chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Moderna Dose administered after 30-day Use By Date; vial undergo temperature excursions; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Dose administered after 30-day Use By Date) and PRODUCT TEMPERATURE EXCURSION ISSUE (vial undergo temperature excursions) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Dec-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (vial undergo temperature excursions). On 20-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Dose administered after 30-day Use By Date). On 19-Jan-2022, PRODUCT TEMPERATURE EXCURSION ISSUE (vial undergo temperature excursions) had resolved. On 20-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Moderna Dose administered after 30-day Use By Date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The vial undergo temperature excursions.  The vials were transported from one facility to another in frozen state. The 2nd facility stored them in refrigerator for 2 days from 20th December 2021 to 22nd December 2021.  Accidentally the vials got misplaced back into freezer on 22nd December 2021 even though they had assigned BUD of 30 days. HCP did not know if vials were frozen or thawed out when moved back into freezer.  The vials were assigned BUD date of 19th January 2022.   0 F was the lowest temperature that vaccine has reached when moved back to freezer.  The excursion duration was reported as 22nd December 2021 to 19th January 2022.  The vials were pulled out of the freezer on 20th January 2022 and 15 doses were administered.  The reporter asked whether they need to revaccinate the patients.  No concomitant and treatment medication information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2022: Significant follow up contains updated reporter details and patient details. Case was upgraded from invalid to valid.
Age: 57.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Drug ineffective, SARS-CoV-1 test
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19) and DRUG INEFFECTIVE (Lack of drug effect) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008132A and 011A21A) for COVID-19 vaccination. No Medical History information was reported. On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jan-2022, the patient experienced COVID-19 (Covid-19) and DRUG INEFFECTIVE (Lack of drug effect). At the time of the report, COVID-19 (Covid-19) had resolved and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Jan-2022, SARS-CoV-1 test: positive (Positive) positive. On an unknown date, SARS-CoV-1 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The patient had tested positive on 10Jan2022, and yesterday he tested negative. No Concomitant medication were reported. No Treatment medication were reported. Company Comment: This is a spontaneous case concerning a 57-year-old, male patient with no relevant medical history, who experienced the unexpected, non-serious, AESI event of COVID-19. The event occurred 8 months 21 days after the second dose of mRNA-1273 vaccine administered on 20-Apr-21 for the indication of COVID-19 vaccination. SARS-CoV-2 test done on 10-Jan-22 was positive and that done on an unknown date was negative. At the time of report outcome of the events was Resolved. Further details about the event are not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This is a spontaneous case concerning a 57-year-old, male patient with no relevant medical history, who experienced the unexpected, non-serious, AESI event of COVID-19. The event occurred 8 months 21 days after the second dose of mRNA-1273 vaccine administered on 20-Apr-21 for the indication of COVID-19 vaccination. SARS-CoV-2 test done on 10-Jan-22 was positive and that done on an unknown date was negative. At the time of report outcome of the events was Resolved. Further details about the event are not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: I had covid 19; This spontaneous case was reported by an other health care professional and describes the occurrence of COVID-19 (I had covid 19) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In November 2021, the patient experienced COVID-19 (I had covid 19). At the time of the report, COVID-19 (I had covid 19) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported.  No treatment medication was reported.  Company Comment: This is a spontaneous case concerning a patient of unknown age and gender, with no relevant medical history, who experienced the unexpected, non-serious, AESI event of COVID-19. The event occurred in Nov-21, an unknown duration after the unknown dose of mRNA-1273 vaccine administered on an unknown date for the indication of COVID-19 vaccination. At the time of report outcome of the events was Resolved. Further details about the event are not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This is a spontaneous case concerning a patient of unknown age and gender, with no relevant medical history, who experienced the unexpected, non-serious, AESI event of COVID-19. The event occurred in Nov-21, an unknown duration after the unknown dose of mRNA-1273 vaccine administered on an unknown date for the indication of COVID-19 vaccination. At the time of report outcome of the events was Resolved. Further details about the event are not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Sex: U
Vaccine: COVID19
Symptoms: Eye pruritus
Clinical narrative: itchy eyes; This spontaneous case was reported by a pharmacist and describes the occurrence of EYE PRURITUS (itchy eyes) 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 EYE PRURITUS (itchy eyes). At the time of the report, EYE PRURITUS (itchy eyes) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not provided. Treatment information was not provided
Sex: U
Vaccine: COVID19
Symptoms: Fatigue, Headache, Lymphadenopathy, Myalgia, Pyrexia
