chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Sex: U
Vaccine: COVID19
Symptoms: Migraine, Pain in extremity, Pyrexia
Clinical narrative: MIGRAINE; MY ARM FELT LIKE IT HAD TAKEN A BULLET; FEVER DURING THE NIGHT; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced migraine, my arm felt like it had taken a bullet, and fever during the night. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the migraine, my arm felt like it had taken a bullet and fever during the night was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Diarrhoea, Dizziness, Fatigue, Hyperhidrosis, Hypoaesthesia
Clinical narrative: CONSTANT DIZZINESS FOR DAYS NO MATTER WHAT EAT; SHAKING DURING OR BEFORE EATING; BLURRY VISION; SWEATING WHILE EATING; DIARRHOEA; NUMBNESS IN HANDS AND FINGERS; FATIGUE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced constant dizziness for days no matter what eat, shaking during or before eating, blurry vision, sweating while eating, diarrhoea, numbness in hands and fingers, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the constant dizziness for days no matter what eat, diarrhoea, shaking during or before eating, blurry vision, numbness in hands and fingers, sweating while eating and fatigue was not reported. This report was non-serious.
Sex: U
Vaccine: COVID19
Symptoms: Tremor, Vision blurred
Clinical narrative: CONSTANT DIZZINESS FOR DAYS NO MATTER WHAT EAT; SHAKING DURING OR BEFORE EATING; BLURRY VISION; SWEATING WHILE EATING; DIARRHOEA; NUMBNESS IN HANDS AND FINGERS; FATIGUE; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced constant dizziness for days no matter what eat, shaking during or before eating, blurry vision, sweating while eating, diarrhoea, numbness in hands and fingers, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the constant dizziness for days no matter what eat, diarrhoea, shaking during or before eating, blurry vision, numbness in hands and fingers, sweating while eating and fatigue was not reported. This report was non-serious.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Back disorder, Back pain, Balance disorder, Gait disturbance, Muscle spasms
Clinical narrative: PAIN LOWER BACK PULSATING TO LEGS; MUSCLES FEEL WEAK CONTRIBUTED TO BACK ISSUES; SOMETHING LIKE SPASMS; LEGS AND THIGHS FEEL LIKE THEY PULSATE WHEN STOOD UP; DIFFICULT TO WALK/PAINFUL TO WALK; DIFFICULTY TO KEEP BALANCE; MUSCLE WEAKNESS CONTRIBUTING TO MORE NERVE CONDITIONS; PAIN IN TOES/PAIN IN ARMS AND LEGS; PAIN IN BICEP OF ARMS WHICH FEELS LIKE IT'S PULSATING AND BOUNCING AROUND; NERVE PAIN LEGS AND ARMS (NERVE PAIN GETTING WORSE AND SPREADING); This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: cholesterol, penicillin allergy, alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient had no drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. Concomitant medications included rosuvastatin for cholesterol. On 16-APR-2021, the patient experienced nerve pain legs and arms (nerve pain getting worse and spreading). On an unspecified date, the patient experienced pain lower back pulsating to legs, muscles feel weak contributed to back issues, something like spasms, legs and thighs feel like they pulsate when stood up, difficult to walk/painful to walk, difficulty to keep balance, muscle weakness contributing to more nerve conditions, pain in toes/pain in arms and legs, and pain in bicep of arms which feels like it's pulsating and bouncing around. Treatment medications (dates unspecified) included: paracetamol, and gabapentin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nerve pain legs and arms (nerve pain getting worse and spreading), pain in toes/pain in arms and legs, pain in bicep of arms which feels like it's pulsating and bouncing around, pain lower back pulsating to legs, muscle weakness contributing to more nerve conditions, muscles feel weak contributed to back issues, something like spasms, legs and thighs feel like they pulsate when stood up, difficult to walk/painful to walk, and difficulty to keep balance. This report was non-serious.
