chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered, Inappropriate schedule of product administration
Clinical narrative: was administrated three doses; first dose 02DEC2020, second 13DEC2021; This case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 89-year-old female patient who received Herpes zoster (Shingrix) (batch number 295s7, expiry date 9th October 2022) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) (batch number xn4fp, expiry date 19th March 2022) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 2nd December 2020).   On 11th February 2022, the patient received the 3rd dose of Shingrix. On 13th December 2021, the patient received the 2nd dose of Shingrix. On 13th December 2021, not applicable after receiving Shingrix and unknown after receiving Shingrix, the patient experienced drug dose administration interval too long. On 11th February 2022, the patient experienced extra dose administered. On an unknown date, the outcome of the drug dose administration interval too long and extra dose administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. After receiving first dose of Shingrix the patient received 2nd dose one year later, which led to lengthening of the recommended interval between vaccine doses. The patient received 3rd dose of Shingrix, which led to extra dose administered. No further events were reported. The vaccine administration facility was the same as primary reporter. Consent for follow up was granted
Sex: M
Vaccine: MENB
Symptoms: Intercepted product prescribing error
Clinical narrative: has Bexsero prescription, older than 25 years old; This case was reported by a pharmacist via call center representative and described the occurrence of intercepted drug prescribing error in a 66-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.   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 intercepted drug prescribing error. On an unknown date, the outcome of the intercepted drug prescribing error was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The age at vaccination was not applicable for this report. The pharmacist reported that a patient had a Bexsero prescription and was older than 25 years old, which led to intercepted drug prescribing error. The reporter did not clarify what was the patient condition. The reporter consented to follow-up.
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Anaphylactic reaction, Erythema, Incomplete course of vaccination
Clinical narrative: experienced anaphylaxis and had to go to urgent care.; her stomach was "beet red."; first dose 2.5 years ago, has not received her second; This case was reported by a consumer via call center representative and described the occurrence of anaphylaxis in a 75-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix and the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced anaphylaxis (serious criteria GSK medically significant), erythema and incomplete course of vaccination. On an unknown date, the outcome of the anaphylaxis was recovered/resolved and the outcome of the erythema and incomplete course of vaccination were unknown.   It was unknown if the reporter considered the anaphylaxis and erythema to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient stated that after receiving the first dose of Shingrix 2.5 years before reporting, she experienced anaphylaxis and had to go to urgent care. The patient stated that her stomach was beet red. The patient received unspecified treatment and anaphylaxis resolved. The patient had not received her second dose of Shingrix till the time of reporting, which led to incomplete course of vaccination. The reporter did not consent to follow-up.
Age: 74.0
Sex: M
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling, Pyrexia
Clinical narrative: Fever of 101.3; Itchiness at the injection site; Swelling at the injection site; Redness at the injection site; This case was reported by a consumer via call center representative and described the occurrence of injection site itching in a 74-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 28th February 2022, the patient received the 2nd dose of Shingrix. On 28th February 2022, less than a day after receiving Shingrix, the patient experienced injection site itching, injection site swelling and injection site erythema. On 1st March 2022, the patient experienced fever. On an unknown date, the outcome of the injection site itching, injection site swelling and injection site erythema were unknown and the outcome of the fever was recovered/resolved.   It was unknown if the reporter considered the injection site itching, injection site swelling, injection site erythema and fever to be related to Shingrix.  Additional details were reported as follows: The patient reported case for himself. The reporter reported that he received his 2nd dose of the Shingrix vaccine on Monday, 28th February 2022. Since then he had been experiencing redness, swelling and itchiness at the injection site. The reporter was inquiring if the symptoms he was experiencing were normal. The reporter did not consent to follow-up. The reporter declined permission to contact HCP (Health care professional).
