chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: VARZOS
Symptoms: Vomiting
Clinical narrative: rash papular excoriations in the injected arm; rash papular excoriations in the injected arm; rash after 5 years of administration/rash similar to a dermatitis going from the back of the deltoid to the wrist; vomiting; itching; This non-serious case was reported by a physician via call center representative and described the occurrence of papular rash in a 63-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix with an associated reaction of rash papular (developed rash papular excoriations in the injected arm (no shingle rash) after getting the first dose of Shingrix in August 2019, refer case US2023103566). Concomitant products included losartan, simvastatin, desvenlafaxine and colecalciferol (Vitamin D3).   In NOV-2019, the patient received the 2nd dose of Shingrix (unknown arm). On 26-JUN-2023, more than 2 years after receiving Shingrix, the patient experienced vomiting (Verbatim: vomiting) and pruritus (Verbatim: itching). On 02-JUL-2023, the patient experienced papular rash (Verbatim: rash papular excoriations in the injected arm), excoriation (Verbatim: rash papular excoriations in the injected arm) and rash (Verbatim: rash after 5 years of administration/rash similar to a dermatitis going from the back of the deltoid to the wrist). Rechallenge with Shingrix was positive. The outcome of the papular rash, excoriation, vomiting and pruritus were not reported and the outcome of the rash was unknown.   It was unknown if the reporter considered the papular rash, excoriation, rash, vomiting and pruritus to be related to Shingrix.     It was unknown if the company considered the papular rash, excoriation, rash, vomiting and pruritus to be related to Shingrix.   Linked case(s) involving the same patient:  US2023103566   Additional Information: GSK receipt date: 28-Jul-2023 The physician reported that the with increase of the same symptoms (rash popular excoriations) during the second dose of Shingrix (greater inflammatory response). The patient was under several medications (Statins, Losartan, simvastatin, desvenlafaxine, Vitamin D3, etc), the same medication that was using during Shingrix administration.  The rash was similar to a dermatitis going from the back of the deltoid to the wrist at the time of vaccination. On 2nd July 2023, the patient after almost 5 years, developed the same reactions as when the vaccines were administered.  On 26th June 2023, the patient started with vomiting, itching and no fever/diarrhea. The reporter asked that it was possible that Shingrix had created an antigenic response to this patient. The reporter was not sure if symptoms were gone by now. The Vaccine Administration Facility was the same as Primary Reporter. Did not consent to follow-up.; Sender's Comments:  US-GSK-US2023103566:Same patient 2 dose
Sex: F
Vaccine: TYP
Symptoms: Headache, Product storage error, Rash
Clinical narrative: Mild rash on the hands; Headache; Administered the full regimen of Vivotif while the vaccine was stored at room temperature; A spontaneous report was received from pharmacist on 05JUL2023 regarding 24-year-old female patient who "administered the full regimen of Vivotif while the vaccine was stored at room temperature" (PT: Product storage error) and experienced "mild rash on the hands" (PT: Rash), and "headache" (PT: Headache). The patient took Vivotif capsules (typhoid vaccine live oral Ty21A; lot number: 3003907) for immunisation.  The patient's medical history, concomitant medications, or known allergies were not reported.  It was reported that the patient administered the full regimen of Vivotif while the vaccine was stored at a temperature of 75 degrees Fahrenheit (F) for a duration of seven days. The patient administered the fourth dose of Vivotif on 03JUL2023 and developed mild rash on the hands and headache. Reportedly, the patient took Benadryl and Claritin for the rash.  The outcome of the event "administered the full regimen of Vivotif while the vaccine was stored at room temperature" was not applicable and for the event's "headache" and "mild rash on the hands" it was unknown.  The action taken with Vivotif with respect to the reported events was not applicable.   No additional information was reported.  Company comment: It was reported that a patient received Vivotif and he developed a "mild rash on the hands" (rash), and headache after the fourth dose. Considering the case information, the role of Vivotif cannot be ruled out and the causality of rash and headache is assessed as possible. Furthermore, the patient had administered the full regimen of Vivotif while the vaccine was stored at room temperature (product storage error). The causality of product storage error is not applicable with Vivotif. The case is considered non serious as per medical assessment.; Sender's Comments: It was reported that a patient received Vivotif and he developed a "mild rash on the hands" (rash), and headache after the fourth dose. Considering the case information, the role of Vivotif cannot be ruled out and the causality of rash and headache is assessed as possible. Furthermore, the patient had administered the full regimen of Vivotif while the vaccine was stored at room temperature (product storage error). The causality of product storage error is not applicable with Vivotif. The case is considered non serious as per medical assessment.
