chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Extra dose administered
Clinical narrative: Patient received 4 doses; Patient received 4 doses; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of extra dose administered in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Co-suspect products included Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received on an unknown date in 2020) and Shingrix (2nd dose received on an unknown date in 2020).   In DEC-2020, the patient received the 4th dose of Shingrix. On an unknown date, the patient received the 3rd dose of Shingrix. In DEC-2020, an unknown time after receiving Shingrix and not applicable after receiving Shingrix, the patient experienced extra dose administered (Verbatim: Patient received 4 doses). On an unknown date, the patient experienced extra dose administered (Verbatim: Patient received 4 doses). The outcome of the extra dose administered and extra dose administered were unknown.   Additional Information: GSK Receipt Date: 18-MAR-2023 The reporter discovered that a patient had received 4 Shingrix between June 2020 and December 2020 at two facilities. The reporter asked was there any safety data or additional steps we should take as a pharmacy now that we have discovered this. The reporter provided all details available per web form.  No further information available at this time.    The reporter consented to follow up. The patient received 3rd and 4th dose of Shingrix, which led to extra dose administered.
Age: 3.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired Havrix 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 3-year-old female patient who received HAV (Havrix 720) (batch number ep47e, expiry date 06-FEB-2023) for prophylaxis.   On 18-MAR-2023, the patient received Havrix 720. On 18-MAR-2023, an unknown time after receiving Havrix 720, the patient experienced expired vaccine used (Verbatim: Expired Havrix 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: 20-MAR-2023 The reporter reported that a patient received an expired dose on 18-Mar-2023. The reporter consented to follow up. At the time of reporting, the patient received an expired dose of Havrix, which led to expired vaccine used.
Age: 47.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Havrix that had expired on January 30th 2023; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 47-year-old female patient who received HAV (Havrix) (batch number H4H53, expiry date 30-JAN-2023) for prophylaxis.   On 01-FEB-2023, the patient received Havrix. On 30-JAN-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Havrix that had expired on January 30th 2023). 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: 20-MAR-2023 The patient received  a dose of Havrix on 1st February 2023 that had expired on January 30th 2023, which led to expired vaccine administered. The nurse asks if the dose is valid. The vaccine administration facility is the same as primary reporter. The reporter did not consent to follow-up.
Age: 17.0
Sex: M
Vaccine: HEP
Symptoms: Accidental overdose, Product administered to patient of inappropriate age
Clinical narrative: Accidental overdose; 17 year old got an adult dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of accidental overdose in a 17-year-old male patient who received HBV (Engerix B adult) (batch number C44K4, expiry date 07-DEC-2024) for prophylaxis.   Concomitant products included HEPATITIS B VACCINE (ENGERIX B 10).   On 17-MAR-2023, the patient received the 2nd dose of Engerix B adult. On 17-MAR-2023, an unknown time after receiving Engerix B adult, the patient experienced accidental overdose (Verbatim: Accidental overdose ) and inappropriate age at vaccine administration (Verbatim: 17 year old got an adult dose). The outcome of the accidental overdose and inappropriate age at vaccine administration were unknown.   Additional Information: GSK receipt date: 20-Mar-2023 The pharmacist reported that 17 year old patient received first dose of Engerix-B vaccine on 19 February 2023. The patient came back for second dose, and was inadvertently administered an adult dose.  The reporter consented to follow up.  The patient inadvertently administered an adult dose, which led to accidental overdose and inappropriate age at vaccine administration.
