chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: M
Vaccine: HEP
Symptoms: Accidental underdose, Product administered to patient of inappropriate age
Clinical narrative: Engerix-B pediatric administred to adult; Engerix-B pediatric administred to adult; This case was reported by a pharmacist via call center representative and described the occurrence of accidental underdose in a adult male patient who received HBV (Engerix B pediatric) (batch number YM444, expiry date 22nd May 2024) for prophylaxis.   Co-suspect products included hepatitis B vaccine pre-filled syringe device (Engerix B Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received Engerix B pediatric 10 µg and Engerix B Pre-Filled Syringe Device. On an unknown date, unknown after receiving Engerix B pediatric and Engerix B Pre-Filled Syringe Device, the patient experienced accidental underdose and adult use of a child product. On an unknown date, the outcome of the accidental underdose and adult use of a child product 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: 18-Nov-2022 Reporter's comment: The reporter transferred to medical information for further assistance. The reporter gave permission for follow-up from GlaxoSmithKline. Additional supportive information: The patient accidently received pediatric dose of Engerix-B, which led to accidental underdose and adult use of a child product.
Sex: F
Vaccine: TDAP
Symptoms: Injection site pain
Clinical narrative: Sore arm at the injection site; This case was reported by a other health professional via call center representative and described the occurrence of injection site pain in a 26-year-old female patient who received DTPa (Reduced antigen) (Boostrix) (batch number DR2GR, expiry date 29th November 2024) for prophylaxis.   The patient's past medical history included febrile seizure. Concurrent medical conditions included pertussis (patient had pertussis allergy from infancy) and allergy to vaccine (pertussis allergy from infancy).   On 16th November 2022, the patient received the 1st dose of Boostrix. In November 2022, less than a week after receiving Boostrix, the patient experienced injection site pain. On an unknown date, the outcome of the injection site pain was unknown.   It was unknown if the reporter considered the injection site pain to be related to Boostrix.     Additional Information: GSK Receipt Date: 21-NOV-2022 Reporter's Comment: The reporter reported that the patient had a pertussis allergy and received Boostrix vaccine. The reporter stated that the patient told by her mother it was an allergy from infancy were she had a febrile seizure. The reporter reported that after received Boostrix vaccine the patient experienced no reaction except sore arm at the injection site. The reporter did consent to follow up via mail. Additional supportive infirmation: From the narrative it was not clear if patient had pertussis vaccine allergy or had pertussis condition. Conservatively both considered as medical history and query raised.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: Menveo reconstituted with sterile water; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMXA728A, expiry date 30th September 2023) for prophylaxis.   On 17th November 2022, the patient received Menveo. On 17th November 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK receipt date: 21-Nov-2022 Reporter's comment: The reporter consented to follow-up. Additional supportive information: The patient received a dose of Menveo incorrectly reconstituted with sterile water, which led to wrong solution used in drug reconstitution.
Sex: F
Vaccine: VARZOS
Symptoms: Circumstance or information capable of leading to medication error
Clinical narrative: Physician requested a 3rd dose of Shingrix; This case was reported by a pharmacist via call center representative and described the occurrence of circumstance or information capable of leading to medication error in a 54-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received two doses on an unknown date).   On an unknown date, the patient received the 3rd dose of Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced circumstance or information capable of leading to medication error. On an unknown date, the outcome of the circumstance or information capable of leading to medication error was unknown.   Additional Information: GSK receipt date:21-Nov-2022 Reporter's comment: Administration dates of two doses were not available, pharmacist could only saw dose one was shipped in September 2020 and dose two was shipped in January 2021. No further information provided on call but pharmacist consented to follow up from safety via email. The reporter consented to follow-up. Additional supportive information: A physician had requested a third dose of Shingrix be given to a patient, which led to circumstance or information capable of leading to medication error.
