chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was administered after beyond use date and CDC expiry date; Vaccine administered to patient past the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patient past the expiration date) and PRODUCT STORAGE ERROR (Vaccine was administered after beyond use date and CDC expiry date) in an adult patient of an unknown gender who received mRNA-1273 (Spikevax) (batch no. 068H21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 08-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 08-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patient past the expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was administered after beyond use date and CDC expiry date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine administered to patient past the expiration date) and PRODUCT STORAGE ERROR (Vaccine was administered after beyond use date and CDC expiry date) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.   The vial was stored in standard freezer for the lot 068H21A with 2 degrees F high -1 degrees F low on 04-Jan-2022. The BUD date and CDC expiry date was reported as 02-Apr-2022.   No treatment medication was reported.  This case contains information for the eleventh of 45 patients described by the reporter.
Age: 40.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was stored in refrigerator/ Administered to the patient past expiration date 22-Jan-2022; 2  doses administered past the expiration date; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2  doses administered past the expiration date) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator/ Administered to the patient past expiration date 22-Jan-2022) in a 41-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 28-Jan-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (2  doses administered past the expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator/ Administered to the patient past expiration date 22-Jan-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (2  doses administered past the expiration date) and PRODUCT STORAGE ERROR (Vaccine was stored in refrigerator/ Administered to the patient past expiration date 22-Jan-2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided by the reporter.  The vaccines were stored in the refrigerator. Temperature ranges were between 2-5 Celsius. Start BUD was  reported as 27-AUG-2022.  Treatment information was not provided.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Limb discomfort
Clinical narrative: Had something in her arm after the first booster but didn't experience the same with the rest of the doses; This spontaneous case was reported by a patient and describes the occurrence of LIMB DISCOMFORT (Had something in her arm after the first booster but didn't experience the same with the rest of the doses) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048c21a, 031m20a and 036a21a) for COVID-19 prophylaxis.     No medical history was provided by the reporter. Patient had never tested positive or diagnosed for COVID-19.  Previously administered products included for Product used for unknown indication: INFLUENZA VACCINE. Past adverse reactions to the above products included No adverse event with INFLUENZA VACCINE.   On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Nov-2021, 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 experienced LIMB DISCOMFORT (Had something in her arm after the first booster but didn't experience the same with the rest of the doses). At the time of the report, LIMB DISCOMFORT (Had something in her arm after the first booster but didn't experience the same with the rest of the doses) outcome was unknown.            Concomitant medication reported included Statin.  Treatment details was not reported by the reporter.   This case was linked to MOD-2022-614403 (Patient Link).
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Eczema
Clinical narrative: had a severe eczema respond in her body, after her second  dose of the Moderna vaccine, that she has  under control now but not 100 %; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ECZEMA (had a severe eczema respond in her body, after her second  dose of the Moderna vaccine, that she has  under control now but not 100 %) in a 47-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    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 ECZEMA (had a severe eczema respond in her body, after her second  dose of the Moderna vaccine, that she has  under control now but not 100 %). At the time of the report, ECZEMA (had a severe eczema respond in her body, after her second  dose of the Moderna vaccine, that she has  under control now but not 100 %) was resolving.            No concomitant medication information provided.  No treatment medication information provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-614701, US-MODERNATX, INC.-MOD-2022-614693 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-614701:patient J-T US-MODERNATX, INC.-MOD-2022-614693:patient R-J
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination complication
Clinical narrative: Two other friends said that taking the vaccine was like having the disease; Pain in the arm; This spontaneous case was reported by a patient family member or friend and describes the occurrence of VACCINATION COMPLICATION (Two other friends said that taking the vaccine was like having the disease) and PAIN IN EXTREMITY (Pain in the arm) in a 45-year-old male patient who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Two other friends said that taking the vaccine was like having the disease) and PAIN IN EXTREMITY (Pain in the arm). At the time of the report, VACCINATION COMPLICATION (Two other friends said that taking the vaccine was like having the disease) and PAIN IN EXTREMITY (Pain in the arm) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.   This case was linked to MOD-2022-614664, MOD-2022-614693 (E2B Linked Report).; Sender's Comments:  MOD-2022-614664:Patient MOD-2022-614693:Patient
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Influenza like illness, Pain, Vaccination site erythema
Clinical narrative: Flu like symptoms; General achiness; The patient reports a red ring around the injection site the size of a nickle; Joint pain; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (General achiness), VACCINATION SITE ERYTHEMA (The patient reports a red ring around the injection site the size of a nickle) and ARTHRALGIA (Joint pain) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (General achiness), VACCINATION SITE ERYTHEMA (The patient reports a red ring around the injection site the size of a nickle) and ARTHRALGIA (Joint pain). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (General achiness), VACCINATION SITE ERYTHEMA (The patient reports a red ring around the injection site the size of a nickle) and ARTHRALGIA (Joint pain) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications details were not reported by the reporter. The patient not got COVID-19 infection.  Treatment details were not reported by the reporter.   This case was linked to MOD-2022-614955, MOD-2022-614959 (Patient Link).
Age: 59.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vaccination site mass, Vaccination site pain
Clinical narrative: Flu like symptoms; General achiness; The patient reports a red ring around the injection site the size of a nickle; Joint pain; This spontaneous case was reported by a patient and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (General achiness), VACCINATION SITE ERYTHEMA (The patient reports a red ring around the injection site the size of a nickle) and ARTHRALGIA (Joint pain) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Apr-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (General achiness), VACCINATION SITE ERYTHEMA (The patient reports a red ring around the injection site the size of a nickle) and ARTHRALGIA (Joint pain). At the time of the report, INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (General achiness), VACCINATION SITE ERYTHEMA (The patient reports a red ring around the injection site the size of a nickle) and ARTHRALGIA (Joint pain) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications details were not reported by the reporter. The patient not got COVID-19 infection.  Treatment details were not reported by the reporter.   This case was linked to MOD-2022-614955, MOD-2022-614959 (Patient Link).
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Arthralgia, Influenza like illness, Pain, Vaccination site erythema
Clinical narrative: sore injection site; after 5 or 6 hours the patient had a lump on his left arm at the injection site about the size of half of a golf ball; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (sore injection site) and VACCINATION SITE MASS (after 5 or 6 hours the patient had a lump on his left arm at the injection site about the size of half of a golf ball) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039FAA, 021C21A and 038B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021, the patient experienced VACCINATION SITE PAIN (sore injection site) and VACCINATION SITE MASS (after 5 or 6 hours the patient had a lump on his left arm at the injection site about the size of half of a golf ball). In December 2021, VACCINATION SITE MASS (after 5 or 6 hours the patient had a lump on his left arm at the injection site about the size of half of a golf ball) had resolved. At the time of the report, VACCINATION SITE PAIN (sore injection site) outcome was unknown.            Concomitant medication of the patient was not reported.  The reporter reported that for the first Moderna COVID-19 vaccine booster the lot number was hard to read.  No treatment information was provided by the reporter. It was reported that, after a day and a half the swelling went away.  The reporter reported that he had not got COVID-19 and he was very thankful for that and also reported that this was because he received the Moderna COVID-19 vaccine.   This case was linked to MOD-2022-614955, MOD-2022-614709 (Patient Link).
Age: 60.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Vaccination site mass, Vaccination site pain
Clinical narrative: sore injection site; after 5 or 6 hours the patient had a lump on his left arm at the injection site about the size of half of a golf ball; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (sore injection site) and VACCINATION SITE MASS (after 5 or 6 hours the patient had a lump on his left arm at the injection site about the size of half of a golf ball) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039FAA, 021C21A and 038B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Dec-2021, the patient experienced VACCINATION SITE PAIN (sore injection site) and VACCINATION SITE MASS (after 5 or 6 hours the patient had a lump on his left arm at the injection site about the size of half of a golf ball). In December 2021, VACCINATION SITE MASS (after 5 or 6 hours the patient had a lump on his left arm at the injection site about the size of half of a golf ball) had resolved. At the time of the report, VACCINATION SITE PAIN (sore injection site) outcome was unknown.            Concomitant medication of the patient was not reported.  The reporter reported that for the first Moderna COVID-19 vaccine booster the lot number was hard to read.  No treatment information was provided by the reporter. It was reported that, after a day and a half the swelling went away.  The reporter reported that he had not got COVID-19 and he was very thankful for that and also reported that this was because he received the Moderna COVID-19 vaccine.   This case was linked to MOD-2022-614955, MOD-2022-614709 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Interchange of vaccine products
Clinical narrative: Caught Covid-19; They both had the Pfizer Moderna Covid-19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Caught Covid-19) and INTERCHANGE OF VACCINE PRODUCTS (They both had the Pfizer Moderna Covid-19 vaccine) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     Concomitant products included TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Caught Covid-19) and INTERCHANGE OF VACCINE PRODUCTS (They both had the Pfizer Moderna Covid-19 vaccine). At the time of the report, COVID-19 (Caught Covid-19) and INTERCHANGE OF VACCINE PRODUCTS (They both had the Pfizer Moderna Covid-19 vaccine) outcome was unknown.            No medical history was reported. No treatment medications were reported. Company comment: This is a spontaneous case concerns a female patient of  unspecified age with no medical history, who experienced the unexpected non-serious adverse events of special interest, COVID-19 (COVID-19) in the context of the administration of a dose of mRNA-1273 vaccine (unknown dose number and schedule of vaccination). No additional information is available regarding diagnostic work-up to support the current diagnosis, concomitant medication and treatment received. The event outcome was unknown. It was noted that patient received 2 doses with PFIZER BIONTECH COVID-19 VACCINE prior to current vaccination (interchange of vaccine products). Ongoing Covid 19 pandemic could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.; Sender's Comments: This is a spontaneous case concerns a female patient of  unspecified age with no medical history, who experienced the unexpected non-serious adverse events of special interest, COVID-19 (COVID-19) in the context of the administration of a dose of mRNA-1273 vaccine (unknown dose number and schedule of vaccination). No additional information is available regarding diagnostic work-up to support the current diagnosis, concomitant medication and treatment received. The event outcome was unknown. It was noted that patient received 2 doses with PFIZER BIONTECH COVID-19 VACCINE prior to current vaccination (interchange of vaccine products). Ongoing Covid 19 pandemic could be considered as confounder to the event. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Event seriousness assessed as per medical judgement.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Transient ischaemic attack
Clinical narrative: The patient did suffer 2 mini strokes; Bad pain in her head; This spontaneous case was reported by a patient and describes the occurrence of TRANSIENT ISCHAEMIC ATTACK (The patient did suffer 2 mini strokes) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030H21B, 046A21A and 013A21A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In January 2022, the patient experienced TRANSIENT ISCHAEMIC ATTACK (The patient did suffer 2 mini strokes) (seriousness criterion medically significant). On an unknown date, the patient experienced HEADACHE (Bad pain in her head). At the time of the report, TRANSIENT ISCHAEMIC ATTACK (The patient did suffer 2 mini strokes) outcome was unknown and HEADACHE (Bad pain in her head) had resolved.            No concomitant medication provided. No treatment information provided.  Patient reported she had 2 mini strokes in Jan 2022. She got her first and second dose of vaccine with no adverse reactions or any side effects. She got the third on 08 Dec 2021, and there were no side effects then too, but patient said they suffered 2 mini strokes in Jan 2022. Had a bad pain in her head which lasted for 4 to 5 minutes as well.  Company comment- This spontaneous case concerns a 74-year-old female patient with no reported medical history, who experienced unexpected, serious (medically significant) AESI Transient ischaemic attack the following month after vaccination with a third dose of mRNA-1273. No further information was provided. The outcome of the events was reported as resolved. The age of the patient maybe a contributory factor to the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This spontaneous case concerns a 74-year-old female patient with no reported medical history, who experienced unexpected, serious (medically significant) AESI Transient ischaemic attack the following month after vaccination with a third dose of mRNA-1273. No further information was provided. The outcome of the events was reported as resolved. The age of the patient maybe a contributory factor to the event. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Hypoaesthesia, Lethargy, Malaise, Myalgia
Clinical narrative: not feeling well; she mentions feeling lethargic; she can barely talk; sores in mouth; red swollen lump under her eye and on the side of her nose,symptoms have gotten progressively worse and today is the worst day of them all; arms and hands are going numb on and off; muscle aches; exhausted; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (not feeling well), LETHARGY (she mentions feeling lethargic), SPEECH DISORDER (she can barely talk), ORAL PAIN (sores in mouth) and SKIN MASS (red swollen lump under her eye and on the side of her nose,symptoms have gotten progressively worse and today is the worst day of them all) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A, 045A21A and 017B22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sulfonamide allergy, Allergy to antibiotic, Penicillin allergy, Allergy to antibiotic, Latex allergy and Drug allergy.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Jul-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jul-2022, the patient experienced MALAISE (not feeling well), LETHARGY (she mentions feeling lethargic), SPEECH DISORDER (she can barely talk), ORAL PAIN (sores in mouth), SKIN MASS (red swollen lump under her eye and on the side of her nose,symptoms have gotten progressively worse and today is the worst day of them all), HYPOAESTHESIA (arms and hands are going numb on and off), MYALGIA (muscle aches) and FATIGUE (exhausted). The patient was treated with NAPROXEN at an unspecified dose and frequency and OXYCODONE at an unspecified dose and frequency. At the time of the report, MALAISE (not feeling well), LETHARGY (she mentions feeling lethargic), SPEECH DISORDER (she can barely talk), ORAL PAIN (sores in mouth), SKIN MASS (red swollen lump under her eye and on the side of her nose,symptoms have gotten progressively worse and today is the worst day of them all), HYPOAESTHESIA (arms and hands are going numb on and off), MYALGIA (muscle aches) and FATIGUE (exhausted) had not resolved.            The patient did not ever have COVID + test or diagnosis.  Patient did not receive other vaccines within 1 month prior to Moderna COVID-19 vaccine.  The AE did not cause patient to seek medical care (office visit, Urgent care, ER, hospitalized).  The patient did not experience a similar event in the past. The symptoms have worsened.  She refers having medications for chronic illnesses but prefers not to share that.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Oral pain, Skin mass, Speech disorder
Clinical narrative: not feeling well; she mentions feeling lethargic; she can barely talk; sores in mouth; red swollen lump under her eye and on the side of her nose,symptoms have gotten progressively worse and today is the worst day of them all; arms and hands are going numb on and off; muscle aches; exhausted; This spontaneous case was reported by a patient and describes the occurrence of MALAISE (not feeling well), LETHARGY (she mentions feeling lethargic), SPEECH DISORDER (she can barely talk), ORAL PAIN (sores in mouth) and SKIN MASS (red swollen lump under her eye and on the side of her nose,symptoms have gotten progressively worse and today is the worst day of them all) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A, 045A21A and 017B22A) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Sulfonamide allergy, Allergy to antibiotic, Penicillin allergy, Allergy to antibiotic, Latex allergy and Drug allergy.   On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Jul-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jul-2022, the patient experienced MALAISE (not feeling well), LETHARGY (she mentions feeling lethargic), SPEECH DISORDER (she can barely talk), ORAL PAIN (sores in mouth), SKIN MASS (red swollen lump under her eye and on the side of her nose,symptoms have gotten progressively worse and today is the worst day of them all), HYPOAESTHESIA (arms and hands are going numb on and off), MYALGIA (muscle aches) and FATIGUE (exhausted). The patient was treated with NAPROXEN at an unspecified dose and frequency and OXYCODONE at an unspecified dose and frequency. At the time of the report, MALAISE (not feeling well), LETHARGY (she mentions feeling lethargic), SPEECH DISORDER (she can barely talk), ORAL PAIN (sores in mouth), SKIN MASS (red swollen lump under her eye and on the side of her nose,symptoms have gotten progressively worse and today is the worst day of them all), HYPOAESTHESIA (arms and hands are going numb on and off), MYALGIA (muscle aches) and FATIGUE (exhausted) had not resolved.            The patient did not ever have COVID + test or diagnosis.  Patient did not receive other vaccines within 1 month prior to Moderna COVID-19 vaccine.  The AE did not cause patient to seek medical care (office visit, Urgent care, ER, hospitalized).  The patient did not experience a similar event in the past. The symptoms have worsened.  She refers having medications for chronic illnesses but prefers not to share that.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vial was exposed to room temperature range for about 25 hours; patient received dose exposed to romm temperature for 25 hours; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient received dose exposed to romm temperature for 25 hours) and PRODUCT STORAGE ERROR (Vial was exposed to room temperature range for about 25 hours) in an 89-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 017B22A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 26-Jul-2022 at 12:15 PM, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 26-Jul-2022 at 12:15 PM, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient received dose exposed to romm temperature for 25 hours). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vial was exposed to room temperature range for about 25 hours). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient received dose exposed to romm temperature for 25 hours) and PRODUCT STORAGE ERROR (Vial was exposed to room temperature range for about 25 hours) outcome was unknown.      For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medication were reported. Pharmacy student administered an expired dose. The vial did not underwent any temperature excursion.  Vial initially stored in the refrigerator19-Jul-2022  First punctured 26-Jul-2022 around 11 AM  No treatment drug were reported.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vial was stored in fridge post puncture.; administered vaccines to patients >12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered vaccines to patients >12 hours post puncture) and PRODUCT STORAGE ERROR (The vial was stored in fridge post puncture.) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 22-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered vaccines to patients >12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vial was stored in fridge post puncture.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered vaccines to patients >12 hours post puncture) and PRODUCT STORAGE ERROR (The vial was stored in fridge post puncture.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   This case contains information for the 1st patient (female) as described by the reporter.  No concomitant medications information was reported.  The vial was initially stored in the refrigerator was 21-Jul-2022. The vial was stored in fridge post puncture. The vial did not undergo any temperature excursions. It was unknown  for how long the vial was exposed to room temperature but it was not greater than 24 hours. Reporter told that patient was fine.  No treatment medications were provided.   This case was linked to MOD-2022-615202 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered vaccines to patients >12 hours post puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccines to patients >12 hours post puncture) in a male patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On 22-Jul-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 22-Jul-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccines to patients >12 hours post puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered vaccines to patients >12 hours post puncture) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. Date the vial was initially stored in the refrigerator on 21Jul2022. the vial  was stored post puncture in Fridge. The vial  doesn't undergo any temperature excursions. Unknown whether the vial exposed to room temperature for how long but not greater than 24 hours No treatment medication was reported.   This case was linked to MOD-2022-615199 (Patient Link).
Age: 4.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Administered vaccine that had been punctured more than 12 hours and placed in the refrigerator; Moderna Covid-19 vaccine was administered to a 4 year old that had been punctured more than 12 hours ago; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine was administered to a 4 year old that had been punctured more than 12 hours ago) and PRODUCT STORAGE ERROR (Administered vaccine that had been punctured more than 12 hours and placed in the refrigerator) in a 4-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. AR9237B) for COVID-19 prophylaxis.     No Medical History information was reported.    On 27-Jul-2022 at 8:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jul-2022 at 8:30 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine was administered to a 4 year old that had been punctured more than 12 hours ago). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Administered vaccine that had been punctured more than 12 hours and placed in the refrigerator). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine was administered to a 4 year old that had been punctured more than 12 hours ago) and PRODUCT STORAGE ERROR (Administered vaccine that had been punctured more than 12 hours and placed in the refrigerator) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug was reported. The vial was initially stored in the refrigerator on 30-Jun-2022. The vial was first punctured on 26-Jul-2022 at 8:27 am. It was reported that vial had not undergone any temperature excursions. No treatment drug was reported.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: patients received the vaccine pass 30 days in the fridge/The vaccine was received frozen from the health department and place in the fridge at proper temperature; Patients received the vaccine pass 30 days in the fridge; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received the vaccine pass 30 days in the fridge) and PRODUCT STORAGE ERROR (patients received the vaccine pass 30 days in the fridge/The vaccine was received frozen from the health department and place in the fridge at proper temperature) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination.     No Medical History information was reported.    In 2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received the vaccine pass 30 days in the fridge). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (patients received the vaccine pass 30 days in the fridge/The vaccine was received frozen from the health department and place in the fridge at proper temperature). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received the vaccine pass 30 days in the fridge) and PRODUCT STORAGE ERROR (patients received the vaccine pass 30 days in the fridge/The vaccine was received frozen from the health department and place in the fridge at proper temperature) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patients was elderly Patients was not immunocompromised. All patients taking medication. Patients received their 2nd booster of the vaccine. No patients reported having side effects. Some patients allergic to penicillin and sulfa. One was allergic to statin drugs like Lipitor.  No treatment information was provided.   This case was linked to US-MODERNATX, INC.-MOD-2022-615211, US-MODERNATX, INC.-MOD-2022-615212, US-MODERNATX, INC.-MOD-2022-615213 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-615211:patient 2- elderly female 2 US-MODERNATX, INC.-MOD-2022-615212:patient 3- elderly male 1 US-MODERNATX, INC.-MOD-2022-615213:patient 4- elderly male 2
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Eye pain, Local reaction, Pain, Pruritus, Urticaria
Clinical narrative: had to go to the Emergency room because he had a  reaction in his hand; everything that he touched hurted him,; extreme itchiness; hives,; everything that he touched hurted him, even in the eyes if he touched them; This spontaneous case was reported by a patient and describes the occurrence of LOCAL REACTION (had to go to the Emergency room because he had a  reaction in his hand), PAIN (everything that he touched hurted him,), PRURITUS (extreme itchiness), URTICARIA (hives,) and EYE PAIN (everything that he touched hurted him, even in the eyes if he touched them) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     The patient had no allergies. The patient never had COVID positive test or diagnosis. The patient had no history of acute and chronic illnesses at the time of vaccination. The patient had not received other vaccines within 1 month prior to Moderna COVID-19 vaccine.    In 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced LOCAL REACTION (had to go to the Emergency room because he had a  reaction in his hand), PAIN (everything that he touched hurted him,), PRURITUS (extreme itchiness), URTICARIA (hives,) and EYE PAIN (everything that he touched hurted him, even in the eyes if he touched them). At the time of the report, LOCAL REACTION (had to go to the Emergency room because he had a  reaction in his hand), PAIN (everything that he touched hurted him,), PRURITUS (extreme itchiness), URTICARIA (hives,) and EYE PAIN (everything that he touched hurted him, even in the eyes if he touched them) had not resolved.            Concomitant medications was not provided by the reporter. On Nov2021 or Dec2021, the patient had to go to the emergency room  because he had a reaction in his hand, everything that he touched hurted him, and extreme itchiness, and hives, even in the eyes if he touched them. Patient controlled the symptoms with medication, but it did not cure him.   Reporter did not allow further contact
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: The vaccine was received frozen from the health department and place in the fridge at proper temperature; Patients received the vaccine pass 30 days in the fridge; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received the vaccine pass 30 days in the fridge) and PRODUCT STORAGE ERROR (The vaccine was received frozen from the health department and place in the fridge at proper temperature) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 prophylaxis.     Patient was not immunocompromised.     In 2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received the vaccine pass 30 days in the fridge). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (The vaccine was received frozen from the health department and place in the fridge at proper temperature). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received the vaccine pass 30 days in the fridge) and PRODUCT STORAGE ERROR (The vaccine was received frozen from the health department and place in the fridge at proper temperature) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Some patients allergic to penicillin and sulfa. One was allergic to statin drugs like Lipitor. All patients were taking medication. It was reported that 3 patients received the vaccine on 24-Jun-2022 and 1 patient received the vaccine on 01-Jul-2022. No patients reported having side effects. No treatment information was provided.  This case is of patient 3- elderly male 1.   This case was linked to US-MODERNATX, INC.-MOD-2022-615208 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-615208:patient 1- elderly female 1
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Patients received the vaccine pass 30 days in the fridge; Vial was placed in the fridge on 13-May-2022 and dose was administered on 24-Jun-2022 and 01-Jul-2022; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patients received the vaccine pass 30 days in the fridge) and PRODUCT STORAGE ERROR (Vial was placed in the fridge on 13-May-2022 and dose was administered on 24-Jun-2022 and 01-Jul-2022) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002M21A) for COVID-19 vaccination. Concurrent medical conditions included Penicillin allergy, Drug allergy (Sulfa) and Drug allergy (statin drugs like Lipitor). On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patients received the vaccine pass 30 days in the fridge) and PRODUCT STORAGE ERROR (Vial was placed in the fridge on 13-May-2022 and dose was administered on 24-Jun-2022 and 01-Jul-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patients received the vaccine pass 30 days in the fridge) and PRODUCT STORAGE ERROR (Vial was placed in the fridge on 13-May-2022 and dose was administered on 24-Jun-2022 and 01-Jul-2022) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. 4 patients received their 2nd booster of the vaccine. Physician stated 3 Patients received the vaccine on 24Jun2022 and 1 patient received the vaccine on 01Jul2022.No patients reported having side effects. Patients are not immunocompromised. All patients were taking medication. No treatment information was provided.   This case was linked to MODERNATX, INC.-MOD-2022-615208 (E2B Linked Report).; Sender's Comments:  MODERNATX, INC.-MOD-2022-615208:patient 1- elderly female 2
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Contracted COVID-19 infection after vaccination; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (Contracted COVID-19 infection after vaccination) in a female patient of an unknown age who received mRNA-1273 (Spikevax) for COVID-19 prophylaxis.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Contracted COVID-19 infection after vaccination). At the time of the report, COVID-19 (Contracted COVID-19 infection after vaccination) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.       Concomitant medications were not provided by the reporter. Patient experienced COVID-19. Reporter wanted to know, howlong could patient give it to someone else. Because they want to go visit. Reporter guessed they were vaccinated. She never mentioned they were vaccinated with the Moderna COVID-19 vaccine. Treatment information was not provided. Company comment: This spontaneous case concerns a female patient of unknown age with no reported medical history, who experienced the unexpected, non-serious AESI of COVID-19. The exact date of administration of an unknown dose of mRNA-1273 and onset of the event was not specified, hence latency could not be assessed. Details of concomitant medications, medical history, clinical course and treatment were not provided. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This spontaneous case concerns a female patient of unknown age with no reported medical history, who experienced the unexpected, non-serious AESI of COVID-19. The exact date of administration of an unknown dose of mRNA-1273 and onset of the event was not specified, hence latency could not be assessed. Details of concomitant medications, medical history, clinical course and treatment were not provided. The outcome of the event was unknown at the time of the report. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Age: 85.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: Mild COVID Disease on 21JUN2022; This spontaneous case was reported by a patient and describes the occurrence of COVID-19 (Mild COVID Disease on 21JUN2022) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026D21A and 007M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 31-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jun-2022, the patient experienced COVID-19 (Mild COVID Disease on 21JUN2022). At the time of the report, COVID-19 (Mild COVID Disease on 21JUN2022) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jun-2022, SARS-CoV-2 test: (Positive) Positive.         No concomitant medications were reported. It was reported that the patient PCP refused to see them because they had symptoms. Patient went to the urgent care.  No treatment medications were reported.  Company comment: This spontaneous case concerns an 86 year old female patient with no reported medical history, who experienced the unexpected non serious AESI of COVID-19 , about 9 months and 21 days after receiving the third dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient received the primary series of doses with the same vaccine in accordance with the recommended schedule. She received the third dose about 6 months and 15 days after the second dose. The patient's COVID-19 PCR test was positive. No further information on risk factors, co morbidities, clinical course, treatment details and outcome of the event was available in the report. The COVID-19 pandemic could be a confounder for the event COVID-19. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous case concerns an 86 year old female patient with no reported medical history, who experienced the unexpected non serious AESI of COVID-19 , about 9 months and 21 days after receiving the third dose of mRNA-1273 vaccine in the COVID-19 vaccination series. The patient received the primary series of doses with the same vaccine in accordance with the recommended schedule. She received the third dose about 6 months and 15 days after the second dose. The patient's COVID-19 PCR test was positive. No further information on risk factors, co morbidities, clinical course, treatment details and outcome of the event was available in the report. The COVID 19 pandemic could be a confounder for the event COVID-19. The benefit-risk relationship of mRNA-1273 is not affected by this report.