chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: MNQ
Symptoms: Expired product administered
Clinical narrative: Menveo was administered after the expiration date; 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 female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced expired vaccine used (Verbatim: Menveo was administered after the expiration date). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 07-NOV-2023 The pharmacy student that unknown presentation of Menveo was administered after the expiration date which led to expired vaccine used. Additional information was not known. The Healthcare professional did not want profile created due to her being a student. The reporter did not consent to follow up.
Age: 1.0
Sex: F
Vaccine: DTAP
Symptoms: Expired product administered
Clinical narrative: infanrix that expired was administered; 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 17-month-old female patient who received DTPa (Infanrix) (batch number 7KM94, expiry date 10-JUN-2023) for prophylaxis.   On 07-NOV-2023, the patient received Infanrix. On 07-NOV-2023, an unknown time after receiving Infanrix, the patient experienced expired vaccine used (Verbatim: infanrix that expired was administered). 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: 07-NOV-2023 Healthcare professional reported that an Infanrix that expired on 10th June 2023 was administered on 7th November 2023. No reactions reported. The reporter consented to follow up. The patient received Infanrix beyond the expiration date, which led to expired vaccine used.
Sex: M
Vaccine: UNK
Symptoms: Incorrect dose administered, Product complaint, Syringe issue
Clinical narrative: Product Complaint; Fluarix less volume administered; while administering Fluarix the syringe leaked most of the volume out; This non-serious case was reported by a nurse via call center representative and described the occurrence of incomplete dose administered in a 18-year-old male patient who received Flu Seasonal QIV Dresden (Fluarix Quadrivalent 2023-2024 season) (batch number AF749, expiry date 30-JUN-2024) for prophylaxis. This case was associated with a product complaint.   On 07-NOV-2023, the patient received Fluarix Quadrivalent 2023-2024 season. On 07-NOV-2023, an unknown time after receiving Fluarix Quadrivalent 2023-2024 season, the patient experienced incomplete dose administered (Verbatim: Fluarix less volume administered) and syringe leak (Verbatim: while administering Fluarix the syringe leaked most of the volume out). On an unknown date, the patient experienced pharmaceutical product complaint (Verbatim: Product Complaint). The outcome of the incomplete dose administered, syringe leak and pharmaceutical product complaint 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: 07-NOV-2023 The nurse called to report while administering Fluarix the syringe leaked most of the volume out which led to incomplete dose administered, syringe leak and pharmaceutical product complaint. The reporter consented to follow up via mail. The vaccine administration facility is the same as primary reporter.
Sex: U
Vaccine: HEP, HEP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: received 3rd dose on 01-NOV-2023; Engerix-b/ Late second 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 short in a patient who received HBV (Engerix B) for prophylaxis.   Co-suspect products included HBV (Engerix B) for prophylaxis.   Previously administered products included Engerix B (received 1st dose on 20th March 2023).   On 01-NOV-2023, the patient received the 3rd dose of Engerix B. On 19-SEP-2023, the patient received the 2nd dose of Engerix B. On 19-SEP-2023, not applicable after receiving Engerix B and an unknown time after receiving Engerix B, the patient experienced drug dose administration interval too long (Verbatim: Engerix-b/ Late second dose). On 01-NOV-2023, the patient experienced drug dose administration interval too short (Verbatim: received 3rd dose on 01-NOV-2023). The outcome of the drug dose administration interval too short and drug dose administration interval too long were unknown.   Additional Information: GSK Receipt Date: 07-NOV-2023 The reporter was a healthcare professional at a clinic.  The interval between the second and the third dose of Engerix-B was 6 weeks.  The reporter asked for guidance on patient schedule. There were no symptoms at this time. The patient received 2nd dose of Engerix-B later than the recommended schedule, which led to lengthening of vaccination schedule. The patient received 3rd dose of Engerix-B earlier than the recommended schedule, which led to shortening of vaccination schedule.
