chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS
Symptoms: Pyrexia, Vomiting
Clinical narrative: The vaccine gave me a fever; some vomiting; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of fever in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received Shingles vaccine. On an unknown date, an unknown time after receiving Shingles vaccine, the patient experienced fever (Verbatim: The vaccine gave me a fever) and vomiting (Verbatim: some vomiting). The outcome of the fever and vomiting were resolved.   The reporter considered the fever and vomiting to be related to Shingles vaccine.     The company considered the fever and vomiting to be related to Shingles vaccine.   Additional Information: GSK receipt date 21 Jul 2023: This case was reported by a consumer via interactive digital media. The vaccine gave him/her a fever and some vomiting one night but the patient would still get the vaccine again when it's time. It was still better then weeks of hell.
Sex: U
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Got shingles; This non-serious case was reported by a consumer via interactive digital media and described the occurrence of shingles in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingles vaccine. On 14-MAY-2023, an unknown time after receiving Shingles vaccine, the patient experienced shingles (Verbatim: Got shingles). The outcome of the shingles was not resolved.   It was unknown if the reporter considered the shingles to be related to Shingles vaccine.     It was unknown if the company considered the shingles to be related to Shingles vaccine.   Additional Information: GSK receipt date: 24-JUL-2023 The case was received from the patient interactive digital media. The patient had a reaction to the first vaccine, and could not take part two. The patient got shingles on Mother's Day and stated that it was worst thing ever and he/she was still suffering. The follow-up could not be possible as no contact details were available.
Sex: U
Vaccine: HEP
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 patient who received HBV (Engerix B) (batch number f73dc7, expiry date 03-JUL-2023) for prophylaxis.   On 19-JUL-2023, the patient received Engerix B. On 19-JUL-2023, an unknown time after receiving Engerix B, 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: 19-JUL-2023 The reporter did not have additional adverse event details. The patient received an Engerix B which was already expired, which led to expired vaccine used. The vaccine administration facility was the same as primary reporter. The reporter did consent to follow up.
Sex: F
Vaccine: MENB
Symptoms: Product storage error
Clinical narrative: patient received a bexsero dose exposed at 28 degree F; This non-serious case was reported by a nurse via call center representative and described the occurrence of incorrect storage of drug in a 18-year-old female patient who received Men B NVS (Bexsero) for prophylaxis.   On an unknown date, the patient received Bexsero. On an unknown date, an unknown time after receiving Bexsero, the patient experienced incorrect storage of drug (Verbatim: patient received a bexsero dose exposed at 28°F). The outcome of the incorrect storage of drug 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: 19-JUL-2023 A nurse reported that a patient received a Bexsero dose exposed at 28 degree F which led to incorrect storage of drug. The reporter consented to follow up.
Sex: U
Vaccine: RV1
Symptoms: Choking
Clinical narrative: witnessed choking; This serious case was reported by a other health professional via sales rep and described the occurrence of choking in an unspecified number of patients who received Rota (Rotarix lyophilized formulation) for prophylaxis.   On an unknown date, the patient received Rotarix lyophilized formulation. On an unknown date, an unknown time after receiving Rotarix lyophilized formulation, the patient experienced choking (Verbatim: witnessed choking) (serious criteria GSK medically significant). The outcome of the choking was unknown.   It was unknown if the reporter considered the choking to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device.  It was unknown if the company considered the choking to be related to Rotarix lyophilized formulation and Rotarix Oral Applicator Device.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date:20-JUL-2023 The reporter was a GlaxoSmithKline representative reporting an adverse event reported by her healthcare professional.  The GlaxoSmithKline representative learned of the event yesterday afternoon.  The healthcare professional reported with the new presentation of the Rotarix vaccine, they had witnessed choking among their youngest patients upon administration (no other information was known). The reporter and healthcare professional both gave consent to be contacted further in this case.  Minimal information was given. The reporter consented to follow up.
