influenza and general body pain. On an unknown date, the outcome of the influenza and general body pain were recovered/resolved.   It was unknown if the reporter considered the influenza and general body pain to be related to Shingrix.  Additional information was received as follows: The age at vaccination was not reported. Thepatient received Shingrix and felt achy and like having the flu within 24 hours of the injection. The reporter consented for follow up. This case has been linked with US2020070100, for 2nd dose, same patient.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Paraesthesia, Pruritus, Rash, Scab, Scratch
Clinical narrative: Like having the flu; Felt achy; This case was reported by a consumer via call center representative and described the occurrence of influenza in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a day after receiving Shingrix, the patient experienced influenza and general body pain. On an unknown date, the outcome of the influenza and general body pain were recovered/resolved.   It was unknown if the reporter considered the influenza and general body pain to be related to Shingrix.  Additional information was received as follows: The age at vaccination was not reported. Thepatient received Shingrix and felt achy and like having the flu within 24 hours of the injection. The reporter consented for follow up. This case has been linked with US2020070100, for 2nd dose, same patient.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Influenza, Pain
Clinical narrative: rash looks like shingles,Rash all over her body; Felt achy; Like having the flu; "Pin prickling" type of rash or burning; Started scabbing; itching; Scratching; Developed an external hemorrhoid; Developed what look like stye under both of her eyes; This case was reported by a consumer via call center representative and described the occurrence of rash in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (1st dose, refer US2020AMR070584).   On 10th March 2020, the patient received the 2nd dose of Shingrix. In April 2020, less than 2 months after receiving Shingrix, the patient experienced external hemorrhoids and stye. On an unknown date, the patient experienced rash, general body pain, influenza, tingling skin, scab, pruritus and scratch. The patient was treated with prednisone. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the rash, pruritus, external hemorrhoids and stye were not recovered/not resolved and the outcome of the general body pain, influenza and scratch were unknown and the outcome of the tingling skin and scab were recovered/resolved.   It was unknown if the reporter considered the rash, general body pain, influenza, tingling skin, scab, pruritus, scratch, external hemorrhoids and stye to be related to Shingrix.  Additional information was received as follows: After receiving 2nd dose of Shingrix, the patient had rash all over her body, it looks like shingles. She did talk to her doctor virtually and sent him pictures of the rash (patient said that she was willing to share these pictures with the company). The rash was on her stomach, arms and all over her body. It was itching and she was scratching a lot and started scabbing all over. The rash appeared to be under the skin initially and then it was raised in rashes. She was put on prednisone 10 mg for a month and some topical creams. After she done with the prednisone, her internal medicine physician recommended no refill.  She was still having itching and sort of a "pin prickling" type of rash or burning. It was not as bad as the beginning but it's still here.  She has not been fully diagnosed with shingles. She said that about 4 days after she stopped the prednisone treatment she developed an external hemorrhoid and what look like stye under both of her eyes. One was normal and the other one was very large. The reporter consented for followup.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Haemorrhoids, Herpes zoster, Hordeolum, Influenza, Pain
Clinical narrative: rash looks like shingles,Rash all over her body; Felt achy; Like having the flu; "Pin prickling" type of rash or burning; Started scabbing; itching; Scratching; Developed an external hemorrhoid; Developed what look like stye under both of her eyes; This case was reported by a consumer via call center representative and described the occurrence of rash in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (1st dose, refer US2020AMR070584).   On 10th March 2020, the patient received the 2nd dose of Shingrix. In April 2020, less than 2 months after receiving Shingrix, the patient experienced external hemorrhoids and stye. On an unknown date, the patient experienced rash, general body pain, influenza, tingling skin, scab, pruritus and scratch. The patient was treated with prednisone. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the rash, pruritus, external hemorrhoids and stye were not recovered/not resolved and the outcome of the general body pain, influenza and scratch were unknown and the outcome of the tingling skin and scab were recovered/resolved.   It was unknown if the reporter considered the rash, general body pain, influenza, tingling skin, scab, pruritus, scratch, external hemorrhoids and stye to be related to Shingrix.  Additional information was received as follows: After receiving 2nd dose of Shingrix, the patient had rash all over her body, it looks like shingles. She did talk to her doctor virtually and sent him pictures of the rash (patient said that she was willing to share these pictures with the company). The rash was on her stomach, arms and all over her body. It was itching and she was scratching a lot and started scabbing all over. The rash appeared to be under the skin initially and then it was raised in rashes. She was put on prednisone 10 mg for a month and some topical creams. After she done with the prednisone, her internal medicine physician recommended no refill.  She was still having itching and sort of a "pin prickling" type of rash or burning. It was not as bad as the beginning but it's still here.  She has not been fully diagnosed with shingles. She said that about 4 days after she stopped the prednisone treatment she developed an external hemorrhoid and what look like stye under both of her eyes. One was normal and the other one was very large. The reporter consented for followup.