Age: 54.0
Sex: M
Vaccine: HEPAB
Symptoms: Wrong product administered
Clinical narrative: Received Twinrix instead of Engerix; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong vaccine administered in a 54-year-old male patient who received HAB (Twinrix adult) (batch number X239D, expiry date 07-AUG-2022) for prophylaxis.   Concomitant products included HEPATITIS B VACCINE (ENGERIX-B).   On 13-JUL-2022, the patient received Twinrix adult. On 13-JUL-2022, an unknown time after receiving Twinrix adult, the patient experienced wrong vaccine administered (Verbatim: Received Twinrix instead of Engerix). The outcome of the wrong vaccine administered 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: 20-MAR-2023 The reporter reported that a patient received Engerix-B (1st dose) on 14-Jun-2022 at another pharmacy and on 13-Jul-2022 received Twinrix inadvertently at her pharmacy. The reporter consented to follow up. The Vaccine Administration Facility was the same as Primary Reporter. HCP was unsure if the lot no. for Twinrix provided was correct - she had a hard time reading it. At the time of reporting, the patient received Twinrix inadvertently instead of Engerix-B, which led to wrong vaccine administered.
Age: 17.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Reconstitution with a non-supplied diluent; Administration with a non-supplied diluent; 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 17-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVVA747A, expiry date 31-OCT-2023) for prophylaxis.   On 17-MAR-2023, the patient received Menveo. On 17-MAR-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Reconstitution with a non-supplied diluent) and inappropriate dose of vaccine administered (Verbatim: Administration with a non-supplied diluent). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt date: 20-MAR-2023 The dose was reconstituted with a non-supplied diluent (reporter believed normal saline was used).  At the time of reporting, the dose had not been repeated. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. The dose was reconstituted with a non-supplied diluent, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 74.0
Sex: F
Vaccine: VARZOS
Symptoms: Product preparation issue
Clinical narrative: Diluent not mixed with lyophilized part; Only diluent administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate preparation of medication in a 74-year-old female patient who received Herpes zoster (Shingrix) (batch number C495B, expiry date 28-JUN-2024) for prophylaxis.  On 20-MAR-2023, the patient received the 1st dose of Shingrix. On 20-MAR-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate preparation of medication (Verbatim: Diluent not mixed with lyophilized part) and inappropriate dose of vaccine administered (Verbatim: Only diluent administered). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.  Additional Information: GSK Receipt Date: 20-MAR-2023 The pharmacist had reported a patient was inadvertently administered a Shingrix AS01b diluent only dose without the lyophilized component on the day of reporting in their facility. The pharmacist had mentioned that this was an attempt as the first dose of Shingrix series.  No additional details were provided. The reporter had denied consent to follow-up. The patient only had received the diluent solution Shingrix vaccine without the lyophilized component, which had led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 17.0
Sex: F
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Reconstituted with sterile water; Reconstituted with sterile water; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 17-year-old female patient who received Men ACWY-CRM NVS (Menveo) for prophylaxis.   On 20-MAR-2023, the patient received Menveo. On 20-MAR-2023, an unknown time after receiving Menveo, the patient experienced wrong solution used in drug reconstitution (Verbatim: Reconstituted with sterile water) and inappropriate dose of vaccine administered (Verbatim: Reconstituted with sterile water). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 20-MAR-2023 The reporter reported that lyophilized portion of Menveo was reconstituted with sterile water and administered to a patient. The reporter consented to follow up via email. Menveo reconstituted with sterile water instead of the supplied CYW-135 liquid conjugate, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.
