chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: VARZOS, VARZOS
Symptoms: Herpes zoster, Pain in extremity, Vaccination failure
Clinical narrative: Got 2 shingle shots and got shingles a year latter/Suspected vaccination failure; got Shingles a year latter; pain down my arm very annoying; This serious case was reported by a consumer via interactive digital media and described the occurrence of vaccination failure in a patient who received Herpes zoster (Shingles vaccine) for prophylaxis.   Co-suspect products included Herpes zoster (Shingles vaccine) for prophylaxis.   On an unknown date, the patient received the 2nd dose of Shingles vaccine and the 1st dose of Shingles vaccine. On an unknown date, 1 year after receiving Shingles vaccine and Shingles vaccine, the patient experienced vaccination failure (Verbatim: Got 2 shingle shots and got shingles a year latter/Suspected vaccination failure) (serious criteria GSK medically significant), shingles (Verbatim: got Shingles a year latter) and pain in arm (Verbatim: pain down my arm very annoying). The outcome of the vaccination failure was unknown and the outcome of the shingles and pain in arm were not reported.   It was unknown if the reporter considered the vaccination failure, shingles and pain in arm to be related to Shingles vaccine and Shingles vaccine.     It was unknown if the company considered the vaccination failure, shingles and pain in arm to be related to Shingles vaccine and Shingles vaccine.   Additional Information: GSK receipt date: 07-JUL-2023 This case was reported by a patient via interactive digital media. The patient reported that he/she had a mild case of shingles and they never got the fluid in them. The patient got pain down his/her arm very annoying. The patient received 2 shingle shots and got shingles a year later. This case was considered as suspected vaccination failure as details regarding laboratory confirmation for shingles were unknown at the time of reporting. The follow-up could not be possible as no contact details were available.
Sex: F
Vaccine: VARZOS
Symptoms: Product storage error
Clinical narrative: refrigerator may or may not have been out of range; This non-serious case was reported by a other health professional via sales rep and described the occurrence of incorrect storage of drug in a female patient who received Herpes zoster (Shingrix) for prophylaxis.   On an unknown date, the patient received the 1st dose of Shingrix. On an unknown date, an unknown time after receiving Shingrix, the patient experienced incorrect storage of drug (Verbatim: refrigerator may or may not have been out of range). The outcome of the incorrect storage of drug was unknown.   Additional Information: GSK receipt date: 06-JUL-2023 The reporter reported that patient came into practice after getting her first Shingrix shot over a year ago at another practice. That practice closed shortly after the patient received the first dose of Shingrix. However, the practice called patient and informed her that their refrigerator may or may not had been out of range and that they were not sure if the dose of Shingrix administered was viable. No further follow up and so the patient transferred to the new clinic and received another dose of Shingrix. Now they wonder what to do in terms of this was finishing the series or they need to give another dose. The patient received Shingrix vaccine of which refrigerator may or may not had been out of range which led to incorrect storage of drug.
Age: 1.0
Sex: F
Vaccine: DTAPHEPBIP
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose of Pediarix on 14-Feb-2023, 2nd dose of Pediarix on 5-July-2023; This non-serious case was reported by a other health professional via call center representative and described the occurrence of drug dose administration interval too long in a 12-month-old female patient who received DTPa-HBV-IPV (Pediarix) (batch number HS4F9, expiry date 11-APR-2025) for prophylaxis.   Previously administered products included Pentacel (received 1st dose on 6th September 2022), Pentacel (received 2nd dose on 2nd November 2022), Pediarix (received 1st dose on 14th February 2023) and Hepatitis B vaccine (received birth dose of Hepatitis B).   On 05-JUL-2023, the patient received the 2nd dose of Pediarix. On 05-JUL-2023, an unknown time after receiving Pediarix, the patient experienced drug dose administration interval too long (Verbatim: 1st dose of Pediarix on 14-Feb-2023, 2nd dose of Pediarix on 5-July-2023). 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: 06-JUL-2023 The reporter was the medical assistant. The reporter who stated a patient received an extra dose of Pediarix and the patient was doing fine.  According to reporter, the system for the state did not record the 3rd dose of Pediarix administered to the patient on 14th February 2023 when the Pediarix dose series was completed and they gave the shot to the patient by mistake.  The reporter was transferred to medical information per request. The reporter consented to follow up. The patient received 2nd dose of Pediarix later than the recommended schedule, which led to lengthening of vaccination schedule.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: The patient received the first dose of SHINGRIX in July, 2022 and has not yet received the second dose; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 81-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   The patient's past medical history included breast cancer and breast cancer. Previously administered products included Shingrix (first dose of shingrix in July 2022 ).   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: The patient received the first dose of SHINGRIX in July, 2022 and has not yet received the second dose). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 10-JUL-2023 The reporter was the patient. The patient received the first dose of SHINGRIX and had not yet received the second dose. It was not clear if the breast cancer was prior to or after the first dose of SHINGRIX. Limited information provided. Did not consent to follow-up.
