chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 24.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Cough, Pyrexia, Rhinorrhoea
Clinical narrative: slight fever; runny nose; dry cough; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the parent.  A 25-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 08Dec2021 as dose 3 (booster), single (Lot number: FG3527) at the age of 24 years for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; Lot number: EM9809), administration date: 27Feb2021, for COVID-19 Immunization; BNT162b2 (DOSE 2, SINGLE; Lot number: EN6203), administration date: 06Nov2021, for COVID-19 Immunization. The following information was reported: COUGH (non-serious) with onset 28Nov2022, outcome "recovering", described as "dry cough"; RHINORRHOEA (non-serious) with onset 28Nov2022, outcome "recovering", described as "runny nose"; PYREXIA (non-serious) with onset 28Nov2022, outcome "recovering", described as "slight fever". Therapeutic measures were not taken as a result of pyrexia, rhinorrhoea, cough.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202201342591 same patient, different vaccine dose number, different event;US-PFIZER INC-202201342590 same patient, different vaccine dose number, different event;
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster, Herpes zoster reactivation, Ill-defined disorder, Post herpetic neuralgia
Clinical narrative: Shingles; Ill-defined disorder; This spontaneous report was received from a lawyer and a patient (pt) of unknown age and gender regarding a case in litigation on 28-NOV-2022. The patient's concurrent conditions, medical history, drug reactions or allergies were not reported. On 08-OCT-2012, the patient was administered with Zoster Vaccine Live (ZOSTAVAX) (dose, lot #, expiration date, route of administration, and anatomical location was not provided) for long-term prevention of shingles and zoster-related conditions in the local pharmacy. At the time of vaccination, the patient relied on the warning label affixed to Zoster Vaccine Live (ZOSTAVAX), and the information relayed through the patient's healthcare provider(s) that Zoster Vaccine Live (ZOSTAVAX)  was effective in preventing shingles on a permanent basis and did not carry any significant risk of adverse effect.Subsequent to the patient inoculation, the patient was treated by healthcare providers at Urgent Care, for shingles and other zoster-related conditions. As a direct and proximate result of the patient used of the Zoster Vaccine Live (ZOSTAVAX),  vaccine, the patient had and will continue suffer ongoing injuries, including but not limited to: mental and physical pain and suffering; medical care and treatment for these injuries; significant medical and related expenses as a result of these injuries, including but not limited to medical losses and costs include care for hospitalization, physician care, monitoring, treatment, medications, and supplies; diminished capacity for the enjoyment of life; diminished quality of life; increased risk of premature death, aggravation of preexisting conditions and activation of latent conditions; and other losses and damages; and will continue to suffer such losses, and damages in the future. At the reporting time, the outcome of herpes zoster reactivation and post herpetic neuralgia was not recovered. The reporter considered the events to be related to Zoster Vaccine Live (ZOSTAVAX).
