chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 69.0
Sex: M
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome, Muscular weakness
Clinical narrative: Guillain Barre syndrome; weakness in arms/ shoulders/ hands; This case was reported by a lawyer and described the occurrence of guillain barre syndrome in a 69-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   The initial information was received on 27 May 2021 via medical record (case is now medically confirmed). As per the medical records plaintiff had received Shingrix first shot on 27 December 2018 for Prophylaxis. On 01 January 2019 patient experienced weakness in arms, shoulders and hands. Patient visited hospital for same reasons and admitted on 04 January 2019 where patient was diagnosed with GBS(Guillain Barre syndrome). The patient currently experiences weakness in arms and hands.
Sex: M
Vaccine: VARZOS
Symptoms: Asthenia, Guillain-Barre syndrome, Immunoglobulin therapy, Muscular weakness
Clinical narrative: GBS; acute weakness all over extrimities/ Weakness generalised; This case was reported by a lawyer and described the occurrence of guillain barre syndrome in a patient who received Herpes zoster (Shingrix) (batch number unk, expiry date unknown) for prophylaxis.   Concurrent medical conditions included hypertension and gastroesophageal reflux disease.   On 8th December 2020, the patient received the 2nd dose of Shingrix (intramuscular). On 17th January 2021, 40 days after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria GSK medically significant) and weakness generalized. The action taken with Shingrix was unknown. On an unknown date, the outcome of the guillain barre syndrome and weakness generalized were unknown.   It was unknown if the reporter considered the guillain barre syndrome and weakness generalized to be related to Shingrix.  The initial information was received on 27 May 2021 via medical record ( case is medically confirmed).The patient received his first shingrix vaccine on 30 October 2020 and his second dose on 08 December 2020.The current condition included hypertension, GERD. On 17 January 2021 he had generalized weakness in all extremities. The physician suspected to be GBS and give IVIG treatments, was admitted 2 months for treatment.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Acoustic neuroma, Ataxia, Balance disorder, Coordination abnormal, Guillain-Barre syndrome
Clinical narrative: Numbness; paresthesia starting at toes, progress up to ankle and invalving hand; poor balance; acoustic neuroma; general sense of incordination, decreased sensation; mild ataxia in legs; postural tremors of hands bilaterally; Guillain Barre Syndrome/AIDP; This case was reported by a lawyer and described the occurrence of guillain barre syndrome in a 66-year-old male patient who received Herpes zoster (Shingrix) (batch number unk, expiry date unknown) for prophylaxis.   Previously administered products included Shingrix (3 July 2019).   On 6th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 12th December 2019, 97 days after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). The action taken with Shingrix was unknown. On an unknown date, the outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to Shingrix.  Initial information received on 27 May 2021 via medical record. The patient received 1st dose of Shingrix on 3 July 2019 and 2nd dose on 6 September 2019. The patient experienced  guillain barre syndrome and AIDP on12 December 2019. The patient had numbness, paresthesia starting at toes, progress up to ankle and involving hand, poor balance, acoustic neuroma, general sense of incordination, decreased sensation, mild ataxia in legs, postural tremors of hands bilaterally.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Paraesthesia, Postural tremor, Tremor
Clinical narrative: Numbness; paresthesia starting at toes, progress up to ankle and invalving hand; poor balance; acoustic neuroma; general sense of incordination, decreased sensation; mild ataxia in legs; postural tremors of hands bilaterally; Guillain Barre Syndrome/AIDP; This case was reported by a lawyer and described the occurrence of guillain barre syndrome in a 66-year-old male patient who received Herpes zoster (Shingrix) (batch number unk, expiry date unknown) for prophylaxis.   Previously administered products included Shingrix (3 July 2019).   On 6th September 2019, the patient received the 1st dose of Shingrix (intramuscular). On 12th December 2019, 97 days after receiving Shingrix, the patient experienced guillain barre syndrome (serious criteria GSK medically significant). The action taken with Shingrix was unknown. On an unknown date, the outcome of the guillain barre syndrome was unknown.   It was unknown if the reporter considered the guillain barre syndrome to be related to Shingrix.  Initial information received on 27 May 2021 via medical record. The patient received 1st dose of Shingrix on 3 July 2019 and 2nd dose on 6 September 2019. The patient experienced  guillain barre syndrome and AIDP on12 December 2019. The patient had numbness, paresthesia starting at toes, progress up to ankle and involving hand, poor balance, acoustic neuroma, general sense of incordination, decreased sensation, mild ataxia in legs, postural tremors of hands bilaterally.
