chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 0.5
Sex: M
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: administration of a Kinrix dose to a 6 month old patient; Inappropriate schedule of vaccine administered; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 6-month-old male patient who received DTPa-IPV (Kinrix) (batch number 7P5J5, expiry date 30th September 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included DTaP (received DTaP doses on an unknown dates).   On 19th April 2021, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 19th April 2021, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and inappropriate schedule of vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were 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 patient received a dose of Kinrix at the age of 6 months, which led to inappropriate age at vaccine administration. The reporter stated that this would have been the third dose in the series, which led to inappropriate schedule of vaccine administered. The reporter called for information regarding safety and validity of the administration of a Kinrix dose to a 6 month old patient. The reporter confirmed that healthcare professional had given previous DTaP doses to the patient but not Kinrix. Kinrix was administered to the patient for the first time. The reporter consented to follow up.
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test abnormal, Computerised tomogram normal, Decreased appetite, Epstein-Barr virus infection, Fatigue
Clinical narrative: severe vertigo / diagnosed with benign vertigo syndrome; not feeling well; fatigue; did not have an appetite; nauseous; dose 1 of Shingrix in October 2020 / dose 2 on November 12, 2020; Epstein Barr syndrome; sore arm; This case was reported by a consumer and described the occurrence of vertigo in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 12th November 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 12th November 2020, 1 hr after receiving Shingrix, the patient experienced pain in arm and drug dose administration interval too short. In November 2020, the patient experienced vertigo (serious criteria hospitalization), feeling unwell (serious criteria hospitalization), fatigue (serious criteria hospitalization), appetite lost (serious criteria hospitalization), nausea (serious criteria hospitalization) and epstein-barr virus infection. On an unknown date, the outcome of the vertigo, feeling unwell and fatigue were not recovered/not resolved and the outcome of the appetite lost, epstein-barr virus infection and drug dose administration interval too short were unknown and the outcome of the nausea and pain in arm were recovered/resolved.   It was unknown if the reporter considered the vertigo, feeling unwell, fatigue, appetite lost, nausea, pain in arm and epstein-barr virus infection to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient himself. In October 2020,the patient received 1st dose of Shingrix concomitantly. The patient received the 2nd dose of Shingrix on unknown arm and 1 hour after the vaccination patient experienced sore arm.. Approximately 1 week after the vaccination, the patient felt unwell, did not have an appetite, fatigue and nauseous. The patient took a nap and when he woke up noted severe vertigo. The patient was called the paramedics and was taken to the emergency department later he was being evaluated for a possible stroke. The patient was later diagnosed with benign vertigo syndrome. The patient did not feel well so insisted the doctor to check for a viral infection. The patient received the 2nd dose of Shingrix before recommended time interval, which led to shortening of the vaccination schedule. The lab tests were performed such as MRI (Magnetic resonance imaging) and CT scan (Computerised tomogram) which was normal;also blood work done and the report received on 20th April 2021 which states the patient had Epstein Barr syndrome. The reporter consented to follow up. This case was linked with US2021089133 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021089133:same reporter
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Magnetic resonance imaging normal, Malaise, Nausea, Pain in extremity
Clinical narrative: severe vertigo / diagnosed with benign vertigo syndrome; not feeling well; fatigue; did not have an appetite; nauseous; dose 1 of Shingrix in October 2020 / dose 2 on November 12, 2020; Epstein Barr syndrome; sore arm; This case was reported by a consumer and described the occurrence of vertigo in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 12th November 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 12th November 2020, 1 hr after receiving Shingrix, the patient experienced pain in arm and drug dose administration interval too short. In November 2020, the patient experienced vertigo (serious criteria hospitalization), feeling unwell (serious criteria hospitalization), fatigue (serious criteria hospitalization), appetite lost (serious criteria hospitalization), nausea (serious criteria hospitalization) and epstein-barr virus infection. On an unknown date, the outcome of the vertigo, feeling unwell and fatigue were not recovered/not resolved and the outcome of the appetite lost, epstein-barr virus infection and drug dose administration interval too short were unknown and the outcome of the nausea and pain in arm were recovered/resolved.   It was unknown if the reporter considered the vertigo, feeling unwell, fatigue, appetite lost, nausea, pain in arm and epstein-barr virus infection to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient himself. In October 2020,the patient received 1st dose of Shingrix concomitantly. The patient received the 2nd dose of Shingrix on unknown arm and 1 hour after the vaccination patient experienced sore arm.. Approximately 1 week after the vaccination, the patient felt unwell, did not have an appetite, fatigue and nauseous. The patient took a nap and when he woke up noted severe vertigo. The patient was called the paramedics and was taken to the emergency department later he was being evaluated for a possible stroke. The patient was later diagnosed with benign vertigo syndrome. The patient did not feel well so insisted the doctor to check for a viral infection. The patient received the 2nd dose of Shingrix before recommended time interval, which led to shortening of the vaccination schedule. The lab tests were performed such as MRI (Magnetic resonance imaging) and CT scan (Computerised tomogram) which was normal;also blood work done and the report received on 20th April 2021 which states the patient had Epstein Barr syndrome. The reporter consented to follow up. This case was linked with US2021089133 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021089133:same reporter