Age: 59.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Paraesthesia, Pruritus, Rash, Scab, Scratch
Clinical narrative: rash looks like shingles,Rash all over her body; Felt achy; Like having the flu; "Pin prickling" type of rash or burning; Started scabbing; itching; Scratching; Developed an external hemorrhoid; Developed what look like stye under both of her eyes; This case was reported by a consumer via call center representative and described the occurrence of rash in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (1st dose, refer US2020AMR070584).   On 10th March 2020, the patient received the 2nd dose of Shingrix. In April 2020, less than 2 months after receiving Shingrix, the patient experienced external hemorrhoids and stye. On an unknown date, the patient experienced rash, general body pain, influenza, tingling skin, scab, pruritus and scratch. The patient was treated with prednisone. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the rash, pruritus, external hemorrhoids and stye were not recovered/not resolved and the outcome of the general body pain, influenza and scratch were unknown and the outcome of the tingling skin and scab were recovered/resolved.   It was unknown if the reporter considered the rash, general body pain, influenza, tingling skin, scab, pruritus, scratch, external hemorrhoids and stye to be related to Shingrix.  Additional information was received as follows: After receiving 2nd dose of Shingrix, the patient had rash all over her body, it looks like shingles. She did talk to her doctor virtually and sent him pictures of the rash (patient said that she was willing to share these pictures with the company). The rash was on her stomach, arms and all over her body. It was itching and she was scratching a lot and started scabbing all over. The rash appeared to be under the skin initially and then it was raised in rashes. She was put on prednisone 10 mg for a month and some topical creams. After she done with the prednisone, her internal medicine physician recommended no refill.  She was still having itching and sort of a "pin prickling" type of rash or burning. It was not as bad as the beginning but it's still here.  She has not been fully diagnosed with shingles. She said that about 4 days after she stopped the prednisone treatment she developed an external hemorrhoid and what look like stye under both of her eyes. One was normal and the other one was very large. The reporter consented for followup.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash, Vaccination failure
Clinical narrative: Mild case of shingles; Mild case of shingles; Skin rash; This case was reported by a consumer and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 22nd July 2018, the patient received the 1st dose of Shingrix. On 20th November 2018, the patient received the 2nd dose of Shingrix. On an unknown date, less than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and rash. On an unknown date, the outcome of the vaccination failure, shingles and rash were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to Shingrix and Shingrix.  Additional information was provided as follows: The age at vaccination was not reported. The patient recently had a skin rash, he/she took pictures of it and sent them to internist. The internist said that it could be several things, one of which was a mild case of shingles. The patient did a one week course of a little reading and saw that Shingrix was about 90% effective he/she also seen 4 years mentioned regarding efficacy. The patient wanted to know about the 10% for whom Shingrix was not effective. For example, did they tend to get only mild cases of shingles. The patient wanted to know the recommendations for re-vaccination, such as after what time period.
