chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Deep vein thrombosis
Clinical narrative: RECURRENCE OF VTE BILATERALLY IN UPPER EXTREMITIES WITHIN A SHORT TIME PERIOD OF STARTING ELIQUIS; This case was received via {BP} Pfizer Inc (Reference number: PV202300024518) on 07-Feb-2023. Information was received from a Health Professional concerning a patient, who received Suspect product APIXABAN for product used for unknown indication, lot number: Unknown; Suspect product COVID-19 VACCINE for COVID 19, lot number: Unknown. On an unknown date, the patient had deep vein thrombosis (recurrence of vte bilaterally in upper extremities within a short time period of starting eliquis), which met the following seriousness criteria: medical significance. It is unknown if treatment was provided. The outcome of the deep vein thrombosis was unknown. Patient with bilateral upper extremity DVTs. Patient was on Eliquis and had recurrence of VTE bilaterally in upper extremities within a short time period of starting Eliquis and had been vaccinated with Covid vaccine. The action taken with APIXABAN medication was unknown. The action taken with COVID-19 VACCINE medication was unknown. Medical history and concurrent conditions included deep venous thrombosis arm. Concomitant medications were not reported. The reporter did not provide a causality assessment for event deep vein thrombosis to APIXABAN. The reporter considered event deep vein thrombosis related to COVID-19 VACCINE. Consent to contact health professional for follow-up information was denied. Tracking of Changes: 07-Feb-2023: Initial information was received.  Eliquis is under agreement the agency.; Sender's Comments: BMS Comment: This patient had recurrent deep vein thrombosis after receiving apixaban therapy along with COVID- 19 vaccine. Based on the limited information available regarding the therapy details, event onset date, action taken with the suspects, treatment given and outcome of the event, it cannot be ascertained with the reasonable possibility that the apixaban/ COVID- 19 vaccine could have contributed to the event deep vein thrombosis. Pfizer comment: Based on temporal association, a contributory role of COVID-19 VACCINE  to the event deep vein thrombosis cannot be excluded. The impact of this report on the benefit/risk profile of the Pfizer product is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees and Investigators, as appropriate.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Asthenia, Dysarthria, Immunisation reaction, Injection site swelling, Magnetic resonance imaging head normal
Clinical narrative: Tension in the upper back; Weakness, severe reaction, hospitalized; Slurred speech; Muscle spasms; Swelling at the injection site; This case was reported by a physician via sales rep and described the occurrence of weakness in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number 9S252, expiry date unknown) for prophylaxis.   On 4th February 2023, the patient received the 1st dose of Shingrix. On 6th February 2023, 2 days after receiving Shingrix, the patient experienced weakness (serious criteria hospitalization), slurred speech (serious criteria hospitalization), muscle spasm (serious criteria hospitalization) and tightness of back muscles (serious criteria hospitalization). In February 2023, the patient experienced injection site swelling. The patient was treated with antiinflammatory/antirheumatic products (Anti Inflammatory Drug (Nos)). On an unknown date, the outcome of the weakness, slurred speech, muscle spasm, tightness of back muscles and injection site swelling were recovered/resolved.   It was unknown if the reporter considered the weakness, slurred speech, muscle spasm, tightness of back muscles and injection site swelling to be related to Shingrix.     Additional Information: GSK Receipt Date: 09-FEB-2023 Reporter's Comment: The reporter was a physician. The reporter stated that the patient received 1st dose of Shingrix vaccine on 4th February 2023. On 5th February 2023, 1 day after received Shingrix vaccine the patient experienced swelling at injection site and went to urgent care. On 6th February 2023, 2 days after received Shingrix vaccine the patient experienced weakness, slurred speech and muscle spasms and tension in the upper back. The patient again went back to urgent care and she was admitted to the hospital and stayed the night. The patient done with the Magnetic resonance imaging and ruled out the myelitis and meningitis but did not do the lumbar puncture. On 7th February 2023 patient was discharged with diagnosis of sever reaction to the Shingrix vaccine and prescribed an anti inflammatory. On 9th February 2023 patient followed up with the physician stated that the patient felt better and all symptoms had resolved. The patient wanted to know if she receive the second dose of Shingrix vaccine and the physician told her that not receive the second dose of Shingrix vaccine. The reporter did not consent to follow up.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Magnetic resonance imaging spinal normal, Muscle spasms, Muscle tightness