Sex: F
Vaccine: COVID19
Symptoms: Biopsy kidney, Blood creatinine, Oedema peripheral, Protein urine
Clinical narrative: week after receiving the second dose, she experienced worsening edema in her legs; This is a literature report.  A 54-year-old female patient received BNT162b2 (BNT162B2), in 2021 as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "hypertension" (ongoing); "MCD", start date: Jun2018 (unspecified if ongoing); "MCD relapsed", start date: Oct2018 (unspecified if ongoing), notes: for 4 months; "CKD stage 2" (unspecified if ongoing); "moon facies" (unspecified if ongoing); "blistering skin" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Prednisone. Vaccination history included: Influenza vaccine, administration date: 2018; Bnt162b2 (DOSE 1, Single, 1 week after the first dose), administration date: Jan2021, for covid-19 immunisation, reaction(s): "Glomerulonephritis minimal lesion"; Bnt162b2 (DOSE 1, Single), administration date: Jan2021, for covid-19 immunization, reaction(s): "Disease recurrence". The following information was reported: OEDEMA PERIPHERAL (medically significant), 1 week after the suspect product(s) administration, outcome "unknown", described as "week after receiving the second dose, she experienced worsening edema in her legs". The patient underwent the following laboratory tests and procedures: Biopsy kidney: Unknown result; Blood creatinine: 0.55 mg/dl; Protein urine: 9977, notes: Unit: mg/day; Protein urine: 85 mg/g. Therapeutic measures were taken as a result of oedema peripheral.  Clinical Information: She was treated with prednisone 50mg/day. The dose of prednisone remained 50mg/day during the 4 week period with a plan to taper the dose afterwards. She was encouraged to start treatment with rituximab, but the patient declined.; Sender's Comments: Based on the given information , the possible contributory role of the suspect for the event oedema peripheral cannot be excluded. The impact of this report on the benefit-risk profile of the Pfizer product and on the conduct of the study is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to regulatory authorities, Ethics Committees, and Investigators, as appropriate.,Linked Report(s) : US-PFIZER INC-PV202300133576 Same article/patient/event and different drug;
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Physician) from product quality group.  A 60-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Nov2022 as dose 5 (booster), single (Lot number: GU5342) at the age of 60 years, in left arm for covid-19 immunisation; BNT162b2 (BNT162B2), on 08Dec2020 as dose 1, single (Lot number: EK5730), on 08Jan2021 as dose 2, single (Lot number: EL1284), in left arm, on 28Sep2021 as dose 3 (booster), single (Lot number: 301358A), in left arm and on 01Apr2022 as dose 4 (booster), single (Lot number: FK9894), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Hypertension" (unspecified if ongoing); "Seasonal allergies" (unspecified if ongoing); "asthma" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: VACCINATION FAILURE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Rebound COVID day 12 with positive rapid COVID antigen testing. Therapeutic measures were taken as a result of vaccination failure, covid-19. The patient was treated with Paxlovid from 23Jul2023 to 28Jul2023 (Oral).; Sender's Comments: The efficacy of a drug varies from patient to patient and can be affected by different factors; however, a contributory role of the suspect product to the reported event vaccination failure and COVID 19 cannot be ruled out.
Age: 39.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID-19 Treatment; COVID-19 Treatment; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 24Jan2023 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 39 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "First-degree AV block" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID-19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient had taken other vaccination and medication in 2 weeks.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 43.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 44-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Sep2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 43 years for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 3 (booster), single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Negative; Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. The patient received treatment with Paxlovid from 26Jul2023 to 31Jul2023. The patient had no known allergies.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  An elderly female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Apr2023 as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19. Therapeutic measures were taken as a result of drug ineffective, covid-19 with paxlovid from 20Jul2023 to 25Jul2023. No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: getting COVID; getting COVID; This is a spontaneous report received from non-contactable reporter(s) (Physician).  A 33-year-old female patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "getting COVID".  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Based on the information provided in the narrative, a causal association between the events and the suspect drug cannot be completely excluded.