Sex: F
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Inappropriate schedule of product administration, Product supply issue, Stress
Clinical narrative: shingles episodes after receiving dose one, past october broke out again; 1st dose on 2018, went back for 2nd but facility didn't have it, received 2nd dose on 03 Mar 2022; This case was reported by a consumer via call center representative and described the occurrence of shingles in a 76-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included herpes zoster.   In April 2018, the patient received the 1st dose of Shingrix. On 3rd March 2022, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced shingles and product supply issue. The patient was treated with valaciclovir hydrochloride (Valtrex). On an unknown date, the outcome of the shingles and product supply issue were unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR042360  Additional details were reported as follows: The patient who was Member of public reported case for herself. The age at vaccination was not unknown but it could be 75 or 76 years at the time of 2nd dose. She received 1st dose of Shingrix in April 2018 but when she went back for 2nd dose in 2018, facility did not have the vaccine so she went without it until receiving second dose on 03rd March 2022, which led to product supply issue. The patient had an episode of Shingles after the 1st dose and was taking Valtrex for it. The patient stated this past October was very stressful and she forgot to take Valtrex for a couple of days and broke out with shingles again. The dose of Valtrex was then increased from 500 mg to 1 g. The reporter did not have lot number or expiration date information for the doses. The reporter gave permission for follow-up. This case has been linked to US2022AMR042360, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022AMR042360:same reporter / Shingrix
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: had not yet received the second 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 (received 1st dose in October 2020).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The age at vaccination was not applicable for this report. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete vaccination schedule. Healthcare professional stated it was not a safety concern.
Age: 31.0
Sex: M
Vaccine: HEPAB, HEPAB
Symptoms: Expired product administered, Inappropriate schedule of product administration
Clinical narrative: 1st one in 2014 and 2nd on 2018; 1st one in 2014, 2nd on 2018 and a 3rd dose on 2022; The reported third dose had expired; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too long in a 31-year-old male patient who received HAB (Twinrix) (batch number DK23D, expiry date 8th February 2022) 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, HAB (Twinrix) for prophylaxis and hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Twinrix (received 1st dose in an unknown date in 2014).   On 18th February 2022, the patient received the 3rd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, the patient received the 2nd dose of Twinrix and Twinrix Pre-Filled Syringe Device. On 18th February 2022, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device and not applicable after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced drug dose administration interval too long and expired vaccine used. On an unknown date, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long, expired vaccine used and drug dose administration interval too long were unknown.    This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were reported as follows: The nurse reported that a patient received 3 doses of Twinrix, 1st dose received in 2014, 2nd dose received in 2018 and 3rd dose received later than the recommended interval, which led to drug dose administration interval too long. The reporter reported that 3rd dose had expired on 08th February 2022, which led to expired vaccine used.  The reporter consented to follow-up.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: reconstituted with unapproved diluent, administered; reconstituted with unapproved diluent, administered; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 63-year-old male patient who received Herpes zoster (Shingrix) (batch number 2NT5L, expiry date 12th May 2023) for prophylaxis.   On 4th March 2022, the patient received Shingrix. On 4th March 2022, 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 details were provided as follows: The reporter stated that they reconstituted the Shingrix Lyophilized powder with an unapproved diluent then inadvertently administered to the patient in the right deltoid, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter wanted to know, how long did the patient had to wait to get the correct dosage. The reporter did not consent to follow-up.
Age: 8.0
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: 8 yr old received Infanrix; received Infanrix instead of Tdap.; This case was reported by a physician via call center representative and described the occurrence of inappropriate age at vaccine administration in a 8-year-old female patient who received DTPa (Infanrix) (batch number 7EC55, expiry date 29th April 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 25th February 2022, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 25th February 2022, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration and wrong vaccine administered. On an unknown date, the outcome of the inappropriate age at vaccine administration and wrong vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: 8 year old patient received Infanrix vaccine instead of Tdap, which led to inappropriate age at vaccine administration and wrong vaccine administered. The reporter consented to follow up via postal.
Age: 72.0
Sex: F
Vaccine: VARZOS
Symptoms: Back pain, Dyspnoea, Insomnia
Clinical narrative: trouble sleeping/sleeplessness; trouble breathing; stabbing back pain; This case was reported by a consumer via call center representative and described the occurrence of difficulty sleeping in a 72-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st March 2022, the patient received the 1st dose of Shingrix. On 1st March 2022, less than a day after receiving Shingrix, the patient experienced difficulty sleeping, difficulty breathing and back pain. On 6th March 2022, the outcome of the difficulty sleeping, difficulty breathing and back pain were recovered/resolved.   It was unknown if the reporter considered the difficulty sleeping, difficulty breathing and back pain to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The patient received dose of Shingrix vaccine and that evening she began to experience stabbing back pain that caused trouble breathing and sleeping. The patient was referred to HCP(health care professional). Spoke per PI(package insert) and content. The reporter consented to follow-up.
Sex: U
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: receiving an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The patient received an expired dose of Twinrix, which led to expired vaccine used.  The administration of the Twinrix took place 5 days after the expiry date.  The reporter had no information regarding the situation. The reporter consented to follow up.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: administered an expired Bexsero; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number ADXA87AZ, expiry date 31st January 2022) 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 5th March 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 5th March 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient inadvertently received an expired dose of Bexsero, which led to expired vaccine used. The reporter inquired if the patient needed to repeat the dose. The reporter did not consent to follow-up.
Age: 17.0
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: was administered an expired dose; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 17-year-old female patient who received Men B NVS (Bexsero) (batch number ABXA82AZ, expiry date 31st January 2022) 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 20th February 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 20th February 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received an expired dose of Bexsero, which led to expired vaccine used.  The reporter consented to follow up.  The Vaccine Administration Facility is the same as Primary Reporter.
Sex: F
Vaccine: HEPAB
Symptoms: Expired product administered
Clinical narrative: received a twinrix 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 47-year-old female patient who received HAB (Twinrix) for prophylaxis.   Co-suspect products included hepatitis A and hepatitis B vaccine pre-filled syringe device (Twinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Twinrix and Twinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Twinrix and Twinrix Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not reported. The patient received a Twinrix expired dose, which led to expired vaccine used.  Vaccine information such as lot number and expiration date were not available.  Medical assistant informed that, Twinrix dose was expired by 10 days. The reporter consented to follow up.
Sex: M
Vaccine: HEP
Symptoms: Hepatitis B antibody, Therapy non-responder
Clinical narrative: completed a hepatitis B series and blood work showed no immunity; This case was reported by a pharmacist via call center representative and described the occurrence of therapy non-responder in a male patient who received Hepatitis B vaccine for prophylaxis.   On an unknown date, the patient received Hepatitis B vaccine. On an unknown date, more than 2 years after receiving Hepatitis B vaccine, the patient experienced therapy non-responder. On an unknown date, the outcome of the therapy non-responder was unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient completed Hepatitis B of unknown brand series in 1999. Last week from the date of reporting, the patient's blood work done for a transporter position which showed no immunity for Hepatitis B. The reporter consented to follow up.
Age: 58.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Chills, Fatigue, Hyperhidrosis, Incomplete course of vaccination
Clinical narrative: Fatigue; Hasn't gotten the second vaccine yet; Chills; Sweating; This case was reported by a consumer via call center representative and described the occurrence of chills in a 58-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In December 2019, the patient received the 1st dose of Shingrix (intramuscular) .5 ml. On an unknown date, the patient received the 2nd dose of Shingrix. In December 2019, less than a day after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced chills and sweating. On an unknown date, the patient experienced fatigue and incomplete course of vaccination. On an unknown date, the outcome of the chills, sweating and fatigue were recovered/resolved and the outcome of the incomplete course of vaccination was unknown.   It was unknown if the reporter considered the chills, sweating and fatigue to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not applicable for 2nd dose of Shingrix. The patient received 1st dose of Shingrix intramuscularly into right arm and experienced chills and sweating that started about 10 to 12 hours after the vaccine and lasted about 15 minutes.  The patient also experienced fatigue that started about 12 hours later and lasted for about half a day. The patient received his first vaccine at his local pharmacy and didn't have anymore information in regards to the vaccine lot number or expiration date. Till the time of reporting, the patient did not receive 2nd dose, which led to incomplete course of vaccination. The patient was asking about needing to restart the Shingrix vaccine series if they were past the 2-6 month time frame.  The reporter did not consent to follow-up.
