chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure 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 vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows: The age at vaccination was not reported. The reporter personally knew the patient, who received Shingles vaccine and developed shingles. The reporter stated that, it was not a vaccination if it did not prevent, it was only another money-making shot. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided. This was 1 of 7 linked cases, reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR265680:Same reporter; US-GLAXOSMITHKLINE-US2021AMR265649:Same reporter US-GLAXOSMITHKLINE-US2021AMR265681:Same reporter; US-GLAXOSMITHKLINE-US2021AMR265682:Same reporter; US-GLAXOSMITHKLINE-US2021AMR265683:Same reporter; US-GLAXOSMITHKLINE-US2021AMR265684:Same reporter; US-GLAXOSMITHKLINE-US2021AMR265685:Same reporter; US-GLAXOSMITHKLINE-US2021AMR265680:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure 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 vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows: The age at vaccination was not reported. The reporter personally knew the patient, who received Shingles vaccine and developed shingles. The reporter stated that, it was not a vaccination if it did not prevent, it was only another money-making shot. This case was considered as suspected vaccination failure, since the details regarding the completion of the primary immunization, time to onset for event and laboratory confirmation of shingles were not provided. This was 1 of 7 linked cases, reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR265680:Same reporter; US-GLAXOSMITHKLINE-US2021AMR265649:Same reporter US-GLAXOSMITHKLINE-US2021AMR265682:Same reporter; US-GLAXOSMITHKLINE-US2021AMR265683:Same reporter; US-GLAXOSMITHKLINE-US2021AMR265684:Same reporter; US-GLAXOSMITHKLINE-US2021AMR265685:Same reporter.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Feeling abnormal, Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis. On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and feeling miserable. On an unknown date, the outcome of the vaccination failure, shingles and feeling miserable were unknown. It was unknown if the reporter considered the vaccination failure, shingles and feeling miserable to be related to Shingles vaccine and Shingles vaccine. Additional details were provided as follows: The reporter was patient. The age at vaccination was not reported. The patient had both shingles shots and still came back with shingles and patient felt so miserable. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: I had the vaccine. Still had the shingles/Suspected vaccination failure; Shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure 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 vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine.  Additional details were provided as follows: The reporter was patient. The age at vaccination was not reported. The patient had shingles shots and still experienced shingles. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule, time to onset and laboratory confirmation of shingles were not provided.
Sex: M
Vaccine: VARZOS
Symptoms: Nerve injury
Clinical narrative: Still dealing with nerves damage; This case was reported by a consumer via interactive digital media and described the occurrence of nerve damage in a male patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In September 2021, the patient received Shingles vaccine. On an unknown date, less than 4 months after receiving Shingles vaccine, the patient experienced nerve damage. On an unknown date, the outcome of the nerve damage was not recovered/not resolved.   It was unknown if the reporter considered the nerve damage to be related to Shingles vaccine.  Additional details were provided as follows: The case was reported by patient's wife. The age at vaccination was not reported. The reporter stated, patient received vaccine when retured home from vacation and was still dealing till the time of reporting with nerve damage in patient's chest. The reporter did not consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Illness
Clinical narrative: 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 and feeling bad. On an unknown date, the outcome of the sickness was recovered/resolved and the outcome of the feeling bad was unknown. It was unknown if the reporter considered the sickness and feeling bad to be related to Shingles vaccine. Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingrix vaccine and felt pretty sick for a day or so and felt bad after the shot. The patient thought that he/she was the only one who felt bad after the shot but since then many of his/her friends had the same reaction. The patient stated that one should still get the vaccine but they should tell them that there were side effects for some people. The patient stated that the shingles would be worse than the reaction from the vaccine. The follow-up would not possible as no contact details were available. For 2nd dose tolerance, refer linked case US2021AMR266216, reported by the same reporter for same patient. This case also has been linked with cases US2021AMR266217 and US2021AMR266243, reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR266216:Same reporter; US-GLAXOSMITHKLINE-US2021AMR266217:Same reporter; US-GLAXOSMITHKLINE-US2021AMR266243:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Feeling abnormal, Illness, Vaccine positive rechallenge