Sex: U
Vaccine: VARZOS
Symptoms: Intercepted product preparation error
Clinical narrative: Dose reconstituted with 2 vials of adjuvant, no patient involved; This case was reported by a pharmacist via call center representative and described the occurrence of intercepted product preparation error in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received Shingrix. On an unknown date, unknown after receiving Shingrix, the patient experienced intercepted product preparation error. On an unknown date, the outcome of the intercepted product preparation error was unknown.   Additional Information: GSK receipt date: 21-Nov-2022 Reporter's comment: The vaccine was not administered to the patient. No further information was provided. No patient involvement. Lot/expiration not obtained. The reporter consented to contact registered pharmacist. The reporter consented to follow-up. Additional supportive information: One of reporter's pharmacists combined 2 vials of adjuvant from the Shingrix box while preparing rather than adding the adjuvant to the antigen vial, which led to intercepted product preparation error.
Age: 11.0
Sex: F
Vaccine: MNQ
Symptoms: Product preparation error
Clinical narrative: Menveo reconstituted with sterile water; This case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 11-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMAA728A, expiry date 31st October 2023) for prophylaxis.   On 15th November 2022, the patient received Menveo. On 15th November 2022, unknown after receiving Menveo, the patient experienced wrong solution used in drug reconstitution. On an unknown date, the outcome of the wrong solution used in drug reconstitution was unknown.   Additional Information: GSK receipt date: 21-Nov-2022 Reporter's comment: The registered nurse called to inquired that the whole dose should be repeated. The reporter confirmed that the dose was administered in their facility. The reporter did not consent to follow-up. Additional supportive information: The patient was inadvertently administered Menveo lyophilized powder component reconstituted with sterile water instead of the supplied Menveo diluent, which led to wrong solution used in drug reconstitution.
Age: 39.0
Sex: F
Vaccine: HEP
Symptoms: Incorrect dose administered
Clinical narrative: Pediatric dose administered to adult; Pediatric dose administered to adult; This case was reported by a pharmacist via call center representative and described the occurrence of underdose in a 39-year-old female patient who received HBV (Engerix B pediatric) (batch number L9Y4G, expiry date 5th April 2024) for prophylaxis.   On 21st November 2022, the patient received Engerix B pediatric. On 21st November 2022, unknown after receiving Engerix B pediatric, the patient experienced underdose and adult use of a child product. On an unknown date, the outcome of the underdose and adult use of a child product were unknown.   Additional Information: GSK receipt date: 21-Nov-2022 Reporter's comment: A pharmacist called to asked for information about the administration of a pediatric dose of Engerix-B to a patient. The reporter asked if they could administer an extra pediatric dose in order to complete a full adult dose of Engerix-B. The reporter consented to follow-up. Additional supportive information: The patient received a pediatric dose of Engerix-B, which led to underdose and adult use of a child product.
Age: 0.17
Sex: U
Vaccine: RV1
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: received only the diluent portion; received only the diluent portion; This case was reported by a other health professional via call center representative and described the occurrence of inappropriate preparation of medication in a 2-month-old patient who received Rota (Rotarix lyophilized formulation) for prophylaxis.   Co-suspect products included rotavirus vaccine oral applicator device (Rotarix Oral Applicator Device) oral applicator for prophylaxis.   On an unknown date, the patient received the 1st dose of Rotarix lyophilized formulation and Rotarix Oral Applicator Device. On an unknown date, unknown after receiving Rotarix lyophilized formulation and Rotarix Oral Applicator Device, the patient experienced inappropriate preparation of medication and inappropriate dose of vaccine administered. On an unknown date, the outcome of the inappropriate preparation of medication and inappropriate dose 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: 21-Nov-2022 Reporter's comment: The health care professional reported that another health care professional called her and mentioned that the patient received a dose in series of the Rotarix with only the diluent portion and wanted guidance on how to proceed.  The reporter was unsure when the maladministration occurred.  No reactions were reported. The reporter consented to follow-up , email follow-up was preferred. Additional supportive information: The patient received only diluent portion of Rotarix, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Sex: F
Vaccine: TDAP, UNK
Symptoms: Expired product administered, Extra dose administered
