chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 1.5
Sex: F
Vaccine: HEPA
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 2nd dose was administered 13 days early. 1st dose on 01/30/2023 2nd dose :07/17/2023; 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 short in a 18-month-old female patient who received HAV (Havrix) (batch number 9r5lc, expiry date 02-NOV-2024) for prophylaxis.   Previously administered products included Havrix (received 1st dose on 30th January 2023).   On 17-JUL-2023, the patient received the 2nd dose of Havrix. On 17-JUL-2023, an unknown time after receiving Havrix, the patient experienced drug dose administration interval too short (Verbatim: 2nd dose was administered 13 days early. 1st dose on 01/30/2023 2nd dose :07/17/2023). The outcome of the drug dose administration interval too short was unknown.   Additional Information: GSK receipt date: 27-Jul-2023 The reporter consented to follow-up. The patient received 2nd dose of Havrix earlier than the recommended interval, which led to shortening of vaccine schedule.
Age: 66.0
Sex: F
Vaccine: VARZOS
Symptoms: Incorrect dose administered, Product preparation error
Clinical narrative: Shingrix antigen was mixed with a regular sterile diluent and not the corresponding adjuvant; Shingrix antigen was mixed with a regular sterile diluent and not the corresponding adjuvant; This non-serious case was reported by a nurse via call center representative and described the occurrence of wrong solution used in drug reconstitution in a 66-year-old female patient who received Herpes zoster (Shingrix) (batch number ZM749, expiry date 22-AUG-2025) for prophylaxis.   On 27-JUL-2023, the patient received the 1st dose of Shingrix (intramuscular, right arm) .5 ml. On 27-JUL-2023, an unknown time after receiving Shingrix, the patient experienced wrong solution used in drug reconstitution (Verbatim: Shingrix antigen was mixed with a regular sterile diluent and not the corresponding adjuvant) and inappropriate dose of vaccine administered (Verbatim: Shingrix antigen was mixed with a regular sterile diluent and not the corresponding adjuvant). The outcome of the wrong solution used in drug reconstitution and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 28-JUL-2023 The reporter reported that a vaccine given to a patient that was reconstituted wrong (Inappropriate Reconstitution Technique).  This was 1 of 2 cases, reported by the same reporter. The reporter consented to follow up. The reporter reported that the Shingrix antigen was mixed with a regular sterile diluent and not the corresponding adjuvant, which led to wrong solution used in drug reconstitution and inappropriate dose of vaccine administered.; Sender's Comments:  US-GSK-US2023103552:Same reporter
Age: 12.0
Sex: M
Vaccine: MNQ
Symptoms: Incorrect dose administered, Product preparation issue
Clinical narrative: inadvertently administered the Menveo(2-vial) diluent component; inadvertently administered the Menveo(2-vial) diluent component; This non-serious case was reported by a nurse via call center representative and described the occurrence of inappropriate preparation of medication in a 12-year-old male patient who received Men ACWY-CRM NVS (Menveo) (batch number AMX8733A, expiry date 31-MAR-2024) for prophylaxis.   On 28-JUL-2023, the patient received Menveo (left deltoid). On 28-JUL-2023, an unknown time after receiving Menveo, the patient experienced inappropriate preparation of medication (Verbatim: inadvertently administered the Menveo(2-vial) diluent component) and inappropriate dose of vaccine administered (Verbatim: inadvertently administered the Menveo(2-vial) diluent component). The outcome of the inappropriate preparation of medication and inappropriate dose of vaccine administered were unknown.   Additional Information: GSK Receipt Date: 28-JUL-2023 The reporter called to inquire that how to proceed. The reporter did not consent to follow-up. The reporter reported that they inadvertently administered the Menveo (2-vial) diluent component only without the lyophilized component to a patient in the left deltoid, which led to inappropriate preparation of medication and inappropriate dose of vaccine administered.