Sex: F
Vaccine: MNQ
Symptoms: Exposure via skin contact, Occupational exposure to product, Product closure issue, Product complaint
Clinical narrative: the liquid sprayed all over her hands upon adding the liquid conjugate to the lyophlized conjugate; liquid sprayed all over her hands; Exposure via skin contact; vial stopper damage; This non-serious case was reported by a other health professional via call center representative and described the occurrence of occupational exposure while preparing product for administration in a 70-year-old female patient who received Men ACWY-CRM NVS (Menveo) (batch number AMVA932A, expiry date 30-JUN-2024) for prophylaxis. This case was associated with a product complaint.   On 10-JUL-2023, the patient received Menveo. On 10-JUL-2023, an unknown time after receiving Menveo, the patient experienced occupational exposure while preparing product for administration (Verbatim: liquid sprayed all over her hands), exposure via skin contact (Verbatim: Exposure via skin contact) and vial stopper damage (Verbatim: vial stopper damage). On an unknown date, the patient experienced pharmaceutical product complaint (Verbatim: the liquid sprayed all over her hands upon adding the liquid conjugate to the lyophlized conjugate). The outcome of the occupational exposure while preparing product for administration, exposure via skin contact, vial stopper damage and pharmaceutical product complaint were unknown.   Additional Information: GSK Receipt Date: 10-JUL-2023. The healthcare professional calling to report a leaking vial of Menveo.   The reporter stated that the liquid conjugate vial was drawn into the syringe and inserted into the lyophilized conjugate component, the liquid sprayed all over reporter hands upon adding the liquid conjugate to the lyophlized conjugate, coming in contact with her skin. During drug preparation the defect was discovered. The reporter did not get far with mixing or shaking performed after reconstitution.  The vial held upside-down when the vaccine was being withdrawn. The product was not administered. The healthcare professional preparing the product is an experienced user. The lyophilized conjugate was affected. Air was injected into the liquid conjugate vial, "the same amount as the liquid in the vial." The leak was coming from the needle puncture in the stopper of the lyophilized conjugate vial. The vial stopper and metallic skirt did not detach or become loose.  The customer removed only the plastic flip-off cover. There was no evidence of leakage in the box. The reporter did not consent to follow-up. Liquid sprayed all over reporter hands upon adding the liquid conjugate to the lyophlized conjugate, coming in contact with her skin which led to occupational exposure while administering product and exposure via skin contact.
Sex: F
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: she has not received the second dose yet due to financial problems; This non-serious case was reported by a consumer via call center representative and described the occurrence of incomplete course of vaccination in a 59-year-old female patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (first dose received in June of 2022).   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: she has not received the second dose yet due to financial problems). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 11-JUL-2023 The reporter was the patient who stated she had not received the second dose yet due to financial problems.  Education provided to patient regarding dosing schedule and CDC guidance per content.  Did not consent to follow-up.