Sex: F
Vaccine: HPV9
Symptoms: Cyst
Clinical narrative: a cyst develop after receiving a GARDSIL 9 vaccination; This spontaneous report was received from a physician and refers to a non-pregnant female patient of unspecified age. Her pertinent medical history, current conditions, past drug reactions or allergies, and concomitant medications were unknown by the reporter.  On an unknown date, the patient was vaccinated with one (1) hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) injection administered intramuscularly (strength, exact dose, vaccination scheme frequency, and anatomical site of application were not provided; lot number and expiration date were unknown by the reporter, however, reported as syringe formulation) used as directed to prevent human papilloma virus infection (prophylaxis). The physician stated that the patient was the daughter of one of her nurses and remarked that the patient had a cyst developed after receiving hpv rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) vaccination. It was unknown by the reporter if the patient was given any treatment for the event. Additionally, it was unknown by the reporter if the patient sought for medical attention, or if any lab diagnostics and studies were performed. The event was reported as cancer no and overdose no.  The outcome of the event was reported as recovered. The causality assessment between the cyst and rl1 6 11 16 18 31 33 45 52 58 vlp vaccine (yeast) (GARDASIL 9) was not reported.    This is one of two reports received from the same reporter. ; Sender's Comments:  US-009507513-2212USA000527:
Sex: U
Vaccine: HEP
Symptoms: Abdominal pain upper
Clinical narrative: Upper Left Quadrant Pain; Initial Report Received on 22-SEP-2022  This is a spontaneous report received from a pharmacist regarding a female patient who received HEPLISAV-B for hepatitis B immunization.   There was no medical history reported.  Concomitant medications were not reported.  On an unknown date, dose 1 of HEPLISAV B (Lot # not reported, expiration date not reported, NDC # not reported), route and site not specified, was administered for hepatitis B immunization.  On an unknown date, after having been vaccinated with the first dose of HEPLISAV B, the patient experienced upper left quadrant pain. The patient did follow through with finishing the vaccine series with a 2nd dose. The dates of the injections are unknown.  No further information was available at the time of the report.   Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: F
Vaccine: HEP
Symptoms: Expired product administered, No adverse event
Clinical narrative: Patient Received An Expired Dose of Heplisav-B; Initial Report Received on 13-Oct-2022  This is a spontaneous report, received from an office manager/health professional  regarding a female patient who received HEPLISAV-B for hepatitis B immunisation.   There was no medical history reported for the patient.  Concomitant medications were not reported.  On 13-Oct-2022, dose 1 of HEPLISAV-B (Lot #935840, expiration date 11-Sep-2022, NDC # unknown), intramuscular, site not specified, was administered for hepatitis B immunization.  The dose was 32 days past the expiration date. No adverse reactions were reported by the patient.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: COVID-19, Exposure to SARS-CoV-2
Clinical narrative: Received Heplisav-B and Developed COVID; Initial Report Received on 18-OCT-2022  This is a spontaneous report, received from a patient, who received HEPLISAV-B for hepatitis B immunization.  Medical history was reported as unknown.   Concomitant medications were not reported.  On 02-SEP-2022, dose 1 of HEPLISAV-B (Lot # unknown, expiration date unknown, NDC # unknown), route and site not specified, was administered for hepatitis B immunization.  The patient subsequently developed COVID after a trip on 11-OCT-2022.  Company Comment: The company assessed the event as non-serious.; Sender's Comments: The company assessed the event as non-serious.
Sex: U
Vaccine: HEP
Symptoms: Circumstance or information capable of leading to medication error, No adverse event
Clinical narrative: 2nd Dose Was Given 3 Months After The First Dose; Received 3rd Dose of Heplisav-B; Initial Report Received on 19-Oct-2022  This is a spontaneous report, received from a nurse in the regarding a female patient who received HEPLISAV-B for hepatitis B immunization.   There was no medical history reported.  Concomitant medications were not reported.  On 01-Mar-2022, dose 1 of HEPLISAV-B (Lot #935844, expiration date 04-Nov-2022, NDC #43528-0003-01), route not specified, was administered in the left deltoid for hepatitis B immunization.  On 07-Jun-2022, 3 months following the first dose, dose 2 of HEPLISAV-B (Lot #935844, expiration date 04-Nov-2022, NDC #43528-0003-01), route not specified, was administered in the left deltoid for hepatitis B immunization.   On 18-Oct-2022, dose 3 of HEPLISAV-B (Lot #937233, expiration date 11-Mar-2023, NDC #43528-0003-01), route not specified, was administered in the left deltoid for hepatitis B immunization.  Concomitant vaccines administered included a dose of a flu vaccine (Lot # not reported), route not specified, in the right arm.    The 3rd dose of HEPLISAV-B was reported as being administered due to a documentation error. The patient did not demonstrate any adverse reactions.  Action taken with HEPLISAV B was not reported.  The outcome of the adverse event was not reported.  No further information was available at the time of the report.   Company Comment: The company assessed the events as non-serious.; Sender's Comments: The company assessed the events as non-serious.