Clinical narrative: a 2nd dose of both was administered after a week; 2nd dose Boostrix received after expiry date; This case was reported by a nurse via call center representative and described the occurrence of extra dose administered in a 12-year-old female patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent 2022-2023 season) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis, DTPa (Reduced antigen) (Boostrix) (batch number B4C44, expiry date 10th November 2022) for prophylaxis and dtpa vaccine. pre-filled syringe device (Boostrix Pre-Filled Syringe Device) injection syringe for prophylaxis.   Concomitant products included INFLUENZA VACCINE INACT (FLULAVAL QUADRIVALENT) and DIPHTHERIA VACCINE TOXOID + PERTUSSIS VACCINE ACELLULAR + TETANUS VACCINE TOXOID (BOOSTRIX).   On 21st November 2022, the patient received the 2nd dose of FluLaval Quadrivalent 2022-2023 season, Flulaval Tetra Pre-Filled Syringe Device, the 2nd dose of Boostrix and Boostrix Pre-Filled Syringe Device. On 21st November 2022, unknown after receiving FluLaval Quadrivalent 2022-2023 season, Flulaval Tetra Pre-Filled Syringe Device, Boostrix and Boostrix Pre-Filled Syringe Device, the patient experienced extra dose administered and expired vaccine used. On an unknown date, the outcome of the extra dose administered and expired vaccine used 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: 21-Nov-2022 Reporter's comment: The reporter called to reported a maladministration of a dose of Flulavsal and Boostrix to a patient, with the first dose given 1 week ago. The reporter gave information for the Boostrix vaccine but not the Flulaval vaccine and also information about the patient. The vaccine administration facility was the same as primary reporter. The call was escalated to second line. The reporter consented to follow-up. Additional supportive information: The patient received an extra dose of expired Boostrix and Flulaval, which led to extra dose administered and expired vaccine used.
Age: 0.33
Sex: U
Vaccine: FLU4
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: administered to a 4 months old pt; This case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 4-month-old patient who received Flu Seasonal QIV Quebec (FluLaval Quadrivalent) for prophylaxis.   Co-suspect products included flu seasonal qiv quebec pre-filled syringe device (Flulaval Tetra Pre-Filled Syringe Device) injection syringe for prophylaxis.   On an unknown date, the patient received FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device. On an unknown date, unknown after receiving FluLaval Quadrivalent and Flulaval Tetra Pre-Filled Syringe Device, the patient experienced inappropriate age at vaccine administration. On an unknown date, the outcome of the inappropriate age at vaccine administration was unknown.     This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK receipt date: 21-Nov-2022 Reporter's comment: The reporter did not had any patient demographics or vaccine details (date of administration, lot, expiry  date).  The reporter consented to follow-up via postal. Additional supportive information: The patient received Flulaval at inappropriate age, which led to inappropriate age at vaccine administration.
Sex: U
Vaccine: COVID19
Symptoms: Adverse drug reaction
Clinical narrative: SOME TERRIBLE J AND J SHOT; This spontaneous report received from a consumer via a company representative concerned multiple patients. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced some terrible j and j shot. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of some terrible j and j shot was not reported. This report was non-serious. This case, from the same reporter is linked to 20220802964.
Sex: M
Vaccine: COVID19
Symptoms: Suspected COVID-19
Clinical narrative: SUSPECTED COVID-19 INFECTION; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced suspected covid-19 infection. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of suspected covid-19 infection was not reported. This report was non-serious. This report was associated with product quality complaint: 90000260740, 90000260729, 90000260730. The suspected product quality complaint has been confirmed to be voided (did not meet definition of product quality complaint for LOE as there is no indication regarding the vaccination date, nor confirmatory test results or symptoms reported, based on the PQC evaluation/investigation performed).
Sex: U
Vaccine: COVID19
Symptoms: Cerebrovascular accident
Clinical narrative: POSSIBLE STROKE; This spontaneous report received from a patient via a company representative via social media concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, batch number: unknown and expiry: unknown) dose was not reported, 01 total administered, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, 20 minutes after vaccination, the patient experienced possible stroke. As per reporter, "after having my first vaccine, within 20 minutes I had a complete collapse (they believe it was a possible stroke), and was completely out for over 4 hours, unable to walk or speak." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of possible stroke was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0:20221159008- Possible Stroke. The event has compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Sex: F
Vaccine: COVID19
Symptoms: Dementia
Clinical narrative: DEMENTIA; This spontaneous report received from a consumer via a company representative via social media and concerned a female of unspecified age, race and ethnic origin. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported, 1 total administrated for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  On an unspecified date, a day after vaccination the patient experienced dementia and was in nursing home. The reported stated "Another friend of mine got it n her husband the day after she started getting dimensia she in a,nursing home k i dunno if its the reason but wst they said prayers for yall bc mayb onr day u c great again my left eye is no vision its called legally blind but it nit from the shot God bless all of yall effective by this". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of dementia was not reported. This report was serious (Other Medically Important Condition). This case, from the same reporter is linked to 20221161446.; Sender's Comments: V0: 20221161477- dementia. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event. Therefore, the WHO Causality is considered indeterminate. The company causality is considered unassessable.