Age: 12.0
Sex: F
Vaccine: HEPA
Symptoms: Accidental overdose, Product administered to patient of inappropriate age
Clinical narrative: Overdose/ adolescent patient was inadvertently administered an 1 mL Adult Havrix dose instead of the 0.5 mL dose; Overdose/ adolescent patient was inadvertently administered an 1 mL Adult Havrix dose instead of the 0.5 mL dose; This non-serious case was reported by a other health professional via call center representative and described the occurrence of accidental overdose in a 12-year-old female patient who received HAV (Havrix adult) (batch number 772YT, expiry date 23-SEP-2025) for prophylaxis.   On 11-JUL-2023, the patient received Havrix adult (left deltoid) 1 ml. On 11-JUL-2023, an unknown time after receiving Havrix adult, the patient experienced accidental overdose (Verbatim: Overdose/ adolescent patient was inadvertently administered an 1 mL Adult Havrix dose instead of the 0.5 mL dose) and inappropriate age at vaccine administration (Verbatim: Overdose/ adolescent patient was inadvertently administered an 1 mL Adult Havrix dose instead of the 0.5 mL dose). The outcome of the accidental overdose and inappropriate age at vaccine administration 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: 12-JUL-2023 The reporter was a medical assistant. The reporter wanted to know if they would still require a second vaccine and how to proceed with series. The reporter further asked if any reaction from getting the higher dose and what to look for. The reporter did not consent to follow-up. The reporter reported that an adolescent patient was inadvertently administered an 1 ml adult Havrix dose instead of the 0.5 mL dose, which led to accidental overdose and inappropriate age at vaccine administration.
Age: 20.0
Sex: F
Vaccine: HEPA
Symptoms: Product administered to patient of inappropriate age, Underdose
Clinical narrative: pediatric dose of Havrix administered to adult patient; pediatric dose of Havrix administered to adult patient; This non-serious case was reported by a other health professional via call center representative and described the occurrence of underdose in a 20-year-old female patient who received HAV (Havrix 720 Junior) (batch number Y3ME2, expiry date 23-FEB-2025) for prophylaxis.  On 15-JUN-2023, the patient received the 1st dose of Havrix 720 Junior. On 15-JUN-2023, an unknown time after receiving Havrix 720 Junior, the patient experienced underdose (Verbatim: pediatric dose of Havrix administered to adult patient) and adult use of a child product (Verbatim: pediatric dose of Havrix administered to adult patient). The outcome of the 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: 12-JUL-2023 The reporter was certified medical assistant. The reporter stated that a pediatric dose of Havrix was administered to an adult patient which led to underdose and adult use of a child product. The vaccine administration facility was the same as primary reporter. The reporter consented to follow up via postal.
Sex: U
Vaccine: VARZOS
Symptoms: Incomplete course of vaccination
Clinical narrative: 4-5 years ago patient got the initial SHINGRIX vaccine, but never got the second shot; This non-serious case was reported by a physician via sales rep and described the occurrence of incomplete course of vaccination in a patient who received Herpes zoster (Shingrix) for prophylaxis.   Previously administered products included Shingrix (4 to 5 years ago patient got the initial Shingrix vaccine).   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: 4-5 years ago patient got the initial SHINGRIX vaccine, but never got the second shot). The outcome of the incomplete course of vaccination was unknown.   Additional Information: GSK receipt date: 12-JUL-2023 Email inquiry sent by sales rep on behalf of HCP. The patient got the initial Shingrix vaccine, but never got the second shot. The reporter wanted to know should the patient start all over or could the patient go and get a second shot. The vaccine administration facility was the same as primary reporter. No additional information available due to the way the question sent in. It was unknown if follow up was permissible.