Clinical narrative: Felt achy,aches; fever/feverish; headaches; swollen glands; extreme fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of MYALGIA (Felt achy,aches), PYREXIA (fever/feverish), HEADACHE (headaches), LYMPHADENOPATHY (swollen glands) and FATIGUE (extreme fatigue) 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 MYALGIA (Felt achy,aches), PYREXIA (fever/feverish), HEADACHE (headaches), LYMPHADENOPATHY (swollen glands) and FATIGUE (extreme fatigue). At the time of the report, MYALGIA (Felt achy,aches), PYREXIA (fever/feverish) and HEADACHE (headaches) had not resolved and LYMPHADENOPATHY (swollen glands) and FATIGUE (extreme fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment medications were reported
Sex: U
Vaccine: COVID19
Symptoms: SARS-CoV-2 test
Clinical narrative: Felt achy,aches; fever/feverish; headaches; swollen glands; extreme fatigue; This spontaneous case was reported by an other health care professional and describes the occurrence of MYALGIA (Felt achy,aches), PYREXIA (fever/feverish), HEADACHE (headaches), LYMPHADENOPATHY (swollen glands) and FATIGUE (extreme fatigue) 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 MYALGIA (Felt achy,aches), PYREXIA (fever/feverish), HEADACHE (headaches), LYMPHADENOPATHY (swollen glands) and FATIGUE (extreme fatigue). At the time of the report, MYALGIA (Felt achy,aches), PYREXIA (fever/feverish) and HEADACHE (headaches) had not resolved and LYMPHADENOPATHY (swollen glands) and FATIGUE (extreme fatigue) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported No treatment medications were reported
Sex: U
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: severe swelling of my left supraclavical lymph node; This spontaneous case was reported by a health care professional and describes the occurrence of LYMPHADENOPATHY (severe swelling of my left supraclavical lymph node) 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 January 2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced LYMPHADENOPATHY (severe swelling of my left supraclavical lymph node). At the time of the report, LYMPHADENOPATHY (severe swelling of my left supraclavical lymph node) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The  concomitant medications on use were not provided. No treatment information was provided.  Patient received vaccine three days ago of reporting.
Sex: M
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: The vaccine Save he's life after contacting covid; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (The vaccine Save he's life after contacting covid) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination.     No Medical History information was reported.    In September 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (The vaccine Save he's life after contacting covid). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (The vaccine Save he's life after contacting covid) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. Reporter stated that caller called to say thank you about having the moderna vaccine last sept 2021 with Lot:014F21A. The vaccine saved he's life after contacting covid. No treatment medications were reported.
Age: 14.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Product administered to patient of inappropriate age
Clinical narrative: 14 year old that was given a dose of the Moderna vaccine; 14 year old that was given a dose of the Moderna vaccine, received Pfizer COVID-19 vaccination as the primary series; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year old that was given a dose of the Moderna vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (14 year old that was given a dose of the Moderna vaccine, received Pfizer COVID-19 vaccination as the primary series) in a 14-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H21B) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer COVID-19 vaccination (patient received Pfizer COVID-19 vaccination as the primary series). Past adverse reactions to the above products included No adverse event with Pfizer COVID-19 vaccination.    On 24-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2022, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year old that was given a dose of the Moderna vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (14 year old that was given a dose of the Moderna vaccine, received Pfizer COVID-19 vaccination as the primary series). On 24-Jan-2022, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (14 year old that was given a dose of the Moderna vaccine) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (14 year old that was given a dose of the Moderna vaccine, received Pfizer COVID-19 vaccination as the primary series) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was provided by the reporter.  Patient was 5feet 10 inches. The Lot number and expiration date for the Pfizer COVID-19 vaccine were unknown
Sex: U
Vaccine: COVID19
Symptoms: Burning sensation, Erythema, Pruritus, Urticaria, Vaccination complication
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (report the side effect/annoying side effect), URTICARIA (I am started getting Hives throughout the body), BURNING SENSATION (It started with the itching and burning sensation), PRURITUS (started with the itching and burning sensation) and ERYTHEMA (later turned to Red skins bumps) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (report the side effect/annoying side effect), URTICARIA (I am started getting Hives throughout the body), BURNING SENSATION (It started with the itching and burning sensation), PRURITUS (started with the itching and burning sensation) and ERYTHEMA (later turned to Red skins bumps). At the time of the report, VACCINATION COMPLICATION (report the side effect/annoying side effect), URTICARIA (I am started getting Hives throughout the body), BURNING SENSATION (It started with the itching and burning sensation), PRURITUS (started with the itching and burning sensation) and ERYTHEMA (later turned to Red skins bumps) had not resolved. No concomitant medication were reported. No treatment information was reported. Most recent FOLLOW-UP information incorporated above includes: On 24-Jan-2022: Non-significant follow-up. On 24-Jan-2022: Significant follow-up: Added events of Hives, itching, Burning sensation and Red skin.
