chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: patient given expired vaccine; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient given expired vaccine) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H21B) for COVID-19 vaccination.     Concurrent medical conditions included Clot blood and Blood disorder. Concomitant products included ASA for Blood disorder.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 25-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient given expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patient given expired vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient did not have immediate allergic reaction to any vaccine, injection or shot or to any component of COVID-19 vaccine or a severe allergic reaction to anything. Patient did not had history of cancer, leukemia, HIV/AIDS or any other condition that weakens the immune system. In the last 10 days, patient did not have COVID-19 test because of symptoms or isolated or quarantine at home due to COVID-10 infection or exposure. On 22-Dec-2021, patient was treated with antibody therapy or convalescent plasma for COVID-19 in the past 90 days. Patient was not taking any medications that affect immune system such as cortisone, prednisone or other steroids, anticancer drugs or had radiation treatments. Patient did not have history of myocarditis or pericarditis. Patient was not taken any other vaccines and did not develop thrombosis with thrombocytopenia syndrome. Patient was not feeling seek on the day of vaccination.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered Moderna Covid 19 Vaccine 2 days after the vaccine expired; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered Moderna Covid 19 Vaccine 2 days after the vaccine expired) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H21B) for COVID-19 vaccination.     Patient did not have history of cancer, leukemia, HIV or AIDS or any other condition that weakens the immune system. Patient did not have history of myocarditis or pericarditis.    On 25-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered Moderna Covid 19 Vaccine 2 days after the vaccine expired). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered Moderna Covid 19 Vaccine 2 days after the vaccine expired) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient did not have immediate allergic reaction to any vaccine, injection or shot or to any component of COVID-19 vaccine or a severe allergic reaction to anything.In the last 10 days, patient did not have COVID-19 test because of symptoms or isolated or quarantine at home due to COVID-19 infection or exposure.She was not treated with antibody therapy or convalescent plasma for COVID-19 in the past 90 days. Patient was not taking any medications that affect immune system such as cortisone, prednisone or other steroids, anticancer drugs or had radiation treatments. Patient did not have bleeding disorder, a history of blood clots or taking any blood thinner. Patient was not feeling sick at the day of reporting. No concomitant medication was provided by reporter. It was reported that administered 8 doses of Moderna COVID-19 Vaccine  2 days after the vaccine expired. No treatment medication was provided by reporter.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired on 23-Mar-2022 and administered on 25-Mar-2022 (2 days after expiration).; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired on 23-Mar-2022 and administered on 25-Mar-2022 (2 days after expiration).) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H21B) for COVID-19 vaccination.     Concomitant products included ASA for Anticoagulant therapy.   On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Mar-2022 at 10:30 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 25-Mar-2022 at 10:30 AM,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (expired on 23-Mar-2022 and administered on 25-Mar-2022 (2 days after expiration).). At the time of the report, EXPIRED PRODUCT ADMINISTERED (expired on 23-Mar-2022 and administered on 25-Mar-2022 (2 days after expiration).) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient was taking ASA as a blood thinner. No further details was provided about the medical history of the patient.  It was reported that they administered 8 doses of Moderna COVID 19 Vaccine (7 boosters and 1 full dose second vaccine) 2 days after the vaccine expired.  Treatment information was not provided.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: possible expired dose administered; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (possible expired dose administered) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21-2A) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (possible expired dose administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (possible expired dose administered) outcome was unknown.            No concomitant medication details was reported.  Patient received the second booster dose. Patient also reported that the lot number does not exist when he puts in the Moderna lot lookup tool and the pharmacy called him and said they put the wrong sticker on his card and asked him to get a new sticker.  No treatment medication details was reported.
