chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: never sick, but shot put me in bed for 3 days; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 21-Jul-2022 Reporter's comment: This case was reported by a consumer via interactive digital media. The patient received a dose of Shingles vaccine and experienced sickness. The patient reported that he/she never got sick but the shot put him/her in bed for 3 days. The patient declined the second dose. The follow up was not possible as no contact details were available.
Sex: M
Vaccine: MEN
Symptoms: Erythema, Injection site discomfort
Clinical narrative: should we use hot pack or cold pack at injection site.; Redness on legs; This case was reported by a consumer via interactive digital media and described the occurrence of injection site discomfort in a male patient who received Men B NVS (Meningococcal B vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Meningococcal B vaccine. On an unknown date, unknown after receiving Meningococcal B vaccine, the patient experienced injection site discomfort and redness of legs. On an unknown date, the outcome of the injection site discomfort was not recovered/not resolved and the outcome of the redness of legs was unknown.   It was unknown if the reporter considered the injection site discomfort and redness of legs to be related to Meningococcal B vaccine.     Additional Information: GSK receipt date: 23-Jul-2022 Reporter comment: This case was reported by a patient via interactive digital media. The patient received of Meningococcal B. The patient experienced redness on legs. The patient asked should we use hot pack or cold pack at injection site. Additional Supportive Information: Follow-up would not possible, as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Swelling, Tenderness
Clinical narrative: Tenderness; Swelling; This case was reported by a consumer via interactive digital media and described the occurrence of tenderness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced tenderness and swelling. On an unknown date, the outcome of the tenderness and swelling were unknown.   It was unknown if the reporter considered the tenderness and swelling to be related to Shingrix.     Additional Information: GSK Receipt Date: 23-JUL-2022 Reporter's Comments: This case was reported by consumer via interactive digital media. The reporter wanted to know that, how long would the tenderness and swelling last after 1st shot. The follow up would not be possible as no contact details provided.
Sex: U
Vaccine: VARZOS
Symptoms: Immediate post-injection reaction, Pain
Clinical narrative: Painful sensation; This case was reported by a pharmacist via sales rep and described the occurrence of pain in an unspecified number of patients who received Herpes zoster (Shingrix) for prophylaxis.  On an unknown date, the patients received Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced pain. On an unknown date, the outcome of the pain was unknown.   It was unknown if the reporter considered the pain to be related to Shingrix.     Additional Information: GSK Receipt Date: 25-JUL-2022  Reporter's Comments: The reporter mentioned that patients had complained said that when administering the vaccine sometimes there was a painful sensation.
Sex: F
Vaccine: FLUX
Symptoms: Hypersensitivity
Clinical narrative: Allergies, INFLUENZA VACCINE; This case was reported by a consumer via other manufacturer and described the occurrence of allergic reaction in a 67-year-old female patient who received Flu unspecified (Flu vaccine) for prophylaxis.   The patient's past medical history included allergy (codeine, Iodine, influenza vaccine). Concurrent medical conditions included hypertension and type ii diabetes mellitus.   On an unknown date, the patient received Flu vaccine. On an unknown date, unknown after receiving Flu vaccine, the patient experienced allergic reaction. On an unknown date, the outcome of the allergic reaction was unknown.   It was unknown if the reporter considered the allergic reaction to be related to Flu vaccine.     Linked case(s) involving the same patient:  US2022AMR109860   Additional Information: GSK Receipt Date: 21-July-2022 Additional supportive information: This case has been linked with case US2022AMR109860 reported by same reporter.; Sender's Comments:  US-GSK-US2022AMR109860:Same patient
Sex: U
Vaccine: VARZOS
Symptoms: Rash, Rash erythematous