Age: 62.0
Sex: M
Vaccine: COVID19
Symptoms: Muscular weakness, Myalgia, Neuralgia, Pain in extremity, Sensory disturbance
Clinical narrative: PAIN LOWER BACK PULSATING TO LEGS; MUSCLES FEEL WEAK CONTRIBUTED TO BACK ISSUES; SOMETHING LIKE SPASMS; LEGS AND THIGHS FEEL LIKE THEY PULSATE WHEN STOOD UP; DIFFICULT TO WALK/PAINFUL TO WALK; DIFFICULTY TO KEEP BALANCE; MUSCLE WEAKNESS CONTRIBUTING TO MORE NERVE CONDITIONS; PAIN IN TOES/PAIN IN ARMS AND LEGS; PAIN IN BICEP OF ARMS WHICH FEELS LIKE IT'S PULSATING AND BOUNCING AROUND; NERVE PAIN LEGS AND ARMS (NERVE PAIN GETTING WORSE AND SPREADING); This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: cholesterol, penicillin allergy, alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient had no drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808609, expiry: UNKNOWN) dose was not reported, administered on 26-MAR-2021 for prophylactic vaccination. Concomitant medications included rosuvastatin for cholesterol. On 16-APR-2021, the patient experienced nerve pain legs and arms (nerve pain getting worse and spreading). On an unspecified date, the patient experienced pain lower back pulsating to legs, muscles feel weak contributed to back issues, something like spasms, legs and thighs feel like they pulsate when stood up, difficult to walk/painful to walk, difficulty to keep balance, muscle weakness contributing to more nerve conditions, pain in toes/pain in arms and legs, and pain in bicep of arms which feels like it's pulsating and bouncing around. Treatment medications (dates unspecified) included: paracetamol, and gabapentin. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nerve pain legs and arms (nerve pain getting worse and spreading), pain in toes/pain in arms and legs, pain in bicep of arms which feels like it's pulsating and bouncing around, pain lower back pulsating to legs, muscle weakness contributing to more nerve conditions, muscles feel weak contributed to back issues, something like spasms, legs and thighs feel like they pulsate when stood up, difficult to walk/painful to walk, and difficulty to keep balance. This report was non-serious.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pyrexia, Rash, Vaccination site reaction
Clinical narrative: 100.3 temp; tired; big breakout; rash in same area but not injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (big breakout), RASH (rash in same area but not injection site), PYREXIA (100.3 temp) and FATIGUE (tired) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. #007H20A and #042L20A) for COVID-19 vaccination.     The patient's past medical history included Hypersensitivity, Asthma in 1955 and Urticaria. Previously administered products included for an unreported indication: SMALLPOX VACCINE (Reactions include itchy left arm for 12 months.) in 1976. Concurrent medical conditions included Allergic reaction to antibiotics (Penicillin -reactions include rash after 10 days.) and Allergic reaction to drug (Codeine - reactions include red cheeks). Concomitant products included albuterol nebs, MONTELUKAST SODIUM (SINGULAIR), FLUTICASONE FUROATE, VILANTEROL TRIFENATATE (BREO ELLIPTA) and TIOTROPIUM BROMIDE (SPIRIVA) for Asthma, ATORVASTATIN CALCIUM (LIPITOR) for Cholesterol, benecar, DENOSUMAB (PROLIA) and mylaanta for an unknown indication.   On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Feb-2021, the patient experienced VACCINATION SITE REACTION (big breakout) and RASH (rash in same area but not injection site). On an unknown date, the patient experienced PYREXIA (100.3 temp) and FATIGUE (tired). The patient was treated with CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) (oral) on 28-Jan-2021 for Allergy, at an unspecified dose and frequency and CLOBETASOL PROPIONATE from 28-Jan-2021 to 05-Feb-2021 for Allergy, at an unspecified dose and frequency. On 16-Feb-2021, VACCINATION SITE REACTION (big breakout) had resolved. At the time of the report, RASH (rash in same area but not injection site), PYREXIA (100.3 temp) and FATIGUE (tired) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the events was not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 17-May-2021: Hypersensitivity form
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered, Product storage error
Clinical narrative: vial that was passed the 12 hour window by 2 weeks/vial has been stored at room temperature for about 2 weeks; vial that was passed the 12 hour window by 2 weeks; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (vial that was passed the 12 hour window by 2 weeks/vial has been stored at room temperature for about 2 weeks) and EXPIRED PRODUCT ADMINISTERED (vial that was passed the 12 hour window by 2 weeks) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Jul-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 PRODUCT STORAGE ERROR (vial that was passed the 12 hour window by 2 weeks/vial has been stored at room temperature for about 2 weeks) and EXPIRED PRODUCT ADMINISTERED (vial that was passed the 12 hour window by 2 weeks). At the time of the report, PRODUCT STORAGE ERROR (vial that was passed the 12 hour window by 2 weeks/vial has been stored at room temperature for about 2 weeks) and EXPIRED PRODUCT ADMINISTERED (vial that was passed the 12 hour window by 2 weeks) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication were provided by the reporter  No treatment medication were provided by the reporter   This case was linked to MOD-2021-248360 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 26-Aug-2021: Follow-up information received as There were no side effects after vaccination
