chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: had the vac & 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.   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 patient self-reported this case. The age at vaccination was not reported. The patient got the Shingle vaccine and got shingles. The patient reported that it was mild one and thanked goodness and advised that one to still could get them. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, 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), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain 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 got the shingle shot and still got shingles. It was very painful. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Sex: M
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, 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 male 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), shingles and pain. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown.   It was unknown if the reporter considered the vaccination failure, shingles and pain to be related to Shingles vaccine.  Additional details were provided as follows: The patient was the reporter's husband. The age at vaccination was not reported. The patient was breaking out with shingles every 4 to 5 weeks and had this for two years. The patient had all the shots nothing helped with pain. This case was considered as suspected vaccination failure as details regarding the completion of primary vaccination schedule, laboratory test confirming shingles and time to onset for shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination, Social problem
Clinical narrative: This case was reported by a consumer via interactive digital media and described the occurrence of social problem in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis. Previously administered products included Shingles vaccine with an associated reaction of herpes zoster (received 1st dose on an unknown date and had outbreak). 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 social problem. On an unknown date, the outcome of the social problem was unknown. Additional details were provided as follows: The reporter was the patient. The age at vaccination was not applicable for this report. The patient did not receive 2nd dose due to pandemic, which led to social problem. The patient stated that, 1st dose did not do so well.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Oral herpes, Pain, 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. 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, oral herpes and pain. The patient was treated with antivirals nos (Antiviral (Drug Name Unknown)) and prednisone. On an unknown date, the outcome of the vaccination failure, shingles and pain were unknown and the outcome of the oral herpes was recovering/resolving. It was unknown if the reporter considered the vaccination failure, shingles, oral herpes and pain to be related to Shingles vaccine and Shingles vaccine. Additional details were provided as follows: The patient self-reported this case. The age at vaccination was not reported. The patient had received both Shingles vaccine. At the time of reporting, the patient was recovering from 4th outbreak. The patient reported that this time he/she got oral shingles, which was very rare and very painful. The patient was fortunately familiar with the pain, so he/she went right away to urgent care. The patient reported that antiviral and Prednisone were working. This case was considered as suspected vaccination failure since the details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow up would not be possible as no contact details were provided.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Pain, 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), shingles and pain. On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the shingles and pain were not recovered/ not resolved. It was unknown if the reporter considered the vaccination failure, shingles and pain 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 got the shingle shot and still got shingles. It had been 5 months now.  The patient was tired of the pain. The patient enquired about what could be done. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Exercise tolerance decreased, Fatigue, Headache, Muscular weakness, Photosensitivity reaction
Clinical narrative: Fever; Headache; Fatigue; Muscle weakness; Exercise intolerance; Photosensitivity; This case was reported by a consumer via call center representative and described the occurrence of fever in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced fever, headache, fatigue, muscle weakness, exercise tolerance decreased and photosensitivity. On an unknown date, the outcome of the fever, headache, fatigue, muscle weakness, exercise tolerance decreased and photosensitivity were recovered/resolved.   It was unknown if the reporter considered the fever, headache, fatigue, muscle weakness, exercise tolerance decreased and photosensitivity 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 immediate after the vaccination experienced fever, headache, fatigue, muscle weakness, exercise intolerance, and photosensitivity. The patient stated that the fever resolved after approximately 24 hours.  The patient also stated that the headache, fatigue, muscle weakness, exercise intolerance, and photosensitivity resolved after approximately 3 weeks, after the first dose of Shingrix. The patient did not remember when the first dose of Shingrix was received, but confirmed it was more than 6 months before they received the second dose.  The reporter did not consent to follow-up. For 2nd dose tolerance, refer linked case US2021259887, reported by the same reporter for same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021259887:2nd dose case, same reporter