Clinical narrative: Tension in the upper back; Weakness, severe reaction, hospitalized; Slurred speech; Muscle spasms; Swelling at the injection site; This case was reported by a physician via sales rep and described the occurrence of weakness in a 50-year-old female patient who received Herpes zoster (Shingrix) (batch number 9S252, expiry date unknown) for prophylaxis.   On 4th February 2023, the patient received the 1st dose of Shingrix. On 6th February 2023, 2 days after receiving Shingrix, the patient experienced weakness (serious criteria hospitalization), slurred speech (serious criteria hospitalization), muscle spasm (serious criteria hospitalization) and tightness of back muscles (serious criteria hospitalization). In February 2023, the patient experienced injection site swelling. The patient was treated with antiinflammatory/antirheumatic products (Anti Inflammatory Drug (Nos)). On an unknown date, the outcome of the weakness, slurred speech, muscle spasm, tightness of back muscles and injection site swelling were recovered/resolved.   It was unknown if the reporter considered the weakness, slurred speech, muscle spasm, tightness of back muscles and injection site swelling to be related to Shingrix.     Additional Information: GSK Receipt Date: 09-FEB-2023 Reporter's Comment: The reporter was a physician. The reporter stated that the patient received 1st dose of Shingrix vaccine on 4th February 2023. On 5th February 2023, 1 day after received Shingrix vaccine the patient experienced swelling at injection site and went to urgent care. On 6th February 2023, 2 days after received Shingrix vaccine the patient experienced weakness, slurred speech and muscle spasms and tension in the upper back. The patient again went back to urgent care and she was admitted to the hospital and stayed the night. The patient done with the Magnetic resonance imaging and ruled out the myelitis and meningitis but did not do the lumbar puncture. On 7th February 2023 patient was discharged with diagnosis of sever reaction to the Shingrix vaccine and prescribed an anti inflammatory. On 9th February 2023 patient followed up with the physician stated that the patient felt better and all symptoms had resolved. The patient wanted to know if she receive the second dose of Shingrix vaccine and the physician told her that not receive the second dose of Shingrix vaccine. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm ached for 3 days; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In February 2023, the patient received the 2nd dose of Shingles vaccine. In February 2023, unknown after receiving Shingles vaccine, the patient experienced pain in arm. In February 2023, the outcome of the pain in arm was recovered/resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK receipt date: 11-Feb-2023 Reporter's comment: This case was reported by a patient via interactive digital media. The patient received the second shot this week. The patient's arm ached for 3 days. Additional Supportive Information: The follow up would not possible as no contact details were available.
Sex: U
Vaccine: MENB
Symptoms: Injection site reaction
Clinical narrative: switched Trumemba to Bexsero, injection site side effects; This case was reported by a physician via sales rep and described the occurrence of injection site reaction in a 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.   On an unknown date, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced injection site reaction. On an unknown date, the outcome of the injection site reaction was unknown.   It was unknown if the reporter considered the injection site reaction to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 6-Feb-2023 Reporter's comment: The reporter reported that his practice had recently switched from Trumemba to Bexsero and there had been some patients had complained about side effects at the injection site. The physician would like to know if there was any clinical data in the side effect profile at injection site of Bexsero in comparison to Trumemba, the efficacy of the first dose of Bexsero versus 2nd dose. Please provide all clinical data. No patients identifiers, practice data, mentioning of adverse events, filed adverse events as conservatory. The reporter consented to follow-up. The case was kept valid for injection site reaction and did not kept interchange of vaccine product as additional event as the case was for unspecified number of patients as we did not have the dose number of prior vaccination .
