chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 28.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received vaccine on 29Oct2021 with an expiration date of 11Oct2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received vaccine on 29Oct2021 with an expiration date of 11Oct2021) in a 28-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for COVID-19 vaccination: Pfizer COViD-19 (Second dose, LOT:EL3249) on 27-Jan-2021 and Pfizer COViD-19 (First dose).    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .25 milliliter. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received vaccine on 29Oct2021 with an expiration date of 11Oct2021). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received vaccine on 29Oct2021 with an expiration date of 11Oct2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No Concomitant medications were provided by the reporter. No Treatment information was reported.
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Received vaccine on 29-Oct-2021 with an expiration date of 11-Oct-2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received vaccine on 29-Oct-2021 with an expiration date of 11-Oct-2021) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received vaccine on 29-Oct-2021 with an expiration date of 11-Oct-2021). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received vaccine on 29-Oct-2021 with an expiration date of 11-Oct-2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant product use was provided by the reporter. No treatment medication was provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Injected arm shoulder to elbow feverish; Injected arm shoulder to elbow swelling; Injected arm shoulder to elbow Redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Injected arm shoulder to elbow feverish), VACCINATION SITE SWELLING (Injected arm shoulder to elbow swelling) and VACCINATION SITE ERYTHEMA (Injected arm shoulder to elbow Redness) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Oct-2021, the patient experienced VACCINATION SITE WARMTH (Injected arm shoulder to elbow feverish), VACCINATION SITE SWELLING (Injected arm shoulder to elbow swelling) and VACCINATION SITE ERYTHEMA (Injected arm shoulder to elbow Redness). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at a dose of 2 tablets. At the time of the report, VACCINATION SITE WARMTH (Injected arm shoulder to elbow feverish), VACCINATION SITE SWELLING (Injected arm shoulder to elbow swelling) and VACCINATION SITE ERYTHEMA (Injected arm shoulder to elbow Redness) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment information included ice pack on the vaccination site.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received vaccine on 29Oct2021 with an expiration date of 11Oct2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received vaccine on 29Oct2021 with an expiration date of 11Oct2021) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED. On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided. No treatment information was provided by the reporter.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Axillary pain, Feeling abnormal, Headache, Lymphadenopathy, Nausea
Clinical narrative: coming down with something/roller coaster/goes back down and feels worse; felt like someone stuck a fork under my armpit; nauseated/still feels nauseated; lymph nodes are swollen/swollen; Sharp pain in the back of her skull from her neck to the top of her skull; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (coming down with something/roller coaster/goes back down and feels worse), PAIN (slight soreness,pain/sharp pain in the back of her skull from her neck to the top of her skull), AXILLARY PAIN (felt like someone stuck a fork under my armpit), LYMPHADENOPATHY (lymph nodes are swollen/swollen) and HEADACHE (headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026D21A, 011L20A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 09-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Oct-2021, the patient experienced LYMPHADENOPATHY (lymph nodes are swollen/swollen) and HEADACHE (headache). On an unknown date, the patient experienced FEELING ABNORMAL (coming down with something/roller coaster/goes back down and feels worse), PAIN (slight soreness,pain/sharp pain in the back of her skull from her neck to the top of her skull), AXILLARY PAIN (felt like someone stuck a fork under my armpit) and NAUSEA (nauseated/still feels nauseated). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Pain, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (coming down with something/roller coaster/goes back down and feels worse), AXILLARY PAIN (felt like someone stuck a fork under my armpit), LYMPHADENOPATHY (lymph nodes are swollen/swollen) and HEADACHE (headache) outcome was unknown, PAIN (slight soreness,pain/sharp pain in the back of her skull from her neck to the top of her skull) had resolved and NAUSEA (nauseated/still feels nauseated) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available) on an unknown date, Ultrasound scan: normal, Patient got a breast sonogram done and the doctor said everything looks fine.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.   This case was linked to MOD-2021-330712 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Employee gave her daughter in law covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Employee gave her daughter in law covid) 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 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 an unknown date, the patient experienced COVID-19 (Employee gave her daughter in law covid). At the time of the report, COVID-19 (Employee gave her daughter in law covid) outcome was unknown.            