Sex: U
Vaccine: COVID19
Symptoms: Malaise
Clinical narrative: VIOLENTLY ILL FOR 3 DAYS AND ENDED UP IN THE ER; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced violently ill for 3 days and ended up in the er. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of violently ill for 3 days and ended up in the er was not reported. This report was non-serious.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity, Paraesthesia, Pyrexia
Clinical narrative: Fatigue; LEG TINGLING; LOW GRADE FEVER; SORE ARM; This spontaneous case was reported by a physician and describes the occurrence of FATIGUE (Fatigue), PARAESTHESIA (LEG TINGLING), PYREXIA (LOW GRADE FEVER) and PAIN IN EXTREMITY (SORE ARM) in a 44-year-old female patient 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 FATIGUE (Fatigue), PARAESTHESIA (LEG TINGLING), PYREXIA (LOW GRADE FEVER) and PAIN IN EXTREMITY (SORE ARM). At the time of the report, FATIGUE (Fatigue), PARAESTHESIA (LEG TINGLING), PYREXIA (LOW GRADE FEVER) and PAIN IN EXTREMITY (SORE ARM) 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 medication information was reported.  No treatment medication information was reported.  The Reference number reported.
Age: 10.0
Sex: F
Vaccine: COVID19
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; given the adult dose of the booster dose; This spontaneous case was reported by a patient family member or friend and describes the occurrence of WRONG PRODUCT ADMINISTERED (given the adult dose of the booster dose) and NO ADVERSE EVENT (No adverse event) in a 10-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 013H22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: Pfizer (1st dose ,lot number FL0894) on 09-Apr-2022, Pfizer (2nd dose and lot number FL8095) on 03-May-2022. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 27-Nov-2022, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 27-Nov-2022, the patient experienced WRONG PRODUCT ADMINISTERED (given the adult dose of the booster dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (given the adult dose of the booster dose) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant information was reported. It was reported that at the time of call the patient was okay. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine was stored in the fridge since 11Oct2022 and administered on 15Nov2022; No adverse event; We had a vaccine that was given past the due date/received expired 2nd primary dose (Monovalent) 4 days beyond the 30 day beyond use date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (We had a vaccine that was given past the due date/received expired 2nd primary dose (Monovalent) 4 days beyond the 30 day beyond use date), PRODUCT STORAGE ERROR (Vaccine was stored in the fridge since 11Oct2022 and administered on 15Nov2022) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 063B22A) for COVID-19 vaccination.     No Medical History information was reported.    On 15-Nov-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 15-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (We had a vaccine that was given past the due date/received expired 2nd primary dose (Monovalent) 4 days beyond the 30 day beyond use date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in the fridge since 11Oct2022 and administered on 15Nov2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (We had a vaccine that was given past the due date/received expired 2nd primary dose (Monovalent) 4 days beyond the 30 day beyond use date), PRODUCT STORAGE ERROR (Vaccine was stored in the fridge since 11Oct2022 and administered on 15Nov2022) 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 (We had a vaccine that was given past the due date/received expired 2nd primary dose (Monovalent) 4 days beyond the 30 day beyond use date) and PRODUCT STORAGE ERROR (Vaccine was stored in the fridge since 11Oct2022 and administered on 15Nov2022).    No concomitant medications were reported.  The cartons were unbroken. The vial size was 5.5 ml. The vial did not undergo any temperature excursions.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 28-Nov-2022: Live-significant Follow-up appended: Suspect vaccine, event, narrative and primary reporter details were updated
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initially stored in the refrigerator on 24-Oct-2022 and vaccine administered on 25-Nov-2022; No adverse event; On 25Nov2022 HCP administered Moderna Monovalent to 3 patients 2 days after 30 Day use by date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (On 25Nov2022 HCP administered Moderna Monovalent to 3 patients 2 days after 30 Day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 24-Oct-2022 and vaccine administered on 25-Nov-2022) and NO ADVERSE EVENT (No adverse event) in a 32-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 082B22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Nov-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 25-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (On 25Nov2022 HCP administered Moderna Monovalent to 3 patients 2 days after 30 Day use by date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 24-Oct-2022 and vaccine administered on 25-Nov-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (On 25Nov2022 HCP administered Moderna Monovalent to 3 patients 2 days after 30 Day use by date), PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 24-Oct-2022 and vaccine administered on 25-Nov-2022) 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 (On 25Nov2022 HCP administered Moderna Monovalent to 3 patients 2 days after 30 Day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 24-Oct-2022 and vaccine administered on 25-Nov-2022).    No concomitant medications were reported.  It was reported that individual vails was used and vial size was 5.5ml. The vial was initially stored in the refrigerator on 24-Oct-2022. The vial did not undergo any temperature excursions.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-679103, US-MODERNATX, INC.-MOD-2022-679108 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-679103:same reporter US-MODERNATX, INC.-MOD-2022-679108:same reporter
