chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Product preparation error
Clinical narrative: Nurse reported that the Shingrix  powder was reconstituted with with Non-GSK diluent and administered to 3 patients; Nurse reported that the Shingrix  powder was reconstituted with with Non-GSK diluent and administered to 3 patients; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 63-year-old patient who received Herpes zoster (Shingrix) (batch number y7pp4, expiry date 07-MAY-2025) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix (intramuscular). On an unknown date, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Nurse reported that the Shingrix  powder was reconstituted with with Non-GSK diluent and administered to 3 patients) and inappropriate dose of vaccine administered (Verbatim: Nurse reported that the Shingrix  powder was reconstituted with with Non-GSK diluent and administered to 3 patients). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 07-FEB-2024 The reporter reported that the staff administered Shingrix vaccine 2nd dose for all to the three patients using a generic diluent. The reporter stated that the patients were contacted and rescheduled for a new dose with correct diluent or adjuvant and staff was educated. The medication error category was medication error without harm. The reporter consented to follow up. This US2024011377 and US2024AMR018460 case has been linked to the case reported by the same reporter.; Sender's Comments:  US-GSK-US2024AMR018460:Same reporter different patient US-GSK-US2024011377:Same reporter different patient
Sex: U
Vaccine: RSV
Symptoms: Pruritus, Rash
Clinical narrative: Itching; rash; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of pruritus in a patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received Arexvy. On an unknown date, 2 days after receiving Arexvy, the patient experienced pruritus (Verbatim: Itching) and rash (Verbatim: rash). The outcome of the pruritus and rash were not reported.   It was unknown if the reporter considered the pruritus and rash to be related to Arexvy.     It was unknown if the company considered the pruritus and rash to be related to Arexvy.   Additional Information: GSK Receipt Date: 08-FEB-2024 This case was reported via (Open field AE monitoring) interactive digital media. The reporter asked what about itching and rash 2 days after injection. The follow-up could not be possible as no contact details were available.
Sex: M
Vaccine: RSV
Symptoms: Feeling hot, Injection site erythema, Injection site pain, Pain, Pruritus
Clinical narrative: pain if pressing on the injection site; still has some redness and pain if pressing on the injection site; pain; swelling; warmth; itching for over a week; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received the 1st dose of Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced injection site pain (Verbatim: pain if pressing on the injection site), injection site erythema (Verbatim: still has some redness and pain if pressing on the injection site), pain (Verbatim: pain), swelling (Verbatim: swelling), feeling of warmth (Verbatim: warmth) and pruritus (Verbatim: itching for over a week). The outcome of the injection site pain, injection site erythema, pain, swelling, feeling of warmth and pruritus were not resolved.   The reporter considered the injection site pain, injection site erythema, pain, swelling, feeling of warmth and pruritus to be possibly related to Arexvy.     The company considered the injection site pain, injection site erythema, pain, swelling, feeling of warmth and pruritus to be possibly related to Arexvy.   Additional Information: GSK Receipt Date: 08-FEB-2024 This case was reported by patient itself.  The patient reported having pain, swelling, warmth and itching for over a week. After two weeks, the patient still has some redness and pain if pressing on the injection site.
Sex: M
Vaccine: RSV
Symptoms: Swelling
Clinical narrative: pain if pressing on the injection site; still has some redness and pain if pressing on the injection site; pain; swelling; warmth; itching for over a week; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of injection site pain in a male patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On an unknown date, the patient received the 1st dose of Arexvy. On an unknown date, an unknown time after receiving Arexvy, the patient experienced injection site pain (Verbatim: pain if pressing on the injection site), injection site erythema (Verbatim: still has some redness and pain if pressing on the injection site), pain (Verbatim: pain), swelling (Verbatim: swelling), feeling of warmth (Verbatim: warmth) and pruritus (Verbatim: itching for over a week). The outcome of the injection site pain, injection site erythema, pain, swelling, feeling of warmth and pruritus were not resolved.   The reporter considered the injection site pain, injection site erythema, pain, swelling, feeling of warmth and pruritus to be possibly related to Arexvy.     The company considered the injection site pain, injection site erythema, pain, swelling, feeling of warmth and pruritus to be possibly related to Arexvy.   Additional Information: GSK Receipt Date: 08-FEB-2024 This case was reported by patient itself.  The patient reported having pain, swelling, warmth and itching for over a week. After two weeks, the patient still has some redness and pain if pressing on the injection site.
