chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Completed suicide, Injury
Clinical narrative: SUICIDE; INJURED; This spontaneous report received from consumer via other manufacturer (Pfizer) through social media (JNJ News) concerned multiple patients. The patient's weight, height, and medical history were not reported. The patients received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin was not reported, batch number: unknown, expiry: unknown) dose was not reported, start therapy date were not reported 1 total administered for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patients lost (died) to suicide who were injured by vaccine. It was not reported if an autopsy was performed or not. It was reported that, "After l-year and sometimes less of suffering, I lost friends to suicide who were injured by the moderna tx pfizer JNJNews. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the injured was not reported. This report was serious (Death).; Sender's Comments: V0: 20230407711- Suicide. Insufficient information is available to make a causality assessment. Therefore, this event is considered unclassifiable.; Reported Cause(s) of Death: SUICIDE
Age: 64.0
Sex: U
Vaccine: COVID19
Symptoms: Lichen planus
Clinical narrative: LICHEN PLANUS ALL OVER BODY AND UNDER THE SOLES OF FEET WITH CRACKING SKIN, BURNING AND ITCHING; This spontaneous report received from a patient via a company representative concerned a 7 decade old of unspecified sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no skin problems. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: UNKNOWN) dose was not reported, administered on 16-MAR-2021 for covid-19 prophylaxis. Age at time of vaccination 64 years old. No concomitant medications were reported. On an unspecified date, the patient experienced lichen planus all over body and under the soles of feet with cracking skin, burning and itching. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from lichen planus all over body and under the soles of feet with cracking skin, burning and itching. This report was non-serious. This case, from the same reporter is linked to 20230411601.
Sex: M
Vaccine: COVID19
Symptoms: Herpes simplex, Herpes simplex test, Herpes zoster, Nervous system disorder
Clinical narrative: HSV SWELLED UP NERVES; SHINGLES; TESTED POSITIVE FOR HSV LAST WEEKEND; This spontaneous report received from a patient concerned a male of unspecified age. The patient's weight, height, and medical history were not reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for covid-19 prophylaxis. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On APR-2023, the patient experienced tested positive for hsv last weekend. Laboratory data included: Herpes simplex test Positive. On an unspecified date, the patient experienced hsv swelled up nerves, and shingles. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the tested positive for hsv last weekend, hsv swelled up nerves and shingles was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Patient received the vaccine after the BUD; vial was initially stored in the refrigerator on 23-Dec-2022; No adverse event; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine after the BUD), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 23-Dec-2022) and NO ADVERSE EVENT (No adverse event) in a child patient of an unknown gender who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 216K22A) for COVID-19 prophylaxis.     No Medical History information was reported.  On an unknown date, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine after the BUD), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 23-Dec-2022) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine after the BUD), PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 23-Dec-2022) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient received the vaccine after the BUD) and PRODUCT STORAGE ERROR (vial was initially stored in the refrigerator on 23-Dec-2022).    No concomitant medications were reported.  It was unknown if the patient receive any other vaccines in the 4 weeks prior to COVID-19 vaccine. Vial size was reported as 0.4 ml per vial. The vial was initially stored in the refrigerator on 23-Dec-2022. Dates of administration of vaccine was reported as 26-Jan-2023, 27-Jan-2023, 30-Jan-2023, 31-Jan-2023 2-Feb-2023, 6-Feb-2023, 8-Feb-2023, 10-Feb-2023, 13-Feb-2023, 14-Feb-2023, 16-Feb-2023, 17-Feb-2023 and  21-Feb-2023.  The vial did not undergo any temperature excursions.  No treatment medications were reported.  This case contains information for the 9th of 42th patients described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-718298 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718298:Patient 1 (Master Case)
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Immunisation reaction
Clinical narrative: Vaccination adverse reaction; This spontaneous case was reported by an other health care professional and describes the occurrence of IMMUNISATION REACTION (Vaccination adverse reaction) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051F22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2023, the patient experienced IMMUNISATION REACTION (Vaccination adverse reaction). At the time of the report, IMMUNISATION REACTION (Vaccination adverse reaction) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: She thinks, twice contracted Covid. Also experienced Covid like symptoms with each vaccine/booster received.; This spontaneous case was reported by a non-health professional and describes the occurrence of COVID-19 (She thinks, twice contracted Covid. Also experienced Covid like symptoms with each vaccine/booster received.) in an adult female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Allergies to vaccines, medications, food, and other products-describe reaction in parentheses (e.g. Sulfa (hives)) was unknown.     On an unknown date, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (She thinks, twice contracted Covid. Also experienced Covid like symptoms with each vaccine/booster received.). At the time of the report, COVID-19 (She thinks, twice contracted Covid. Also experienced Covid like symptoms with each vaccine/booster received.) had resolved.            Concomitant medications were not reported.  It was reported that patient was contracted with Covid twice. Also experienced the Covid like symptoms with vaccine  The symptoms from virus and shots lasted a couple of days before subsiding.  Treatment information was not reported.   This case was linked to MOD-2023-718542 (Patient Link).