Age: 75.0
Sex: M
Vaccine: VARZOS
Symptoms: Hypersensitivity, Rash
Clinical narrative: allergic reaction; developed a rash; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of allergic reaction in a 75-year-old male patient who received Herpes zoster (Shingrix) (batch number 597C4, expiry date 04-AUG-2024) for prophylaxis.   On 16-MAY-2023, the patient received the 1st dose of Shingrix (right deltoid) .5 ml. On an unknown date, an unknown time after receiving Shingrix, the patient experienced allergic reaction (Verbatim: allergic reaction) and rash (Verbatim: developed a rash). The patient was treated with medication unknown (Topical (Nos)). The outcome of the allergic reaction was not reported and the outcome of the rash was resolved (duration 2 weeks).   It was unknown if the reporter considered the allergic reaction and rash to be related to Shingrix.     It was unknown if the company considered the allergic reaction and rash to be related to Shingrix.   Additional Information: GSK Receipt Date: 20-JUL-2023 The reporter was a pharmacist calling to report an adverse event for a customer.  Pharmacist reports that customer developed a rash on his abdomen 2 weeks after receiving his first dose of Shingrix.  Reports that customer went to a dermatologist, was diagnosed with an allergic reaction to Shingrix vaccine, and was ordered a topical cream as treatment.  Rash on abdomen resolved after 2 weeks of using unspecified topical cream.   Pharmacist states that were at pharmacy today for 2nd Shingrix dose and would like further instructions.   The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Expired product administered
Clinical narrative: expired dose was administered to a patient; This non-serious case was reported by a physician via sales rep and described the occurrence of expired vaccine used in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 19-JUL-2023, the patient received the 1st dose of Shingrix. On 19-JUL-2023, an unknown time after receiving Shingrix, the patient experienced expired vaccine used (Verbatim: expired dose was administered to a patient). The outcome of the expired vaccine used was unknown.   Additional Information: GSK receipt date: 20 Jul 2023 The health care professional stated that an expired dose was administered to a patient, which led to expired vaccine used.  The reporter consented to follow up.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Longer than Recommended Interval/received first dose at pharmacy and didn't complete series; This non-serious case was reported by a physician via call center representative and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix  (received 1st dose on an unknown date at pharmacy).   On an unknown date, the patient did not received the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Longer than Recommended Interval/received first dose at pharmacy and didn't complete series). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date 20 Jul 2023: The patient received first dose at pharmacy and did not complete the series. The reporter asked should the series be restarted? Till the time of reporting the patient did not received 2nd dose of shingrix which led to incomplete course of vaccination.
Sex: M
Vaccine: VARZOS
Symptoms: Inappropriate schedule of product administration, Medication error
Clinical narrative: Circumstance or information capable of leading to medication error; administration of 2nd dose of Shingrix less than 2 months from 1st dose of Shingrix; This non-serious 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 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   Concomitant products included VARICELLA ZOSTER VACCINE RGE (CHO) (SHINGRIX).   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 circumstance or information capable of leading to medication error (Verbatim: Circumstance or information capable of leading to medication error) and drug dose administration interval too short (Verbatim: administration of 2nd dose of Shingrix less than 2 months from 1st dose of Shingrix). The outcome of the circumstance or information capable of leading to medication error and drug dose administration interval too short were unknown.   Additional Information: GSK Receipt Date: 21-JUL-2023 The reporter reported that potential of administration of 2nd dose of Shingrix less than 2 months from 1st dose of Shingrix.  The patient received 1st Shingrix vaccine on 26th May 2023 and wanted to have 2nd Shingrix vaccine on 21st July 2023.  The reporter stated that patient wanted to come at the time of reporting for 2nd dose of Shingrix.  The second dose of Shingrix had not been administered at the time of the call. The reporter consented to follow up. The reporter reported that potential of administration of 2nd dose of Shingrix less than 2 months from 1st dose of Shingrix, which led to circumstance or information capable of leading to medication error and drug dose administration interval too short.
Sex: M
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Twinrix on 14Jan2023, received a late 2nd dose on 24Feb2023; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a male patient who received HAB (Twinrix) for prophylaxis.   Concomitant products included HEPATITIS A VACCINE + HEPATITIS B VACCINE (TWINRIX).   On 24-FEB-2023, the patient received the 2nd dose of Twinrix. On 24-FEB-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Twinrix on 14Jan2023, received a late 2nd dose on 24Feb2023). The outcome of the drug dose administration interval too long 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-JUL-2023 A pharmacist reported that a patient received the 1st dose of Twinrix on 14January 2023, received a late 2nd dose on 24th February 2023 which led to lengthening of vaccination schedule. Possibly a late 3rd dose, as he had not received 3rd dose as of time of the report. The vaccine administration facility is the same as primary reporter. The health care professional was in car driving while giving the report she did not have patient details or lot number or expiration date. The health care professional consented to follow-up via email.