Age: 16.0
Sex: M
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: Expired Bexsero 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 16-year-old male patient who received Men B NVS (Bexsero) (batch number AZX3Y, expiry date 28-FEB-2023) for prophylaxis.  On 14-MAR-2023, the patient received the 1st dose of Bexsero. On 14-MAR-2023, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: Expired Bexsero 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: 20-MAR-2023 The reporter was a Certified Medical Assistant. The vaccine administration facility was the same as primary reporter. Lot number provided by Healthcare Professional (HCP) did not pull up as a GlaxoSmithKline (GSK)vaccine. It was repeated and confirmed with HCP. The reporter had consented to follow-up via postal. The patient had received a dose of expired Bexsero vaccine, which had led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Arthralgia, Tenosynovitis
Clinical narrative: Sharp pain on left arm wrist; Tenosynovitis on left wrist; This non-serious case was reported by a physician via call center representative and described the occurrence of wrist pain in a 58-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   In FEB-2023, the patient received the 1st dose of Shingrix (left arm). On an unknown date, 2 hrs after receiving Shingrix, the patient experienced wrist pain (Verbatim: Sharp pain on left arm wrist) and tenosynovitis (Verbatim: Tenosynovitis on left wrist). The outcome of the wrist pain and tenosynovitis were unknown.   It was unknown if the reporter considered the wrist pain and tenosynovitis to be related to Shingrix.     It was unknown if the company considered the wrist pain and tenosynovitis to be related to Shingrix.   Additional Information: GSK Receipt Date: 20-MAR-2023 The patient self-reported this case.  The reporter reported that tenosynovitis after the administration of Shingrix, the administration of the 1st dose was around February 2023. The patient did not want to go for the 2nd shot, she was a little bit concern about it. The patient said the same site on the shot, within 2 to 3 hours of the shot, she started having sharp pain on the left arm wrist and progressed to tenosynovitis, it was just very peculiar as the patient was right-handed person. The reporter was consented to follow up.
Age: 43.0
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired dose of Havrix 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 43-year-old female patient who received HAV (Havrix 1440) (batch number H4H53, expiry date 30-JAN-2023) for prophylaxis.  On 06-FEB-2023, the patient received the 1st dose of Havrix 1440. On 06-FEB-2023, an unknown time after receiving Havrix 1440, the patient experienced expired vaccine used (Verbatim: Expired dose of Havrix 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: 20-MAR-2023 The reporter was an Office Admin. The vaccine administration facility was the same as primary reporter. The reporter had consented to follow-up via postal. The patient received a dose of expired Havrix vaccine, which had led to expired vaccine used.
Age: 52.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Reconstituted with sterile water; Reconstituted with sterile water; This non-serious case was reported by a other health professional via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 52-year-old female patient who received Herpes zoster (Shingrix) (batch number YCIY7, expiry date 25-OCT-2024) for prophylaxis.   On 20-MAR-2023, the patient received the 1st dose of Shingrix. On 20-MAR-2023, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Reconstituted with sterile water) and inappropriate dose of vaccine administered (Verbatim: Reconstituted with sterile water). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 20-MAR-2023 The reporter reported that on 20th March 2023 morning, a Shingrix first dose was reconstituted with sterile water and administered to a patient.  The patient received Shingrix vaccine which was reconstituted with sterile water, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. The reporter was consented to follow up.
Age: 63.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Reconstituted with sterile diluent; Reconstituted with sterile diluent; 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 male patient who received Herpes zoster (Shingrix) (batch number 3FE44, expiry date 17-JUN-2024) for prophylaxis.   On 13-MAR-2023, the patient received Shingrix. On 13-MAR-2023, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Reconstituted with sterile diluent) and inappropriate dose of vaccine administered (Verbatim: Reconstituted with sterile diluent). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 20-MAR-2023 The Licensed Practical Nurse (LPN) enquired that was the vaccine invalid and how long to wait? The reporter reported that they inadvertently administered a patient with Shingrix lyophilized powder reconstituted with a sterile diluent.  The reporter confirmed that this was an attempt at the second dose of Shingrix series for the patient. The reporter did not consent to follow-up. At the time of reporting, the patient was inadvertently administered with Shingrix lyophilized powder reconstituted with a sterile diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This case was linked with US2023042731 reported by the same reporter.; Sender's Comments:  US-GSK-US2023042731:Same reporter