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Interchange of vaccine products, Suspected COVID-19
Clinical narrative: doesn't have a problem when he got the Moderna; nine health threats for death by COVID; nine health threats for death by COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A male patient received BNT162b2 (BNT162B2 NOS), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), as dose number unknown, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant), outcome "unknown", described as "doesn't have a problem when he got the Moderna"; DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "nine health threats for death by COVID".  Clinical course: It was reported that "Caller is trying to find the RSV vaccine. He heard over a month ago back in May they had distribution of the RSV vaccine or (withheld) in (withheld), He also mentioned that was like one of the last in line to get the COVID vaccine. When he had nine health threats for death by COVID. He doesn't have a problem when he got the Moderna but whenever he takes the Pfizer Covid vaccine was bad for him. He had problems with the Pfizer vaccine every time. He is upset that its across the bay over a month and none of the RSV vaccine are there yet."  The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.
Age: 11.0
Sex: F
Vaccine: MEN
Symptoms: Incorrect dose administered, Medication error, No adverse event
Clinical narrative: administering Menquadfi to a patient and that the patient pulled back resulting in getting a partial dose, full dose was not able to be administered with no reported adverse event; Initial information received on 03-Aug-2023 regarding an unsolicited valid non-serious case received from a other health professional.  This case involves administering Meningococcal A-C-Y-W135 (T CONJ) vaccine [Menquadfi] to a 11 years old female patient and that the patient pulled back resulting in getting a partial dose, full dose was not able to be administered with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included Diphtheria Vaccine Toxoid, Pertussis Vaccine Acellular, Tetanus Vaccine Toxoid (TDAP) for Prophylactic vaccination.  On 27-Jul-2023, the patient while receiving a dose (1x) of suspect Meningococcal A-C-Y-W135 (T CONJ) vaccine solution for injection (lot: U7616AB) with unknown strength & expiry date via unknown route in unknown administration site for Immunization and that the patient pulled back resulting in getting a partial dose, full dose was not able to be administered with no reported adverse event (incorrect dose administered) (latency: same day).  Action taken: not applicable.  At time of reporting, the outcome was Unknown.   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Impaired quality of life
Clinical narrative: This report is submitted on behalf of my father, a previously robust and health older man. In my life I can only remember just once before COVID where he was sick. Since my father received his three COVID vaccines he has not been the same. He gets COVID nearly every time he travels to include every wedding, every plane flight, etc. As a result he can't enjoy his life, is more hesitant to visit family and has suffered from COVID multiple times and has had to take Paxlovid twice.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: expired Shingrix Vaccine was given to a patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of expired vaccine used in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 01-AUG-2023, the patient received Shingrix (intramuscular, unknown arm) .5 ml. On 01-AUG-2023, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: expired Shingrix Vaccine was given to a patient). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 02-AUG-2023 The reporter reported that an expired Shingrix vaccine was given to a patient the day before reporting which led to expired vaccine used. No other information known. The reporter consented to follow up.
Age: 2.0
Sex: M
Vaccine: DTAP
Symptoms: Expired product administered, Medication error, No adverse event
Clinical narrative: Patient was administered expired Daptacel with no reported adverse event; Initial information received on 03-Aug-2023 regarding an unsolicited valid  non-serious case received from a other health professional.  This case involves a 2 years old male patient who was administered expired Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel] with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  Concomitant medications included PNEUMOCOCCAL VACCINE CONJ 7V (CRM197) (PREVNAR) for Immunisation; and HIB VACCINE CONJ (TET TOX) (ACTHIB) for Immunisation.  On 19-Jul-2023, the patient received 0.5 ml of suspect Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine Suspension for injection (Strength: Standard) (Frequency: once) (lot number: C5893AA; Expiry date: 21-Jun-2023) via intramuscular route in the left thigh for immunization.  On 19-Jul-2023, the patient was administered expired Diphtheria-15/Tetanus/5 Ac Pertussis Vaccine [Daptacel] with no reported adverse event (expired product administered) (Latency: same day).  It was reported, Caller would like to know if there is any information to support the use of the expired product? Caller would like to know if there is any safety information on a repeat dose of the Daptacel product in such a short interval.  Action taken: not applicable.  Outcome: Unknown   This suspected adverse reaction report is submitted and classified as a medication error solely and exclusively to ensure the marketing authorization holder's compliance with the requirements set out in the Directive 2001/83/EC and Module VI of the Good Pharmacovigilance Practices. The classification as a medical error is in no way intended, nor should it be interpreted or construed as an allegation or claim made by the marketing authorization holder that any third party has contributed to or is to be held liable for the occurrence of this medication error.