Age: 29.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-2 test
Clinical narrative: Tested positive for COVID-19; Lack of drug effect; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Tested positive for COVID-19) and DRUG INEFFECTIVE (Lack of drug effect) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 03BC21A and 006B21A) for COVID-19 vaccination.     Concurrent medical conditions included Asthma and Egg allergy. Concomitant products included SALBUTAMOL SULFATE (ALBUTEROL SULFATE HFA) for an unknown indication.   On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 10-Jun-2021 at 2:03 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 01-Feb-2022, the patient experienced COVID-19 (Tested positive for COVID-19) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (Tested positive for COVID-19) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Feb-2022, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient did not had any adverse events including signs symptoms,clinical course and or treatment with dates/timelines. Patient did not experience any symptoms during temperature excursion. No treatment medications were reported. COMPANY COMMENT: This is a Spontaneous case concerning a 29 -years-old male patient with clinical history of Asthma and Egg allergy, concomitant products included SALBUTAMOL SULFATE who experienced the unexpected events of COVID-19 (AESI) and DRUG INEFFECTIVE 236 days after 2nd  dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Terms and onset were captured as provided.    This case was linked to MOD-2022-504757 (Patient Link).; Sender's Comments: COMPANY COMMENT: This is a Spontaneous case concerning a 29 -years-old male patient with clinical history of Asthma and Egg allergy, concomitant products included SALBUTAMOL SULFATE who experienced the unexpected events of COVID-19 (AESI) and DRUG INEFFECTIVE 236 days after 2nd  dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Terms and onset were captured as provided.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 02 Mar 2021 and second dose on 13 Apr 2021) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 006M20A) for COVID-19 vaccination. Concurrent medical conditions included Hypertensive, Hyperlipidemia, Diabetes and Hyperthyroidism. Concomitant products included: Amlodipine; Atorvastatin; Metformin; Olmesartan; Methimazole for an unknown indication. On 02-Mar-2021 at 2:15 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 13-Apr-2021 at 2:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 13-Apr-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 02 Mar 2021 and second dose on 13 Apr 2021). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (First dose on 02 Mar 2021 and second dose on 13 Apr 2021) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The patient had no allergies to medications, food and other products. The patient had not tested positive for COVID-19. The patient did not have any adverse event. No treatment medications were reported. This case was linked to MOD-2022-503824 (Patient Link).
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, SARS-CoV-2 test, Vaccination failure
Clinical narrative: Tested positive for COVID-19; Lack of drug effect; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (Tested positive for COVID-19) and VACCINATION FAILURE (Lack of drug effect) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 031I20a) for COVID-19 vaccination.     Concurrent medical conditions included Hypertension, Hypercholesterolemia and Benign prostatic hyperplasia. Concomitant products included AMLODIPINE, ROSUVASTATIN, LOSARTAN and TAMSULOSIN for an unknown indication.   On 27-Jan-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 24-Feb-2021 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. On 20-Dec-2021, the patient experienced COVID-19 (Tested positive for COVID-19) and VACCINATION FAILURE (Lack of drug effect). At the time of the report, COVID-19 (Tested positive for COVID-19) and VACCINATION FAILURE (Lack of drug effect) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Dec-2021, SARS-CoV-2 test: positive (Positive) Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   It was reported that patient had tested positive for COVID-19 3 days later he received the booster vaccine on 20-Dec-2021. No treatment medications were reported.  Company comment: This spontaneous case concerns a 76-year-old male patient with no relevant medical history who experienced the unexpected non-serious AESI of COVID-19. Vaccination failure was considered as an additional event. The event occurred approximately 10 months after the second dose of mRNA-1273 Vaccine. Patient tested positive for COVID 19 by rapid test. The benefit-risk relationship of mRNA-1273 is not affected by this report.   This case was linked to MOD-2022-503367 (Patient Link).; Sender's Comments: This spontaneous case concerns a 76-year-old male patient with no relevant medical history who experienced the unexpected non-serious AESI of COVID-19. Vaccination failure was considered as an additional event. The event occurred approximately 10 months after the second dose of mRNA-1273 Vaccine. Patient tested positive for COVID 19 by rapid test. The benefit-risk relationship of mRNA-1273 is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 03-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine administered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Reporter reported that the expired date of vaccine was overlooked and accidentally administered to one of the  patient, who was the employe of same facility.  Concomitant drugs were not reported.  Treatment details were not given.   Most recent FOLLOW-UP information incorporated above includes: On 04-Apr-2022: Follow up received contains non-significant information-Reporter's contact details were updated.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: vaccine given after the published expiry date.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (vaccine given after the published expiry date.) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 060H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine given after the published expiry date.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (vaccine given after the published expiry date.) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications reported. No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Poor quality product administered, Product storage error