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster, Pruritus, Scab
Clinical narrative: itching; scabbing, mild little outbreak of scabs; This non-serious case was reported by a consumer via call center representative and described the occurrence of pruritus in a 71-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included chickenpox. Concurrent medical conditions included migraine, fibromyalgia and chronic pain. Concomitant products included montelukast sodium (Singulair). Family history included shingles.   On an unknown date, the patient received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced pruritus (Verbatim: itching) and scab (Verbatim: scabbing, mild little outbreak of scabs). The outcome of the pruritus and scab were unknown.   It was unknown if the reporter considered the pruritus and scab to be related to Shingrix.     It was unknown if the company considered the pruritus and scab to be related to Shingrix.   Additional Information: GSK Receipt Date: 08-FEB-2024 The reporter had wanted to be on Shingrix and certainly one and a half noon and had chickenpox really bad she did have disaster series many years ago. The reporter reported that she started and completed her Shingrix vaccination in 2017. Consumer states she has a family history of shingles but she has never had a case. Called to report that she was having an outbreak that she suspects was Shingles in her neural arc on her back. States she has not been examined or diagnosed by her doctor, but she suspects that it is shingles. The reporter stated that she was experiencing scabbing and itching. The reporter consented to follow up
Sex: F
Vaccine: HEP, HEPAB
Symptoms: Incomplete course of vaccination
Clinical narrative: Incomplete course of vaccination; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a elderly female patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HAB (Twinrix) for prophylaxis.   Previously administered products included Havrix (Received 1st dose of havrix in 2022), Engerix-B (Received 1st dose of Engerix b on 2nd March 2022) and Twinrix (Received 1st dose of Twinrix on October 2023).   On an unknown date, the patient did not receive the 2nd dose of Engerix B and the 2nd dose of Twinrix. On an unknown date, an unknown time after receiving Engerix B and Twinrix, the patient experienced incomplete course of vaccination (Verbatim: Incomplete course of vaccination). The outcome of the incomplete course of vaccination was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date : 07-FEB-2024 The pharmacist had an patient (old woman around 70 years old),who was planning to travel. The patient had 1st dose of Havrix, Engerix-B  and Twinrix administered on Oct 2023. The pharmacist was planning to administer a second dose of Twinrix. At the time of reporting, the patient did not received the 2nd dose of engerix-b and 2nd dose of twinrix which led to incomplete course of vaccination.  The reporter consented to follow up.
Age: 67.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: he received his first dose of SHINGRIX in July 2020. He received his second dose today; This non-serious case was reported by a consumer via call center representative and described the occurrence of drug dose administration interval too long in a 67-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in JUL-2022).   On 07-FEB-2024, the patient received the 2nd dose of Shingrix. On 07-FEB-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too long (Verbatim: he received his first dose of SHINGRIX in July 2020. He received his second dose today). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK receipt date: 07-FEB-2024 The patient self-reported this case. The patient received 2nd dose of Shingrix vaccine on reporting day, later than recommended interval, which led to lengthening vaccination schedule. The reporter did not consent to follow up.
Age: 65.0
Sex: F
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Rash, Secretion discharge, Skin lesion, Skin swelling
Clinical narrative: she began to have a rash on her chin, which over the course of the day/evening, spread to her entire face.; She describes it as small lesions which are slightly swollen with a little bit of oozing; She describes it as small lesions; little bit oozing; first dose was years ago/received her second dose of SHINGRIX yesterday.; This non-serious case was reported by a consumer via call center representative and described the occurrence of exanthema facial in a 65-year-old female patient who received Herpes zoster (Shingrix) (batch number FF25X, expiry date 21-NOV-2025) for prophylaxis.   Previously administered products included Shingrix (received first dose years ago).   On 07-FEB-2024, the patient received the 2nd dose of Shingrix (intramuscular, left deltoid) .5 ml. On 07-FEB-2024, 5 hrs after receiving Shingrix and an unknown time after starting Valtrex, the patient experienced exanthema facial (Verbatim: she began to have a rash on her chin, which over the course of the day/evening, spread to her entire face.), facial swelling (Verbatim: She describes it as small lesions which are slightly swollen with a little bit of oozing), skin lesion (Verbatim: She describes it as small lesions), skin oozing (Verbatim: little bit oozing) and drug dose administration interval too long (Verbatim: first dose was years ago/received her second dose of SHINGRIX yesterday.). The patient was treated with valaciclovir hydrochloride (Valtrex), prednisone and acrivastine (Benadryl). The outcome of the exanthema facial, facial swelling, skin lesion and skin oozing were not resolved and the outcome of the drug dose administration interval too long was unknown.   