chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Injection site reaction
Clinical narrative: CHIP IN HIS ARM/SPOT ON HIS ARM THAT WAS HARD AND PROTRUDING ON HIS DELTOID MUSCLE; This spontaneous report received from a patient via a company representative concerned a 35 year old male. 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 not reported, batch number: 211A21A expiry: 14-DEC-2021) dose was not reported, administered on 23-SEP-2021 for covid-19 prophylaxis. Age at time of vaccination 35 years old. No concomitant medications were reported. On 30-SEP-2021, the patient experienced chip in his arm/spot on his arm that was hard and protruding on his deltoid muscle. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of chip in his arm / spot on his arm that was hard and protruding on his deltoid muscle was not reported. This report was non-serious.
Sex: M
Vaccine: VARZOS
Symptoms: Colitis ulcerative, Functional gastrointestinal disorder
Clinical narrative: Ulcerative colitis; bowel symptoms; This serious case was reported by a consumer and described the occurrence of ulcerative colitis in a 61-year-old male patient who received Herpes zoster (Shingrix) for prophylaxis.   On 11-JUL-2023, the patient received the 2nd dose of Shingrix. On 12-JUL-2023, 1 days after receiving Shingrix, the patient experienced ulcerative colitis (Verbatim: Ulcerative colitis) (serious criteria GSK medically significant). In JUL-2023, the patient experienced bowel dysfunction (Verbatim: bowel symptoms). The patient was treated with tofacitinib citrate (Xeljanz). The outcome of the ulcerative colitis and bowel dysfunction were not resolved.   It was unknown if the reporter considered the ulcerative colitis and bowel dysfunction to be related to Shingrix.     It was unknown if the company considered the ulcerative colitis and bowel dysfunction to be related to Shingrix.   Additional Information: GSK receipt date: 26-Jul-2023 Ulcerative colitis was in remission.  The patient took Xeljanz to treat, 2 days after dose 2 the patient started to have bowel symptoms that were still ongoing. The reporter was requested for consent to follow up.
Age: 62.0
Sex: M
Vaccine: COVID19-2
Symptoms: Migraine
Clinical narrative: Migraine Headaches (Frequency every 2 weeks); This spontaneous case was reported by a patient family member or friend and describes the occurrence of MIGRAINE (Migraine Headaches (Frequency every 2 weeks)) in a 62-year-old male patient 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.     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).    On an unknown date, 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 an unknown date, the patient experienced MIGRAINE (Migraine Headaches (Frequency every 2 weeks)). At the time of the report, MIGRAINE (Migraine Headaches (Frequency every 2 weeks)) 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.  It was reported that patient had an increase in Migraine Headaches (Frequency every 2 weeks) after vaccination. The patient received 4 Moderna COVID-19 vaccines, the last one about 2 months ago.  Patient had received dose 1, 2 and 3 of Moderna vaccine previously on an unknown date.  No treatment medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-734616 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2023: Live follow-up received contains non significant information; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-734616:Patient's brother case
Sex: U
Vaccine: COVID19
Symptoms: Death
Clinical narrative: Death; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (Death) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was stated that reporter has lost 22 family members in the past 2 years due to covid vaccine. Of this, 2 received with Moderna vaccine and 2 received the Pfizer.  No treatment medications were reported.  This case was for the first of 2 patients reported who died. Company comment- This is a fatal spontaneous case concerning a patient of unknown age and gender with no reported medical history who experienced the serious (death and medically significant), unexpected event of death.  A dose mRNA-1273 vaccine was administered. Temporal association cannot be assessed due to lack of information on onset date of the event and vaccination date. It is unknown if an autopsy was performed. It was stated that reporter lost family members in the past 2 years due to Moderna vaccine. No further details were provided for medical review. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-734472, MOD-2023-734863, US-MODERNATX, INC.-MOD-2023-734538, US-MODERNATX, INC.-MOD-2023-734864 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-734472:Invalid case (Patient 1 - MOD-2023-734472) MOD-2023-734863:Patient 3 (Fatal outcome) US-MODERNATX, INC.-MOD-2023-734538:Grandmother's case (Patient 2 - MOD-2023-734538) US-MODERNATX, INC.-MOD-2023-734864:Patient 4 (Fatal - MOD-2023-734864); Reported Cause(s) of Death: Death