Age: 51.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: receiving 2nd dose with less than a 2 month interval; This case was reported by a nurse via call center representative and described the occurrence of drug dose administration interval too short in a 51-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included Herpes zoster (Shingrix).   On 10th December 2020, the patient received the 2nd dose of Shingrix. On 10th December 2020, unknown after receiving Shingrix, the patient experienced drug dose administration interval too short. On an unknown date, the outcome of the drug dose administration interval too short was unknown.  Additional details were provided as follows: The patient never received a valid 2nd dose of Shingrix, received 2nd dose with less than a 2-months interval, earlier than the recommended schedule, which led to shortening of vaccination schedule.  No additional doses were given.  The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022042575:FU1 - duplicate - deleted
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: an expired dose of Bexsero was administered; This case was reported by a physician via call center representative and described the occurrence of expired vaccine used in a 16-year-old male patient who received Men B NVS (Bexsero) (batch number ABXA82AZ, expiry date 31st January 2022) 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 7th March 2022, the patient received Bexsero and Bexsero Pre-Filled Syringe Device. On 7th March 2022, unknown after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received an expired dose of Bexsero vaccine, which led to expired vaccine used. No further information reported. The reporter consented to follow-up via mail.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Didn't get the Shingix shot 2; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had severe shingles outbreak 5 years ago before reporting (could not walk)). Previously administered products included Shingrix (1st dose received in November 2020) and COVID-19 vaccine (unspecified Covid shots, received months after the 1st dose of Shingrix).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not applicable for this report. The patient had yet to receive 2nd dose of Shingrix and was outside of the 6-month dosing window. The patient mentioned that the reason she did not get the Shingrix shot 2 was because she was instead getting the Covid shots and did not want to get both. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination. The reporter did not want to answer any further questions. The reporter provided limited information.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Bell's palsy, Eyelid disorder, Facial paralysis, Facial paresis, Headache
Clinical narrative: symptoms of bells palsy, droopy left side of face and eyelid; droopy left side of face and eyelid; droopy left side of face and eyelid; sore arm; headache; This case was reported by a consumer via call center representative and described the occurrence of bell's palsy in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st March 2022, the patient received the 1st dose of Shingrix. On 1st March 2022, less than a day after receiving Shingrix, the patient experienced pain in arm and headache. On 5th March 2022, the patient experienced bell's palsy (serious criteria GSK medically significant), facial muscle weakness and eyelid disorder. On an unknown date, the outcome of the bell's palsy, facial muscle weakness and eyelid disorder were not recovered/not resolved and the outcome of the pain in arm and headache were recovered/resolved.   It was unknown if the reporter considered the bell's palsy, facial muscle weakness, eyelid disorder, pain in arm and headache to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The patient experienced a sore arm and headache that went away after a few days. On Saturday,4 days after vaccination, the patient started to exhibit symptoms of bell's palsy, droopy left side of face including eyelid. The patient went to emergency room on 5th March 2022. The reporter consented to follow up. This case had been linked with US2022042580, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022042580:same reporter - different patient
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: symptoms of bells palsy, droopy left side of face and eyelid; droopy left side of face and eyelid; droopy left side of face and eyelid; sore arm; headache; This case was reported by a consumer via call center representative and described the occurrence of bell's palsy in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st March 2022, the patient received the 1st dose of Shingrix. On 1st March 2022, less than a day after receiving Shingrix, the patient experienced pain in arm and headache. On 5th March 2022, the patient experienced bell's palsy (serious criteria GSK medically significant), facial muscle weakness and eyelid disorder. On an unknown date, the outcome of the bell's palsy, facial muscle weakness and eyelid disorder were not recovered/not resolved and the outcome of the pain in arm and headache were recovered/resolved.   It was unknown if the reporter considered the bell's palsy, facial muscle weakness, eyelid disorder, pain in arm and headache to be related to Shingrix.  Additional details were provided as follows: The reporter was the patient. The patient experienced a sore arm and headache that went away after a few days. On Saturday,4 days after vaccination, the patient started to exhibit symptoms of bell's palsy, droopy left side of face including eyelid. The patient went to emergency room on 5th March 2022. The reporter consented to follow up. This case had been linked with US2022042580, reported by same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022042580:same reporter - different patient