It was unknown if the reporter considered the exanthema facial, facial swelling, skin lesion and skin oozing to be related to Shingrix.     It was unknown if the company considered the exanthema facial, facial swelling, skin lesion and skin oozing to be related to Shingrix.   Additional Information: GSK Receipt Date: 08-FEB-2024 The patient received her second dose of Shingrix vaccine and few hours after receiving the vaccine, she began to had a rash on her chin, which over the course of the day/evening, spread to her entire face.  She described it as small lesions which were slightly swollen with a little bit of oozing. The patient received second dose of Shingrix later than recommended interval, which led to lengthening of vaccine schedule. The reporter did not consent to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: appearance of Welts after the first dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of welts in a 60-year-old male patient who received Herpes zoster (Shingrix) (batch number 58160082311, expiry date 22-NOV-2025) for prophylaxis.   On 31-JAN-2024, the patient received the 1st dose of Shingrix. On 31-JAN-2024, less than a day after receiving Shingrix, the patient experienced welts (Verbatim: appearance of Welts after the first dose). The outcome of the welts was unknown.   It was unknown if the reporter considered the welts to be related to Shingrix.     It was unknown if the company considered the welts to be related to Shingrix.   Additional Information: GSK Receipt date: 08-FEB-2024 An HCP reported to inquiring about Shingrix and what information was available about the administration of Shingrix in a patient with the appearance of Welts after the first dose.  Partial information about the event, vaccine an patient provided.  The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Age: 56.0
Sex: F
Vaccine: HEP, HEP, HEP
Symptoms: Inappropriate schedule of product administration, Underdose
Clinical narrative: 3rd dose of Engerix-B adult administered on 7th February 2024; a 56 year old patient received 2 dose of Pediatric dose of Engerix-B and one dose of the adult Engerix-B; a 56 year old patient received 2 dose of Pediatric dose of Engerix-B and one dose of the adult Engerix-B; a 56 year old patient received 2 dose of Pediatric dose of Engerix-B and one dose of the adult Engerix-B; a 56 year old patient received 2 dose of Pediatric dose of Engerix-B and one dose of the adult Engerix-B; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 56-year-old female patient who received HBV (Engerix B adult) (batch number PE9G5, expiry date 19-MAY-2025) for prophylaxis.   Co-suspect products included HBV (Engerix B pediatric) (batch number N73FA, expiry date 31-MAY-2024) for prophylaxis and HBV (Engerix B pediatric) (batch number N73FA, expiry date 31-MAY-2024) for prophylaxis.   On 07-FEB-2024, the patient received the 3rd dose of Engerix B adult. On 11-AUG-2023, the patient received the 2nd dose of Engerix B pediatric. On 11-JUL-2023, the patient received the 1st dose of Engerix B pediatric. On 11-JUL-2023, not applicable after receiving Engerix B adult and Engerix B pediatric and an unknown time after receiving Engerix B pediatric, the patient experienced underdose (Verbatim: a 56 year old patient received 2 dose of Pediatric dose of Engerix-B and one dose of the adult Engerix-B) and adult use of a child product (Verbatim: a 56 year old patient received 2 dose of Pediatric dose of Engerix-B and one dose of the adult Engerix-B). On 11-AUG-2023, the patient experienced underdose (Verbatim: a 56 year old patient received 2 dose of Pediatric dose of Engerix-B and one dose of the adult Engerix-B) and adult use of a child product (Verbatim: a 56 year old patient received 2 dose of Pediatric dose of Engerix-B and one dose of the adult Engerix-B). On 07-FEB-2024, the patient experienced drug dose administration interval too long (Verbatim: 3rd dose of Engerix-B adult administered on 7th February 2024). The outcome of the underdose, adult use of a child product, underdose, adult use of a child product and drug dose administration interval too long were unknown.   Additional Information: GSK receipt date: 08-FEB-2024 Pharmacist reported that a 56 year old patient received 2 dose of Pediatric dose of Engerix-B, which led to underdose and adult use of a child product and one dose of the adult Engerix-B. The patient received 3rd dose of Enegrix-B adult (20mcg) later than the recommended schedule, which led to lengthening of vaccination schedule. The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Circumstance or information capable of leading to medication error, Underdose
Clinical narrative: dint get full dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of incomplete dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete dose administered (Verbatim: dint get full dose). The outcome of the incomplete dose administered was unknown.   Additional Information: GSK Receipt Date: 09-FEB-2024 Reporter had a question about re vaccinating if a patient pulled their arm away and a small about of vaccine squired out of the syringe, which led to incomplete dose administered. No other information was provided. The reporter did not consent to follow-up.