Age: 30.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue, Wrong product administered
Clinical narrative: pharmacist called to inform that a dose of Arexvy was administered by error to a pregnant woman; 30 year old patient; This non-serious prospective pregnancy case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 30-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 3N3CT, expiry date 29-JAN-2025) for prophylaxis.   On 04-NOV-2023, the patient received Arexvy. On 04-NOV-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: 30 year old patient). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: pharmacist called to inform that a dose of Arexvy was administered by error to a pregnant woman). The outcome of the inappropriate age at vaccine administration and vaccine exposure during pregnancy were unknown.   Pregnancy exposure: Pregnancy Exposure (Arexvy): To mother in third trimester  Pregnancy Details (Neonate 1):  Pregnancy Outcome: Pregnancy was ongoing Delivery Notes: around 32-36 weeks gestation   Additional Information: GSK Receipt Date: 08-NOV-2023 The reporter stated a dose of Arexvy was administered by error to a 30-year-old pregnant patient, the patient was around 32-36 weeks gestation, which led to inappropriate age at vaccine administration. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up.
Age: 91.0
Sex: F
Vaccine: RSV
Symptoms: Dizziness
Clinical narrative: dizziness.; This non-serious case was reported by a consumer via call center representative and described the occurrence of dizziness in a 91-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 27-OCT-2023, the patient received Arexvy. On 07-NOV-2023, 11 days after receiving Arexvy, the patient experienced dizziness (Verbatim: dizziness.). The outcome of the dizziness was not resolved.   It was unknown if the reporter considered the dizziness to be related to Arexvy.     It was unknown if the company considered the dizziness to be related to Arexvy.   Additional Information: GSK receipt date: 08-NOV-2023 The patient reported that she received a dose of Arexvy and day before reporting and on day of reporting she had been experiencing dizziness. The reporter did not consent to follow up.
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Vaccination failure
Clinical narrative: Suspected vaccination failure; still had shingles afterwards; This serious case was reported by a physician via sales rep and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingrix and the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix and Shingrix, the patient experienced vaccination failure (Verbatim: Suspected vaccination failure) (serious criteria GSK medically significant) and shingles (Verbatim: still had shingles afterwards). The outcome of the vaccination failure and shingles were unknown.   It was unknown if the reporter considered the vaccination failure and shingles to be related to Shingrix and Shingrix.     It was unknown if the company considered the vaccination failure and shingles to be related to Shingrix and Shingrix.   Additional Information: GSK receipt date: 08-NOV-2023 The field representative send via source that the physician requested information on how to treat a patient that completed Shingrix series and still had shingles afterwards. This case was considered as suspected vaccination failure as details regarding time to onset and laboratory test confirming shingles were unknown at the time of reporting. The reporter consented to follow up.
Sex: M
Vaccine: VARZOS
Symptoms: Post herpetic neuralgia
Clinical narrative: Post herpetic neuralgia; This non-serious case was reported by a consumer via call center representative and described the occurrence of post herpetic neuralgia in a male patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included shingles (diagnosed with shingles approximately two years ago).   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced post herpetic neuralgia (Verbatim: Post herpetic neuralgia). The outcome of the post herpetic neuralgia was not resolved.   It was unknown if the reporter considered the post herpetic neuralgia to be related to Shingrix.     It was unknown if the company considered the post herpetic neuralgia to be related to Shingrix.   