Sex: F
Vaccine: COVID19-2
Symptoms: COVID-19, Vaccination failure
Clinical narrative: She thinks, twice contracted Covid. Also experienced Covid like symptoms with each vaccine/booster received.; Lack of effect; This spontaneous case was reported by a non-health professional and describes the occurrence of COVID-19 (She thinks, twice contracted Covid. Also experienced Covid like symptoms with each vaccine/booster received.) and VACCINATION FAILURE (Lack of effect) 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 that the patient had any allergies to vaccines, medications, food, and other products-describe reaction in parentheses (e.g. Sulfa (hives)).     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 (She thinks, twice contracted Covid. Also experienced Covid like symptoms with each vaccine/booster received.) and VACCINATION FAILURE (Lack of effect). At the time of the report, COVID-19 (She thinks, twice contracted Covid. Also experienced Covid like symptoms with each vaccine/booster received.) had resolved and VACCINATION FAILURE (Lack of effect) outcome was unknown.            Concomitant Medication use information was not provided by reporter.  It was reported that patient was contracted with Covid twice. Also experienced the Covid like symptoms with vaccine.  The symptoms from virus and shots were lasted a couple of days before subsiding.  Treatment Medication use information was not provided by reporter.  Company comment: This spontaneous case concerns a female patient (age not specified), with no relevant medical history reported, who experienced unexpected non-serious event of COVID-19 that occurred in the context of a dose of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine. Latency could not be assessed as the exact date of vaccination and onset date of the event was not available. Vaccination failure is also reported. No further information on additional vaccination details, clinical course, investigations and treatment received was available in the report. The benefit-risk relationship of mRNA-1273.222 (Original/Omicron BA.4/5) vaccine is not affected by this report.   This case was linked to MOD-2023-718540 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Tubulointerstitial nephritis
Clinical narrative: acute granulomatous tubulointerstitial nephritis; This literature-non-study case was reported in a literature article and describes the occurrence of TUBULOINTERSTITIAL NEPHRITIS (acute granulomatous tubulointerstitial nephritis) 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 third dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced TUBULOINTERSTITIAL NEPHRITIS (acute granulomatous tubulointerstitial nephritis) (seriousness criterion medically significant). At the time of the report, TUBULOINTERSTITIAL NEPHRITIS (acute granulomatous tubulointerstitial nephritis) was resolving.     For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  The patient was treated with an unspecified steroids showed rapid improvement in kidney function.  Company comment-This literature non study case concerns a patient of unknown age and gender with no medical history reported, who experienced the unexpected, serious (Medically significant) event of Tubulointerstitial nephritis (reported as acute granulomatous tubulointerstitial nephritis) that occurred about one month after a booster dose of mRNA-1273 vaccination. It was reported that patient had no clinical evidence of renal injury after the first two doses of vaccine. Renal dysfunction was incidentally observed about month after the booster dose of vaccine. The patient responded to steroids with rapid improvement in kidney function. No further clinical information was available for medical review. Outcome of the event was recovering at the time of report. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: F
Vaccine: COVID19-2
Symptoms: Peripheral swelling
Clinical narrative: unresolved swelling in her hand; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PERIPHERAL SWELLING (unresolved swelling in her hand) 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.     No Medical History information was reported.  In 2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (unresolved swelling in her hand). At the time of the report, PERIPHERAL SWELLING (unresolved swelling in her hand) had not resolved.     Concomitant product use was not provided by the reporter.  The patient received booster in fall 2022 in right arm which led to unresolved swelling in hand that still persists. No treatment information was provided.