Clinical narrative: Health care provider for the caller did not do the proper storage. No records of it available/ Possible administration of vaccine that may have experienced temperature excursion; Possible administration of vaccine that may have experienced temperature excursion; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT STORAGE ERROR (Health care provider for the caller did not do the proper storage. No records of it available/ Possible administration of vaccine that may have experienced temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Possible administration of vaccine that may have experienced temperature excursion) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Health care provider for the caller did not do the proper storage. No records of it available/ Possible administration of vaccine that may have experienced temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Possible administration of vaccine that may have experienced temperature excursion). At the time of the report, PRODUCT STORAGE ERROR (Health care provider for the caller did not do the proper storage. No records of it available/ Possible administration of vaccine that may have experienced temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Possible administration of vaccine that may have experienced temperature excursion) outcome was unknown.            Concomitant medications were not reported.  On 02 Nov 2021, the patient received a booster dose of Pfizer.  Patient received a letter from State health department. They did an inspection of a clinic where the patient got 1st, 2nd and booster shot (Pfizer). They (State health department) are claiming that vaccine provider who was also the health care provider for the caller did not do the proper storage. No records of it available. They can't prove proper storage. Patient spoke to the HCP, and they said that they have not done anything wrong, since they can't prove due to lack of documentation of temperature state is sending a warning letter.  Treatment information was not reported.   Reporter did not allow further contact
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Angiogram, Magnetic resonance imaging, Neck pain, Sinus pain, Tinnitus
Clinical narrative: Neck Pain, Sinus Pain, and Tinnitus - Sinus Medication and Antibotics did NOT work.  Prednisone worked.
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Administered expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  It was reported that the patient was over 50 years and the 4th dose (2nd booster) of the patient was administered on 02April2022.  No treatment medications was reported.   This case was linked to MOD-2022-532102 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rashes started appearing on my fingers / Thought  may be allergy / rashes have spread to all fingers, hands, elbows, thighs,knees, shin, back, butt and now appearing in the chest and stomach area.; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rashes started appearing on my fingers / Thought  may be allergy / rashes have spread to all fingers, hands, elbows, thighs,knees, shin, back, butt and now appearing in the chest and stomach area.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH (Rashes started appearing on my fingers / Thought  may be allergy / rashes have spread to all fingers, hands, elbows, thighs,knees, shin, back, butt and now appearing in the chest and stomach area.). At the time of the report, RASH (Rashes started appearing on my fingers / Thought  may be allergy / rashes have spread to all fingers, hands, elbows, thighs,knees, shin, back, butt and now appearing in the chest and stomach area.) had not resolved.            No concomitant product was provided by the reporter.  The treatment provided was creams which did not help. Dermatalogist tried to get approved for ILUMYA. But was denied by the insurance company.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient was administered Moderna COVID-19 vaccine past the expiration date / Administered expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered Moderna COVID-19 vaccine past the expiration date / Administered expired vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L21B) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered Moderna COVID-19 vaccine past the expiration date / Administered expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient was administered Moderna COVID-19 vaccine past the expiration date / Administered expired vaccine) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product reported by reporter.  Age of the patient was reported as over 50 years and the 4th dose (2nd booster) of the patient was administered on 02 April 2022. Manufacturing date of the vaccine was 01 Dec 2021. Date the vial was initially stored in the refrigerator 24 Mar 2022 3:05 PM. The vial did not undergo any temperature excursions.  No treatment medication reported by reporter.   This case was linked to MOD-2022-532061 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Feeling abnormal
Clinical narrative: felt bad; painful as hell in my shoulder/he couldn't lay on it; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt bad) and ARTHRALGIA (painful as hell in my shoulder/he couldn't lay on it) 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 03-Apr-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Apr-2022, the patient experienced FEELING ABNORMAL (felt bad) and ARTHRALGIA (painful as hell in my shoulder/he couldn't lay on it). At the time of the report, FEELING ABNORMAL (felt bad) and ARTHRALGIA (painful as hell in my shoulder/he couldn't lay on it) outcome was unknown.            Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Accidental underdose