Age: 68.0
Sex: M
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Reconstituted with sterile diluent; Reconstituted with sterile diluent; 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 68-year-old male patient who received Herpes zoster (Shingrix) (batch number 3FE44, expiry date 17-JUN-2024) for prophylaxis.   Previously administered products included Shingrix (Received first dose on an unknown date).   On 13-MAR-2023, the patient received the 2nd dose of Shingrix. On 13-MAR-2023, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Reconstituted with sterile diluent) and inappropriate dose of vaccine administered (Verbatim: Reconstituted with sterile diluent). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK receipt date: 20-MAR-2023 The reporter reported that they inadvertently administered a patient with Shingrix lyophilized powder reconstituted with a sterile diluent.  The reporter confirmed that this was an attempt at the second dose of Shingrix series for the patient. The reporter did not consent to follow-up. At the time of reporting, the patient was inadvertently administered with Shingrix lyophilized powder reconstituted with a sterile diluent, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered. This case was linked with US2023042730 reported by the same reporter.; Sender's Comments:  US-GSK-US2023042730:Same reporter
Age: 25.0
Sex: M
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired dose of Havrix administered; This non-serious case was reported by a nurse via call center representative and described the occurrence of expired vaccine used in a 25-year-old male patient who received HAV (Havrix) (batch number H4H53, expiry date 30-JAN-2023) for prophylaxis.   On 17-MAR-2023, the patient received Havrix. On 17-MAR-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: Expired dose of Havrix 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:20-MAR-2023 The nurse reported that a patient administered a expired dose of Havrix.  The reporter consented to follow up. The patient was administered with expired vaccine of Havrix which led to Expired vaccine used.
Sex: F
Vaccine: DTAPIPV
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: Kinrix given to a 12-month-old; Kinrix as third dose of DTaP and IPV; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate age at vaccine administration in a 12-month-old female patient who received DTPa-IPV (Kinrix) (batch number 24T2N, expiry date 07-MAY-2023) for prophylaxis.   Previously administered products included Vaxelis (first dose of DTaP and IPV as Vaxelis received on 29 December 2022) and Pediarix (second dose received on 30 January 2023).   On 20-MAR-2023, the patient received the 1st dose of Kinrix. On 20-MAR-2023, an unknown time after receiving Kinrix, the patient experienced inappropriate age at vaccine administration (Verbatim: Kinrix given to a 12-month-old) and inappropriate schedule of vaccine administered (Verbatim: Kinrix as third dose of DTaP and IPV). The outcome of the inappropriate age at vaccine administration and inappropriate schedule of vaccine administered were unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 20-Mar-2023 and 21-Mar-2023 The nurse manager called back to report that patient received their first dose of DTaP and IPV as Vaxelis on 29 December 2022 and second dose of each as Pediarix on 30 January 2023. The nurse called to report that a 12-month old patient accidentally received 3rd dose of Kinrix and wished to know how to proceed. Kinrix was the patient's third dose of DTaP and IPV.The reporter consented to follow up. Information about the vaccine and patient were provided.  The vaccine administration facility was the same as primary reporter. The 12-month old patient accidentally received 3rd dose of Kinrix, which led to inappropriate age at vaccine administration and inappropriate schedule of vaccine administered.
Age: 62.0
Sex: F
Vaccine: VARZOS
Symptoms: Urticaria
Clinical narrative: I woke up with hives; This non-serious case was reported by a consumer via call center representative and described the occurrence of hives in a 62-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.  On 16-MAR-2023, the patient received the 1st dose of Shingrix. On 20-MAR-2023, 4 days after receiving Shingrix, the patient experienced hives (Verbatim: I woke up with hives). The outcome of the hives was not recovered/not resolved.  It was unknown if the reporter considered the hives to be related to Shingrix.  It was unknown if the company considered the hives to be related to Shingrix.  Additional Information: GSK receipt date: 20-MAR-2023 The reporter was the patient and stated that, she had the shot and on the day of reporting, she woke up with hives. She had asked, if she needs to get the second shot. The patient asked what should she should do about hives as she was contiguous. No further details were provided. The patient had received the vaccine at a pharmacy but did not recalled the name of the pharmacy or contact information for the pharmacy. The reporter had denied consent to follow-up.