Age: 60.0
Sex: M
Vaccine: VARZOS
Symptoms: Vertigo positional
Clinical narrative: severe vertigo / diagnosed with benign vertigo syndrome; not feeling well; fatigue; did not have an appetite; nauseous; dose 1 of Shingrix in October 2020 / dose 2 on November 12, 2020; Epstein Barr syndrome; sore arm; This case was reported by a consumer and described the occurrence of vertigo in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 12th November 2020, the patient received the 2nd dose of Shingrix (intramuscular) .5 ml. On 12th November 2020, 1 hr after receiving Shingrix, the patient experienced pain in arm and drug dose administration interval too short. In November 2020, the patient experienced vertigo (serious criteria hospitalization), feeling unwell (serious criteria hospitalization), fatigue (serious criteria hospitalization), appetite lost (serious criteria hospitalization), nausea (serious criteria hospitalization) and epstein-barr virus infection. On an unknown date, the outcome of the vertigo, feeling unwell and fatigue were not recovered/not resolved and the outcome of the appetite lost, epstein-barr virus infection and drug dose administration interval too short were unknown and the outcome of the nausea and pain in arm were recovered/resolved.   It was unknown if the reporter considered the vertigo, feeling unwell, fatigue, appetite lost, nausea, pain in arm and epstein-barr virus infection to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient himself. In October 2020,the patient received 1st dose of Shingrix concomitantly. The patient received the 2nd dose of Shingrix on unknown arm and 1 hour after the vaccination patient experienced sore arm.. Approximately 1 week after the vaccination, the patient felt unwell, did not have an appetite, fatigue and nauseous. The patient took a nap and when he woke up noted severe vertigo. The patient was called the paramedics and was taken to the emergency department later he was being evaluated for a possible stroke. The patient was later diagnosed with benign vertigo syndrome. The patient did not feel well so insisted the doctor to check for a viral infection. The patient received the 2nd dose of Shingrix before recommended time interval, which led to shortening of the vaccination schedule. The lab tests were performed such as MRI (Magnetic resonance imaging) and CT scan (Computerised tomogram) which was normal;also blood work done and the report received on 20th April 2021 which states the patient had Epstein Barr syndrome. The reporter consented to follow up. This case was linked with US2021089133 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021089133:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Inflammation, Swelling, Synovial cyst, White blood cell count, White blood cell count increased
Clinical narrative: diagnosis of inflammation of the gangloids; high white cell count; swollen neck; This case was reported by a consumer via call center representative and described the occurrence of lymphadenitis in a 69-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced lymphadenitis, white blood cell count increased and neck swelling. On an unknown date, the outcome of the lymphadenitis, white blood cell count increased and neck swelling were unknown.   It was unknown if the reporter considered the lymphadenitis, white blood cell count increased and neck swelling to be related to Shingrix.  Additional details were provided as follows: The case was reported by patient's brother. The age at vaccination was not reported. The patient received the 2nd dose of Shingrix and experienced a swollen neck and a diagnosis of inflammation of the gangloids and a high white cell count. The reporter did not consented to follow up This case was linked with US2021089130 reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021089130:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Loss of personal independence in daily activities, Pain in extremity
Clinical narrative: lost range of motion for 4 months / could not put her left arm above her head / difficulty getting dressed; severe arm pain; This case was reported by a consumer via call center representative and described the occurrence of injected limb mobility decreased in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   In November 2020, the patient received the 1st dose of Shingrix (intramuscular). On an unknown date, less than 2 months after receiving Shingrix, the patient experienced injected limb mobility decreased and pain in arm. On an unknown date, the outcome of the injected limb mobility decreased and pain in arm were recovered/resolved.   It was unknown if the reporter considered the injected limb mobility decreased and pain in arm to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received 1st dose of shingrix in her left arm had severe arm pain and lost range of motion for 4 months.  The patient could not put her left arm above her head and had difficulty getting dressed. The reporter did not consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: first dose of Shingrix in 2018 and had not received dose two.; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in 2018.).   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 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter consent to follow up.