Age: 2.0
Sex: M
Vaccine: HEPA
Symptoms: Extra dose administered
Clinical narrative: patient received a third dose of Havrix; This non-serious case was reported by a other health professional via call center representative and described the occurrence of extra dose administered in a 29-month-old male patient who received HAV (Havrix) (batch number 2yX23, expiry date 10-FEB-2025) for prophylaxis.  On 12-JUL-2023, the patient received the 3rd dose of Havrix. On 12-JUL-2023, an unknown time after receiving Havrix, the patient experienced extra dose administered (Verbatim: patient received a third dose of Havrix). The outcome of the extra dose administered was unknown.  This report is made by GSK without prejudice and does not imply any admission or liability for the incident or its consequences.  Additional Information: GSK receipt date: 12-JUL-2023 The medical assistant reported that a patient received a third dose of Havrix and wished to know how to proceed. Information about the event, patient and vaccine was given. The vaccine administration facility was the same as primary reporter. A patient received a third dose of Havrix, which led to extra dose administered. The reporter consented to follow up.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DEATH; This spontaneous report received from a consumer via social media 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, expiry: unknown) 1 in total, dose and 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 died from an unknown cause of death. It was unknown if an autopsy was performed. The consumer reported as, "News You Murdered my sister with you Johnson and Johnson kill shot. Do you think it ends here. Sleep With One Eye Open... Track and Trace". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20230721115-Death. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Post-acute COVID-19 syndrome
Clinical narrative: My husband and I both had Covid for the first time in December, 2022; it could have been "Long Covid"; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (My husband and I both had Covid for the first time in December, 2022) and POST-ACUTE COVID-19 SYNDROME (it could have been "Long Covid") in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     Concurrent medical conditions included Bladder cancer.   On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2022, the patient experienced COVID-19 (My husband and I both had Covid for the first time in December, 2022) and POST-ACUTE COVID-19 SYNDROME (it could have been "Long Covid"). At the time of the report, COVID-19 (My husband and I both had Covid for the first time in December, 2022) had resolved and POST-ACUTE COVID-19 SYNDROME (it could have been "Long Covid") outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient has been going through BCG treatments immunotherapy for bladder cancer the last year and a half.  Patient had took the same vaccine shots as of his wife. Patient had Covid for the first time in Dec-2022 and it took a long time to get over. Patient had not took Paxlovid as he did not know exactly when it started. Patient thought it could have been "Long Covid". He was interested in taking new bivalent booster.   This case was linked to US-MODERNATX, INC.-MOD-2023-732537 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2023: Non-significant follow up received. On 09-Jul-2023: Non-significant follow up received.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732537:Linked case ID MOD-2023-732537 Wife case
Sex: M
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; She states that a child received the yellow label dark pink cap 0.2 ml/10mcg dose as a first and/or second dose; This spontaneous case was reported by a nurse and describes the occurrence of WRONG PRODUCT ADMINISTERED (She states that a child received the yellow label dark pink cap 0.2 ml/10mcg dose as a first and/or second dose) and NO ADVERSE EVENT (No adverse event) in an infant male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 10-Jun-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On 10-Jun-2023, the patient experienced WRONG PRODUCT ADMINISTERED (She states that a child received the yellow label dark pink cap 0.2 ml/10mcg dose as a first and/or second dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (She states that a child received the yellow label dark pink cap 0.2 ml/10mcg dose as a first and/or second 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 assessment was provided for WRONG PRODUCT ADMINISTERED (She states that a child received the yellow label dark pink cap 0.2 ml/10mcg dose as a first and/or second dose).    Concomitant medication details not reported by the reporter. Dosage text was reported as unknown. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-732798 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732798:Same report
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: My husband has a head cold after all the vaccines he received; This spontaneous case was reported by a non-health professional and describes the occurrence of NASOPHARYNGITIS (My husband has a head cold after all the vaccines he received) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.   On an unknown date, the patient received fifth dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, received fourth dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form, third dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form, second dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Spikevax) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (My husband has a head cold after all the vaccines he received). At the time of the report, NASOPHARYNGITIS (My husband has a head cold after all the vaccines he received) had resolved.            Concomitant medications were not reported. Patient had a head cold after all the vaccines he received. That was a typical symptom of the vaccines Reporter confirmed that they only received all six doses of Moderna COVID-19 vaccines. Treatment medications were not reported.   This case was linked to MOD-2023-733140 (Patient Link).
Sex: M
Vaccine: COVID19-2
Symptoms: Nasopharyngitis
Clinical narrative: My husband has a head cold after all the vaccines he received; This spontaneous case was reported by a non-health professional and describes the occurrence of NASOPHARYNGITIS (My husband has a head cold after all the vaccines he received) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received sixth 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 NASOPHARYNGITIS (My husband has a head cold after all the vaccines he received). The patient was treated with ATORVASTATIN at an unspecified dose and frequency. At the time of the report, NASOPHARYNGITIS (My husband has a head cold after all the vaccines he received) outcome was unknown.            Concomitant medications were not reported. Patient had a head cold after all the vaccines he received. That was a typical symptom of the vaccines Reporter confirmed that they only received all six doses of Moderna COVID-19 vaccines.   This case was linked to MOD-2023-732936 (Patient Link).
Age: 35.0
Sex: M
Vaccine: COVID19-2
Symptoms: Renal failure
Clinical narrative: Lost his kidneys; This spontaneous case was reported by a physician and describes the occurrence of RENAL FAILURE (Lost his kidneys) in a 35-year-old male 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 RENAL FAILURE (Lost his kidneys) (seriousness criterion medically significant). At the time of the report, RENAL FAILURE (Lost his kidneys) outcome was unknown.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown) 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 was reported.  No treatment drug was reported.  Company comment: This spontaneous case concerns a 35-year-old, male patient with no medical history information reported, who experienced the unexpected serious (medically significant) AESI of renal failure. The event occurred on an unknown date after a dose of mRNA-1273 bivalent BA.4/BA.5 (of note vaccine type and brand was not specified). As reported, 35 year old patient lost his kidneys because of the vaccine. No further information about the events was provided. The reported was not sure if the patient received Pfizer of Moderna. The benefit-risk relationship of mRNA-1273 bivalent BA.4/BA.5 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-732229 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732229:Case for other people
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Heart rate, Post-acute COVID-19 syndrome
Clinical narrative: it could have been "Long Covid".; My husband and I both had Covid for the first time in December, 2022; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (My husband and I both had Covid for the first time in December, 2022) and POST-ACUTE COVID-19 SYNDROME (it could have been "Long Covid".) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient's past medical history included Mitral valve disease, Atrial fibrillation (which got repaired through doing an add on "maize procedure".) and Mitral valve repair (by using a minimally invasive and robotic approach at facility.) in March 2019. Concurrent medical conditions included Allergy.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In December 2022, the patient experienced COVID-19 (My husband and I both had Covid for the first time in December, 2022). On an unknown date, the patient experienced POST-ACUTE COVID-19 SYNDROME (it could have been "Long Covid".). At the time of the report, COVID-19 (My husband and I both had Covid for the first time in December, 2022) had resolved and POST-ACUTE COVID-19 SYNDROME (it could have been "Long Covid".) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: Decreased.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. It was reported that patient was planning to travel in the coming weeks and concerned about to get another booster as will be among many people in their apartment. Additional patient have scheduled cataract surgery upon return back to state. So certainly don't want to have a problem with covid before the surgery.  Patient was concerned about taking the more recent bivalent booster which has been available for quite some time and read about issues with those who have allergies and also about people who had experienced any previous heart issues. Patient also fall into both categories and also seem to have a low heart rate so that is always a concern.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-732538 (Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 09-Jul-2023: Non significant information received. On 09-Jul-2023: Non significant information received.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-732538:Linked husband case ID MOD-2023-732538, same reporter
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, Mycobacterium tuberculosis complex test, No adverse event, Wrong product administered
Clinical narrative: Expiration Vaccine was administered Exp: 07-Jul-2023; Adult patient received MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5 as first dose.; No adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expiration Vaccine was administered Exp: 07-Jul-2023), WRONG PRODUCT ADMINISTERED (Adult patient received MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5 as first dose.) and NO ADVERSE EVENT (No adverse event) in an adult 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. 019H22A) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: IMVANEX. Past adverse reactions to the above products included No adverse event with IMVANEX.    On an unknown date, the patient received first 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 EXPIRED PRODUCT ADMINISTERED (Expiration Vaccine was administered Exp: 07-Jul-2023), WRONG PRODUCT ADMINISTERED (Adult patient received MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5 as first dose.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expiration Vaccine was administered Exp: 07-Jul-2023), WRONG PRODUCT ADMINISTERED (Adult patient received MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5 as first dose.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jul-2023, Mycobacterium tuberculosis complex test: Inconclusive.     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 (Expiration Vaccine was administered Exp: 07-Jul-2023) and WRONG PRODUCT ADMINISTERED (Adult patient received MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5 as first dose.).    Concomitant product use was not provided by the reporter.  Expiry date of suspect vaccine was reported as 07-Jul-2023.  Treatment information was not provided.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Chest discomfort, Hyperhidrosis, Palpitations
Clinical narrative: Intermittent chest discomfort/pain; Irregular heartbeat/palpitations; Diaphoresis lasting minutes to hours; This spontaneous case was reported by a patient and describes the occurrence of CHEST DISCOMFORT (Intermittent chest discomfort/pain), PALPITATIONS (Irregular heartbeat/palpitations) and HYPERHIDROSIS (Diaphoresis lasting minutes to hours) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jun-2021, the patient experienced CHEST DISCOMFORT (Intermittent chest discomfort/pain), PALPITATIONS (Irregular heartbeat/palpitations) and HYPERHIDROSIS (Diaphoresis lasting minutes to hours). At the time of the report, CHEST DISCOMFORT (Intermittent chest discomfort/pain), PALPITATIONS (Irregular heartbeat/palpitations) and HYPERHIDROSIS (Diaphoresis lasting minutes to hours) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Patient was seen by insurance companies urgent care, a cardiologist for the events reported and it was noted that patient had a right axis deviation in heart. This was confirmed at a follow up visit to a cardiologist. A few months later, patient had a clinic visit for evaluation of vascular system to determine if he had Vascular Ehlers Danlos, which was negative. At that time he no longer had a right axis deviation. Since then, patient moved to state and continued to experience intermittent chest discomfort/pain. Patient would provide EKG, echo cardio and other test/lab results from his clinic visits. Treatment information was not reported.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Expired Vaccination Administed; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccination Administed) and NO ADVERSE EVENT (No adverse event) in a  patient of an unknown age and gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7170B) for COVID-19 prophylaxis.     The patient received other vaccines in the 4 weeks prior to COVID-19 vaccine.    On 15-May-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) 1 dosage form. On 20-Jun-2023, received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) dosage was changed to .25 milliliter. On 20-Jun-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccination Administed). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired Vaccination Administed) and NO ADVERSE EVENT (No adverse event) outcome was unknown.            No concomitant medication was reported. No treatment medication was reported.
Age: 65.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; HCP advised that her office administer 3 vaccinations with expired vaccines; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP advised that her office administer 3 vaccinations with expired vaccines) and NO ADVERSE EVENT (No adverse event) in a 65-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. 069H22A) for COVID-19 prophylaxis.     Patient's relevant medical history/conditions, allergy, concomitant diseases and risk factor were unknown.     On 12-Jul-2023, 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 12-Jul-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP advised that her office administer 3 vaccinations with expired vaccines). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP advised that her office administer 3 vaccinations with expired vaccines) 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 (HCP advised that her office administer 3 vaccinations with expired vaccines).    Patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine were unknown. Concomitant medication details not reported by the reporter. Dosage text was reported as unknown. Treatment details was not reported by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-733100, US-MODERNATX, INC.-MOD-2023-733104 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-733100:Same reporter US-MODERNATX, INC.-MOD-2023-733104:Same reporter
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Constant headache located front/top of the head; This is a spontaneous report received from a contactable reporter (Other HCP). The reporter is the patient.  A 28-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 19Jan2023 as dose 3 (booster), single (Lot number: GJ6742) at the age of 28 years, in left arm for COVID-19 immunisation. The patient's relevant medical history included: "Migraines", start date: 2010 (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: prior to vaccination. The patient's concomitant medications were not reported. Vaccination history included: BNT162b2 (dose 1, single; lot number: FJ9943; site: left arm), administration date: 29Mar2022, when the patient was 27-year-old, for COVID-19 immunization; BNT162b2 (dose 2, single; lot number: FJ9943; site: left arm), administration date: 26Apr2022, when the patient was 27-year-old, for COVID-19 immunization. The following information was reported: HEADACHE (medically significant) with onset 20Jan2023, outcome "not recovered", described as "Constant headache located front/top of the head". The event "constant headache located front/top of the head" required physician office visit. Therapeutic measures were taken as a result of headache. Clinical course: Constant headache located front/top of the head. No relief even with OTC medications and prescribed medications (3 different medications). Went to the doctor 4 times with the same complaint. Headaches started the day after 3rd dose of the Pfizer COVID shot. The patient has not tested for COVID post-vaccination. She has no known allergies.  