Reporter states that the patient was vaccinated and had both vaccinations but does not know which vaccines he had. The caller also verified that the patient was asymptomatic.  No concomitant medications were reported  No treatment information was provided  Company Comment-This case concerns a male patient of unknown age, with no medical history reported, who experienced the unexpected non-serious adverse event of special interest of COVID-19. The event occurred after the first dose of COVID-19 vaccine, suspected to be Moderna vaccine but brand was not specified by the reporter. Exact vaccination and event dates were not provided. The rechallenge was not applicable since the events occurred after the second dose. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report. More information is requested for confirmation of vaccine brand, vaccination and event date.; Sender's Comments: This case concerns a male patient of unknown age, with no medical history reported, who experienced the unexpected non-serious adverse event of special interest of COVID-19. The event occurred after the first dose of COVID-19 vaccine, suspected to be Moderna vaccine but brand was not specified by the reporter. Exact vaccination and event dates were not provided. The rechallenge was not applicable since the events occurred after the second dose. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report. More information is requested for confirmation of vaccine brand, vaccination and event date.
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site pain
Clinical narrative: sore injection site to first vaccine; low grade fever to first vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN and PYREXIA 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 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE PAIN and PYREXIA. At the time of the report, VACCINATION SITE PAIN and PYREXIA outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medication was reported by the reporter. No treatment was reported by the reporter.   This case was linked to MOD-2021-370295 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Sore arm; Tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY and FATIGUE in a 78-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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY and FATIGUE. At the time of the report, PAIN IN EXTREMITY and FATIGUE outcome was unknown.            No Concomitant medications were provided by the reporter. No Treatment information was reported.   This case was linked to MOD-2021-370396, MOD-2021-370380, MOD-2021-369443 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Vaccination site erythema, Vaccination site pruritus
Clinical narrative: Itching at the injection site; Redness at injection site/redness extends 3 inches; Had a low grade fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itching at the injection site), VACCINATION SITE ERYTHEMA (Redness at injection site/redness extends 3 inches) and PYREXIA (Had a low grade fever) 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 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Oct-2021, the patient experienced VACCINATION SITE PRURITUS (Itching at the injection site), VACCINATION SITE ERYTHEMA (Redness at injection site/redness extends 3 inches) and PYREXIA (Had a low grade fever). At the time of the report, VACCINATION SITE PRURITUS (Itching at the injection site), VACCINATION SITE ERYTHEMA (Redness at injection site/redness extends 3 inches) and PYREXIA (Had a low grade fever) outcome was unknown.            No concomitant product use was provided by the reporter. No treatment medication was provided.   This case was linked to MOD-2021-370270 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Nasopharyngitis, Product dose omission issue
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS and PRODUCT DOSE OMISSION ISSUE 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Nov-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE. On an unknown date, the patient experienced NASOPHARYNGITIS. On 01-Nov-2021, PRODUCT DOSE OMISSION ISSUE had resolved. At the time of the report, NASOPHARYNGITIS outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.       Concomitant information was not provided. Treatment information was not provided.
Age: 84.0
Sex: F
Vaccine: COVID19
Symptoms: Decreased appetite, Headache, Nausea
Clinical narrative: She didn't feel like eating anything; She said she had a bad headache; She said she had a bad headache and nausea; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (She didn't feel like eating anything), HEADACHE (She said she had a bad headache) and NAUSEA (She said she had a bad headache and nausea) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DECREASED APPETITE (She didn't feel like eating anything), HEADACHE (She said she had a bad headache) and NAUSEA (She said she had a bad headache and nausea). At the time of the report, DECREASED APPETITE (She didn't feel like eating anything), HEADACHE (She said she had a bad headache) and NAUSEA (She said she had a bad headache and nausea) outcome was unknown.            No Concomitant and Treatment medication were reported.    This case was linked to MOD-2021-369303 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Accidental overdose
Clinical narrative: Full dose instead of half of a dose; This spontaneous case was reported by a consumer and describes the occurrence of ACCIDENTAL OVERDOSE 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 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 ACCIDENTAL OVERDOSE. At the time of the report, ACCIDENTAL OVERDOSE had resolved.      No relevant concomitant medications was reported. Treatment information was not provided.  The reporter also stated that they saw on TV a little boy got a full dose instead of half of a dose for the Moderna booster shot.