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL UNDERDOSE (Got a half dose (0.25mL) as the third dose instead of a full dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 076C21A, 001B21A and 006M20A) for COVID-19 vaccination. Concurrent medical conditions included Immunocompromised, Hashimoto's disease and Inflammatory arthritis (Rare type that is autoimmune). On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 22-Oct-2021, the patient experienced ACCIDENTAL UNDERDOSE (Got a half dose (0.25mL) as the third dose instead of a full dose). At the time of the report, ACCIDENTAL UNDERDOSE (Got a half dose (0.25mL) as the third dose instead of a full dose) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant medications were provided. No treatment medications were provided.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: 1st dose: 27Feb2021, 0.5mL intramuscular injection (documentation says 1mL administered); This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (1st dose: 27Feb2021, 0.5mL intramuscular injection (documentation says 1mL administered)) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 milliliter. On 27-Feb-2021, the patient experienced ACCIDENTAL OVERDOSE (1st dose: 27Feb2021, 0.5mL intramuscular injection (documentation says 1mL administered)). At the time of the report, ACCIDENTAL OVERDOSE (1st dose: 27Feb2021, 0.5mL intramuscular injection (documentation says 1mL administered)) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant drug was reported. No treatment drug was reported.   This case was linked to MOD-2022-532408, MOD-2022-532418 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Full dose is administered for a booster; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (Full dose is administered for a booster) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On an unknown date, the patient experienced ACCIDENTAL OVERDOSE (Full dose is administered for a booster). At the time of the report, ACCIDENTAL OVERDOSE (Full dose is administered for a booster) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. No treatment details were reported.
Age: 80.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: Arm is killing him today like with the other 3 injections; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (Arm is killing him today like with the other 3 injections) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     The patient did not have any allergies and was never tested or diagnosed for Covid-19. Patient did not have acute or chronic illnesses at the time of vaccination. Patient did not receive other vaccines within 1 month prior to Moderna COVID-19 vaccine.    On 03-Apr-2022, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 milliliter. 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. On 04-Apr-2022, the patient experienced VACCINATION SITE PAIN (Arm is killing him today like with the other 3 injections). At the time of the report, VACCINATION SITE PAIN (Arm is killing him today like with the other 3 injections) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication information was provided. On 03-Apr-2022, the patient received second booster dose injection. The reporter stated that optimal place to inject vaccine was deltoid muscle, but it was injected low.  The reporter concerned whether there was any concern with injecting too high, still in deltoid region but almost to the subcutaneous fat and lower than safety zone of 2 inches below shoulder. The reporter asked whether dose needs to be repeated. No treatment medication were provided.   This case was linked to MOD-2022-532671, MOD-2022-532675, MOD-2022-532678 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received a booster dose of the Moderna Covid 19 vaccine that was expired on 02Apr2022; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a booster dose of the Moderna Covid 19 vaccine that was expired on 02Apr2022) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 068H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Apr-2022 at 7:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Apr-2022 at 7:00 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a booster dose of the Moderna Covid 19 vaccine that was expired on 02Apr2022). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received a booster dose of the Moderna Covid 19 vaccine that was expired on 02Apr2022) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. It was reported that patient received a booster dose. This vial was stored in the freezer until this morning (04Apr2022) at 6AM. Vial did not undergo any temperature excursions. No treatment medications were reported.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: Vaccine was expired on 27-Mar-2022 and store in refrigerator on 3 day before the administration date (1-Apr-2022); 1 dose was administered past manufacturer expiration date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (1 dose was administered past manufacturer expiration date) and PRODUCT STORAGE ERROR (Vaccine was expired on 27-Mar-2022 and store in refrigerator on 3 day before the administration date (1-Apr-2022)) 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 01-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 01-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (1 dose was administered past manufacturer expiration date). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (Vaccine was expired on 27-Mar-2022 and store in refrigerator on 3 day before the administration date (1-Apr-2022)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (1 dose was administered past manufacturer expiration date) and PRODUCT STORAGE ERROR (Vaccine was expired on 27-Mar-2022 and store in refrigerator on 3 day before the administration date (1-Apr-2022)) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported. No treatment medications was reported.   Reporter did not allow further contact
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: 2nd dose - documentation says 1mL adminsitered; This spontaneous case was reported by an other health care professional and describes the occurrence of ACCIDENTAL OVERDOSE (2nd dose - documentation says 1mL adminsitered) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 013A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 milliliter. On 29-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 milliliter. On 29-Mar-2021, the patient experienced ACCIDENTAL OVERDOSE (2nd dose - documentation says 1mL adminsitered). At the time of the report, ACCIDENTAL OVERDOSE (2nd dose - documentation says 1mL adminsitered) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were mentioned. It was reported that on 29 March 2021 patient had 2nd dose of 0.5mL for which documentation says 1 mL administered. No treatment details were reported.   This case was linked to MOD-2022-532364, MOD-2022-532418 (Patient Link).
