chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19; This spontaneous report received from a patient concerned an adult of unspecified ethnicity. Initial information was processed along with the additional information received on 24-FEB-2022.  The patient's weight was 160 pounds, and height was 69 inches. The patient's concurrent conditions included: non-smoker, alcohol use and shellfish allergy. The patient had no history of trauma, had no infection, no head injury, had no immune disorders. The patient reports that she does not even have any family history, had no brain surgery, had no seizure disorder. The patient had no similar reactions in past associated with vaccine/drug. The patient had no history of drug abuse. The patient had no illness at the time of vaccination, had no past history of similar event, had no adverse event after any previous vaccination, had no pre-existing acute illness 30 days prior to vaccination, had no family history of any disease (relevant to vaccination) or allergy. The patient was not pregnant at the time of vaccination and was not breastfeeding. The patient does not have other suspected causes including co-administered vaccine(s)/risk factors.  The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: 21-SEP-2021) dose was not reported, 1 total administered on 19-AUG-2021 for prophylactic vaccination.  Concomitant medications included acetylcysteine for as preventative measure, ascorbic acid for as preventative measure, curcuma longa for as preventative measure, ergocalciferol for as preventative measure, and quercetin for as preventative measure.  In DEC-2021, the patient had covid (suspected clinical vaccination failure). The patient reported, she believed it was the omicron variant and had fever for 1 day. After 3 days symptoms were resolved. Patient reported she was absolutely fine and it just felt like a cold. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint: 90000218979. This case, involving the same patient is linked to 20220230270.; Sender's Comments: V0:20220255106-COVID-19 VACCINE Ad26.COV2.S-suspected clinical vaccine failure . The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Feeling cold, Somnolence
Clinical narrative: SLEEPINESS; FEELING LIKE FREEZING; TIREDNESS; This spontaneous report received from a patient via a company representative through social media concerned a 64 year old of unspecified sex, race and ethnic origin. The patient's height, and weight were not reported. Patient reported that they worked a 12 hour shift and had a way of life to blame. The patient previously received covid-19 vaccine ad26.cov2.s (Dose number in series 1) (suspension for injection, route of administration, batch number and expiry not reported) dose was not reported, 01 total, administered on an unspecified date for prophylactic vaccination. Patient reported to be fine and that the vaccine did not bother at all (Dose number in series 1).  The patient additionally received covid-19 vaccine ad26.cov2.s booster (Dose number in series 2) (suspension for injection, route of administration not reported, batch number and expiry: Unknown) dose, start therapy date were not reported, 01 total was administered for prophylactic vaccination. 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, after vaccination with booster, the patient experienced sleepiness, feeling like freezing, and tiredness (Dose number in series 2). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sleepiness, and feeling like freezing after over a month (dates unspecified), and had not recovered from tiredness. This report was non-serious.
Sex: F
Vaccine: COVID19
Symptoms: Death
Clinical narrative: DIED; This spontaneous report received from a consumer via company representative via social media concerned a female of unspecified age, race and ethnicity. 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, batch number and expiry were not reported) dose, 1 total administered start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient was died, as per the reporter stated that, my wife died from the Johnson and Johnson vaccine. On an unspecified date, "the patient died from unknown cause of death. It was unknown if an autopsy was performed". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0- 20220256305- COVID-19 VACCINE AD26.COV2.S- Died. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: F
Vaccine: COVID19
Symptoms: Medication error, Underdose
Clinical narrative: GIVEN HALF-DOSE; MEDICATION ERROR; This spontaneous report received from a parent concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's concurrent conditions included: allergic to all nuts, and allergic to animal dander. The patient was previously treated with bnt 162 (Dose number in series 1) (form of admin, route of admin, and batch number were not reported, expiry: unknown) dose was not reported, administered on an unspecified date for prophylactic vaccination. On an unspecified date following vaccination with bnt 162, the patient had her throat closed up and experienced allergy. (Dose number in series 1). The outcome of throat closed up and allergy was not reported. The patient additionally received covid-19 vaccine ad26.cov2.s (Dose number in series 2) (suspension for injection, route of admin, and batch number were not reported, expiry: unknown) half of the dose administered by mistake by the pharmacy which was vaccine underdose and a medication error, 1 total administered on FEB-2022 for prophylactic vaccination. (Dose number in series 2) The batch number was not reported and has been requested. Concomitant medications included epinephrine (epipen) which the patient carried with her.  The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the given half-dose and medication error was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Death, Thrombosis
Clinical narrative: PASSED AWAY; CLOTS; This spontaneous report received from a patient through social media via a company representative concerned two patients of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient did not have history of drug abuse or illicit drug usage. Both had no health issues and were under 50. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: unknown and expiry: unknown) dose not reported, 01 total administered, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported.  Reporter stated that 2 friends through clots and passed from the single shot vaccine. On an unspecified date, the patient died from unknown cause of death. It was unknown if autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of clots was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0: 20220256761-COVID-19 VACCINE AD26.COV2.S-Passed away,Clots. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH
Sex: U
Vaccine: COVID19
Symptoms: Deep vein thrombosis, Embolism
Clinical narrative: DEEP VEIN THROMBOSIS; CHRONIC EMBOLISM; This spontaneous report received from a patient concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: UNKNOWN) dose was not reported, 1 total administered on 08-APR-2021 for prophylactic vaccination. No concomitant medications were reported.  The patient was trying to get in contact for blood clots after receiving Janssen vaccine. The patient had very bad pain and swelling in leg and foot from 23-APR-2021 and was sent to the hospital on 26-AUG-2021. The patient had to be in hospital for a week from 26-AUG-2021 to 02-SEP-2021 for chronic embolism and thrombosis of vein in left lower extremity, Deep vein thrombosis. The patient's leg started turning black and had very bad shoot pains. The patient's leg was still not well and hurt whole lower leg and foot turned black and it went all the way to knee. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from deep vein thrombosis, and chronic embolism. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20220257075-COVID-19 VACCINE AD26.COV2.S-chronic embolism and Deep vein thrombosis. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). Therefore, this event(s) is considered unassessable.
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test, Suspected COVID-19, Vaccination failure
Clinical narrative: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a physician concerned a 55 year old male of unknown race and ethnicity. The patient's height, and weight were not reported. The patient's past medical history included: multiple sclerosis. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, 1 total, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported.  On an unspecified date, the patient experienced suspected clinical vaccination failure, suspected covid-19 infection and mild symptoms of covid-19. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) Positive. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from suspected covid-19 infection, and the outcome of suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with a product quality complaint.; Sender's Comments: V0:20220257506-COVID-19 VACCINE Ad26.COV2.S-suspected clinical vaccination failure . The event(s) has an unknown/unclear  temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS. Therefore, this event(s) is considered not related.
Sex: F
Vaccine: COVID19
Symptoms: Menstrual disorder, Peripheral swelling, Sensory disturbance
Clinical narrative: PERIOD RESTART AFTER MENOPAUSE FOR 18 MONTHS; SWOLLEN LEGS WITHIN 24 HOURS OF RECEIVING VACCINE; DEEP CHILL IN ARM SPREADING INTO CHEST; This spontaneous report received from a patient via a company representative concerned a 56 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 12-MAR-2021, the patient experienced deep chill in arm spreading into chest. On 13-MAR-2021, the patient experienced swollen legs within 24 hours of receiving vaccine. On an unspecified date, the patient experienced period restart after menopause for 18 months. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the period restart after menopause for 18 months, deep chill in arm spreading into chest and swollen legs within 24 hours of receiving vaccine was not reported. This report was non-serious.