Additional Information: GSK Receipt date: 09-NOV-2023 Consumer was the reporter. The patient received first dose of Shingrix about 2 months ago and now experiencing postherpetic neuralgia. The consumer reported that postherpetic neuralgia felt the same as when he had an active case of shingles. No further information was known. The reporter did not consent to follow-up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: not received the 2nd dose yet; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (On 02-DEC-2021, the patient received the 1st dose almost 2 years ago).   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: not received the 2nd dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 09-NOV-2023 The pharmacist stated that the patient received the 1st dose of Shingrix almost 2 years ago. The patient not received the 2nd dose yet. Till the time of reporting, the patient did not receive 2nd dose of Shingrix vaccine, which led to incomplete course of vaccination. The reporter consented to follow up. The Vaccine Administration Facility was the same as Primary Reporter. Healthcare professional declined to provide patient's demographics but gave permission for follow up via postal. VAERS details provided corresponding to the 1st dose and the case is an incomplete course of vaccination
Age: 74.0
Sex: F
Vaccine: RSV
Symptoms: Fatigue, Immediate post-injection reaction, Injection site pain, Injection site swelling, Injection site warmth
Clinical narrative: felt burning and stinging during injection/ sore hot arm at injection site; arm is hot at the injection site; swollen arm at injection site; she was fatigued; This non-serious case was reported by a consumer via call center representative and described the occurrence of injection site burning in a 74-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) for prophylaxis.   On 07-NOV-2023, the patient received Arexvy (left arm). On 07-NOV-2023, immediately after receiving Arexvy, the patient experienced injection site burning (Verbatim: felt burning and stinging during injection/ sore hot arm at injection site). In NOV-2023, the patient experienced injection site warmth (Verbatim: arm is hot at the injection site), injection site swelling (Verbatim: swollen arm at injection site) and fatigue (Verbatim: she was fatigued). The outcome of the injection site burning, injection site warmth and injection site swelling were not resolved and the outcome of the fatigue was resolved.   It was unknown if the reporter considered the injection site burning, injection site warmth, injection site swelling and fatigue to be related to Arexvy.     It was unknown if the company considered the injection site burning, injection site warmth, injection site swelling and fatigue to be related to Arexvy.   Additional Information: GSK Receipt Date: 09-Nov-2023 The patient was self-reported this case. The patient reported that she received Shingrix vaccine and it was burning and stinging as injection was being administered.  Hours later patient was fatigued, which was resolved.  Patient still had some soreness, swelling and arm was hot at the injection site. The reporter did not consent to follow up.
Age: 39.0
Sex: F
Vaccine: RSV
Symptoms: Exposure during pregnancy, Product administered to patient of inappropriate age, Product use issue
Clinical narrative: use of Arexvy in pregnant patients; 39 year old recieved Arexvy; This non-serious prospective pregnancy case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 39-year-old female patient who received RSVPreF3 adjuvanted (Arexvy) (batch number 5H3BB, expiry date 23-MAR-2025) for prophylaxis.   On 06-NOV-2023, the patient received Arexvy. On 06-NOV-2023, an unknown time after receiving Arexvy, the patient experienced inappropriate age at vaccine administration (Verbatim: 39 year old recieved Arexvy). On an unknown date, the patient experienced vaccine exposure during pregnancy (Verbatim: use of Arexvy in pregnant patients). The outcome of the inappropriate age at vaccine administration and vaccine exposure during pregnancy were unknown.    Pregnancy Outcome: Pregnancy was ongoing   Additional Information: GSK Receipt Date: 09-NOV-2023 A registered nurse contacted to inquire about Arexvy and what information was available for the use of Arexvy in pregnant patients and also asked if any of the components could be harmful to the mother or fetus. Partial information given about vaccine, patient and event. The reporter did not consent to follow-up. The Vaccine Administration Facility is the same as Primary Reporter. The 39 years old pregnant patient received a dose of Arexvy, which led to inappropriate age at vaccine administration.