Sex: U
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: extremely sore arm; This spontaneous case was reported by a pharmacist and describes the occurrence of PAIN IN EXTREMITY (extremely sore 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (extremely sore arm). At the time of the report, PAIN IN EXTREMITY (extremely sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment details were reported.
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: booster dose < 5 months after second dose; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (booster dose < 5 months after second dose) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030H21AB) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 24-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (booster dose < 5 months after second dose). On 24-Jan-2022, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (booster dose < 5 months after second dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported.  No treatment information was reported.  The nurse stated the patient was not immunocompromised.   This case was linked to MOD-2022-460376 (Patient Link).
Age: 26.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: The employee got her first dose of Moderna COVID19 Vaccine on 18Nov2021 and 30Dec2021.; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The employee got her first dose of Moderna COVID19 Vaccine on 18Nov2021 and 30Dec2021.) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Nov-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Dec-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Dec-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The employee got her first dose of Moderna COVID19 Vaccine on 18Nov2021 and 30Dec2021.). On 30-Dec-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The employee got her first dose of Moderna COVID19 Vaccine on 18Nov2021 and 30Dec2021.) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication and treatment information was reported.  Reporter stated that the patient has received her first dose of Moderna COVID-19 Vaccine on 18-Nov-2021 and second dose on 30-Dec-2021 and did not have any reactions.   Reporter also stated that the patient was not immunocompromised.   This case was linked to MOD-2022-460371 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Dyspnoea, Maternal exposure before pregnancy, Urticaria
Clinical narrative: This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of URTICARIA (Severe urticaria), DYSPNOEA (Shortness of breath) and MATERNAL EXPOSURE BEFORE PREGNANCY (Pregnant after vaccination) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On an unknown date, the patient experienced URTICARIA (Severe urticaria), DYSPNOEA (Shortness of breath) and MATERNAL EXPOSURE BEFORE PREGNANCY (Pregnant after vaccination). At the time of the report, URTICARIA (Severe urticaria), DYSPNOEA (Shortness of breath) and MATERNAL EXPOSURE BEFORE PREGNANCY (Pregnant after vaccination) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant and treatment medication information were not provided. Patient was 14 weeks and 4 days pregnant and received Moderna COVID-19 vaccine in summer.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Dose administered to a patient after >12 hours post punctured, Dose administered to a patient after exposure to room temperature >24 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered to a patient after >12 hours post punctured, Dose administered to a patient after exposure to room temperature >24 hours) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L21B) for COVID-19 vaccination.     Concomitant products included LOSARTAN, METOPROLOL, ATORVASTATIN, APIXABAN (ELIQUIS) and AMLODIPINE for an unknown indication.    On 24-Jan-2022 at 10:15 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered to a patient after >12 hours post punctured, Dose administered to a patient after exposure to room temperature >24 hours). On 24-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Dose administered to a patient after >12 hours post punctured, Dose administered to a patient after exposure to room temperature >24 hours) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No medical history was reported by the reporter. No treatment was given. Patient did not experienced any symptoms. Vaccine vial that was punctured first on 23 Jan 2022 approximately at 10:00 a.m.Vial was stored at room temperature since it was first punctured, at least 24 hours ago. Date of first and second vaccination was unknown.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Respiratory disorder
Clinical narrative: battling respiratory problems for 6 weeks; This spontaneous case was reported by a consumer and describes the occurrence of RESPIRATORY DISORDER (battling respiratory problems for 6 weeks) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received 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 06-Dec-2021, the patient experienced RESPIRATORY DISORDER (battling respiratory problems for 6 weeks). At the time of the report, RESPIRATORY DISORDER (battling respiratory problems for 6 weeks) had resolved.            No relevant concomitant medications were reported. Treatment information was unknown.   Reporter did not allow further contact
Age: 42.0
Sex: M
Vaccine: COVID19
Symptoms: Burning sensation, Pruritus, Urticaria