Age: 58.0
Sex: F
Vaccine: VARZOS
Symptoms: Pyrexia
Clinical narrative: Fever; Headache; Fatigue; Muscle weakness; Exercise intolerance; Photosensitivity; This case was reported by a consumer via call center representative and described the occurrence of fever in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, immediately after receiving Shingrix, the patient experienced fever, headache, fatigue, muscle weakness, exercise tolerance decreased and photosensitivity. On an unknown date, the outcome of the fever, headache, fatigue, muscle weakness, exercise tolerance decreased and photosensitivity were recovered/resolved.   It was unknown if the reporter considered the fever, headache, fatigue, muscle weakness, exercise tolerance decreased and photosensitivity 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 immediate after the vaccination experienced fever, headache, fatigue, muscle weakness, exercise intolerance, and photosensitivity. The patient stated that the fever resolved after approximately 24 hours.  The patient also stated that the headache, fatigue, muscle weakness, exercise intolerance, and photosensitivity resolved after approximately 3 weeks, after the first dose of Shingrix. The patient did not remember when the first dose of Shingrix was received, but confirmed it was more than 6 months before they received the second dose.  The reporter did not consent to follow-up. For 2nd dose tolerance, refer linked case US2021259887, reported by the same reporter for same patient.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021259887:2nd dose case, same reporter
Sex: M
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 male 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 patient was the reporter's husband. The age at vaccination was not reported. The reporter stated that, the patient took the shingles shot then he came down with the shingles and had to visit the emergency room. This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting. The follow-up would not possible as no contact details were available.
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: This case was reported by the patient's friend. The age at vaccination was not reported. The patient got the shingle from the Shingles vaccine. This case was considered as suspected vaccination failure since the details regarding completion of primary immunization schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting.
Age: 19.0
Sex: M
Vaccine: HEPA
Symptoms: Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: received 2nd pediatric dose of Havrix when having 19 years old; received 2nd pediatric dose of Havrix when having 19 years old; This case was reported by a nurse via call center representative and described the occurrence of underdose in a 19-year-old male patient who received HAV (Havrix pediatric) (batch number EP47E, expiry date 28th February 2023) for prophylaxis.   Co-suspect products included hepatitis A vaccine pre-filled syringe device (Havrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 16th December 2021, the patient received the 2nd dose of Havrix pediatric and Havrix Pre-Filled Syringe Device. On 16th December 2021, unknown after receiving Havrix pediatric and Havrix Pre-Filled Syringe Device, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The patient received dose of Havrix pediatric at the age of 19 years old, which led to underdose and adult use of a child product. The reporter did not consent to follow up.
Age: 10.0
Sex: M
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 10-year-old male patient who received DTPa (Infanrix) (batch number 23T73, expiry date 30th April 2023) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 10th December 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 10th December 2021, 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: The nurse manager reported that, the patient received infanrix vaccine instead of Boostrix, which led to inappropriate age at vaccine administration and wrong vaccine administered. The reporter consented to follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021071603:same reporter
Age: 78.0
Sex: M
Vaccine: VARZOS
Symptoms: Dizziness, Lethargy, Malaise, Nausea
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of nausea in a 78-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 9th December 2021, the patient received the 1st dose of Shingrix (intramuscular). On 10th December 2021, 1 days after receiving Shingrix, the patient experienced nausea, dizziness, malaise and lethargy. On an unknown date, the outcome of the nausea, dizziness, malaise and lethargy were recovering/resolving.   It was unknown if the reporter considered the nausea, dizziness, malaise and lethargy to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient. The patient had the dose of Shingrix vaccination in his right arm.  The next day experienced nausea, dizzy, malaise, lethargy, these were better but persisted.  The reporter was given medical disclaimer and was referred to health care professional (HCP). The reporter was offered (product information) PI, provided medical information phone number for HCP reference. The reporter did not consent to follow-up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose in Aug 2018 has not received the 2nd; 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.   Previously administered products included Shingrix (1st dose received in August 2018).   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.  Additional details were reported as follows: The case was reported by the patient. The age at vaccination was not applicable. The patient had not yet received the 2nd dose of Shingrix till the time of reporting which led to incomplete course of vaccination. No demographics provided. The reporter did not consent to follow-up.