Sex: M
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; The first case was about a little less than a year ago; The second case of shingles on his left cheek started about 2 weeks ago; This serious case was reported by a consumer via call center representative and described the occurrence of vaccination failure in a elderly male patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (had shingles on his left cheek on his face in past year). Previously administered products included Acyclovir (had received acyclovir less than a year ago).   On an unknown date, the patient received the 2nd dose of Shingrix (unknown arm) and the 1st dose of Shingrix (unknown arm). In JAN-2024, an unknown time after receiving Shingrix and Shingrix, the patient experienced shingles (Verbatim: The second case of shingles on his left cheek started about 2 weeks ago). On an unknown date, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: The first case was about a little less than a year ago). The patient was treated with betamethasone valerate. The outcome of the vaccination failure was unknown and the outcome of the shingles and shingles were resolved.   It was unknown if the reporter considered the vaccination failure, shingles and shingles to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure, shingles and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK receipt date: 09-FEB-2024 The reporter reported that patient had received both doses of Shingrix vaccine over 6 years ago, in an unknown arm. The reporter stated in the past year he had two cases of shingles on his left cheek on his face. The first case had about a little less than a year ago and he took acyclovir immediately and it cleared up in a week. The second case of shingles on his left cheek started about 2 weeks ago and the physician misdiagnosed it as impetigo, it got worse and spread more on his face, then the health care professional started Betamethasone Valerate Ointment twice daily. The reporter stated it was staring to look better now. The reporter did not consent to follow-up.  This case was considered as suspected vaccination failure as details regarding time to onset for shingles and laboratory confirmation regarding shingles were unknown at the time of reporting.
Sex: F
Vaccine: RSV
Symptoms: Pulmonary embolism, Respiratory symptom
Clinical narrative: She began having respiratory symptoms (the symptoms were not specified); Bilateral pulmonary emboli; This serious case was reported by a physician via sales rep and described the occurrence of respiratory symptom in a 73-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 11-JAN-2024, the patient received Arexvy. On 25-JAN-2024, 14 days after receiving Arexvy, the patient experienced respiratory symptom (Verbatim: She began having respiratory symptoms (the symptoms were not specified)) (serious criteria hospitalization) and pulmonary embolism (Verbatim: Bilateral pulmonary emboli) (serious criteria hospitalization and GSK medically significant). The outcome of the respiratory symptom and pulmonary embolism were unknown.   It was unknown if the reporter considered the respiratory symptom to be related to Arexvy. The reporter considered the pulmonary embolism to be possibly related to Arexvy.     It was unknown if the company considered the respiratory symptom to be related to Arexvy. The company considered the pulmonary embolism to be possibly related to Arexvy.   Additional Information: GSK receipt date: 09-FEB-2024 The reporter reported that patient had received Arexvy vaccine and she began respiratory symptom (the symptom were not specified). The patient had admitted to the hospital on 27th January 2024 with a diagnosis of bilateral pulmonary emboli.  The reporter stated in the hospital's hematologists noted that the bilateral pulmonary emboli might be related to the RSV vaccine. The patient had been discharged, but the discharge date was unknown.  The reporter consent to follow up.
Age: 25.0
Sex: M
Vaccine: HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: late second dose of Engerix-B was administered to a patient; This non-serious case was reported by a physician via call center representative and described the occurrence of drug dose administration interval too long in a 25-year-old male patient who received HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (1st dose received on 29-AUG-2023).   On 30-NOV-2023, the patient received the 2nd dose of Engerix B. On 30-NOV-2023, an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: late second dose of Engerix-B was administered to a patient). The outcome of the drug dose administration interval too long was unknown.   Additional Information: GSK Receipt Date: 12-FEB-2024 The physician called to report a late second dose of Engerix-B was administered to a patient, which led to lengthening of the vaccination scheduled. Details of the vaccine were asked but reporter declined to give any information. The vaccine administration facility was the same as primary reporter. The reporter did not consent to follow-up.
Age: 53.0
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration
Clinical narrative: gave the 2nd dose of Shingrix early; 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 short in a 53-year-old male patient who received Herpes zoster (Shingrix) (batch number F4LD5, expiry date 27-SEP-2025) for prophylaxis.   Concomitant products included Varicella zoster vaccine rgE (CHO) (Shingrix).   On 08-FEB-2024, the patient received the 2nd dose of Shingrix. On 08-FEB-2024, an unknown time after receiving Shingrix, the patient experienced drug dose administration interval too short (Verbatim: gave the 2nd dose of Shingrix early). The outcome of the drug dose administration interval too short was unknown.  Additional Information: GSK Receipt Date: 12-FEB-2024 The medical assistant stated that she misread the date and gave the 2nd dose of Shingrix early.  The first dose of Shingrix was administered on 18-DEC-2023 and the patient came in on 08-FEB-2024 and the second dose was administered, earlier than the recommended time interval, which led to shortening of the vaccination schedule. The reporter consented to follow up.