Age: 38.0
Sex: F
Vaccine: COVID19-2
Symptoms: Anxiety, Axillary pain, Breast pain, Breast swelling, Discomfort
Clinical narrative: The next day I started out with a normal sore arm feeling in my left arm as with any vaccine.   By two days later I was having pain and swelling in my left arm pit and side of my left breast causing discomfort and worry.   I read online that swollen lymphnodes post vaccine can be normal but I have never had this reaction with my first two moderna vaccines, nor did I have it with my first booster dose.   I do plan on bringing this to my primary care providers attention on 08/08/2023 at an appointment I had previously scheduled for other health issues just to make sure I seem ok otherwise.
Age: 38.0
Sex: F
Vaccine: COVID19-2
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: The next day I started out with a normal sore arm feeling in my left arm as with any vaccine.   By two days later I was having pain and swelling in my left arm pit and side of my left breast causing discomfort and worry.   I read online that swollen lymphnodes post vaccine can be normal but I have never had this reaction with my first two moderna vaccines, nor did I have it with my first booster dose.   I do plan on bringing this to my primary care providers attention on 08/08/2023 at an appointment I had previously scheduled for other health issues just to make sure I seem ok otherwise.
Age: 14.0
Sex: U
Vaccine: VARCEL
Symptoms: Product storage error
Clinical narrative: No additional AE/PQC; Caller reported AE for improperly stored administered VARIVAX.; This spontaneous report has been received from a Healthcare Professional and refers to a 14-year-old patient of unknown age and gender.  The patient's pertinent medical history, other drug reactions or allergies, concurrent conditions an concomitant therapies were not reported.  On 03-JUL-2023, the patient was vaccinated with an improperly stored varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection (product storage error), at a dose of 0.5 milliliter (lot number W017551 has been determined to be valid for varicella virus vaccine live (oka/merck) (VARIVAX), with an expiration date established as 01-JUN-2024), administered for prophylaxis (strength, and anatomical site of administration were not provided). Temperature excursion lasted for 6 hours and 15 minutes at -10 degrees Celsius up to 8 degrees Celsius.
Sex: F
Vaccine: HEP, HEP
Symptoms: Inappropriate schedule of product administration, Incorrect dose administered, Product administered to patient of inappropriate age
Clinical narrative: Inappropriate dose; Late 2nd dose; adult patient received a pediatric dose; adult patient received a pediatric dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 20-year-old female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HBV (Engerix B pediatric) (batch number 9TG49, expiry date 31-DEC-2024) for prophylaxis.   Previously administered products included Engerix B (received 1st dose on 12-JAN-2023).   On 30-MAY-2023, the patient received the 3rd dose of Engerix B. On 27-APR-2023, the patient received the 2nd dose of Engerix B pediatric. On 27-APR-2023, not applicable after receiving Engerix B and an unknown time after receiving Engerix B pediatric, the patient experienced drug dose administration interval too long (Verbatim: Late 2nd dose), underdose (Verbatim: adult patient received a pediatric dose) and adult use of a child product (Verbatim: adult patient received a pediatric dose). On 30-MAY-2023, the patient experienced drug dose administration interval too short (Verbatim: Inappropriate dose). The outcome of the drug dose administration interval too long, underdose, adult use of a child product and drug dose administration interval too short 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 Information: GSK Receipt Date: 20-JUL-2023 A medical assistant called to inform that an adult patient received a pediatric dose of Engerix-B and dose was administered after recommended interval, which led to lengthening of vaccination schedule, underdose and adult use of a child product  and received the 3rd dose before recommended interval, which led to shortening of vaccination schedule. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: never got the 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a 79-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on 10th December 2018).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: never got the 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date:31-JUL-2023 The pharmacist reported a patient never got the 2nd dose. The reporter consented to follow up. Till the time of reporting, the patient did not receive the 2nd dose of Shignrix, which led to incomplete course of vaccination
Sex: F
Vaccine: VARZOS
Symptoms: Fatigue, Neuropathy peripheral, Pain in extremity, Thermal burn
Clinical narrative: feet burned; neuropathy; arms and legs ached/sore arm; very tired; This serious case was reported by a consumer via call center representative and described the occurrence of neuropathy in a 50-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 10-JUL-2023, the patient received the 1st dose of Shingrix. In JUL-2023, 10 days after receiving Shingrix, the patient experienced neuropathy (Verbatim: neuropathy) (serious criteria GSK medically significant) and pain in extremity (Verbatim: arms and legs ached/sore arm). On an unknown date, the patient experienced burn of unspecified degree of foot (Verbatim: feet burned) and tiredness (Verbatim: very tired). The outcome of the neuropathy and burn of unspecified degree of foot were unknown and the outcome of the pain in extremity and tiredness were resolved (duration 2 days).   It was unknown if the reporter considered the neuropathy, burn of unspecified degree of foot, pain in extremity and tiredness to be related to Shingrix.     It was unknown if the company considered the neuropathy, burn of unspecified degree of foot, pain in extremity and tiredness to be related to Shingrix.   Additional Information: GSK Receipt Date: 01-AUG-2023 After the administration of first dose of Shingrix patient was very tired and her arm wee sore for 2 days. After 10 days, she got bad neuropathy. No further information was known. The call was disconnected before the consent for follow up was asked.
Age: 70.0
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Rash, Scar
Clinical narrative: patient with soreness and scarred patch that looks like leather at the injection site; patient with soreness and scarred patch that looks like leather at the injection site; scarred patch; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of injection site pain in a 70-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   On 02-AUG-2022, the patient received the 2nd dose of Shingrix. On an unknown date, 1 month after receiving Shingrix, the patient experienced injection site pain (Verbatim: patient with soreness and scarred patch that looks like leather at the injection site), skin scarring (Verbatim: patient with soreness and scarred patch that looks like leather at the injection site) and patchy rash (Verbatim: scarred patch). The outcome of the injection site pain was not resolved and the outcome of the skin scarring and patchy rash were unknown.   It was unknown if the reporter considered the injection site pain, skin scarring and patchy rash to be related to Shingrix.     It was unknown if the company considered the injection site pain, skin scarring and patchy rash to be related to Shingrix.   Additional Information: GSK receipt date:02-AUG-2023 The pharmacist called to get instructions how to care for patient with soreness and scarred patch that looks like leather at the injection site. The patch was about 1.5cm x 1cm oval-shaped. The patch began to appear about 1 month after receiving her 2nd Shingrix injection. The call was transferred call to Medical Information department after gathering Adverse Event details. The reporter consented to follow up.