Age: 66.0
Sex: M
Vaccine: VARZOS
Symptoms: Guillain-Barre syndrome, Influenza, Malaise
Clinical narrative: Guillain Barre Syndrome; Malaise; Flu syndrome; This case was reported by a lawyer and described the occurrence of guillain barre syndrome in a 66-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 7th January 2019, the patient received the 1st dose of Shingrix (intramuscular). On 8th January 2019, 1 days after receiving Shingrix, the patient experienced malaise and flu syndrome. On 11th January 2019, the patient experienced guillain barre syndrome (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the guillain barre syndrome, malaise and flu syndrome were unknown.   It was unknown if the reporter considered the guillain barre syndrome, malaise and flu syndrome to be related to Shingrix.  Initial information received via legal complaint on 27 May 2021.The patient received 1st dose of Shingrix on 7 January 2019. The patient experienced malaise and flue syndrome on 8 January 2019 and guillain barre syndrome on 11 January 2019.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Bell's palsy, Facial pain, Hypoaesthesia, Lacrimation increased, Sinusitis
Clinical narrative: Bells Palsy; numbness (R side of face); Sinusitis; right eye watering non-stop; pain right side of face; This case was reported by a lawyer and described the occurrence of bell's palsy in a 63-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no reaction on previous exposure to drug. Concurrent medical conditions included hyperlipidemia.   On 24th September 2020, the patient received the 2nd dose of Shingrix (unknown). On 28th September 2020, unknown after receiving Shingrix, the patient experienced sinusitis, watering eyes and facial pain. On an unknown date, the patient experienced bell's palsy (serious criteria GSK medically significant) and numbness facial. On an unknown date, the outcome of the bell's palsy, numbness facial, sinusitis, watering eyes and facial pain were unknown.   It was unknown if the reporter considered the bell's palsy, numbness facial, sinusitis, watering eyes and facial pain to be related to Shingrix.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Blindness unilateral, Central vision loss, Headache, Injection site pain, Macular oedema
Clinical narrative: swelling in the macula; Optic Neuritis; central loss of vision to left eye; ischemic optic neuropathy; myalgia; headache; fever; pain at injection site; This case was reported by a consumer and described the occurrence of optic neuritis in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced optic neuritis (serious criteria GSK medically significant), central vision loss (serious criteria GSK medically significant), ischemic optic neuropathy (serious criteria GSK medically significant), macular swelling (serious criteria GSK medically significant), myalgia, headache, fever and injection site pain. On an unknown date, the outcome of the optic neuritis, central vision loss, ischemic optic neuropathy, macular swelling, myalgia, headache, fever and injection site pain were unknown.   It was unknown if the reporter considered the optic neuritis, central vision loss, ischemic optic neuropathy, macular swelling, myalgia, headache, fever and injection site pain to be related to Shingrix.  The patient received the Shingrix vaccine on 12/17/2018. For three (3) days following the vaccine, The patient was ill (myalgia, headache, fever, pain at injection site) and experienced loss of vision in his left eye on 12/24/2018. The patient suffered from swelling in the macula and was ultimately diagnosed with ischemic optic neuropathy/optic neuritis. The patient's treatment regimen has included steroids, which provided some improvement. He has yet to regain his eyesight and the prognosis is permanent vision loss.
Age: 51.0
Sex: M
Vaccine: VARZOS
Symptoms: Malaise, Myalgia, Optic ischaemic neuropathy, Optic neuritis, Pyrexia
Clinical narrative: swelling in the macula; Optic Neuritis; central loss of vision to left eye; ischemic optic neuropathy; myalgia; headache; fever; pain at injection site; This case was reported by a consumer and described the occurrence of optic neuritis in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced optic neuritis (serious criteria GSK medically significant), central vision loss (serious criteria GSK medically significant), ischemic optic neuropathy (serious criteria GSK medically significant), macular swelling (serious criteria GSK medically significant), myalgia, headache, fever and injection site pain. On an unknown date, the outcome of the optic neuritis, central vision loss, ischemic optic neuropathy, macular swelling, myalgia, headache, fever and injection site pain were unknown.   It was unknown if the reporter considered the optic neuritis, central vision loss, ischemic optic neuropathy, macular swelling, myalgia, headache, fever and injection site pain to be related to Shingrix.  The patient received the Shingrix vaccine on 12/17/2018. For three (3) days following the vaccine, The patient was ill (myalgia, headache, fever, pain at injection site) and experienced loss of vision in his left eye on 12/24/2018. The patient suffered from swelling in the macula and was ultimately diagnosed with ischemic optic neuropathy/optic neuritis. The patient's treatment regimen has included steroids, which provided some improvement. He has yet to regain his eyesight and the prognosis is permanent vision loss.