Sex: M
Vaccine: COVID19
Symptoms: Rash pruritic
Clinical narrative: RASH BROKE OUT ON BACK/ARMS AND WAS ACCOMPANIED WITH ITCHINESS; This spontaneous report received from a patient. The patient's height, and weight were not reported. The patient's concurrent conditions included: sulfa allergy. The patient had no pertinent medical history. The patient previously received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, dose number in series 01, 01 in total, administered on an unspecified date in APR-2021 for prophylactic vaccination. No adverse events were reported following administration of covid-19 vaccine ad26.cov2.s (dose number in series 01). The patient stated he did not have any problem with the first dose. The patient additionally received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 855794, expiry: unknown) dose was not reported, dose number in series 02, 01 in total, administered on an unspecified date in OCT-2021 at left arm for prophylactic vaccination. No concomitant medications were reported. On an unspecified date in OCT-2021, 6 days after vaccination, rash broke out on his back and later rash also started showing on his arms, the patient also stated that the rash was accompanied with itchiness (dose number in series 02). The patient had been seen by 3 different doctors including an allergist and dermatologist. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from rash broke out on back/arms and was accompanied with itchiness. This report was non-serious.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: PERSISTENT HEADACHE; This spontaneous report received from a patient concerned a 48 year old female.  The patient's past medical history included: headache, and concurrent conditions included: alcohol use, and other pre-existing medical conditions included: The patient was not suffering from any other conditions and was not on any other medication. The patient was previously treated with paracetamol for headache. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1855190, expiry: 27-APR-2022) dose was not reported, administered on 19-FEB-2022 for prophylactic vaccination. No concomitant medications were reported. On 25-FEB-2022, the patient experienced persistent headache. Treatment medications (dates unspecified) included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from persistent headache. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Vaccine breakthrough infection
Clinical narrative: Vaccine breakthrough infection; This literature-non-study case was reported in a literature article and describes the occurrence of VACCINE BREAKTHROUGH INFECTION (Vaccine breakthrough infection) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.   No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINE BREAKTHROUGH INFECTION (Vaccine breakthrough infection) (seriousness criterion medically significant). At the time of the report, VACCINE BREAKTHROUGH INFECTION (Vaccine breakthrough infection) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered VACCINE BREAKTHROUGH INFECTION (Vaccine breakthrough infection) to be related.    Concomitant, treatment medication information were not reported.  This is a literature-non-study case  concerning  a  patient of unknown age and gender, with no reported medical history, who experienced the unexpected serious event of Vaccine breakthrough infection. The event occurred on an unknown day after the unspecified dose of mRNA-1273 COVID 19 Vaccine. The reporter assessed the events as related to the product. The event outcome was unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.   This case was linked to MOD-2022-491471, MOD-2022-491379, MOD-2022-491473, MOD-2022-491474, MOD-2022-491475, MOD-2022-491476, MOD-2022-491477, MOD-2022-491478, MOD-2022-491479, MOD-2022-491480, MOD-2022-491481 (Patient Link).; Sender's Comments: This is a literature-non-study case  concerning  a  patient of unknown age and gender, with no reported medical history, who experienced the unexpected serious event of Vaccine breakthrough infection. The event occurred on an unknown day after the unspecified dose of mRNA-1273 COVID 19 Vaccine. The reporter assessed the events as related to the product. The event outcome was unknown. The benefit-risk relationship of mRNA-1273 COVID 19 Vaccine, is not affected by this report.
Age: 45.0
Sex: F
Vaccine: COVID19, COVID19
Symptoms: COVID-19, Ear discomfort, Interchange of vaccine products, SARS-CoV-2 test
Clinical narrative: Interchange of vaccine products (1st dose of Janssen COVID-19 Vaccine and 2nd dose of  Moderna); Covid-19 infection; Congestion in ear clogged; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19 infection), EAR DISCOMFORT (Congestion in ear clogged) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products (1st dose of Janssen COVID-19 Vaccine and 2nd dose of  Moderna)) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033F21A) for Prophylactic vaccination.    Co-suspect product included non-company product COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) for Prophylactic vaccination.    No Medical History information was reported.   On 10-Apr-2021, the patient received first dose of COVID-19 VACCINE NRVV AD26 (JNJ 78436735) (JANSSEN COVID-19 VACCINE) (unknown route) 1 dosage form. On 03-Dec-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2022, the patient experienced COVID-19 (Covid-19 infection) and EAR DISCOMFORT (Congestion in ear clogged). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products (1st dose of Janssen COVID-19 Vaccine and 2nd dose of  Moderna)). At the time of the report, COVID-19 (Covid-19 infection) was resolving and EAR DISCOMFORT (Congestion in ear clogged) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products (1st dose of Janssen COVID-19 Vaccine and 2nd dose of  Moderna)) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Jan-2022, SARS-CoV-2 test: positive (Positive) Positive.         No treatment details reported. Company comment: This case concerns a 45 year old female patient with prior vaccination with COVID-19 vaccine NRVV AD26, who experienced the unexpected non serious AESI event of Covid 19 1 month 28 days after receiving a dose of mRNA-1273 Vaccine. Current pandemic of Covid 19 can be a risk factor. Covid 19 rapid test was reported to be positive. Interchange of vaccine products also noted in the case. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 45 year old female patient with prior vaccination with COVID-19 vaccine NRVV AD26, who experienced the unexpected non serious AESI event of Covid 19 1 month 28 days after receiving a dose of mRNA-1273 Vaccine. Current pandemic of Covid 19 can be a risk factor. Covid 19 rapid test was reported to be positive. Interchange of vaccine products also noted in the case. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 42.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: COVID-19 Test Positive; Lack of drug effect; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (COVID-19 Test Positive) and DRUG INEFFECTIVE (Lack of drug effect) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022m20A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-2021 at 11:50 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 20-Feb-2021 at 11:51 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 28-Jan-2022, the patient experienced COVID-19 (COVID-19 Test Positive) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (COVID-19 Test Positive) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jan-2022, SARS-CoV-2 test: positive (Positive) positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant products were not provided. Treatment medications were not reported.  Company Comment: This is a spontaneous case concerning a 42-year-old, female patient with no medical history reported, who experienced the unexpected, non-serious, AESI event of COVID-19. Additional non-serious event of Drug ineffective was also reported. The events occurred 11 months 8 days after the second dose of mRNA-1273 vaccine. SARS-CoV-2 test was positive. Current COVID-19 pandemic is a confounder. At the time of report, outcome of the events was Unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as Serious as per Regulatory Authority report.   This case was linked to MOD-2022-489190 (Patient Link).; Sender's Comments: This is a spontaneous case concerning a 42-year-old, female patient with no medical history reported, who experienced the unexpected, non-serious, AESI event of COVID-19. Additional non-serious event of Drug ineffective was also reported. The events occurred 11 months 8 days after the second dose of mRNA-1273 vaccine. SARS-CoV-2 test was positive. Current COVID-19 pandemic is a confounder. At the time of report, outcome of the events was Unknown. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. The case was assessed as Serious as per Regulatory Authority report.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm for a day; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm for a day) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination.     Concurrent medical conditions included COPD, Blood pressure high, Diabetes and Obesity.    On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced PAIN IN EXTREMITY (Sore arm for a day). In 2021, PAIN IN EXTREMITY (Sore arm for a day) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No Concomitant product use was reported.  The patient reported that after the 1st dose, the patient had sore arm for a day.  No treatment information was provided.   This case was linked to MOD-2022-494502, MOD-2022-494503 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: 27 hours at room temperature; more than 12 hours after the first puncture/Vaccine administered 24 hours after first puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (more than 12 hours after the first puncture/Vaccine administered 24 hours after first puncture) and PRODUCT STORAGE ERROR (27 hours at room temperature) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 00J212A, 002FF21A and 091D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Feb-2022 at 2:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (more than 12 hours after the first puncture/Vaccine administered 24 hours after first puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (27 hours at room temperature). At the time of the report, EXPIRED PRODUCT ADMINISTERED (more than 12 hours after the first puncture/Vaccine administered 24 hours after first puncture) and PRODUCT STORAGE ERROR (27 hours at room temperature) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant information was not provided.  Vaccine stored in the refrigerator on 14-Feb-2022. Vial was first punctured on 15-Feb-2022  at 11:42AM. Administration of vaccine on 16-Feb-2022 at 2:00PM. Post puncture vial stored in room temperature. Treatment information was not provided.   This case was linked to MOD-2022-494521 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-Feb-2022: Patient demographics and dose details added.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: after receiving the booster dose on 26Oct2021 has a sore shoulder patient has continued shoulder pain; This spontaneous case was reported by a physician and describes the occurrence of ARTHRALGIA (after receiving the booster dose on 26Oct2021 has a sore shoulder patient has continued shoulder pain) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 01721) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, the patient experienced ARTHRALGIA (after receiving the booster dose on 26Oct2021 has a sore shoulder patient has continued shoulder pain). At the time of the report, ARTHRALGIA (after receiving the booster dose on 26Oct2021 has a sore shoulder patient has continued shoulder pain) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Information on concomitant medications received was reported as unknown.  Patient received booster dose. The reporter stated that the patient after receiving the booster dose on 26Oct2021 had a sore shoulder on X-ray radiographic line. Event description was the patient has continued shoulder pain since the injection and pain was toward lower deltoid on humoral bone. Treatment medications were not reported.