Clinical narrative: red rash; rash; This case was reported by a consumer via interactive digital media and described the occurrence of red rash in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 22nd July 2022, the patient received the 1st dose of Shingrix. In July 2022, less than a week after receiving Shingrix, the patient experienced red rash and rash. On an unknown date, the outcome of the red rash and rash were unknown.   It was unknown if the reporter considered the red rash and rash to be related to Shingrix.     Additional Information: GSK Receipt Date: 24-JUL-2022 Reporter's Comments: The case was reported via interactive digital media. The patient received his/her 1st shingles vaccine on Friday and now had a red rash all over torso.  The reporter asked what should do. Additional Supportive Information: The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Dizziness
Clinical narrative: Dizziness; This case was reported by a consumer via interactive digital media and described the occurrence of dizziness in a 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 dizziness. On an unknown date, the outcome of the dizziness was unknown.   It was unknown if the reporter considered the dizziness to be related to Shingrix.     Additional Information: GSK Receipt Date: 24-JUL-2022 Reporter's Comments: This case was reported by the consumer via interactive digital media. The patient had dizziness after Shingrix. The follow up not possible as contact details were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Rash
Clinical narrative: Rash; This case was reported by a consumer via interactive digital media and described the occurrence of rash in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced rash. On an unknown date, the outcome of the rash was unknown.   It was unknown if the reporter considered the rash to be related to Shingles vaccine.     Additional Information: GSK receipt date: 23-Jul-2022:  Reporter comment: This case was reported by a patient via interactive digital media. The patient experienced the rash. Follow-up would not possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Contusion
Clinical narrative: Significantly bruised armpit down to chest wall.; This case was reported by a physician via sales rep and described the occurrence of bruise in a 66-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced bruise. Shingrix was discontinued. On an unknown date, the outcome of the bruise was unknown.   It was unknown if the reporter considered the bruise to be related to Shingrix.     Additional Information: GSK Receipt Date: 25-JUL-2022 Reporter's Comments: The patient was significantly bruised from the armpit down the chest wall.  It was significant enough that doctor would not give second dose. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Myalgia
Clinical narrative: Muscle soreness; This case was reported by a consumer via call center representative and described the occurrence of muscle soreness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, less than a week after receiving Shingrix, the patient experienced muscle soreness. On an unknown date, the outcome of the muscle soreness was not recovered/not resolved.   It was unknown if the reporter considered the muscle soreness to be related to Shingrix.     Additional Information: GSK Receipt Date: 26-Jul-2022 Reporter's comment: The reporter asked whether he/she could take an aspirin or ibuprofen for muscle soreness on 2nd day of first shot. The reporter asked whether he/she could take an aspirin for muscle soreness.
Sex: U
Vaccine: VARZOS
Symptoms: Varicella
Clinical narrative: Chicken Pox after 2nd Shingles Vaccination; This case was reported by a consumer via interactive digital media and described the occurrence of chickenpox in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   The patient's past medical history included chickenpox (had as a child).   On an unknown date, the patient received the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced chickenpox. On an unknown date, the outcome of the chickenpox was unknown.   It was unknown if the reporter considered the chickenpox to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 23-JUL-2022 Reporter's Comments: This case reported by the patient via interactive digital media. The patient broke out with Chicken Pox after 2nd Shingles Vaccination.  The patient stated that what a ride down memory lane. Additional Supportive Information: Follow-up would not be possible as no contact details available.