Age: 66.0
Sex: F
Vaccine: FLU4
Symptoms: Dyspnoea, Electrocardiogram ambulatory, Heart rate increased, Influenza, Vaccination failure
Clinical narrative: heart rate while laying in bed has been at 115 beats per second; was diagnosed with the flu; flu; breathing issues; This case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a 66-year-old female patient who received Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2019-2020 season) for prophylaxis.   In November 2019, the patient received Influenza vaccine Quadrivalent 2019-2020 season. On 31st January 2020, between 2 and 3 months after receiving Influenza vaccine Quadrivalent 2019-2020 season, the patient experienced vaccination failure (serious criteria GSK medically significant), influenza and difficulty breathing. On an unknown date, the patient experienced heart rate increased. The patient was treated with fluticasone furoate, vilanterol trifenatate (Breo Ellipta). On an unknown date, the outcome of the vaccination failure, difficulty breathing and heart rate increased were unknown and the outcome of the influenza was recovering/resolving.   It was unknown if the reporter considered the vaccination failure, influenza, difficulty breathing and heart rate increased to be related to Influenza vaccine Quadrivalent 2019-2020 season.  Additional information was received as follows: The patient received flu vaccine on left arm. The Patient received a flu shot from an unknown manufacturer in mid-November 2019. On 31st January 2020, she was diagnosed with the flu which was still unresolved. The patient had breathing issues which get bad at night since having the flu. The patient mentioned that her heart was working hard to get her lungs to work, her heart rate while lying in bed has been at 115 beats per second. The patient would now wear a heart monitor at night. The patient was prescribed Breo Ellipta for her breathing issues, however, she is unable to afford the medication.  The report consented to follow up.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chest X-ray normal, Pneumonia
Clinical narrative: Pneumonia; sOCIAL PROBLEM; This case was reported by a consumer via call center representative and described the occurrence of pneumonia in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Concurrent medical conditions included sinus infection and cancer (Since 20 to 25 years).   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 not applicable after receiving Shingrix, the patient experienced pneumonia (serious criteria GSK medically significant) and social problem. On an unknown date, the outcome of the pneumonia was recovering/resolving and the outcome of the social problem was unknown.   The reporter considered the pneumonia to be unrelated to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient was cancer survivor for 20-25 years and had recurrent sinus infections on and off but not lately. The patient wanted to know if there was any reason not to receive 2nd dose and briefly mentioned having a light, mild case of pneumonia back in January or February 2020.  The patient reported being healthy since pneumonia infection as chest x-rays were good as of 1st March 2020. The patient declined to provide further information for safety report due to knowing that pneumonia was unrelated to Shingrix.  It was reported that the patient was in good health and due to have 2nd Shingrix dose this coming week but there was concerned due to COVID-19 and therefore would be pushing it off. The patient's demographics not provided and limited information was provided.
Age: 74.0
Sex: M
Vaccine: UNK, UNK
Symptoms: Biopsy, Blood test, Chemotherapy, Feeling abnormal, Injection site pain
Clinical narrative: Was off Jakafi for a couple of weeks for an unspecified reason; Experienced pain in the same shoulder pain that was miserable for the next 2 days; This spontaneous case, initially received on 27-Mar-2018, was reported by a physician and concerns a 74-year-old, elderly, male patient.    The patient's current condition included anemia (since an unspecified date). The concomitant medication included Vicodin (hydrocodone bitartrate, paracetamol), magnesium, vitamin d3 for unknown indications.  Since 22-Dec-2017, the patient was taking non-company suspect product Jakafi (ruxolitinib Phosphate, dose: 5 mg, route of administration: oral, frequency: qd (daily once), batch number, expiry date: not reported) for myelofibrosis.   On 05-Jan-2018, the patient was administered with INN Flu Vaccine Seasonal (Influenza vaccine, influenza virus vaccine polyvalent, dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported) as flu prophylaxis.  On 06-Jan-2018, the next day of vaccination, the patient experienced pain in the same shoulder (described as miserable for next 2 days). The patient consulted medical doctor and was prescribed with unspecified pain medication, which relieved the pain. On an unspecified date, during a follow-up, it was reported that, the patient was off from Jakafi regimen for an unspecified reason. Later, Jakafi 5 mg bid (twice-a-day) was included in the care plan. On an unspecified date, Jakafi 10 mg bid was initiated. On 16-Jan-2018, the patient had recovered from the event shoulder pain.   On 06-Feb-2018, the patient underwent unspecified blood tests, biopsy and chemotherapy.  The reporter assessed this case as non-serious and the causality of the event (shoulder pain) was considered as related to the flu shot.; Reporter's Comments: A 74-year-old elderly male patient, with concurrent condition anemia, was administered with suspect product INN Flu Vaccine Seasonal and co-suspect Jakafi and developed shoulder pain, the next day of vaccination. Considering the close temporal relationship and possibility of flu vaccine to cause the event, the causality is assessed as related. The event drug dose omission is assessed as not related, as it is related to the co-suspect drug Jakafi.