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Hypersensitivity, Incomplete course of vaccination
Clinical narrative: 1st dose 05Jan2020, 2nd not yet; Unknown allergic reaction; This case was reported by a physician via sales rep and described the occurrence of allergic reaction in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 5th January 2020, the patient did not receive the 1st dose of Shingrix. On an unknown date, the patient received the 2nd dose of Shingrix. On 5th January 2020, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced allergic reaction. On an unknown date, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the allergic reaction and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the allergic reaction to be related to Shingrix.     Additional Information: GSK Receipt Date: 06-Feb-2023: The patient received first dose of Shingrix. The patient experienced an unknown allergic reaction.  The patient had not received second dose.  The healthcare professional inquired about giving second dose now.  The adverse event contains all information reported information.  The patient saw email to safety team regarding sales representative contact information.  Additional supportive information: Till the time of reporting, the patient did not receive the 2nd dose, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 26May2020, 2nd not yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 64-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix  (received initial dose on 26th May 2020).   On an unknown date, the patient did not receive 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 Information: GSK receipt date: 6-Feb-2023 Reporter's comment: A pharmacist was transferred over by a member of the product team, whom gave the information of the pharmacist.  When the pharmacist was transferred over to the line, they were asked to verify their information, which they did, and asked if it was necessary to restart a Shingrix series if the initial dose was given on 26th May 2020. Information was collected about the patient and the provider was told that the call would be transferred to a second line agent, but during the hold period, they hung up. The Vaccine Administration Facility was the same as Primary Reporter. The provider sounded extremely exasperated about the fact that he needed to, quote, 'be transferred 3 times for a simple clinical question'. The tone of voice used by the provider was perceived as exasperated and they were explained the protocol due to the nature of his inquiry, but he responded in an abrasive manner and hung up the call whilst a second line agent was being contacted. They did not give information about the vaccine and did not give information for follow-up. Additional supportive information: Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination. Vaers details were captured for the first dose of Shingrix serie.
Age: 0.33
Sex: F
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 4 month old female received Shingrix; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 6th February 2023, the patient received the 1st dose of Shingrix. On 6th February 2023, unknown after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK receipt date: 6-Feb-2023 Reporter's comment: The reporter did not had the exact information for the vaccine facility or vaccine information such as lot number/expiration date but told that such information could be shared on follow-up. The reporter consented to follow-up. Additional supportive information: The patient accidentally received a dose of Shingrix at inappropriate age, which led to inappropriate age at vaccine administration.
Sex: F
Vaccine: VARZOS
Symptoms: Illness, Pain in extremity, Rash, Rash macular, Rash pruritic
Clinical narrative: Made her really sick; Arm really sore; Itchy spots on face; Red spots on face; This case was reported by a consumer via call center representative and described the occurrence of sickness in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th January 2023, the patient received the 1st dose of Shingrix. On 2nd February 2023, 13 days after receiving Shingrix, the patient experienced itchy rash and red spotty rash. On an unknown date, the patient experienced sickness and pain in arm. The patient was treated with alendronate sodium (Fosamax), prednisone and antibiotics nos (Antibiotic (Unknown Type)). On an unknown date, the outcome of the sickness was recovered/resolved and the outcome of the pain in arm was unknown and the outcome of the itchy rash and red spotty rash were not recovered/not resolved.   It was unknown if the reporter considered the sickness, pain in arm, itchy rash and red spotty rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 06-FEB-2023 Reporter's Comment: The reporter was the owner of the medical spa where the patient came for regular facials. The reporter reported that the patient came in for facial on 1st February 2023 and then started with red itchy spots on face. The patient failed to mention at the time of her facial that she received first dose of Shingrix which made her really sick and her arm really sore. The reporter did not have any further information regarding these side effects, but rather just what the patient stated. The patient also did not mentioned until after the spots appeared that she just started taking Fosamax, Prednisone and an Antibiotic. The patient still had the red spots. The patient sent a picture to the reporter on day of reporting and it was hard to determine if the spots were all over the face or only on one side. The reporter consented to follow up.