Sex: F
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: expired dose of Shingrix was administered to a patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a adult female patient who received Herpes zoster (Shingrix) (batch number 2JA2N, expiry date 06-OCT-2023) for prophylaxis.   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 expired vaccine used (Verbatim: expired dose of Shingrix was administered to a patient). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 10-NOV-2023 The reporter stated that an expired dose of Shingrix was administered to a patient, which led to expired vaccine used. The Vaccine Administration Facility was the same as Primary Reporter. The reporter consented to follow up via postal.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Malaise
Clinical narrative: she had the Spikevax on 07Nov2023 and in the afternoon had the usual chills and not feeling well which she also got after getting her previous Covid-19 vaccines.; she had the Spikevax on 07Nov2023 and in the afternoon had the usual chills and not feeling well which she also got after getting her previous Covid-19 vaccines.; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (she had the Spikevax on 07Nov2023 and in the afternoon had the usual chills and not feeling well which she also got after getting her previous Covid-19 vaccines.) and CHILLS (she had the Spikevax on 07Nov2023 and in the afternoon had the usual chills and not feeling well which she also got after getting her previous Covid-19 vaccines.) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039F21A, 032M20A and 045A21A) for COVID-19 prophylaxis.     Concurrent medical conditions included Left ventricular dysfunction (on medication) and Left bundle branch block (on medication).   On 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (she had the Spikevax on 07Nov2023 and in the afternoon had the usual chills and not feeling well which she also got after getting her previous Covid-19 vaccines.) and CHILLS (she had the Spikevax on 07Nov2023 and in the afternoon had the usual chills and not feeling well which she also got after getting her previous Covid-19 vaccines.). At the time of the report, MALAISE (she had the Spikevax on 07Nov2023 and in the afternoon had the usual chills and not feeling well which she also got after getting her previous Covid-19 vaccines.) and CHILLS (she had the Spikevax on 07Nov2023 and in the afternoon had the usual chills and not feeling well which she also got after getting her previous Covid-19 vaccines.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment medication reported.   This case was linked to MOD-2023-748940, MOD-2023-748947 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19-2
Symptoms: Chills, Malaise
Clinical narrative: patient had the usual chills and not feeling well which she also got after getting her previous Covid-19 vaccines; patient had the usual chills and not feeling well which she also got after getting her previous Covid-19 vaccines; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (patient had the usual chills and not feeling well which she also got after getting her previous Covid-19 vaccines) and CHILLS (patient had the usual chills and not feeling well which she also got after getting her previous Covid-19 vaccines) in a 73-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 057F22A) for COVID-19 prophylaxis.     Concurrent medical conditions included Left ventricular dysfunction (on medications) and Left bundle branch block.    On 04-Oct-2022, the patient received fourth 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 MALAISE (patient had the usual chills and not feeling well which she also got after getting her previous Covid-19 vaccines) and CHILLS (patient had the usual chills and not feeling well which she also got after getting her previous Covid-19 vaccines). At the time of the report, MALAISE (patient had the usual chills and not feeling well which she also got after getting her previous Covid-19 vaccines) and CHILLS (patient had the usual chills and not feeling well which she also got after getting her previous Covid-19 vaccines) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications included left ventricular dysfunction medicines (not specified).  On 05-Mar-2021, patient received first dose of Moderna vaccine with lot number 032M20A. On 02-Apr-2021, patient received second dose of Moderna vaccine with lot number 045A21A. On 10-Nov-2021, patient received second dose of Moderna vaccine with lot number 039F21A.  A caller stated, she had the usual chills and was not feeling well which, she also got after getting her previous COVID-19 vaccines.  No treatment information was provided.   This case was linked to MOD-2023-748940, MOD-2023-748946 (Patient Link).