Age: 64.0
Sex: F
Vaccine: FLU4
Symptoms: Hypoaesthesia, Injection site swelling, Mobility decreased, Pain in extremity
Clinical narrative: She couldn't move her arm [and had pain and numbness in that arm]; [She couldn't move her arm and] had pain [and numbness] in that arm; [She couldn't move her arm and had pain and] numbness in that arm; The same day of the vaccine she developed swelling at the injection site; This non-serious spontaneous case, initially received from other non-health care professional on 11-Apr-2018, concerning a 64-year-old, adult, female patient.  The patient's current condition included diabetes (since an unspecified date).  On 09-Jan-2018, the patient was administered with Afluria (TIV) Thiomersal (influenza vaccine, dose: reported as 1 dose, batch number: 15049211A (reported as 150492110), expiry date: 30-Jun-2018, route of administration and anatomical location: not reported) for influenza prophylaxis.  On the same day, after the vaccination, the patient developed swelling at the injection site. She couldn't move her arm and had pain and numbness in that arm. On an unspecified date, the patient visited her HCP (health care professional) for treatment.  As of 23-Mar-2018, the patient had not recovered from the events.  The reporter did not provide the seriousness assessment.  Update received on 22-Oct-2018: Significant case correction (IRD: 11-Apr-2018): The suspect product coding was changed from Afluria (TIV) to Afluria (TIV) Thiomersal in the product tab. Narrative was amended accordingly.; Reporter's Comments: This 64-year-old, adult, female patient with concurrent condition of diabetes was administered with influenza vaccine. On the same day after the vaccination with Afluria (TIV) Thiomersal, the patient developed injection site swelling, her mobility decreased (couldn't move her arm), pain in arm and numbness of upper extremities. Considering the close temporal relationship between the vaccination and biological nature of the events, the events are assessed as related to the influenza vaccine.
Sex: F
Vaccine: FLUX, PPV
Symptoms: Injection site erythema, Injection site swelling
Clinical narrative: Injection site redness [and swelling]; Injection site [redness] and swelling; This is a non-serious spontaneous case, initially received from other non- health professional via pharmaceutical manufacturer (Merck) on 07-May-2018, concerning a female patient of unspecified age.  On an unspecified date, the patient was administered with INN Flu Vaccine Seasonal (influenza vaccine, influenza virus vaccine polyvalent, dose, route of administration, anatomical location, batch number, expiry date, trade name, manufacturer: not reported) for an unknown indication and Pneumovax 23 (Pneumococcal vaccine, dose, route of administration, anatomical location, batch number, expiry date: not reported) for an unknown indication.  On an unspecified date, next day of vaccination, the patient experienced redness and swelling at injection site. At the time of this report, the outcome of the events was not reported.; Reporter's Comments: A female patient of unspecified age experienced redness and swelling at injection site after vaccination. The causality of the events is assessed as related due to the anatomical location of the events.