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered; 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 HAV (Havrix) (batch number H4H53, expiry date 30th January 2023) for prophylaxis.   On 6th February 2023, the patient received Havrix. On 6th February 2023, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 6-Feb-2023 Reporter's comment: The reporter did not had patient information besides gender. The reporter consented to follow-up via email. Additional supportive information: The patient received an expire dose of Havrix, which led to expired vaccine used.
Age: 84.0
Sex: M
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: Expired Shingrix administered; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 84-year-old male patient who received Herpes zoster (Shingrix) (batch number 299BM, expiry date 10th October 2022) for prophylaxis.   On 2nd February 2023, the patient received the 1st dose of Shingrix. On 2nd February 2023, unknown after receiving Shingrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 06-Feb-2023 Reporter's comment: The reporter consented to follow-up by email. Additional supportive information: The patient received an expired dose of Shingrix by error, which led to expired vaccine used.
Age: 7.0
Sex: F
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 7 year old patient recieved KINRIX; 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 7-year-old female patient who received DTPa-IPV (Kinrix) (batch number C472T, expiry date 31st March 2024) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 1st February 2023, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 1st February 2023, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration 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 Information: GSK receipt date: 06-Feb-2023 Reporter's comment: The package insert stated vaccine should be given prior to the patient's 7th birthday. The reporter consented to follow-up. Additional supportive information: The patient received a dose of Kinrix in right arm at inappropriate age, which led to inappropriate age at vaccine administration.
Age: 49.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Burning sensation, Herpes zoster, Insomnia, Pain, Paraesthesia
Clinical narrative: Chronic pain in whole body, cannot get rid of it; Tingling in back, hands, feet; Cannot sleep, is suffering day and night; Received only 1 dose 24-JUL-2022; Burning sensation; Shingles the next day from 1st dose; Age at vaccination 49 years old; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 49-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 24th July 2022, the patient received the 1st dose of Shingrix. On an unknown date, the patient did not receive the 2nd dose of Shingrix. On 24th July 2022, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On 25th July 2022, the patient experienced shingles. On 28th August 2022, the patient experienced burning sensation. On an unknown date, the patient experienced general body pain, tingling, sleeplessness and incomplete course of vaccination. The patient was treated with prednisone and gabapentin. On an unknown date, the outcome of the shingles, tingling, burning sensation, sleeplessness, inappropriate age at vaccine administration and incomplete course of vaccination were unknown and the outcome of the general body pain was not recovered/not resolved.   It was unknown if the reporter considered the shingles, general body pain, tingling, burning sensation and sleeplessness to be related to Shingrix.     Additional Information: GSK Receipt Date: 06-FEB-2023  Reporter's Comments: The reporter was the daughter of the patient. The patient received only one dose of Shingrix into right arm and 1 day after vaccination got shingles. A week later, the patient started having chronic pain in whole body and tingling in back, hands and feet.  The patient went to the doctor and was prescribed Gabapentin and Prednisone. The pain went away for 2 days and on 28th August 2022, the patient was in an extremely hot place, and the pain and burning sensation came back. Until this day (the day of reporting) the patient had pain everywhere and could not get rid of it. The patient could not sleep and was suffering day and night. The patient used all the medication she was given, but nothing was helping her and the next step was injections for her nerves. The reporter consented to follow up. Additional Supportive Information: The patient received a dose of Shingrix at inappropriate age, which led to inappropriate age at vaccine administration. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 49.0