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Patient / administrated with an expired dose of Bexsero; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a female patient who received Men B NVS (Bexsero) (batch number ABXA14BA, expiry date 31st March 2021) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th April 2021, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 8th April 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used 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 follow: The case reported by other health professional via call center rep. The patient received an expired dose of Bexsero. No other adverse events were reported related to vaccine. The reporter consented to follow up. No patient's identifiers were provided.
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration, Incomplete course of vaccination
Clinical narrative: late in receiving the 2nd dose/ late for 2nd dose coming in today to receive it; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 63-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 (received 1st dose on 6th October 2020, batch number: 3Y7NL, expiry date: 24th May 2022).   On an unknown date, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination 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 applicable for this case. The patient was late for 2nd dose and was coming in on the day of reporting to receive it. Till the time of reporting, the patient did not receive the 2nd dose of the vaccine, which led to incomplete course of vaccination. The reporter wanted to know when could they get their 3rd dose how long can it spaced. The reporter did not consent to follow up.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Inflammation, Pruritus
Clinical narrative: developed inflammation on the right arm; Slight itchiness; This case was reported by a pharmacist via call center representative and described the occurrence of inflammation localized in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th April 2021, the patient received the 2nd dose of Shingrix (intramuscular). On 15th April 2021, 3 days after receiving Shingrix, the patient experienced inflammation localized and pruritus. On 21st April 2021, the outcome of the inflammation localized and pruritus were recovered/resolved.   It was unknown if the reporter considered the inflammation localized and pruritus to be related to Shingrix.  Additional details were provided as follows: The patient received second dose of Shingrix on the left arm and developed inflammation on the right arm at a similar level of location as the injection site arm and had slight itchiness. The reporter enquired whether the adverse events that the patient reported had been documented before. The reporter consented to follow up. Note- The reporter also mentioned that, since then inflammation had not diminished and there was slight itchiness but in the same source document outcome of both events was reported as recovered. Therefore the outcome captured as per event section.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: was only injected the adjuvant component of Shingrix; was only injected the adjuvant component of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a adult 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 inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional information was provided as follows: The age at vaccination was reported. The pharmacist reported that a patient was only injected the adjuvant component of Shingrix which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.  No adverse event was reported. The reporter consented to follow up.
Age: 59.0
Sex: F
Vaccine: VARZOS
Symptoms: Swelling, Urticaria
Clinical narrative: pt developed hives / to shingrix; pt developed /swelling to shingrix; This case was reported by a physician via call center representative and described the occurrence of hives in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In March 2021, the patient received Shingrix. In March 2021, less than a month after receiving Shingrix, the patient experienced hives and swelling. On an unknown date, the outcome of the hives and swelling were unknown.   It was unknown if the reporter considered the hives and swelling to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received Shingrix and experienced hives and swelling. The reporter asked if it was safe to take covid 19 shot. No other details of Shingrix were available. The reporter consented to follow up.
Sex: F
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: administrated /an expired dose of Engerix-b on April 21 2021/ expired on April 8 2021.; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a female patient who received HBV (Engerix B) (batch number A35ML, expiry date 8th April 2021) for prophylaxis.   On 21st April 2021, the patient received Engerix B. On 21st April 2021, unknown after receiving Engerix B, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.  Additional details were reported as follows: The age at vaccination was not reported. The patient was administrated with an expired dose of Engerix B, which led to expired vaccine used. No adverse event was reported. The reporter did not consent to follow up.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia, Tachycardia
Clinical narrative: Tachycardia; fever of 101.6; This case was reported by a consumer via call center representative and described the occurrence of tachycardia in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number C47FY, expiry date 16th September 2022) for prophylaxis.   On 19th October 2020, the patient received the 1st dose of Shingrix (intramuscular). On 20th October 2020, 1 days after receiving Shingrix, the patient experienced tachycardia and fever. On 20th October 2020, the outcome of the fever was recovered/resolved. On an unknown date, the outcome of the tachycardia was recovered/resolved.   It was unknown if the reporter considered the tachycardia and fever to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient herself. The patient received 1st dose of Shingrix in right deltoid and the day after vaccination experienced fever of 101.6 degree C, which resolved the same day and tachycardia (increased heart rate noted on her apple watch). The patient was concerned due to the side effects she experienced after her 1st dose and till the time of reporting, patient did not receive 2nd dose of Shingrix due to covid 19 vaccine timing. The reporter asked about the efficacy of single dose vs two doses of Shingrix. The reporter consented to follow up.
Age: 70.0
Sex: M
Vaccine: VARZOS
Symptoms: Fatigue, Injection site pain
Clinical narrative: has muscle soreness at the injection site; left very fatigued / feels tired; This case was reported by a consumer via call center representative and described the occurrence of injection site muscle pain in a 70-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th April 2021 12:00, the patient received the 1st dose of Shingrix (intramuscular). On 20th April 2021, 5 hrs after receiving Shingrix, the patient experienced injection site muscle pain and fatigue. On an unknown date, the outcome of the injection site muscle pain and fatigue were not recovered/not resolved.   The reporter considered the injection site muscle pain and fatigue to be related to Shingrix.  Additional details were provided as follows: This case was reported by patient himself. The patient received 1st dose of Shingrix in the left arm and 5 to 6 hours later he left very fatigued and had muscle soreness at the injection site. The patient stated that the night before reporting, he slept like a baby, which was not normal for him. The reporter did not consent to follow up and did not give permission to contact healthcare professional.
Age: 70.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: received 3 doses of Shingrix; First dose:¨11/12/2019 / Second dose: 9/17/2020 (late dose); This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 71-year-old female patient who received Herpes zoster (Shingrix) (batch number 5S43T, expiry date unknown) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 12th November 2019).   On 2nd February 2021, the patient received the 3rd dose of Shingrix. On 17th September 2020, the patient received the 2nd dose of Shingrix. On 17th September 2020, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On 2nd February 2021, the patient experienced extra dose administered. On an unknown date, the outcome of the drug dose administration interval too long and extra dose administered were unknown.  Additional details were provided as follows: The patient received 2nd dose of Shingrix, later than the recommended interval, which led to lengthening of vaccination schedule. The patient received 3rd dose of Shingrix, which led to extra dose administered. No information about lot number of 1st and 2nd at the time of reporting. The reporter consented to follow up by email.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st Shingrix dose on 09/20/2019 / 2nd dose of Shingrix on 04/19/2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 73-year-old female patient who received Herpes zoster (Shingrix) (batch number 95R52, expiry date 11th December 2021) for prophylaxis.   Previously administered products included Shingrix (Received 1st dose on 20th September 2019.).   On 19th April 2021, the patient received the 2nd dose of Shingrix. On 19th April 2021, unknown after receiving Shingrix, 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.  Additional details were provided as follow: The patient received her 2nd dose of Shingrix, later than the recommended schedule,  which led to lengthening of vaccination schedule. The reporter consented to follow-up. The reported batch number 95R5 was not available in sales data sheet, hence updated to 95R52.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: first dose of Shingrix on September 30th, 2020 / second dose on Nov 3th, 2020 / given less than 2 months apart (34 days apart); This case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too short in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 3rd November 2020, the patient received the 2nd dose of Shingrix. On 3rd November 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The sister called for her brother. Age at vaccination was not reported. The patient had first dose of Shingrix on 30th September 2020. The patient received the second dose less than 2 months apart (34 days apart) from 1st dose which led to shortening of vaccination schedule. The reporter did not consent to follow-up. This case is linked to the case US2021090119, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021090119:Possible same reporter and patient
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: delayed shingrix dose, received first dose in jan 2020; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in January 2020).   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 to this report. The reporter stated that patient received the 1st dose of Shingrix and asymptomatic, delayed for the 2nd dose of shingrix , which led to incomplete course of vaccination . No further information was reported. Reporter consented to follow up.