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Ageusia, Burning sensation, Sensory loss
Clinical narrative: LOST THE TASTE; LOST ALL THE FEELINGS IN THE RIGHT FOOT AND IT IS GOING UP HIS LEG; AMBER BURN THROUGH THE TOP OF THE SHOE AND WENT IN BETWEEN HIS BIG TOE AND HE NEVER FELT IT; This spontaneous report received from a patient concerned a 42 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: patient stated that he does not take any medications or anything else and was healthy before vaccination. 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 and has been requested. Age at time of vaccination 5 decade old. No concomitant medications were reported. On an unspecified date, the patient experienced lost the taste, lost all the feelings in the right foot and it is going up his leg, and amber burn through the top of the shoe and went in between his big toe and he never felt it. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from lost the taste, had not recovered from lost all the feelings in the right foot and it is going up his leg, and the outcome of amber burn through the top of the shoe and went in between his big toe and he never felt it was not reported. This report was non-serious. This report was associated with product quality complaint: 90000291079. The suspected product quality complaint has been confirmed to this customer preference case had been assessed and does not represent a product quality complaint or product performance issue based on the PQC evaluation/investigation performed.    .  .
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: PAXLOVID REBOUND; This spontaneous report received from a patient concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. Non-company suspect drugs included: nirmatrelvir/ritonavir ( form of admin, route of admin, and batch number were not reported) dose and frequency were not reported from 09-JUL-2023 to 13-JUL-2023 for covid-19 treatment. No concomitant medications were reported. On an unspecified date, the patient experienced paxlovid rebound. The action taken with covid-19 vaccine ad26.cov2.s was not applicable and action taken with nirmatrelvir/ritonavir was not reported. The patient was recovering from paxlovid rebound. This report was non-serious.
Sex: U
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Got Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Got Covid) 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. A3716313) for COVID-19 prophylaxis.     Previously administered products included for Product used for unknown indication: PFIZER BIONTECH COVID-19 VACCINE (Dose Number: 1, Batch/Lot No.: EL3247) on 30-Mar-2021, PFIZER BIONTECH COVID-19 VACCINE (Dose Number: 2 and Batch/Lot No.: EL3247) on 21-Apr-2021. Past adverse reactions to the above products included No adverse effect with PFIZER BIONTECH COVID-19 VACCINE and PFIZER BIONTECH COVID-19 VACCINE.    On 01-Oct-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 24-Jul-2023, the patient experienced COVID-19 (Got Covid). At the time of the report, COVID-19 (Got Covid) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jul-2023, SARS-CoV-2 test: (Positive) Nasal Swab.         Concomitant medication information was not provided.  The patient received third dose of Moderna vaccine (having lot no. 060H21A) on 11-Dec-2021.  Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Blood pressure measurement, Headache, Malaise, SARS-CoV-2 test
Clinical narrative: Felt very uncomfortable with all the Covid-19 vaccines; Had flu like headache for 4 days but survived it; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt very uncomfortable with all the Covid-19 vaccines) and HEADACHE (Had flu like headache for 4 days but survived it) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939903 and 054222A) for COVID-19 prophylaxis.     Previously administered products included for Drug use for unknown indication: Pfizer vaccine (Lot number - EL3247) on 19-Jan-2021 and Pfizer vaccine (Lot number EM9810) on 09-Feb-2021. Past adverse reactions to the above products included Chills with Pfizer vaccine and Pfizer vaccine. Concurrent medical conditions included AFib and Drug allergy.   On 10-Dec-2021 at 3:40 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Jun-2022 at 5:20 PM, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MALAISE (Felt very uncomfortable with all the Covid-19 vaccines) and HEADACHE (Had flu like headache for 4 days but survived it). At the time of the report, MALAISE (Felt very uncomfortable with all the Covid-19 vaccines) and HEADACHE (Had flu like headache for 4 days but survived it) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Jan-2023, SARS-CoV-2 test: Positive. On 12-Jul-2023, SARS-CoV-2 test: Positive. On an unknown date, Blood pressure measurement: Over 151.         