Sex: U
Vaccine: COVID19-2
Symptoms: Death
Clinical narrative: Death; This spontaneous case was reported by a patient family member or friend and describes the occurrence of DEATH (Death) 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)) 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. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed.        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 relevant concomitant medications were reported. Reporter stated that he lost 22 family members in the past 2 years due to covid vaccine. Of this, 2 received the Moderna vaccine and 2 received the Pfizer. No treatment medication reported.  This case was for the second of 2 patients reported who died. Company comment This spontaneous case concerns a patient of an unknown age and gender, with no medical history reported, who experienced the unexpected, serious (medically significant and fatal), event of death. The patient received a dose of mRNA-1273.222 (BA.4/BA.5). The event onset date and vaccination date were not provided, thus, exact latency between vaccination and onset of the events could not be assessed. Reporter stated that he lost 22 family members in the past 2 years due to covid vaccine. Of this, 2 received the Moderna vaccine and 2 received the Pfizer. No treatment medication reported. This case was for the second of 2 patients reported who died. No further clinical information was provided for review. The benefit-risk relationship of mRNA-1273.222 (BA.4/BA.5) vaccine is not affected by this report.   This case was linked to US-MODERNATX, INC.-MOD-2023-734472, US-MODERNATX, INC.-MOD-2023-734538, US-MODERNATX, INC.-MOD-2023-734863 (E2B Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-734472:Invalid case (MOD-2023-734472 - Patient 1) US-MODERNATX, INC.-MOD-2023-734538:Grandmother case (MOD-2023-734538 - Patient 2) US-MODERNATX, INC.-MOD-2023-734863:Patient 4 (Fatal - MOD-2023-734864); Reported Cause(s) of Death: Unknwon cause of death
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Fatigue, Immunisation reaction
Clinical narrative: My husband and I had some of what I would consider to be minor reactions to our Moderna Covid-19 vaccine; Patient felt tired; The patient saw Dermatologist and the Dermatologist said that the condition was Covid elbow; This spontaneous case was reported by a consumer and describes the occurrence of IMMUNISATION REACTION (My husband and I had some of what I would consider to be minor reactions to our Moderna Covid-19 vaccine), FATIGUE (Patient felt tired) and COVID-19 (The patient saw Dermatologist and the Dermatologist said that the condition was Covid elbow) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IMMUNISATION REACTION (My husband and I had some of what I would consider to be minor reactions to our Moderna Covid-19 vaccine), FATIGUE (Patient felt tired) and COVID-19 (The patient saw Dermatologist and the Dermatologist said that the condition was Covid elbow). At the time of the report, IMMUNISATION REACTION (My husband and I had some of what I would consider to be minor reactions to our Moderna Covid-19 vaccine), FATIGUE (Patient felt tired) and COVID-19 (The patient saw Dermatologist and the Dermatologist said that the condition was Covid elbow) outcome was unknown.     mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant product use was not provided by the reporter.  On an unknown date, the patient saw Dermatologist and the Dermatologist said that the condition was Covid elbow, patient is not sure which shot this occurred after.  Treatment information was not provided.   This case was linked to US-MODERNATX, INC.-MOD-2023-734586 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-734586:Bivalent case (Monovalent MOD-2023-734866) (Same patient)
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Seasonal allergy
Clinical narrative: Hay fever; This spontaneous case was reported by a patient and describes the occurrence of SEASONAL ALLERGY (Hay fever) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    Patient had no ongoing medical conditions.  Previously administered products included for Product used for unknown indication: COVID vaccine (Patient have had the COVID vaccine and three boosters.). Past adverse reactions to the above products included No adverse event with COVID vaccine.   On 18-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Oct-2022, the patient received dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced SEASONAL ALLERGY (Hay fever). The patient was treated with FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Hay fever, at an unspecified dose and frequency. At the time of the report, SEASONAL ALLERGY (Hay fever) outcome was unknown.            No relevant concomitant medications were reported.   Patient had never contracted COVID and his last dose was of Pfizer.