Clinical narrative: Getting Hives through out the body with Itching and burning sensation.; Getting Hives through out the body with Itching and burning sensation.; Getting Hives through out the body with Itching and burning sensation.; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Getting Hives through out the body with Itching and burning sensation.), PRURITUS (Getting Hives through out the body with Itching and burning sensation.) and BURNING SENSATION (Getting Hives through out the body with Itching and burning sensation.) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication.     No Medical History information was reported.    On 25-Nov-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced URTICARIA (Getting Hives through out the body with Itching and burning sensation.), PRURITUS (Getting Hives through out the body with Itching and burning sensation.) and BURNING SENSATION (Getting Hives through out the body with Itching and burning sensation.). The patient was treated with LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) at an unspecified dose and frequency. At the time of the report, URTICARIA (Getting Hives through out the body with Itching and burning sensation.), PRURITUS (Getting Hives through out the body with Itching and burning sensation.) and BURNING SENSATION (Getting Hives through out the body with Itching and burning sensation.) had not resolved.            The patient's height was reported as 167.64 cm.  No concomitant medication information was provided.  Patient took the steroids (unspecified) prescribed by the doctor but still the events exists.   The doctor suggested Xyzal over the counter medication but that also not helping much.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: she received the full dose of the Moderna COVID 19 vaccine instead of the half dose for the booster; This spontaneous case was reported by a patient and describes the occurrence of ACCIDENTAL OVERDOSE (she received the full dose of the Moderna COVID 19 vaccine instead of the half dose for the booster) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025C21A and 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Jan-2022, the patient experienced ACCIDENTAL OVERDOSE (she received the full dose of the Moderna COVID 19 vaccine instead of the half dose for the booster). On 24-Jan-2022, ACCIDENTAL OVERDOSE (she received the full dose of the Moderna COVID 19 vaccine instead of the half dose for the booster) had resolved.            No concomitant medications were reported.  Treatment information was not provided by the reporter.  She confirmed that she was not immunocompromised.  The batch number for third dose was reported as 042J21A or 042C21A (could not see the writing very well).
Age: 14.0
Sex: F
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Unauthorized booster dose administered to a minor, 14 year old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Unauthorized booster dose administered to a minor, 14 year old) in a 14-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027h21b) for COVID-19 vaccination.     No Medical History information was reported.    On 13-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .25 milliliter once. On 13-Jan-2022,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Unauthorized booster dose administered to a minor, 14 year old). On 13-Jan-2022, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Unauthorized booster dose administered to a minor, 14 year old) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were reported. No treatment medications were reported.
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Impaired work ability
Clinical narrative: The patient was out of work for 4 days; This spontaneous case was reported by a consumer and describes the occurrence of IMPAIRED WORK ABILITY (The patient was out of work for 4 days) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 003C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Jun-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced IMPAIRED WORK ABILITY (The patient was out of work for 4 days). At the time of the report, IMPAIRED WORK ABILITY (The patient was out of work for 4 days) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was provided by the reporter No treatment medication was provided by the reporter. The patient's weight was provided as 180.   This case was linked to MOD-2021-123321, MOD-2022-460419 (Patient Link).
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Body temperature, Headache, Illness, Joint swelling, Mobility decreased
Clinical narrative: right shoulder is swollen; there is tingling in fore fingers in his right hand; tingling in fore fingers in right hand and cannot move it; got really sick; booster and first shot hurt It felt like a tetanus shot; had pounding headache; had fever of 103F; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (right shoulder is swollen), PARAESTHESIA (there is tingling in fore fingers in his right hand), MOBILITY DECREASED (tingling in fore fingers in right hand and cannot move it), ILLNESS (got really sick) and PAIN (booster and first shot hurt It felt like a tetanus shot) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0541121A, 027C21A and 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: tetanus shot. Past adverse reactions to the above products included No adverse event with tetanus shot.   On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jan-2022, the patient experienced JOINT SWELLING (right shoulder is swollen), PARAESTHESIA (there is tingling in fore fingers in his right hand), MOBILITY DECREASED (tingling in fore fingers in right hand and cannot move it), ILLNESS (got really sick), PAIN (booster and first shot hurt It felt like a tetanus shot), HEADACHE (had pounding headache) and PYREXIA (had fever of 103F). At the time of the report, JOINT SWELLING (right shoulder is swollen), PARAESTHESIA (there is tingling in fore fingers in his right hand), MOBILITY DECREASED (tingling in fore fingers in right hand and cannot move it), ILLNESS (got really sick), PAIN (booster and first shot hurt It felt like a tetanus shot), HEADACHE (had pounding headache) and PYREXIA (had fever of 103F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2022, Body temperature: 103 (High) fever of 103F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was provided by the reporter. The patient's weight was provided as 180.   This case was linked to MOD-2021-123321, MOD-2022-460417 (Patient Link).