Age: 0.17
Sex: F
Vaccine: HEPA
Symptoms: No adverse event, Product administered to patient of inappropriate age
Clinical narrative: 2 month old, received Havrix; This case was reported by a nurse via sales rep and described the occurrence of inappropriate age at vaccine administration in a 2-month-old female patient who received HAV (Havrix) for prophylaxis.   On 23rd November 2022, the patient received Havrix. On 23rd November 2022, unknown after receiving Havrix, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK receipt date: 23-Nov-2022 Reporter's comment: The physician's office observed the patient for extra time, but did not report any adverse events. The reporter did not consent to follow-up. Additional supportive information: The patient was accidentally administered Havrix on the day of reporting at inappropriate age, which led to inappropriate age at vaccine administration.
Sex: U
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Had first vaccine on 2020 and second November 2022; This case was reported by a consumer via interactive digital media and described the occurrence of drug dose administration interval too long in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (first dose received in the year 2020).   In November 2022, the patient received the 2nd dose of Shingles vaccine. In November 2022, unknown after receiving Shingles vaccine, the patient experienced drug dose administration interval too long. On an unknown date, the outcome of the drug dose administration interval too long was unknown.      Additional Information: GSK Receipt Date: 23-NOV-2022 Reporter's comment: This case was reported by the patient via (Shingrix GSK) interactive digital media. The reporter had asked if that was ok. Additional supportive information: The patient received the second dose later than the recommended interval, which led to lengthening of vaccination schedule. Follow-up would not possible, as no contact, details were available.
Age: 8.0
Sex: M
Vaccine: MENB
Symptoms: Fatigue, Product administered to patient of inappropriate age, Pyrexia
Clinical narrative: 8 year old got his 2nd dose of Bexsero; is fatigued; fever of 101.8; This case was reported by a consumer via interactive digital media and described the occurrence of fatigue in a 8-year-old male patient who received Men B NVS (Bexsero) for prophylaxis.   Co-suspect products included meningococcal B recom vaccine + aloh + omv pre-filled syringe device (Bexsero Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 23rd November 2022, the patient received the 2nd dose of Bexsero and Bexsero Pre-Filled Syringe Device. In November 2022, less than a week after receiving Bexsero and Bexsero Pre-Filled Syringe Device, the patient experienced fatigue and fever. On 23rd November 2022, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the fatigue, fever and inappropriate age at vaccine administration were unknown.   It was unknown if the reporter considered the fatigue and fever to be related to Bexsero and Bexsero Pre-Filled Syringe Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 24-NOV-2022 Reporter's Comment: This case was reported by a consumer via interactive digital media. The reporter reported that his/her sister's son got second dose of Bexsero vaccine yesterday (the day before reporting) and the patient now was fatigued and had a fever of 101.8 degree Fahrenheit.  The reporter asked do GlaxoSmithKline think the vaccine could cause the fever. Additional Supportive Information: The eight year old patient received a dose of Bexsero, which led to inappropriate age at vaccine administration. Follow-up would not possible as no contact details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Pain, Pain in extremity
Clinical narrative: serious pain when moving arm; This case was reported by a consumer via interactive digital media and described the occurrence of pain in arm in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, 2 months after receiving Shingles vaccine, the patient experienced pain in arm (serious criteria other: Serious by reporter). On an unknown date, the outcome of the pain in arm was unknown.   It was unknown if the reporter considered the pain in arm to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 26-NOV-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The reporter stated that 2 months after the shot he/she had a serious pain every time he/she moved his/her arm. Additional supportive information: Follow-up would not possible, as no contact, details were available.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose 11 months ago; This case was reported by a consumer and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Previously administered products included Shingles vaccine (received 1st part of Shingles vaccination 11 months ago).   On an unknown date, the patient did not receive the 2nd dose of Shingles vaccine. On an unknown date, unknown after receiving Shingles vaccine, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 23-NOV-2022  Reporter's comment: The case was self reported by the patient. The patient asked should he/she bother taking the second dose.  Additional Supportive Information: Till the time of reporting, the patient did not receive 2nd dose of Shingles vaccine, which led to incomplete course of vaccination.