Patient had afib heart problem and talked to cardiologist when medication came in they told to take half of the Eliquis prescribed and Cholesterol medication. When patient was looking on medication packet, the manufacturer was Pfizer hence said no, did not want any problem again. Patient also had upper respiratory hence doctor gave antibiotics for 3 days. Patient had dose1 of Pfizer and later had awful chill all night and flu like haeadche and all that type for 3 days. Patient had dose 2 of Pfizer COVID-19 vaccine and had chills again and next day woke-up with swollen lips and tingling sensation.Patient pressure was 151 over something and they did neurological. Patient had allergic reaction with Pfizer. Patient had same kind of throat problem and thought it was strep. Patient was on blood thinner. Concomitant medications were not reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-734475 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-734475:Bivalent Suspect for same patient
Age: 38.0
Sex: M
Vaccine: COVID19-2
Symptoms: Myelitis transverse
Clinical narrative: Transverse Myelitis attack shortly after booster.; This spontaneous case was reported by a patient and describes the occurrence of MYELITIS TRANSVERSE (Transverse Myelitis attack shortly after booster.) in a 38-year-old male 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.     No Medical History information was reported.    On 06-Jan-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) .5 milliliter. On an unknown date, the patient experienced MYELITIS TRANSVERSE (Transverse Myelitis attack shortly after booster.) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 04-May-2023 due to MYELITIS TRANSVERSE. At the time of the report, MYELITIS TRANSVERSE (Transverse Myelitis attack shortly after booster.) had not resolved.        The action taken with mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) was unknown.   For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication was not provided. Patient experienced transverse Myelitis attack shortly after booster and was hospitalized on 4/05/2023. He stayed in the hospital for a month and a half. Treatment information was not reported. Company Comment: This is a spontaneous case concerning a 38-year-old male patient with no medical history, who experienced the serious (due to medically significant and hospitalization) unexpected, AESI event of myelitis transverse, which occurred on an unknown date after a dose of mRNA-1273 Bivalent .222 (original and omicron BA.4/BA.5), received as the third dose of COVID-19 vaccination schedule. The outcome of the event was reported as not recovered. It was reported that patient experienced transverse Myelitis attack shortly after booster and was hospitalized. He stayed in the hospital for a month and a half. The benefit-risk relationship of mRNA-1273 Bivalent .222 (original and omicron BA.4/BA.5), is not affected by this report.
Age: 64.0
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Pharyngitis streptococcal, Sinusitis
Clinical narrative: Sinus infection; strep throat; Covid 19; This spontaneous case was reported by a consumer and describes the occurrence of SINUSITIS (Sinus infection), PHARYNGITIS STREPTOCOCCAL (strep throat) and COVID-19 (Covid 19) in a 64-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.     Concomitant products included PROCAINE BENZYLPENICILLIN (PENICILLIN PROCAIN) for an unknown indication.  On 08-Sep-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 24-Jul-2023,  after starting mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)), the patient experienced COVID-19 (Covid 19). On an unknown date, the patient experienced SINUSITIS (Sinus infection) and PHARYNGITIS STREPTOCOCCAL (strep throat). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at an unspecified dose and frequency. At the time of the report, SINUSITIS (Sinus infection) outcome was unknown and PHARYNGITIS STREPTOCOCCAL (strep throat) and COVID-19 (Covid 19) had not resolved.     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.   The patient received 4 doses of the Moderna COVID-19 vaccines and now has COVID-19.  The patient received first dose on 03-Mar-2021 (lot number 026A21A), second dose on 31-Mar-2021 (lot number 025B21A) and third dose on 25-Aug-2021 (lot number 028D21A).  On an unknown date, the symptoms started with mostly fatigue, and feeling overall crappy and tired. She went to the doctor yesterday who diagnosed her with COVID after a test. She also had a sinus infection and was taking penicillin.   The patient was so sick with COVID. HCP diagnosed her with COVID 4 days ago and prescribed her with Pfizer's Paxlovid and penicillin. Patient had throat and nasal swab 4 days ago and tested it and Doctor said she had COVID and strep throat. Taking Paxlovid and penicillin for 4 days. Feeling sicker than when she had chemo. This was patient's first time having COVID.   Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2023: Live follow-up information received included updated narrative.