Sex: U
Vaccine: FLU4
Symptoms: Expired product administered
Clinical narrative: Expired dose given; 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 Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) (batch number 3AH4A, expiry date 20-JUN-2023) for prophylaxis.   On 14-FEB-2024, the patient received the 1st dose of FluLaval Quadrivalent 2022-2023 season. On 14-FEB-2024, an unknown time after receiving FluLaval Quadrivalent 2022-2023 season, the patient experienced expired vaccine used (Verbatim: Expired dose given). 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: 14-FEB-2024 A Office manager contacted GSK via phone on inquiring about FluLaval and what information was available about the coadministration of FluLaval 2022-2023 after the expiration date.  They gave partial information about the event, vaccine and patient.  The Vaccine Administration Facility was the same as Primary Reporter. Patient received a dose of FluLaval Quadrivalent 2022-2023 season on 14th February 2024 which was expired on 20th June 2023, which led to expired vaccine used. The reporter consented to follow up.
Sex: U
Vaccine: COVID19, COVID19, COVID19
Symptoms: COVID-19, COVID-19 immunisation
Clinical narrative: REVACCINATION WITH DIFFERENT COVID-19 VACCINE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer by a Business partner (Pfizer Inc.) on 25-JAN-2024 was received on 25-JAN-2024 and concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: allergy, and mild lactose intolerance, and concurrent conditions included: hypertension. The patient was previously treated with amoxicillin, lisinopril, and lactose. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, route of admin not reported, batch number: 1805018) dose was not reported, administered on 03-DEC-2020 for covid-19 prophylaxis. Non-company suspect vaccine included: elasomeran (batch number: AS7180B, batch number: 061F22A, batch number: 083J21A A, batch number: 017E21A A, form of admin, route of admin, and were not reported) dose was not reported, administered on 09-MAY-2023, dose was not reported, administered on 13-DEC-2022, dose was not reported, administered on 04-APR-2022, and dose was not reported, administered on 01-NOV-2021 for covid-19 prophylaxis. ; and tozinameran (form of admin, route of admin, and were not reported, batch number: HG4677) dose was not reported, administered on 28-SEP-2023 10:00 to left Arm for covid-19 prophylaxis (coded as revaccination with different covid-19 vaccine). Concomitant medications included ascorbic acid, boric acid/calcium citrate/colecalciferol/copper gluconate/magnesium oxide/manganese gluconate/pyridoxine hydrochloride/zinc oxide, chlortalidone, curcuma longa, and losartan. On an unspecified date, the patient experienced revaccination with different covid-19 vaccine (dose number in series 2). On 10-JAN-2024, the patient experienced suspected covid-19 infection (dose number in series 6). On 12-JAN-2024, treatment medications included: nirmatrelvir/ritonavir. Day 0: Continuous cough at bedtime. Day 1: felt like a bad cold another day or two, then felt fine. Tested for rebound on 22-JAN-2024 because of runny nose again. . The action taken with covid-19 vaccine ad26.cov2.s, elasomeran, and tozinameran was not applicable. The patient was recovering from suspected covid-19 infection, and the outcome of revaccination with different covid-19 vaccine was not reported. This report was non-serious.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired vaccine administered, no reported adverse effects
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Binocular eye movement disorder, Laboratory test normal, Metamorphopsia
Clinical narrative: Three approximately 10 minute episodes of a visual convergence issue (both eyes not working together so everything was very distorted only when both eyes were open). First one was 1/11/24 around 7pm, next was 1/12/24 around 12:45pm and last one was 1/15/24 around 1:30pm.
Age: 77.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: Expired vaccine administered no adverse effects reported
Age: 9.0
Sex: M
Vaccine: FLU4, HEP, HEPA, IPV
Symptoms: Dizziness, Immediate post-injection reaction, Syncope
Clinical narrative: Per report by the vaccinator, patient fainted immediately after vaccination. Patient immediately was alert and oriented x3, said he felt dizzy. Mom stated that patient had similar incident in the past after vaccination, but she did not inform us before vaccination. Mom said patient had not eating since morning. The school brought food for him, I gave him water to drink, applied ice and observed him for 30 minutes. Mom declined calling ambulance. Vital signs were WNR. He felt better and they left.