Age: 0.17
Sex: F
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 2-month-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2021-2022 season) (batch number 54C23, expiry date 30th June 2022) 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 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving Fluarix Quadrivalent 2021-2022 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.  This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences. Additional details were provided as follows: Practice administrator reported that a dose of Fluarix vaccine was given to a 2 month old inadvertently, which led to inappropriate age at vaccine administration. The reporter consented to follow up by email or phone.
Sex: U
Vaccine: DTAP
Symptoms: Incomplete course of vaccination
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of incomplete course of vaccination in a patient who received DTPa (Infanrix) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Previously administered products included Infanrix (received unknown dose on an unknow date).   On an unknown date, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Infanrix and Infanrix Pre-Filled Syringe Device, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional details were provided as follows: The age at vaccination was not applicable for this report. The patient had missing vaccination schedule regarding Infanrix.The reporter did not know how many doses were missing. Till the time of reporting, the patient did not receive remaining dose of Infanrix, which led to incomplete course of vaccination. The reporter wanted to proceed with Boostrix and asked which would it be the best option to proceed with vaccination schedule. The reporter did not consent to follow up.
Age: 50.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Pain, Pyrexia
Clinical narrative: chills; fever; body aches; This case was reported by a consumer via call center representative and described the occurrence of chills in a adult female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of pain (1st  dose received on an unknown date, the body ache resolved after about 3 days refer case US2021AMR259260).   On 15th December 2021, the patient received the 2nd dose of Shingrix (intramuscular). In December 2021, less than a week after receiving Shingrix, the patient experienced chills, fever and general body pain. Rechallenge with Shingrix was positive. On an unknown date, the outcome of the chills, fever and general body pain were recovered/resolved.   It was unknown if the reporter considered the chills, fever and general body pain to be related to Shingrix.  Additional details were reported as follows: The case was reported by the patient's husband. Age at vaccination was not reported. The patient received 2nd Shingrix dose and she had fever, chills and body ache for almost 2 days.  The patient was now feeling better at the time of reporting. The reporter had nothing else to report. The patient was not available to provide consent for MD follow up. The reporter permission denied for follow up.; Sender's Comments:  US-GLAXOSMITHKLINE-US2021AMR259260:same reporter
Sex: M
Vaccine: FLU4, VARZOS
Symptoms: Fatigue, Myalgia
Clinical narrative: This case was reported by a consumer via call center representative and described the occurrence of myalgia of lower extremities in a male patient who received Herpes zoster (Shingrix) for prophylaxis. Co-suspect products included Flu Seasonal QIV Dresden (Influenza vaccine Quadrivalent 2021-2022 season) for prophylaxis. On 10th December 2021, the patient received the 1st dose of Shingrix (intramuscular) and Influenza vaccine Quadrivalent 2021-2022 season. On 11th December 2021, 1 days after receiving Shingrix and Influenza vaccine Quadrivalent 2021-2022 season, the patient experienced myalgia of lower extremities and tiredness. On an unknown date, the outcome of the myalgia of lower extremities and tiredness were not recovered/not resolved. It was unknown if the reporter considered the myalgia of lower extremities and tiredness to be related to Shingrix and Influenza vaccine Quadrivalent 2021-2022 season. 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 into left arm and flu vaccination on the same day in his opposite arm and next day he felt very tired and that his leg muscles were sore. The reporter called today (day of reporting) to requested a copy of the product insert for Shingrix. The reporter was given medical disclaimer. The reporter was referred to health care professional. The reporter was offered medical information phone number for HCP reference. No further information reported. The reporter consented to follow-up.
Sex: F
Vaccine: DTAP
Symptoms: Product administered to patient of inappropriate age, Wrong product administered
Clinical narrative: This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 24-year-old female patient who received DTPa (Infanrix) (batch number yk2ff, expiry date 28th May 2022) for prophylaxis.   Co-suspect products included dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 17th December 2021, the patient received Infanrix and Infanrix Pre-Filled Syringe Device. On 17th December 2021, 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: The patient inadvertently administered Infanrix instead of Boostrix was intended to be given as a booster dose, which led to inappropriate age at vaccine administration and wrong vaccine administered. The reporter did not consent to follow up.