Age: 63.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Migraine, Nasal congestion, SARS-CoV-2 test
Clinical narrative: migraine/So far he had 41 Migraine attacks since; stuffy nose; Covid 19; This spontaneous case was reported by a patient and describes the occurrence of MIGRAINE (migraine/So far he had 41 Migraine attacks since), NASAL CONGESTION (stuffy nose) and COVID-19 (Covid 19) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 067F21A, 003A21 and 030B21A) for COVID-19 prophylaxis.     Family history included Migraine (Brother also had 3-4 migraines per year prior to vaccination). Concurrent medical conditions included Migraine (3-4 Migraines per year prior to vaccination.). Concomitant products included CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for Discomfort in nose, SUMATRIPTAN for Headache, ZINC and MAGNESIUM for an unknown indication.   On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced COVID-19 (Covid 19). On an unknown date, the patient experienced MIGRAINE (migraine/So far he had 41 Migraine attacks since) and NASAL CONGESTION (stuffy nose). The patient was treated with CAFFEINE at an unspecified dose and frequency; ACETAMINOPHEN at an unspecified dose and frequency and ACETYLSALICYLIC ACID (ASPIRINE) at an unspecified dose and frequency. At the time of the report, MIGRAINE (migraine/So far he had 41 Migraine attacks since), NASAL CONGESTION (stuffy nose) and COVID-19 (Covid 19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2022, SARS-CoV-2 test: (Positive) Since COVID Disease, his mouth and tongue still has metallic taste..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Because patient's migraine frequency increased he did not get any more shots. He used to have 3-4 Migraines per year prior to vaccination. The Migraine appeared when they were 13-yrears-old. Doctor prescribed Amitriptyline 10 mg once a day at bedtime but he has not been taking it. He was afraid of the medication side effects. After vaccination, a lot of times, he needed that second Sumatriptan 50 mg dose. 3-4 times, the headache was so bad, and not controlled with medicine, that he had to visit the emergency room.   This case was linked to US-MODERNATX, INC.-MOD-2023-734525 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2023: Patient details, medical history, lab, concomitant and event information reported.; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-734525:Patient's brother case
Age: 76.0
Sex: F
Vaccine: COVID19-2
Symptoms: Fatigue
Clinical narrative: The patient felt tired; This spontaneous case was reported by a patient and describes the occurrence of FATIGUE (The patient felt tired ) in a 76-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 057F22A) for COVID-19 prophylaxis.     No Medical History information was reported.  Concomitant products included LEVOTHYROXINE for an unknown indication.    On 07-Oct-2022, the patient received fifth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (The patient felt tired ). At the time of the report, FATIGUE (The patient felt tired ) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   Patient was generally healthy.  No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-734615, US-MODERNATX, INC.-MOD-2023-734756 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-734615:Daughter's case US-MODERNATX, INC.-MOD-2023-734756:Husband's case
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: covid19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (covid19) in an adult female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     It was unknown if patient received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     In July 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 an unknown date, the patient experienced COVID-19 (covid19). At the time of the report, COVID-19 (covid19) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: Positive.     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. On an unknown date patient received Moderna Covid-19 Vaccine.  Suspect product dosage text was reported as unknown. It was reported that patient had some mild symptoms, achiness, muscle aches, fatigue, no respiratory issues. No treatment medication was reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19
Clinical narrative: Covid 19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Covid 19) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     There was no information about previous COVID-19 vaccination doses.     On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Covid 19). At the time of the report, COVID-19 (Covid 19) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. The dosage text was reported as unknown.  The patient's mother reported that the patient and other people that she had heard of have received the Moderna Covid-19 vaccine and then caught Covid-19. They had a milder case of Covid-19. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-734586, US-MODERNATX, INC.-MOD-2003-734594 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-734586:Patient's case US-MODERNATX, INC.-MOD-2003-734594:Patient's husband case
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event
Clinical narrative: no adverse event; patient was administered with the vaccine on 26 Jul 2023 and BUD date was 06 Jun 2023; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient was administered with the vaccine on 26 Jul 2023 and BUD date was 06 Jun 2023) 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. ASKU) for COVID-19 prophylaxis.     No Medical History information was reported.    On 26-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 26-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 (patient was administered with the vaccine on 26 Jul 2023 and BUD date was 06 Jun 2023). On an unknown date, the patient experienced NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient was administered with the vaccine on 26 Jul 2023 and BUD date was 06 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 (patient was administered with the vaccine on 26 Jul 2023 and BUD date was 06 Jun 2023).    Concomitant medication not reported.   Treatment medication not reported.   Reporter did not allow further contact