Sex: U
Vaccine: RAB
Symptoms: Intercepted product prescribing error
Clinical narrative: prescription to have 4 doses of post exposure; This case was reported by a pharmacist via call center representative and described the occurrence of intercepted product prescribing error in a patient who received Rabies NVS (RabAvert) for prophylaxis.   On an unknown date, the patient received RabAvert. On an unknown date, unknown after receiving RabAvert, the patient experienced intercepted product prescribing error. On an unknown date, the outcome of the intercepted product prescribing error was unknown.  Additional details were reported as follows: The age at vaccination was not applicable for this report. Pharmacist reported the patient had a prescription to have 4 doses of post exposure treatment with RabAvert instead of 5, which led to intercepted product prescribing error. The Pharmacist said that he was going to make the doctors change the prescription to 5 doses. This case has been linked with case US2020AMR139748, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2020AMR139748:
Sex: U
Vaccine: RAB
Symptoms: Incomplete course of vaccination
Clinical narrative: Missed the third dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Rabies NVS (RabAvert) for prophylaxis.   Concomitant products included Rabies NVS (RabAvert) and Rabies NVS (RabAvert).   On an unknown date, the patient received the 3rd dose of RabAvert. On an unknown date, unknown after receiving RabAvert, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The type of exposure (pre or post prophylaxis) was unknown. The pharmacist reported that a patient missed the third dose of Rabavert which should have been given on 4th August 2020, which led to incomplete course of vaccination. The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS
Symptoms: Medication error
Clinical narrative: a patient who is under 50 years old has a prescription to receive Shingrix; a patient who is under 50 years old has a prescription to receive Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of circumstance or information capable of leading to medication error in a 49-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced circumstance or information capable of leading to medication error and drug prescribing error. On an unknown date, the outcome of the circumstance or information capable of leading to medication error and drug prescribing error were unknown.   Additional details were provided as follows: The age at vaccination not reported. The patient under 50 years old had a prescription to receive Shingrix, which led to drug prescribing error and circumstance or information capable of leading to medication error. The reporter consented to follow up.
Age: 42.0
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Late second dose of Twinrix/ first dose 11/23/2021 and the second dose 5 months later; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 42-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (1st dose received on 23rd November 2020, batch number H4A37, expiry date 18th October 2021).   In April 2021, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. In April 2021, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows:  The age at vaccination was not reported.  The patient received 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccination schedule. At the time of reporting, a month had approximately passed by since the 2nd dose. No further events were reported. The reporter consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: had the first dose of Shingrix in 10/2020 and is overdue for the second dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose in October 2020, intramuscularly).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix as per the vaccination schedule, which led to incomplete course of vaccination. The reporter was planning on scheduling an appointment at this time. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: third dose of shingrix was given to patient; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number 3XR3X, expiry date 12th September 2022) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on an unknown date) and Shingrix (received 2nd dose on an unknown date).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.  Additional details were reported as follows: The age at vaccination was not reported. The pharmacist reported that a 3rd dose of Shingrix was given to the patient which led to extra dose administered. The pharmacist asked how to proceed and what to expect side effects wise. The reporter did not consent to follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Lip blister
Clinical narrative: Blister on lower lip/ appeared the next day; This case was reported by a pharmacist via call center representative and described the occurrence of lip blister in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number 3K743, expiry date 7th November 2022) for prophylaxis.   On 26th May 2021, the patient received the 1st dose of Shingrix (intramuscular) 50 µg. On 27th May 2021, 1 days after receiving Shingrix, the patient experienced lip blister. On an unknown date, the outcome of the lip blister was not recovered/not resolved.   It was unknown if the reporter considered the lip blister to be related to Shingrix.  Additional details were provided as follows: The pharmacy intern called and reported that the patient received the 1st dose of Shingrix on left arm and 1 day after the vaccination patient experienced a blister on lower lip. On 28th May 2021 the patient visited pharmacy to show the blister. The patient stated that blister appeared the next day after receiving Shingrix vaccine.