Sex: F
Vaccine: MENB
Symptoms: Expired product administered
Clinical narrative: expired dose administered; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a female patient who received Men B NVS (Bexsero) (expiry date DEC-2022) for prophylaxis.   On 22-MAR-2023, the patient received Bexsero. On 22-MAR-2023, an unknown time after receiving Bexsero, the patient experienced expired vaccine used (Verbatim: expired dose 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: 22-Mar-2023. Pharmacist calls to report an expired dose of Bexsero was administered. Information for expiration date and lot number were asked but declined.  Initials and age about the patient were asked and declined.The reporter consented to follow up. Patient received an expired Bexsero vaccine, which led to expired vaccine used.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: hadn't 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 78-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (1st dose received in July 2020).   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: hadn't received the 2nd dose yet). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt date: 22-MAR-2023 The pharmacist called to inform that a patient received the first dose of Shingrix back in July 2020 but had not receive the 2nd dose yet. The vaccine administration facility is the same as primary reporter for 1st dose. The reporter consented to follow up. Till the time of reporting, the patient did not receive 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: U
Vaccine: MMRV
Symptoms: Expired product administered, No adverse event
Clinical narrative: No additional AE/PQC reported; Nurse calling to report administration of expired PROQUAD.; This spontaneous report was received from a nurse and refers to a patient of unknown age and gender. There was no information about the patient's concurrent conditions, concomitant therapies, or medical history provided.  On 30-APR-2019, the patient was vaccinated with a dose of measles, mumps, rubella and varicella (oka-merck) virus vaccine live (PROQUAD) subcutaneous injection, albumin status has been verified as recombinant human albumin (rHa), lot #U R015744, expiration date was reported as 12-FEB-2019 (also reported as 30-APR-2023, discrepancy) (expired product administered) for prophylaxis (strength, dose, anatomical location, and route of administration were not provided). The reporter was unaware if there were any temperature excursions in the products lifetime. No additional adverse event (AE) was reported (no adverse event).
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: No adverse event, Product administration interrupted
Clinical narrative: Product administration interrupted; No adverse event; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTRATION INTERRUPTED (Product administration interrupted) and NO ADVERSE EVENT (No adverse event) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     It was unknown if the patient was ever been diagnosed with or tested positive for COVID-19. It was unknown if the patient had any acute illnesses at the time of vaccination and up to one month before. It was also unknown whether the patient had any chronic or long standing health conditions.     On 24-Aug-2021 at 1:33 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On an unknown date, the patient experienced PRODUCT ADMINISTRATION INTERRUPTED (Product administration interrupted) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT ADMINISTRATION INTERRUPTED (Product administration interrupted) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for PRODUCT ADMINISTRATION INTERRUPTED (Product administration interrupted).    No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-716566 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-716566:Patient 2: Case for Bivalent
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Dyskinesia, Neuropathy peripheral, Tremor
Clinical narrative: Neuropathy; Tremor; I stared getting involuntary head jerks and leg jerks; This spontaneous case was reported by a patient and describes the occurrence of NEUROPATHY PERIPHERAL (Neuropathy) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 061E21A and 052E21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 31-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NEUROPATHY PERIPHERAL (Neuropathy) (seriousness criterion medically significant), TREMOR (Tremor) and DYSKINESIA (I stared getting involuntary head jerks and leg jerks). At the time of the report, NEUROPATHY PERIPHERAL (Neuropathy), TREMOR (Tremor) and DYSKINESIA (I stared getting involuntary head jerks and leg jerks) outcome was unknown.            No concomitant medications were reported. It was reported that patient had started developing a tremor. And then the next couple of nights the patient stared getting involuntary head jerks and leg jerks. When the neuropathy came, it spread through the whole body. The patient remember staring at the ceiling and thinking that was it  the patient was dying. No treatment medications were reported.  Company comment.  This spontaneous case concerns an adult female patient, with no medical history reported, who received two doses of mRNA  1273 original vaccine and experienced the unexpected, serious (medically significant) event of neuropathy peripheral. Latency cannot be properly assessed since exact onset date was not provided. It was reported that the patient started developing a tremor. After a "couple of nights" she experienced involuntary head and leg jerks. She also mentioned "When the neuropathy came, it spread through my whole body". No further clinical details were provided for medical reviewing. The benefit-risk relationship of mRNA  1273 original vaccine is not affected by this report.