Age: 79.0
Sex: M
Vaccine: COVID19-2
Symptoms: Fatigue, Immunisation reaction, Pain in extremity
Clinical narrative: My husband and I had some of what I would consider to be minor reactions to our Moderna Covid-19 vaccine; Her husband was very tired after the 5th dose; Arm was very sore; This spontaneous case was reported by a patient family member or friend and describes the occurrence of IMMUNISATION REACTION (My husband and I had some of what I would consider to be minor reactions to our Moderna Covid-19 vaccine), FATIGUE (Her husband was very tired after the 5th dose) and PAIN IN EXTREMITY (Arm was very sore) in an 80-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.    In October 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 09-Oct-2022, the patient experienced PAIN IN EXTREMITY (Arm was very sore). On an unknown date, the patient experienced IMMUNISATION REACTION (My husband and I had some of what I would consider to be minor reactions to our Moderna Covid-19 vaccine) and FATIGUE (Her husband was very tired after the 5th dose). At the time of the report, IMMUNISATION REACTION (My husband and I had some of what I would consider to be minor reactions to our Moderna Covid-19 vaccine) outcome was unknown and FATIGUE (Her husband was very tired after the 5th dose) and PAIN IN EXTREMITY (Arm was very sore) had 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.   No concomitant medications were reported. The reporter stated that doesn't have the reliable information on previous vaccines doses.  It was reported that soreness was lasted for 3-4 days. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2023-734586, US-MODERNATX, INC.-MOD-2003-734594 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2023: Follow up received with significant information; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-734586:Master case (For wife) US-MODERNATX, INC.-MOD-2003-734594:Non Reatin Case (Deletion case)
Age: 32.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was initially stored in the refrigerator was 25 Mar 2022, they administered an expired vaccine by 5 days and date of administration of vaccine was 25 Mar 2022.; no adverse event; they administered an expired vaccine by 5 days; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (they administered an expired vaccine by 5 days), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator was 25 Mar 2022, they administered an expired vaccine by 5 days and date of administration of vaccine was 25 Mar 2022.) and NO ADVERSE EVENT (no adverse event) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 25-Mar-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 25-Mar-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (they administered an expired vaccine by 5 days). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator was 25 Mar 2022, they administered an expired vaccine by 5 days and date of administration of vaccine was 25 Mar 2022.) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (they administered an expired vaccine by 5 days), PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator was 25 Mar 2022, they administered an expired vaccine by 5 days and date of administration of vaccine was 25 Mar 2022.) 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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (they administered an expired vaccine by 5 days) and PRODUCT STORAGE ERROR (Vial was initially stored in the refrigerator was 25 Mar 2022, they administered an expired vaccine by 5 days and date of administration of vaccine was 25 Mar 2022.).    Concomitant medication not reported.   The vial did not undergo any temperature excursions.  Treatment medication not reported.
Age: 31.0
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: vaccine places out of the freezer into fridge on 07-Jun-2023 and was administered on 27-Jul-2023; no adverse event; Administered an expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered an expired vaccine), PRODUCT STORAGE ERROR (vaccine places out of the freezer into fridge on 07-Jun-2023 and was administered on 27-Jul-2023) and NO ADVERSE EVENT (no adverse event) in a 31-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. AS7184B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Jul-2023, the patient received third dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 27-Jul-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered an expired vaccine). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (vaccine places out of the freezer into fridge on 07-Jun-2023 and was administered on 27-Jul-2023) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered an expired vaccine), PRODUCT STORAGE ERROR (vaccine places out of the freezer into fridge on 07-Jun-2023 and was administered on 27-Jul-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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Administered an expired vaccine) and PRODUCT STORAGE ERROR (vaccine places out of the freezer into fridge on 07-Jun-2023 and was administered on 27-Jul-2023).    No concomitant medication was reported. The vaccine expired date was reported as 03-Jul-2023.  No treatment medication was reported.