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Nausea, Pain, Swelling
Clinical narrative: Sore; patient mentioned that she was fine after every Moderna vaccine, just sore, queasy, rundown, and didn't feel that great the next day, but was fine by night time; it just lasted 24 hours.; Swelling; patient mentioned that she was fine after every Moderna vaccine, just sore, queasy, rundown, and didn't feel that great the next day, but was fine by night time; it just lasted 24 hours.; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Sore), FEELING ABNORMAL (patient mentioned that she was fine after every Moderna vaccine, just sore, queasy, rundown, and didn't feel that great the next day, but was fine by night time; it just lasted 24 hours.), SWELLING (Swelling) and NAUSEA (patient mentioned that she was fine after every Moderna vaccine, just sore, queasy, rundown, and didn't feel that great the next day, but was fine by night time; it just lasted 24 hours.) in a 5-decade-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.    In March 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Sore), FEELING ABNORMAL (patient mentioned that she was fine after every Moderna vaccine, just sore, queasy, rundown, and didn't feel that great the next day, but was fine by night time; it just lasted 24 hours.), SWELLING (Swelling) and NAUSEA (patient mentioned that she was fine after every Moderna vaccine, just sore, queasy, rundown, and didn't feel that great the next day, but was fine by night time; it just lasted 24 hours.). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, PAIN (Sore), FEELING ABNORMAL (patient mentioned that she was fine after every Moderna vaccine, just sore, queasy, rundown, and didn't feel that great the next day, but was fine by night time; it just lasted 24 hours.), SWELLING (Swelling) and NAUSEA (patient mentioned that she was fine after every Moderna vaccine, just sore, queasy, rundown, and didn't feel that great the next day, but was fine by night time; it just lasted 24 hours.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter.   This case was linked to MOD-2023-749212 (Patient Link).   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia
Clinical narrative: fever; Chills; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PYREXIA (fever) and CHILLS (Chills) in a male patient of an unknown age who received SPIKEVAX NOS (SPIKEVAX NOS) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine in March 2021. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine.    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 PYREXIA (fever) and CHILLS (Chills). At the time of the report, PYREXIA (fever) and CHILLS (Chills) outcome was unknown.        The action taken with SPIKEVAX NOS (SPIKEVAX NOS) (Unknown) was unknown.   For SPIKEVAX NOS (SPIKEVAX NOS) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter. On 28-OCT-2023 patient had hip replacement surgery.  The treatment medication was not reported by reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-749212, US-MODERNATX, INC.-MOD-2023-749212 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-749212:Husband case
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: She has had COVID-19 twice; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (She has had COVID-19 twice) in a female patient of an unknown age 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 COVID-19 (She has had COVID-19 twice). At the time of the report, COVID-19 (She has had COVID-19 twice) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. No treatment medication reported.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Lethargy
Clinical narrative: Patient had a sore shoulder and was lethargic for a couple of hours; Patient had a sore shoulder and was lethargic for a couple of hours; This spontaneous case was reported by a patient and describes the occurrence of LETHARGY (Patient had a sore shoulder and was lethargic for a couple of hours) and ARTHRALGIA (Patient had a sore shoulder and was lethargic for a couple of hours) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 066F21A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (en6201, no expiration date was provided.) on 10-Feb-2021 and Pfizer. Past adverse reactions to the above products included Adverse drug reaction with Pfizer and Pfizer.    On 17-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LETHARGY (Patient had a sore shoulder and was lethargic for a couple of hours) and ARTHRALGIA (Patient had a sore shoulder and was lethargic for a couple of hours). At the time of the report, LETHARGY (Patient had a sore shoulder and was lethargic for a couple of hours) and ARTHRALGIA (Patient had a sore shoulder and was lethargic for a couple of hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication use information was not provided by reporter.  The patient reported side effects to his one Moderna Covid-19 vaccine which was his third Covid-19 vaccine. The other vaccines including his fourth vaccine were all Pfizer vaccines.   The patient received a Pfizer Covid -19 vaccine on the February 10, 2021, no expiration date was provided. Patient did not remember arm. Patient had a sore shoulder but did not have anything beyond that. Patient may had been lethargic for a couple of hours after the vaccine. The patient did drive himself home. The patient had the Pfizer Covid-19 for his first and second doses.   The patient received first Moderna vaccine was November 17, 2021, expiration date was not known. Arm of injection was not known. Patient had a sore shoulder and was lethargic for a couple of hours. The patient thought that he had a Moderna vaccine for his fourth dose however at the end of the telephone interview the patient realized that he had a Pfizer vaccine for his fourth Covid-19 dose.  Treatment medication use information was not provided by reporter.