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pyrexia
Clinical narrative: arm Muscle pain; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (arm Muscle pain) and PYREXIA (Fever) in a 61-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 4782591) for COVID-19 vaccination.    Co-suspect product included non-company product RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) for Plaque psoriasis.    No Medical History information was reported.   On 08-Apr-2022, the patient started RISANKIZUMAB (SKYRIZI [RISANKIZUMAB]) (Subcutaneous) at an unspecified dose. 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)) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced MYALGIA (arm Muscle pain) and PYREXIA (Fever). At the time of the report, MYALGIA (arm Muscle pain) and PYREXIA (Fever) had resolved. Not Provided          No concomitant medication information was reported.  It was reported that adult female with events of non-serious arm Muscle pain, and fever with SKYRIZI ( Risankizumab) Solution for Injection, Single-Dose Prefilled Syringe with Needle Guard.  It was unknown if patient was enrolled in COVID-19-Vaccine Trial. The patient reported arm muscle pain and fever after receiving covid booster dose.  Agency's opinion was that the causality for the event(s) of arm Muscle pain and fever with Moderna COVID-19 vaccine (Elasomeran) was Not Provided Agency's opinion was that the causality for the event(s) of arm Muscle pain and fever with Risankizumab Solution for Injection was Not Provided.  No treatment medication information was reported.  The MFR CONTROL NO is US-ABBVIE-4177117.
Age: 56.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was first punctured on 15-Nov-2022 and administered on 16-Nov-2022; No adverse event; Vaccine administered after the 12 hr period/ post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after the 12 hr period/ post puncture), PRODUCT STORAGE ERROR (Vial was first punctured on 15-Nov-2022 and administered on 16-Nov-2022) and NO ADVERSE EVENT (No adverse event) in a 56-year-old 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. 020H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 16-Nov-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 16-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after the 12 hr period/ post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was first punctured on 15-Nov-2022 and administered on 16-Nov-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after the 12 hr period/ post puncture), PRODUCT STORAGE ERROR (Vial was first punctured on 15-Nov-2022 and administered on 16-Nov-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Vaccine administered after the 12 hr period/ post puncture) and PRODUCT STORAGE ERROR (Vial was first punctured on 15-Nov-2022 and administered on 16-Nov-2022).    Concomitant medication was not provided.  Nurse reported that only 2 doses were administered from the vail and size was 2.5 ml. The vial was stored post puncture in refrigerator. The vial did not undergo any temperature excursion.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-679129 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-679129:Patient 2 (Crosslink - MI case # MOD22-030049)
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Feeling abnormal, Gait inability, Hypoaesthesia, Mobility decreased
Clinical narrative: cannot walk; cannot move at all; no control of balance; barely talk; slowly getting scared; numbness/numbness started on the right side and moved to the left; This spontaneous case was reported by a patient family member or friend and describes the occurrence of GAIT INABILITY (cannot walk), MOBILITY DECREASED (cannot move at all), BALANCE DISORDER (no control of balance), SPEECH DISORDER (barely talk) and FEELING ABNORMAL (slowly getting scared) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028K21A, 031B21A and 004C21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Type 2 diabetes mellitus (But pretty much healthy working construction).   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced GAIT INABILITY (cannot walk), MOBILITY DECREASED (cannot move at all), BALANCE DISORDER (no control of balance), SPEECH DISORDER (barely talk), FEELING ABNORMAL (slowly getting scared) and HYPOAESTHESIA (numbness/numbness started on the right side and moved to the left). The patient was treated with Physical therapy for Gait inability; Physical therapy for Mobility decreased; Physical therapy for Balance disorder; Physical therapy for Speech disorder; Physical therapy for Feeling abnormal and Physical therapy for Hypoaesthesia. At the time of the report, GAIT INABILITY (cannot walk), MOBILITY DECREASED (cannot move at all), BALANCE DISORDER (no control of balance), SPEECH DISORDER (barely talk), FEELING ABNORMAL (slowly getting scared) and HYPOAESTHESIA (numbness/numbness started on the right side and moved to the left) outcome was unknown.            No concomitant medications were reported.  The reporter feel like they were losing patient little by little. Reporter reported that the patient been to doctors and been to a medical hospital and the numbness started on the right side and moved to the left.  No treatment information was reported.