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; HCP stated a vaccine that expired in 02Apr2022 was administered to 2 patients on 05Apr2022; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP stated a vaccine that expired in 02Apr2022 was administered to 2 patients on 05Apr2022) and NO ADVERSE EVENT (No adverse event) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 prophylaxis.     It was reported that HCP did not describe medical history or condition. It was reported that patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 05-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 05-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP stated a vaccine that expired in 02Apr2022 was administered to 2 patients on 05Apr2022). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP stated a vaccine that expired in 02Apr2022 was administered to 2 patients on 05Apr2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP stated a vaccine that expired in 02Apr2022 was administered to 2 patients on 05Apr2022).    No concomitant medication was reported. Suspect product dosage text was reported as unknown. It was reported that patient received the second booster. This case is reported for patient 2. No treatment medication was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-734675 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-734675:Same Reporter ,Patient 1
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; HCP stated a vaccine that expired in 02-Apr-2022 was administered to patient on 05-Apr-2022, 3 days later; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP stated a vaccine that expired in 02-Apr-2022 was administered to patient on 05-Apr-2022, 3 days later) and NO ADVERSE EVENT (No adverse event) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 05-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 05-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP stated a vaccine that expired in 02-Apr-2022 was administered to patient on 05-Apr-2022, 3 days later). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP stated a vaccine that expired in 02-Apr-2022 was administered to patient on 05-Apr-2022, 3 days later) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP stated a vaccine that expired in 02-Apr-2022 was administered to patient on 05-Apr-2022, 3 days later).    It was unknown patient did receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No concomitant medication was reported.  Dosage text reported as unknown. No treatment information was reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-734665 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-734665:Same Reporter ,Patient 2
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Blood cholesterol, 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 67-year-old female patient (not pregnant) received BNT162b2 (BNT162B2 NOS), on 10Sep2022 as dose number unknown, single (Batch/Lot number: unknown) at the age of 66 years, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Diabetic" (ongoing); "Thyroid" (unspecified if ongoing); "high cholesterol" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2023, outcome "unknown" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: Blood cholesterol: High. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: COVID 19 treatment was Paxlovid. Treatment start date was 10Jul2023 and treatment stop date was 14Jul2023.  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-202300259273 same reporter/patient, different drug/event;
Age: 32.0
Sex: F
Vaccine: COVID19
Symptoms: Fungal infection, Oral candidiasis
Clinical narrative: oral thrush; I am severely ill but both times taking the bivalent booster has resulted in mild to severe fungal infections for me; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 32-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), in Sep2022 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 32 years for covid-19 immunisation. The patient's relevant medical history included: "POTS" (unspecified if ongoing); "IST" (unspecified if ongoing); "MCAS" (unspecified if ongoing); "hEDS" (unspecified if ongoing); "sleep apnea" (unspecified if ongoing); "asthma" (unspecified if ongoing); "IBS" (unspecified if ongoing); "arthritis" (unspecified if ongoing); "Known allergies: peanuts" (unspecified if ongoing); "Known allergies: cashews" (unspecified if ongoing); "immune compromised" (unspecified if ongoing); "oral thrush, which I have had before" (unspecified if ongoing). The patient's concomitant medications were not reported. Past drug history included: Known allergies: morphine, reaction(s): "Known allergies: morphine"; Known allergies: fluoroquinolones, reaction(s): "Known allergies: fluoroquinolones". Vaccination history included: Covid-19 vaccine (DOSE 1; MANUFACTURER UNKNOWN), for COVID-19 immunization; Covid-19 vaccine (DOSE 2; MANUFACTURER UNKNOWN), for COVID-19 immunization. The following information was reported: ORAL CANDIDIASIS (non-serious), outcome "unknown", described as "oral thrush"; FUNGAL INFECTION (non-serious), outcome "unknown", described as "I am severely ill but both times taking the bivalent booster has resulted in mild to severe fungal infections for me". The events "oral thrush" and "i am severely ill but both times taking the bivalent booster has resulted in mild to severe fungal infections for me" required physician office visit. Therapeutic measures were taken as a result of fungal infection.  Additional information: After her first bivalent does last Sep2022 she noticed that she had developed a case of oral thrush, which se had before so she thought nothing of that. she did not normally had fungus reactions like that unless she was severely ill but both times taking the bivalent booster had resulted in mild to severe fungal infections for her. she contacted her Dr. both times and she offered to prescribe fluconazole for the yeast infection but she had already taken Monistat over the counter and that started to recede by the time she offered. Patient had no covid prior vaccination. Patient had not covid tested post vaccination.  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.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300262392 same reporter/patient/drug, different dose/event;