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Chronic pain in whole body, cannot get rid of it; Tingling in back, hands, feet; Cannot sleep, is suffering day and night; Received only 1 dose 24-JUL-2022; Burning sensation; Shingles the next day from 1st dose; Age at vaccination 49 years old; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 49-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 24th July 2022, the patient received the 1st dose of Shingrix. On an unknown date, the patient did not receive the 2nd dose of Shingrix. On 24th July 2022, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced inappropriate age at vaccine administration. On 25th July 2022, the patient experienced shingles. On 28th August 2022, the patient experienced burning sensation. On an unknown date, the patient experienced general body pain, tingling, sleeplessness and incomplete course of vaccination. The patient was treated with prednisone and gabapentin. On an unknown date, the outcome of the shingles, tingling, burning sensation, sleeplessness, inappropriate age at vaccine administration and incomplete course of vaccination were unknown and the outcome of the general body pain was not recovered/not resolved.   It was unknown if the reporter considered the shingles, general body pain, tingling, burning sensation and sleeplessness to be related to Shingrix.     Additional Information: GSK Receipt Date: 06-FEB-2023  Reporter's Comments: The reporter was the daughter of the patient. The patient received only one dose of Shingrix into right arm and 1 day after vaccination got shingles. A week later, the patient started having chronic pain in whole body and tingling in back, hands and feet.  The patient went to the doctor and was prescribed Gabapentin and Prednisone. The pain went away for 2 days and on 28th August 2022, the patient was in an extremely hot place, and the pain and burning sensation came back. Until this day (the day of reporting) the patient had pain everywhere and could not get rid of it. The patient could not sleep and was suffering day and night. The patient used all the medication she was given, but nothing was helping her and the next step was injections for her nerves. The reporter consented to follow up. Additional Supportive Information: The patient received a dose of Shingrix at inappropriate age, which led to inappropriate age at vaccine administration. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient received a 3rd dose; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK Receipt Date: 06-FEB-2023 Reporter's comment:No other data was available. The reporter did not consent to follow up. Additional supportive information: The patient had received the 3rd dose of Shingrix, which led to extra dose administered.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 2018, no 2nd dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 85-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received around 2018).   On an unknown date, the patient did not receive 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 Information: GSK Receipt Date: 06-FEB-2023 Reporter's comment: The reporter consented to follow up. The case was linked for case US2023018229, reported by same reporter for different patient. Additional supportive information: Till the time of reporting, the patient had not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.; Sender's Comments:  US-GSK-US2023018229:Same reporter.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Fatigue, Headache, Nausea
Clinical narrative: Nausea; Headache; Chills; Tiredness; This case was reported by a consumer via call center representative and described the occurrence of nausea in a 65-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   On 4th February 2023, the patient received the 2nd dose of Shingrix. On 4th February 2023, less than a day after receiving Shingrix, the patient experienced nausea, headache, chills and tiredness. On an unknown date, the outcome of the nausea, chills and tiredness were recovered/resolved and the outcome of the headache was not recovered/not resolved.   It was unknown if the reporter considered the nausea, headache, chills and tiredness to be related to Shingrix.     Additional Information: GSK Receipt date: 07-Feb-2023. Reporter's Comment: The patient received Shingrix on left arm. The patient received 1st dose of Shingrix about 2.5 months prior to the reporting. The reporter stated that she felt fine after the first vaccine, but following the second vaccine, she had nausea, headache, chills, and tiredness. She is still having headaches, but her other symptoms have resolved The reporter consented to follow-up.
Sex: U
Vaccine: HIBV
Symptoms: Product preparation error
Clinical narrative: Dose may have been reconstituted with sterile water; This case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 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 wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK Receipt Date: 07-FEB-2023 Reporter's Comment: The reporter was an office manager. The reporter reported that they had an extra vial of Hiberix diluent so they believed that a dose might had been reconstituted with sterile water and possibly gave to the patient. The reporter stated that there was no specific patient at the time of the reporting and there was only speculation since there was an extra vial of supplied diluent. The reporter did consent to follow up via email. Additional supportive information: Hiberix reconstituted with sterile water instead of the GlaxoSmithKline supplied diluent, which led to wrong solution used in drug reconstitution.