Age: 16.0
Sex: U
Vaccine: MENB
Symptoms: Wrong product administered
Clinical narrative: Patient that got a dose of Bexsero by mistake (Menactra was intended); This case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a 16-year-old patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Menactra (1st dose received on an unknown date).   On 21st April 2021, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On 21st April 2021, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced wrong vaccine administered. On an unknown date, the outcome of the wrong vaccine administered 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 reporter inquired that how soon they could administer Menactra to a patient that got a dose of Bexsero by mistake as Menactra was intended, which led to wrong vaccine administered. This was the 1st dose of Bexsero and the intention was to provide the 2nd dose of Menactra. The reporter refused any information because patient was in the location and they were in a hurry.  The reporter did not consent to follow-up.
Sex: U
Vaccine: HIBV
Symptoms: Product administered to patient of inappropriate age, Product prescribing error
Clinical narrative: Doctor prescribe Hiberix to a 81 years old patient; Prescribe / to a 81 years old patient / having a anticipating splenectomy; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 81-year-old patient who received Hib (Hiberix) for prophylaxis.   On an unknown date, the patient received Hiberix. On an unknown date, unknown after receiving Hiberix, the patient experienced inappropriate age at vaccine administration and product prescribing error. On an unknown date, the outcome of the inappropriate age at vaccine administration and product prescribing error were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The doctor prescribed Hiberix to a 81 years old patient because he or she was having a anticipating splenectomy, which led to inappropriate age at vaccine administration and product prescribing error. The reporter consented to follow up.
Sex: M
Vaccine: COVID19
Symptoms: Malaise, Myalgia
Clinical narrative: FEEL SICK; PAIN IN MUSCLES/HOT IN MUSCLES; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported.  The patient received COVID-19 vaccine AD26.COV2.S (suspension for injection, intramuscular) 0.5 ml, on 04-MAR-2021 to left deltoid for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date in Mar-2021, the patient was feeling sick, had pain in muscles, and hotness in muscles. The action taken with COVID-19 vaccine AD26.COV2.S was not applicable. The outcome of the feel sick, pain in muscles and hot in muscles was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Body temperature, Fatigue, Herpes zoster, Neck pain
Clinical narrative: OPEN SORES; LOOKS LIKE SHINGLES ON BOTH SIDES UNDER THE ARMPIT AT THE BACK AREA; ITCHING RASH; PALMS, HANDS, WRIST STINGS; NECK HURTS; DIDN'T SLEEP; ACHE UNDER EARS; WRIST ACHE; EXHAUSTED; WELTS; Sluggish; This spontaneous report received from a patient and concerned a  female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. The vaccination site was left arm. No concomitant medications were reported.  On MAR-2021, the patient experienced sluggish, exhausted (PT of Fatigue) and didn't sleep; however, that could have been due to being up late to get the vaccine at 3am. On unspecified date in MAR-2021, the patient checked her temperature and reported it was fine, no value provided. On 07-MAR-2021, the patient experienced welts on both sides under her armpit at the back area in the morning, around 10 am. On 07-MAR-2021, the patient experienced open sores. On 07-MAR-2021, the patient experienced looks like shingles on both sides under the armpit at the back area and developed a rash, described as itchy. The itchiness was noticed this morning around 8-9am however it was not itchy anymore. On 07-MAR-2021, the patient experienced palms, hands, wrist stings and developed wrist ache. On 07-MAR-2021, the patient reported that her neck hurts in the morning around 4 hours after getting the vaccine. On 07-MAR-2021, the patient experienced ache under ears. The action taken with COVID-19 vaccine ad26.cov2.s was not reported. The patient recovered from itching rash on 07-MAR-2021, and had not recovered from welts, open sores, looks like shingles on both sides under the armpit at the back area, palms, hands, wrist stings, wrist ache, neck hurts, exhausted, didn't sleep, ache under ears, and sluggish. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pain, Rash pruritic, Sleep deficit, Sluggishness, Urticaria