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: 11 patients received dose from expired vial/ Should a patient be revaccinated if they received lot 033C21A on 10/28/21  note the vial expiration date printed is 10/27/21; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (11 patients received dose from expired vial/ Should a patient be revaccinated if they received lot 033C21A on 10/28/21  note the vial expiration date printed is 10/27/21) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (11 patients received dose from expired vial/ Should a patient be revaccinated if they received lot 033C21A on 10/28/21  note the vial expiration date printed is 10/27/21). On 28-Oct-2021, EXPIRED PRODUCT ADMINISTERED (11 patients received dose from expired vial/ Should a patient be revaccinated if they received lot 033C21A on 10/28/21  note the vial expiration date printed is 10/27/21) 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.   Most recent FOLLOW-UP information incorporated above includes: On 01-Nov-2021: Non-Significant Follow up received.Email attached.
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Pain in extremity
Clinical narrative: pain in my upper back/left upper back; Left arm, left hand pain; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (pain in my upper back/left upper back) and PAIN IN EXTREMITY (Left arm, left hand pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021 at 2:00 PM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BACK PAIN (pain in my upper back/left upper back) and PAIN IN EXTREMITY (Left arm, left hand pain). At the time of the report, BACK PAIN (pain in my upper back/left upper back) and PAIN IN EXTREMITY (Left arm, left hand pain) had not resolved.            Concomitant medication of the patient was not reported.   The patient received the booster shot at 2 pm on Friday but still getting pain in upper back ,left arm, left hand pain, left upper back.. When the patient was sitting or driving the pain become a little unbearable.  No treatment information was provided by the reporter.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received vaccine on 29Oct2021 with an expiration date of 11Oct2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received vaccine on 29Oct2021 with an expiration date of 11Oct2021) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 043L20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 ml. On 29-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (received vaccine on 29Oct2021 with an expiration date of 11Oct2021). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received vaccine on 29Oct2021 with an expiration date of 11Oct2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.   This case was linked to MOD-2021-370033 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Product storage error
Clinical narrative: dose administered from a vial that was in refrigeration and then was refrozen; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT STORAGE ERROR (dose administered from a vial that was in refrigeration and then was refrozen) 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 PRODUCT STORAGE ERROR (dose administered from a vial that was in refrigeration and then was refrozen). At the time of the report, PRODUCT STORAGE ERROR (dose administered from a vial that was in refrigeration and then was refrozen) had resolved.            No concomitant and treatment medications are provided by the reporter.
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received vaccine on 29Oct2021 with an expiration date of 11Oct2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received vaccine on 29Oct2021 with an expiration date of 11Oct2021) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .25 milliliter. On 29-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received vaccine on 29Oct2021 with an expiration date of 11Oct2021). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received vaccine on 29Oct2021 with an expiration date of 11Oct2021) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received vaccine on 29Oct2021 with an expiration date of 11Oct2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 037K20A) for COVID-19 vaccination.   No Medical History information was reported. On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (received vaccine on 29Oct2021 with an expiration date of 11Oct2021). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received vaccine on 29Oct2021 with an expiration date of 11Oct2021) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant product was provided by the reporter. No treatment medication was provided.