Age: 40.0
Sex: F
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose 22Jul2022, 2nd dose on 07Oct2022; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 40-year-old female patient who received HAB (Twinrix) (batch number J477Y, expiry date 20th May 2023) 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 (on 22 July 2022 received 1st dose with batch number J477Y, expiry date 20th May 2023).   On 7th October 2022, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 7th October 2022, 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 Information: GSK Receipt Date: 07-FEB-2023 Reporter's Comment: The pharmacist reported that the patient received first dose of Twinrix on 22nd Jul 2022 and did not receive second dose until 07th Oct 2022.  At the time of reporting, no further doses had been administered.  The reporter consent to follow up. Additional Supportive Information: The patient received 2nd dose of Twinrix later than the recommended interval, which led to lengthening of the vaccine schedule.
Age: 76.0
Sex: M
Vaccine: VARZOS
Symptoms: Hiccups
Clinical narrative: hiccup; This case was reported by a pharmacist via call center representative and described the occurrence of hiccups in a 76-year-old male patient who received Herpes zoster (Shingrix) (batch number 73XT7, expiry date 18th June 2024) for prophylaxis.   On 7th February 2023, the patient received the 1st dose of Shingrix. In February 2023, unknown after receiving Shingrix, the patient experienced hiccups. On an unknown date, the outcome of the hiccups was unknown.   It was unknown if the reporter considered the hiccups to be related to Shingrix.     Additional Information: GSK Receipt Date: 08-Feb-2023: The pharmacist called the patient to saw if hiccup after Shingrix first dose was normal or expected.  The patient received Shingrix first dose and started with hiccup.  The reported consented to follow up.
Age: 73.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose 11Jan2021, 2nd 08Feb2023; 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 FA277, expiry date 27th May 2024) for prophylaxis.   Previously administered products included Shingrix (on 11th January 2021 received 1st dose).   On 8th February 2023, the patient received the 2nd dose of Shingrix. On 8th February 2023, 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 Information: GSK Receipt Date: 08-FEB-2023 Reporter's Comment: The pharmacist called to inquire that does the patient need to restart the Shingrix series. The reporter reported that the patient received the first dose of Shingrix back on 11th Jan 2021 and just received the second dose today on 8th FEB 2023. The reporter did not consent to follow up. Additional Supportive Information: The patient received 2nd dose of Shingrix later than the recommended interval, which led to lengthening of the vaccine schedule.
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Headache, Pain, Pain in extremity, Pyrexia
Clinical narrative: Fever; Headache; Body aches; Chills; Arm soreness; This case was reported by a consumer via call center representative and described the occurrence of fever in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, 18 hrs after receiving Shingrix, the patient experienced fever, headache, general body pain, chills and pain in arm. On an unknown date, the outcome of the fever, headache, general body pain, chills and pain in arm were recovered/resolved.   It was unknown if the reporter considered the fever, headache, general body pain, chills and pain in arm to be related to Shingrix.     Additional Information: GSK Receipt Date: 08-Feb-2023: This case was self reported by the patient. The patient received first dose of Shingrix last week.  The patient experienced fever, headache, body aches, chills, and arm soreness.  The patient reported all symptoms began approximately 18 hours after vaccination.  The patient reported all symptoms resolved after approximately 36 hours.  The reporter did not consent to follow up
Sex: F
Vaccine: VARZOS
Symptoms: Blister, Chills, Diarrhoea, Erythema, Fatigue