Sex: M
Vaccine: COVID19, COVID19-2
Symptoms: COVID-19
Clinical narrative: Diagnosed with Covid-19; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Diagnosed with Covid-19) in a male patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    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 and first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form and dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On 27-Mar-2023, the patient experienced COVID-19 (Diagnosed with Covid-19). The patient was treated with NIRMATRELVIR, RITONAVIR (PAXLOVID) at an unspecified dose and frequency. At the time of the report, COVID-19 (Diagnosed with Covid-19) outcome was unknown.            The patient was fully vaccinated, got primary series, boosters and, got Covid-19. It was reported that the patient was taking some meds but were told to stop taking one while on Paxlovid. It was reported that the patient felt like they got everything, got really sick. Was sicker than a dog.   This case was linked to US-MODERNATX, INC.-MOD-2023-718731 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718731:Wife case
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; 2 adults patients received expired first primary dose of Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 adults patients received expired first primary dose of Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 042C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Apr-2023, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 04-Apr-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (2 adults patients received expired first primary dose of Moderna COVID-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2 adults patients received expired first primary dose of Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (2 adults patients received expired first primary dose of Moderna COVID-19 vaccine).    No concomitant medications was reported. Those were intact cartons and size of the vial was 2.5 ml. The vial was initially stored in refrigerator on 29-mar-2023. The vial did not undergo any temperature excursions. No treatment drug details was reported. This case contains information patient 1 out of 2 adult patients as described by the reporter.   This case was linked to US-MODERNATX, INC.-MOD-2023-718682 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718682:(Patient 2 out of 2)
Sex: U
Vaccine: COVID19
Symptoms: No adverse event, Product storage error, Product temperature excursion issue
Clinical narrative: The vaccine were at a TE for about 32 minutes/10 shots of TE vaccine were administer to patients; The vaccine were at a TE for about 32 minutes/10 shots of TE vaccine were administer to patients; no adverse event; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (The vaccine were at a TE for about 32 minutes/10 shots of TE vaccine were administer to patients), PRODUCT STORAGE ERROR (The vaccine were at a TE for about 32 minutes/10 shots of TE vaccine were administer to patients) and NO ADVERSE EVENT (no adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 042C22A) 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. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (The vaccine were at a TE for about 32 minutes/10 shots of TE vaccine were administer to patients), PRODUCT STORAGE ERROR (The vaccine were at a TE for about 32 minutes/10 shots of TE vaccine were administer to patients) and NO ADVERSE EVENT (no adverse event). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (The vaccine were at a TE for about 32 minutes/10 shots of TE vaccine were administer to patients), PRODUCT STORAGE ERROR (The vaccine were at a TE for about 32 minutes/10 shots of TE vaccine were administer to patients) and NO ADVERSE EVENT (no adverse event) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (no adverse event) to be not related. No further causality assessments were provided for PRODUCT TEMPERATURE EXCURSION ISSUE (The vaccine were at a TE for about 32 minutes/10 shots of TE vaccine were administer to patients) and PRODUCT STORAGE ERROR (The vaccine were at a TE for about 32 minutes/10 shots of TE vaccine were administer to patients).    No treatment medications were reported No concomitant medications were reported  Highest temperature reach 47.5 F. Both vaccines Bivalent and primary were involved.    This case was linked to MOD-2023-718496 (Patient Link).