Age: 74.0
Sex: M
Vaccine: COVID19, VARZOS
Symptoms: Asthenia, Hyperhidrosis, Myalgia, Pyrexia
Clinical narrative: Outbreak of sweating within two hours; sweating, fever, weakness. achey muscles, for five weeks.
Sex: U
Vaccine: COVID19, COVID19, COVID19, COVID19, COVID19-2
Symptoms: COVID-19, COVID-19 immunisation, SARS-CoV-2 test
Clinical narrative: REVACCINATION WITH DIFFERENT COVID-19 VACCINE; SUSPECTED COVID-19; This spontaneous report received from a consumer and concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: allergy, and concurrent conditions included: sarcoidosis. The patient received covid-19 vaccine ad26.cov2.s (dose number in series 1) (suspension for injection, intramuscular, batch number: 1808978) dose was not reported, administered on 31-MAR-2021 on left arm for covid-19 prophylaxis.  Non-company suspect vaccine included: elasomeran (dose number in series 2) (form of admin, route of admin, and batch number: 061E) dose was not reported, administered on 29-OCT-2021 to left arm for covid-19 prophylaxis. On 29-OCT-2021, following vaccination with non-company suspect vaccine elasomeran, patient had revaccination with different covid-19 vaccine (dose number in series 2). The action taken with revaccination with different covid-19 vaccine was not applicable.  The outcome was not reported for revaccination with different covid-19 vaccine. he patient received Non-company suspect vaccine included: elasomeran (dose number in series 3) (form of admin, route of admin, and batch number: 048L21A) dose was not reported, administered on 05-APR-2022 on left arm for covid-19 prophylaxis; davesomeran/elasomeran (dose number in series 4)(form of admin, route of admin, and batch number: 055F22B) dose was not reported, administered on 27-OCT-2022 on right arm for covid-19 prophylaxis; and elasomeran (dose number in series 5) (form of admin, route of admin, and batch number: 8057965) dose was not reported, administered on 07-NOV-2023 03:00 on left arm for covid-19 prophylaxis.  Concomitant medications included hydrocodone bitartrate/paracetamol, ibuprofen, methylphenidate, pseudoephedrine, and zolpidem.  On 10-JAN-2024, following vaccination with non-company suspect vaccine elasomeran, patient experienced suspected covid-19 (dose number in series 5). Nausea, vomiting, dizziness, chills, fever, fatigue and rebound symptoms 2-3 days after testing negative and feeling better. Treatment medication included: Pfizer. Patient was taking any other medications/products within 2 weeks of starting COVID-19 treatment. The action taken with covid-19 vaccine ad26.cov2.s, elasomeran (dose series 3), davesomeran/elasomeran (dose series 4), and elasomeran (dose series 5) were not applicable. The patient was recovering from suspected covid-19. This report was non- serious.
Sex: U
Vaccine: COVID19
Symptoms: Adverse event
Clinical narrative: Adverse event; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Adverse event) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Adverse event). At the time of the report, ADVERSE EVENT (Adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  This case was identified during the RA inspection 2023 as part of the no patient identifier clean-up finding. All corrections and updates to the case have been made and the case is locked.  No treatment medications were provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Dec-2020: Case unlocked on 12-Feb-2024 as a part of EMA inspection 2023 to perform significant correction. Classification of no patient identifier was removed as patient initial was provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: all the symptoms you have if you had the virus; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE DRUG REACTION (all the symptoms you have if you had the virus) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE DRUG REACTION (all the symptoms you have if you had the virus). At the time of the report, ADVERSE DRUG REACTION (all the symptoms you have if you had the virus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication use information was not provided by reporter. Treatment medication use information was not provided by reporter.  This case was identified during the RA inspection 2023 as part of the no patient identifier clean-up finding. All corrections and updates to the case have been made and the case is locked.   Most recent FOLLOW-UP information incorporated above includes: On 10-Feb-2021: Case unlocked on 15-Feb-2024 as a part of RA inspection 2023 to perform significant correction. Case upgraded as valid, and classification of no patient identifier was removed.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction, Anxiety
Clinical narrative: your drug almost killed me; I gotta get a chip off my shoulder; This spontaneous case was reported by a patient and describes the occurrence of ANXIETY (your drug almost killed me) and ADVERSE DRUG REACTION (I gotta get a chip off my shoulder) in a patient of an unknown age and gender who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of SPIKEVAX NOS (SPIKEVAX NOS) (unknown route) 1 dosage form. On an unknown date, the patient experienced ANXIETY (your drug almost killed me) and ADVERSE DRUG REACTION (I gotta get a chip off my shoulder). At the time of the report, ANXIETY (your drug almost killed me) and ADVERSE DRUG REACTION (I gotta get a chip off my shoulder) had resolved.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.       Concomitant product use was not provided by the reporter.  