Age: 55.0
Sex: M
Vaccine: COVID19
Symptoms: Pain, Paraesthesia, Pyrexia
Clinical narrative: right shoulder is swollen; there is tingling in fore fingers in his right hand; tingling in fore fingers in right hand and cannot move it; got really sick; booster and first shot hurt It felt like a tetanus shot; had pounding headache; had fever of 103F; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (right shoulder is swollen), PARAESTHESIA (there is tingling in fore fingers in his right hand), MOBILITY DECREASED (tingling in fore fingers in right hand and cannot move it), ILLNESS (got really sick) and PAIN (booster and first shot hurt It felt like a tetanus shot) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0541121A, 027C21A and 003C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Previously administered products included for Product used for unknown indication: tetanus shot. Past adverse reactions to the above products included No adverse event with tetanus shot.   On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jan-2022, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jan-2022, the patient experienced JOINT SWELLING (right shoulder is swollen), PARAESTHESIA (there is tingling in fore fingers in his right hand), MOBILITY DECREASED (tingling in fore fingers in right hand and cannot move it), ILLNESS (got really sick), PAIN (booster and first shot hurt It felt like a tetanus shot), HEADACHE (had pounding headache) and PYREXIA (had fever of 103F). At the time of the report, JOINT SWELLING (right shoulder is swollen), PARAESTHESIA (there is tingling in fore fingers in his right hand), MOBILITY DECREASED (tingling in fore fingers in right hand and cannot move it), ILLNESS (got really sick), PAIN (booster and first shot hurt It felt like a tetanus shot), HEADACHE (had pounding headache) and PYREXIA (had fever of 103F) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2022, Body temperature: 103 (High) fever of 103F.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were reported. No treatment information was provided by the reporter. The patient's weight was provided as 180.   This case was linked to MOD-2021-123321, MOD-2022-460417 (Patient Link).
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Vaccination site pain
Clinical narrative: the shots hurt so much/ the arm stills hurts when they touch it; received 2 injections, one in each arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (the shots hurt so much/ the arm stills hurts when they touch it) and EXTRA DOSE ADMINISTERED (received 2 injections, one in each arm) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0T0M21A, 048A21A and 23M20DA) for COVID-19 vaccination.     Concurrent medical conditions included Chronic obstructive pulmonary disease and Chronic pain. Concomitant products included OXYGEN for Chronic obstructive pulmonary disease.   On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Dec-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Dec-2021, the patient experienced VACCINATION SITE PAIN (the shots hurt so much/ the arm stills hurts when they touch it) and EXTRA DOSE ADMINISTERED (received 2 injections, one in each arm). On 20-Dec-2021, EXTRA DOSE ADMINISTERED (received 2 injections, one in each arm) had resolved. At the time of the report, VACCINATION SITE PAIN (the shots hurt so much/ the arm stills hurts when they touch it) had not resolved.            Patient stated that HCP told them it was a third round of the Moderna vaccine but the vaccination card does not state the type of dose they received. Concomitant medications included breathing medicine 3 to 4 times a day and pain medicine for chronic condition. It was reported that Oxygen was given all the time for  Chronic obstructive pulmonary disease. Patient also stated she takes around 16 medications. Treatment medications were not reported.