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Received expired doses of the Moderna COVID vaccine; Vaccines placed in refrigerator was on 13 Jan 2022 but doses were administered to patient on 17 Feb 2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired doses of the Moderna COVID vaccine) and PRODUCT STORAGE ERROR (Vaccines placed in refrigerator was on 13 Jan 2022 but doses were administered to patient on 17 Feb 2022) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2022, the patient experienced PRODUCT STORAGE ERROR (Vaccines placed in refrigerator was on 13 Jan 2022 but doses were administered to patient on 17 Feb 2022). On 17-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired doses of the Moderna COVID vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired doses of the Moderna COVID vaccine) and PRODUCT STORAGE ERROR (Vaccines placed in refrigerator was on 13 Jan 2022 but doses were administered to patient on 17 Feb 2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  It was reported that the vaccines placed in refrigerator was on 13 Jan 2022, expiration date placed on vial was on 12 Feb 2022 and doses administered to patient on 17 Feb 2022. No treatment information was provided.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Hives all over the body 14 days after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives all over the body 14 days after vaccination) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Hives all over the body 14 days after vaccination). At the time of the report, URTICARIA (Hives all over the body 14 days after vaccination) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient got Moderna COVID-19 vaccine and 14 days later he had hives. No concomitant medication were provided. No treatment information were given.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication, Vaccination site pain
Clinical narrative: stuff including a few minor symptoms and the expected side effects; Sore left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (stuff including a few minor symptoms and the expected side effects) and VACCINATION SITE PAIN (Sore left arm) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     The patient's past medical history included Acupuncture (Acupuncture injury). Concurrent medical conditions included Neuropathy (started 22 years ago from an acupuncture injury), Groin pain (he pulled a groin muscle getting into a car and stated it still hurts today) since April 2020, Rotator cuff injury (has not healed completely and hurts every day) since November 2020 and Drug allergy (Any product containing Thimerosal preservative.).    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 26-Mar-2021, the patient experienced VACCINATION COMPLICATION (stuff including a few minor symptoms and the expected side effects) and VACCINATION SITE PAIN (Sore left arm). At the time of the report, VACCINATION COMPLICATION (stuff including a few minor symptoms and the expected side effects) and VACCINATION SITE PAIN (Sore left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication reported included several medications to treat foot neuropathy.  The patient reported after they received the first Moderna COVID-19 dose on 26-Mar-2021, the patient experienced a sore left arm and stuff including a few minor symptoms and the expected side effects.  The patient's past medical history reported includes ongoing left foot neuropathy that started 22 years ago from an acupuncture injury. The patient reported that the patient was not a diabetic. In Apr-2020, the patient stated that they pulled a groin muscle getting into a car and stated it was still hurting today (ongoing). The patient reported a right rotator cuff injury Nov-2020 that had not healed completely and hurts every day. The patient also stated that the patient couldn't work out any longer because of the rotator cuff injury and stated the rotator cuff area was sensitive and feels like it could be sprained easily since the injury. It was also reported that the patient had a cut under their fingernail that took 6 months to heal. The patient stated they took the medication Decadron years ago to treat an allergic reaction.  No treatment information was provided.   This case was linked to MOD-2022-495246, MOD-2022-495247 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by a pharmacist, describes the occurrence of administered expired product (patient received expired dose of the Moderna COVID-19 vaccine) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 068H21A) for COVID-19 immunization. No medical history reported. On Feb 17, 2022, patient received the third dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Feb 17, 2022, patient administered expired product (patient received expired dose of the Moderna COVID-19 vaccine). At the time of the report, administered expired product (patient received expired dose of the Moderna COVID-19 vaccine) outcome: unknown. The vaccine placed in refrigerator on Jan 13, 2022. The reporter did not provide any causality assessments, concomitant medication or treatment information.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patients who received expired doses of the Moderna COVID vaccine; Vaccines placed in refrigerator on 1/13/2022 and dose administered to patient on 2/17/2022; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients who received expired doses of the Moderna COVID vaccine) and PRODUCT STORAGE ERROR (Vaccines placed in refrigerator on 1/13/2022 and dose administered to patient on 2/17/2022) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2022, the patient experienced PRODUCT STORAGE ERROR (Vaccines placed in refrigerator on 1/13/2022 and dose administered to patient on 2/17/2022). On 17-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients who received expired doses of the Moderna COVID vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients who received expired doses of the Moderna COVID vaccine) and PRODUCT STORAGE ERROR (Vaccines placed in refrigerator on 1/13/2022 and dose administered to patient on 2/17/2022) 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.   This case was linked to MOD-2022-491752 (Patient Link).