Clinical narrative: Pretty sick; Felt bad after the shot; 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.   Previously administered products included Shingles vaccine with an associated reaction of illness (1st dose received on an unknown date, refer case US2021AMR266214).   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 sickness and feeling bad. Rechallenge with Shingles vaccine was positive. On an unknown date, the outcome of the sickness was recovered/resolved and the outcome of the feeling bad was unknown.   It was unknown if the reporter considered the sickness and feeling bad to be related to Shingles vaccine.  Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient received dose of Shingrix vaccine and felt pretty sick for a day or so and felt bad after the shot. The patient thought that he/she was the only one who felt bad after the shot but since then many of his/her friends had the same reaction. The patient stated that one should still get the vaccine but they should tell them that there were side effects for some people. The patient stated that the shingles would be worse than the reaction from the vaccine. The follow-up would not possible as no contact details were available. This case has been linked with cases US2021AMR266217 and US2021AMR266243, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR266214:Same reporter. US-GLAXOSMITHKLINE-US2021AMR266217:Same reporter. US-GLAXOSMITHKLINE-US2021AMR266243:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Pain in extremity, Pyrexia
Clinical narrative: Fever; Chills; Arm was sore; 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 29th December 2021, the patient received Shingles vaccine. On 29th December 2021, less than a day after receiving Shingles vaccine, the patient experienced pain in arm, fever and chills. On an unknown date, the outcome of the pain in arm, fever and chills were recovered/resolved.   It was unknown if the reporter considered the pain in arm, fever and chills to be related to Shingles vaccine.  Additional details were reported as follows: The case was reported by the patient for himself/herself. The age at vaccination was not reported. The patient's arm was sore for the day, and got a fever and chills later in the evening of vaccination day. The patient said all good at the time of reporting. The reporter said the insurance should cover it but he/she had to sign a waiver that he/she would pay the $140 if it did not. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain in extremity
Clinical narrative: Arm still hurts; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   In December 2021, the patient received Shingles vaccine. In December 2021, 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 details were provided as follows: The case was reported by the patient for himself/herself. The age at vaccination was not reported. The patient said his/her arm still hurts from the vaccine after 3 days. The follow-up could not be possible as no contact details were available.
Age: 67.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site erythema, Injection site induration, Injection site pain, Injection site rash, Injection site warmth
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of injection site induration in a 67-year-old female patient who received Herpes zoster (shingrix) (batch number 333TE, expiry date 15th April 2023) for prophylaxis. Previously administered products included shingrix with an associated reaction of injection site pain (received 1st dose on 14th September 2021 and patient's (injected) arm and shoulder were sore, refer case US2021AMR266339). On 27th December 2021, the patient received the 2nd dose of shingrix. In December 2021, less than a week after receiving shingrix, the patient experienced injection site induration, injection site redness, injection site rash, injection site warmth and injection site pain. Rechallenge with shingrix was positive. On an unknown date, the outcome of the injection site induration, injection site redness, injection site rash, injection site warmth and injection site pain were recovering/resolving. It was unknown if the reporter considered the injection site induration, injection site redness, injection site rash, injection site warmth and injection site pain to be related to shingrix. Additional details were provided as follows: The patient self-reported this case. The patient received shingrix on arm. The patient indicated that with her 2nd shingrix shot her (injected arm) was a lot more soar this time and she got a red and raised spot. The patient stated with 2nd shingrix shot, had hard, red, raised and warm area on her arm about 3 inches wide and was very sore and asked was this normal. The patient indicated that on the morning of reporting day, when she got up, she noticed that it seemed to be getting better. It was not as big and not as hard as it was. It was not fully resolved till the time of reporting. The patient consented to contact her physician.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR266339:same reporter.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had both shots, still got shingles/suspected vaccination failure; shingles; This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine and Shingles vaccine.  Additional details were provided as follows: The reporter was patient. The age at vaccination was not reported. The patient got both shots of shingles vaccine still experienced mild shingles. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: VARZOS
Symptoms: Condition aggravated, Herpes zoster, Vaccination failure
