chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 21.0
Sex: F
Vaccine: COVID19
Symptoms: Hypoaesthesia, Paraesthesia
Clinical narrative: tingling from the entire body neck down; numbness from entire body neck down; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling from the entire body neck down) and HYPOAESTHESIA (numbness from entire body neck down) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2022 at 7:00 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2022, the patient experienced PARAESTHESIA (tingling from the entire body neck down) and HYPOAESTHESIA (numbness from entire body neck down). At the time of the report, PARAESTHESIA (tingling from the entire body neck down) and HYPOAESTHESIA (numbness from entire body neck down) had not resolved.            The patient was not taking any concomitant medication. Treatment information was not provided.   The patient had received the booster dose and woke up on the next morning of 02-Apr-2022 experiencing the adverse events. The patient went to the emergency room and visited the primary care provider (PCP) to rule out anything else that could have caused these side effects.
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Illness, Loss of personal independence in daily activities, Myalgia
Clinical narrative: a little sick; Didn't want to do anything; Tired; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (a little sick), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Didn't want to do anything), FATIGUE (Tired) and MYALGIA (Body aches) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Mar-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2022, the patient experienced ILLNESS (a little sick), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Didn't want to do anything), FATIGUE (Tired) and MYALGIA (Body aches). At the time of the report, ILLNESS (a little sick), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Didn't want to do anything), FATIGUE (Tired) and MYALGIA (Body aches) outcome was unknown.            No concomitant medication were given. The patient received the 2nd booster. No treatment information were given.   Reporter did not allow further contact
Age: 88.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: slightly sore left arm (1st dose); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (slightly sore left arm (1st dose)) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination.     Patient had never tested positive for COVID.  Previously administered products included for Product used for unknown indication: seasonal flu vaccine (Sometime in 2021) in 2021. Past adverse reactions to the above products included No adverse event with seasonal flu vaccine. Concurrent medical conditions included Seafood allergy (Shrimp) and Seafood allergy (Lobster). Concomitant products included ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION) and VITAMIN D [VITAMIN D NOS] for an unknown indication.    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 29-Jan-2021, the patient experienced VACCINATION SITE PAIN (slightly sore left arm (1st dose)). At the time of the report, VACCINATION SITE PAIN (slightly sore left arm (1st dose)) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medications included unknown  low blood pressure medication used as preventative.  No treatment information was provided.   This case was linked to MOD-2022-533478, MOD-2022-533479 (Patient Link).   Reporter did not allow further contact
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Arthropathy, Fatigue, Myalgia
Clinical narrative: it was hard for her to turn head "it must having affected the little joints in my head/neck ( ~ 10 days); after the first 2 doses she was really achy; after the first 2 doses she was really achy and tired; joint aches; This spontaneous case was reported by a consumer and describes the occurrence of ARTHROPATHY (it was hard for her to turn head "it must having affected the little joints in my head/neck ( ~ 10 days)), MYALGIA (after the first 2 doses she was really achy), FATIGUE (after the first 2 doses she was really achy and tired) and ARTHRALGIA (joint aches) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHROPATHY (it was hard for her to turn head "it must having affected the little joints in my head/neck ( ~ 10 days)), MYALGIA (after the first 2 doses she was really achy), FATIGUE (after the first 2 doses she was really achy and tired) and ARTHRALGIA (joint aches). At the time of the report, ARTHROPATHY (it was hard for her to turn head "it must having affected the little joints in my head/neck ( ~ 10 days)), MYALGIA (after the first 2 doses she was really achy), FATIGUE (after the first 2 doses she was really achy and tired) and ARTHRALGIA (joint aches) outcome was unknown.            Concomitant mediations were not reported.  Patient stated after the first 2 doses she was really achy and tired and it was hard for her to turn head it must having affected the little joints in my head/neck (10 days). She also mentioned joint aches.  Treatment information was not reported.   This case was linked to MOD-2022-533476, MOD-2022-533335 (Patient Link).
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Joint range of motion decreased, Pain
Clinical narrative: achy; it was hard for her to turn head "it must having affected the little joints in my head/neck (10 days).; joint aches; tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achy), JOINT RANGE OF MOTION DECREASED (it was hard for her to turn head "it must having affected the little joints in my head/neck (10 days).), ARTHRALGIA (joint aches) and FATIGUE (tired) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     Concurrent medical conditions included Immunocompromised.    On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN (achy), JOINT RANGE OF MOTION DECREASED (it was hard for her to turn head "it must having affected the little joints in my head/neck (10 days).), ARTHRALGIA (joint aches) and FATIGUE (tired). At the time of the report, PAIN (achy), JOINT RANGE OF MOTION DECREASED (it was hard for her to turn head "it must having affected the little joints in my head/neck (10 days).), ARTHRALGIA (joint aches) and FATIGUE (tired) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       Concomitant medications were not reported. Treatment medications were not reported. She had reactions to the previous doses. She mentioned patient daughter got 3 Pfizer vaccines and had really bad reactions. She woke up screaming several times and got COVID shortly after.   This case was linked to MOD-2022-533467, MOD-2022-533335 (Patient Link).
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: slightly sore left arm (2nd dose); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (slightly sore left arm (2nd dose)) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Seasonal Flu vaccine (Seasonal flu vaccine sometime in 2021.) in 2021. Past adverse reactions to the above products included No adverse event with Seasonal Flu vaccine. Concurrent medical conditions included Seafood allergy (Shrimp) and Seafood allergy (Lobster). Concomitant products included VITAMIN D [VITAMIN D NOS] and ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION) for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 26-Feb-2021, the patient experienced VACCINATION SITE PAIN (slightly sore left arm (2nd dose)). At the time of the report, VACCINATION SITE PAIN (slightly sore left arm (2nd dose)) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       Concomitant medication details include PreserVision Vitamin, Unknown low dose blood pressure medication for use as a preventative.  No treatment details were reported.   This case was linked to MOD-2022-533466, MOD-2022-533479 (Patient Link).   Reporter did not allow further contact
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Nausea, Pain in extremity
Clinical narrative: Nauseated; Experienced chills; 24 hours later sore left arm; Headache; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nauseated), CHILLS (Experienced chills), PAIN IN EXTREMITY (24 hours later sore left arm) and HEADACHE (Headache) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012F21A and 038K20A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Flu Vaccine in 2021. Past adverse reactions to the above products included No adverse event with Flu Vaccine. Concurrent medical conditions included Seafood allergy and Seafood allergy. Concomitant products included VITAMIN D NOS for an unknown indication.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 05-Nov-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 03-Apr-2022, received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. On 04-Apr-2022, the patient experienced NAUSEA (Nauseated), CHILLS (Experienced chills), PAIN IN EXTREMITY (24 hours later sore left arm) and HEADACHE (Headache). On 05-Apr-2022, CHILLS (Experienced chills), PAIN IN EXTREMITY (24 hours later sore left arm) and HEADACHE (Headache) had resolved. At the time of the report, NAUSEA (Nauseated) had resolved.            No Treatment information was provided.  Other medications: Preservision Vitamins, Low dose blood pressure medication- For use as a Prevention   This case was linked to MOD-2022-533478 (Patient Link).   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccines administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccines administered) in a  patient of an unknown age and gender who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Apr-2022, the patient received second dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccines administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccines administered) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication was not provided. The vaccines  was expired on 27-Mar-2022. Treatment information was not provided.   This case was linked to MOD-2022-533553 (Patient Link).