No follow-up attempts are possible. No further information is expected.; Sender's Comments: Based on the temporal relation, the association between the event headache and the suspect product cannot be completely ruled out. The impact of this report on the benefit/risk profile of the Pfizer drug is evaluated as part of Pfizer procedures for safety evaluation, including the review and analysis of aggregate data for adverse events. Any safety concern identified as part of this review, as well as any appropriate action in response, will be promptly notified to Regulatory Authorities, Ethics Committees, and Investigators, as appropriate.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; 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 male patient received BNT162b2 (BNT162B2 NOS), on 15Nov2022 at 10:00 as dose number unknown, single (Batch/Lot number: unknown) at the age of 70 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "diabetes" (unspecified if ongoing); "high blood pressure" (unspecified if ongoing). There were no concomitant medications. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid treatment from 02Jul2023 to 06Jul2023. Clinical Course: Patient reported to have no known allergies.  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-202300249023 Same patient, different product, different event (Paxlovid);
Sex: M
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: mentioned that he took the 5th dose of Pfizer COVID vaccines and it screwed up his arm; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID: (RA). The reporter is the patient.  A male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 5 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 2, SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunization; Bnt162b2 (DOSE 4 (BOOSTER), SINGLE), for COVID-19 immunization. The following information was reported: LIMB DISCOMFORT (non-serious), outcome "unknown", described as "mentioned that he took the 5th dose of Pfizer COVID vaccines and it screwed up his arm".  Additional information : The caller, who was a consumer, mentioned that he took the 5th dose of Pfizer COVID vaccines and it screwed up his arm. He wanted to know if they had an antidote for what he was experiencing. Caller stated his side effect which was not mentioned was going all the way to his shoulder. neck, and ear.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.
Sex: M
Vaccine: COVID19
Symptoms: Dialysis, Dizziness, Fatigue, Feeling hot, Headache
Clinical narrative: Dialysis; While in the procedure he started to feel unwell; Headache; felt hot in the back of the head; Tiredness; he felt dizzy 4 times/Dizziness; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the patient.  A 73-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 11Jul2023 at 09:00 as dose number unknown (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. Vaccination history included: Covid-19 vaccine (Primary Immunization series complete; unknown manufacturer, 1 year ago he had received another dose of the vaccine.), for COVID-19 immunisation. The following information was reported: DIALYSIS (medically significant) with onset 12Jul2023, outcome "unknown"; HEADACHE (non-serious) with onset 12Jul2023, outcome "recovering"; FATIGUE (non-serious) with onset 12Jul2023, outcome "recovering", described as "Tiredness"; MALAISE (medically significant) with onset 12Jul2023, outcome "recovering", described as "While in the procedure he started to feel unwell"; FEELING HOT (non-serious) with onset 12Jul2023, outcome "recovering", described as "felt hot in the back of the head"; DIZZINESS (non-serious) with onset 12Jul2023, outcome "recovering", described as "he felt dizzy 4 times/Dizziness". Therapeutic measures were taken as a result of malaise, headache, feeling hot, fatigue, dizziness. Clinical course: Caller explained that yesterday (11Jul2023) around 9 AM, he received the booster dose of the Pfizer-BioNTech COVID-19 vaccine. He mentioned that 1 year ago he had received another dose of the vaccine. Today (12Jul2023) around 8:30 AM he underwent dialysis. While in the procedure he started to feel unwell; he felt dizzy 4 times. About every half hour he felt dizzy again, and this was repeated 4 times. He described that he was lying down and that's why he couldn't fall, but he felt like he was going to faint. He had a headache and felt "hot" in the back of the head. He was given Tylenol at the site. All of these symptoms occurred about 24 hours after vaccination. He explained that at the time of the call he had no longer had those symptoms and that he was feeling better. He wanted to know how to treat his symptoms if it happened again.  The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5 has been requested and will be submitted if and when received.