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Balance disorder, Blood pressure measurement, Brain fog, Computerised tomogram, Dizziness
Clinical narrative: cannot stand up; vertigo; balance issue; legs are weak; heavy head, pressure in head, foggy head; shakiness and tremors; dizziness / being dizzy to walk; headache; This spontaneous case was reported by a consumer and describes the occurrence of DYSSTASIA (cannot stand up), VERTIGO (vertigo), BALANCE DISORDER (balance issue), MUSCULAR WEAKNESS (legs are weak) and FEELING ABNORMAL (heavy head, pressure in head, foggy head) in a 67-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 024H22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Patient had no allergies and no health conditions. Concomitant products included FISH OIL, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and VITAMIN C [ASCORBIC ACID] for an unknown indication. On 08-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 09-Oct-2022, the patient experienced DYSSTASIA (cannot stand up), VERTIGO (vertigo), BALANCE DISORDER (balance issue), MUSCULAR WEAKNESS (legs are weak), FEELING ABNORMAL (heavy head, pressure in head, foggy head), TREMOR (shakiness and tremors), DIZZINESS (dizziness / being dizzy to walk) and HEADACHE (headache). The patient was treated with MAGNESIUM at an unspecified dose and frequency and VITAMINS NOS at an unspecified dose and frequency. At the time of the report, DYSSTASIA (cannot stand up), VERTIGO (vertigo), BALANCE DISORDER (balance issue), MUSCULAR WEAKNESS (legs are weak), FEELING ABNORMAL (heavy head, pressure in head, foggy head), TREMOR (shakiness and tremors), DIZZINESS (dizziness / being dizzy to walk) and HEADACHE (headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: Low. On an unknown date, Computerised tomogram: Normal.     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.   It was reported that Patient took 1st dose on 10-Mar-2021 and Lot number-029A21A, 2nd dose on 07-Apr-2021 and Lot number 030B21A, 1st booster dose on 16-Dec-2021 and Lot number 069F22A. Doctor told patient to take vitamins and magnesium and it got patient so dizzy. Magnesium causes more dizziness.
Age: 67.0
Sex: F
Vaccine: COVID19-2
Symptoms: Dysstasia, Headache, Muscular weakness, Tremor, Vertigo
Clinical narrative: cannot stand up; vertigo; balance issue; legs are weak; heavy head, pressure in head, foggy head; shakiness and tremors; dizziness / being dizzy to walk; headache; This spontaneous case was reported by a consumer and describes the occurrence of DYSSTASIA (cannot stand up), VERTIGO (vertigo), BALANCE DISORDER (balance issue), MUSCULAR WEAKNESS (legs are weak) and FEELING ABNORMAL (heavy head, pressure in head, foggy head) in a 67-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 024H22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below. Patient had no allergies and no health conditions. Concomitant products included FISH OIL, COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) and VITAMIN C [ASCORBIC ACID] for an unknown indication. On 08-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 09-Oct-2022, the patient experienced DYSSTASIA (cannot stand up), VERTIGO (vertigo), BALANCE DISORDER (balance issue), MUSCULAR WEAKNESS (legs are weak), FEELING ABNORMAL (heavy head, pressure in head, foggy head), TREMOR (shakiness and tremors), DIZZINESS (dizziness / being dizzy to walk) and HEADACHE (headache). The patient was treated with MAGNESIUM at an unspecified dose and frequency and VITAMINS NOS at an unspecified dose and frequency. At the time of the report, DYSSTASIA (cannot stand up), VERTIGO (vertigo), BALANCE DISORDER (balance issue), MUSCULAR WEAKNESS (legs are weak), FEELING ABNORMAL (heavy head, pressure in head, foggy head), TREMOR (shakiness and tremors), DIZZINESS (dizziness / being dizzy to walk) and HEADACHE (headache) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: Low. On an unknown date, Computerised tomogram: Normal.     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.   It was reported that Patient took 1st dose on 10-Mar-2021 and Lot number-029A21A, 2nd dose on 07-Apr-2021 and Lot number 030B21A, 1st booster dose on 16-Dec-2021 and Lot number 069F22A. Doctor told patient to take vitamins and magnesium and it got patient so dizzy. Magnesium causes more dizziness.