Sex: U
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: patients of the pharmacy received only the diluent portion of Menveo; patients of the pharmacy received only the diluent portion of Menveo; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate dose of vaccine administered in a patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA933A) for prophylaxis.   On an unknown date, the patient received Menveo. On an unknown date, an unknown time after receiving Menveo, the patient experienced inappropriate dose of vaccine administered (Verbatim: patients of the pharmacy received only the diluent portion of Menveo) and inappropriate preparation of medication (Verbatim: patients of the pharmacy received only the diluent portion of Menveo). The outcome of the inappropriate dose of vaccine administered and inappropriate preparation of medication were unknown.   Additional Information: GSK receipt date 21 Jul 2023 The pharmacist called to inform that one of the patients of the pharmacy received only the diluent portion of Menveo. At the moment of the reporting, the pharmacist had not determined who was the patient that received only the liquid portion. The reporter consented to follow up. The vaccine administration facility was the same as primary reporter. The reporter wasn't able to provide any information on the patient. The patients of the pharmacy received only the diluent portion of Menveo, which led to inappropriate dose of vaccine administered and inappropriate preparation of medication.
Age: 19.0
Sex: F
Vaccine: VARZOS
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: immunocompetent patient was administered of Shingrix; 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 19-year-old female patient who received Herpes zoster (Shingrix) (batch number 7532P, expiry date 18-AUG-2024) for prophylaxis.   On 22-JUN-2023, the patient received Shingrix. On 22-JUN-2023, an unknown time after receiving Shingrix, the patient experienced inappropriate age at vaccine administration (Verbatim: immunocompetent patient was administered of Shingrix). The outcome of the inappropriate age at vaccine administration was unknown.   Additional Information: GSK Receipt Date: 21-JUL-2023 The reporter reported that a 19 years old immunocompetent patient was administered of Shingrix. The reporter consented to follow up. The patient received Shingrix below than the recommended age schedule, which led to inappropriate age at vaccine administration.
Sex: U
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: Expired dose given; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of expired vaccine used in a patient who received HAV (Havrix 1440) (expiry date 30-JAN-2023) for prophylaxis.   On 12-JUL-2023, the patient received Havrix 1440. On 12-JUL-2023, an unknown time after receiving Havrix 1440, the patient experienced expired vaccine used (Verbatim: Expired dose given). The outcome of the expired vaccine used was unknown.   This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.   Additional Information: GSK Receipt Date: 21-JUL-2023 The reporter wanted to know if the vaccine dose was still viable. The reporter asked what steps need to be taken after the fact. The patient received a Havrix vaccine which was already expired, which led to expired vaccine used. The reporter did not consent to follow up.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: Shingrix 4 years ago and is late for the 2nd dose; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of incomplete course of vaccination in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (received 1st dose 4 years ago).   On an unknown date, the patient did not receive the 2nd dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incomplete course of vaccination (Verbatim: Shingrix 4 years ago and is late for the 2nd dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK Receipt Date: 24-JUL-2023 The reporter reported that a patient received the 1st dose of Shingrix 4 years ago and was late for the 2nd dose. The healthcare professional did not have exact date of vaccination (and only stated that the patient received it 4 years ago), lot, or expiration. The patient's DOB (date of birth) was not asked. The reporter consented to follow up via email. Till the time of reporting, the patient did not receive the 2nd dose of Shingrix, which led to incomplete course of vaccination.
Sex: F
Vaccine: HEPA
Symptoms: Expired product administered
Clinical narrative: nows the vaccine expired in January 2023; 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 HAV (Havrix) (expiry date JAN-2023) for prophylaxis.   On 12-JUL-2023, the patient received Havrix. On 12-JUL-2023, an unknown time after receiving Havrix, the patient experienced expired vaccine used (Verbatim: nows the vaccine expired in January 2023). The outcome of the expired vaccine used was unknown.   Additional Information: GSK Receipt Date: 24-JUL-2023 Pharmacist did not have vaccine lot number at the time of reporting, but knows the vaccine expired in January 2023. Reporter did not have any patient details available at time of reporting. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up. The patient received expired Havrix, which led to expired vaccine used. This case had been linked with US2023101230, reported by same reporter.
Sex: U
Vaccine: HEPAB
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Longer than recommended Interval; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of drug dose administration interval too long in a 66-year-old patient who received HAB (Twinrix) for prophylaxis.   Previously administered products included Twinrix  (1st dose received on 19th February 2023).   On 14-MAY-2023, the patient received the 2nd dose of Twinrix. On 14-MAY-2023, an unknown time after receiving Twinrix, the patient experienced drug dose administration interval too long (Verbatim: Longer than recommended Interval). The outcome of the drug dose administration interval too long 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: 24-JUL-2023 The Pharmacist would like to know how to proceed with the third dose. The reporter consented to follow up. The patient received 2nd dose of Twinrix, later than the recommended interval, which led to lengthening of vaccination schedule.
Age: 53.0
Sex: F
Vaccine: VARZOS
Symptoms: Herpes zoster
Clinical narrative: Shingles; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of shingles in a 53-year-old female patient who received Herpes zoster (Shingrix) (batch number 5YZ5L, expiry date 25-OCT-2024) for prophylaxis.   On 14-JUL-2023, the patient received the 1st dose of Shingrix. On 23-JUL-2023, 9 days after receiving Shingrix, the patient experienced shingles (Verbatim: Shingles). The outcome of the shingles was unknown.   It was unknown if the reporter considered the shingles to be related to Shingrix.     It was unknown if the company considered the shingles to be related to Shingrix.   Additional Information: GSK receipt date: 24-Jul-2023 The pharmacist reported that the patient received a dose of Shingrix and one day before the reporting day, developed shingles. The reporter did not consent to follow-up.
Age: 69.0
Sex: M
Vaccine: MENB
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Bexsero was administered to a 69 year old patient; This non-serious case was reported by a pharmacist via call center representative and described the occurrence of inappropriate age at vaccine administration in a 69-year-old male patient who received Men B NVS (Bexsero) (batch number G7KX2, expiry date 31-MAR-2024) for prophylaxis.   On 20-JUL-2023, the patient received Bexsero. On 20-JUL-2023, an unknown time after receiving Bexsero, the patient experienced inappropriate age at vaccine administration (Verbatim: Bexsero was administered to a 69 year old patient). 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: 24-Jul-2023 The vaccine administration facility was the same as primary reporter. The reporter consented to follow-up via postal. The patient received a dose of Bexsero at an inappropriate age, which led to inappropriate age at vaccine administration.
Sex: F
Vaccine: COVID19
Symptoms: Fall, Mental impairment, Musculoskeletal disorder, Speech disorder, Suspected COVID-19
Clinical narrative: UNABLE PUT TWO THOUGHT TOGETHER; SUSPECTED COVID-19 INFECTION; MUSCULOSKELETAL SYSTEM PROBLEM; FALLS; PATIENT TALKING WAS VERY BIZARRE; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's concurrent conditions included: autoimmune problem. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, 1 total administered, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, patient had covid (suspected covid-19 infection) and it was really bad. She had more falls and it affected her musculoskeletal system (musculoskeletal system problem). She was unable to put 2 thoughts together and her talking was very bizarre. There was no syntax, no subject and her son noticed this. She states that the vaccine and covid causing problems to her musculoskeletal systems. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection, musculoskeletal system problem, unable put two thought together, falls and patient talking was very bizarre was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20230742693-unable put two thought together. 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 Causality is considered indeterminate. The company causality is considered unassessable.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: LEG PAIN; This spontaneous report received from a consumer concerned a 56 year old female. 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. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported.  On an unspecified date, the patient experienced leg pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of leg pain was not reported. This report was non-serious.
Age: 0.5
Sex: F
Vaccine: COVID19-2, DTAPHEPBIP, HIBV, PNC13
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Nurse is calling to report that patient received expired vaccine on 12-JUN-2023; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Nurse is calling to report that patient received expired vaccine on 12-JUN-2023) and NO ADVERSE EVENT (No adverse event) in a 6-month-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7170B) for COVID-19 prophylaxis.    Co-suspect products included non-company products PEDIARIX for an unknown indication, HIB VACCINE CONJ (TET TOX) (ACTHIB) for an unknown indication and PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) for an unknown indication.    No Medical History information was reported.   On 12-Jun-2023, the patient received third dose of PEDIARIX (Intramuscular) 1 dosage form, third dose of HIB VACCINE CONJ (TET TOX) (ACTHIB) (Intramuscular) 1 dosage form and third dose of PNEUMOCOCCAL VACCINE CONJ 13V (CRM197) (PREVNAR 13) (Intramuscular) 1 dosage form. On 12-Jun-2023 at 10:00 AM, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 12-Jun-2023 at 10:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Nurse is calling to report that patient received expired vaccine on 12-JUN-2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Nurse is calling to report that patient received expired vaccine on 12-JUN-2023) 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 EXPIRED PRODUCT ADMINISTERED (Nurse is calling to report that patient received expired vaccine on 12-JUN-2023).    Event Outcome was given as Recovered and date of recovery was given as 12-Jun-2023  No concomitant information was reported. No treatment information was provided.  Suspect product dosage text was reported as unknown. The 2.5ml vial was initially stored in refrigerator on 09-Jun-2023 and did not underwent temperature excursions.  This case is reported for 6 month old baby. No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-728850 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 24-Jul-2023: Follow-up information received and reporter information updated, secondary reporter details was added. Patient details and dose details were updated, other co suspects were added; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-728850:69-year-old patient
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse event; Customer called in to report that they gave 2 children the 6mo-2yr vaccine dose 2 months past expiration; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Customer called in to report that they gave 2 children the 6mo-2yr vaccine dose 2 months past expiration) and NO ADVERSE EVENT (No Adverse event) in a child 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. 214K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 02-May-2023, 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 02-May-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Customer called in to report that they gave 2 children the 6mo-2yr vaccine dose 2 months past expiration). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Customer called in to report that they gave 2 children the 6mo-2yr vaccine dose 2 months past expiration) and NO ADVERSE EVENT (No Adverse event) outcome was unknown. Not Provided      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 EXPIRED PRODUCT ADMINISTERED (Customer called in to report that they gave 2 children the 6mo-2yr vaccine dose 2 months past expiration).    No concomitant medication was reported.  No treatment medication was reported.  This case was reported for patient 2 out of 2 patients.   This case was linked to US-MODERNATX, INC.-MOD-2023-734150 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-734150:Patient 01
Sex: U
Vaccine: COVID19, COVID19
Symptoms: Immunisation reaction
Clinical narrative: When I got J and J, it was 30 hours of yuck, Moderna booster a year ago was 56 hours of yuck; This spontaneous case was reported by a patient and describes the occurrence of IMMUNISATION REACTION (When I got J and J, it was 30 hours of yuck, Moderna booster a year ago was 56 hours of yuck) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for COVID-19 prophylaxis.    Previously administered products included for Product used for unknown indication: Shingles vaccine (Patient had received both shingles vaccine doses and had side effect for 2.5 days each.) and Shingles vaccine (Patient had received both shingles vaccine doses and had side effect for 2.5 days each.). Past adverse reactions to the above products included Adverse event with Shingles vaccine and Shingles vaccine. Concomitant products included INFLUENZA VACCINE for an unknown indication.   In 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient received dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (When I got J and J, it was 30 hours of yuck, Moderna booster a year ago was 56 hours of yuck). At the time of the report, IMMUNISATION REACTION (When I got J and J, it was 30 hours of yuck, Moderna booster a year ago was 56 hours of yuck) had resolved. Not Provided          It was reported that the only vaccine from which patient didn't got any side effects was the annual Flu vaccine. Patient had experienced general side effects after Janssen and Moderna vaccinations.   The causality of the events wrt to Janssen vaccine was related as possible.   Treatment drug information was unknown.
Age: 3.0
Sex: F
Vaccine: COVID19-2, DTAP, IPV
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; Expired product administered; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired product administered) and NO ADVERSE EVENT (no adverse event) in a 3-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 065H22A and 065H22A) for COVID-19 prophylaxis.    Co-suspect products included non-company products DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) for an unknown indication and POLIO VACCINE (POLIO) for an unknown indication.    The patient had no relevant medical history/conditions, allergy, concomitant diseases and risk factor. The patient had received other vaccines in the 4 weeks prior to COVID-19 vaccine.    On 07-Jun-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .25 milliliter. On 11-Jul-2023, received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) dosage was changed to .25 milliliter. On 11-Jul-2023, the patient received dose of DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (DTAP) (unknown route) 1 dosage form and dose of POLIO VACCINE (POLIO) (unknown route) 1 dosage form. On 11-Jul-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired product administered). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired product administered) 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)) (Intramuscular), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Expired product administered).    No concomitant medication was reported. It was reported that a pediatrician inadvertently administered an expired dose of the bivalent vaccine (blue cap) to a 3 year old patient. The expiry date for dose 2 was reported as 13-Jun-2023. No adverse events were reported after the administration. No treatment medication was reported.   Reporter did not allow further contact
Age: 24.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: Expired vaccine used; No adverse event; Dose 1 on 13-APR-2023 and dose 2 on 8-JUN-2023; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 on 13-APR-2023 and dose 2 on 8-JUN-2023) and NO ADVERSE EVENT (No adverse event) in a 24-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019H22A and 015B22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 13-Apr-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 08-Jun-2023, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 08-Jun-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 on 13-APR-2023 and dose 2 on 8-JUN-2023). On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 on 13-APR-2023 and dose 2 on 8-JUN-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Dose 1 on 13-APR-2023 and dose 2 on 8-JUN-2023).    No concomitant medication was reported.  Patient was given expired dose, lot analysis determined vaccine maintained the activity necessary to protect. It was unknown if the patient experienced any additional symptoms/events.  No treatment medication was reported.
Age: 9.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Wrong product administered
Clinical narrative: No adverse event; Administered a dose from a potentially punctured vial (blue cap); Patient received Bivalent vaccine as first dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered a dose from a potentially punctured vial (blue cap)), WRONG PRODUCT ADMINISTERED (Patient received Bivalent vaccine as first dose) and NO ADVERSE EVENT (No adverse event) in a 9-month-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7185B) for COVID-19 prophylaxis.     It was reported that patient was basically a healthy baby.  Previously administered products included for Product used for unknown indication: Hib. Past adverse reactions to the above products included No adverse event with Hib.    On 20-Jul-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .25 milliliter. On 20-Jul-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered a dose from a potentially punctured vial (blue cap)) and WRONG PRODUCT ADMINISTERED (Patient received Bivalent vaccine as first dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered a dose from a potentially punctured vial (blue cap)), WRONG PRODUCT ADMINISTERED (Patient received Bivalent vaccine as first dose) 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 a dose from a potentially punctured vial (blue cap)) and WRONG PRODUCT ADMINISTERED (Patient received Bivalent vaccine as first dose).    Patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Concomitant medication details not reported by the reporter. The vial might have been potentially initially punctured on 19-JUL-2023. Treatment details was not reported by the reporter.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Myalgia, Pain
Clinical narrative: Persistent joint pain; Body aches; Muscle pain; Fatigue; This spontaneous case was reported by a patient and describes the occurrence of ARTHRALGIA (Persistent joint pain) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Persistent joint pain) (seriousness criterion life threatening), PAIN (Body aches), MYALGIA (Muscle pain) and FATIGUE (Fatigue). At the time of the report, ARTHRALGIA (Persistent joint pain), PAIN (Body aches), MYALGIA (Muscle pain) and FATIGUE (Fatigue) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided. It was reported as persistent for medication Details and reason for taking the medicine. Under lab data/results: CT, MRI EEG, EMG, EKG were mentioned with no results being reported. Treatment information was not reported.  Company Comment: This is a Spontaneous case reported by a patient, concerning a 52-year-old female patient, with no medical history reported, who experienced the unexpected and serious (due to life-threatening) event of Arthralgia, which occurred on an unknown date related to the first dose of mRNA-1273 vaccine. Since no vaccination nor event dates were provided, temporal association and latency cannot be properly assessed. Computed tomography, magnetic resonance imaging, electroencephalogram, electromyogram and EKG were performed, with no results reported. No information about treatments received was disclosed. At the time of the report, the event had not resolved. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: M
Vaccine: COVID19
Symptoms: Fall, Mobility decreased, Sensory loss
Clinical narrative: falling down; Left leg lost movement and feeling and then both legs; Left leg lost movement and feeling and then both legs; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 78-year-old male patient received BNT162b2 (BNT162B2), in Feb2021 as dose 1, single (Batch/Lot number: unknown), in left arm for covid-19 immunisation. The patient's relevant medical history included: "Abalone" (unspecified if ongoing). There were no concomitant medications. Past drug history included: Sulpa drug, reaction(s): "Allergy: sulpa drug". The following information was reported: SENSORY LOSS (disability, medically significant), MOBILITY DECREASED (disability, medically significant) all with onset 2021, outcome "not recovered" and all described as "Left leg lost movement and feeling and then both legs"; FALL (disability, medically significant) with onset 2021, outcome "not recovered", described as "falling down". Therapeutic measures were taken as a result of fall, sensory loss, mobility decreased. Clinical course: Patient started falling down 5 or so days after the vaccine. Left leg lost movement and feeling and then both legs after 3 or so months. Patient had undergone back surgery then IVIG 27 doses so far. It was reported that the onset date and time of the events are 25Jan2021 14:00 (discrepant information). Patient was vaccinated at 04:00   The information on the batch/lot number for BNT162b2 has been requested and will be submitted if and when received.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300258727 same reporter/patient/product/event, different dose;
Sex: M
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 47-year-old male patient received BNT162b2 (BNT162B2), as dose 3 (booster), single (Lot number: EN6202) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High Cholesterol" (unspecified if ongoing); "IBS-D/Irritable bowel syndrome with Diarrhoea" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Aspirin, reaction(s): "known allergies: Aspirin". The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jun2023, outcome "recovered" (19Jun2023) and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: (unspecified date) Positive, notes: Treatment of Covid-19; (19Jun2023) Negative. Therapeutic measures: Paxlovid as COVID-19 treatment from 12Jun2023 to 17Jun2023 were taken as a result of drug ineffective, covid-19.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300257324 same patient, different drug and event;
Age: 3.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Pyrexia
Clinical narrative: Fever; This is a spontaneous report received from a non-contactable reporter(s) (Consumer or other non HCP).  A 3-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Jul2023 at 16:30 as dose 2 (maroon cap), single (Batch/Lot number: unknown) at the age of 3 years, in left leg for covid-19 immunisation. The patient had no relevant medical history. There were no concomitant medications. Vaccination history included: Bnt162b2, bnt162b2 omi ba.4-5 (DOSE 1 (MAROON CAP), SINGLE, Anatomical location: Right leg), for Covid-19 Immunisation. The following information was reported: PYREXIA (non-serious) with onset 22Jul2023 at 12:00, outcome "recovering", described as "Fever". The event "fever" required physician office visit. Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were taken as a result of pyrexia.  Additional information: Patient received Children's Tylenol as treatment for fever. Patient did not have covid prior vaccination or tested post vaccination  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Headache, Myalgia, Nausea
Clinical narrative: Terrible joint pain; Muscle aches; Headaches; Nausea; Terrible fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 70-year-old female patient (not pregnant) received BNT162b2 (BNT162B2), on 21Oct2021 as dose 3 (booster), single (Lot number: PF2590), in left arm for covid-19 immunisation. The patient's relevant medical history was not reported. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE, Lot Number: EN6201, Anatomical site of vaccine administration: Left arm), administration date: 10Mar2021, for Covid-19 Immunization, reaction(s): "Terrible joint pain", "Muscle aches", "Headaches", "Nausea", "Terrible fatigues"; BNT162b2 (DOSE 2, SINGLE, Lot Number: ER8732, Anatomical site of vaccine administration: Left arm), administration date: 31Mar2021, for Covid-19 Immunization, reaction(s): "Terrible joint pain", "Muscle aches", "Headaches", "Nausea", "Terrible fatigues". The following information was reported: HEADACHE (non-serious) with onset 2021, outcome "recovered", described as "Headaches"; MYALGIA (non-serious) with onset 2021, outcome "recovered", described as "Muscle aches"; NAUSEA (non-serious) with onset 2021, outcome "recovered"; FATIGUE (non-serious) with onset 2021, outcome "recovered", described as "Terrible fatigue"; ARTHRALGIA (non-serious) with onset 2021, outcome "recovered", described as "Terrible joint pain".  Additional Information: Beginning with the first vaccine, within hours and within minutes for subsequent does she had terrible joint pain and muscle aches in all parts of her body at various times; she also had headaches, nausea and terrible fatigues. The reaction after the first lasted about 2 weeks. She reported this reaction when she went for the second dose. She had the same types of reaction for the 2nd dose, but the issues lasted about 6 weeks. She reported the reaction when she went for the first booster. Again, had a similar reaction which lasted a few months. When she went for the second booster, she reported her previous reactions.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300258400 same patient/event, different drug dose;