Age: 82.0
Sex: F
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Date the vial was initially stored in the refrigerator on 05-JUN-2023 and administred to patient 26-JUL-2023; No adverse event; Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 05-JUN-2023 and administred to patient 26-JUL-2023) and NO ADVERSE EVENT (No adverse event) in an 82-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7643E) 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) .5 milliliter. 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 (Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 05-JUN-2023 and administred to patient 26-JUL-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 05-JUN-2023 and administred to patient 26-JUL-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 assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after Manufacturer Date of Expiry) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator on 05-JUN-2023 and administred to patient 26-JUL-2023).    It was unknown patient did receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. No concomitant medication was reported.  Vial size was 2.5 mL. Date the vial was initially stored in the refrigerator on 05-JUN-2023. The vial did not undergo any temperature excursions. No treatment information was reported.  This case contains information for patient 2 of 2.   This case was linked to US-MODERNATX, INC.-MOD-2023-734830 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-734830:Patient 1
Age: 18.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: initially stored in the refrigerator on 20 Jun 2023, date of administration 27 Jul 2023 and Dose administered after 30-day Use by Date; no adverse event; Dose administered after 30-day Use By Date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (initially stored in the refrigerator on 20 Jun 2023, date of administration 27 Jul 2023 and Dose administered after 30-day Use by Date) and NO ADVERSE EVENT (no adverse event) in an 18-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 062F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Jul-2023, the patient received first dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 2.5 milliliter. On 27-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 (Dose administered after 30-day Use By Date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (initially stored in the refrigerator on 20 Jun 2023, date of administration 27 Jul 2023 and Dose administered after 30-day Use by Date) and NO ADVERSE EVENT (no adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date), PRODUCT STORAGE ERROR (initially stored in the refrigerator on 20 Jun 2023, date of administration 27 Jul 2023 and Dose administered after 30-day Use by Date) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date) and PRODUCT STORAGE ERROR (initially stored in the refrigerator on 20 Jun 2023, date of administration 27 Jul 2023 and Dose administered after 30-day Use by Date).    Concomitant medication not reported.   The vial did not undergo any temperature excursions.  Treatment medication not reported.
Age: 3.0
Sex: F
Vaccine: COVID19-2
Symptoms: No adverse event, Wrong product administered
Clinical narrative: No adverse event; The patient got bivalent pink cap 0.25mL pink instead of the blue cap for their second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (The patient got bivalent pink cap 0.25mL pink instead of the blue cap for their second dose) and NO ADVERSE EVENT (No adverse event) in a 3-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch nos. 216K22A and AS7643E) for COVID-19 prophylaxis.     Relevant medical history or conditions, allergy, concomitant diseases and risk factor were none.    On 28-Jun-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 26-Jul-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 26-Jul-2023, the patient experienced WRONG PRODUCT ADMINISTERED (The patient got bivalent pink cap 0.25mL pink instead of the blue cap for their second dose). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, WRONG PRODUCT ADMINISTERED (The patient got bivalent pink cap 0.25mL pink instead of the blue cap for their 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 (The patient got bivalent pink cap 0.25mL pink instead of the blue cap for their second dose).    Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  Concomitant product use was not provided by the reporter.  Patient one bivalent toddler dose previously and no monovalent doses. First dose was bivalent blue cap. No side effects were reported by parent.  Treatment information was not provided.