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of suspected vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. The patient's past medical history included shingles. On an unknown date, the patient received Shingles vaccine. In December 2021, less than a year after receiving Shingles vaccine, the patient experienced vaccination failure (serious criteria GSK medically significant) and shingles. On an unknown date, the outcome of the vaccination failure and shingles were unknown. It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingles vaccine. Additional details were provided as follows: The reporter was patient. The age at vaccination was not reported. The patient got shingles vaccine over the summer but broke out with shingles again this week of reporting. This case was considered as suspected vaccination failure since the details regarding completion of primary vaccination schedule and laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: administered frozen Fluarix; This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal QIV Dresden (Fluarix Tetra 2020-2021 season) for prophylaxis.   Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix Tetra 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The reporter was a medical assistant. The age at vaccination was not reported. The reporter stated that, the patient was inadvertently administered frozen Fluarix vaccine (vaccine was exposed to minus 1.0 degree C), which led to incorrect storage of drug. The reporter did not have any information of patient available at hand and would call back later with patient information. The reporter consented to follow up. This was 1 of the 3 linked cases, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021265861:Same reporter US-GLAXOSMITHKLINE-US2021AMR266362:Same reporter
Sex: U
Vaccine: VARZOS
Symptoms: Chills, Lethargy, Pyrexia
Clinical narrative: fever; chills; lethargy; This case was reported by a consumer via call center representative and described the occurrence of fever 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 fever, chills and lethargy. On an unknown date, the outcome of the fever, chills and lethargy were unknown. It was unknown if the reporter considered the fever, chills and lethargy to be related to shingrix. Additional details were provided as follows: The reporter was known to the patient. The age at vaccination was not reported. The reporter stated that, she heard about individual (patient) that experienced fever, chills and lethargy after dose of shingrix (dose number was unknown). The reporter did not have any patient identifiers. The reporter did not consent to follow-up. The case had been linked with US2021265875, reported by the same reporter; Sender's Comments:  US-GLAXOSMITHKLINE-US2021265875:Same reporter
Age: 63.0
Sex: F
Vaccine: VARZOS
Symptoms: Erythema, Mobility decreased, Peripheral swelling, Syncope
Clinical narrative: she fainted; had striped redness; swelling along her lateral deltoid extending to her medial bicep; unable to get up; This case was reported by a other health professional via call center representative and described the occurrence of fainting in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 2nd December 2021, the patient received the 2nd dose of Shingrix (intramuscular) 50 µg. On 3rd December 2021, 1 days after receiving Shingrix, the patient experienced erythema, peripheral swelling and mobility decreased. On 3rd December 2021 04:00, the patient experienced fainting (serious criteria hospitalization and GSK medically significant). On an unknown date, the outcome of the fainting and mobility decreased were unknown and the outcome of the erythema and peripheral swelling were recovered/resolved.   It was unknown if the reporter considered the fainting, erythema, peripheral swelling and mobility decreased to be related to Shingrix.  Additional details were provided as follows: The patient self-reported this case, who was an health care professional (HCP)/physical therapist. The patient received her 2nd dose of Shingrix in her left deltoid intramuscularly and next day around 4am,  she fainted and was unable to get up and she was taken to the hospital.  The patient reported that one episode of fainting, however her physician was requiring her to get an MRI and cardiac workup.  The patient's physician had also taken away her driving privileges for 2 months.  The patient stated she also had striped redness and swelling along her lateral deltoid extending to her medial bicep that took 2 to 3 days to resolve. The patient gave consent to contact her, but not her HCP and did not provide her email or doctor's demographics. She could not provide the lot or expiration date of the Shingrix vaccine she was administered Emergency room (ER) visit was required. The reporter consented to follow up.
Age: 79.0
Sex: F
Vaccine: HEP
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of underdose in a 79-year-old female patient who received HBV (Engerix B pediatric) (batch number 77X47, expiry date 22nd December 2023) for prophylaxis. On 28th December 2021, the patient received Engerix B pediatric. On 28th December 2021, unknown after receiving Engerix B pediatric, the patient experienced underdose and adult use of a child product. On 29th December 2021, the outcome of the underdose was unknown. On an unknown date, the outcome of the adult use of a child product was unknown. Additional details were provided as follows: The vaccine was administered in left deltoid. The reporter reported that Engerix B pediatric administered to an adult, which led to underdose and adult use of a child product. The reporter consented to follow up. The permission granted for safety to follow up. No additional details were available at time of reporting and no further information given upon callback.