Age: 63.0
Sex: F
Vaccine: MNQ
Symptoms: Extra dose administered, Product administered to patient of inappropriate age
Clinical narrative: Menveo given to 63 year old; Menveo, 2 doses 1 week apart; Menveo given to 63 year old; This case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 63-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMV576A, expiry date 31st July 2022) for prophylaxis.   Co-suspect products included Men ACWY-CRM NVS (Menveo) (batch number AMVA576A, expiry date 31st July 2022) for prophylaxis.   On 15th December 2021, the patient received the 2nd dose of Menveo. On 9th December 2021, the patient received the 1st dose of Menveo. On 9th December 2021, not applicable after receiving Menveo and unknown after receiving Menveo, the patient experienced inappropriate age at vaccine administration. On 15th December 2021, the patient experienced inappropriate age at vaccine administration and extra dose administered. On an unknown date, the outcome of the inappropriate age at vaccine administration, extra dose administered and inappropriate age at vaccine administration were unknown.  Additional details were provided as follows: The patient received 2 doses of Menveo 1 week apart at the age of 63 years old, which led to inappropriate age at vaccine administration and extra dose administered. The reporter consented to follow up.
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: administered Only the Liquid Component; administered Only the Liquid Component; This case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA689A, expiry date 1st April 2023) for prophylaxis.   On 17th December 2021, the patient received Menveo. On 17th December 2021, unknown after receiving Menveo, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional details were provided as follows: The age at vaccination was not reported. The patient received only the liquid component of (MenCWY) of Menveo, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered. The reporter did not consent to follow up.
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: This case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 68-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis. On 22nd October 2021, the patient received the 1st dose of Shingrix. On 22nd October 2021, 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 patient received shingrix reconstituted with normal saline, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter consented to follow up.
Sex: M
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEAD FROM THE BOOSTER; This spontaneous report received from a consumer via a company representative via social media  concerned a 57 year old male of unknown race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient was previously received covid-19 vaccine ad26. cov2. s (unspecified manufacturer) (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 1 total, start therapy date were not reported, for prophylactic vaccination (Dose number in series 1). No adverse event reported with previously treated with covid-19 vaccine ad26. cov2. s. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, batch number and expiry were not reported) dose was not reported, 1 total administered on 11-DEC-2021 for prophylactic vaccination (Dose number series 2). 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 13-DEC-2021, the patient died due to unspecified cause (Dose number series 2). As per report, "My friend that was only 57, he took the Booster on Saturday and his wife went to wake him up on Monday morning and he was dead from the booster". It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0:20211229888-COVID-19 VACCINE AD26.COV2.S-Dead from the booster. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patient was exposed to his wife who started feeling bad on Thursday and tested positive for Covid-19 on Friday 12-OCT-2021. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of administration not reported, batch number: 204B219, expiry: unknown) dose was not reported, 01 total administered on 15-OCT-2021 for prophylactic vaccination. No concomitant medications were reported.  On 12-DEC-2021, the patient experienced suspected covid-19 (coronavirus disease) infection. Patient stated that on 12-DEC-2021 late in the afternoon, he started experiencing symptoms which included cough, nasal congestion, fever, loss of smell, loss of taste and body aches. On same day patient underwent COVID-19 (coronavirus disease) rapid test which was found to be positive (suspected clinical vaccination failure). Reportedly, on an unspecified date in DEC-2021 patient was also underwent to COVID-19 PCR (polymerase chain reaction) test and awaiting for PCR test results. 