Age: 64.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19 Treatment; COVID 19 Treatment; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 65-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 04Dec2022 at 17:45 as dose 3 (booster), single (Batch/Lot number: unknown) at the age of 64 years, in left arm for covid-19 immunisation; coviD-19 vaccine (COVID-19 VACCINE), as dose 1, single (Batch/Lot number: unknown) and as dose 2, single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "IBS" (unspecified if ongoing), notes: Other medical history: IBS. Concomitant medication(s) included: OMEPRAZOLE, start date: Jan2019. Past drug history included: Lactose, reaction(s): "Known allergies: Lactose intolerant", notes: Known allergies: Lactose intolerant. The following information was reported: DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "not recovered" and all described as "COVID 19 Treatment". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Tested positive immediately. Therapeutic measures were taken as a result of drug ineffective, covid-19 with Paxlovid.  Clinical course: It was reported that the patient had taken previous vaccination and medications within 2 weeks rebound occurred four days after last pill was taken. Basically the same symptoms of head congestion, fatigue, watery eyes and dry mouth. Tested positive immediately. Initial Paxlovid was taken with hours of first symptoms.  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: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure measurement, Ear discomfort, Head discomfort, Hypoacusis
Clinical narrative: head is full or pressured; hearing is distorted; pressure in my ears; feel weak; general malaise; upper body aches; dose 1 to dose 5: Moderna, dose 6: Pfizer; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). 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 27Jul2023 at 14:30 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 73 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Food allergies" (unspecified if ongoing), notes: Food allergies, all of which I avoid; "Blood pressure" (unspecified if ongoing). Concomitant medication(s) included: DILTIAZEM; HCTZ; ELIQUIS; ATORVASTATIN. Vaccination history included: coviD-19 vaccine moderna (DOSE 5 (BOOSTER), SINGLE), administration date: 03Mar2022, when the patient was 71-year-old, for COVID-19 Immunization; Covid-19 vaccine moderna (DOSE 1, SINGLE), for COVID-19 Immunization; Covid-19 vaccine moderna (DOSE 2, SINGLE), for COVID-19 Immunization; Covid-19 vaccine moderna (DOSE 3 (BOOSTER), SINGLE), for COVID-19 Immunization; Covid-19 vaccine moderna (DOSE 4 (BOOSTER), SINGLE), for COVID-19 Immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 27Jul2023 at 14:30, outcome "not recovered", described as "dose 1 to dose 5: Moderna, dose 6: Pfizer"; ASTHENIA (non-serious) with onset 27Jul2023 at 19:00, outcome "not recovered", described as "feel weak"; MALAISE (non-serious) with onset 27Jul2023 at 19:00, outcome "not recovered", described as "general malaise"; HEAD DISCOMFORT (non-serious) with onset 27Jul2023 at 19:00, outcome "not recovered", described as "head is full or pressured"; HYPOACUSIS (non-serious) with onset 27Jul2023 at 19:00, outcome "not recovered", described as "hearing is distorted"; EAR DISCOMFORT (non-serious) with onset 27Jul2023 at 19:00, outcome "not recovered", described as "pressure in my ears"; PAIN (non-serious) with onset 27Jul2023 at 19:00, outcome "not recovered", described as "upper body aches". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of head discomfort, hypoacusis, ear discomfort, asthenia, malaise, pain.  Additional information: The patient did not receive any other vaccines within 4 weeks prior vaccination. The patient had not been diagnosed with COVID-19 prior vaccination and had not been tested for COVID-19 since vaccination. The side effects of Moderna were short lived and minimal.  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: 73.0
Sex: M
Vaccine: COVID19
Symptoms: Interchange of vaccine products, Malaise, Pain
Clinical narrative: head is full or pressured; hearing is distorted; pressure in my ears; feel weak; general malaise; upper body aches; dose 1 to dose 5: Moderna, dose 6: Pfizer; This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). 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 27Jul2023 at 14:30 as dose 6 (booster), single (Batch/Lot number: unknown) at the age of 73 years intramuscular, in left arm for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Food allergies" (unspecified if ongoing), notes: Food allergies, all of which I avoid; "Blood pressure" (unspecified if ongoing). Concomitant medication(s) included: DILTIAZEM; HCTZ; ELIQUIS; ATORVASTATIN. Vaccination history included: coviD-19 vaccine moderna (DOSE 5 (BOOSTER), SINGLE), administration date: 03Mar2022, when the patient was 71-year-old, for COVID-19 Immunization; Covid-19 vaccine moderna (DOSE 1, SINGLE), for COVID-19 Immunization; Covid-19 vaccine moderna (DOSE 2, SINGLE), for COVID-19 Immunization; Covid-19 vaccine moderna (DOSE 3 (BOOSTER), SINGLE), for COVID-19 Immunization; Covid-19 vaccine moderna (DOSE 4 (BOOSTER), SINGLE), for COVID-19 Immunization. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (non-serious) with onset 27Jul2023 at 14:30, outcome "not recovered", described as "dose 1 to dose 5: Moderna, dose 6: Pfizer"; ASTHENIA (non-serious) with onset 27Jul2023 at 19:00, outcome "not recovered", described as "feel weak"; MALAISE (non-serious) with onset 27Jul2023 at 19:00, outcome "not recovered", described as "general malaise"; HEAD DISCOMFORT (non-serious) with onset 27Jul2023 at 19:00, outcome "not recovered", described as "head is full or pressured"; HYPOACUSIS (non-serious) with onset 27Jul2023 at 19:00, outcome "not recovered", described as "hearing is distorted"; EAR DISCOMFORT (non-serious) with onset 27Jul2023 at 19:00, outcome "not recovered", described as "pressure in my ears"; PAIN (non-serious) with onset 27Jul2023 at 19:00, outcome "not recovered", described as "upper body aches". Relevant laboratory tests and procedures are available in the appropriate section. Therapeutic measures were not taken as a result of head discomfort, hypoacusis, ear discomfort, asthenia, malaise, pain.  Additional information: The patient did not receive any other vaccines within 4 weeks prior vaccination. The patient had not been diagnosed with COVID-19 prior vaccination and had not been tested for COVID-19 since vaccination. The side effects of Moderna were short lived and minimal.  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: Incorrect route of product administration, Neoplasm
Clinical narrative: Had a growth on my inside of my right big toe; I called it a tumor; Intravenous in the arm/Inappropriate route of vaccination; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). 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 (Lot number: GJ3268) intravenous, in arm for covid-19 immunisation. The patient's relevant medical history included: "blood pressure" (unspecified if ongoing); "Smoke cigarettes" (not ongoing), notes: I was smoking 2 packs of Marlboros a day. Concomitant medication(s) included: MECLIZINE [MECLOZINE]. Vaccination history included: Bnt162b2 (DOSE 1, SINGLE, Batch/lot number: EN6200), for COVID-19 immunisation, reaction(s): "Intravenous in arm/Inappropriate route of vaccination"; Bnt162b2 (DOSE 2, SINGLE, Batch/lot number: FJ8157), for COVID-19 immunisation, reaction(s): "Intravenous in arm/Inappropriate route of vaccination"; Bnt162b2 (DOSE 3 (BOOSTER), SINGLE), for COVID-19 immunisation, reaction(s): "Intravenous in the arm/Inappropriate route of vaccination". The following information was reported: NEOPLASM (non-serious), outcome "unknown", described as "Had a growth on my inside of my right big toe; I called it a tumor"; INCORRECT ROUTE OF PRODUCT ADMINISTRATION (non-serious), outcome "unknown", described as "Intravenous in the arm/Inappropriate route of vaccination".  Additional information: Patient had discovered a plant that when a proper catalyst was used it made a compound, a new compound that, one, it stopped the desire to smoke cigarettes and tobacco, it took the desire away completely. Patient used it topically. A new compound that did certain things, it definitely stopped the desire to smoke cigarettes 3 to 5 days. Patient was smoking 2 packs of Marlboros a day and tried to quit and didn't and then made some inquires and found this wonderful plant. Patient called it the leaf of life but that not what the withheld call it. Patient had all 3 shots and booster and it worked, Patient had a wonderful experience. There was only one time somebody stuck the needle in patient's arm to near the bone but otherwise the vaccine was great. The third dose LOT was FJ875 patient could not tell the last number was 1 or 7. Patient had 4th Pfizer shot (COVID 19 Vaccine) also. The 4th one that was listed on the other one was G looked like J3268. The first two doses were given at patient's residence. The third and fourth in the withheld. The two of them on the withheld.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300263549 Same Patient/Product, Different Dose/Event (Dose 1);US-PFIZER INC-202300263551 Same Patient/Product, Different Dose/Event (Dose 3);US-PFIZER INC-202300263550 Same Patient/Product, Different Dose/Event (Dose 2);
Age: 44.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Other HCP) from product quality group. The reporter is the patient.  A 45-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 12Sep2022 at 13:00 as dose 4 (booster), single (Lot number: Gj2524) at the age of 44 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 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history was not reported. Concomitant medication(s) included: ETHINYLESTRADIOL;NORETHISTERONE ACETATE, start date: 13Jul2022. Past drug history included: Gadolinium, reaction(s): "Known allergies: Gadolinium"; Vancomycin, reaction(s): "Known allergies: vancomycin". 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". Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: COVID 19 Treatment with Paxlovid, treatment start date: 15Jul2023 and treatment stop date: 19Jul2023.; Sender's Comments: Based on the available information in the case, an association between the reported events DRUG INEFFECTIVE,COVID-19 and The suspected drug cannot be ruled out.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, Interchange of vaccine products