Age: 73.0
Sex: M
Vaccine: VARZOS
Symptoms: Abdominal pain upper, Diarrhoea, Headache, Myalgia
Clinical narrative: diarrhea; stomach ache; headache; muscle pain; This non-serious case was reported by a consumer via call center representative and described the occurrence of diarrhea in a 73-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 01-AUG-2023, the patient received Shingrix (left arm). On 02-AUG-2023, 1 days after receiving Shingrix, the patient experienced diarrhea (Verbatim: diarrhea), stomach pain (Verbatim: stomach ache), headache (Verbatim: headache) and muscle pain (Verbatim: muscle pain). The outcome of the diarrhea, stomach pain, headache and muscle pain were not resolved.   It was unknown if the reporter considered the diarrhea, stomach pain, headache and muscle pain to be related to Shingrix.     It was unknown if the company considered the diarrhea, stomach pain, headache and muscle pain to be related to Shingrix.   Additional Information: GSK receipt date: 02-AUG-2023 The reporter was the wife calling on behalf of her husband who received a Shingrix shot (unknown if 1st or 2nd dose) and on day of reporting, the patient started having muscle pain, headache, stomachache, and diarrhea. The reporter did not have any information about the vaccination facility other that the patient went to his doctor a day before and was given the shot.  The reporter did not have lot/expiry information. The consent to follow up with Healthcare Professional (HCP) was not asked.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: We have a patient who received a vaccine that was in the fridge for 33 days(rather than 30).; We have a patient who received a vaccine that was in the fridge for 33 days(rather than 30).; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We have a patient who received a vaccine that was in the fridge for 33 days(rather than 30).), PRODUCT STORAGE ERROR (We have a patient who received a vaccine that was in the fridge for 33 days(rather than 30).) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (We have a patient who received a vaccine that was in the fridge for 33 days(rather than 30).), PRODUCT STORAGE ERROR (We have a patient who received a vaccine that was in the fridge for 33 days(rather than 30).) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We have a patient who received a vaccine that was in the fridge for 33 days(rather than 30).), PRODUCT STORAGE ERROR (We have a patient who received a vaccine that was in the fridge for 33 days(rather than 30).) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (We have a patient who received a vaccine that was in the fridge for 33 days(rather than 30).) and PRODUCT STORAGE ERROR (We have a patient who received a vaccine that was in the fridge for 33 days(rather than 30).).    Concomitant medication was not provided. Treatment information was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2023: Follow-up received and had no new information.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Electric shock sensation, Headache, Nasopharyngitis
Clinical narrative: Headache, Arthralgia, cold, shocking sensation Narrative:
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Head discomfort, Headache, Muscular weakness, Myalgia
Clinical narrative: Headache, Myalgia, NauseaVomiting, weakness Narrative: Recveived 2nd vaccine 2/3/21, was fine for a few hours except instant headache then 2 am developed nausea, bad body aches, head feels heavy, legs are weak. She experienced the same type of reaction to 1st dose. Was advised to continue to monitor signs and symptoms and follow up with PCP if does not reside in 24-48 hours.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Pain, Vomiting
Clinical narrative: Headache, Myalgia, NauseaVomiting, weakness Narrative: Recveived 2nd vaccine 2/3/21, was fine for a few hours except instant headache then 2 am developed nausea, bad body aches, head feels heavy, legs are weak. She experienced the same type of reaction to 1st dose. Was advised to continue to monitor signs and symptoms and follow up with PCP if does not reside in 24-48 hours.
Age: 1.42
Sex: F
Vaccine: COVID19, COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received COVID shot after beyond use date.
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received COVID shot after beyond use date.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Headache, Myalgia, Phlebitis, Pyrexia
Clinical narrative: Headache, Sedation, Myalgia, Arthralgia, Phlebitis & visit Fever
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Sedation
Clinical narrative: Headache, Sedation, Myalgia, Arthralgia, Phlebitis & visit Fever
Age: 68.0
Sex: F
Vaccine: TDAP
Symptoms: Immediate post-injection reaction, Vaccination site bruising, Vaccination site swelling
Clinical narrative: Immediate reaction: bruising and serious swelling. Pharmacist applied ice-pak and asked if I took a blood thinner or aspirin. Neither. Looked like a ping-pong ball immediately at the vaccine site. Experienced pharmacist.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Laboratory test normal, Tachycardia
Clinical narrative: I experienced unexplained tachacardia after my third vaccine for Covid Mederna. Hospitalized for four nights. Tests all normal.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Fatigue, Headache, Injection site erythema, Injection site macule
Clinical narrative: Got a shingrix vaccine #1 dose and developed red blotches at the injection site. Also a lot of soreness in that shoulder. I've had achy muscles and joints for two days and I've been taking ibuprofen. I've had extreme tiredness and headache for two days. Today I developed red blotches on both sides of my neck
Sex: F
Vaccine: VARZOS