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: sore arm; This case was reported by a consumer via call center representative and described the occurrence of pain in arm in a 52-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 1st March 2022, the patient received the 1st dose of Shingrix. On 1st March 2022, less than a day after receiving Shingrix, the patient experienced pain in arm. On an unknown date, 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 Shingrix.  Additional details were provided as follows: The reporter was the patient's spouse. The patient received her first dose of Shingrix and experienced a sore arm for a few days and had resolved. The reporter did not consent to follow-up. This case has been linked to US2022042578, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2022042578:same reporter - different patient
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer concerned an 81 year old male of unspecified race and ethnic origin. Initial information was processed along with the additional information received on 03-MAR-2022.  The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously treated with covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on an unspecified date for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s. The patient received booster dose of covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, 1 total administered on an unspecified date for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the reporter stated her husband (patient) and herself were trying to recover from Covid and had been very sick (suspected clinical vaccination failure, and suspected covid-19 infection) (dose number in series 2). They had the J and J shot and booster, as the physician said it could have been worse. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20220304761. This report was associated with product quality complaint: 90000220206.; Sender's Comments: V0: 20220302858- COVID-19 VACCINE AD26.COV2.S- Suspected clinical vaccination failure. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: SIDE EFFECTS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced side effects. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from side effects. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: SOME POSITIVE EFFECT OF JOHNSON VACCINES; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced some positive effect of johnson vaccines. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of some positive effect of johnson vaccines was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Cerebrovascular accident, Hemiplegia
Clinical narrative: RIGHT SIDED HEMIPLEGIA; PONTINE STROKE; This spontaneous report received from a consumer (patient's mother) via a company representative concerned a 22 year old male of an unspecified race and ethnicity. The patient's height and weight were not reported. The patient was previously a healthy college athlete.  It was noted the patient had a Covid-19 infection, and received the vaccine due to a mandate at school 10 days after recovering from Covid-19 infection. The school mandate was to follow the CDC 10-day rule, but the patient's mother reported he received it "two weeks" after he recovered from COVID  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total administered on 08-JAN-2022 for prophylactic vaccination. The batch number was not reported and has been requested.  No concomitant medications were reported.  On 21-FEB-2022, 44 days after vaccine administration, the patient experienced a pontine stroke. The pontine stroke resulted in dense right sided hemiplegia. It is reported that despite many diagnostic tests, they were unable to find any cause. Platelet factor 4, fibrin D-dimer, platelets and other laboratory results were pending. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of pontine stroke and right sided hemiplegia were not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: This spontaneous report received via a company representative concerns a 22-year-old male who experienced pontine stroke 44 days after receiving the Janssen COVID-19 vaccine for COVID-19 prophylaxis. Patient was described as previously healthy however, no specific medical history or concomitant medications were provided. Laboratory tests, diagnostics and medical records were not provided. It was noted that approximately two weeks prior to receiving the vaccine, the patient had recovered from a COVID-19 infection. The patient experienced a pontine stroke and "dense right-sided hemiplegia" 44 days after receiving the vaccine. Treatment and patient outcome were not provided. Latency between the vaccine and the event was somewhat prolonged. In addition, the history of a COVID-19 infection prior to vaccination may represent a confounding factor. However, given the current lack of information, the events are considered possibly related for reporting purposes while more information is being requested for further assessment.