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 report was associated with product quality complaint: 90000206881 and 90000207019. The suspected product quality complaint has been confirmed to be not voided. The reported allegation could not be confirmed and a manufacturing related root cause could not be identified based on the PQC evaluation/investigation performed.; Sender's Comments: V0: 20211230245-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: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: COVID-19; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age, race and ethnic origin. 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.(manufacturer not specified) (suspension for injection, route of admin, batch number and expiry date not reported) dose, 1 total, administered on unspecified date (therapy start date and therapy end date were not provided) for prophylactic vaccination (dose number series 1). No adverse events were reported following vaccination with covid-19 vaccine ad26. cov2. s (dose number in series 1).  The patient additional received Covid-19 vaccine ad26.cov2.s (manufacturer not specified)(suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose, 1 total, administered on unspecified date (therapy start date and therapy end date were not provided) for prophylactic vaccination (dose number series 2). 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 was a covid-19 positive. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. (dose number series 2).  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of covid-19 was not reported. This report was non-serious. This case, from the same reporter is linked to 20211229726.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Fatigue, Headache, Malaise
Clinical narrative: NO APPETITE; GENERAL MALAISE; HEADACHE; EXTREMELY TIRED; NOT FEELING WELL; This spontaneous report received from a patient concerned a 71 year old female. The patient's weight was 110 pounds, and height was 61 inches. The patient's concurrent conditions included: sulfa allergy (Bactrim). The patient was previously treated with covid-19 vaccine ad26. cov2. s (suspension for injection, route of admin not reported, batch number: 1805018, expiry: 23-AUG-2021) dose was not reported, 1 total administered on 06-MAR-2021,10:00 for prophylactic vaccination. (Dose number in series 1). Patient did not experienced any adverse reaction after vaccination.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822809, expiry: 07-MAR-2022) dose was not reported,1 total administered on 10-NOV-2021 to left arm for prophylactic vaccination (Dose number in series 2). No concomitant medications were reported.  On 10-NOV-2021 patient became extremely tired by afternoon, and she was not feeling well by night. On 11-DEC-2021 (next morning), she had no appetite at all and desperately not well (Dose number in series 2). This continued for the next 24 hours with general malaise, headache, for which patient took Benadryl and Tylenol every six hours and increased oral fluids to wash it out of system. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from no appetite, not feeling well, general malaise, extremely tired, and headache on NOV-2021. This report was non-serious. This case is associated with product quality complaint: 90000207091.
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Cough, Fear, Fibromyalgia, Guillain-Barre syndrome
Clinical narrative: FIBROMYALGIA; GUILLAIN BARRE SYNDROME; COUGHING; BECAME AFRAID; ALARMED; This spontaneous report received from a patient via a company representative concerned a female of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. The patient's concurrent conditions were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported, expiry; Unknown) dose was not reported, 1 total administered on APR-2021 for prophylactic vaccination (Dose number series 1). The batch number was not reported and has been requested. No concomitant medications were reported. Shortly after patient received the vaccine, In APR-2021, developed strange numbness and pain in arms, legs, neck and had tingling, cough and other symptoms throughout body. Guillain Barre Syndrome was the reason for which the patient was instructed to go to the emergency room at a Hospital. The patient became very alarmed and afraid as took that shot and a woman died of Guillain Barre Syndrome. The patient was unemployed due to Fibromyalgia and needed a complete shoulder replacement. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the guillain barre syndrome, coughing, became afraid ,alarmed and Fibromyalgia was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20211233584.; Sender's Comments: V0: 20211233505- Covid-19 vaccine ad26.cov2.s -Guillain-Barre Syndrome. This event(s) is labeled and is therefore considered potentially related.