Sex: U
Vaccine: VARZOS
Symptoms: Ophthalmic herpes zoster, Vaccination failure
Clinical narrative: Shingles shots dont work. Getting over them in my EYE/ Suspected vaccination failure; Getting over them from being in my EYE; 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.   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 ophthalmic herpes zoster (serious criteria GSK medically significant). On an unknown date, the outcome of the vaccination failure was unknown and the outcome of the ophthalmic herpes zoster was recovered/resolved.   It was unknown if the reporter considered the vaccination failure and ophthalmic herpes zoster to be related to Shingles vaccine.     Additional Information: GSK Receipt Date: 26-NOV-2022 Reporter's comment: This case was reported by the patient via interactive digital media. The reporter stated that the shingle shots did not always work.  He/she was just getting over them from being in his/her eye which was not good at all. Additional supportive information: This case was considered as suspected vaccination failure as details regarding completion of primary vaccination schedule, time to onset and laboratory test confirming shingles were unknown at the time of reporting. Follow-up would not possible, as no contact, details were available.
Age: 25.0
Sex: F
Vaccine: HEP
Symptoms: Expired product administered
Clinical narrative: received a dose that expired; This case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a 25-year-old female patient who received HBV (Engerix B) (batch number AN599, expiry date 8th November 2022) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 21st November 2022, the patient received Engerix B and Engerix B Pre-Filled Syringe Device. On 21st November 2022, unknown after receiving Engerix B and Engerix B Pre-Filled Syringe Device, the patient experienced expired vaccine used. On an unknown date, the outcome of the expired vaccine used was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 22-Nov-2022 Reporter's comment: The pharmacist asked that should they repeat the dose. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up. Additional supportive information: The patient received an expired dose of Engerix-B, which led to expired vaccine used.
Age: 85.0
Sex: M
Vaccine: UNK
Symptoms: Incorrect route of product administration
Clinical narrative: administered Fluarix QIV via IV; This case was reported by a pharmacist via call center representative and described the occurrence of intramuscular formulation administered by other route in a 85-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number t4jg7, expiry date 30th June 2023) 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 22nd November 2022, the patient received Fluarix Quadrivalent 2022-2023 season (intravenous) and Fluarix Tetra Pre-Filled Syringe Device. On 22nd November 2022, unknown after receiving Fluarix Quadrivalent 2022-2023 season and Fluarix Tetra Pre-Filled Syringe Device, the patient experienced intramuscular formulation administered by other route. On an unknown date, the outcome of the intramuscular formulation administered by other route was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 22-Nov-2022 Reporter's comment: The registered reported did not had details regarding her own zip code but gave consent for follow up. Email address was provided. The reporter consented to follow-up. Additional supportive information: The nurse inadvertently administered Fluarix Quadrivalent via intravenous administration to a patient on the day of reporting, which led to intramuscular formulation administered by other route.
Sex: U
Vaccine: DTAP, HEPA, MNQ
Symptoms: Product storage error
Clinical narrative: Administration after temperature excursion; This case was reported by a physician via call center representative and described the occurrence of incorrect storage of drug in an unspecified number of patients who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   Co-suspect products included HAV (Havrix) for prophylaxis, DTPa (Infanrix) for prophylaxis and dtpa vaccine pre-filled syringe device (Infanrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Menveo, Havrix, Infanrix and Infanrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Menveo, Havrix, Infanrix and Infanrix 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 Information: GSK receipt date: 22-Nov-2022 Reporter's comment: The physician called on the day of reporting, to reported that in July  Menveo, Infanrix and Havrix had a temperature excursion and were administered after that. The reporter was asked twice to give information on the vaccines or patients but declined. No consent for the follow-up but no declined either, the reporter was asked but the answer was about how they had no information about the event. Additional supportive information: The patients received Menveo, Infanrix and Havrix after temperature excursion, which led to incorrect storage of drug.