Symptoms: Injection site pain, Myalgia, Rash macular
Clinical narrative: Got a shingrix vaccine #1 dose and developed red blotches at the injection site. Also a lot of soreness in that shoulder. I've had achy muscles and joints for two days and I've been taking ibuprofen. I've had extreme tiredness and headache for two days. Today I developed red blotches on both sides of my neck
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Blood test abnormal, Diplopia, Dizziness, Fatigue, Feeling abnormal
Clinical narrative: I went to the agency and got the SHINGRIX vaccine shot for shingles. Within 2 hours I started to experience dizziness, swollen face, double vision, hallucinations, and red blotches all over my body. After two days of complete and total bed rest, I still felt really lethargic and exhausted. I couldn't do anything without having to lay down. I felt terrible. Somethings not right. I called the agency nurse and tried to explain my situation. I was told that it sounded like a reaction of some kind that they have not heard of anything like this before. Well as days passed, I was not feeling much better. After approximately 12 days I had an unrelated appointment with the agency. The first thing I said to the team of doctors (the pain clinic) I was told to see my primary. Well 11 vials of blood later, and then 2 days later another 9 vials of blood, I was at the agency and was told by one of the doctors that he believed that the shot da.aged my liver and that was the reason I was feeling so bad. I looked on the agency health website at my blood work results myself and sure enough my levels in quite a few areas were outside the normal limits indicating liver problems. (This is 3 weeks now). Coincidentally the next day my primary calls me and says that my results indicate I "may" have a hep c problem and was to come in for more blood work. Well 6 years earlier the agency cured me of hep c and I was verified cured by the agency and by a private doctor. This is available on my health website. I don't have this information on hand
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Hallucination, Immunisation reaction, Lethargy, Liver disorder, Liver injury
Clinical narrative: I went to the agency and got the SHINGRIX vaccine shot for shingles. Within 2 hours I started to experience dizziness, swollen face, double vision, hallucinations, and red blotches all over my body. After two days of complete and total bed rest, I still felt really lethargic and exhausted. I couldn't do anything without having to lay down. I felt terrible. Somethings not right. I called the agency nurse and tried to explain my situation. I was told that it sounded like a reaction of some kind that they have not heard of anything like this before. Well as days passed, I was not feeling much better. After approximately 12 days I had an unrelated appointment with the agency. The first thing I said to the team of doctors (the pain clinic) I was told to see my primary. Well 11 vials of blood later, and then 2 days later another 9 vials of blood, I was at the agency and was told by one of the doctors that he believed that the shot da.aged my liver and that was the reason I was feeling so bad. I looked on the agency health website at my blood work results myself and sure enough my levels in quite a few areas were outside the normal limits indicating liver problems. (This is 3 weeks now). Coincidentally the next day my primary calls me and says that my results indicate I "may" have a hep c problem and was to come in for more blood work. Well 6 years earlier the agency cured me of hep c and I was verified cured by the agency and by a private doctor. This is available on my health website. I don't have this information on hand
Age: 64.0
Sex: M
Vaccine: VARZOS
Symptoms: Rash macular, Rest regimen, Swelling face
Clinical narrative: I went to the agency and got the SHINGRIX vaccine shot for shingles. Within 2 hours I started to experience dizziness, swollen face, double vision, hallucinations, and red blotches all over my body. After two days of complete and total bed rest, I still felt really lethargic and exhausted. I couldn't do anything without having to lay down. I felt terrible. Somethings not right. I called the agency nurse and tried to explain my situation. I was told that it sounded like a reaction of some kind that they have not heard of anything like this before. Well as days passed, I was not feeling much better. After approximately 12 days I had an unrelated appointment with the agency. The first thing I said to the team of doctors (the pain clinic) I was told to see my primary. Well 11 vials of blood later, and then 2 days later another 9 vials of blood, I was at the agency and was told by one of the doctors that he believed that the shot da.aged my liver and that was the reason I was feeling so bad. I looked on the agency health website at my blood work results myself and sure enough my levels in quite a few areas were outside the normal limits indicating liver problems. (This is 3 weeks now). Coincidentally the next day my primary calls me and says that my results indicate I "may" have a hep c problem and was to come in for more blood work. Well 6 years earlier the agency cured me of hep c and I was verified cured by the agency and by a private doctor. This is available on my health website. I don't have this information on hand
Age: 55.0
Sex: F
Vaccine: HEP
Symptoms: Diplopia, Headache, Nausea, Pyrexia, Vision blurred
Clinical narrative: 2nd Hep B vaccine administered 7/31/23. 8/1/23 experienced onset of side effects: double / blurred vision, nausea, severe headache. Nausea was alleviated with anti-nausea med and headache with Tylenol and sleep. 8-3 woke up with slight fever nausea and headache remaining.