Sex: U
Vaccine: VARZOS
Symptoms: Illness
Clinical narrative: sick with side effects; This case was reported by a consumer via interactive digital media and described the occurrence of sickness in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st July 2022, the patient received Shingrix. In July 2022, less than a week after receiving Shingrix, the patient experienced sickness. On an unknown date, the outcome of the sickness was recovered/resolved.   It was unknown if the reporter considered the sickness to be related to Shingrix.     Additional Information: GSK Receipt Date: 23-July-2022 Reporter's Comment: The patient self-reported this case via interactive digital media. The patient got the Shingrix vaccine this past Thursday, and has been sick with side effects for two days, but would take two days of side effects over getting shingles any time. The follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Very Sore arm; 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.   On 23rd July 2022, the patient received the 1st dose of Shingles vaccine. In July 2022, less than a week after receiving Shingles vaccine, the patient experienced pain in arm. On an unknown date, the outcome of the pain in arm was not recovered/not resolved.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 24-Jul-2022 Reporter's Comments: This case was received from consumer via interactive digital media.  The patient  got my first shingles shot yesterday and had very sore arm but no more symptoms. Get your shot. The follow-up would not possible as no contact details were available. Additional supportive Information: Theas event description event outcome captured as not recovered. The event onset date and TTO were captured with respect to event description and GSK receipt date.
Age: 2.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administered to a two year old; This case was reported by a other health professional via sales rep and described the occurrence of inappropriate age at vaccine administration in a 2-year-old male patient who received DTPa-IPV (Kinrix) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th July 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 25th July 2022, 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: 26-Jul-2022 Reporter's comment: Kinrix was administered to a two year old. Additional Supportive Information: The patient received a dose of Kinrix at age of 2 years, which led to  inappropriate age at vaccine administration.
Age: 0.33
Sex: F
Vaccine: RV1
Symptoms: Expired product administered
Clinical narrative: given two days after the expiry date; This case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a 4-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number 329J9, expiry date 16th July 2022) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 18th July 2022, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 18th July 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator 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: 18-JUL-2022 Reporter's comments: The patient was given Rotarix two days after the expiry date. The reporter consented to follow-up. Additional supportive information : The patient received a dose of Rotarix which was already expired, which led to expired vaccine used.
Age: 12.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 12 year old patient received a dose of DTaP instead of receiving TDaP; 12 year old patient received a dose of DTaP instead of receiving TDaP; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 12-year-old male patient who received DTPa (DTaP vaccine) for prophylaxis.   On an unknown date, the patient received DTaP vaccine. On an unknown date, unknown after receiving DTaP vaccine, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date:18-Jul-2022 Reporter's comments: The patient received the dose of DTaP instead of receiving TDaP. Additional supportive information: The 12 year old patient received a dose of DTaP instead of receiving TDaP, which led to wrong vaccine administered and inappropriate age at vaccine administration.
Sex: M
Vaccine: VARZOS
Symptoms: Arthralgia, Mobility decreased
Clinical narrative: pain in my shoulder; unable to lift my right arm over my head; This case was reported by a consumer via call center representative and described the occurrence of shoulder pain in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 18th July 2022 10:20, the patient received Shingrix. On 18th July 2022, less than a day after receiving Shingrix, the patient experienced shoulder pain and mobility decreased. The patient was treated with paracetamol (Acetaminophen) and meloxicam. On an unknown date, the outcome of the shoulder pain and mobility decreased were not recovered/not resolved.   It was unknown if the reporter considered the shoulder pain and mobility decreased to be related to Shingrix.     Additional Information: GSK Receipt Date:  18-JUL-2022 Reporter's Comments: The patient reported case for himself.  The patient took the Shingrix shot and about an hour to an hour and a half later the patient had pain in his shoulder that had persisted.  The patient took acetaminophen twice and meloxicam. The patient was unable to lift his right arm over his head without using left arm to assist.
Sex: F
Vaccine: VARZOS
Symptoms: Hypertension
Clinical narrative: blood pressure is higher than usual; This case was reported by a consumer via call center representative and described the occurrence of blood pressure high in a 74-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 20th July 2022, the patient received the 1st dose of Shingrix. On 21st July 2022, 1 days after receiving Shingrix, the patient experienced blood pressure high. On an unknown date, the outcome of the blood pressure high was unknown.   It was unknown if the reporter considered the blood pressure high to be related to Shingrix.     Additional Information: GSK Receipt Date: 21-JUL-2022. Reporter's Comments: The patient stated she received her dose of Shingrix yesterday (from the date of reporting). She stated this morning (on the day of reporting) she took her blood pressure and it was higher than usual. The reporter did not consent to follow-up.