Sex: U
Vaccine: COVID19
Symptoms: Blood test, Fatigue
Clinical narrative: I got the first vaccine and had one week of fatigue; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 1, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: FATIGUE (non-serious), outcome "recovered", described as "I got the first vaccine and had one week of fatigue". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: I'm reaching out to you to find out if fatigue is one of the side effects of the Pfizer vaccine. I got the first vaccine and had one week of fatigue. It is continued sporadically almost every month with fatigue that last from 2 to 5 days. If it is from the vaccine what actions can I take to deal with this situation. Please reply since my internist doesn't know why I'm getting this fatigue blood work shows no indications. case was reported as non-serious.  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: U
Vaccine: COVID19
Symptoms: Blood test, Fatigue
Clinical narrative: after the second vaccine I had 22 days of fatigue.; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team, Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 2, 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, bnt162b2 omi ba.4-5 (Dose 1, Single. I got the first vaccine and had one week of fatigue), for COVID-19 immunization, reaction(s): "fatigue". The following information was reported: FATIGUE (non-serious), outcome "not recovered", described as "after the second vaccine I had 22 days of fatigue.". Relevant laboratory tests and procedures are available in the appropriate section.  Additional information: I'm reaching out to you to find out if fatigue is one of the side effects of the Pfizer vaccine. After the second vaccine I had 22 days of fatigue. It is continued sporadically almost every month with fatigue that last from 2 to 5 days. If it is from the vaccine what actions can I take to deal with this situation. Please reply since my internist doesn't know why I'm getting this fatigue blood work shows no indications. case was reported as non-serious.  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.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Patient has had continuous tinnitus since receiving original COVID-19 vaccine series; This is a spontaneous report received from a contactable reporter(s) (Pharmacist).  A 61-year-old male patient received BNT162b2 (BNT162B2), on 02Jul2021 as dose 2, single (Lot number: EW0182) at the age of 61 years for covid-19 immunisation. The patient's relevant medical history included: "ADHD" (unspecified if ongoing); "hyperlipidemia" (unspecified if ongoing); "COVID-19" (unspecified if ongoing), notes: If covid prior vaccination: Yes. There were no concomitant medications. Vaccination history included: BNT162b2 (DOSE 1, SINGLE; lot number: ew018), administration date: 11Jun2021, when the patient was 61-year-old, for COVID-19 immunization. The following information was reported: TINNITUS (non-serious) with onset Jul2021, outcome "not recovered", described as "Patient has had continuous tinnitus since receiving original COVID-19 vaccine series". Therapeutic measures were not taken as a result of tinnitus.  Additional Information: The patient had covid prior vaccination and not tested positive post vaccination. No other vaccine in four weeks, no other medications in two weeks. No known allergies. Facility type vaccine was Doctor's office/urgent care.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Drug ineffective, Suspected COVID-19
Clinical narrative: There is something not right since I had the COVID shot; it did not help as far as I kept getting COVID but it did not helped COVID / I did get the vaccination and I did get COVID; There is something not right since I had the COVID shot; it did not help as far as I kept getting COVID but it did not helped COVID / I did get the vaccination and I did get COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Lot number: EN6201), on 17Mar2021 as dose 2, single (Lot number: ER2613), on 08Oct2021 as dose 3 (booster), single (Lot number: FE3590) and on 25Aug2022 as dose 4 (booster), single (Lot number: FT7140) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN taken for diabetes mellitus. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "There is something not right since I had the COVID shot; it did not help as far as I kept getting COVID but it did not helped COVID / I did get the vaccination and I did get COVID". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Dizziness, Dyspnoea, Erectile dysfunction, Fatigue, Feeling abnormal
Clinical narrative: There is something not right since I had the COVID shot; it did not help as far as I kept getting COVID but it did not helped COVID / I did get the vaccination and I did get COVID; There is something not right since I had the COVID shot; it did not help as far as I kept getting COVID but it did not helped COVID / I did get the vaccination and I did get COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Lot number: EN6201), on 17Mar2021 as dose 2, single (Lot number: ER2613), on 08Oct2021 as dose 3 (booster), single (Lot number: FE3590) and on 25Aug2022 as dose 4 (booster), single (Lot number: FT7140) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN taken for diabetes mellitus. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "There is something not right since I had the COVID shot; it did not help as far as I kept getting COVID but it did not helped COVID / I did get the vaccination and I did get COVID". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.