Clinical narrative: OPEN SORES; LOOKS LIKE SHINGLES ON BOTH SIDES UNDER THE ARMPIT AT THE BACK AREA; ITCHING RASH; PALMS, HANDS, WRIST STINGS; NECK HURTS; DIDN'T SLEEP; ACHE UNDER EARS; WRIST ACHE; EXHAUSTED; WELTS; Sluggish; This spontaneous report received from a patient and concerned a  female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. The vaccination site was left arm. No concomitant medications were reported.  On MAR-2021, the patient experienced sluggish, exhausted (PT of Fatigue) and didn't sleep; however, that could have been due to being up late to get the vaccine at 3am. On unspecified date in MAR-2021, the patient checked her temperature and reported it was fine, no value provided. On 07-MAR-2021, the patient experienced welts on both sides under her armpit at the back area in the morning, around 10 am. On 07-MAR-2021, the patient experienced open sores. On 07-MAR-2021, the patient experienced looks like shingles on both sides under the armpit at the back area and developed a rash, described as itchy. The itchiness was noticed this morning around 8-9am however it was not itchy anymore. On 07-MAR-2021, the patient experienced palms, hands, wrist stings and developed wrist ache. On 07-MAR-2021, the patient reported that her neck hurts in the morning around 4 hours after getting the vaccine. On 07-MAR-2021, the patient experienced ache under ears. The action taken with COVID-19 vaccine ad26.cov2.s was not reported. The patient recovered from itching rash on 07-MAR-2021, and had not recovered from welts, open sores, looks like shingles on both sides under the armpit at the back area, palms, hands, wrist stings, wrist ache, neck hurts, exhausted, didn't sleep, ache under ears, and sluggish. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Wound
Clinical narrative: OPEN SORES; LOOKS LIKE SHINGLES ON BOTH SIDES UNDER THE ARMPIT AT THE BACK AREA; ITCHING RASH; PALMS, HANDS, WRIST STINGS; NECK HURTS; DIDN'T SLEEP; ACHE UNDER EARS; WRIST ACHE; EXHAUSTED; WELTS; Sluggish; This spontaneous report received from a patient and concerned a  female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022) dose was not reported, administered on 06-MAR-2021 for prophylactic vaccination. The vaccination site was left arm. No concomitant medications were reported.  On MAR-2021, the patient experienced sluggish, exhausted (PT of Fatigue) and didn't sleep; however, that could have been due to being up late to get the vaccine at 3am. On unspecified date in MAR-2021, the patient checked her temperature and reported it was fine, no value provided. On 07-MAR-2021, the patient experienced welts on both sides under her armpit at the back area in the morning, around 10 am. On 07-MAR-2021, the patient experienced open sores. On 07-MAR-2021, the patient experienced looks like shingles on both sides under the armpit at the back area and developed a rash, described as itchy. The itchiness was noticed this morning around 8-9am however it was not itchy anymore. On 07-MAR-2021, the patient experienced palms, hands, wrist stings and developed wrist ache. On 07-MAR-2021, the patient reported that her neck hurts in the morning around 4 hours after getting the vaccine. On 07-MAR-2021, the patient experienced ache under ears. The action taken with COVID-19 vaccine ad26.cov2.s was not reported. The patient recovered from itching rash on 07-MAR-2021, and had not recovered from welts, open sores, looks like shingles on both sides under the armpit at the back area, palms, hands, wrist stings, wrist ache, neck hurts, exhausted, didn't sleep, ache under ears, and sluggish. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Back pain, Body temperature, Dizziness, Headache
Clinical narrative: WEAKNESS; HEADACHE; Flu like symptoms; FEVER; SEVERE BACK PAIN; RUNNY NOSE; BODY ACHES; DIZZINESS; INSOMNIA; PAIN AT THE INJECTION SITE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018) dose was not reported, administered on 06-MAR-2021 16:50 to right arm for prophylactic vaccination. No concomitant medications were reported.  On 06-MAR-2021, the patient experienced pain at the injection site and insomnia. On 07-MAR-2021, the patient experienced flu-like symptoms, fever  99.0 in am and 102.5 (units unspecified), severe back pain, runny nose, body aches, dizziness, headache. On an unspecified date, the subject experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain at the injection site, fever, insomnia, severe back pain, runny nose, body aches, dizziness, weakness, headache, and flu like symptoms. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Influenza like illness, Injection site pain, Insomnia, Pain, Pyrexia
Clinical narrative: WEAKNESS; HEADACHE; Flu like symptoms; FEVER; SEVERE BACK PAIN; RUNNY NOSE; BODY ACHES; DIZZINESS; INSOMNIA; PAIN AT THE INJECTION SITE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018) dose was not reported, administered on 06-MAR-2021 16:50 to right arm for prophylactic vaccination. No concomitant medications were reported.  On 06-MAR-2021, the patient experienced pain at the injection site and insomnia. On 07-MAR-2021, the patient experienced flu-like symptoms, fever  99.0 in am and 102.5 (units unspecified), severe back pain, runny nose, body aches, dizziness, headache. On an unspecified date, the subject experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain at the injection site, fever, insomnia, severe back pain, runny nose, body aches, dizziness, weakness, headache, and flu like symptoms. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Rhinorrhoea