Age: 0.08
Sex: F
Vaccine: RV1
Symptoms: Expired product administered
Clinical narrative: Received a rotarix vaccine that was 2 days expired on 18-July-2022; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 1-month-old female patient who received Rota (Rotarix lyophilized formulation) (batch number unknown, expiry date 16th July 2022) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On 18th July 2022, the patient received Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On 18th July 2022, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator 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: 21-Jul-2022 Reporter's comment: Nurse reported that the patient received Rotarix vaccine that was 2 days expired on 18th July 2022.  The consented to follow up was given. Additional supportive information: The patient received Rotarix vaccine that was 2 days expired on 18th July 2022, which led to expired vaccine used.
Age: 67.0
Sex: F
Vaccine: HEPA
Symptoms: Breast cancer female
Clinical narrative: Breast Cancer; This case was reported by a nurse via call center representative and described the occurrence of breast cancer in a 67-year-old female patient who received HAV (Havrix) (batch number K4Y4L, expiry date 17th June 2022) for prophylaxis.   On 26th March 2022, the patient received the 1st dose of Havrix. In June 2022, less than 4 months after receiving Havrix, the patient experienced breast cancer (serious criteria GSK medically significant). On an unknown date, the outcome of the breast cancer was not recovered/not resolved.   It was unknown if the reporter considered the breast cancer to be related to Havrix.     Additional Information: GSK Receipt Date: 21-Jul-2022 Reporter's comment: Nurse reported that the patient was diagnosed with breast cancer in early June 2022. The patient was scheduled to have a lumpectomy on 18 Aug 2022. The second dose of Havrix had not yet been administered. The Vaccine Administration Facility was the same as Primary Reporter. The consent to follow up was given.
Age: 4.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Expired product administered
Clinical narrative: expired dose of Kinrix was given to male patient; This case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 4-year-old male patient who received DTPa-IPV (Kinrix) (batch number 3DZ45, expiry date 15th January 2022) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 29th March 2022, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On 29th March 2022, unknown after receiving Kinrix and Kinrix 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: 21-JUL-2022 Reporter's Comments: The expired dose of Kinrix was given to patient. No symptoms reported. The reporter consented to follow-up via email. Additional Supportive Information: The patient received Kinrix, which was already expired, which led to expired vaccine used.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: spacing for the 2nd dose if a patient has been waiting greater than a year to get dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received greater than a year before).   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: 21-Jul-2022 Reporter's comments: Pharmacist would like to know about the spacing for the 2nd dose if the patient had been waited greater than a year to get the dose. The consent to follow up was given. No additional details were provided. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: VARZOS
Symptoms: Extra dose administered
Clinical narrative: received 3rd dose  inadvertently; This case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced extra dose administered. On an unknown date, the outcome of the extra dose administered was unknown.   Additional Information: GSK receipt date: 22-Jul-2022 Reporter's comment: The pharmacist reported that a patient received a third dose of Shingrix inadvertently. The Vaccine Administration Facility was the same as Primary Reporter. The reporter was in the car at time of call, follow up for details via email. The reporter consented to follow-up. Additional supportive information: The patient received a third dose of Shingrix inadvertently, which led to extra dose administered.
Age: 75.0
Sex: M
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 75 years received 1st dose of Bexsero after patient had a splenectomy; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 75-year-old male 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.   The patient's past medical history included splenectomy.   On an unknown date, the patient received the 1st dose of Bexsero and Bexsero Pre-Filled Syringe Device. On an unknown date, unknown after receiving Bexsero and Bexsero 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: 21-Jul-2022 Reporter's comment: Registered Pharmacist reported that the patient age was 75 years and he received his 1st dose of Bexsero after patient had a splenectomy.  No reports of side effects was given. The consent to follow-up was declined. Additional supportive information: The patient received his 1st dose of Bexsero at the age of 75 years, hence inappropriate age at vaccine administration was captured.