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered after more than 12 hours post punctured; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after more than 12 hours post punctured) in a 40-year-old male patient who received mRNA-1273 (Spikevax) (batch no. 022J21A) for COVID-19 vaccination.     Concurrent medical conditions included Reflux gastritis since 04-Apr-2022. Concomitant products included DIPHTHERIA VACCINE TOXOID, PERTUSSIS VACCINE ACELLULAR, TETANUS VACCINE TOXOID (TDAP) for an unknown indication.    On 04-Apr-2022, the patient received first dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 04-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after more than 12 hours post punctured). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administered after more than 12 hours post punctured) 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.   No treatment medication information provided. Hight: 6 feet 7 inch. Weight: 232 Ibs.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: patient received doses more than 12 hours post-puncture and stored in room temperature; patients received doses more than 12 hours post-puncture; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients received doses more than 12 hours post-puncture) and PRODUCT STORAGE ERROR (patient received doses more than 12 hours post-puncture and stored in room temperature) in a 69-year-old female patient who received mRNA-1273 (Spikevax) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2022, the patient received dose of mRNA-1273 (Spikevax) (unknown route) 1 dosage form. On 01-Apr-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (patients received doses more than 12 hours post-puncture). On an unknown date, the patient experienced PRODUCT STORAGE ERROR (patient received doses more than 12 hours post-puncture and stored in room temperature). At the time of the report, EXPIRED PRODUCT ADMINISTERED (patients received doses more than 12 hours post-puncture) and PRODUCT STORAGE ERROR (patient received doses more than 12 hours post-puncture and stored in room temperature) outcome was unknown.        For mRNA-1273 (Spikevax) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   It was reported that the Moderna vial was set to the counter on 31-Mar-2022 at 12:10 PM. The vial was first punctured on 31-Apr-2022 at 12:25 PM. It was stored at room temperature post puncture. Total amount of time the vial was exposed to room temperature range was a little over 25 hours and 20 minutes before the first dose was administered. The vaccine was administered on 01-Apr-2022 at 1:30 PM, 2:15 PM, 2:30 PM, and 3:30 PM. The vial was stored at room temperature post puncture.  No treatment information was provided.   This case was linked to MOD-2022-532655, MOD-2022-532656 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Wrong technique in device usage process
Clinical narrative: put the needled in and he said that the needle was empty and had to do it again/they felt like he push it in,/he came back  with another needle and put another needle in their arm.; This spontaneous case was reported by a consumer and describes the occurrence of WRONG TECHNIQUE IN DEVICE USAGE PROCESS (put the needled in and he said that the needle was empty and had to do it again/they felt like he push it in,/he came back  with another needle and put another needle in their arm.) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 01-Apr-2022, the patient received fourth dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2022, the patient experienced WRONG TECHNIQUE IN DEVICE USAGE PROCESS (put the needled in and he said that the needle was empty and had to do it again/they felt like he push it in,/he came back  with another needle and put another needle in their arm.). At the time of the report, WRONG TECHNIQUE IN DEVICE USAGE PROCESS (put the needled in and he said that the needle was empty and had to do it again/they felt like he push it in,/he came back  with another needle and put another needle in their arm.) outcome was unknown.            Concomitant medication was not provided. Patient got their second booster on Friday 01-Apr-2022 Treatment information was not provided.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administrated after expiration date; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administrated after expiration date) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059H21A, 033C21A and 023C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 08-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Apr-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administrated after expiration date). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Dose administrated after expiration date) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Oxygen saturation, Pain, Vaccination site erythema, Vaccination site movement impairment