Age: 61.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: The vial was initial stored in the refrigerator on 21-Feb-2023, vaccine expired on 01-Apr-2023 and administered to patient on 04-Apr-2023; No adverse event; Inadvertently administered a monovalent vaccine which was beyond the published expiration date to a patient; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Inadvertently administered a monovalent vaccine which was beyond the published expiration date to a patient), PRODUCT STORAGE ERROR (The vial was initial stored in the refrigerator on 21-Feb-2023, vaccine expired on 01-Apr-2023 and administered to patient on 04-Apr-2023) and NO ADVERSE EVENT (No adverse event) in a 61-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 044C22A) for COVID-19 prophylaxis.   Concurrent medical conditions included Essential hypertension, Chronic kidney disease and Benign prostatic hyperplasia.    On 04-Apr-2023, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 04-Apr-2023, after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Inadvertently administered a monovalent vaccine which was beyond the published expiration date to a patient). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was initial stored in the refrigerator on 21-Feb-2023, vaccine expired on 01-Apr-2023 and administered to patient on 04-Apr-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Inadvertently administered a monovalent vaccine which was beyond the published expiration date to a patient), PRODUCT STORAGE ERROR (The vial was initial stored in the refrigerator on 21-Feb-2023, vaccine expired on 01-Apr-2023 and administered to patient on 04-Apr-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered PRODUCT STORAGE ERROR (The vial was initial stored in the refrigerator on 21-Feb-2023, vaccine expired on 01-Apr-2023 and administered to patient on 04-Apr-2023) and NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Inadvertently administered a monovalent vaccine which was beyond the published expiration date to a patient).    No concomitant medications were reported.  No treatment information was provided.
Age: 6.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; accidentally administered 1 dose of Moderna COVID-19 Vaccine for 6 to 11 years to a patient on 05APR2023 but the vial expired on 03APR2023.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (accidentally administered 1 dose of Moderna COVID-19 Vaccine for 6 to 11 years to a patient on 05APR2023 but the vial expired on 03APR2023.) and NO ADVERSE EVENT (No adverse event) in a 6-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019C22A) for COVID-19 prophylaxis.     Patient had no known conditions.  Previously administered products included for Product used for unknown indication: flu shot. Past adverse reactions to the above products included No adverse event with flu shot.    On 05-Apr-2023, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 05-Apr-2023,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (accidentally administered 1 dose of Moderna COVID-19 Vaccine for 6 to 11 years to a patient on 05APR2023 but the vial expired on 03APR2023.). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (accidentally administered 1 dose of Moderna COVID-19 Vaccine for 6 to 11 years to a patient on 05APR2023 but the vial expired on 03APR2023.) 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 (accidentally administered 1 dose of Moderna COVID-19 Vaccine for 6 to 11 years to a patient on 05APR2023 but the vial expired on 03APR2023.).    No concomitant medications was reported. No AEs were reported. No treatment medications was reported.
Age: 2.0
Sex: M
Vaccine: COVID19-2
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vial was initially stored in refrigerator on 22-FEB-2023 and administered to patient on 05-APR-2023; No adverse event; accidentally administered a booster dose which was past the 30 day BUD; This spontaneous case was reported by a medical assistant and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (accidentally administered a booster dose which was past the 30 day BUD), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 22-FEB-2023 and administered to patient on 05-APR-2023) and NO ADVERSE EVENT (No adverse event) in a 2-year-old male patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. 215K22A) for COVID-19 prophylaxis.     Previously administered products included for COVID-19 prophylaxis: Moderna COVID-19 Vaccine (1st dose, lot number AS1412B ) on 09-Sep-2022, Moderna COVID-19 Vaccine (2nd dose and  lot number AR9236B ) on 14-Oct-2022. Past adverse reactions to the above products included No adverse event with Moderna COVID-19 Vaccine and Moderna COVID-19 Vaccine.    On 05-Apr-2023, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) .2 milliliter. On 05-Apr-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 (accidentally administered a booster dose which was past the 30 day BUD). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 22-FEB-2023 and administered to patient on 05-APR-2023) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (accidentally administered a booster dose which was past the 30 day BUD), PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 22-FEB-2023 and administered to patient on 05-APR-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 (accidentally administered a booster dose which was past the 30 day BUD) and PRODUCT STORAGE ERROR (Vial was initially stored in refrigerator on 22-FEB-2023 and administered to patient on 05-APR-2023).    Concomitant medication details not reported by the reporter. Vaccine was given at 0.2 ml, intramuscularly on the right thigh. Vial was initially stored in refrigerator on 22-FEB-2023. Treatment details was not reported by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Inappropriate schedule of product administration, No adverse event