Age: 16.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: Lyophilized component  left in the box.; Only diluent administered; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA701A, expiry date 28th February 2023) for prophylaxis.   On 23rd July 2022, the patient received Menveo. On an unknown date, unknown after receiving Menveo, 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: GSK Receipt Date: 25-Jul-2022 Reporter's Comments: Practice Manager stated that she believed that only the liquid component of Menveo was administered to a patient as only the lyophilized component was left in the box. The reporter consented to follow up. Additional Supportive Information: The reporter believed that only the liquid component of Menveo was administered to a patient as only the lyophilized component was left in the box, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st 22jul19,never got 2nd dose; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 83-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received on 22nd July 2019).   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 Information: GSK Receipt Date: 25-Jul-2022 Reporter's Comments: The patient received Shingrix first dose on 22nd July 2019 and he never got the second dose. The reporter consented to follow up by email. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Age: 8.0
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administered to an 8 year old; 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 8-year-old male patient who received DTPa (Reduced antigen) (Boostrix) (batch number M442P, expiry date 27th October 2023) for prophylaxis.   Co-suspect products included dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th July 2022, the patient received the 1st dose of Boostrix and Boostrix Pre-Filled Syringe Device. On 25th July 2022, unknown after receiving Boostrix and Boostrix 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: 25-Jul-2022 Reporter's comment: The certified medical assistant stated that the Boostrix was administered to 8 years old patient. The reporter consented to follow-up via postal. Additional supportive information: The patient received a dose of Boostrix vaccine at inappropriate age, which led to inappropriate age at vaccine administration.
Age: 1.25
Sex: M
Vaccine: TDAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: Boostrix instead of Infanrix; 15 month old was administered Boostrix; This case was reported by a other health professional via call center representative and described the occurrence of wrong vaccine administered in a 15-month-old male patient who received DTPa (Reduced antigen) (Boostrix) for prophylaxis.   On 25th July 2022, the patient received Boostrix. On 25th July 2022, unknown after receiving Boostrix, the patient experienced wrong vaccine administered and inappropriate age at vaccine administration. On an unknown date, the outcome of the wrong vaccine administered and inappropriate age at vaccine administration were unknown.   Additional Information: GSK Receipt Date: 26-JUL-2022 Reporter's Comments: The medical assistant called in to inquired and reported a 15 month old patient was administered Boostrix instead of Infanrix.  The Infanrix would have been the patient's 4th dose.  The reporter unable to provide any additional details regarding patient and vaccines.  The reporter did not consent to follow-up.
Age: 64.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, No adverse event, Product preparation issue
Clinical narrative: administrated with adjuvant only; administrated with adjuvant only; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number 4ft7z, expiry date 26th August 2023) for prophylaxis.   On 25th July 2022, the patient received Shingrix. On 25th July 2022, unknown after receiving Shingrix, the patient experienced inappropriate preparation of medication. On an unknown date, the patient experienced 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: GSK Receipt Date: 26-Jul-2022 Reporter's Comments: Nurse reported on 26th July 2022, that a patient was administrated with the adjuvant only on 25th July 2022.  The patient did not experience adverse event. The reporter consented to follow up. Additional Supportive Information: The patient was administrated with the adjuvant only, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Second dose has not been administered; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 60-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included shingrix (1st dose received 3 years before date of reporting).   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: 26-Jul-2022 Reporter's Comments: The second dose had not yet been administered. Additional AE information not available per health care professional (HCP).  AE contains all information provided by HCP.  HCP gives consent for safety team to follow up. Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered only the liquid portion; administered only the liquid portion; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, unknown after receiving Menveo, 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: GSK Receipt Date: 26-Jul-2022 Reporter's Comments: The patient was administered only the liquid portion of the Menveo vaccine. The reporter consented to follow up. Additional Supportive Information: The patient was administered only the liquid portion of the Menveo vaccine, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: TIREDNESS; This spontaneous report received from a patient concerned a 70 year old male. 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: 1808609 expiry: 04-FEB-2022) dose was not reported, administered on 17-MAR-2021 for covid-19 prophylaxis. Age at time of vaccination 70 years old. No concomitant medications were reported. On 18-MAR-2021, the patient experienced tiredness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of tiredness was not reported. This report was non-serious. This case, involving the same patient is linked to 20220752348. This case, from the same reporter is linked to 20220754682.