Age: 67.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patients who received expired doses of the Moderna COVID vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients who received expired doses of the Moderna COVID vaccine) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients who received expired doses of the Moderna COVID vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients who received expired doses of the Moderna COVID vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided. On 13-Jan-2022, Vaccines placed in refrigerator. No treatment information was provided.
Age: 48.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received expired doses of the Moderna COVID vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired doses of the Moderna COVID vaccine) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 17-Feb-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired doses of the Moderna COVID vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received expired doses of the Moderna COVID vaccine) 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.  On 13-Jan-2022, the vial was initially stored in the refrigerator.  It was reported that as per the healthcare provider, the vials were set to expire on 12-Feb-2022 based on the stickers put on them. The healthcare provider was not sure and did not have the exact expiration date of the vial itself. The healthcare provider asked if they are going to revaccinate the patient or not.
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Doses administered after 30-day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Feb-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   BUD Date the vial was initially stored in the refrigerator: 17Dec2021.  No concomitant medication was provided. No treatment information was provided.
Age: 43.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Influenza like illness, Pyrexia
Clinical narrative: Standard reaction like a flu; A little fever; Headache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Standard reaction like a flu), PYREXIA (A little fever) and HEADACHE (Headache) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination.     The patient's past medical history included Cancer from 2016 to 2017. Concurrent medical conditions included Neck discomfort (25 years ago), Arthritis (15 years ago) and Scoliosis (since birth). Concomitant products included IBUPROFEN for Neck discomfort, ACYCLOVIR [ACICLOVIR] for an unknown indication.    On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Standard reaction like a flu), PYREXIA (A little fever) and HEADACHE (Headache). The patient was treated with IBUPROFEN for Headache, at an unspecified dose and frequency. On 23-Apr-2021, INFLUENZA LIKE ILLNESS (Standard reaction like a flu), PYREXIA (A little fever) and HEADACHE (Headache) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Other vaccines given within 1 month prior to Moderna COVID-19 vaccine  chicken pox vaccine around both fist.  Patient taking Acyclovir since 24 years ago.  Other concomitant medication include vitamins.     This case was linked to MOD-2022-495240, MOD-2022-495241 (Patient Link).
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered after 30 day use by date; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30 day use by date) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Feb-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30 day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30 day use by date) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided by the reporter. No treatment information was provided.  Reporter stated that on 17-Dec-2021, the vial was initially stored in the refrigerator and the use by date was 16-Jan-2022. Also stated that the vial did not undergo any temperature excursions.
Age: 49.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Doses administered after 30-day use by date; Date the vial was initially stored in the refrigerator: 17Dec2021/Date of administration of vaccine: 21Feb2022; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: 17Dec2021/Date of administration of vaccine: 21Feb2022) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Feb-2022, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: 17Dec2021/Date of administration of vaccine: 21Feb2022). On 21-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator: 17Dec2021/Date of administration of vaccine: 21Feb2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. No treatment medication were provided. Beyond use date (BUD) of the vaccine was 16-Jan-2022. Date the vial was initially stored in the refrigerator was 17-Dec-2021 and the vial did not undergo any temperature excursions.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Doses administered after 30-day use by date; The vial was initially stored in the refrigerator on 17-Dec-2021 and was administered on 21-Feb-2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 17-Dec-2021 and was administered on 21-Feb-2021) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027H21B) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Feb-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 17-Dec-2021 and was administered on 21-Feb-2021). On 21-Feb-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Doses administered after 30-day use by date) and PRODUCT STORAGE ERROR (The vial was initially stored in the refrigerator on 17-Dec-2021 and was administered on 21-Feb-2021) outcome was unknown. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vial had not undergone any temperature excursions and Vaccine beyond use date was 16-Jan-2022. The vial was initially stored in the refrigerator on 17-Dec-2021. No treatment medications were reported.