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Injection site hypoaesthesia, Injection site pain, Myalgia, Pain
Clinical narrative: Injection site sore; the right arm which is numb.; fever; Chills; muscle aches; pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included hepatitis B shot with an associated reaction of illness (received 3 or 4 shot series, many yeras ago from the date of reporting and the patient's body did not build up the titers. For the tolerance of doses, refer linked case US2021AMR116449) and Shingles vaccine (1st dose received on an unknown date at age 55 years; 2nd dose received on an unknown date at age 60 years).   In November 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced injection site pain, injection site numbness, fever, chills, muscle pain and pain. On an unknown date, the outcome of the injection site pain, fever, chills, muscle pain and pain were recovered/resolved and the outcome of the injection site numbness was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site numbness, fever, chills, muscle pain and pain to be related to Shingrix.  Additional details were provided as follow: This case was reported by patient herself. In mid-November 2020, the patient received 1st dose of Shingrix in left arm and had a mild reaction included fever, chills, muscle aches, pains, and her left arm was sore (at the injection site).  The reported events were resolved except numbness. The patient had a little numb spot at the site of the injection which had not resolved, the patient felt it was still there, and it felt weird and was numb. The reporter consented to follow up. For tolerance of 2nd dose refer case US2021AMR116458. This is 1 of 3 cases reported by the same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR116458:Same patient: Shingrix 2nd dose US-GLAXOSMITHKLINE-US2021AMR116458:Same patient, 2nd dose
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: Injection site sore; the right arm which is numb.; fever; Chills; muscle aches; pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included hepatitis B shot with an associated reaction of illness (received 3 or 4 shot series, many yeras ago from the date of reporting and the patient's body did not build up the titers. For the tolerance of doses, refer linked case US2021AMR116449) and Shingles vaccine (1st dose received on an unknown date at age 55 years; 2nd dose received on an unknown date at age 60 years).   In November 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced injection site pain, injection site numbness, fever, chills, muscle pain and pain. On an unknown date, the outcome of the injection site pain, fever, chills, muscle pain and pain were recovered/resolved and the outcome of the injection site numbness was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site numbness, fever, chills, muscle pain and pain to be related to Shingrix.  Additional details were provided as follow: This case was reported by patient herself. In mid-November 2020, the patient received 1st dose of Shingrix in left arm and had a mild reaction included fever, chills, muscle aches, pains, and her left arm was sore (at the injection site).  The reported events were resolved except numbness. The patient had a little numb spot at the site of the injection which had not resolved, the patient felt it was still there, and it felt weird and was numb. The reporter consented to follow up. For tolerance of 2nd dose refer case US2021AMR116458. This is 1 of 3 cases reported by the same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR116458:Same patient: Shingrix 2nd dose US-GLAXOSMITHKLINE-US2021AMR116458:Same patient, 2nd dose
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Feeling abnormal, Injection site hypoaesthesia, Injection site pain, Myalgia
Clinical narrative: Injection site sore; the right arm which is numb.; fever; Chills; muscle aches; pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included hepatitis B shot with an associated reaction of illness (received 3 or 4 shot series, many yeras ago from the date of reporting and the patient's body did not build up the titers. For the tolerance of doses, refer linked case US2021AMR116449) and Shingles vaccine (1st dose received on an unknown date at age 55 years; 2nd dose received on an unknown date at age 60 years).   In November 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced injection site pain, injection site numbness, fever, chills, muscle pain and pain. On an unknown date, the outcome of the injection site pain, fever, chills, muscle pain and pain were recovered/resolved and the outcome of the injection site numbness was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site numbness, fever, chills, muscle pain and pain to be related to Shingrix.  Additional details were provided as follow: This case was reported by patient herself. In mid-November 2020, the patient received 1st dose of Shingrix in left arm and had a mild reaction included fever, chills, muscle aches, pains, and her left arm was sore (at the injection site).  The reported events were resolved except numbness. The patient had a little numb spot at the site of the injection which had not resolved, the patient felt it was still there, and it felt weird and was numb. The reporter consented to follow up. For tolerance of 2nd dose refer case US2021AMR116458. This is 1 of 3 cases reported by the same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR116458:Same patient: Shingrix 2nd dose US-GLAXOSMITHKLINE-US2021AMR116458:Same patient, 2nd dose