Sex: F
Vaccine: FLUX
Symptoms: Hypersensitivity
Clinical narrative: Allergies; This non-serious spontaneous case, initially received from a physician via pharmaceutical manufacturer Merck (reference number: 00843915) on 12-Jun-2018, concerning a female patient of an unspecified age.  The patient had been allergic to morphine, nickel, formaldehyde and bee stings.  On an unspecified date, the patient was administered with INN Flu Vaccine Seasonal (influenza vaccine, influenza virus vaccine polyvalent, dose, route of administration, anatomical location, batch number, expiry date, manufacturer and trade name: not reported) for an unknown indication.  On an unspecified date, after vaccination, the patient experienced allergies (unspecified).   At the time of this report, the outcome of the event was not reported.   Th reporter considered the causality of the event as related to suspect vaccine.; Reporter's Comments: A female patient of an unspecified age experienced allergy (unspecified) on an unspecified date, after vaccination, the causality of the event is unassessable due lack of information regarding vaccination date, onset date of the event and type of allergy.
Age: 24.0
Sex: M
Vaccine: FLU4
Symptoms: Body temperature increased, Chills, Headache, Malaise, Pain
Clinical narrative: Body aches; Chills; Headaches; 99.2 F; Feeling unwell/ felt unwell/ unwell; This is a spontaneous case, initially received from other healthcare professional (nurse) on 23-Aug-2018 (combined follow up 24-Aug-2018), concerning a 24-year-old adult male patient.  The patient's medical and medication history were not reported.  On 22-Aug-2018, the patient was administered with Afluria Quadrivalent (Influenza Vaccine, Dose: 0.5 ml, batch number: YF37005, expiry date: 17-May-2019, route of administration and anatomical location: not reported) for an unknown indication.  On the same day after vaccination at night, the patient felt unwell. On 23-Aug-2018 at 8 AM, the patient complained of body aches, chills and headache. The patient's temperature was 99.2F. The patient went home without working as he was still unwell.  The outcome of the events felt unwell, body aches, chills, headaches and increased body temperature was not recovered.  The reporter assessed this case as non-serious.; Reporter's Comments: A 24-year-old adult male patient felt unwell on the same day after vaccination with the suspect vaccine Afluria Quadrivalent. On the next day after vacccination, the patient complained of body aches, chills, headaches and body temperature of 99.2F. The causality assessed as related based on the plausible temporal relationship between the suspect vaccine and the events.
Age: 48.0
Sex: F
Vaccine: FLU4
Symptoms: Musculoskeletal stiffness
Clinical narrative: Stiff neck; This spontaneous case, initially received on 29-Aug-2018 and reported by other healthcare professional, concerns a 48-year-old adult female patient.  The patient's medical history was not available. The patient's concomitant medication included Venlafaxine for an unknown indication.  On 27-Aug-2018, the patient was administered Afluria Quadrivalent [influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: YF36105 (as reported) and expiry date: 07-May-2019] for active immunization against influenza disease caused by influenza virus subtypes A and type B. The reported batch number (YF36105), did not match Seqirus batch numbers, however, because the reporter named Seqirus product Afluria Quadrivalent' as the suspect vaccine, this report had been conservatively entered as a Seqirus case.  On 28-Aug-2018 (reported as yesterday), 1 day after vaccination, the patient woke up with a stiff neck. On 29-Aug-2018 (reported as today), the patient's neck was still stiff with no improvement and the patient was scheduled for a visit with her doctor.  At the time of this report, the patient had not recovered from the event.  The reporter assessed this case as non-serious.  Follow-up report received from pharmacist on 11-Oct-2018: The reporter confirmed the dose of suspect product as 0.5 ml, route of administration as intramuscular and anatomical location as deltoid. The secondary reporter was added. The narrative amended accordingly.; Reporter's Comments: A 48-year-old female patient developed neck stiffness, 1 day after vaccination with suspect vaccine Afluria Quadrivalent. The company assessed the causality of the event as related due to plausible temporal relationship between the event and suspect vaccine.
