chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Erythema, Pain in extremity, Pruritus
Clinical narrative: Soreness in her arm; Itchiness going down to her elbow; Redness going down to her elbow; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness in her arm), PRURITUS (Itchiness going down to her elbow) and ERYTHEMA (Redness going down to her elbow) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045c21a, 026l20a and 038l20a) for COVID-19 vaccination.     No Medical History information was reported.   On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Sep-2021, the patient experienced PAIN IN EXTREMITY (Soreness in her arm), PRURITUS (Itchiness going down to her elbow) and ERYTHEMA (Redness going down to her elbow). At the time of the report, PAIN IN EXTREMITY (Soreness in her arm), PRURITUS (Itchiness going down to her elbow) and ERYTHEMA (Redness going down to her elbow) had not resolved.            No concomitant medication reported. No treatment medication reported.  Patient stated she didn't experience any similar reaction with the 1st and 2nd dose.
Age: 86.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered, Off label use
Clinical narrative: received his 3rd dose despite not being immunocompromised; Received an expired dose; This spontaneous case was reported by a consumer and describes the occurrence of OFF LABEL USE (received his 3rd dose despite not being immunocompromised) and EXPIRED PRODUCT ADMINISTERED (Received an expired dose) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 028A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Sep-2021, the patient experienced OFF LABEL USE (received his 3rd dose despite not being immunocompromised) and EXPIRED PRODUCT ADMINISTERED (Received an expired dose). On 07-Sep-2021, OFF LABEL USE (received his 3rd dose despite not being immunocompromised) and EXPIRED PRODUCT ADMINISTERED (Received an expired 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 provided by the reporter.  Patient received 3rd dose despite not being immunocompromised. Patient entered the lot number of third dose into the Moderna online Expiration Date Lookup tool and it showed that that lot expired on 28Apr2021. Patient received the first 2 doses from doctor, and the lot of 1st dose is missing from the card.
Sex: F
Vaccine: COVID19
Symptoms: Menstruation irregular
Clinical narrative: Menstrual period delayed by approximately 2 weeks; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUATION IRREGULAR (Menstrual period delayed by approximately 2 weeks) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049E21A and 004F21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 milliliter. On 22-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to .5 milliliter. In September 2021, the patient experienced MENSTRUATION IRREGULAR (Menstrual period delayed by approximately 2 weeks). At the time of the report, MENSTRUATION IRREGULAR (Menstrual period delayed by approximately 2 weeks) outcome was unknown.            Concomitant medication was not provided.  The patient was expecting menstrual period on 23-Aug-2021 but it came 1st week of September approximately 2 weeks delayed).  Treatment information was not provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Vaccination site reaction
Clinical narrative: Had injection site reaction such as sore arm; Had injection site reaction such as sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (Had injection site reaction such as sore arm) and PAIN IN EXTREMITY (Had injection site reaction such as sore arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination.     No Medical History information was reported.  On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (Had injection site reaction such as sore arm) and PAIN IN EXTREMITY (Had injection site reaction such as sore arm). At the time of the report, VACCINATION SITE REACTION (Had injection site reaction such as sore arm) and PAIN IN EXTREMITY (Had injection site reaction such as sore arm) had resolved.      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 medications were reported.  No treatment information was provided.   This case was linked to MOD-2021-333515 (Patient Link).
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: Ageusia, Anosmia, Dysgeusia, Magnetic resonance imaging, Parosmia
Clinical narrative: parosmia; Metallic taste in her mouth; loss of sense of taste; loss of sense of smell; This spontaneous case was reported by a consumer and describes the occurrence of DYSGEUSIA (Metallic taste in her mouth), AGEUSIA (loss of sense of taste), ANOSMIA (loss of sense of smell) and PAROSMIA (parosmia) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     Concomitant products included GABAPENTIN, DULOXETINE, FUROSEMIDE, OMEPRAZOLE, IBUPROFEN and Elitriptan for an unknown indication.    On 04-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced DYSGEUSIA (Metallic taste in her mouth), AGEUSIA (loss of sense of taste) and ANOSMIA (loss of sense of smell). On 04-Feb-2021, the patient experienced PAROSMIA (parosmia). On 09-Jan-2021, DYSGEUSIA (Metallic taste in her mouth) had resolved. On 04-Feb-2021, AGEUSIA (loss of sense of taste) and ANOSMIA (loss of sense of smell) had resolved. On 27-Sep-2021, PAROSMIA (parosmia) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Magnetic resonance imaging: normal (normal) MRI of brain.  Everything returned normal.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-333434 (Patient Link).; Sender's Comments: This case concerns a 51-year-old, female patient with unknown medical history, who experienced the unexpected non-serious events of dysgeusia, ageusia, anosmia and parosmia. The events ageusia, anosmia occurred after receiving the first dose whereas parosmia occurred after second of Moderna mRNA-1273 vaccine. The rechallenge is applicable for the parosmia events, as the events appeared after second dose. The reporter did not provide the causality assessment. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Tinnitus, Vaccination site pain
Clinical narrative: Felt tired; Patient felt ringing in her ears; Left arm injection site arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Patient felt ringing in her ears), VACCINATION SITE PAIN (Left arm injection site arm hurt) and FATIGUE (Felt tired) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced TINNITUS (Patient felt ringing in her ears) and VACCINATION SITE PAIN (Left arm injection site arm hurt). On an unknown date, the patient experienced FATIGUE (Felt tired). At the time of the report, TINNITUS (Patient felt ringing in her ears), VACCINATION SITE PAIN (Left arm injection site arm hurt) and FATIGUE (Felt tired) 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 treatment information were provided.   This case was linked to MOD-2021-333554 (Patient Link).
Age: 70.0
Sex: M
Vaccine: COVID19
Symptoms: Magnetic resonance imaging head, Magnetic resonance imaging spinal, Miller Fisher syndrome, Tongue paralysis, Ultrasound scan
Clinical narrative: Miller Fisher syndrome(Gullian Barre variant); Tongue deviation; This spontaneous case was reported by a physician and describes the occurrence of MILLER FISHER SYNDROME (Miller Fisher syndrome(Gullian Barre variant)) and TONGUE PARALYSIS (Tongue deviation) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041L20A and 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Cipro allergy), Allergy to antibiotic (Cefapime allergy), Hypertension, Hypercholesterolemia and Acid reflux (esophageal). Concomitant products included FAMOTIDINE for Acid reflux (esophageal), UBIDECARENONE (COQ) and ATORVASTATIN for Cholesterol, LISINOPRIL for Hypertension.   On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MILLER FISHER SYNDROME (Miller Fisher syndrome(Gullian Barre variant)) (seriousness criterion medically significant) and TONGUE PARALYSIS (Tongue deviation) (seriousness criterion medically significant). At the time of the report, MILLER FISHER SYNDROME (Miller Fisher syndrome(Gullian Barre variant)) and TONGUE PARALYSIS (Tongue deviation) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Magnetic resonance imaging head: negative (Negative) Negative. In 2021, Magnetic resonance imaging spinal: negative (Negative) negative. In 2021, Ultrasound scan: negative (Negative) negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MILLER FISHER SYNDROME (Miller Fisher syndrome(Gullian Barre variant)) and TONGUE PARALYSIS (Tongue deviation) to be probably related.    No treatment information was provided.  The symptoms remain appear after 2nd dose of vaccine, slightly milder but not resolved.  This case concerns a 70 year old male patient, with no relevant medical history, who experienced the serious unexpected AESI of MILLER-FISHERMAN SYNDROME. The event occurred on an unknown date after the second dose of Spikevax. Rechallenge is not applicable since no additional dose will be given. The benefit-risk relation of Spikevax is not affected by this report.   This case was linked to MOD-2021-071178 (Patient Link).; Sender's Comments: This case concerns a 70 year old male patient, with no relevant medical history, who experienced the serious unexpected AESI of MILLER-FISHERMAN SYNDROME. The event occurred on an unknown date after the second dose of Spikevax. Rechallenge is not applicable since no additional dose will be given. The benefit-risk relation of Spikevax is not affected by this report.
Age: 92.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: This spontaneous case reported by an other healthcare professional, describes the occurrence of administered expired product (vaccine administered after 6 days of puncturing the vial) in a 92-year-old patient, of an unknown gender, who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 006C21A) for COVID-19 immunization. No medical history reported. On Sep 2, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Sep 2, 2021, patient administered expired product (vaccine administered after 6 days of puncturing the vial). On Sep 2, 2021, administered expired product (vaccine administered after 6 days of puncturing the vial) resolved. The reporter did not provide any causality assessments, concomitant medications or treatment information. This case linked to MOD-2021-337437 (patient link). Most recent follow-up information incorporated. On Sep 28, 2021: Follow-up received contained updated event verbatim.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Inappropriate schedule of product administration, Pain
Clinical narrative: achy; Inappropriate schedule of vaccine administered (<25 days); tired; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (achy), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered (<25 days)) and FATIGUE (tired) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041120A and 025L20A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Feb-2021, the patient experienced PAIN (achy), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered (<25 days)) and FATIGUE (tired). On 09-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered (<25 days)) had resolved. On 10-Feb-2021, PAIN (achy) and FATIGUE (tired) had resolved.            No treatment information was provided.   This case was linked to MOD-2021-333541 (Patient Link).
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Gait inability, Inappropriate schedule of product administration, Pain, Peripheral swelling
Clinical narrative: lower limb swelling; I can't walk; pain; 1st dose on 18Mar2021and the 2nd dose on 29Apr2021; This spontaneous case was reported by a patient and describes the occurrence of PERIPHERAL SWELLING (lower limb swelling), GAIT INABILITY (I can't walk), PAIN (pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 18Mar2021and the 2nd dose on 29Apr2021) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A and 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (lower limb swelling), GAIT INABILITY (I can't walk), PAIN (pain) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 18Mar2021and the 2nd dose on 29Apr2021). At the time of the report, PERIPHERAL SWELLING (lower limb swelling), GAIT INABILITY (I can't walk) and PAIN (pain) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose on 18Mar2021and the 2nd dose on 29Apr2021) had resolved.            No concomitant medications were reported.  No treatment medications were reported.
Age: 64.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after 9 days of puncturing the vial; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after 9 days of puncturing the vial) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after 9 days of puncturing the vial). On 03-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after 9 days of puncturing the vial) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was reported by reporter. No treatment medication was reported by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow up received contains updated event verbatim
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Chills
Clinical narrative: Chills; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E21A, 010M20A and 012L20A) for COVID-19 vaccination.     Concurrent medical conditions included Lung disorder NOS.   On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Aug-2021, the patient experienced CHILLS (Chills). At the time of the report, CHILLS (Chills) outcome was unknown.            Patient uses medication for cholesterol, heart condition, diabetes and high blood pressure.   No treatment information was provided.   This case was linked to MOD-2021-333507 (Patient Link).
Age: 24.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered after 7 days of puncturing the vial; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered after 7 days of puncturing the vial) in a 25-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered after 7 days of puncturing the vial). On 03-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered after 7 days of puncturing the vial) had resolved. Not Provided      For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication information provided bythe reporter. No treatment information provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow up received contains updated event verbatim.
Age: 74.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Vaccine administered 10 days after puncturing the vial; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered 10 days after puncturing the vial) in a 74-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered 10 days after puncturing the vial). On 09-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered 10 days after puncturing the vial) 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 provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 28-Sep-2021: Follow up received and included no new information.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in jaw
Clinical narrative: jaw pain on the right side; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN JAW (jaw pain on the right side) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.     On 16-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Sep-2021, the patient experienced PAIN IN JAW (jaw pain on the right side). The patient was treated with PARACETAMOL (TYLENOL) for Jaw pain, at a dose of 1 dosage form and IBUPROFEN (MOTRIN [IBUPROFEN]) for Jaw pain, at a dose of 1 dosage form. At the time of the report, PAIN IN JAW (jaw pain on the right side) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was reported as none
Age: 43.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and LOT 031B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired dose) outcome 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 medications were provided.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Urticaria
Clinical narrative: Developed hives all over the body; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Developed hives all over the body) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No medical history was provided by the reporter.  The patient's past medical history included Skin reaction. Concurrent medical conditions included Parkinson's disease, Sulfonamide allergy (Had skin reaction to sulfa) and Penicillin allergy (Had skin reaction to penicillin). Concomitant products included LEVOTHYROXINE, VITAMINS NOS, LEVODOPA, CARBIDOPA and PRAMIPEXOLE for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced URTICARIA (Developed hives all over the body). In March 2021, URTICARIA (Developed hives all over the body) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Other concomitant medication included Aceclopar and tremor medication.  The patient was not sure but think that the vaccine administered on the left arm. Then, 4 days after the second dose the patient developed hives all over the body. This lasted for a week and the patient mentions taking antihistamines for it.  Patient stated having same kind of skin reaction with other medicines like sulfa, penicillin and Thoudsand X.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: expired dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (expired dose) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031B21A, 48A21A and 048A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (expired dose). On 24-Sep-2021, EXPIRED PRODUCT ADMINISTERED (expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were not reported. No treatment medications were not provided.
Sex: M
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0321B21A) for COVID-19 vaccination.     No Medical History information was reported.   On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose). On 24-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Expired dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The report  was reported by  clinical supervisor . Concomitant medicine were not provided.  Treatment medicine were not provided.  It was reported Patient received vaccines post manufacture expiration dates .
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersensitivity, Product dose omission issue, Swollen tongue, Tongue pruritus
Clinical narrative: she had a severe allergic reaction; Over 35 days and 2nd shot not administered; Tongue swelling; Tongue itching; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (Tongue swelling), TONGUE PRURITUS (Tongue itching), HYPERSENSITIVITY (she had a severe allergic reaction) and PRODUCT DOSE OMISSION ISSUE (Over 35 days and 2nd shot not administered) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced SWOLLEN TONGUE (Tongue swelling), TONGUE PRURITUS (Tongue itching) and PRODUCT DOSE OMISSION ISSUE (Over 35 days and 2nd shot not administered). On 04-Sep-2021, the patient experienced HYPERSENSITIVITY (she had a severe allergic reaction). At the time of the report, SWOLLEN TONGUE (Tongue swelling), TONGUE PRURITUS (Tongue itching) and HYPERSENSITIVITY (she had a severe allergic reaction) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Over 35 days and 2nd shot not administered) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant and no treatment information were provided by reporter .   Most recent FOLLOW-UP information incorporated above includes: On 27-Sep-2021: Follow-up was received on 27-SEP-2021 and contain no new information .
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Nausea, Tongue discolouration, Vaccination site pain
Clinical narrative: white spots on my tongue; sore left injection site arm; light nausea; Headache; This spontaneous case was reported by a consumer and describes the occurrence of TONGUE DISCOLOURATION (white spots on my tongue), VACCINATION SITE PAIN (sore left injection site arm), NAUSEA (light nausea) and HEADACHE (Headache) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062E21A and 046C219) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Sep-2021, the patient experienced VACCINATION SITE PAIN (sore left injection site arm), NAUSEA (light nausea) and HEADACHE (Headache). On 26-Sep-2021, the patient experienced TONGUE DISCOLOURATION (white spots on my tongue). At the time of the report, TONGUE DISCOLOURATION (white spots on my tongue), VACCINATION SITE PAIN (sore left injection site arm), NAUSEA (light nausea) and HEADACHE (Headache) outcome was unknown.            Concomitant medications were not reported. treatment medications were not reported.
Age: 66.0
Sex: M
Vaccine: COVID19
Symptoms: Headache, Pain of skin
Clinical narrative: sore skin on his back; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN OF SKIN (sore skin on his back) and HEADACHE (headache) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in December 2020.   On 31-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN OF SKIN (sore skin on his back) and HEADACHE (headache). At the time of the report, PAIN OF SKIN (sore skin on his back) and HEADACHE (headache) 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 drug details were reported. No treatment details were reported.   This case was linked to MOD-2021-333654 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Cough, Feeling hot, Flushing, Headache
Clinical narrative: sickness; Cough; Feeling hot; Flushing; fever; chills; headache; body aches; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (sickness), COUGH (Cough), FEELING HOT (Feeling hot), FLUSHING (Flushing) and PYREXIA (fever) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Fibromyalgia in 1989. Concurrent medical conditions included Drug allergy (Seizures) since 1981 and Drug allergy (Rash,itching) since 2015. Concomitant products included Multi Vitamin Nos. (MULTI VITAMIN & MINERAL), ASCORBIC ACID (VITAMIN C ACID) and COLECALCIFEROL (D3).    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced ILLNESS (sickness), COUGH (Cough), FEELING HOT (Feeling hot), FLUSHING (Flushing), PYREXIA (fever), CHILLS (chills), HEADACHE (headache) and MYALGIA (body aches). At the time of the report, ILLNESS (sickness), COUGH (Cough), FEELING HOT (Feeling hot), FLUSHING (Flushing), PYREXIA (fever), CHILLS (chills), HEADACHE (headache) and MYALGIA (body aches) had resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient took concomitant medications-COLO, Bilberry & Lutein once daily. No treatment medications were reported.   This case was linked to MOD-2021-170412.   Most recent FOLLOW-UP information incorporated above includes: On 27-Sep-2021: Follow up received contains no new information. On 27-Sep-2021: Follow up received contains no new information.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Illness, Myalgia, Pyrexia
Clinical narrative: sickness; Cough; Feeling hot; Flushing; fever; chills; headache; body aches; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (sickness), COUGH (Cough), FEELING HOT (Feeling hot), FLUSHING (Flushing) and PYREXIA (fever) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Fibromyalgia in 1989. Concurrent medical conditions included Drug allergy (Seizures) since 1981 and Drug allergy (Rash,itching) since 2015. Concomitant products included Multi Vitamin Nos. (MULTI VITAMIN & MINERAL), ASCORBIC ACID (VITAMIN C ACID) and COLECALCIFEROL (D3).    On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced ILLNESS (sickness), COUGH (Cough), FEELING HOT (Feeling hot), FLUSHING (Flushing), PYREXIA (fever), CHILLS (chills), HEADACHE (headache) and MYALGIA (body aches). At the time of the report, ILLNESS (sickness), COUGH (Cough), FEELING HOT (Feeling hot), FLUSHING (Flushing), PYREXIA (fever), CHILLS (chills), HEADACHE (headache) and MYALGIA (body aches) had resolved. Not Provided      mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Patient took concomitant medications-COLO, Bilberry & Lutein once daily. No treatment medications were reported.   This case was linked to MOD-2021-170412.   Most recent FOLLOW-UP information incorporated above includes: On 27-Sep-2021: Follow up received contains no new information. On 27-Sep-2021: Follow up received contains no new information.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Heart rate, Nausea, SARS-CoV-2 test, Tachycardia, Vomiting
Clinical narrative: Tachycardia (Increased heart rate); Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Tachycardia (Increased heart rate)), NAUSEA (Nausea) and VOMITING (Vomiting) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Sep-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion hospitalization) and VOMITING (Vomiting) (seriousness criterion hospitalization). On 25-Sep-2021, the patient experienced TACHYCARDIA (Tachycardia (Increased heart rate)) (seriousness criterion hospitalization). The patient was hospitalized from 25-Sep-2021 to 26-Sep-2021 due to NAUSEA, TACHYCARDIA and VOMITING. The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. On 26-Sep-2021, TACHYCARDIA (Tachycardia (Increased heart rate)), NAUSEA (Nausea) and VOMITING (Vomiting) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: increased (High) increased. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. On an unknown date, White blood cell count: 21000 (High) 21000.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient does not have a heart issue and she has never had high blood pressure.She states that her blood pressure was not affected during this reaction Treatment details includes: IV antibiotics. Concomitant medication was not reported by the reporter.  Company comment: This case concerns a 35-year-old, female patient with no relevant medical history, who experienced the unexpected events of Nausea, Vomiting, and Tachycardia. The events of Nausea and Vomiting occurred approximately 22 days after the first dose of mRNA-1273 (Moderna Covid-19 vaccine)  and the event of Tachycardia occurred 24 days after the first dose of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This case concerns a 35-year-old, female patient with no relevant medical history, who experienced the unexpected events of Nausea, Vomiting, and Tachycardia. The events of Nausea and Vomiting occurred approximately 22 days after the first dose of mRNA-1273 (Moderna Covid-19 vaccine)  and the event of Tachycardia occurred 24 days after the first dose of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: White blood cell count
Clinical narrative: Tachycardia (Increased heart rate); Nausea; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Tachycardia (Increased heart rate)), NAUSEA (Nausea) and VOMITING (Vomiting) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Sep-2021, the patient experienced NAUSEA (Nausea) (seriousness criterion hospitalization) and VOMITING (Vomiting) (seriousness criterion hospitalization). On 25-Sep-2021, the patient experienced TACHYCARDIA (Tachycardia (Increased heart rate)) (seriousness criterion hospitalization). The patient was hospitalized from 25-Sep-2021 to 26-Sep-2021 due to NAUSEA, TACHYCARDIA and VOMITING. The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. On 26-Sep-2021, TACHYCARDIA (Tachycardia (Increased heart rate)), NAUSEA (Nausea) and VOMITING (Vomiting) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: increased (High) increased. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. On an unknown date, White blood cell count: 21000 (High) 21000.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The patient does not have a heart issue and she has never had high blood pressure.She states that her blood pressure was not affected during this reaction Treatment details includes: IV antibiotics. Concomitant medication was not reported by the reporter.  Company comment: This case concerns a 35-year-old, female patient with no relevant medical history, who experienced the unexpected events of Nausea, Vomiting, and Tachycardia. The events of Nausea and Vomiting occurred approximately 22 days after the first dose of mRNA-1273 (Moderna Covid-19 vaccine)  and the event of Tachycardia occurred 24 days after the first dose of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.   Reporter did not allow further contact; Sender's Comments: This case concerns a 35-year-old, female patient with no relevant medical history, who experienced the unexpected events of Nausea, Vomiting, and Tachycardia. The events of Nausea and Vomiting occurred approximately 22 days after the first dose of mRNA-1273 (Moderna Covid-19 vaccine)  and the event of Tachycardia occurred 24 days after the first dose of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was not applicable, as the event happened after the first dose. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Malaise, Musculoskeletal stiffness
Clinical narrative: didn't feel well; Headache/ wake up next morning with the headache; neck stiffness; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (neck stiffness), MALAISE (didn't feel well) and HEADACHE (Headache/ wake up next morning with the headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Mar-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (neck stiffness) and HEADACHE (Headache/ wake up next morning with the headache). On 04-Mar-2021, the patient experienced MALAISE (didn't feel well). On 06-Mar-2021, MUSCULOSKELETAL STIFFNESS (neck stiffness), MALAISE (didn't feel well) and HEADACHE (Headache/ wake up next morning with the headache) had resolved.            No concomitant medications were reported.  No treatment medications were reported.  Patient have medical history of lupus since 1979.   This case was linked to MOD-2021-333577, MOD-2021-333670 (Patient Link).
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Headache, Musculoskeletal stiffness, Pain in extremity
Clinical narrative: a slight stiff neck; little soreness in her left arm; headache; dizziness; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (a slight stiff neck), PAIN IN EXTREMITY (little soreness in her left arm), DIZZINESS (dizziness) and HEADACHE (headache) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 015M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced DIZZINESS (dizziness). On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (a slight stiff neck), PAIN IN EXTREMITY (little soreness in her left arm) and HEADACHE (headache). At the time of the report, MUSCULOSKELETAL STIFFNESS (a slight stiff neck), PAIN IN EXTREMITY (little soreness in her left arm), DIZZINESS (dizziness) and HEADACHE (headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported.   No treatment medications were provided.  Crosslinked to MOD21-147667 & MOD21-147668.   This case was linked to MOD-2021-333577, MOD-2021-333655 (Patient Link).
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia, Tremor
Clinical narrative: Shaky and feverish at midnight; Feverish at midnight; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (Shaky and feverish at midnight) and PYREXIA (Feverish at midnight) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Patient medical history was not provided.  Concomitant products included APIXABAN (ELIQUIS), LISINOPRIL, ROSUVASTATIN, PRIMIDONE, METOPROLOL and PROPAFENONE for an unknown indication.   In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced TREMOR (Shaky and feverish at midnight) and PYREXIA (Feverish at midnight). On 28-Feb-2021, TREMOR (Shaky and feverish at midnight) and PYREXIA (Feverish at midnight) had resolved.            No treatment medications were reported.  Patient received the doses in her left arm, non dominant arm.   This case was linked to MOD-2021-333682 (Patient Link).
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Pregnancy test
Clinical narrative: Vaccine expired yesterday/Second dose given today; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine expired yesterday/Second dose given today) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 046A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 19-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Sep-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine expired yesterday/Second dose given today). On 27-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine expired yesterday/Second dose given today) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-May-2021, Pregnancy test: negative Negative.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant information was reported.  No treatment information was reported.