Sex: M
Vaccine: VARZOS
Symptoms: Anorectal swelling
Clinical narrative: swollen butthole; This case was reported by a consumer via call center representative and described the occurrence of anorectal swelling in a male 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 anorectal swelling. On an unknown date, the outcome of the anorectal swelling was not recovered/not resolved.   It was unknown if the reporter considered the anorectal swelling to be related to Shingrix.     Additional Information: GSK Receipt Date: 22-NOV-2022 Reporter's Comments:  The reporter reported to the agent that the patient received the Shingrix vaccine  The patient butthole was now swollen.  The reporter asked for further details, the caller promptly disconnected the call.  The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Chills, Malaise, Nausea, Pain, Pyrexia
Clinical narrative: Fever; Chills; Aches; Feeling Sick; Nausea; This case was reported by a physician via call center representative and described the occurrence of fever in a 53-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 21st November 2022, the patient received the 1st dose of Shingrix. In November 2022, less than a week after receiving Shingrix, the patient experienced fever, chills, pain, feeling unwell and nausea. On an unknown date, the outcome of the fever, chills, pain, feeling unwell and nausea were not recovered/not resolved.   It was unknown if the reporter considered the fever, chills, pain, feeling unwell and nausea to be related to Shingrix.     Additional Information: GSK receipt date: 22 Nov 2022 Reporter comment: This case was reported by physician. The physician reported patient received his first dose of Shingrix yesterday that is 21st November 2022. The patient was experiencing, fever, chills, aches, feeling sick and nausea. The reporter provided limited information The reporter believes the patient received the vaccine at a drug store. Additional supportive information : The outcome was captured as not recovered, as patient is experiencing events however in field as per code it is unknown, hence not recovered was captured conservatively.
Age: 72.0
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Illness, Incomplete course of vaccination, Influenza like illness
Clinical narrative: sick as a dog, out of it; felt like the flu; 1st dose 16May2022, 2nd not yet; headache; This case was reported by a consumer via call center representative and described the occurrence of sickness in a 72-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On 16th May 2022, the patient received the 1st dose of Shingrix. On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, less than 9 months after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced sickness, influenza-like symptoms, headache and incomplete course of vaccination. On an unknown date, the outcome of the sickness, influenza-like symptoms and incomplete course of vaccination were unknown and the outcome of the headache was recovered/resolved.   It was unknown if the reporter considered the sickness, influenza-like symptoms and headache to be related to Shingrix.     Additional Information: GSK Receipt Date: 22-NOV-2022 Reporter's Comments:  The patient received first shingrix shot and he was sick as a dog out of it had a bad reaction and felt like the flu after getting the first shingrix shot.  The patient further described his symptoms by saying he had a headache for 2 days.  The patient reported that he was not received the second shingrix shot.  The patient declined to give further information for the safety report.  No other information reported by the patient to the GRC agent.  The reporter did not consent to follow-up.  Additional Supportive Information: Till the time of reporting the patient did not receive 2nd dose of vaccine, which led to incomplete course of vaccination. From the narrative it was not clear if patient did not receive 2nd dose due to medical reason or not hence incomplete course of vaccination was coded as event conservatively.