Sex: F
Vaccine: VARZOS
Symptoms: Hypotonia, Paralysis
Clinical narrative: Arms and legs felt like rubber; Paralyzed; This case was reported by a pharmacist via call center representative and described the occurrence of paralysis in a female patient who received Herpes zoster (Shingrix) (batch number E99E7, expiry date 11th May 2023) for prophylaxis.   On 2nd September 2021, the patient received Shingrix. On 2nd September 2021, less than a day after receiving Shingrix, the patient experienced paralysis (serious criteria GSK medically significant). On an unknown date, the patient experienced flaccidity. On an unknown date, the outcome of the paralysis and flaccidity were unknown.   It was unknown if the reporter considered the paralysis and flaccidity to be related to Shingrix.  Additional details were provided as follows: The age at vaccination was not reported. The patient received the Shingrix and was paralyzed. On an unknown date in 2021, less than 4 months after receiving the Shingrix, the patient's arms and legs felt like rubber. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Has not yet received the 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose on 05th November 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 patient self-reported this case. The age at vaccination was not applicable for this report. The patient had not yet received the second dose of Shingrix, which led to incomplete course of vaccination. The patient requested information regarding the recommendation for receiving the second dose after the suggested 2 to 6 months. No additional details were provided by the reporter. The reporter consented to follow up and provided permission to contact healthcare professional.
Age: 55.0
Sex: F
Vaccine: VARZOS
Symptoms: Injected limb mobility decreased, Injection site pain, Laboratory test normal, Tenderness, X-ray normal
Clinical narrative: Nearly incapacitated, unable to lift arm without pain; even light touch of her skin causes pain; Arm pain even with light touch of skin, progressively worse; This case was reported by a consumer via call center representative and described the occurrence of injection site pain in a 55-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In February 2021, the patient received the 1st dose of Shingrix 50 ug. In February 2021, 5 min after receiving Shingrix, the patient experienced injection site pain (serious criteria disability). On an unknown date, the patient experienced injected limb mobility decreased (serious criteria disability) and tenderness (serious criteria disability). On an unknown date, the outcome of the injection site pain, injected limb mobility decreased and tenderness were not recovered/not resolved.   It was unknown if the reporter considered the injection site pain, injected limb mobility decreased and tenderness to be related to Shingrix.  Additional details were provided as follows: The case was reported by the patient's husband. The patient received her first dose of Shingrix in February 2021 (exact date unknown) in her left arm.  Soon after the injection, she started experiencing arm pain in her left arm that got progressively worse and was still unresolved.  The reporter stated that, the patient's pain had left her nearly incapacitated (she was unable to lift her arm without experiencing pain) and even light touch of her skin caused pain. On an unknown date, less than a year after receiving the Shingrix, the patient experienced injected limb mobility decreased and tenderness. The patient had multiple tests performed and x-rays done for the issue and the doctors had not been able to identify the reason for the pain. The reporter could not provide the lot or expiration date of the Shingrix vaccines administered. The reporter gave consent to contact the patient and healthcare professional. The reporter consented to follow up. For tolerance of 2nd dose, refer case US2021AMR266081, reported by the same reporter.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR266081:Same reporter.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Rash, Vaccination failure
Clinical narrative: 1st dose 2018, 2nd dose 2019, mild outbreak 2021; Mild case of shingles; Rash; This case was reported by a consumer via call center representative and described the occurrence of suspected vaccination failure in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   In February 2019, the patient received the 2nd dose of Shingrix. In November 2018, the patient received the 1st dose of Shingrix. On an unknown date, more than 2 years after receiving Shingrix and Shingrix, the patient experienced vaccination failure (serious criteria GSK medically significant), shingles and rash. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and rash were recovered/resolved.   It was unknown if the reporter considered the vaccination failure, shingles and rash to be related to Shingrix and Shingrix.  Additional details were provided as follows: The reporter was patient. The age at vaccination was not reported. The reporter stated that he received both doses of Shingrix and he developed a mild case of shingles in July or August 2021. The mild case of shingles was resolved. The patient stated that the rash from shingles lasted for 1 to 2 weeks, only. Very limited information was provided.  The consent to follow up was not asked. This case was considered as suspected vaccination failure since the details regarding laboratory confirmation of shingles were not provided.