Age: 79.0
Sex: M
Vaccine: COVID19-2
Symptoms: Body temperature, COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (COVID-19) in a 79-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AFF166B) for COVID-19 prophylaxis.     Concurrent medical conditions included COPD.    On 05-Oct-2022, 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 11-Jan-2023, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2023, Body temperature: Mild.     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 concomitant medications were reported.    The patient first shot was in 2021, had every booster and last booster was 05-Oct-2022. COVID-19 symptoms included Small cough, mild cold, Mild fever temperature.    No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-717379 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 27-Mar-2023: Live Follow up : Upon duplicate search, it was identified that the case MOD-2023-717380 is a duplicate of case MOD-2023-717202.Hence Argus ID MOD-2023-717380 has been incorporated into case MOD-2023-717202 and we have added documents from case of deletion MOD-2023-717380 into retained case  MOD-2023-717202. Hence case MOD-2023-717380 sent for deletion. Primary reporter details added, suspect administration date, event onset date and narrative updated. On 27-Mar-2023: IRD of deletion case (From subordinate duplicate case).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-717379:Wife case
Age: 25.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Administered expired vaccine today; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine today) and NO ADVERSE EVENT (No adverse event) in a 25-year-old patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 047C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Mar-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 29-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine today). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine today) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine today).    No concomitant medications were provided. Patient was administered with expired vaccine on 29-Mar-2023. No treatment medication was provided.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Illness
Clinical narrative: Patient was sick for 2 days, and bounced back up.; Patient was exposed to someone who was sick and caught covid; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (Patient was sick for 2 days, and bounced back up.) and COVID-19 (Patient was exposed to someone who was sick and caught covid) in a 66-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. In October 2022, the patient experienced ILLNESS (Patient was sick for 2 days, and bounced back up.) and COVID-19 (Patient was exposed to someone who was sick and caught covid). At the time of the report, ILLNESS (Patient was sick for 2 days, and bounced back up.) had resolved and COVID-19 (Patient was exposed to someone who was sick and caught covid) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered ILLNESS (Patient was sick for 2 days, and bounced back up.) to be not related. No further causality assessment was provided for COVID-19 (Patient was exposed to someone who was sick and caught covid).    It was unknown patient did have previous COVID-19 vaccinations. No concomitant medication was reported.    Patient stated his doctor, allergist, and every person he knew, including nurses told him to take Moderna, because it does well with ethnic people. Patient stated its a superior product. Patient informed that he received his first and second primary doses and was good and didn't have any problems. Patient wasn't sick because of the vaccine. No treatment information was reported.
Age: 13.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Dose administered after manufacturer date of expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) in a 13-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Mar-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 28-Mar-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry).    Patient did not reported any allergy or disease. Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Concomitant medication details not reported by the reporter. Treatment details was not reported by the reporter.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: came down with COVID symptoms; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (came down with COVID symptoms) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M21A, 026D21A, 029A21A and 013M20A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Mar-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (came down with COVID symptoms). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) on 22-Mar-2023 for COVID-19, at an unspecified dose and frequency. On 26-Mar-2023, COVID-19 (came down with COVID symptoms) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Mar-2023, SARS-CoV-2 test: Positive. On 26-Mar-2023, SARS-CoV-2 test: Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant drugs were not reported.