Clinical narrative: red blister on cheek; diarrhea; blisters in nose; Fatigue; Shivering; cold; headache; This case was reported by a consumer via call center representative and described the occurrence of shivering in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included lung disorder, dry mouth, eye dryness and gluten sensitivity (Gluten hypersensitivity). Concomitant products included iron (Iron Infusion).   On 2nd February 2023, the patient received the 2nd dose of Shingrix. On 2nd February 2023, less than a day after receiving Shingrix, the patient experienced shivering and cold. On 3rd February 2023, the patient experienced fatigue. On 5th February 2023, the patient experienced blister. On 6th February 2023, the patient experienced diarrhea. On 8th February 2023, the patient experienced blistery rash. In February 2023, the patient experienced headache. On an unknown date, the outcome of the shivering, cold, fatigue, diarrhea, blister, blistery rash and headache were unknown.   It was unknown if the reporter considered the shivering, cold, fatigue, diarrhea, blister, blistery rash and headache to be related to Shingrix.     Additional Information: GSK Receipt Date: 08-FEB-2023  Reporter's Comments: The case was self reported by the patient. The patient received second dose of Shingrix into left arm and experienced shivering, cold, fatigue, diarrhea, headache, red blisters in nose and on cheek. The reporter consented to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Headache, Nasopharyngitis, Rash vesicular
Clinical narrative: red blister on cheek; diarrhea; blisters in nose; Fatigue; Shivering; cold; headache; This case was reported by a consumer via call center representative and described the occurrence of shivering in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included lung disorder, dry mouth, eye dryness and gluten sensitivity (Gluten hypersensitivity). Concomitant products included iron (Iron Infusion).   On 2nd February 2023, the patient received the 2nd dose of Shingrix. On 2nd February 2023, less than a day after receiving Shingrix, the patient experienced shivering and cold. On 3rd February 2023, the patient experienced fatigue. On 5th February 2023, the patient experienced blister. On 6th February 2023, the patient experienced diarrhea. On 8th February 2023, the patient experienced blistery rash. In February 2023, the patient experienced headache. On an unknown date, the outcome of the shivering, cold, fatigue, diarrhea, blister, blistery rash and headache were unknown.   It was unknown if the reporter considered the shivering, cold, fatigue, diarrhea, blister, blistery rash and headache to be related to Shingrix.     Additional Information: GSK Receipt Date: 08-FEB-2023  Reporter's Comments: The case was self reported by the patient. The patient received second dose of Shingrix into left arm and experienced shivering, cold, fatigue, diarrhea, headache, red blisters in nose and on cheek. The reporter consented to follow up.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Inflammation, Pruritus, Vomiting
Clinical narrative: Inflamed arm; Itching; Vomiting; This case was reported by a nurse via sales rep and described the occurrence of inflammation localized in a 64-year-old female patient who received Herpes zoster (Shingrix) (batch number 7GH33, expiry date 13th October 2023) for prophylaxis.   On 27th January 2023, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced inflammation localized, pruritus and vomiting. On an unknown date, the outcome of the inflammation localized, pruritus and vomiting were unknown.   It was unknown if the reporter considered the inflammation localized, pruritus and vomiting to be related to Shingrix.     Additional Information: GSK Receipt Date: 08-Feb-2023 The representative called in to report that nurse from a clinic services had an adverse reaction to a dose of Shingrix.  The representative stated that the nurse who was the patient experienced an inflamed arm, itching, and vomiting after getting the vaccination. The representative did not inquire about consent to follow up for the safety team.