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; Interchange of vaccine products; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 39-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 4 (booster), single (Lot number: GM9694) at the age of 38 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 28Nov2021 as dose 3 (booster), single (Lot number: FM8030) for covid-19 immunisation; elasomeran (MODERNA COVID-19 VACCINE), on 27Feb2021 as dose 1, single (Lot number: 027A21A) and on 27Mar2021 as dose 2, single (Lot number: 028A21A) for covid-19 immunisation. The patient's relevant medical history included: "Asthma" (unspecified if ongoing); "Endometriosis" (unspecified if ongoing). The patient's concomitant medications were not reported. The following information was reported: INTERCHANGE OF VACCINE PRODUCTS (medically significant) with onset 28Nov2021, outcome "unknown"; DRUG INEFFECTIVE (medically significant), COVID-19 (medically significant), outcome "unknown" and all described as "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19. Clinical course: Patient received Covid-19 treatment from 12Jul2023 to 17Jul2023.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300263627 same patient, diff drug/event;
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 10Nov2022 at 12:45 as dose 5 (booster), single (Batch/Lot number: unknown), 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure" (unspecified if ongoing); "known allergies: Penn" (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 "unknown" and all described as "Treatment of COVID-19". The patient underwent the following laboratory tests and procedures: SARS-CoV-2 test: Positive, notes: Treatment of COVID-19; Positive, notes: positive by thursday; Negative, notes: covid tested negative Monday. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Additional information: The patient had not received any other medication in 2weeks. Rebound of covid tested negative Monday positive by Thursday  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: 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). The reporter is the patient.  A 72-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 16Sep2022 as dose 5 (booster), single (Batch/Lot number: unknown), in right 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), as dose 3 (booster), single (Batch/Lot number: unknown) and as dose 4 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "High blood pressure under control" (unspecified if ongoing); "High cholesterol treated" (unspecified if ongoing); "Lung surgery as a child" (unspecified if ongoing); "Known allergies: Penicillin" (unspecified if ongoing); "Known allergies: Nuts" (unspecified if ongoing), notes: \. The patient's concomitant medications were not reported. Past drug history included: Vioxx, reaction(s): "Known allergies: Vioxx"; Lisinopril, reaction(s): "Known allergies: lisinopril"; Antibiotics, reaction(s): "Known allergies: Some antibiotics.".  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". Therapeutic measures were taken as a result of drug ineffective, covid-19. it was reported that the patient received treatment of Paxlovid from 12Jul2023 to 16Jul2023 for COVID-19 infection.  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: 57.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Drug ineffective
Clinical narrative: Treatment of COVID-19; Treatment of COVID-19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 57-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 as dose 4 (booster), single (Lot number: GH9703) at the age of 57 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 (booster), single (Batch/Lot number: unknown) for covid-19 immunisation. The patient's relevant medical history included: "Known allergies: Sulfa" (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 "Treatment of COVID-19". Therapeutic measures were taken as a result of drug ineffective, covid-19 which included paxlovid from 27Jul2023 Batch/lot number: GK2931.; Sender's Comments: Linked Report(s) : US-PFIZER INC-202300263865 same patient, different drug/event;
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID 19; COVID 19; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 66-year-old female patient (not pregnant) received BNT162b2, BNT162b2 omi ba.4-5 (BNT162B2, BNT162B2 OMI BA.4-5), on 07Oct2022 as dose 5 (booster), single (Lot number: GH9693) at the age of 65 years for covid-19 immunisation; BNT162b2 (BNT162B2), on 03Mar2021 as dose 1, single (Lot number: EN6198), on 24Mar2021 as dose 2, single (Lot number: EP6955), on 12Nov2021 as dose 3 (booster), single (Lot number: FG3527) and on 05Aug2022 as dose 4 (booster), single (Lot number: FM0173) for covid-19 immunisation. The patient's relevant medical history included: "Overweight" (unspecified if ongoing); "Sulfa allergies" (unspecified if ongoing); "Penicillin allergies" (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 17Jul2023, outcome "recovering" and all described as "COVID 19". The patient underwent the following laboratory tests and procedures: Body temperature: (Jul2023) never over 101; SARS-CoV-2 test: (26Jul2023) negative; (29Jul2023) positive. Therapeutic measures were taken as a result of drug ineffective, covid-19.  Clinical course: The patient was contracted with Covid on 17Jul2023. Fever (never over 101), headache, congestion, dry cough. She received Paxlovid from 17Jul2023 to 22Jul2023 as treatment of COVID-19.