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Dose administered after manufacturer date of expiry 12-Mar-2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry 12-Mar-2023) and NO ADVERSE EVENT (No adverse event) in a 71-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 071B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Mar-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 28-Mar-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry 12-Mar-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry 12-Mar-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacturer date of expiry 12-Mar-2023).    The concomitant medication was not reported by reporter. The vaccine was shipped frozen to the facility on 01-Mar-2023 and was initially stored in the refrigerator on the same day. The vial did not undergo any temperature excursions. It was unknown whether patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. The treatment medication was not reported by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine beyond use date was 24-Mar-2023 , Dose was administered on 29-Mar-2023; No adverse event; Inadvertently administered an expired dose (beyond the BUD) of the monovalent vaccine to a patient; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Inadvertently administered an expired dose (beyond the BUD) of the monovalent vaccine to a patient), PRODUCT STORAGE ERROR (Vaccine beyond use date was 24-Mar-2023 , Dose was administered on 29-Mar-2023) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 063B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 29-Mar-2023, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 29-Mar-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Inadvertently administered an expired dose (beyond the BUD) of the monovalent vaccine to a patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine beyond use date was 24-Mar-2023 , Dose was administered on 29-Mar-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Inadvertently administered an expired dose (beyond the BUD) of the monovalent vaccine to a patient), PRODUCT STORAGE ERROR (Vaccine beyond use date was 24-Mar-2023 , Dose was administered on 29-Mar-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Inadvertently administered an expired dose (beyond the BUD) of the monovalent vaccine to a patient) and PRODUCT STORAGE ERROR (Vaccine beyond use date was 24-Mar-2023 , Dose was administered on 29-Mar-2023).    No concomitant medications were reported.  It was unknown whether the dose was the patient 1st or 2nd dose.  No treatment information was provided.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; inadvertently administered an expired dose of a monovalent vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (inadvertently administered an expired dose of a monovalent vaccine) and NO ADVERSE EVENT (No adverse event) in a 44-year-old female patient who received mRNA-1273 (Spikevax) (batch nos. 071B22A and 071B22A) for COVID-19 prophylaxis.     Patient has no allergy, concomitant diseases and risk factors.    On 01-Mar-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 29-Mar-2023, received second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to .5 milliliter. On 29-Mar-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (inadvertently administered an expired dose of a monovalent vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (inadvertently administered an expired dose of a monovalent vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (inadvertently administered an expired dose of a monovalent vaccine).    Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medications was reported. No adverse event was reported by the patient after the administration.  No treatment drug details was reported.
Sex: U
Vaccine: COVID19-2
Symptoms: Immunisation reaction
Clinical narrative: i did read the disclosure and let her know concerning the vaccine I am also doing a AE for having to much vaccine; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (i did read the disclosure and let her know concerning the vaccine I am also doing a AE for having to much vaccine) in an elderly patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. ASKU) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: COVID-19 VACCINE, COVID-19 VACCINE, COVID-19 VACCINE and COVID-19 VACCINE. Past adverse reactions to the above products included No adverse event with COVID-19 VACCINE, COVID-19 VACCINE, COVID-19 VACCINE and COVID-19 VACCINE.    On an unknown date, the patient received fifth 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 IMMUNISATION REACTION (i did read the disclosure and let her know concerning the vaccine I am also doing a AE for having to much vaccine). At the time of the report, IMMUNISATION REACTION (i did read the disclosure and let her know concerning the vaccine I am also doing a AE for having to much vaccine) 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 concomitant medications were reported.     No treatment medications were reported.
Sex: U
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: did get Covid in Dec 2022 after having the 5 shots; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (did get Covid in Dec 2022 after having the 5 shots) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.     No Medical History information was reported.    In September 2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. In December 2022, the patient experienced COVID-19 (did get Covid in Dec 2022 after having the 5 shots). At the time of the report, COVID-19 (did get Covid in Dec 2022 after having the 5 shots) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drug was reported. The patient said that they got Covid in Dec-2022 after having the 5 shots. It was a very mild infection.  No treatment drug was reported.   Most recent FOLLOW-UP information incorporated above includes: On 29-Mar-2023: Live non significant follow up