Clinical narrative: No adverse event; They applied the second dose on 03Apr2023, 1 year and a half after the first dose; vaccine administered on 03Apr2023 expired on 01Apr2023; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (They applied the second dose on 03Apr2023, 1 year and a half after the first dose), EXPIRED PRODUCT ADMINISTERED (vaccine administered on 03Apr2023 expired on 01Apr2023) and NO ADVERSE EVENT (No adverse event) in a patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 044C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 03-Apr-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 03-Apr-2023, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (They applied the second dose on 03Apr2023, 1 year and a half after the first dose) and EXPIRED PRODUCT ADMINISTERED (vaccine administered on 03Apr2023 expired on 01Apr2023). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (They applied the second dose on 03Apr2023, 1 year and a half after the first dose), EXPIRED PRODUCT ADMINISTERED (vaccine administered on 03Apr2023 expired on 01Apr2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (They applied the second dose on 03Apr2023, 1 year and a half after the first dose) and EXPIRED PRODUCT ADMINISTERED (vaccine administered on 03Apr2023 expired on 01Apr2023).    No concomitant medications were reported.     It was reported that patient had received the first dose of the Moderna Covid-19 vaccine 1 year and a half ago.  No treatment medications were reported.
Sex: F
Vaccine: COVID19-2
Symptoms: Circumstance or information capable of leading to medication error, Extra dose administered, No adverse event
Clinical narrative: She has had 5 or 6 shots she can not remember / I also am doing an AE because she may have had 6 vaccinations; Extra dose administered; No adverse event; This spontaneous case was reported by a patient and describes the occurrence of CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (She has had 5 or 6 shots she can not remember / I also am doing an AE because she may have had 6 vaccinations), EXTRA DOSE ADMINISTERED (Extra dose administered) and NO ADVERSE EVENT (No adverse event) in an elderly female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis.     Concurrent medical conditions included Immunocompromised.    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 CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (She has had 5 or 6 shots she can not remember / I also am doing an AE because she may have had 6 vaccinations), EXTRA DOSE ADMINISTERED (Extra dose administered) and NO ADVERSE EVENT (No adverse event). At the time of the report, CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (She has had 5 or 6 shots she can not remember / I also am doing an AE because she may have had 6 vaccinations), EXTRA DOSE ADMINISTERED (Extra dose administered) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (She has had 5 or 6 shots she can not remember / I also am doing an AE because she may have had 6 vaccinations) and EXTRA DOSE ADMINISTERED (Extra dose administered).    No concomitant medication were reported.  Patient wanted to know if she should get another vaccine. Patient wanted to know if the information concerning the CDC had updated or if the covid vaccine would be like the flu vaccine Patient had 5 or 6 shots, could not remember. No treatment information was provided by the reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Adult patient received expired first primary dose of Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Adult patient received expired first primary dose of Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 042C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Apr-2023, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) 1 dosage form. On 04-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Adult patient received expired first primary dose of Moderna COVID-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Adult patient received expired first primary dose of Moderna COVID-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown. For mRNA-1273 (Spikevax) (Intramuscular), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Adult patient received expired first primary dose of Moderna COVID-19 vaccine).    No concomitant medication was reported.    Date of expiration was reported as 01-APR-2023. Date the vial was initially stored in the refrigerator on 29-MAR-2023. The vial did not undergo any temperature excursions. No treatment information was reported.  This case contains information patient 2 of 2.   This case was linked to US-MODERNATX, INC.-MOD-2023-718681 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2023-718681:(MASTER)
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient received expired Moderna Covid-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event) in a 29-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 044C22A) for COVID-19 prophylaxis.     No Medical History information was reported.  On 05-Apr-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 05-Apr-2023, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient received expired Moderna Covid-19 vaccine).    No concomitant medications were reported.  The patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.  No other adverse events were reported.  No treatment medications were reported.