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Chills, Pyrexia
Clinical narrative: high fever for 5-6 hours; chills for 5-6 hours; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (high fever for 5-6 hours) and CHILLS (chills for 5-6 hours) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027621A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (high fever for 5-6 hours) and CHILLS (chills for 5-6 hours). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) at an unspecified dose and frequency. At the time of the report, PYREXIA (high fever for 5-6 hours) and CHILLS (chills for 5-6 hours) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2022, Body temperature: 99.1 (High) 99.1 F.         Patient reported he was on concomitant medication, but did not specify which ones.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination site joint pain, Vaccination site joint swelling
Clinical narrative: Joint swelling on the shoulder nearest to the injection site/ it's been moving from my wrist to my elbow and I thought it would be weird.; Joint pain on the shoulder nearest to the injection site/  it's been moving from my wrist to my elbow and I thought it would be weird.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE JOINT SWELLING (Joint swelling on the shoulder nearest to the injection site/ it's been moving from my wrist to my elbow and I thought it would be weird.) and VACCINATION SITE JOINT PAIN (Joint pain on the shoulder nearest to the injection site/  it's been moving from my wrist to my elbow and I thought it would be weird.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    In November 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE JOINT SWELLING (Joint swelling on the shoulder nearest to the injection site/ it's been moving from my wrist to my elbow and I thought it would be weird.) and VACCINATION SITE JOINT PAIN (Joint pain on the shoulder nearest to the injection site/  it's been moving from my wrist to my elbow and I thought it would be weird.). At the time of the report, VACCINATION SITE JOINT SWELLING (Joint swelling on the shoulder nearest to the injection site/ it's been moving from my wrist to my elbow and I thought it would be weird.) and VACCINATION SITE JOINT PAIN (Joint pain on the shoulder nearest to the injection site/  it's been moving from my wrist to my elbow and I thought it would be weird.) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.  It was reported that joint pain and swelling were moving from wrist to elbow. Patient have an MRI scheduled because they were going to get to the bottom of this and figure out what was going on and why joints kept swelling up.  No treatment drugs were reported.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Administration of vaccine past published expiry; The vaccine was stored on 01-Apr-2022 and thawed on the day of use during Mar-2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry) and PRODUCT STORAGE ERROR (The vaccine was stored on 01-Apr-2022 and thawed on the day of use during Mar-2022) in a 45-year-old female patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 vaccination.     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 EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry) and PRODUCT STORAGE ERROR (The vaccine was stored on 01-Apr-2022 and thawed on the day of use during Mar-2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry) and PRODUCT STORAGE ERROR (The vaccine was stored on 01-Apr-2022 and thawed on the day of use during Mar-2022) outcome was unknown.        The action taken with mRNA-1273 (Spikevax) (Unknown) was unknown.   For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   On 01-Apr-2022, the vial was initially stored in the refrigerator  and thawed on the day of use. Patients administered the vaccines on 29-Mar-2022, 30-Mar-2022, 31-Mar-2022,01-Apr-2022 and 04-Apr-2022 No concomitant medication information provided. No treatment medication information provided.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of vaccine past published expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry) in an adult female patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 vaccination.     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 EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant mediations were not reported. Treatment information was not reported.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of vaccine past published expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry) in an adult female patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 vaccination.     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 EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Vaccines were administered to 19 patients on 29-Mar-2022, 30-Mar-2022, 31-Mar-2022, 01-APR-2022 and 04-APR-2022. Reportedly, 19 doses or Vials were initially stored in the refrigerator on 01-Apr-2022 and thawed on the day of use. The Vials did not undergo any temperature excursions. The doses were administered after 30-day Use By Date and after manufacturer date of expiry. The vaccine were thawed on the day of administration and administration was spread out throughout the end of March to the beginning of April. Treatment details were not reported by the reporter.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of vaccine past published expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry) in a 57-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 vaccination.     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 EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications was not provided by the reporter.  The HCP stated that 19 patients were administered on 29Mar2022, 30Mar2022, 31Mar2022, 01Apr2022 and 04Apr2022.  The vaccine were thawed on the day of administration and administration was spread out throughout the end of March to the beginning of April.  The vial did not undergo any temperature excursions.  Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of vaccine past published expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry) in an adult female patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 vaccination.     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 EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication reported.  The first dose details were not asked. The vaccine was thawed on the day of administration and administration was spread out throughout the end of March to the beginning of April.  The vial was initially stored in the refrigerator on 01Apr2022/thawed on the day of use. 19 patients were administered on 29 Mar 2022, 30 Mar 2022, 31 Mar 2022, 01 Apr 2022 and 04 Apr 2022. The vial did not undergo any temperature excursions.  No treatment information was provided.