Sex: M
Vaccine: COVID19
Symptoms: Cardiac disorder, Off label use
Clinical narrative: RARE UNKNOWN HEART CONDITION; OFF LABEL USE IN UNAPPROVED AGE GROUP; This spontaneous report received from a consumer concerned a 17 year old male. 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, and batch number were not reported) dose, 1 total, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. The patient was 17 year old and received vaccine which was (off label use in unapproved age group). The drug was associated with Off label use. No concomitant medications were reported. On an unspecified date, the patient experienced rare unknown heart condition. On an unspecified date, the patient died from rare unknown heart condition. It was unknown whether the autopsy was performed. The reporter stated that, "I have close friends that work for J and J and their 17 year old son passed away from an rare unknown heart condition." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the off label use in unapproved age group was not reported. This report was serious (Death). This case, from the same reporter is linked to 20220745936 and 20220745839.; Sender's Comments: V0: 20220746027- covid-19 vaccine ad26.cov2.s- rare unknown heart condition. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: RARE UNKNOWN HEART CONDITION
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis, Vomiting
Clinical narrative: SEVERE SINUS INFECTION; VOMITING/THROWING UP; This spontaneous report received from a patient concerned a female of an unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: covid (in MAR-2021). The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 211D21A expiry: UNKNOWN) dose was not reported, dose 1, 1 total was administered on 17-NOV-2021 on right arm for covid-19 prophylaxis. No concomitant medications were reported. Around 07-DEC-2021, the patient experienced severe sinus infection, a high fever and for vomiting/throwing up and was hospitalized (date unspecified). Number of days of hospitalization was not reported. It was unknown if patient was discharged. She think it was a case of meningitis but it was not confirmed by the doctor. She was prescribed antibiotic, steroid and she needed to be on bed rest. She did not received the booster. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from severe sinus infection, and vomiting/throwing up. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20220749810-covid-19 vaccine ad26.cov2.s- Severe sinus infection. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable. 20220749810-covid-19 vaccine ad26.cov2.s- Vomiting/throwing up. This event(s) is labeled per RA and is therefore considered potentially related.