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Speech disorder
Clinical narrative: cannot walk; cannot move at all; no control of balance; barely talk; slowly getting scared; numbness/numbness started on the right side and moved to the left; This spontaneous case was reported by a patient family member or friend and describes the occurrence of GAIT INABILITY (cannot walk), MOBILITY DECREASED (cannot move at all), BALANCE DISORDER (no control of balance), SPEECH DISORDER (barely talk) and FEELING ABNORMAL (slowly getting scared) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028K21A, 031B21A and 004C21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Type 2 diabetes mellitus (But pretty much healthy working construction).   On 08-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced GAIT INABILITY (cannot walk), MOBILITY DECREASED (cannot move at all), BALANCE DISORDER (no control of balance), SPEECH DISORDER (barely talk), FEELING ABNORMAL (slowly getting scared) and HYPOAESTHESIA (numbness/numbness started on the right side and moved to the left). The patient was treated with Physical therapy for Gait inability; Physical therapy for Mobility decreased; Physical therapy for Balance disorder; Physical therapy for Speech disorder; Physical therapy for Feeling abnormal and Physical therapy for Hypoaesthesia. At the time of the report, GAIT INABILITY (cannot walk), MOBILITY DECREASED (cannot move at all), BALANCE DISORDER (no control of balance), SPEECH DISORDER (barely talk), FEELING ABNORMAL (slowly getting scared) and HYPOAESTHESIA (numbness/numbness started on the right side and moved to the left) outcome was unknown.            No concomitant medications were reported.  The reporter feel like they were losing patient little by little. Reporter reported that the patient been to doctors and been to a medical hospital and the numbness started on the right side and moved to the left.  No treatment information was reported.
Age: 50.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Asthenia, Cognitive disorder, Insomnia, Migraine
Clinical narrative: MIGRAINE ON OCASSION; Low Energy Level; Cognitive alertness/cannot think as straight; Could not Sleep; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (MIGRAINE ON OCASSION), INSOMNIA (Could not Sleep), ASTHENIA (Low Energy Level) and COGNITIVE DISORDER (Cognitive alertness/cannot think as straight) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.    Co-suspect products included non-company products ADALIMUMAB (HUMIRA) for Psoriatic arthritis and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    Concurrent medical conditions included Psoriatic arthritis.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Nov-2021, the patient received dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (Intramuscular) 1 dosage form. On an unknown date, the patient started ADALIMUMAB (HUMIRA) (Subcutaneous) 40 mg 40 mg. In 2021, the patient experienced INSOMNIA (Could not Sleep). On an unknown date, the patient experienced MIGRAINE (MIGRAINE ON OCASSION), ASTHENIA (Low Energy Level) and COGNITIVE DISORDER (Cognitive alertness/cannot think as straight). The patient was treated with ZOLPIDEM TARTRATE (AMBIEN) for Difficulty sleeping, at an unspecified dose and frequency. In 2021, INSOMNIA (Could not Sleep) had resolved. At the time of the report, MIGRAINE (MIGRAINE ON OCASSION), ASTHENIA (Low Energy Level) and COGNITIVE DISORDER (Cognitive alertness/cannot think as straight) had not resolved.            Concomitant medications were not reported.  It was unknown if patient was enrolled in COVID-19-Vaccine Trial. Patient did not felt humira effective for 14 day, Humira did not work and Cognitive alertness/cannot think as straight with Adalimumab Solution for Injection, Single-Dose Pen.  The reporter's causality for the event(s) of Cognitive alertness/cannot think as straight, Could not Sleep, Low Energy Level and MIGRAINE ON OCASSION with adalimumab Solution for Injection was Not Provided
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (COVID-19) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis.    Concurrent medical conditions included Rheumatoid arthritis.   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)) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) 40 milligram. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) outcome was unknown.            No concomitant medications were reported.  On an unknown date, the patient received first dose of Moderna COVID-19 vaccine (Intramuscular) one in once.  No treatment medications were reported.  The reporter's causality for the event of COVID-19 with Adalimumab Solution for Injection was not provided.  The reporter's causality for the event of COVID-19 with Moderna COVID-19 vaccine (Elasomeran) was reasonable possibility.