Age: 65.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: Injection site sore; the right arm which is numb.; fever; Chills; muscle aches; pain; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included hepatitis B shot with an associated reaction of illness (received 3 or 4 shot series, many yeras ago from the date of reporting and the patient's body did not build up the titers. For the tolerance of doses, refer linked case US2021AMR116449) and Shingles vaccine (1st dose received on an unknown date at age 55 years; 2nd dose received on an unknown date at age 60 years).   In November 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced injection site pain, injection site numbness, fever, chills, muscle pain and pain. On an unknown date, the outcome of the injection site pain, fever, chills, muscle pain and pain were recovered/resolved and the outcome of the injection site numbness was not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site numbness, fever, chills, muscle pain and pain to be related to Shingrix.  Additional details were provided as follow: This case was reported by patient herself. In mid-November 2020, the patient received 1st dose of Shingrix in left arm and had a mild reaction included fever, chills, muscle aches, pains, and her left arm was sore (at the injection site).  The reported events were resolved except numbness. The patient had a little numb spot at the site of the injection which had not resolved, the patient felt it was still there, and it felt weird and was numb. The reporter consented to follow up. For tolerance of 2nd dose refer case US2021AMR116458. This is 1 of 3 cases reported by the same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR116458:Same patient: Shingrix 2nd dose US-GLAXOSMITHKLINE-US2021AMR116458:Same patient, 2nd dose
Age: 55.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Injection site hypoaesthesia, Injection site pain, Myalgia, Pain
Clinical narrative: her left arm was sore (at the injection site).; has a little numb spot at the site of the injection/still there and it feels weird and is numb; fever; chills; muscle aches; pain; Feeling weird; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 66-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Hepatitis B vaccine with an associated reaction of illness (received 3 or 4 shot series, many yeras ago from the date of reporting. For the tolerance of doses, refer linked case US2021AMR116449).   In November 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced injection site pain, injection site numbness, fever, chills, muscle pain, pain and weird feeling. On an unknown date, the outcome of the injection site pain, fever, chills, muscle pain and pain were recovered/resolved and the outcome of the injection site numbness and weird feeling were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site numbness, fever, chills, muscle pain, pain and weird feeling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had reported fot him/herself. The patient received Shingrix in left arm.  After receiving Shingrix, the patient experienced fever, chills, muscle aches and pains, and her left arm was sore at the injection site.  All these events were resolved.   The patient had a little numb spot at the site of the injection which had not resolved at the time of reporting.  It was still there at the time of reporting, and it felt weird and was numb, due to this she had been avoiding getting any immunizations in her left arm. For the tolerance of 2nd dose, refer linked case US2021115923.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR116449:Same patient: Hepatitis B vaccine US-GLAXOSMITHKLINE-US2021115923:Same patient: Shingrix 2nd dose US-GLAXOSMITHKLINE-US2021115923:
Age: 55.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Pyrexia
Clinical narrative: her left arm was sore (at the injection site).; has a little numb spot at the site of the injection/still there and it feels weird and is numb; fever; chills; muscle aches; pain; Feeling weird; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 66-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Hepatitis B vaccine with an associated reaction of illness (received 3 or 4 shot series, many yeras ago from the date of reporting. For the tolerance of doses, refer linked case US2021AMR116449).   In November 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced injection site pain, injection site numbness, fever, chills, muscle pain, pain and weird feeling. On an unknown date, the outcome of the injection site pain, fever, chills, muscle pain and pain were recovered/resolved and the outcome of the injection site numbness and weird feeling were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site numbness, fever, chills, muscle pain, pain and weird feeling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had reported fot him/herself. The patient received Shingrix in left arm.  After receiving Shingrix, the patient experienced fever, chills, muscle aches and pains, and her left arm was sore at the injection site.  All these events were resolved.   The patient had a little numb spot at the site of the injection which had not resolved at the time of reporting.  It was still there at the time of reporting, and it felt weird and was numb, due to this she had been avoiding getting any immunizations in her left arm. For the tolerance of 2nd dose, refer linked case US2021115923.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR116449:Same patient: Hepatitis B vaccine US-GLAXOSMITHKLINE-US2021115923:Same patient: Shingrix 2nd dose US-GLAXOSMITHKLINE-US2021115923:
Age: 55.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Feeling abnormal, Injection site hypoaesthesia, Injection site pain, Myalgia