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dyspepsia, Dyspnoea, Myalgia
Clinical narrative: heartburn; shortness of breath,Labored breathing; a lot of muscle pain; weakness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness), DYSPEPSIA (heartburn), DYSPNOEA (shortness of breath,Labored breathing) and MYALGIA (a lot of muscle pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Previously administered products included for Product used for unknown indication: influenza vaccine on 27-Oct-2021. Past adverse reactions to the above products included No adverse event with influenza vaccine.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Oct-2021, the patient experienced ASTHENIA (weakness) and MYALGIA (a lot of muscle pain). On 01-Nov-2021, the patient experienced DYSPEPSIA (heartburn) and DYSPNOEA (shortness of breath,Labored breathing). The patient was treated with PARACETAMOL (TYLENOL [PARACETAMOL]) on 01-Nov-2021 for Heartburn, at an unspecified dose and frequency. At the time of the report, ASTHENIA (weakness), DYSPEPSIA (heartburn), DYSPNOEA (shortness of breath,Labored breathing) and MYALGIA (a lot of muscle pain) was resolving.            No concomitant medication was provided.  Patient experienced shortness of breath, requiring labored breathing. Patient didn't visit the doctor as the shortness of breath has improved.
Age: 81.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Pain in extremity, Pruritus
Clinical narrative: A lot of itching; Little bit of headache; Arm was hurting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was hurting), PRURITUS (A lot of itching) and HEADACHE (Little bit of headache) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038C21A) for COVID-19 vaccination.     The patient's past medical history included Shingles (shingles 2 weeks before booster vaccine) in October 2021. Concurrent medical conditions included Asthma (mild case of asthma), Cognitive disorder (some cognitive issue that is because of fibromyalgia) and Fibromyalgia. Concomitant products included DULOXETINE HYDROCHLORIDE (CYMBALTA), ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]), MAGNESIUM, VITAMIN B NOS and CODEINE PHOSPHATE, GUAIFENESIN, PHENIRAMINE MALEATE (ROBITUSSIN WITH CODEINE) for an unknown indication.    On 25-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm was hurting), PRURITUS (A lot of itching) and HEADACHE (Little bit of headache). The patient was treated with HYDROCORTISONE (topical) for Itching, at an unspecified dose and frequency and CAFFEINE, CODEINE PHOSPHATE, PARACETAMOL (TYLENOL NO.2) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Arm was hurting), PRURITUS (A lot of itching) and HEADACHE (Little bit of headache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 98.8 (High) temperature of 98.8. and 99.6 (High) temperature of 99.6.         Treatment included cold Compression.     Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Incorrect route of product administration, Product administration error, Taste disorder, Vaccination complication
Clinical narrative: severe side effects; funny taste on their mouth; vaccine was being administered directly in vessels; not being correctly administered; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of VACCINATION COMPLICATION, TASTE DISORDER, INCORRECT ROUTE OF PRODUCT ADMINISTRATION, and PRODUCT ADMINISTRATION ERROR 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 VACCINATION COMPLICATION, TASTE DISORDER, INCORRECT ROUTE OF PRODUCT ADMINISTRATION and PRODUCT ADMINISTRATION ERROR. At the time of the report, VACCINATION COMPLICATION and TASTE DISORDER outcome was unknown and INCORRECT ROUTE OF PRODUCT ADMINISTRATION and PRODUCT ADMINISTRATION ERROR had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Concomitant medication were not reported. Treatment medication were not reported.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus, Vaccination site reaction
Clinical narrative: Covid arm; a big red oval around the injection site; itchy; extra sore compared to the 1st 2 shots and tenderness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Covid arm), VACCINATION SITE ERYTHEMA (a big red oval around the injection site), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE PAIN (extra sore compared to the 1st 2 shots and tenderness) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047C21A, 001021A and 031M20A) for COVID-19 vaccination.     Concomitant products included INFLUENZA VACCINE (FLU) for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced VACCINATION SITE REACTION (Covid arm), VACCINATION SITE ERYTHEMA (a big red oval around the injection site), VACCINATION SITE PRURITUS (itchy) and VACCINATION SITE PAIN (extra sore compared to the 1st 2 shots and tenderness). The patient was treated with CALAMINE for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE REACTION (Covid arm) and VACCINATION SITE PAIN (extra sore compared to the 1st 2 shots and tenderness) outcome was unknown and VACCINATION SITE ERYTHEMA (a big red oval around the injection site) and VACCINATION SITE PRURITUS (itchy) was resolving.            This case was linked to MOD-2021-370373, MOD-2021-370374 (Patient Link).