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Malaise, Pyrexia
Clinical narrative: Felt lousy; Fever; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Felt lousy) and PYREXIA (Fever) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included Hypothyroidism. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jan-2022, the patient experienced MALAISE (Felt lousy) and PYREXIA (Fever). At the time of the report, MALAISE (Felt lousy) and PYREXIA (Fever) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment medication reported.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain
Clinical narrative: back sore due to shoveling snow; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (back sore due to shoveling snow) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0066H21A) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: Pfizer (1st dose -EW0172) on 24-Jun-2021 and Pfizer (2nd dose - EW0173) on 17-Jul-2021. Past adverse reactions to the above products included No adverse event with Pfizer and Pfizer.    On 22-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2022, the patient experienced BACK PAIN (back sore due to shoveling snow). At the time of the report, BACK PAIN (back sore due to shoveling snow) outcome was unknown.            No Concomitant medications were provided The patient wanted to know if he could take Ibuprofen for the back sore.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: temp excursion/beyond use date excursion; temp excursion/beyond use date excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (temp excursion/beyond use date excursion) and EXPIRED PRODUCT ADMINISTERED (temp excursion/beyond use date excursion) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (temp excursion/beyond use date excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (temp excursion/beyond use date excursion). On 20-Jan-2022, EXPIRED PRODUCT ADMINISTERED (temp excursion/beyond use date excursion) had resolved. At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (temp excursion/beyond use date excursion) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication of the patient was not reported.  No treatment information was provided by the reporter.
Age: 33.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Temp excursion/beyond use date excursion I called about on1/21/22.; Temp excursion/beyond use date excursion I called about on1/21/22.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Temp excursion/beyond use date excursion I called about on1/21/22.) and PRODUCT TEMPERATURE EXCURSION ISSUE (Temp excursion/beyond use date excursion I called about on1/21/22.) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2022, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2021, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Temp excursion/beyond use date excursion I called about on1/21/22.). On 20-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Temp excursion/beyond use date excursion I called about on1/21/22.). On 20-Jan-2021, PRODUCT TEMPERATURE EXCURSION ISSUE (Temp excursion/beyond use date excursion I called about on1/21/22.) had resolved. On 20-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Temp excursion/beyond use date excursion I called about on1/21/22.) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided No treatment medication was provided
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: temp excursion/beyond use date excursion; temp excursion/beyond use date excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (temp excursion/beyond use date excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (temp excursion/beyond use date excursion) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (temp excursion/beyond use date excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (temp excursion/beyond use date excursion). On 20-Jan-2022, EXPIRED PRODUCT ADMINISTERED (temp excursion/beyond use date excursion) had resolved. At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (temp excursion/beyond use date excursion) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medications were not reported.   Treatment information was not reported.
Age: 35.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Here is the patient info for the temp excursion/beyond use date excursion I called about on1/21/22. There were 15 total patients; Here is the patient info for the temp excursion/beyond use date excursion I called about on1/21/22. There were 15 total patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Here is the patient info for the temp excursion/beyond use date excursion I called about on1/21/22. There were 15 total patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Here is the patient info for the temp excursion/beyond use date excursion I called about on1/21/22. There were 15 total patients) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (Here is the patient info for the temp excursion/beyond use date excursion I called about on1/21/22. There were 15 total patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Here is the patient info for the temp excursion/beyond use date excursion I called about on1/21/22. There were 15 total patients). On 20-Jan-2022, EXPIRED PRODUCT ADMINISTERED (Here is the patient info for the temp excursion/beyond use date excursion I called about on1/21/22. There were 15 total patients) and PRODUCT TEMPERATURE EXCURSION ISSUE (Here is the patient info for the temp excursion/beyond use date excursion I called about on1/21/22. There were 15 total patients) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant and treatment medications were reported.
Age: 62.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product temperature excursion issue
Clinical narrative: Here is the patient info for the temp excursion/beyond use date excursion; temp excursion/beyond use date excursion; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (temp excursion/beyond use date excursion) and PRODUCT TEMPERATURE EXCURSION ISSUE (Here is the patient info for the temp excursion/beyond use date excursion) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 067H21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-Jan-2022, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Jan-2022, the patient experienced EXPIRED PRODUCT ADMINISTERED (temp excursion/beyond use date excursion). On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Here is the patient info for the temp excursion/beyond use date excursion). On 20-Jan-2022, EXPIRED PRODUCT ADMINISTERED (temp excursion/beyond use date excursion) had resolved. At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Here is the patient info for the temp excursion/beyond use date excursion) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications was reported. Treatment medications was not provided.