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 1st dose -17 Jan 2021 ,2nd dose - 21 Feb 2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose -17 Jan 2021 ,2nd dose - 21 Feb 2021) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 039K20-2A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: FLU VACCINE VII. Past adverse reactions to the above products included No adverse event with FLU VACCINE VII. Concurrent medical conditions included Blood pressure high.   On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose -17 Jan 2021 ,2nd dose - 21 Feb 2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose -17 Jan 2021 ,2nd dose - 21 Feb 2021) outcome was unknown.            Patient didn't had Covid-19 prior to or after the getting the vaccines. Concomitant medication stated lot of medications that controlled high blood pressure with specific medication information declined. It was reported that patient had 1st dose on 17 January 2021 and 2nd dose on 21 February 2021, more than 1 month apart. No treatment details were reported.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Dose administered greater than 12 hours post puncture; Dose administered greater than 12 hours post puncture; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours post puncture) and PRODUCT STORAGE ERROR (Dose administered greater than 12 hours post puncture) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048L21A) for COVID-19 vaccination.     No Medical History information was reported.    On 05-Apr-2022 at 9:00 AM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2022 at 9:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours post puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Dose administered greater than 12 hours post puncture). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered greater than 12 hours post puncture) and PRODUCT STORAGE ERROR (Dose administered greater than 12 hours post puncture) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  Patient took the second booster dose. The vial was initially stored in the refrigerator on 22 Mar 2022. The vial was first punctured on 04 Apr 2022 at 9 am. The vial was stored in fridge post puncture. The vial did not undergo any temperature excursions. Total amount of time the vial was exposed to room temperature range was less than 10 total minutes while drawing but otherwise the vial was in the fridge. The vial exposed to room temperature for greater than 24 hours.   No treatment medications were reported.   This case was linked to MOD-2022-533442 (Patient Link).
Age: 36.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Administration of vaccine past published expiry; The vaccine were thawed on the day of administration and administration was spread out throughout the end of March to the beginning of April; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry) and PRODUCT STORAGE ERROR (The vaccine were thawed on the day of administration and administration was spread out throughout the end of March to the beginning of April) in a 36-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 vaccination.     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 EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry) and PRODUCT STORAGE ERROR (The vaccine were thawed on the day of administration and administration was spread out throughout the end of March to the beginning of April). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry) and PRODUCT STORAGE ERROR (The vaccine were thawed on the day of administration and administration was spread out throughout the end of March to the beginning of April) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.  The first dose details were not asked. The vaccine was thawed on the day of administration and administration was spread out throughout the end of March to the beginning of April.  The vial was initially stored in the refrigerator on 01Apr2022/thawed on the day of use. 19 patients were administered on 29Mar2022, 30Mar2022, 31Mar2022, 01Apr2022 and 04Apr2022. The vial did not undergo any temperature excursions.  No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Dose administered after 30-day Use By Date or after manufacturer date of expiry; The vaccine was thawed before the administration throughout the end of March to the beginning of April.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (The vaccine was thawed before the administration throughout the end of March to the beginning of April.) in an adult female patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 vaccination.     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 EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (The vaccine was thawed before the administration throughout the end of March to the beginning of April.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after 30-day Use By Date or after manufacturer date of expiry) and PRODUCT STORAGE ERROR (The vaccine was thawed before the administration throughout the end of March to the beginning of April.) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug information was provided. Dates of administration of vaccine: 19 patients were administered on 29Mar2022, 30Mar2022, 31Mar2022, 01Apr2022 and 04Apr2022. The vaccine didn't undergo any temperature excursion issue. Product was placed in refrigerator on 1-Apr-2022.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of vaccine past published expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry) in an adult female patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 vaccination.     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 EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No Concomitant information was reported. The vial was initially stored in the refrigerator on 01-Apr-2022. The vaccine were thawed on the day of administration and administration was spread out throughout  the end of March to the beginning of April. The vial did not undergone any temperature excursions.  No Treatment information was reported.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of vaccine past published expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry) in an elderly male patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 vaccination.     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 EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information was provided. The reporter reported about administration of the Moderna COVID-19 vaccine past the published expiry.  