Sex: U
Vaccine: FLU4
Symptoms: Product storage error
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of incorrect storage of drug in a patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2020-2021 season) for prophylaxis. Co-suspect products included flu seasonal qiv dresden pre-filled syringe device (Fluarix Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis. On an unknown date, the patient received Fluarix Quadrivalent 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix Quadrivalent 2020-2021 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced incorrect storage of drug. On an unknown date, the outcome of the incorrect storage of drug 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 reporter stated that the patient was inadvertently administered frozen Fluarix vaccine (vaccine was exposed to minus 1.0 degree Celsius), which led to incorrect storage of drug. The reporter did not have any information of patient available at hand at the time of reporting and would call back later with patient information. The reporter consented to follow up. This case has been linked to US2021AMR266362 and US2021AMR266361, reported by the same reporter.; Sender's Comments: US-GLAXOSMITHKLINE-US2021AMR266361:Same reporter; US-GLAXOSMITHKLINE-US2021AMR266362:Same reporter.
Sex: U
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: administered with the wrong diluent; administered with the wrong diluent; This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution 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 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 age at vaccination was not reported. The pharmacist reported that a nurse at another facility inadvertently administered Shingrix powder (antigen) with the wrong diluent which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The powder component was mixed with sterile water. The reporter did not consented to follow-up.
Sex: F
Vaccine: COVID19
Symptoms: Diplopia, Illness
Clinical narrative: VERY SICK, SICKER THEN A DOG; DOUBLE VISION; This spontaneous report received from a consumer via social media via a company representative 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 very sick, sicker then a dog, and double vision. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the very sick, sicker then a dog and double vision was not reported. This report was non-serious.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Ear infection, SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; FEELING LIKE EAR INFECTION; This spontaneous report received from a patient concerned a 52 year old female of an unspecified ethnic origin. 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, batch number: 1808609, and expiry: unknown) dose was not reported, dose number in series was 1, 1 total administered on 26-MAY-2021 to right arm for prophylactic vaccination. No concomitant medications were reported.  On 29-DEC-2021 in morning, the patient started having symptoms of cold, headache, fever and sore throat (suspected covid-19 infection) and feeling like ear infection. On an unspecified date, the patient had suspected clinical vaccination failure (dose number in series was 1). Laboratory data (dates unspecified) included: EE home kit test (COVID-19 virus test) (NR: not provided) Negative. The patient had not taken any other tests. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from suspected covid-19 infection, and feeling like ear infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000209648.; Sender's Comments: V0: 20211266394 -Covid-19 vaccine ad26.cov2.s- Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive 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.
Sex: F
Vaccine: COVID19
Symptoms: Adverse event, Antibody test, Therapeutic response unexpected
Clinical narrative: AUTOIMMUNE DISEASES UNDER CONTROL; INITIAL REACTION WAS HORRIFIC; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: autoimmune disease. 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 autoimmune diseases under control, and initial reaction was horrific. Laboratory data (dates unspecified) included: Antibody test (NR: not provided) improving. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the autoimmune diseases under control and initial reaction was horrific was not reported. This report was non-serious.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Blood pressure increased, Blood pressure measurement, Cardiac monitoring, Feeling abnormal, Heart rate
Clinical narrative: SLIGHTLY ELEVATED BLOOD PRESSURE; COULD FEEL BODY FIGHTING VACCINE; RAPID HEART BEAT; IRREGULAR HEART BEAT EVERY ONCE IN A WHILE; This spontaneous report received from a patient concerned a 63 year old male. The patient's weight was 210 pounds, and height was 187 centimeters. The patient's concurrent conditions included: asthma, non smoker, dust allergy, and alcohol user, and other pre-existing medical conditions included: Patient was on prostate medication slowmax exercises every week. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. Concomitant medications included budesonide for asthma, and salbutamol for asthma. On APR-2021, the patient experienced irregular heart beat every once in a while. On 12-APR-2021, the patient experienced rapid heart beat, and could feel body fighting vaccine. On 13-APR-2021, the patient experienced slightly elevated blood pressure. Laboratory data included: Blood pressure (NR: not provided) Little high, and Heart rate (NR: not provided) little high. Laboratory data (dates unspecified) included: Cardiac monitoring (NR: not provided) Data inconclusive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rapid heart beat on 14-APR-2021, had not recovered from irregular heart beat every once in a while, and the outcome of could feel body fighting vaccine and slightly elevated blood pressure was not reported. This report was non-serious.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: Heart rate increased, Heart rate irregular