Clinical narrative: her left arm was sore (at the injection site).; has a little numb spot at the site of the injection/still there and it feels weird and is numb; fever; chills; muscle aches; pain; Feeling weird; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 66-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Hepatitis B vaccine with an associated reaction of illness (received 3 or 4 shot series, many yeras ago from the date of reporting. For the tolerance of doses, refer linked case US2021AMR116449).   In November 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced injection site pain, injection site numbness, fever, chills, muscle pain, pain and weird feeling. On an unknown date, the outcome of the injection site pain, fever, chills, muscle pain and pain were recovered/resolved and the outcome of the injection site numbness and weird feeling were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site numbness, fever, chills, muscle pain, pain and weird feeling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had reported fot him/herself. The patient received Shingrix in left arm.  After receiving Shingrix, the patient experienced fever, chills, muscle aches and pains, and her left arm was sore at the injection site.  All these events were resolved.   The patient had a little numb spot at the site of the injection which had not resolved at the time of reporting.  It was still there at the time of reporting, and it felt weird and was numb, due to this she had been avoiding getting any immunizations in her left arm. For the tolerance of 2nd dose, refer linked case US2021115923.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR116449:Same patient: Hepatitis B vaccine US-GLAXOSMITHKLINE-US2021115923:Same patient: Shingrix 2nd dose US-GLAXOSMITHKLINE-US2021115923:
Age: 55.0
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Pain, Pyrexia
Clinical narrative: her left arm was sore (at the injection site).; has a little numb spot at the site of the injection/still there and it feels weird and is numb; fever; chills; muscle aches; pain; Feeling weird; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 66-year-old patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Hepatitis B vaccine with an associated reaction of illness (received 3 or 4 shot series, many yeras ago from the date of reporting. For the tolerance of doses, refer linked case US2021AMR116449).   In November 2020, the patient received the 1st dose of Shingrix. On an unknown date, less than 6 months after receiving Shingrix, the patient experienced injection site pain, injection site numbness, fever, chills, muscle pain, pain and weird feeling. On an unknown date, the outcome of the injection site pain, fever, chills, muscle pain and pain were recovered/resolved and the outcome of the injection site numbness and weird feeling were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injection site numbness, fever, chills, muscle pain, pain and weird feeling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient had reported fot him/herself. The patient received Shingrix in left arm.  After receiving Shingrix, the patient experienced fever, chills, muscle aches and pains, and her left arm was sore at the injection site.  All these events were resolved.   The patient had a little numb spot at the site of the injection which had not resolved at the time of reporting.  It was still there at the time of reporting, and it felt weird and was numb, due to this she had been avoiding getting any immunizations in her left arm. For the tolerance of 2nd dose, refer linked case US2021115923.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR116449:Same patient: Hepatitis B vaccine US-GLAXOSMITHKLINE-US2021115923:Same patient: Shingrix 2nd dose US-GLAXOSMITHKLINE-US2021115923:
Sex: U
Vaccine: TDAP
Symptoms: Incorrect route of product administration
Clinical narrative: patient received Boostrix subcutaneously; This case was reported by a nurse via call center representative and described the occurrence of intramuscular formulation administered by other route in a patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On an unknown date, the patient received Boostrix (subcutaneous). On an unknown date, unknown after receiving Boostrix, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The nurse reported that the patient received Boostrix subcutaneously which led to intramuscular formulation administered by other route. No other information was available. The reporter did not consented to follow up.
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Device connection issue, Syringe issue, Underdose
Clinical narrative: the needle unscrewed and leaked; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a 78-year-old male patient who received Herpes zoster (Shingrix) (batch number K3YC7, expiry date 7th November 2022) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose of Shingrix on 25th November 2020).   On 28th May 2021, the patient received the 2nd dose of Shingrix (unknown). On 28th May 2021, unknown after receiving Shingrix, the patient experienced accidental underdose. On an unknown date, the outcome of the accidental underdose was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The reporter stated that, during administering needle unscrewed and leaked, which led to accidental underdose. The Healthcare professional would contact CDC for recommendations regarding revaccination scheduling. The reporter consented to follow up. The Healthcare professional agrees to postal follow-up.
Age: 1.0
Sex: M
Vaccine: HIBV
Symptoms: Expired product administered
Clinical narrative: patient who received an expired dose / it expired on 20May2021 and was administered on 26May2021; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 12-month-old male patient who received Hib (Hiberix) (batch number 49S44, expiry date 20th May 2021) for prophylaxis.   On 26th May 2021, the patient received Hiberix. On 26th May 2021, unknown after receiving Hiberix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details provided were as follows: The reported batch number was not found in the sales data sheet and captured as 49S44 according to sales data sheet. On 28th May 2021, the reporter reported that the patient received an expired dose of Hiberix, which was already expired on 20th May 2021.  The health care professional declined to provide the last name of the patient but consented follow up and provided mailing address.