Sex: U
Vaccine: DTAPHEPBIP, DTAPIPV, FLU4
Symptoms: Product storage error
Clinical narrative: Administration after temperature excursion; 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  (FluLaval Quadrivalent) for prophylaxis.   Co-suspect products included flu seasonal qiv pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-HBV-IPV (Pediarix) for prophylaxis, dtpa-hbv-ipv vaccine pre-filled syringe device (Pediarix Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa-IPV (Kinrix) for prophylaxis and dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent, Flulaval Tetra Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent, Flulaval Tetra Pre-Filled Syringe Device, Pediarix, Pediarix Pre-Filled Syringe Device, Kinrix and Kinrix 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 Information: GSK Receipt Date: 22-NOV-2022 Reporter's comment: The reporter stated that there were multiple excursions over 21 days that it went below 34.7 Faraday temperature and was administered.  HCP(Health Care Professional) did not have patient's details, lot number or expiration dates.  No additional information provided. The reporter consented to follow-up. Additional Supportive Information: The administration of FluLaval Quadrivalent, Pediarix and Kinrix after being exposed to freezing temperature, which led to Incorrect storage of drug.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Chills, Influenza like illness, Pain, Pyrexia
Clinical narrative: Chills; Fever; Aches; Flu-like symptoms; This case was reported by a consumer via call center representative and described the occurrence of chills in a 53-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (first dose received on an unknown date).   On 22nd November 2022, the patient received the 2nd dose of Shingrix. In November 2022, less than a week after receiving Shingrix, the patient experienced chills, fever, pain and influenza-like symptoms. On an unknown date, the outcome of the chills, fever, pain and influenza-like symptoms were unknown.   It was unknown if the reporter considered the chills, fever, pain and influenza-like symptoms to be related to Shingrix.     Linked case(s) involving the same patient:  US2022AMR175866   Additional Information: GSK Receipt Date: 23-NOV-2022 Reporter's Comments:  The case was self reported by the patient.  The patient received her second dose of Shingrix on the day before the reporting. The patient experienced fever, chills, aches, and flu like symptoms.  The patient did not experience adverse effects from the first dose.  The adverse event was filed. The reporter was consented to follow up. This case had been linked with US2022AMR175866 same patient. Note: Outcome for the event chills was captured as unknown as in structured field reported as fatal but as per narrative did not seems that patient was died as reporter was patient.; Sender's Comments:  US-GSK-US2022AMR175866:same reporter
Sex: F
Vaccine: VARZOS
Symptoms: Intercepted product preparation error, Product complaint
Clinical narrative: Shingrix sprayed out when reconstituted; Product Complaint; This case was reported by a other health professional via call center representative and described the occurrence of intercepted product preparation error in a female patient who received Herpes zoster (Shingrix) (batch number ya29d, expiry date 6th October 2023) for prophylaxis. This case was associated with a product complaint.   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced intercepted product preparation error and pharmaceutical product complaint. Shingrix was interrupted. On an unknown date, the outcome of the intercepted product preparation error and pharmaceutical product complaint were unknown.   Additional Information: GSK receipt date: 23-Nov-2022 Reporter's comment: An administrator from a medical clinic stating that they had a dose of Shingrix that sprayed out when the nurse went to withdraw the reconstituted vaccine, not enough of the vaccine was able to be withdrawn to make a full dose and they did not have another dose on hand to give the patient.  The patient was not able to get the vaccine at that time. The nurse reconstituting the vaccine was an experienced user.  None of the vaccine in question was given. Asked the questions as per content. The reporter answered the questioned as 0.25 ml vaccine was left in the affected vial, the nurse stopped trying to withdraw the vaccine after it started to spray out, the stopper pierced was in the circular area dedicated to perforation, no air was injected into the vial, the nurse could not told exactly where the leak was coming from, no the vial rubber stopper/metallic skirt detach or become loose during handling or without any manipulation, only the plastic flip top was removed before handling the vial and there was no evidence of leakage in package or carton (example wet PIL or faded label) Related product quality complaint report was completed.  The reporter will send pictures and request to please send a single dose replacement to the clinic and also send a return shipping label for them to mail back the defective vials. Did not consent to follow-up. Additional supportive information: A dose of Shingrix that sprayed out when the nurse went to withdraw the reconstituted vaccine, not enough of the vaccine was able to be withdrawn to make a full dose, which led to intercepted product preparation error. In worst approach case was processed with intercepted product preparation error as the vaccine was leaked while handling during reconstitution and even the patient was not involved. Product complaint event was coded in worst approach as product complaint reference number was reported.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose years ago. Never received 2nd dose; This case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose 5 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 23-Nov-2022 Reporter's comment: The patient stated he had never received his second dose. The reporter did not consent to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.