The vial was initially stored in the refrigerator on 01-Apr-2022 and vaccine were thawed on the day of administration. The administration was spread out throughout the end of March to the beginning of April.  The dates for vaccine administration were reported as 29-Mar-2022, 30-Mar-2022, 31-Mar-2022, 01-Apr-2022 and 04-Apr-2022. The vial did not undergo any temperature excursions. No treatment medication were provided.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of vaccine past published expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry) in an adult female patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 vaccination.     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 EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.  It was reported 19 patients were administered vaccine  on 29-Mar-2022, 30-Mar-2022, 31-Mar-2022, 01-Apr-2022 and 04-Apr-2022.The Vials did not undergo any temperature excursions. The doses were administered after 30-day Use By Date and after manufacturer date of expiry.  Treatment information was not reported.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (had a headache for half a day) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In 2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced HEADACHE (had a headache for half a day). In 2021, HEADACHE (had a headache for half a day) had resolved. Concomitant medication was not reported. Patient had a headache for half a day after receiving booster late last year (2021). Patient received the first dose of the Moderna COVID-19 vaccine in February or March and received Moderna COVID-19 Booster late in the year. Patient was not sure of exact dates. Treatment medication was not reported. This case was linked to MOD-2022-533524, MOD-2022-533526 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of vaccine past published expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry) in an elderly female patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 vaccination.     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 EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. Administration of the Moderna COVID-19 vaccine past the published expiry to 19 patients. The vaccine were thawed on the day of administration and administration was spread out throughout  the end of March to the beginning of April.  Number of doses/vials: 19 doses. Date the vial was initially stored in the refrigerator: 01Apr2022/thawed on the day of use. Date(s) of administration of vaccine: 19 patients were administered on 29Mar2022, 30Mar2022, 31Mar2022, 01Apr2022 and 04Apr2022.. The vial did not undergo any temperature excursions.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of vaccine past published expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry) in an adult male patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 vaccination.     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 EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. The vials were thawed on 01 Apr 2022 the day of administration and administration was spread throughout on 29 Mar 2022, 30 Mar 2022, 31 Mar 2022, 01 Apr 2022 and 04 Apr 2022. It mentioned that the vials did not undergo any temperature excursions. No treatment medications were reported.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administration of vaccine past published expiry; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry) in an adult male patient who received mRNA-1273 (Spikevax) (batch no. 059H21A) for COVID-19 vaccination.     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 EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administration of vaccine past published expiry) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant product reported by reporter.  On 01-Apr-2022  vial was initially stored in the refrigerator  and thawed on the day of use. Patients administered the vaccines on 29-Mar-2022, 30-Mar-2022, 31-Mar-2022,01-Apr-2022 and 04-Apr-2022. Vial did not undergo any temperature excursion issue.  No treatment medication reported by reporter.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccines administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccines administered) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccines administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccines administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant drug details were reported. No treatment details were reported. Vial was initially stored in the refrigerator on 24-Mar-2022    This case was linked to MOD-2022-533485 (Patient Link).
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Catheterisation cardiac, Cerebrovascular accident, Muscle swelling, Myalgia
Clinical narrative: Your shot almost killed me now; Vertigo; Stroke; heart cath; vision off; muscle soreness; muscle at base of my brain gets swollen; balance off; The initial case was missing the following minimum criteria: Unspecified product. Upon receipt of follow-up information on (28Mar2022), this case now contains all required information to be considered valid. This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old male patient received bnt162b2 (BNT162B2), administration date 16Aug2021 (Lot number: EW01991) at the age of 46 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEAR DEATH EXPERIENCE (hospitalization, medically significant) with onset 25Aug2021, outcome "not recovered", described as "Your shot almost killed me now"; VERTIGO (hospitalization) with onset 25Aug2021, outcome "not recovered", described as "Vertigo"; CEREBROVASCULAR ACCIDENT (medically significant) with onset 25Aug2021, outcome "recovered" (2021), described as "Stroke"; VISUAL IMPAIRMENT (non-serious) with onset 2021, outcome "not recovered", described as "vision off"; MYALGIA (non-serious) with onset 2021, outcome "not recovered", described as "muscle soreness"; MUSCLE SWELLING (non-serious) with onset 2021, outcome "not recovered", described as "muscle at base of my brain gets swollen"; BALANCE DISORDER (non-serious) with onset 2021, outcome "not recovered", described as "balance off"; CATHETERISATION CARDIAC (non-serious) with onset 25Aug2021, outcome "recovered" (2021), described as "heart cath". Therapeutic measures were taken as a result of near death experience, vertigo, cerebrovascular accident, catheterisation cardiac.  Follow up (28Mar2022): This is a follow-up spontaneous report from a same contactable consumer. This consumer (patient) reported in response to non-HCP letter sent via follow-up letter which included that: New event, suspect product detail, was added   No follow-up attempts are possible. No further information is expected.