Sex: U
Vaccine: COVID19
Symptoms: Death, Thrombosis
Clinical narrative: TAKEN FROM THIS EARTH; BLOOD CLOT; This spontaneous report received from a consumer via social media concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number: Unknown, expiry: unknown) dose, 1 total, start therapy date were not reported for prophylactic vaccination. 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 blood clot and was died from unknown cause of death. It was unspecified if an autopsy was performed. As per reporter "Two dear friends TRUSTED the J& J vaccine, and were taken from this earth...One, blood clot. The other? Heart. Way before their time." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died on an unspecified date, and the outcome of blood clot was not reported. This report was serious (Death, and Other Medically Important Condition). This case, from the same reporter is linked to 20220313855.; Sender's Comments: V0: 20220313454 -COVID-19 VACCINE Ad26.COV2.S- Taken from this earth, Blood clot.  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: DEATH
Sex: U
Vaccine: COVID19
Symptoms: Cardiac disorder, Death
Clinical narrative: TAKEN FROM THIS EARTH; HEART DISORDER; This spontaneous report received from a consumer via a company representative via media concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry date: unknown) dose, therapy start date were not reported, 1 total administered for prophylactic vaccination. 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 disorder and was taken from this earth (death). The cause of death was unknown. As per reporter, "two dear friends trusted the J and J vaccine and were taken from this earth. One, blood clot. The other, heart. Way before their time." It was unknown if the autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died on an unspecified date, and the outcome of heart disorder was not reported. This report was serious (Death). This case, from the same reporter is linked to 20220313454.; Sender's Comments: V0:20220313855-Covid-19 vaccine ad26.cov2.s-Taken from this earth.The event(s) has an unkown/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: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Influenza, Nasopharyngitis
Clinical narrative: This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 04-MAR-2021 for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 04-MAR-2021, the patient experienced cold symptoms, and flu symptoms. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the cold symptoms and flu symptoms was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: HAD A REACTION TO THE VACCINE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient previously received covid-19 vaccine ad26.cov2.s. (unspecified manufacturer) (dose number in series 1) (suspension for injection, route of administration were not reported, batch number: unknown and expiry date: unknown) dose, start therapy date were not reported, 1 total was administered for prophylactic vaccination. It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26.cov2.s. (dose number in series 1). The patient additionally received covid-19 vaccine ad26.cov2.s (dose number in series 2) (suspension for injection, route of administration were not reported, batch number: unknown and expiry date: unknown) dose, start therapy date were not reported, 1 total was administered for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the patient had a reaction to the vaccine and wanted to know how many hours between taking Tylenol extra strength (paracetamol) (treatment medication). The patient stated that it helped and took two doses of one each (vaccine) (dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from had a reaction to the vaccine. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Injection site discomfort, Nausea, Pain in extremity, Peripheral swelling
Clinical narrative: This spontaneous report received from a patient concerned a 27 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1855835 expiry: UNKNOWN) dose was not reported, administered on 03-MAR-2022 for prophylactic vaccination. No concomitant medications were reported. On MAR-2022, the patient experienced arm still swollen, bruise on arm, feels like there are fire ants in my left arm where got the shot, left arm hurts, nausea, throwing up, and fever. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm still swollen, bruise on arm, left arm hurts, and feels like there are fire ants in my left arm where got the shot, and the outcome of nausea, throwing up and fever was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vomiting
Clinical narrative: This spontaneous report received from a patient concerned a 27 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported and batch number: 1855835 expiry: UNKNOWN) dose was not reported, administered on 03-MAR-2022 for prophylactic vaccination. No concomitant medications were reported. On MAR-2022, the patient experienced arm still swollen, bruise on arm, feels like there are fire ants in my left arm where got the shot, left arm hurts, nausea, throwing up, and fever. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from arm still swollen, bruise on arm, left arm hurts, and feels like there are fire ants in my left arm where got the shot, and the outcome of nausea, throwing up and fever was not reported. This report was non-serious.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site rash
Clinical narrative: RASH AROUND THE INJECTION SITE IN LEFT ARM OF ABOUT SIX INCHES IN DIAMETER; This spontaneous report received from a patient concerned a 4 decade old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced rash around the injection site in left arm of about six inches in diameter. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rash around the injection site in left arm of about six inches in diameter. This report was non-serious.