Age: 14.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Patient inadvertently got an expired dose; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 14-year-old male patient who received HAV (Havrix) (batch number EP47E, expiry date 6th February 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 8th February 2023, the patient received Havrix and Havrix Pre-Filled Syringe Device. On 8th February 2023, unknown after receiving Havrix and Havrix 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 Information: GSK Receipt Date: 08-FEB-2023 Reporter's Comment: The reporter was a clinic manager. The reporter reported that the patient was inadvertently administered an expired Havrix vaccine. The reporter did not consent to follow up. Additional supportive information: The patient received a Havrix which was already expired, which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Inadvertently reconstituted with sterile water; Inadvertently reconstituted with sterile water; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a adult female patient who received Herpes zoster (Shingrix) (batch number xg7rf, expiry date 21st May 2024) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. On an unknown date, the outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 08-FEB-2023 Reporter's Comment: The reporter was a nurse. The reporter reported that the patient received Shingrix vaccine which was inadvertently reconstituted with Merck sterile water diluent for mmr or varicella vaccine. The reporter did consent to follow up Additional supportive information: Shingrix reconstituted with Merck sterile water diluent for MMR or varicella instead of the GlaxoSmithKline supplied diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix Administered; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 31-year-old male patient who received HAV (Havrix) (batch number H4H53, expiry date 30th January 2023) for prophylaxis.   On 8th February 2023, the patient received the 2nd dose of Havrix. On 8th February 2023, unknown after receiving Havrix, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 08-FEB-2023 Reporter's Comment: The reporter was a medical assistant. The reporter reported that the patient inadvertently received Havrix vaccine which was expired on 30th January 2023. The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up. Additional supportive information: The patient received a Havrix which was already expired, which led to expired vaccine used.
Sex: M
Vaccine: VARZOS
Symptoms: Headache, Pain in extremity, Vaccine positive rechallenge
Clinical narrative: Left arm in pain; headache; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain in extremity (received 1st dose on 15th November 2022 and experienced pain in arm, refer case US2023AMR021808).   On 8th February 2023, the patient received the 2nd dose of Shingrix. In February 2023, unknown after receiving Shingrix, the patient experienced pain in arm and headache. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the pain in arm and headache were unknown.   It was unknown if the reporter considered the pain in arm and headache to be related to Shingrix.     Linked case(s) involving the same patient: US2023AMR021808   Additional Information: GSK Receipt Date: 09-FEB-2023 Reporter's Comment: The case was self reported by the patient. The patient received the second dose of Shingrix yesterday (the day before reporting) into left arm and had left arm pain and a headache.   The reporter did not consent to follow up.; Sender's Comments:  US-GSK-US2023AMR021808:Same reporter
Age: 0.33
Sex: F
Vaccine: RV1, RV5
Symptoms: Interchange of vaccine products
Clinical narrative: 1st dose Rotateq, 2nd Rotarix; This case was reported by a nurse via call center representative and described the occurrence of interchange of vaccine products in a 4-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number L4HN3, expiry date 8th July 2023) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis and ROTAVIRUS VACCINE LIVE REASSORT ORAL 5V (ROTATEQ) for prophylaxis.   On 8th February 2023, the patient received the 2nd dose of Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On an unknown date, the patient received ROTATEQ. On 8th February 2023, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced interchange of vaccine products. On an unknown date, the outcome of the interchange of vaccine products 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 Information: GSK receipt date: 09-FEB-2023 Reporter's comment: The health department nurse reported that one of their staff members yesterday gave Rotarix vaccine to the patient who previously received a dose of Rotateq eight weeks after the Rotateq dose was give. The reporter reported that this was the patient's second dose of a rotavirus vaccine. The reporter consented to follow up. Additional supportive information: The patient received a dose of Rotarix and Rotateq, which led to interchange of vaccine products.
Sex: M
Vaccine: VARZOS
Symptoms: Rash, Rash papular
Clinical narrative: raised bumps on shoulder and bodys left side; rash on left side of back; This case was reported by a consumer via call center representative and described the occurrence of papular rash in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   In January 2023, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, 1 week after receiving Shingrix, the patient experienced papular rash and rash. On an unknown date, the outcome of the papular rash and rash were unknown.   It was unknown if the reporter considered the papular rash and rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 09-FEB-2023 Reporter's Comments: The patient self-reported this case.  The patient who received his 2nd Shingrix dose approximately two weeks ago.  About one week after the vaccination, he developed raised bumps on his back low shoulder blade area and low back on the left side of his body.  He was asked if this could be a side effect of the vaccine.  He had an appointment with his HCP tomorrow.  The reporter was consented to follow up.