Age: 46.0
Sex: M
Vaccine: COVID19
Symptoms: Near death experience, Vertigo, Visual impairment
Clinical narrative: Your shot almost killed me now; Vertigo; Stroke; heart cath; vision off; muscle soreness; muscle at base of my brain gets swollen; balance off; The initial case was missing the following minimum criteria: Unspecified product. Upon receipt of follow-up information on (28Mar2022), this case now contains all required information to be considered valid. This is a spontaneous report received from contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 46 year-old male patient received bnt162b2 (BNT162B2), administration date 16Aug2021 (Lot number: EW01991) at the age of 46 years as dose 1, single for covid-19 immunisation. The patient's relevant medical history and concomitant medications were not reported. The following information was reported: NEAR DEATH EXPERIENCE (hospitalization, medically significant) with onset 25Aug2021, outcome "not recovered", described as "Your shot almost killed me now"; VERTIGO (hospitalization) with onset 25Aug2021, outcome "not recovered", described as "Vertigo"; CEREBROVASCULAR ACCIDENT (medically significant) with onset 25Aug2021, outcome "recovered" (2021), described as "Stroke"; VISUAL IMPAIRMENT (non-serious) with onset 2021, outcome "not recovered", described as "vision off"; MYALGIA (non-serious) with onset 2021, outcome "not recovered", described as "muscle soreness"; MUSCLE SWELLING (non-serious) with onset 2021, outcome "not recovered", described as "muscle at base of my brain gets swollen"; BALANCE DISORDER (non-serious) with onset 2021, outcome "not recovered", described as "balance off"; CATHETERISATION CARDIAC (non-serious) with onset 25Aug2021, outcome "recovered" (2021), described as "heart cath". Therapeutic measures were taken as a result of near death experience, vertigo, cerebrovascular accident, catheterisation cardiac.  Follow up (28Mar2022): This is a follow-up spontaneous report from a same contactable consumer. This consumer (patient) reported in response to non-HCP letter sent via follow-up letter which included that: New event, suspect product detail, was added   No follow-up attempts are possible. No further information is expected.
Sex: F
Vaccine: PPV
Symptoms: Blood test, Coagulation test, Echocardiogram, Frustration tolerance decreased, Laboratory test
Clinical narrative: feet were swollen up/legs were swollen up; This is a spontaneous report received from a contactable reporter(s) (Consumer or other non HCP). The reporter is the patient.  A 80 year-old female patient received pneumococcal 13-val conj vac (dipht crm197 protein) (PNEUMOCOCCAL 13-VAL CONJ VAC (DIPHT CRM197 PROTEIN)) (Batch/Lot number: unknown) as dose number unknown, single for immunisation. The patient's relevant medical history and concomitant medications were not reported.  The following information was reported: PERIPHERAL SWELLING (medically significant), outcome "unknown", described as "feet were swollen up/legs were swollen up". The event "feet were swollen up/legs were swollen up" was evaluated at the physician office visit. The patient underwent the following laboratory tests and procedures: blood test: unknown results; coagulation time: unknown results; echocardiogram: unknown results; x-ray: unknown results. Clinical course: Call in January went in for a wellness check. Caller told doctor it had been more than 10 years and her doctor told her she had to get the pneumonia shot. A couple of days after the pneumonia shot caller's feet were swollen up, within 4 days her legs were swollen up.  She went back to doctor, sent for a blood clots in the leg test for both legs because both legs are swollen up. Can't get shoes on. Tests: Caller has had an echocardiogram, x-rays, orthopedic surgeons, more blood tests and no one can help, doctors can't help. Caller has spoken to people and no one can help. She has been up and down since January and no one can help. Caller is 80 years old, pissed, frustrated, could be dead.   No follow-up attempts are possible; information about lot/batch number cannot be obtained. No further information is expected.