Age: 33.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No Adverse Event; HCP stated they accidentally administered 4 doses of Moderna COVID-19 Vaccine on 4 APR 2023 after the expiration date of 01 APR 2023.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 4 doses of Moderna COVID-19 Vaccine on 4 APR 2023 after the expiration date of 01 APR 2023.) and NO ADVERSE EVENT (No Adverse Event) in a 33-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 044C22A) for COVID-19 prophylaxis.     Patient had no allergies and no medical history conditions. Patient did not receive any other vaccines in the 4 weeks prior to COVID-19 vaccine.     On 04-Apr-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-Apr-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 4 doses of Moderna COVID-19 Vaccine on 4 APR 2023 after the expiration date of 01 APR 2023.). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse Event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 4 doses of Moderna COVID-19 Vaccine on 4 APR 2023 after the expiration date of 01 APR 2023.) and NO ADVERSE EVENT (No Adverse Event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No Adverse Event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (HCP stated they accidentally administered 4 doses of Moderna COVID-19 Vaccine on 4 APR 2023 after the expiration date of 01 APR 2023.).    No concomitant medication details was reported. No adverse events were reported. No treatment medication details was reported.
Age: 19.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Patient was accidentally administered dose of Moderna COVID-19 Vaccine on 4-APR-2023 after the expiration date of 01-APR-2023; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was accidentally administered dose of Moderna COVID-19 Vaccine on 4-APR-2023 after the expiration date of 01-APR-2023) and NO ADVERSE EVENT (No adverse event) in a 19-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 044C22A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 04-Apr-2023, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-Apr-2023,  after starting mRNA-1273 (Spikevax), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was accidentally administered dose of Moderna COVID-19 Vaccine on 4-APR-2023 after the expiration date of 01-APR-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 accidentally administered dose of Moderna COVID-19 Vaccine on 4-APR-2023 after the expiration date of 01-APR-2023) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Patient was accidentally administered dose of Moderna COVID-19 Vaccine on 4-APR-2023 after the expiration date of 01-APR-2023).    No concomitant medications were reported. Patient did not received any other vaccines in the 4 weeks prior to COVID-19 vaccine. Patient did not report any adverse events No treatment information was provided.
Age: 22.0
Sex: M
Vaccine: COVID19
Symptoms: Circumstance or information capable of leading to medication error, No adverse event, Product availability issue
Clinical narrative: Patient went to pharmacies, and nobody had Moderna COVID-19 2nd primary dose in stock; Patient went to pharmacies, and nobody had Moderna COVID-19 2nd primary dose in stock; No adverse event; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT AVAILABILITY ISSUE (Patient went to pharmacies, and nobody had Moderna COVID-19 2nd primary dose in stock), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Patient went to pharmacies, and nobody had Moderna COVID-19 2nd primary dose in stock) and NO ADVERSE EVENT (No adverse event) in a 22-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.   No Medical History information was reported.    On 07-Mar-2023, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT AVAILABILITY ISSUE (Patient went to pharmacies, and nobody had Moderna COVID-19 2nd primary dose in stock), CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Patient went to pharmacies, and nobody had Moderna COVID-19 2nd primary dose in stock) and NO ADVERSE EVENT (No adverse event). At the time of the report, PRODUCT AVAILABILITY ISSUE (Patient went to pharmacies, and nobody had Moderna COVID-19 2nd primary dose in stock) had not resolved and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Patient went to pharmacies, and nobody had Moderna COVID-19 2nd primary dose in stock) and NO ADVERSE EVENT (No adverse event) outcome was unknown.     For mRNA-1273 (Spikevax) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for PRODUCT AVAILABILITY ISSUE (Patient went to pharmacies, and nobody had Moderna COVID-19 2nd primary dose in stock) and CIRCUMSTANCE OR INFORMATION CAPABLE OF LEADING TO MEDICATION ERROR (Patient went to pharmacies, and nobody had Moderna COVID-19 2nd primary dose in stock).    No concomitant medications were reported.  No treatment information was provided.   Reporter did not allow further contact