Clinical narrative: SLIGHTLY ELEVATED BLOOD PRESSURE; COULD FEEL BODY FIGHTING VACCINE; RAPID HEART BEAT; IRREGULAR HEART BEAT EVERY ONCE IN A WHILE; This spontaneous report received from a patient concerned a 63 year old male. The patient's weight was 210 pounds, and height was 187 centimeters. The patient's concurrent conditions included: asthma, non smoker, dust allergy, and alcohol user, and other pre-existing medical conditions included: Patient was on prostate medication slowmax exercises every week. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, and batch number: 205A21A expiry: UNKNOWN) dose was not reported, administered on 12-APR-2021 for prophylactic vaccination. Concomitant medications included budesonide for asthma, and salbutamol for asthma. On APR-2021, the patient experienced irregular heart beat every once in a while. On 12-APR-2021, the patient experienced rapid heart beat, and could feel body fighting vaccine. On 13-APR-2021, the patient experienced slightly elevated blood pressure. Laboratory data included: Blood pressure (NR: not provided) Little high, and Heart rate (NR: not provided) little high. Laboratory data (dates unspecified) included: Cardiac monitoring (NR: not provided) Data inconclusive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from rapid heart beat on 14-APR-2021, had not recovered from irregular heart beat every once in a while, and the outcome of could feel body fighting vaccine and slightly elevated blood pressure was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Joint swelling, Skin lesion
Clinical narrative: PUFFY SORES; SWOLLEN JOINTS; This spontaneous report received from a consumer via a company representative concerned a male 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 puffy sores, and swollen joints. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the puffy sores and swollen joints was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Headache, Injection site pain, Nausea, Sleep disorder
Clinical narrative: SLEEPING PATTERN OFF; NAUSEOUS; SHOOTING PAIN FROM INJECTION SHOT; FREQUENT HEADACHES; This spontaneous report received from a patient concerned a 24 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: carpal tunnel syndrome. 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 09-JUL-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 sleeping pattern off, nauseous, shooting pain from injection shot, and frequent headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sleeping pattern off, nauseous, shooting pain from injection shot and frequent headaches was not reported. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Vaccine virus shedding
Clinical narrative: VIRAL SHEDDING/COVID-19 VACCINE SHEDS; This spontaneous report received from a consumer 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 not reported, and batch number: Unknown) 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 viral shedding/covid-19 vaccine sheds. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of viral shedding/covid-19 vaccine sheds was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Anxiety, Body temperature, Pyrexia
Clinical narrative: BIT ANXIOUS; FEVER OF 110; 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 bit anxious, and fever of 110. Laboratory data (dates unspecified) included: Body temperature (not provided) 110. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the fever of 110 and bit anxious was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Chest pain, Pain, Pyrexia
Clinical narrative: SEVERE CHEST PAIN; ACHES EVERY WHERE; FEVER; SO WEAK COULD HARDLY CRAWL OUT OF BED FOR 5 DAYS; 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 severe chest pain, aches every where, fever, and so weak could hardly crawl out of bed for 5 days. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the severe chest pain, aches every where, fever and so weak could hardly crawl out of bed for 5 days was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Pain, Pyrexia
Clinical narrative: 4 DAYS OF ACHES; 4 DAYS OF FEVER; MANY DAYS OF FATIGUE; 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 4 days of aches, 4 days of fever, and many days of fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from 4 days of aches, and 4 days of fever, and the outcome of many days of fatigue was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Hypoaesthesia, Pain in extremity
Clinical narrative: PAINFUL LEFT ARM STARTING ON SHOULDER RADIATING TO THE FINGER; NUMBNESS; This spontaneous report received from a patient 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 and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced painful left arm starting on shoulder radiating to the finger, and numbness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from painful left arm starting on shoulder radiating to the finger, and numbness. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Blood pressure measurement, Headache, Hypertension, Hypoaesthesia, Muscular weakness
Clinical narrative: INCREASED BLOOD PRESSURE; ARM WEAK; SEVERE RINGING; MASSIVE HEADACHE; ARM NUMB; This spontaneous report received from a patient 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 not reported, batch number: unknown) dose was not reported, administered on DEC-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On DEC-2021, the patient experienced increased blood pressure, arm weak, severe ringing, massive headache, and arm numb. Laboratory data included: Blood pressure (NR: not provided) increased. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from increased blood pressure, arm weak, severe ringing, massive headache, and arm numb on DEC-2021. This report was non-serious.