Sex: F
Vaccine: COVID19
Symptoms: Sinusitis
Clinical narrative: sinus infections; This spontaneous case was reported by a patient and describes the occurrence of SINUSITIS (sinus infections) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced SINUSITIS (sinus infections). At the time of the report, SINUSITIS (sinus infections) outcome was unknown.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       It was unknown if patient was received any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Patient already received all her Moderna shots, and she did not remember the dates and currently she wanted to get Spikevax next week, but she recently had sinus infections and received several different antibiotics, name was not specified.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Fatigue
Clinical narrative: she had one day of fatigue with her experience with Spikevax; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (she had one day of fatigue with her experience with Spikevax) in a female patient of an unknown age who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (she had one day of fatigue with her experience with Spikevax). At the time of the report, FATIGUE (she had one day of fatigue with her experience with Spikevax) had resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.       No concomitant medication was reported.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-749162 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-749162:Son's case
Age: 40.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal, Nausea, Pain, Swelling
Clinical narrative: Sore; patient mentioned that she was fine after every Moderna vaccine, just sore, queasy, rundown, and didn't feel that great the next day, but was fine by night time; it just lasted 24 hours.; Rundown, and didn't feel that great the next day, but was fine by night time; it just lasted 24 hours.; Swelling; This spontaneous case was reported by a patient and describes the occurrence of PAIN (Sore), NAUSEA (patient mentioned that she was fine after every Moderna vaccine, just sore, queasy, rundown, and didn't feel that great the next day, but was fine by night time; it just lasted 24 hours.), FEELING ABNORMAL (Rundown, and didn't feel that great the next day, but was fine by night time; it just lasted 24 hours.) and SWELLING (Swelling) in a 5-decade-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (Sore), NAUSEA (patient mentioned that she was fine after every Moderna vaccine, just sore, queasy, rundown, and didn't feel that great the next day, but was fine by night time; it just lasted 24 hours.), FEELING ABNORMAL (Rundown, and didn't feel that great the next day, but was fine by night time; it just lasted 24 hours.) and SWELLING (Swelling). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, PAIN (Sore), NAUSEA (patient mentioned that she was fine after every Moderna vaccine, just sore, queasy, rundown, and didn't feel that great the next day, but was fine by night time; it just lasted 24 hours.), FEELING ABNORMAL (Rundown, and didn't feel that great the next day, but was fine by night time; it just lasted 24 hours.) and SWELLING (Swelling) had resolved.        The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter. Patient had a total knee replacement surgery on 28-Sep-2023.   This case was linked to US-MODERNATX, INC.-MOD-2023-749216 (E2B Linked Report). This case was linked to MOD-2023-749215 (Patient Link).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-749216:Husband case
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: covid 19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (covid 19) in a 60-year-old female patient who received mRNA-1273.815 (SPIKEVAX 2023-2024) for COVID-19 prophylaxis.     No Medical History information was reported.    On 09-Nov-2023, the patient received dose of mRNA-1273.815 (SPIKEVAX 2023-2024) (unknown route) 1 dosage form. On 10-Nov-2023,  after starting mRNA-1273.815 (SPIKEVAX 2023-2024), the patient experienced COVID-19 (covid 19). At the time of the report, COVID-19 (covid 19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Nov-2023, SARS-CoV-2 test: Positive.     The action taken with mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown) was unknown.   For mRNA-1273.815 (SPIKEVAX 2023-2024) (Unknown), the reporter did not provide any causality assessments.   The concomitant medication was not reported by reporter. Patient never had covid and never thought she would get covid because exposure was minimal. The treatment medication was not reported by reporter.   Reporter did not allow further contact
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: in transit for too long, and the vaccines were still cold to the touch and they placed the vaccines in the refrigerator with no adverse event; She mentioned that they received the vaccines with no adverse event; Initial information was received on 01-Nov-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2023SA342573.  This case involves 6 patients an unknown age and gender patient who experienced in transit for too long, and the vaccines were still cold to the touch and they placed the vaccines in the refrigerator with no adverse event and mentioned that they received the influenza quadrival A-B high dose HV vaccine [Fluzone high-dose quadrivalent] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza quadrival A-B high dose HV vaccine (unknown formulation) (lot number, expiry date, strength, was unknown) via unknown route in unknown administration site for Immunization and was in transit for too long, and the vaccines were still cold to the touch and they placed the vaccines in the refrigerator with no adverse event (product storage error) and she mentioned that they received the vaccines with no adverse event (poor quality product administered) (unknown latency). The information on the batch number was requested.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  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.