Sex: M
Vaccine: COVID19
Symptoms: Off label use, Product administered to patient of inappropriate age
Clinical narrative: INAPPROPRIATE AGE AT VACCINE ADMINISTRATION; OFF LABEL USE; This spontaneous report received from a pharmacist concerned an adolescent male. The patient's height, and weight were not reported. The patient's concurrent conditions included: smoker, and non alcoholic, and other pre-existing medical conditions included: The patient did not have known allergies and no history of drug abuse. 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 inappropriate age at vaccine administration, and off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the inappropriate age at vaccine administration and off label use was not reported. This report was non-serious. This case, from the same reporter is linked to 20211140013.; Sender's Comments:  Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Amenorrhoea, Chest discomfort, Dyspnoea, Headache
Clinical narrative: CHEST TIGHTNESS; HAIR FALLING OUT ABOUT 3-4 WEEKS NONSTOP; PERIOD STOPPED FOR 4 MONTHS/AMENORRHEA; SHORTNESS OF BREATH/DIFFICULTY BREATHING; INVOLUNTARY WEIGHT LOSS; SICK FOR ABOUT A WEEK; HEADACHE/TOP OF HEAD SUPER TENDER; PAIN AT INJECTION SITE/RIGHT ARM HURT FOR ABOUT A WEEK A HALF; This spontaneous report received from a patient concerned a 39 year old female of unspecified race and ethnicity. The patient's weight was 118 pounds (135 pounds before vaccine), and height was 170 centimeters. The patient's concurrent conditions included: non smoker, non alcohol user, autistic spectrum (processing disorder), Ehlers-Danlos (connective tissue disorder),severe anxiety disorder, attention deficit hyperactivity disorder (ADHD),  complex post-traumatic stress disorder (CPTSD),  contrast dies allergy,  allergy to anti-depressants and allergy medication. Other pre-existing medical conditions included: Patient had no drug abuse or illicit drug use. The patient had a history of  vaccine reaction (" vaccine given in 1/4 doses"). The patient was planning to have genetic test for allergies and how medications react. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 12-APR-2021 in right arm for prophylactic vaccination. Concomitant medications included Xanax (alprazolam), marijuana (cannabis sativa) and ketamine for complex post-traumatic stress disorder. On an unspecified date, the patient experienced chest tightness, hair falling out about 3-4 weeks nonstop, period stopped for 4 months (amenorrhea) shortness of breath/difficulty breathing, weight loss, sick for about a week, headache/top of head super tender, and pain at injection site/right arm hurt for about a week a half (dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest tightness, shortness of breath/difficulty breathing, sick for about a week, headache/top of head super tender, and pain at injection site/right arm hurt for about a week a half, had not recovered from hair falling out about 3-4 weeks nonstop, and involuntary weight loss. The outcome of period stopped for 4 months/amenorrhea was unknown. This report was non-serious. This case, involving the same patient is linked to 20211235188 (dose number in series 2).
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Injection site pain, Weight decreased
Clinical narrative: CHEST TIGHTNESS; HAIR FALLING OUT ABOUT 3-4 WEEKS NONSTOP; PERIOD STOPPED FOR 4 MONTHS/AMENORRHEA; SHORTNESS OF BREATH/DIFFICULTY BREATHING; INVOLUNTARY WEIGHT LOSS; SICK FOR ABOUT A WEEK; HEADACHE/TOP OF HEAD SUPER TENDER; PAIN AT INJECTION SITE/RIGHT ARM HURT FOR ABOUT A WEEK A HALF; This spontaneous report received from a patient concerned a 39 year old female of unspecified race and ethnicity. The patient's weight was 118 pounds (135 pounds before vaccine), and height was 170 centimeters. The patient's concurrent conditions included: non smoker, non alcohol user, autistic spectrum (processing disorder), Ehlers-Danlos (connective tissue disorder),severe anxiety disorder, attention deficit hyperactivity disorder (ADHD),  complex post-traumatic stress disorder (CPTSD),  contrast dies allergy,  allergy to anti-depressants and allergy medication. Other pre-existing medical conditions included: Patient had no drug abuse or illicit drug use. The patient had a history of  vaccine reaction (" vaccine given in 1/4 doses"). The patient was planning to have genetic test for allergies and how medications react. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 12-APR-2021 in right arm for prophylactic vaccination. Concomitant medications included Xanax (alprazolam), marijuana (cannabis sativa) and ketamine for complex post-traumatic stress disorder. On an unspecified date, the patient experienced chest tightness, hair falling out about 3-4 weeks nonstop, period stopped for 4 months (amenorrhea) shortness of breath/difficulty breathing, weight loss, sick for about a week, headache/top of head super tender, and pain at injection site/right arm hurt for about a week a half (dose number in series 1). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest tightness, shortness of breath/difficulty breathing, sick for about a week, headache/top of head super tender, and pain at injection site/right arm hurt for about a week a half, had not recovered from hair falling out about 3-4 weeks nonstop, and involuntary weight loss. The outcome of period stopped for 4 months/amenorrhea was unknown. This report was non-serious. This case, involving the same patient is linked to 20211235188 (dose number in series 2).