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: a big red oval around the injection site; itchy; Sore arm /tenderness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA, VACCINATION SITE PRURITUS, and VACCINATION SITE PAIN in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001021A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA, VACCINATION SITE PRURITUS, and VACCINATION SITE PAIN. At the time of the report, VACCINATION SITE ERYTHEMA, VACCINATION SITE PRURITUS, and VACCINATION SITE PAIN had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   This case concerns a 78-year-old female patient with no relevant medical history provided, who experienced the expected non-serious events of Vaccination site erythema, Vaccination site pruritus, and Vaccination site pain. The events occurred after the patient received the second dose of Moderna COVID-19, however the exact dates were not provided. Having in mind that the patient reported that these events also occurred after the patient received the booster dose, as well, the rechallenge is considered positive. The benefit-risk relationship of Moderna COVID-19 is not affected by this report.   This case was linked to MOD-2021-370338, MOD-2021-370374 (Patient Link). This case concerns a 78-year-old female patient with no relevant medical history provided, who experienced the expected non-serious events of Vaccination site erythema, Vaccination site pruritus, and Vaccination site pain. The events occurred after the patient received the second dose of Moderna COVID-19, however the exact dates were not provided. Having in mind that the patient reported that these events also occurred after the patient received the booster dose, as well, the rechallenge is considered positive. The benefit-risk relationship of Moderna COVID-19 is not affected by this report.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: a big red oval around the injection site; itchy; Sore arm/tenderness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA, VACCINATION SITE PRURITUS, and VACCINATION SITE PAIN in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination.     Concomitant products included INFLUENZA VACCINE for Flu.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA, VACCINATION SITE PRURITUS, and VACCINATION SITE PAIN. The patient was treated with CALAMINE for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA, VACCINATION SITE PRURITUS, and VACCINATION SITE PAIN outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown.       This case was linked to MOD-2021-370373, MOD-2021-370338 (Patient Link). This case concerns a 78-year-old female patient with no relevant medical history, who experienced the unexpected events of Vaccination Site Erythema, Vaccination Site Pruritus, and Vaccination Site Pain. The event occurred on an unknown date after receiving the booster dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was unknown as outcome from other events from other doses were unknown. The events of Vaccination Site Erythema, Vaccination Site Pruritus, and Vaccination Site Pain is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.
Sex: F
Vaccine: COVID19
Symptoms: Memory impairment
Clinical narrative: forgetful; This spontaneous case was reported by a consumer and describes the occurrence of MEMORY IMPAIRMENT (forgetful) 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 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) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MEMORY IMPAIRMENT (forgetful). At the time of the report, MEMORY IMPAIRMENT (forgetful) outcome was unknown.            Concomitant medication information was not provided by the reporter.  Treatment information was not provided by the reporter.
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received vaccine after expiry date; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry date) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination.     No Medical History information was reported.   On 26-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry date). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine after expiry date) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medications were not provided.  Treatment information was not provided.