Sex: U
Vaccine: FLU4
Symptoms: No adverse event, Product storage error
Clinical narrative: in transit for too long, and the vaccines were still cold to the touch and they placed the vaccines in the refrigerator with no adverse event; She mentioned that they received the vaccines with no adverse event; Initial information was received on 01-Nov-2023 regarding an unsolicited valid non-serious case received from a nurse.  This case is linked to case 2023SA342577.  This case involves 4 patients an unknown age and gender patient who experienced in transit for too long, and the vaccines were still cold to the touch and they placed the vaccines in the refrigerator with no adverse event and mentioned that they received the influenza quadrival A-B vaccine [Fluzone quadrivalent] with no adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On an unknown date, the patient received an unknown dose of suspect influenza quadrival A-B vaccine (Suspension for injection) (lot number, expiry date, strength, was unknown) via unknown route in unknown administration site for Immunization and was in transit for too long, and the vaccines were still cold to the touch and they placed the vaccines in the refrigerator with no adverse event (product storage error) (unknown latency) and she mentioned that they received the vaccines with no adverse event (poor quality product administered) (Latency: same day)  The information on the batch number was requested.  Action taken: not applicable.  At time of reporting, the outcome was Unknown for the event.  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: 1.0
Sex: F
Vaccine: HIBV
Symptoms: Expired product administered, No adverse event
Clinical narrative: an expired dose of ACTHIB was given to a patient with no reported adverse event; Initial information received on 01-Nov-2023 regarding an unsolicited valid  non-serious case received from a health professional.  This case involves a 1 years old female patient who received an expired dose of Hib (Prp/T) Vaccine [Act-Hib], was given to a patient, with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.   On 01-Nov-2023, the patient received an expired dose of suspect Hib (Prp/T) Vaccine (Powder and solvent for solution for injection), with no reported adverse event (expired product administered) (latency: same day) (strength: unknown) (lot: UJ836AA, Expiry date: 28-Oct-2023) via intramuscular route in unknown administration site for immunization.  No lab data reported.  Action taken : not applicable.  At time of reporting, the outcome was Unknown for the event.  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.
Sex: M
Vaccine: YF
Symptoms: Incorrect route of product administration, No adverse event
Clinical narrative: Caller stated that she gave a patient the vaccine IM in his deltoid muscle and not in the back of his arm with no reported adverse event; Initial information received on 02-Nov-2023 regarding an unsolicited valid  non-serious case received from a pharmacist.  This case involves a male patient of unknown age who was administered with the YELLOW FEVER VACCINE - [YF-VAX] vaccine intramuscular in his deltoid muscle and not in the back of his arm with no reported adverse event.  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided.  On an unknown date, the patient received a dose of suspect Solution for injection of YELLOW FEVER VACCINE - US in his deltoid muscle intramuscular and not in the back of his arm  (dose, strength, expiry date, batch number was unknown) as prophylactic vaccination (incorrect route of product administration) (latency: same day).  It was reported "The pharmacist would like to know if the patient will experience more adverse events because it was administered IM and if she should call the patient. The pharmacist states that there is no literature out there on this and it can be very common mistake because 90%, if not more of the vaccines, are to be administered IM. This is all the information the pharmacist provided at the time of her call."  Action taken was not applicable.  At time of reporting, the outcome was Unknown for the event    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: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Asthenia, Balance disorder, Blood pressure increased, Body temperature decreased, Fall