Sex: U
Vaccine: COVID19
Symptoms: Thrombosis
Clinical narrative: CLOTS; This spontaneous report received from a consumer from social media via a company representative concerned a patient of an unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: myocarditis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose 1, 1 total, dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced clots. Consumer reported that "...2 friends with myocarditis..one had a stroke..one a clot..2 now with kidney issues..." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of clots was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220750301, 20220750036, 20220750167, 20220752074 and 20220752219.; Sender's Comments: V0: 20220750085 -Covid-19 vaccine ad26.cov2.s -CLOTS. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Sex: F
Vaccine: COVID19
Symptoms: Myocardial infarction
Clinical narrative: HEART ATTACK; This spontaneous report received from a consumer via a company representative via social media concerned a 38 year old female. 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, and batch number were not reported, expiry: unknown)  dose not reported, 1 total (dose 1) administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced heart attack and died. It was unspecified if an autopsy was performed. It was reported that, "a young 38 year old friends daughter died of a heart attack". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. On an unspecified date, the patient died from heart attack. This report was serious (Death). This case, from the same reporter is linked to 20220750085, 20220750036, 20220750301, 20220752074 and 20220752219.; Sender's Comments: V0: 20220750167-covid-19 vaccine ad26.cov2.s- Heart attack. The event(s) has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable; Reported Cause(s) of Death: HEART  ATTACK
Sex: F
Vaccine: COVID19
Symptoms: Abortion spontaneous, Exposure during pregnancy
Clinical narrative: MISCARRIED TWICE; VACCINE EXPOSURE DURING PREGNANCY; This spontaneous pregnancy report received from a consumer via a company representative via social media concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported.  The patient was pregnant at the time of vaccination. The patient was gravida 2 and para 0. The date of the patient's last menstrual period and expected delivery date were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced vaccine exposure during pregnancy and had miscarried twice. It was reported that "A niece miscarried twice". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the miscarried twice and vaccine exposure during pregnancy was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220750036, 20220750167, 20220750301, 20220752219 and 20220750085.; Sender's Comments: V0:  20220752074- covid-19 vaccine ad26.cov2.s -Miscarried twice. The event(s) has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable  20220752074 -Covid-19 vaccine ad26.CoV-2.s- Vaccine exposure during pregnancy. This event is considered not related. The event has a unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use
Clinical narrative: OFF LABEL DOSING FREQUENCY; This spontaneous report received from a patient via other company  concerned a 2 decade old adult female of an unspecified race and ethnicity.  The patient's height, and weight were not reported. The patient's concurrent conditions included: rheumatoid arthritis, and other pre-existing medical conditions included: The patient had no known allergies or no relevant medical history. The patient received first dose of covid-19 vaccine ad26.cov2.s (Dose number in series 1), (suspension for injection, intramuscular, batch number and expiry date were not reported) dose, 1 total administered on 31-MAR-2021 for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination (Dose number in series 1). The patient received second dose of covid-19 vaccine ad26.cov2.s (Dose number in series 2), (suspension for injection, intramuscular, batch number and expiry date were not reported) dose, start therapy date were not reported, 1 total administered for covid-19 prophylaxis which was an off label dosing frequency (Dose number in series 2). The drug was associated with Off label use. Age at time of vaccination 2 decade old. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Concomitant medications included Humira (adalimumab) for rheumatoid arthritis (subcutaneous). On an unspecified date, the patient received booster dose with Covid-19 Vaccine (unspecified manufacturer), (Dose number in series 3), (intramuscular, form of admin, batch number and expiry date were not reported) dose was not reported, administered for covid-19 prophylaxis. It was unknown whether patient had any adverse events following vaccination (Dose number in series 3). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of off label dosing frequency was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, SARS-CoV-2 test positive
Clinical narrative: COVID-19 VIRUS TEST POSITIVE; This spontaneous report received from a patient via other manufacturer (AbbVie) concerned a 63 year old female. The patient's height, and weight were not reported.  The patient's concurrent conditions included: non-infectious intermediate posterior and panuveitis, and moderate to severe rheumatoid arthritis. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, intramuscular, batch number was not reported) dose, start therapy date were not reported, 1 total for covid-19 prophylaxis.  The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine (Dose number in series 1). Non-company suspect drug included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number: 1160291) dose, frequency, and therapy dates were not reported for moderate to severe rheumatoid arthritis, and non-infectious intermediate posterior and panuveitis.  The patient received booster dose with non-company suspect vaccine: tozinameran (Pfizer vaccine, Dose number in series 2) (form of admin unknown, intramuscular, batch number was not reported) dose, start therapy date were not reported, 1 total for covid-19 prophylaxis.  On an unspecified date in JUL-2022, the patient experienced covid-19 virus test positive (Dose number in series 2). Laboratory data included: COVID-19 virus test Positive. It was unknown if patient was enrolled in a COVID-19 Vaccine Trial. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab, and tozinameran was not reported. The patient recovered from covid-19 virus test positive on JUL-2022. This report was non-serious.