Age: 36.0
Sex: M
Vaccine: FLU4
Symptoms: Back pain, Mobility decreased
Clinical narrative: Lower and middle back pain that is progressively worse; Trouble getting up; Lower and middle back pain; This spontaneous case, initially received on 05-Sep-2018 reported by a Pharmacist in and concerns a 36-year-old, adult male patient.  The patient did not receive any concomitant medications.   On 31-Aug-2018, the patient was administered Afluria Quadrivalent (influenza vaccine, dose: reported as full dose, batch number: YF36705, expiry date: 15-May-2019, route of administration, anatomical location: not reported) for active immunization against influenza. The Seqirus confirmed that, the reported batch number was Afluria PFS 0.5ml x 10 (QIV).   On an unspecified date, after vaccination, the patient experienced lower and middle back pain which progressively worsened and had trouble in getting up. It was reported that, the patient did not receive any treatment.   At the time of this report, the outcome of the events was not reported.  The reporter assessed the case as non-serious.; Reporter's Comments: A 36-year-old, male patient experienced lower and middle back pain, condition worsened and movement disorder on an unspecified date after vaccination with Afluria Quadrivalent. The causality of the events was unassessable due to the lack of onset latency.
Age: 63.0
Sex: M
Vaccine: FLU4
Symptoms: Migraine, Musculoskeletal stiffness
Clinical narrative: Migraine headache; Had neck stiffness; This spontaneous case, initially received on 17-Sep-2018, reported by a physician, concerns a 63-year-old, adult male patient.   The patient had not received any concomitant medications.  On an unspecified date, the patient was administered Afluria Quadrivalent (influenza vaccine, dose: 0.5 ml, anatomical location: deltoid, batch number: YF36505, route of administration: intramuscular, expiry date: not reported) for influenza prophylaxis.   On an unspecified date, 24 hours after vaccination, the patient experienced neck stiffness and migraine headache.  At the time of this report, the patient was almost back to normal, but was not quite yet (recovering).  The reporter assessed the case as non-serious.   Follow-up received from the physician on 26-Sep-2018: The patient's age 63 year was added in the patient tab. The event onset latency was changed from 2 days to 24 hours in the event tab. The outcome of the events was changed from recovered to recovering. The narrative and case comment were amended accordingly.; Reporter's Comments: A 63-year-old, male patient, experienced neck stiffness and migraine headache, 24 hours after vaccination with the suspect vaccine Afluria Quadrivalent. The company assessed the causality of the events as related due to plausible temporal relationship between events and suspect vaccine.
Age: 50.0
Sex: M
Vaccine: FLU4
Symptoms: Injection site erythema, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: Injection site [red and] hot to the touch; Injection site went tall and swollen; Injection site red [and hot to the touch]; Injection site sore/the area is also tender to the touch and very painful; This spontaneous case, initially received from other healthcare professional (nurse) on 28-Sep-2018, concerns a 50-year-old, adult, male patient.  The patient had no historical conditions. The patient was not taking any concomitant medications at the time of vaccination.  On 26-Sep-2018, the patient was administered Afluria (QIV) [influenza vaccine, dose: 0.5 ml, route of administration: intramuscular, anatomical location: deltoid, batch number: 02444611A and expiry date: 06-Jun-2019] for active immunization against influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine.  On 27-Sep-2018, one day after vaccination, the patient's injection site went tall (as reported) and swollen, bigger than half a dollar. It was red, hot and tender to touch and was very painful. The patient's treatment measure included ice.  On an unspecified date in 2018, the patient had recovered from the events within one week after administration of the vaccine. The patient felt better.  The reporter assessed this case as non-serious.  This case 201804183 was cross-linked with the original case 201804181 due to same reporter.  Follow up received on 26-Oct-2018: The expiry date of the suspect product was updated as 06-Jun-2019 in the product tab. The outcome for all the events was changed from not recovered to recovered in the event tab. It was reported that, the patient felt better. The narrative was amended accordingly.; Reporter's Comments: A 50-year-old male patient experienced injection site warmth, pain, swelling and redness, one day after the administration of suspect vaccine Afluria (QIV). The company assessed the causality of the events as related due to plausible temporal relationship between vaccination to event onset and localized events of the injected limb.