Age: 3.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: 3 YO received Kinrix; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate age at vaccine administration in a 3-year-old male patient who received DTPa-IPV (Kinrix) (batch number 3KS4F, expiry date 22nd March 2024) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On 18th November 2022, the patient received the 1st dose of Kinrix and Kinrix Pre-Filled Syringe Device. On 18th November 2022, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 23-Nov-2022 Reporter's comment: The medical assistant called in to reported that a dose of Kinrix had been administered to a patient that was younger than the age group mentioned in the prescribing information. Personal information was collected form the reporter but they declined for it to be stored into their database. Information about the patient was collected, except for the patient's initials, which the health care professional stated was not available at the moment. At the site from which the reporter called. The call was escalated to second line. The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up. Additional supportive information: The patient received a dose of Kinrix at inappropriate age, which led to inappropriate age at vaccine administration.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 1st dose in 2020, no 2nd dose yet; This case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received first dose in July 2020).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced incomplete course of vaccination. On an unknown date, the outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 23-Nov-2022 Reporter's comment: The pharmacist called to request information on how to proceed with the vaccination of a patient who wanted to receive the second dose to complete the scheme. The reporter agreed to follow-up by safety team.  More details of the event were unknown to the reporter since the patient received the first dose in another facility. The reporter consented to follow-up. Additional supportive information: Till the time of reporting, the patient did not receive second dose of Shingrix, which led to incomplete course of vaccination.
Age: 2.0
Sex: M
Vaccine: DTAPIPV
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Kinrix administered to a 2-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 2-year-old male patient who received DTPa-IPV (Kinrix) (batch number 2KL4K, expiry date 9th November 2023) for prophylaxis.   Co-suspect products included dtpa-ipv vaccine pre-filled syringe device (Kinrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Kinrix and Kinrix Pre-Filled Syringe Device. On an unknown date, unknown after receiving Kinrix and Kinrix Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 23-Nov-2022 Reporter's comment: The reporter consented to follow-up. Additional supportive information: The patient received a dose of Kinrix at inappropriate age, which led to inappropriate age at vaccine administration.
Sex: F
Vaccine: HEP
Symptoms: Overdose, Product administered to patient of inappropriate age
Clinical narrative: 20 mcg dose administered to a 14-year-old; 20 mcg dose administered instead of a 10 mcg; This case was reported by a pharmacist via call center representative and described the occurrence of overdose in a 14-year-old female patient who received HBV (Engerix B adult) (batch number TB3KN, expiry date 3rd December 2023) for prophylaxis.   On 23rd November 2022, the patient received the 1st dose of Engerix B adult 20 µg. On 23rd November 2022, unknown after receiving Engerix B adult, the patient experienced overdose and adult product administered to child. On an unknown date, the outcome of the overdose and adult product administered to child were unknown.   Additional Information: GSK receipt date: 23-Nov-2022 Reporter's comment: The dose administrated was 20 mcg not 10 mcg dose. The vaccine administration facility was the same as primary reporter. The reporter agreed to follow-up. Additional supportive information: A dose of Engerix-B vaccine (20 mcg) had been administered to a patient of inappropriate age, which led to overdose and adult product administered to child.
Sex: F
Vaccine: UNK
Symptoms: Incorrect dose administered, Product leakage
Clinical narrative: Received less volume than recommended; Leakage during administration; This case was reported by a nurse via call center representative and described the occurrence of incomplete dose administered in a 12-year-old female patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2022-2023 season) (batch number 9TG4D, expiry date 30th June 2023) for prophylaxis.   On an unknown date, the patient received Fluarix Quadrivalent 2022-2023 season. On an unknown date, unknown after receiving Fluarix Quadrivalent 2022-2023 season, the patient experienced incomplete dose administered and product leakage. On an unknown date, the outcome of the incomplete dose administered and product leakage were unknown.   Additional Information: GSK receipt date: 23-Nov-2022 Reporter's comment: The reporter did not mentioned about exposure to skin was done during the call. Product quality complaint was not mentioned by the reporter.  This could suggest that the vaccine leaked from the site of administration and not from the syringe itself (as a side note, leakage was a rare event that happens during injections that was related to the route, way or site of administration). The reporter consented to follow-up. Additional supportive information: The patient received less volume than recommended due to some leakage on a fluarix administration, which led to incomplete dose administered and product leakage. Suspect was coded as per reported expiry date. Product leakage was coded as event as per reported verbatim,' due to some leakage'.