Clinical narrative: WEAKNESS; HEADACHE; Flu like symptoms; FEVER; SEVERE BACK PAIN; RUNNY NOSE; BODY ACHES; DIZZINESS; INSOMNIA; PAIN AT THE INJECTION SITE; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805018) dose was not reported, administered on 06-MAR-2021 16:50 to right arm for prophylactic vaccination. No concomitant medications were reported.  On 06-MAR-2021, the patient experienced pain at the injection site and insomnia. On 07-MAR-2021, the patient experienced flu-like symptoms, fever  99.0 in am and 102.5 (units unspecified), severe back pain, runny nose, body aches, dizziness, headache. On an unspecified date, the subject experienced weakness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from pain at the injection site, fever, insomnia, severe back pain, runny nose, body aches, dizziness, weakness, headache, and flu like symptoms. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Headache, Pyrexia, Vomiting
Clinical narrative: FEVER; VOMITING; HEADACHE; CHILLS; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose was not reported, administered on 06-MAR-2021 to Right Arm for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On 06-MAR-2021 (about 5 hours post vaccination), the patient experienced chills. On 07-MAR-2021, the patient experienced fever, vomiting and headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever, chills, vomiting and headache was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Injection site erythema, Malaise
Clinical narrative: CHILLS; FEVER; LIGHT-HEADED; Feeling ill; SLIGHT REDNESS IN SITE OF INJECTION; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802068) dose was not reported, administered on 05-MAR-2021 at 9:45am, to Right Arm for prophylactic vaccination. No concomitant medications were reported.  On 05-MAR-2021, the patient experienced chills, fever, light-headed, feeling ill, and slight redness in site of injection. Laboratory data included: Body temperature (NR: not provided) 100.4. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from light-headed on 05-MAR-2021, had not recovered from chills, and fever, and the outcome of feeling ill and slight redness in site of injection was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: CHILLS; FEVER; LIGHT-HEADED; Feeling ill; SLIGHT REDNESS IN SITE OF INJECTION; This spontaneous report received from a consumer concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1802068) dose was not reported, administered on 05-MAR-2021 at 9:45am, to Right Arm for prophylactic vaccination. No concomitant medications were reported.  On 05-MAR-2021, the patient experienced chills, fever, light-headed, feeling ill, and slight redness in site of injection. Laboratory data included: Body temperature (NR: not provided) 100.4. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from light-headed on 05-MAR-2021, had not recovered from chills, and fever, and the outcome of feeling ill and slight redness in site of injection was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: CHILLS; FEVER 103.9F; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 1805022) dose and vaccination anatomical site were not reported, administered on 06-MAR-2021 for prophylactic vaccination. No concomitant medications were reported.  On 07-MAR-2021, the patient developed chills and fever 103.9F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills and fever 103.9F was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Headache, Pain, Pyrexia
Clinical narrative: GENERAL ACHINESS; FEVER; HEADACHE; This spontaneous report received from a patient via a company representative concerned multiple patients. The patient's weight, height, and medical history were not reported.The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 03-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 03-MAR-2021, the subject experienced general achiness. On 03-MAR-2021, the subject experienced fever. On 03-MAR-2021, the subject experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever, headache, and general achiness. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Ear discomfort, Headache
Clinical narrative: HEADACHE; PLUGGED EARS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: Unknown) dose, start therapy date and vaccination site were not reported for covid-19 prevention. No concomitant medications were reported.  On an unspecified date, the patient experienced headache, and plugged ears. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the headache and plugged ears was not reported. This report was non-serious.