The patient got a chip off from shoulder, went and got vaccinated for COVID-19 drug and reported drug almost killed. It was an MRNA, and it woke up a gene and that was asleep. The patient would have never woken up if, the patient did not get vaccinated for COVID-19.   The patient made a full recovery and was just irritated because, the patient will be on medication for the rest of the life.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Not had covid until yesterday/ tested positive; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Not had covid until yesterday/ tested positive) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2024, the patient experienced COVID-19 (Not had covid until yesterday/ tested positive). At the time of the report, COVID-19 (Not had covid until yesterday/ tested positive) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In February 2024, SARS-CoV-2 test: Positive.         No concomitant medication was reported.  Patient was really sick, was not feeling well.  On the day of reporting, patient was prescribed with Paxlovid as treatment but had not yet started taking it. The patient was on coughing spree while speaking and does not feel good. Patient was old.  The patient was never sick and has not had COVID until a day before where patient tested positive. Patient was also not happy about weight.  Patient did not take fourth dose.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Illness
Clinical narrative: Two days after receiving the booster, reporter felt a little bad and thinks that he was not feeling normal and a little bit sick but now during conversation he stated that he recovered from it; Two days after receiving the booster, reporter felt a little bad and thinks that he was not feeling normal and a little bit sick but now during conversation he stated that he recovered from it; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (Two days after receiving the booster, reporter felt a little bad and thinks that he was not feeling normal and a little bit sick but now during conversation he stated that he recovered from it) and ILLNESS (Two days after receiving the booster, reporter felt a little bad and thinks that he was not feeling normal and a little bit sick but now during MIS conversation he stated that he recovered from it) in a 70-year-old male patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: INFLUENZA VACCINE; for COVID-19 prophylaxis: Spikevax. Past adverse reactions to the above products included No adverse event with INFLUENZA VACCINE and Spikevax.    On 20-Nov-2023, the patient received second dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. In November 2023, the patient experienced FEELING ABNORMAL (Two days after receiving the booster, reporter felt a little bad and thinks that he was not feeling normal and a little bit sick but now during conversation he stated that he recovered from it) and ILLNESS (Two days after receiving the booster, reporter felt a little bad and thinks that he was not feeling normal and a little bit sick but now during conversation he stated that he recovered from it). At the time of the report, FEELING ABNORMAL (Two days after receiving the booster, reporter felt a little bad and thinks that he was not feeling normal and a little bit sick but now during conversation he stated that he recovered from it) and ILLNESS (Two days after receiving the booster, reporter felt a little bad and thinks that he was not feeling normal and a little bit sick but now during conversation he stated that he recovered from it) had resolved.            No concomitant medication was reported. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2024-760500 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2024-760500:Wife case
Sex: U
Vaccine: PNC20
Symptoms: Device leakage, Needle issue
Clinical narrative: malfunction on Prevnar 20 which as stated by the agent, the entire top came off and the needle is broken; malfunction on Prevnar 20 which as stated by the agent, the entire top came off and the needle is broken; when they administered the vaccine the needle went in and as they pushed the vaccine out it leaked from the adapter and went all over the place; This is a spontaneous report received from a Nurse from medical information team.  A patient (age and gender not provided) received pneumococcal 20-val conj vac (dipht CRM197 protein) (PREVNAR 20), as dose number unknown, single (Lot number: HL3888, Expiration Date: 30Jun2025) for immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DEVICE MALFUNCTION (non-serious), NEEDLE ISSUE (non-serious), outcome "unknown" and all described as "malfunction on Prevnar 20 which as stated by the agent, the entire top came off and the needle is broken"; DEVICE LEAKAGE (non-serious), outcome "unknown", described as "when they administered the vaccine the needle went in and as they pushed the vaccine out it leaked from the adapter and went all over the place". Additional information: Reported a malfunction on Prevnar 20 which as stated by the agent, the entire top came off and the needle is broken. Caller stated that they put the needle on the grooves and when they administered the vaccine the needle went in and as they pushed the vaccine out it leaked from the adapter and went all over the place. Caller is asking if they can have a credit or replacement for the product.   Causality for "malfunction on prevnar 20 which as stated by the agent, the entire top came off and the needle is broken" and "when they administered the vaccine the needle went in and as they pushed the vaccine out it leaked from the adapter and went all over the place" was determined associated to device constituent of pneumococcal 20-val conj vac (dipht CRM197 protein) (malfunction).