Sex: M
Vaccine: COVID19
Symptoms: Prostatic specific antigen, Prostatic specific antigen increased
Clinical narrative: PSA INCREASED/CHEMICAL REOCCURRENCE; 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 past medical history included: prostatectomy (in 2005). On 31-AUG-2020, Laboratory data included: PSA (prostate-specific antigen) test which resulted 06.  The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on unspecified date for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with first dose of covid-19 vaccine ad26. cov2.s (dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, and batch number were not reported) dose was not reported, 1 total, administered on 09-NOV-2021 for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date (after J and J Vaccine), the patient had prostate-specific antigen test which went to 0.29 and has risen ever since (Dose number in series 2). The patient underwent hormone therapy and radiation therapy at this time for chemical reoccurrence. Patient would like to inquire if there is any relationship between the vaccine and PSA which was risen (after 17 years). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from PSA (prostate-specific antigen) increased. This report was serious (Other Medically Important Condition).; Sender's Comments: V0-20221156381- PSA increased/ Chemical reoccurrence. The event 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. Specifically: MEDICAL HISTORY. Therefore, this event is considered inconsistent with vaccine administration.
Sex: U
Vaccine: COVID19
Symptoms: Dyspnoea exertional, Neuropathy peripheral, Peripheral swelling, Skin hypopigmentation
Clinical narrative: NEUROPATHY; CAN BARELY WALK A FEW FEET WITHOUT GIVING COMPLETELY OUT OF BREATH; WHITE SPOTS EVERYWHERE; SWOLLEN FEET; This spontaneous report received from a patient via a company representative via social media (J and J Corporate) concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient previously received covid-19 vaccine ad26. cov2. s (Dose number in series 1) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, 01 total administered on an unspecified date in 2021 for covid-19 prophylaxis.  It was unknown whether patient had any adverse events following vaccination with covid-19 vaccine ad26. cov2. s (Dose number in series 1). The patient received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin was not reported, batch number: unknown and expiry: unknown) dose was not reported, 01 total administered on an unspecified date in 2021 for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient experienced can barely walk a few feet without giving completely out of breath, white spots everywhere (on lungs, breasts, heart), neuropathy, and swollen feet (Dose number in series 2). As per reporter, "I had the shots last year I can barely walk a few feet without giving completely out of breath I also have white spots everywhere. My lungs, heart breast not sure where all the white spots are also I have developed neuropathy, swollen feet never goes away why do the shots cause more problems". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from neuropathy, and swollen feet, and the outcome of can barely walk a few feet without giving completely out of breath and white spots everywhere was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221161247- Neuropathy-  Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEAD; This spontaneous report received from a consumer via a company representative via social media concerned 03 multiple patients. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: Patients were healthy. 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, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patients died from unknown cause of death. It was unknown whether an autopsy was performed or not. It was reported as "Johnson & Johnson Stop with your bs concern J&J. You ARE the problem. You have killed more than you have helped. 3 healthy dead in my circle after J&J jab. Stop lying" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20221166018- Dead. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: M
Vaccine: COVID19
Symptoms: Paralysis
Clinical narrative: ALMOST PARALYZED; This spontaneous report received from a consumer by a company representative via a social media (J and J Corporate) concerned a male of unspecified age, race and ethnicity. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown and expiry: unknown) dose was not reported, 1 total, administered on an unspecified date for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, the patient was almost paralyzed, and unable to perform work and lost the job. The reporter stated that "my brother is almost paralyze. Took the jab to keep his job now he's unable to perform he lost the job." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of almost paralyzed was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20221166143- Almost paralyzed. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.