Clinical narrative: Achiness; Could not barely lift arms for 3 days; Pain in the injection site; Tiredness; Redness in the injection site,; rash an inch in diameter in the injection site for 6 days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achiness), VACCINATION SITE MOVEMENT IMPAIRMENT (Could not barely lift arms for 3 days), VACCINATION SITE PAIN (Pain in the injection site), FATIGUE (Tiredness) and VACCINATION SITE ERYTHEMA (Redness in the injection site,) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K212A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 immunisation: Pfizer COVID 19 vaccine (First dose , LOT : EWO177) on 01-Jul-2021 and Pfizer COVID 19 vaccine (Second dose) on 22-Jul-2021. Past adverse reactions to the above products included No adverse event with Pfizer COVID 19 vaccine and Pfizer COVID 19 vaccine. Concurrent medical conditions included Penicillin allergy.    On 28-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2022, the patient experienced PAIN (Achiness), VACCINATION SITE MOVEMENT IMPAIRMENT (Could not barely lift arms for 3 days), VACCINATION SITE PAIN (Pain in the injection site), FATIGUE (Tiredness), VACCINATION SITE ERYTHEMA (Redness in the injection site,) and VACCINATION SITE RASH (rash an inch in diameter in the injection site for 6 days). The patient was treated with HYDROGEN PEROXIDE for Adverse event, at an unspecified dose and frequency. On 30-Mar-2022, VACCINATION SITE MOVEMENT IMPAIRMENT (Could not barely lift arms for 3 days) had resolved. On 02-Apr-2022, VACCINATION SITE RASH (rash an inch in diameter in the injection site for 6 days) had resolved. At the time of the report, PAIN (Achiness) and VACCINATION SITE PAIN (Pain in the injection site) had not resolved and FATIGUE (Tiredness) and VACCINATION SITE ERYTHEMA (Redness in the injection site,) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Oxygen saturation: 97-98% (normal) 97-98%.         No concomitant medications were reported.  Treatment given was washing with water, hot compress and applying hydrogen peroxide on the injection site area.  Patient reports that she was still experiencing pain and could not barely lift arms for 3 days, and rash an inch in diameter in the injection site for 6 days.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site rash
Clinical narrative: Achiness; Could not barely lift arms for 3 days; Pain in the injection site; Tiredness; Redness in the injection site,; rash an inch in diameter in the injection site for 6 days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Achiness), VACCINATION SITE MOVEMENT IMPAIRMENT (Could not barely lift arms for 3 days), VACCINATION SITE PAIN (Pain in the injection site), FATIGUE (Tiredness) and VACCINATION SITE ERYTHEMA (Redness in the injection site,) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033K212A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for COVID-19 immunisation: Pfizer COVID 19 vaccine (First dose , LOT : EWO177) on 01-Jul-2021 and Pfizer COVID 19 vaccine (Second dose) on 22-Jul-2021. Past adverse reactions to the above products included No adverse event with Pfizer COVID 19 vaccine and Pfizer COVID 19 vaccine. Concurrent medical conditions included Penicillin allergy.    On 28-Mar-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2022, the patient experienced PAIN (Achiness), VACCINATION SITE MOVEMENT IMPAIRMENT (Could not barely lift arms for 3 days), VACCINATION SITE PAIN (Pain in the injection site), FATIGUE (Tiredness), VACCINATION SITE ERYTHEMA (Redness in the injection site,) and VACCINATION SITE RASH (rash an inch in diameter in the injection site for 6 days). The patient was treated with HYDROGEN PEROXIDE for Adverse event, at an unspecified dose and frequency. On 30-Mar-2022, VACCINATION SITE MOVEMENT IMPAIRMENT (Could not barely lift arms for 3 days) had resolved. On 02-Apr-2022, VACCINATION SITE RASH (rash an inch in diameter in the injection site for 6 days) had resolved. At the time of the report, PAIN (Achiness) and VACCINATION SITE PAIN (Pain in the injection site) had not resolved and FATIGUE (Tiredness) and VACCINATION SITE ERYTHEMA (Redness in the injection site,) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Oxygen saturation: 97-98% (normal) 97-98%.         No concomitant medications were reported.  Treatment given was washing with water, hot compress and applying hydrogen peroxide on the injection site area.  Patient reports that she was still experiencing pain and could not barely lift arms for 3 days, and rash an inch in diameter in the injection site for 6 days.