Age: 24.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: received vaccine on 29Oct2021 with an expiration date of 11Oct2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received vaccine on 29Oct2021 with an expiration date of 11Oct2021) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 037K20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Oct-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (received vaccine on 29Oct2021 with an expiration date of 11Oct2021). On 29-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received vaccine on 29Oct2021 with an expiration date of 11Oct2021) 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: 27.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Myalgia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 COVID-19 (1st dose) and MYALGIA in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049E21A and 039D21A) for COVID-19 vaccination.     Medical history was not reported.  Concomitant products included GABAPENTIN and MELATONIN for an unknown indication.   On 29-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Oct-2021, the patient experienced COVID-19 (1st dose). On an unknown date, the patient experienced MYALGIA. The patient was treated with TYLENOL for Adverse event, at an unspecified dose and frequency. At the time of the report, COVID-19 (1st dose) and MYALGIA outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       This case concerns a 27-year-old, female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19. The event occurred approximately 9 days after the first dose of Moderna COVID-19 vaccine. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.   This case was linked to MOD-2021-370418 (Patient Link). This case concerns a 27-year-old, female patient with no relevant medical history reported, who experienced the unexpected non-serious AESI event of COVID-19. The event occurred approximately 9 days after the first dose of Moderna COVID-19 vaccine. The benefit-risk relationship of Moderna COVID-19 vaccine is not affected by this report.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain, Vaccination complication, Vaccination site erythema, Vaccination site pain
Clinical narrative: Started with covid arm next day; Injection site warm; Pain going up back of neck; It is red about 4 inches long and 4 inches wide, It is extremely large., It is red, left arm extremely red (like an uneven sunburn); It is Itchy; Shoulder pain; By evening left arm was  verypainful; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION, VACCINATION SITE WARMTH, NECK PAIN, VACCINATION SITE ERYTHEMA, and VACCINATION SITE PAIN in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 011L20A, and 012MWA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy to Levoquin, Medrol PAK, and Sulfa. Concomitant products included VITAMIN D, VITAMIN B COMPLEX, and INFLUENZA VACCINE INACT SPLIT 3V (FLUZONE HIGH DOSE) for an unknown indication.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Oct-2021 at 11:15 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 ml. On 30-Oct-2021, the patient experienced VACCINATION SITE PAIN. On 31-Oct-2021, the patient experienced VACCINATION COMPLICATION, VACCINATION SITE WARMTH, NECK PAIN, and VACCINATION SITE ERYTHEMA. It is red, left arm extremely red. 31-Oct-2021, the patient experienced VACCINATION SITE PRURITUS and ARTHRALGIA. At the time of the report, VACCINATION COMPLICATION, VACCINATION SITE WARMTH, NECK PAIN, VACCINATION SITE PAIN, VACCINATION SITE PRURITUS, and ARTHRALGIA outcome was unknown, and VACCINATION SITE ERYTHEMA had not resolved.            No treatment information was provided. The patient was recommended to put cool compression. This case was linked to MOD-2021-008089, MOD-2021-373331 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes on 02-Nov-2021 allergy details, new concomitant medication, new event of itchy, By evening left arm was very painful, pain going up back of neck, and shoulder pain.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site warmth
Clinical narrative: Started with covid arm next day; Injection site warm; Pain going up back of neck; It is red about 4 inches long and 4 inches wide, It is extremely large., It is red, left arm extremely red (like an uneven sunburn); It is Itchy; Shoulder pain; By evening left arm was  verypainful; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION, VACCINATION SITE WARMTH, NECK PAIN, VACCINATION SITE ERYTHEMA, and VACCINATION SITE PAIN in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032F21A, 011L20A, and 012MWA) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy to Levoquin, Medrol PAK, and Sulfa. Concomitant products included VITAMIN D, VITAMIN B COMPLEX, and INFLUENZA VACCINE INACT SPLIT 3V (FLUZONE HIGH DOSE) for an unknown indication.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Oct-2021 at 11:15 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .25 ml. On 30-Oct-2021, the patient experienced VACCINATION SITE PAIN. On 31-Oct-2021, the patient experienced VACCINATION COMPLICATION, VACCINATION SITE WARMTH, NECK PAIN, and VACCINATION SITE ERYTHEMA. It is red, left arm extremely red. 31-Oct-2021, the patient experienced VACCINATION SITE PRURITUS and ARTHRALGIA. At the time of the report, VACCINATION COMPLICATION, VACCINATION SITE WARMTH, NECK PAIN, VACCINATION SITE PAIN, VACCINATION SITE PRURITUS, and ARTHRALGIA outcome was unknown, and VACCINATION SITE ERYTHEMA had not resolved.            No treatment information was provided. The patient was recommended to put cool compression. This case was linked to MOD-2021-008089, MOD-2021-373331 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes on 02-Nov-2021 allergy details, new concomitant medication, new event of itchy, By evening left arm was very painful, pain going up back of neck, and shoulder pain.