Sex: U
Vaccine: VARCEL
Symptoms: Expired product administered, No adverse event, Product expiration date issue, Product storage error
Clinical narrative: the vaccines were "short dated" and a new expiration date of 6/30/2023 was given. She states that the products were labeled but still accidentally administered; vaccine with expipratio date 16-NOV-2022 administered on 30-JUN-2023; Caller reports that they had a temperature excursion 3/31/2023; This spontaneous report was received from a office manager and refers to a patient of unknown age and gender.  The patient's medical history, concurrent conditions and concomitant therapies were not reported.  On 30-JUN-2023, the patient was vaccinated with  "short dated"  and expired dose of varicella virus vaccine live (oka/merck) (VARIVAX) subcutaneous injection, 0.5 milliliter, lot #W031816, expiration date: 16-NOV-2022, administered for prophylaxis (strength, and route of administration were not provided) (Product expiration date issue and Expired product administered). This vaccine underwent temperature excursion on 31-MAR-2023, for 4 hours in 6 degree Farenheit to 14 degree Farenheit, 4 hours in 14 degree Farenheit to 46 degree Farenheit and for 3 hours 57 minutes in 47 degree Farenheit to 77 degree Farenheit (Product storage error). No additional adverse event was reported.
Sex: F
Vaccine: RV5
Symptoms: Product storage error
Clinical narrative: improperly stored administered ROTATEQ; This spontaneous report as received from a consumer referring to a female patient of unknown age.   Information of the patients' pertinent medical history, concomitant medications, concurrent conditions, and drug reactions or allergies were not reported.   On 20-JUN-2023, a rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid (lot number 1968385, which had been verified to be a valid lot number for this vaccine, with an expiration date reported and upon internal validation established as 22-MAY-2024) experienced a temperature excursion of 34.9 degrees Fahrenheit (F) for 6 hours and 34 minutes. On 03-JUL-2023, the vaccine experienced a temperature excursion of 51.4 F for 7 hours and 33 minutes. On 04-JUL-2023, the vaccine experienced another temperature excursion of 51.1 F for 24 hours; and on 05-JUL-2023, another one of 50.7 F for 9 hours and 27 minutes.    On 07-JUL-2023, the patient was vaccinated with an improperly stored (product storage error) of the previously mentioned rotavirus vaccine, live, oral, pentavalent (ROTATEQ) oral liquid, at a dose of 2 mL (indication, strength, frequency, and route of administration were not provided).
Sex: U
Vaccine: MMR
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; Improperly Stored / Administered; This spontaneous report was received from a nurse (other health professional) referred to a patient of unknown age and gender via phone call. The patient's medical history was not reported. The patient's concurrent conditions were not reported. Concomitant therapies were not reported.  On 26-JUL-2023, the patient was administered with measles, mumps, and rubella (wistar ra 27-3) virus vaccine, live (M-M-R II) injection, 0.5 milliliter once, lot #U031359, expiration date: 07-OCT-2023, administered for prophylaxis (strength, and route of administration were not provided). The administered vaccine had twice temperature excursion (improper storage of product in use). No symptomatic adverse event was reported. Caller declined to provide full patient demographics and could only provide initials of patient. No additional details at this time. No additional AE/PQC reported.
Sex: U
Vaccine: MMRV
Symptoms: No adverse event, Product storage error
Clinical narrative: no adverse event; HBP called to report a TE with PROQUAD from 8/19/2022. Administered to this patient on 1/7/2023.; This spontaneous report has been received from a physician referred to an 1-year-old patient of unknown gender. The patient's pertinent medical history, concurrent conditions, concomitant medications, and drug reactions or allergies were not provided.  On 07-JAN-2023, the patient was vaccinated with Measles, Mumps, Rubella and Varicella (Oka-Merck) Virus Vaccine Live, recombinant human albumin (rha) (PROQUAD) injection, 0.5 milliliter (ml) (valid lot number U039261 [expiration date 09-JUN-2023]) (dose number, frequency, route of administration vaccination scheme, and anatomical location were not provided), administered for prophylaxis, after a temperature excursion (product storage error).  No adverse effects reported.