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Pruritus, Rash
Clinical narrative: red, itching rash on her face and scalp / rash is on her face in the area where she wears a face mask; red, itching rash on her face and scalp / rash is on her face in the area where she wears a face mask; muscle pains that she described as cramps in her calf muscles; cramp in calf muscle; This case was reported by a consumer and described the occurrence of itchy rash in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included muscle pain and cramps calf.   On 12th February 2021, the patient received the 1st dose of Shingrix. On an unknown date, less than 4 months after receiving Shingrix, the patient experienced itchy rash, red rash, muscle pain and cramps calf. On an unknown date, the outcome of the itchy rash, red rash, muscle pain and cramps calf were not recovered/not resolved.   It was unknown if the reporter considered the itchy rash, red rash and cramps calf to be related to Shingrix. The reporter considered the muscle pain to be unrelated to Shingrix.  Additional details provided were as follows: The patient received the first dose and later and experienced red and itching rash on her face and scalp the patient reported muscle pains that she described as cramps in her calf muscles. She had experienced these events prior to receiving Shingrix. It was unclear how long after the injection these symptoms were noted. The patient had planned to consult with a dermatologist soon. The reporter did not consented to follow up. The reporter does not feel muscle pain was related to Shingrix vaccine.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Pt received first dose / on oct 2019 (2 years ago ) never got the 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of no adverse event (received 1st dose of Shingrix in October 2019 (2 years ago), batch number-3553N.).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details was reported as follows: The age at vaccination was not applicable for this report. Till the time of reporting, patient did not received the 2nd dose of shingrix, which led to incomplete course of vaccination. The reporter stated that, no other details of vaccine were available. The reporter consented to follow up.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Haemorrhage, Injury, Physical examination, Road traffic accident
Clinical narrative: MASSIVE BLUNT FORCE TRAUMA; CAR ACCIDENT; BLEEDING PROBLEMS; FELT PUNK; POSITIVE COVID TEST/ CONFIRMED COVID-19 INFECTION; This spontaneous report received from a consumer concerned an 77year old male.  The patient's weight was 216 pounds, and height was 65 inches. The patient's concurrent conditions included pacemaker, and copd (Chronic obstructive pulmonary disease), and other pre-existing medical conditions included the patient was on respiratory medications and blood thinners. The patient was previously treated with warfarin.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, Expiry :unknown) dose was not reported, 1 total, administered on 10-MAY-2021 for prophylactic vaccination. The batch number was not provided and has been requested. On an unspecified date in JAN-2021, Laboratory data included: COVID-19 virus test (NR: not provided) positive. The patient felt a little punk from the vaccine initially. On 18-MAY-2021, the patient was in a car accident. He was driving a truck and got T-boned by a car and pushed 40 feet into a ditch. He was hospitalized and had 2 negative rapid tests for COVID. He decompensated and was intubated. Upon intubation, another rapid COVID test was done and was positive. They did an additional test that was also positive. He passed away on 25-MAY-2021. An autopsy was performed on an unspecified date. It was reported that she believed the cause of death to be the massive blunt force trauma and bleeding problems. He tested positive for COVID with a 5 day test in JAN-2021. During that time, he had received the monoclonal infusion. She noted that he did not get ivermectin. He also got a physical examination done. Laboratory data included: COVID-19 virus test (NR: not provided) not reported, and SARS-CoV-2 rapid diagnostic test (NR: not provided) positive, positive. Laboratory data included: SARS-CoV-2 rapid diagnostic test (NR: not provided) negative, negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died of massive blunt force trauma and bleeding problems on 25-MAY-2021, and the outcome of positive covid test/ confirmed covid-19 infection, car accident and felt punk was not reported. This report was serious (Death, and Hospitalization Caused / Prolonged).; Sender's Comments: V0. 20210554454-COVID-19 VACCINE AD26.COV2.S. Massive blunt force trauma, bleeding problems, car accident. This events is considered unassessable. The events have an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the events.; Reported Cause(s) of Death: MASSIVE BLUNT FORCE TRAUMA; BLEEDING