Age: 10.0
Sex: M
Vaccine: DTAP
Symptoms: No adverse event, Wrong patient received product, Wrong product administered
Clinical narrative: this RN confused siblings and the pt was given wrong dtap vaccine for age. pt and family made to stay 10 minutes to ensure no adverse reaction. no adverse reaction noted.
Age: 66.0
Sex: F
Vaccine: RSV
Symptoms: Injection site pain
Clinical narrative: PERSIST SORENESS IN ARM AT INJECTION SITE THAT NEVER WENT AWAY...STARTED WITH 2/10  IN PAIN INTENSITY IN THE BEGINNING AND NOW ITS 5 TO 6 OUT OF 10.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Blood culture negative, Blood lactic acid, Brain natriuretic peptide increased, Chest X-ray normal, Cough
Clinical narrative: The patient is a 45 year(s) old Female complaining of shortness of breath. patient arrives EMS from Dialysis where she did complete her 4 hour treatment. PT reports that she has had a cough for a few days, patient is HOH and wear hearing aid in her right ear. Fever on arrival. 02-01-2024 17:15 Acute shortness of breath occurring while in dialysis.  The patient developed shortness of breath and cough today.  She was found to have a fever upon presentation to the emergency department.  Patient's oxygen saturation was identified in the 70s on room air by medics.  The patient did complete her dialysis session today.  The patient states that she has been ill for the past week but describes acute worsening today with the onset of cough, labored respirations.  She states in the past week she has been experiencing nasal drainage and mild cough.  The patient has been vaccinated for COVID-19 with a total of 3 shots.  She did not have preceding fever prior to this event this evening.  On arrival the patient demonstrated oxygen saturation in the 80s on room air.  She has no past history of pulmonary disease other than hypoventilation of obesity.  Patient is rather hard of hearing and appeared in distress.  This limited my ability to provide further history of present illness and review of systems could not be fully obtained, as well.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Emotional distress, Full blood count abnormal, Haematocrit decreased, Haemoglobin decreased
Clinical narrative: The patient is a 45 year(s) old Female complaining of shortness of breath. patient arrives EMS from Dialysis where she did complete her 4 hour treatment. PT reports that she has had a cough for a few days, patient is HOH and wear hearing aid in her right ear. Fever on arrival. 02-01-2024 17:15 Acute shortness of breath occurring while in dialysis.  The patient developed shortness of breath and cough today.  She was found to have a fever upon presentation to the emergency department.  Patient's oxygen saturation was identified in the 70s on room air by medics.  The patient did complete her dialysis session today.  The patient states that she has been ill for the past week but describes acute worsening today with the onset of cough, labored respirations.  She states in the past week she has been experiencing nasal drainage and mild cough.  The patient has been vaccinated for COVID-19 with a total of 3 shots.  She did not have preceding fever prior to this event this evening.  On arrival the patient demonstrated oxygen saturation in the 80s on room air.  She has no past history of pulmonary disease other than hypoventilation of obesity.  Patient is rather hard of hearing and appeared in distress.  This limited my ability to provide further history of present illness and review of systems could not be fully obtained, as well.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Metabolic function test abnormal, Pyrexia, Red blood cell count decreased, Rhinorrhoea
Clinical narrative: The patient is a 45 year(s) old Female complaining of shortness of breath. patient arrives EMS from Dialysis where she did complete her 4 hour treatment. PT reports that she has had a cough for a few days, patient is HOH and wear hearing aid in her right ear. Fever on arrival. 02-01-2024 17:15 Acute shortness of breath occurring while in dialysis.  The patient developed shortness of breath and cough today.  She was found to have a fever upon presentation to the emergency department.  Patient's oxygen saturation was identified in the 70s on room air by medics.  The patient did complete her dialysis session today.  The patient states that she has been ill for the past week but describes acute worsening today with the onset of cough, labored respirations.  She states in the past week she has been experiencing nasal drainage and mild cough.  The patient has been vaccinated for COVID-19 with a total of 3 shots.  She did not have preceding fever prior to this event this evening.  On arrival the patient demonstrated oxygen saturation in the 80s on room air.  She has no past history of pulmonary disease other than hypoventilation of obesity.  Patient is rather hard of hearing and appeared in distress.  This limited my ability to provide further history of present illness and review of systems could not be fully obtained, as well.