Age: 64.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Hot flush, Memory impairment, Pain
Clinical narrative: There is something not right since I had the COVID shot; it did not help as far as I kept getting COVID but it did not helped COVID / I did get the vaccination and I did get COVID; There is something not right since I had the COVID shot; it did not help as far as I kept getting COVID but it did not helped COVID / I did get the vaccination and I did get COVID; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old male patient received BNT162b2 (BNT162B2), on 24Feb2021 as dose 1, single (Lot number: EN6201), on 17Mar2021 as dose 2, single (Lot number: ER2613), on 08Oct2021 as dose 3 (booster), single (Lot number: FE3590) and on 25Aug2022 as dose 4 (booster), single (Lot number: FT7140) at the age of 64 years for covid-19 immunisation. The patient's relevant medical history included: "Diabetes" (unspecified if ongoing). Concomitant medication(s) included: METFORMIN taken for diabetes mellitus. The following information was reported: DRUG INEFFECTIVE (medically significant), SUSPECTED COVID-19 (medically significant), outcome "unknown" and all described as "There is something not right since I had the COVID shot; it did not help as far as I kept getting COVID but it did not helped COVID / I did get the vaccination and I did get COVID". Therapeutic measures were taken as a result of drug ineffective, suspected covid-19.
Sex: F
Vaccine: COVID19, 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).  An adult female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 and treated with anti-viral (Paxlovid) from Jul2023 to Jul2023.  No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.
Age: 31.0
Sex: M
Vaccine: COVID19, 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 32-year-old male patient received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 05Oct2022 as dose 4 (booster), single (Batch/Lot number: unknown) at the age of 31 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient had no relevant medical history. The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant) all with onset Jul2023, outcome "recovered" (Jul2023) and all described as "COVID 19 Treatment". Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid from 15Jul2023 to 19Jul2023. The patient had no known allergies.  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: Myocarditis, Pericarditis
Clinical narrative: myocarditis; pericarditis; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP) from medical information team. The reporter is the parent.  A 26-year-old male patient received BNT162b2 (BNT162B2), in Jun2021 as dose 1, single (Lot number: EW0180) for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: MYOCARDITIS (medically significant) with onset Jun2021, outcome "unknown"; PERICARDITIS (medically significant) with onset Jun2021, outcome "unknown".  Clinical course: It was reported she had been sending documentation for Pfizer since April, May and June about her son who was not supposed to receive the same shot, but had not received a clear answer. She mentioned since receiving the vaccination, her son had been dealing with myocarditis and pericarditis, and that she had been told by nurses that their sons have been getting sick too after receiving the vaccinations, and also a bunch of young people because of the proteins in the vaccine. Caller mentioned she had previously spoken to someone who advised her the timing between doses of the Purple Cap was 2 months and not 3 weeks and that we were lying to her.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300263441 same reprter, different patient/dose/event;US-PFIZER INC-202300263440 same reporter, different patient/event/dose;US-PFIZER INC-202300263439 same patient/event, different dose;
Sex: U
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested COVID positive; Tested COVID positive; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP), Program ID. The reporter is the patient.  A patient (no qualifiers provided) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation; BNT162b2 (BNT162B2), as dose 1, single (Batch/Lot number: unknown), as dose 2, single (Batch/Lot number: unknown) and as dose 3 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Chemotherapy" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "recovering" and all described as "Tested COVID positive". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive. Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient was taking 4th dose of the antiviral regimen and was amazed at how quickly she started improving after starting that medicine. she then noticed Pfizer was the brand.   The information on the batch/lot number for BNT162b2, BNT162b2 omi ba.4-5, BNT162b2 has been requested and will be submitted if and when received.