Clinical narrative: feels like it feels like bad flu; said her normal bp is 1teens/85 but is also now elevated.; fall; shakiness; running a low temp of 96.1 she said she is freezing; balance has been affected; has no strength; Initial information received on 02-Nov-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 73 years old female patient who feels like it feels like bad flu, said her normal bp is 1teens/85 but is also now elevated., fall, shakiness, balance has been affected, has no strength and running a low temp of 96.1 she said she is freezing after receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Parkinson's disease.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (dose, strength, form,, batch number, expiry date, route, administration site was unknown) as prophylactic vaccination. Information on batch number was requested  On an unknown date the patient states that she had a fall in May so she has a physical therapist that has been working with her. She says that she was doing great. She states her physical therapist commented "What happened to you" referring to her not doing well and she said she took the flu shot. Patient reported reports with 24 hrs or taking flu shot she felt like she had bad flu (influenza), she has no strength (asthenia), balance has been affected, (balance disorder) shakiness (tremor), and running a low temp of 96.1 she said she is freezing (body temperature decreased). . He doc said to drink water. She also said her normal BP is 1teens/85 but is also now elevated (hypertension). Patient stated she also had a pneumonia vaccination at the same time. She did not know which Sanofi vaccine she received only stating it was the Heavy-Duty flu shot. She also stated her Parkinsons disease symptoms were also severely affected  Relevant laboratory test results included: Blood pressure measurement - On an unknown date:  [She also said her normal BP is 1teens/85 but is also now elevated] Body temperature - On an unknown date:  [running a low temp of 96.1]  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for all the events
Age: 73.0
Sex: F
Vaccine: FLU4
Symptoms: Feeling cold, Influenza like illness, Tremor
Clinical narrative: feels like it feels like bad flu; said her normal bp is 1teens/85 but is also now elevated.; fall; shakiness; running a low temp of 96.1 she said she is freezing; balance has been affected; has no strength; Initial information received on 02-Nov-2023 regarding an unsolicited valid non-serious case received from a consumer/non-hcp.  This case involves a 73 years old female patient who feels like it feels like bad flu, said her normal bp is 1teens/85 but is also now elevated., fall, shakiness, balance has been affected, has no strength and running a low temp of 96.1 she said she is freezing after receiving vaccine INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE [FLUZONE HIGH-DOSE QUADRIVALENT].  The patient's past medical history, medical treatment(s), vaccination(s) and family history were not provided. At the time of the event, the patient had ongoing Parkinson's disease.   On an unknown date, the patient received a dose of suspect INFLUENZA QUADRIVAL A-B HIGH DOSE HV VACCINE (dose, strength, form,, batch number, expiry date, route, administration site was unknown) as prophylactic vaccination. Information on batch number was requested  On an unknown date the patient states that she had a fall in May so she has a physical therapist that has been working with her. She says that she was doing great. She states her physical therapist commented "What happened to you" referring to her not doing well and she said she took the flu shot. Patient reported reports with 24 hrs or taking flu shot she felt like she had bad flu (influenza), she has no strength (asthenia), balance has been affected, (balance disorder) shakiness (tremor), and running a low temp of 96.1 she said she is freezing (body temperature decreased). . He doc said to drink water. She also said her normal BP is 1teens/85 but is also now elevated (hypertension). Patient stated she also had a pneumonia vaccination at the same time. She did not know which Sanofi vaccine she received only stating it was the Heavy-Duty flu shot. She also stated her Parkinsons disease symptoms were also severely affected  Relevant laboratory test results included: Blood pressure measurement - On an unknown date:  [She also said her normal BP is 1teens/85 but is also now elevated] Body temperature - On an unknown date:  [running a low temp of 96.1]  Action taken was not applicable.  It was not reported if the patient received a corrective treatment for the events.  At time of reporting, the outcome was Unknown for all the events