Age: 29.0
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; We administered a Moderna Covid-19 vaccine bivalent booster dose to a patient that had not received a primary series; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (We administered a Moderna Covid-19 vaccine bivalent booster dose to a patient that had not received a primary series) and NO ADVERSE EVENT (No adverse event) in a 29-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 017H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Nov-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 28-Nov-2022, the patient experienced WRONG PRODUCT ADMINISTERED (We administered a Moderna Covid-19 vaccine bivalent booster dose to a patient that had not received a primary series). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (We administered a Moderna Covid-19 vaccine bivalent booster dose to a patient that had not received a primary series) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for WRONG PRODUCT ADMINISTERED (We administered a Moderna Covid-19 vaccine bivalent booster dose to a patient that had not received a primary series).    Concomitant medication was not provided. Treatment medication information was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 29-Nov-2022: Live significant follow up included patient information, suspect product start date, batch/Lot no and expiration date information added.
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.    Co-suspect product included non-company product ADALIMUMAB (HUMIRA) solution for injection for Rheumatoid arthritis and Ulcerative colitis.    Concurrent medical conditions included Rheumatoid arthritis and Ulcerative colitis.   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)) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) Single Dose Pen. On an unknown date, the patient experienced COVID-19 (COVID-19). At the time of the report, COVID-19 (COVID-19) was resolving.            No concomitant medications were reported.   On an unknown date, the patient had COVID. It was unknown if patient was enrolled in COVID-19-Vaccine Trial.  The reporter's causality for the event of Covid with Adalimumab solution for injection was no reasonable possibility. The reporter's causality for the event of Covid with Moderna COVID-19 vaccine (Elasomeran) was reasonable possibility.  No treatment details were reported.
Age: 81.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was first punctured on 15-Nov-2022 and administered on 17-Nov-2022; No adverse event; Administered Moderna Covid-19 Vaccine, Bivalent after the 12 hr period; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered Moderna Covid-19 Vaccine, Bivalent after the 12 hr period), PRODUCT STORAGE ERROR (Vial was first punctured on 15-Nov-2022 and administered on 17-Nov-2022) and NO ADVERSE EVENT (No adverse event) in an 81-year-old 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. 020H22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 17-Nov-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 17-Nov-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered Moderna Covid-19 Vaccine, Bivalent after the 12 hr period). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was first punctured on 15-Nov-2022 and administered on 17-Nov-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered Moderna Covid-19 Vaccine, Bivalent after the 12 hr period), PRODUCT STORAGE ERROR (Vial was first punctured on 15-Nov-2022 and administered on 17-Nov-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered Moderna Covid-19 Vaccine, Bivalent after the 12 hr period) and PRODUCT STORAGE ERROR (Vial was first punctured on 15-Nov-2022 and administered on 17-Nov-2022).    Concomitant medication was not provided.  Nurse reported that only 2 doses were administered from the vail and size was 2.5 ml. The vial was first punctured on 15-Nov-2022 and was administered to patient on 16-Nov-2022 and 17-Nov-2022. The vial was stored post puncture in refrigerator. The vial did not undergo any temperature excursion.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-679118 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-679118: