chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Tremor
Clinical narrative: She's been so sick , sick as a dog; headache that doesn't go away ,It's like a burning headache; She has fevers going up and down - not extremely high, but 99 or 100; She has chills; She's trembling; body pain; body is burning; This spontaneous case was reported by a patient and describes the occurrence of TREMOR (She's trembling), PAIN (body pain), BURNING SENSATION (body is burning), ILLNESS (She's been so sick , sick as a dog) and HEADACHE (headache that doesn't go away ,It's like a burning headache) in a 66-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 prophylaxis. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 11-Nov-2022, the patient received fourth dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 12-Nov-2022, the patient experienced ILLNESS (She's been so sick , sick as a dog). In November 2022, the patient experienced TREMOR (She's trembling), PAIN (body pain), BURNING SENSATION (body is burning), HEADACHE (headache that doesn't go away ,It's like a burning headache), PYREXIA (She has fevers going up and down - not extremely high, but 99 or 100) and CHILLS (She has chills). On 13-Nov-2022, ILLNESS (She's been so sick , sick as a dog) had resolved. At the time of the report, TREMOR (She's trembling), PAIN (body pain), BURNING SENSATION (body is burning), HEADACHE (headache that doesn't go away ,It's like a burning headache), PYREXIA (She has fevers going up and down - not extremely high, but 99 or 100) and CHILLS (She has chills) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2022, Body temperature: not extremely high, but 99 or 100.         No concomitant medications were reported.  The patient took 4 shots of Moderna. The patient states that she got very sick from the last one that she took in Dec-2021.  No treatment medications were reported.   This case was linked to MOD-2022-674590.
Sex: M
Vaccine: COVID19
Symptoms: Psoriasis
Clinical narrative: psoriasis came all the way back/bumps on buttocks, groin, back of legs, thighs, elbows and spotty/rashes on back, elbow, ankles, private parts, and buttocks; This spontaneous case was reported by a consumer and describes the occurrence of PSORIASIS (psoriasis came all the way back/bumps on buttocks, groin, back of legs, thighs, elbows and spotty/rashes on back, elbow, ankles, private parts, and buttocks) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 01M20A and 029L20A) for COVID-19 prophylaxis.     The patient's past medical history included Psoriasis (had a couple of patches, approximately 3 years ago). Concomitant products included VITAMIN D3, VITAMIN C [ASCORBIC ACID] and ZINC for an unknown indication.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced PSORIASIS (psoriasis came all the way back/bumps on buttocks, groin, back of legs, thighs, elbows and spotty/rashes on back, elbow, ankles, private parts, and buttocks). At the time of the report, PSORIASIS (psoriasis came all the way back/bumps on buttocks, groin, back of legs, thighs, elbows and spotty/rashes on back, elbow, ankles, private parts, and buttocks) outcome was unknown.            Patient had psoriasis symptoms as bumps on buttocks, groin, back of legs, thighs and rashes on back, elbow, ankles, private parts, and even buttocks. Patient also had it on elbows and it was spotty. It was usually on there for a bit, then after awhile the dead skin pealed off. They also mentioned that a lot of elderly people are getting rashes and maybe not connecting the dots that it was due to the Moderna COVID-19 vaccine. Patient received pfizer vaccine as first booster on 27-Dec-2021 (batch lot number fe3594). patient had dead skin on face. but it was caused by the sun and did not look like psoriasis. Patient had this procedure done by dermatologist, regularly and used liquid nitrogen that dermatologist sprays on patient face. Patient would be going to going to see dermatologist again next month. Patient got covid in august of this year (2022). it was a mild case, though.   This case was linked to MOD-2022-674526 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 17-Nov-2022: Live Follow up received contains reporter added and narrative Updated.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: got very sick from the last one; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (got very sick from the last one) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 prophylaxis.     No Medical History information was reported.   In December 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. In December 2021, the patient experienced ILLNESS (got very sick from the last one). At the time of the report, ILLNESS (got very sick from the last one) outcome was unknown.            No concomitant medication were reported.  Patient stated that she got very sick from the last one that patient took in December 2021. Patient received Moderna booster on 11-NOV-2022.  No treatment information was provided by the reporter.   This case was linked to MOD-2022-674381 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: patient says that her and her husband had Covid-19 in August of 2022 after they had received 3 Moderna Covid-19 vaccines.; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (patient says that her and her husband had Covid-19 in August of 2022 after they had received 3 Moderna Covid-19 vaccines.) in an adult female 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2022, the patient experienced COVID-19 (patient says that her and her husband had Covid-19 in August of 2022 after they had received 3 Moderna Covid-19 vaccines.). At the time of the report, COVID-19 (patient says that her and her husband had Covid-19 in August of 2022 after they had received 3 Moderna Covid-19 vaccines.) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2022, SARS-CoV-2 test: Positive.         No concomitant medications were reported. No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-674609 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-674609:cross link MOD-2022-674609 (husband case)
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test
Clinical narrative: patient had Covid-19 in August of 2022 after he had received 3 Moderna Covid-19 vaccines; This spontaneous case was reported by a patient family member or friend and describes the occurrence of COVID-19 (patient had Covid-19 in August of 2022 after he had received 3 Moderna Covid-19 vaccines) in an adult 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 August 2022, the patient experienced COVID-19 (patient had Covid-19 in August of 2022 after he had received 3 Moderna Covid-19 vaccines). At the time of the report, COVID-19 (patient had Covid-19 in August of 2022 after he had received 3 Moderna Covid-19 vaccines) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In August 2022, SARS-CoV-2 test: Positive.         No concomitant medications were reported.  No treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2022-674607 (Linked Report).   Reporter did not allow further contact; Sender's Comments:  US-MODERNATX, INC.-MOD-2022-674607:wife case
Age: 69.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Date the vial was initially stored in the refrigerator was 12-Nov-2021, product expiry date 08-Nov-2021; No adverse event; patient got 1 dose of Moderna Covid-19 vaccine last yr on 12Nov2021 with expiry date on 08-Nov-2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient got 1 dose of Moderna Covid-19 vaccine last yr on 12Nov2021 with expiry date on 08-Nov-2021), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 12-Nov-2021, product expiry date 08-Nov-2021) and NO ADVERSE EVENT (No adverse event) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 prophylaxis.     No Medical History information was reported.   On 12-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient got 1 dose of Moderna Covid-19 vaccine last yr on 12Nov2021 with expiry date on 08-Nov-2021). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 12-Nov-2021, product expiry date 08-Nov-2021) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient got 1 dose of Moderna Covid-19 vaccine last yr on 12Nov2021 with expiry date on 08-Nov-2021), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 12-Nov-2021, product expiry date 08-Nov-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (patient got 1 dose of Moderna Covid-19 vaccine last yr on 12Nov2021 with expiry date on 08-Nov-2021) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 12-Nov-2021, product expiry date 08-Nov-2021).    Concomitant drugs were not reported. It was reported that the monovalent vial of size 5.5 ml was initially stored in refrigerator on 12-Nov-2021  The vial did not underwent any temperature excursion. Treatment medications were not provided.
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pruritus, Vaccination site rash, Vaccination site swelling
Clinical narrative: Site even red; Like a big, round, size of a quarter rash/today it's even bigger; Became swollen again; It started itching above the site/itching/itchy; Her left arm started swelling; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE SWELLING (Became swollen again), VACCINATION SITE ERYTHEMA (Site even red), VACCINATION SITE RASH (Like a big, round, size of a quarter rash/today it's even bigger), VACCINATION SITE SWELLING (Her left arm started swelling) and VACCINATION SITE PRURITUS (It started itching above the site/itching/itchy) in a 50-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 063B22A) for COVID-19 vaccination.     Patient had no allergic reaction. Patient had no Medical history relating to mentioned AE and both Acute and Chronic illnesses at the time of vaccination. Patient did not received other vaccines within 1 month prior to Moderna COVID-19 vaccine. Patient did not had history of COVID-19.  The patient's past medical history included Anemia.   On 08-Nov-2022, the patient received first dose of mRNA-1273 (Spikevax) (Intramuscular) .5 milliliter. On 09-Nov-2022, the patient experienced VACCINATION SITE SWELLING (Her left arm started swelling). On 13-Nov-2022, the patient experienced VACCINATION SITE SWELLING (Became swollen again), VACCINATION SITE RASH (Like a big, round, size of a quarter rash/today it's even bigger) and VACCINATION SITE PRURITUS (It started itching above the site/itching/itchy). On 17-Nov-2022, the patient experienced VACCINATION SITE ERYTHEMA (Site even red). On 10-Nov-2022, VACCINATION SITE SWELLING (Her left arm started swelling) had resolved. At the time of the report, VACCINATION SITE SWELLING (Became swollen again), VACCINATION SITE ERYTHEMA (Site even red), VACCINATION SITE RASH (Like a big, round, size of a quarter rash/today it's even bigger) and VACCINATION SITE PRURITUS (It started itching above the site/itching/itchy) had not resolved.      The action taken with mRNA-1273 (Spikevax) (Intramuscular) was unknown.   Patient was not on any concomitant medication.  Patient did not treated the rash with any medications  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, No adverse event, Wrong product administered
Clinical narrative: No Adverse event; Went to receive 2nd primary dose more than 35 days; Patient went to pharmacy to receive the second Moderna vaccine dose and was given the bivalent instead; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Went to receive 2nd primary dose more than 35 days), WRONG PRODUCT ADMINISTERED (Patient went to pharmacy to receive the second Moderna vaccine dose and was given the bivalent instead) and NO ADVERSE EVENT (No Adverse event) in a female patient of an unknown age who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Oct-2022, the patient received second dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular) 1 dosage form. On 19-Oct-2022, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Went to receive 2nd primary dose more than 35 days) and WRONG PRODUCT ADMINISTERED (Patient went to pharmacy to receive the second Moderna vaccine dose and was given the bivalent instead). On an unknown date, the patient experienced NO ADVERSE EVENT (No Adverse event). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Went to receive 2nd primary dose more than 35 days), WRONG PRODUCT ADMINISTERED (Patient went to pharmacy to receive the second Moderna vaccine dose and was given the bivalent instead) and NO ADVERSE EVENT (No Adverse event) outcome was unknown.        For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Intramuscular), the reporter considered NO ADVERSE EVENT (No Adverse event) to be not related. No further causality assessments were provided for INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Went to receive 2nd primary dose more than 35 days) and WRONG PRODUCT ADMINISTERED (Patient went to pharmacy to receive the second Moderna vaccine dose and was given the bivalent instead).    No concomitant drug was reported.  Patient received first dose (Intramuscular) on Jan-2022. Reporter stated that patient did not tell them that patient needed the second dose.  No treatment drug was reported.
Age: 69.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: 12 patients got 1 dose of Moderna Covid-19 vaccine last yr on 12Nov2021./ Dose administered after 30-day Use By Date or after manufacturer date of expiry; No adverse event; 12 patients got 1 dose of Moderna Covid-19 vaccine last yr on 12Nov2021./ Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (12 patients got 1 dose of Moderna Covid-19 vaccine last yr on 12Nov2021./ Dose administered after 30-day Use By Date or after manufacturer date of expiry), PRODUCT STORAGE ERROR (12 patients got 1 dose of Moderna Covid-19 vaccine last yr on 12Nov2021./ Dose administered after 30-day Use By Date or after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (12 patients got 1 dose of Moderna Covid-19 vaccine last yr on 12Nov2021./ Dose administered after 30-day Use By Date or after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (12 patients got 1 dose of Moderna Covid-19 vaccine last yr on 12Nov2021./ Dose administered after 30-day Use By Date or after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (12 patients got 1 dose of Moderna Covid-19 vaccine last yr on 12Nov2021./ Dose administered after 30-day Use By Date or after manufacturer date of expiry), PRODUCT STORAGE ERROR (12 patients got 1 dose of Moderna Covid-19 vaccine last yr on 12Nov2021./ Dose administered after 30-day Use By Date or after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (12 patients got 1 dose of Moderna Covid-19 vaccine last yr on 12Nov2021./ Dose administered after 30-day Use By Date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (12 patients got 1 dose of Moderna Covid-19 vaccine last yr on 12Nov2021./ Dose administered after 30-day Use By Date or after manufacturer date of expiry).    No concomitant medications were reported. Dose administered after 30-day Use By Date or after manufacturer date of expiry Vial size was reported as 5.5 mL On 12-Nov-2021, the vial was initially stored in the refrigerator The vial did not undergo any temperature excursions.  No treatment medications were reported.
Age: 73.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Date the vial was initially stored in the refrigerator was 12-Nov-2021, product expiry date 08-Nov-2021; No adverse event; patient got 1 dose of Moderna Covid-19 vaccine last yr on 12Nov2021 with expiry date on 08-Nov-2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient got 1 dose of Moderna Covid-19 vaccine last yr on 12Nov2021 with expiry date on 08-Nov-2021), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 12-Nov-2021, product expiry date 08-Nov-2021) and NO ADVERSE EVENT (No adverse event) in a 73-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient got 1 dose of Moderna Covid-19 vaccine last yr on 12Nov2021 with expiry date on 08-Nov-2021). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 12-Nov-2021, product expiry date 08-Nov-2021) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient got 1 dose of Moderna Covid-19 vaccine last yr on 12Nov2021 with expiry date on 08-Nov-2021), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 12-Nov-2021, product expiry date 08-Nov-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (patient got 1 dose of Moderna Covid-19 vaccine last yr on 12Nov2021 with expiry date on 08-Nov-2021) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 12-Nov-2021, product expiry date 08-Nov-2021).    Concomitant drugs were not reported. It was reported that the monovalent vial of size 5.5 ml was initially stored in refrigerator on 12-Nov-2021  The vial did not underwent any temperature excursion. Treatment medications were not provided.
Age: 60.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Date the vial was initially stored in the refrigerator was 12-Nov-2021, product expiry date 08-Nov-2021 and administered on 12-Nov-2021.; No adverse event; patient got 1 dose of Moderna Covid-19 vaccine last yr on 12Nov2021 with expiry date on 08-Nov-2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient got 1 dose of Moderna Covid-19 vaccine last yr on 12Nov2021 with expiry date on 08-Nov-2021), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 12-Nov-2021, product expiry date 08-Nov-2021 and administered on 12-Nov-2021.) and NO ADVERSE EVENT (No adverse event) in a 60-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient got 1 dose of Moderna Covid-19 vaccine last yr on 12Nov2021 with expiry date on 08-Nov-2021). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 12-Nov-2021, product expiry date 08-Nov-2021 and administered on 12-Nov-2021.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient got 1 dose of Moderna Covid-19 vaccine last yr on 12Nov2021 with expiry date on 08-Nov-2021), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 12-Nov-2021, product expiry date 08-Nov-2021 and administered on 12-Nov-2021.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (patient got 1 dose of Moderna Covid-19 vaccine last yr on 12Nov2021 with expiry date on 08-Nov-2021) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 12-Nov-2021, product expiry date 08-Nov-2021 and administered on 12-Nov-2021.).    No concomitant medications were reported.  It was reported that patient received the Monovalent expired dose of vaccine, it was first booster dose of Moderna COVID-19 vaccine. The vial size was 5.5 ml. The vial was initially stored in the refrigerator on 12-Nov-2021. The vial did not undergo any temperature excursions.  No treatment details were reported.
Age: 55.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Date the vial was initially stored in the refrigerator was 12-Nov-2021, product expiry date 08-Nov-2021 and administered on 12-Nov-2021.; No adverse event; 12 patients got 1 dose of Moderna Covid-19 vaccine last yr on 12Nov2021./ Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (12 patients got 1 dose of Moderna Covid-19 vaccine last yr on 12Nov2021./ Dose administered after 30-day Use By Date or after manufacturer date of expiry), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 12-Nov-2021, product expiry date 08-Nov-2021 and administered on 12-Nov-2021.) and NO ADVERSE EVENT (No adverse event) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (12 patients got 1 dose of Moderna Covid-19 vaccine last yr on 12Nov2021./ Dose administered after 30-day Use By Date or after manufacturer date of expiry). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 12-Nov-2021, product expiry date 08-Nov-2021 and administered on 12-Nov-2021.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (12 patients got 1 dose of Moderna Covid-19 vaccine last yr on 12Nov2021./ Dose administered after 30-day Use By Date or after manufacturer date of expiry), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 12-Nov-2021, product expiry date 08-Nov-2021 and administered on 12-Nov-2021.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (12 patients got 1 dose of Moderna Covid-19 vaccine last yr on 12Nov2021./ Dose administered after 30-day Use By Date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 12-Nov-2021, product expiry date 08-Nov-2021 and administered on 12-Nov-2021.).    No concomitant medications was reported.  It was reported that patient received the Monovalent expired dose of vaccine, it was first booster dose of Moderna COVID-19 vaccine. The vial size was 5.5 ml. The vial was initially stored in the refrigerator on 12-Nov-2021. The vial did not undergo any temperature excursions.  No treatment medications was reported.
Age: 65.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event
Clinical narrative: No adverse event; Dose administered after 30-day Use By Date or after manufacturer date of expiry; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) in a 65-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry). On an unknown date, the patient experienced NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry).    No concomitant medication was reported.  No treatment medication was reported.  The vial size was of 5.5 mL and was initially stored in the refrigerator on 12-Nov-2021.  The vial did not undergo any temperature excursions. The patient received the first booster dose of Moderna vaccine on 12-Nov-2021.
Age: 62.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Date the vial was initially stored in the refrigerator was 12-Nov-2021, product expiry date 08-Nov-2021; No adverse event; Patient got 1 dose of Moderna COVID-19 vaccine last yr on 12-Nov-2021 with expiry date 08-Nov-2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient got 1 dose of Moderna COVID-19 vaccine last yr on 12-Nov-2021 with expiry date 08-Nov-2021), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 12-Nov-2021, product expiry date 08-Nov-2021) and NO ADVERSE EVENT (No adverse event) in a 62-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient got 1 dose of Moderna COVID-19 vaccine last yr on 12-Nov-2021 with expiry date 08-Nov-2021). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 12-Nov-2021, product expiry date 08-Nov-2021) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient got 1 dose of Moderna COVID-19 vaccine last yr on 12-Nov-2021 with expiry date 08-Nov-2021), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 12-Nov-2021, product expiry date 08-Nov-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Patient got 1 dose of Moderna COVID-19 vaccine last yr on 12-Nov-2021 with expiry date 08-Nov-2021) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 12-Nov-2021, product expiry date 08-Nov-2021).    Concomitant drugs were not reported.  It was reported that the monovalent vial of size 5.5 ml was initially stored in refrigerator on 12-Nov-2021.  The vial did not underwent any temperature excursion.  Treatment medications were not reported.
Age: 69.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Date the vial was initially stored in the refrigerator was 12-Nov-2021, product expiry date 08-Nov-2021; No adverse event; patient got 1 dose of Moderna Covid-19 vaccine last yr on 12Nov2021 with expiry date on 08-Nov-2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient got 1 dose of Moderna Covid-19 vaccine last yr on 12Nov2021 with expiry date on 08-Nov-2021), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 12-Nov-2021, product expiry date 08-Nov-2021) and NO ADVERSE EVENT (No adverse event) in a 69-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient got 1 dose of Moderna Covid-19 vaccine last yr on 12Nov2021 with expiry date on 08-Nov-2021). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 12-Nov-2021, product expiry date 08-Nov-2021) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient got 1 dose of Moderna Covid-19 vaccine last yr on 12Nov2021 with expiry date on 08-Nov-2021), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 12-Nov-2021, product expiry date 08-Nov-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (patient got 1 dose of Moderna Covid-19 vaccine last yr on 12Nov2021 with expiry date on 08-Nov-2021) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 12-Nov-2021, product expiry date 08-Nov-2021).    Concomitant drugs were not reported. It was reported that the monovalent vial of size 5.5 ml was initially stored in refrigerator on 12-Nov-2021  The vial did not underwent any temperature excursion. Treatment medications were not provided.
Age: 46.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Vaccine expiry date was 08-Nov-2021, the vial was initially stored in the refrigerator on 12-Nov-2021; No adverse event; Vaccine expiry date was 08-Nov-2021, the vaccine was administered on 12-Nov-2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine expiry date was 08-Nov-2021, the vaccine was administered on 12-Nov-2021), PRODUCT STORAGE ERROR (Vaccine expiry date was 08-Nov-2021, the vial was initially stored in the refrigerator on 12-Nov-2021) and NO ADVERSE EVENT (No adverse event) in a 46-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine expiry date was 08-Nov-2021, the vaccine was administered on 12-Nov-2021). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine expiry date was 08-Nov-2021, the vial was initially stored in the refrigerator on 12-Nov-2021) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Vaccine expiry date was 08-Nov-2021, the vaccine was administered on 12-Nov-2021), PRODUCT STORAGE ERROR (Vaccine expiry date was 08-Nov-2021, the vial was initially stored in the refrigerator on 12-Nov-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (Vaccine expiry date was 08-Nov-2021, the vaccine was administered on 12-Nov-2021) and PRODUCT STORAGE ERROR (Vaccine expiry date was 08-Nov-2021, the vial was initially stored in the refrigerator on 12-Nov-2021).    No concomitant drug was reported. Vial size was reported as 5.5 ml. The vial did not undergo any temperature excursions. No treatment drug was reported.
Age: 28.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: Date the vial was initially stored in the refrigerator was 12-Nov-2021, product expiry date 08-Nov-2021; No adverse event; patient got 1 dose of Moderna Covid-19 vaccine last yr on 12Nov2021 with expiry date on 08-Nov-2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient got 1 dose of Moderna Covid-19 vaccine last yr on 12Nov2021 with expiry date on 08-Nov-2021), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 12-Nov-2021, product expiry date 08-Nov-2021) and NO ADVERSE EVENT (No adverse event) in a 28-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient got 1 dose of Moderna Covid-19 vaccine last yr on 12Nov2021 with expiry date on 08-Nov-2021). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 12-Nov-2021, product expiry date 08-Nov-2021) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient got 1 dose of Moderna Covid-19 vaccine last yr on 12Nov2021 with expiry date on 08-Nov-2021), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 12-Nov-2021, product expiry date 08-Nov-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (patient got 1 dose of Moderna Covid-19 vaccine last yr on 12Nov2021 with expiry date on 08-Nov-2021) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 12-Nov-2021, product expiry date 08-Nov-2021).    No concomitant medications were reported. It was reported that total 12 patients received the Monovalent expired dose of vaccine, it was their first booster dose of Moderna COVID-19 vaccine. There were 12 doses with vial size 5.5 ml. The vial was initially stored in the refrigerator on 12-Nov-2021. The vial did not undergo any temperature excursions. No treatment details were reported.
Age: 27.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 12-Nov-2021, product expiry date 08-Nov-2021 and administered on 12-Nov-2021.) and NO ADVERSE EVENT (No adverse event) in a 27-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient got 1 dose of Moderna Covid-19 vaccine last year on 12Nov2021 with expiry date on 08-Nov-2021). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 12-Nov-2021, product expiry date 08-Nov-2021 and administered on 12-Nov-2021.) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient got 1 dose of Moderna Covid-19 vaccine last year on 12Nov2021 with expiry date on 08-Nov-2021), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 12-Nov-2021, product expiry date 08-Nov-2021 and administered on 12-Nov-2021.) and NO ADVERSE EVENT (No adverse event) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered NO ADVERSE EVENT (No adverse event) to be not related. No further causality assessments were provided for EXPIRED PRODUCT ADMINISTERED (patient got 1 dose of Moderna Covid-19 vaccine last year on 12Nov2021 with expiry date on 08-Nov-2021) and PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 12-Nov-2021, product expiry date 08-Nov-2021 and administered on 12-Nov-2021.).    No concomitant medications were reported.  It was reported that patient received the Monovalent expired dose of vaccine, it was first booster dose of Moderna COVID-19 vaccine. The vial size was 5.5 ml. The vial was initially stored in the refrigerator on 12-Nov-2021. The vial did not undergo any temperature excursions.  No treatment details were reported.
Age: 66.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, No adverse event, Product storage error
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient got 1 dose of Moderna Covid-19 vaccine last yr on 12Nov2021 with expiry date on 08-Nov-2021), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 12-Nov-2021, product expiry date 08-Nov-2021) and NO ADVERSE EVENT (No adverse event) in a 66-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 prophylaxis.     No Medical History information was reported.    On 12-Nov-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Nov-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient got 1 dose of Moderna Covid-19 vaccine last yr on 12Nov2021 with expiry date on 08-Nov-2021). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 12-Nov-2021, product expiry date 08-Nov-2021) and NO ADVERSE EVENT (No adverse event). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient got 1 dose of Moderna Covid-19 vaccine last yr on 12Nov2021 with expiry date on 08-Nov-2021), PRODUCT STORAGE ERROR (Date the vial was initially stored in the refrigerator was 12-Nov-2021, product expiry date 08-Nov-2021) and NO ADVERSE EVENT (No adverse event) outcome was unknown.
Sex: U
Vaccine: VARZOS
Symptoms: Hypoaesthesia, Paralysis
Clinical narrative: I was paralyzed (ER); Face was going numb (ER); This case was reported by a consumer via interactive digital media and described the occurrence of paralysis in a patient who received Herpes zoster (Shingrix) for prophylaxis.   On 12th May 2022, the patient received the 1st dose of Shingrix. On 12th May 2022, less than a day after receiving Shingrix, the patient experienced paralysis (serious criteria hospitalization and GSK medically significant) and numbness facial (serious criteria hospitalization). The patient was treated with steroids nos (Steroids). In May 2022, the outcome of the paralysis and numbness facial were recovered/resolved.   It was unknown if the reporter considered the paralysis and numbness facial to be related to Shingrix.     Additional Information: GSK Receipt Date: 15-NOV-2022 Reporter's Comment: This case was reported by a patient via interactive digital media. The patient received dose of Shingrix vaccine and within 3 hours he/she was rushed to the ER (emergency room), his/her face was going numb by the time and he/she got to the hospital, he/she was paralyzed. The patient took 7 days high intravenous steroids and was blessed to be 100 percent ok. The patient stated that he/she never had reaction to vaccines before. This was horrifying. Additional supportive information: The follow-up would not possible, as no contact, details were available.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Vaccination site pain
Clinical narrative: Slightly sore left arm; Patient received 1st booster dose on 15-Jul-2022/2nd booster on 07-Sep-2022; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Slightly sore left arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st booster dose on 15-Jul-2022/2nd booster on 07-Sep-2022) in a 65-year-old female patient who received mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (batch no. AS7143C) for COVID-19 prophylaxis.     The patient's past medical history included Chemotherapy, Radiation therapy, Lumpectomy and Lymphadenectomy (lymph nodes on her left side were removed). Previously administered products included for Product used for unknown indication: Pfizer vaccine (primary series). Past adverse reactions to the above products included No adverse event with Pfizer vaccine. Concurrent medical conditions included Type 1 diabetes mellitus since 1987, Breast cancer (Left) since 2006, Hypertension and Graves' disease. Concomitant products included INSULIN GLARGINE (LANTUS), INSULIN LISPRO (HUMALOG), ATORVASTATIN, LISINOPRIL, METOPROLOL SUCCINATE, ALENDRONATE SODIUM (ALENDRONATE), AMLODIPINE, ASPIRIN [ACETYLSALICYLIC ACID] and CEPHALEXIN [CEFALEXIN] for an unknown indication.   On 07-Sep-2022, the patient received dose of mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (unknown route) 1 dosage form. On 07-Sep-2022, the patient experienced VACCINATION SITE PAIN (Slightly sore left arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st booster dose on 15-Jul-2022/2nd booster on 07-Sep-2022). At the time of the report, VACCINATION SITE PAIN (Slightly sore left arm) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient received 1st booster dose on 15-Jul-2022/2nd booster on 07-Sep-2022) outcome was unknown.      For mRNA-1273 BIVALENT .222 (MODERNA COVID-19 VACCINE, BIVALENT (ORIGINAL AND OMICRON BA.4/BA.5)) (Unknown), the reporter did not provide any causality assessments.   No treatment medications were reported.   This case was linked to MOD-2022-674650, MOD-2022-674619 (Patient Link).