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: waited 8-10 weeks after his first moderna shot; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (waited 8-10 weeks after his first moderna shot) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (waited 8-10 weeks after his first moderna shot). At the time of the report, PRODUCT DOSE OMISSION ISSUE (waited 8-10 weeks after his first moderna shot) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Reporter reported that they have a patient who has waited 8-10 weeks after his first moderna shot.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Blood pressure measurement, Chills, Dyspnoea, Fatigue
Clinical narrative: weak central pulse/low central pulse rate; Chills; Shortness of breath, Breathing difficulty; Nausea; Headache; Mild fever; Muscle pain; Articular pain; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath, Breathing difficulty), PULSE ABNORMAL (weak central pulse/low central pulse rate), NAUSEA (Nausea), HEADACHE (Headache) and PYREXIA (Mild fever) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included MAGNESIUM and L-TYROSINE for an unknown indication.   On 27-May-2021 at 4:35 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jun-2021 at 3:50 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Jun-2021, the patient experienced DYSPNOEA (Shortness of breath, Breathing difficulty), NAUSEA (Nausea), HEADACHE (Headache), PYREXIA (Mild fever), MYALGIA (Muscle pain), ARTHRALGIA (Articular pain) and FATIGUE (Fatigue). On an unknown date, the patient experienced PULSE ABNORMAL (weak central pulse/low central pulse rate) and CHILLS (Chills). At the time of the report, DYSPNOEA (Shortness of breath, Breathing difficulty), PULSE ABNORMAL (weak central pulse/low central pulse rate), NAUSEA (Nausea), HEADACHE (Headache), PYREXIA (Mild fever), MYALGIA (Muscle pain), ARTHRALGIA (Articular pain), FATIGUE (Fatigue) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jun-2021, Blood pressure measurement: decreased (Low) Decreased. On an unknown date, Heart rate: low (Low) weak, Low central pulse rate.         No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Aug-2021: Significant information added - Date of first dose and concomitant medications added On 23-Aug-2021: Translation Received on 27-AUG-2021
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate, Myalgia, Nausea, Pulse abnormal
Clinical narrative: weak central pulse/low central pulse rate; Chills; Shortness of breath, Breathing difficulty; Nausea; Headache; Mild fever; Muscle pain; Articular pain; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath, Breathing difficulty), PULSE ABNORMAL (weak central pulse/low central pulse rate), NAUSEA (Nausea), HEADACHE (Headache) and PYREXIA (Mild fever) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included MAGNESIUM and L-TYROSINE for an unknown indication.   On 27-May-2021 at 4:35 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jun-2021 at 3:50 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Jun-2021, the patient experienced DYSPNOEA (Shortness of breath, Breathing difficulty), NAUSEA (Nausea), HEADACHE (Headache), PYREXIA (Mild fever), MYALGIA (Muscle pain), ARTHRALGIA (Articular pain) and FATIGUE (Fatigue). On an unknown date, the patient experienced PULSE ABNORMAL (weak central pulse/low central pulse rate) and CHILLS (Chills). At the time of the report, DYSPNOEA (Shortness of breath, Breathing difficulty), PULSE ABNORMAL (weak central pulse/low central pulse rate), NAUSEA (Nausea), HEADACHE (Headache), PYREXIA (Mild fever), MYALGIA (Muscle pain), ARTHRALGIA (Articular pain), FATIGUE (Fatigue) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jun-2021, Blood pressure measurement: decreased (Low) Decreased. On an unknown date, Heart rate: low (Low) weak, Low central pulse rate.         No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Aug-2021: Significant information added - Date of first dose and concomitant medications added On 23-Aug-2021: Translation Received on 27-AUG-2021
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: weak central pulse/low central pulse rate; Chills; Shortness of breath, Breathing difficulty; Nausea; Headache; Mild fever; Muscle pain; Articular pain; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath, Breathing difficulty), PULSE ABNORMAL (weak central pulse/low central pulse rate), NAUSEA (Nausea), HEADACHE (Headache) and PYREXIA (Mild fever) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included MAGNESIUM and L-TYROSINE for an unknown indication.   On 27-May-2021 at 4:35 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jun-2021 at 3:50 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Jun-2021, the patient experienced DYSPNOEA (Shortness of breath, Breathing difficulty), NAUSEA (Nausea), HEADACHE (Headache), PYREXIA (Mild fever), MYALGIA (Muscle pain), ARTHRALGIA (Articular pain) and FATIGUE (Fatigue). On an unknown date, the patient experienced PULSE ABNORMAL (weak central pulse/low central pulse rate) and CHILLS (Chills). At the time of the report, DYSPNOEA (Shortness of breath, Breathing difficulty), PULSE ABNORMAL (weak central pulse/low central pulse rate), NAUSEA (Nausea), HEADACHE (Headache), PYREXIA (Mild fever), MYALGIA (Muscle pain), ARTHRALGIA (Articular pain), FATIGUE (Fatigue) and CHILLS (Chills) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jun-2021, Blood pressure measurement: decreased (Low) Decreased. On an unknown date, Heart rate: low (Low) weak, Low central pulse rate.         No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 23-Aug-2021: Significant information added - Date of first dose and concomitant medications added On 23-Aug-2021: Translation Received on 27-AUG-2021
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered
Clinical narrative: three doses of the Moderna vaccine given; This spontaneous case was reported by an other health care professional and describes the occurrence of EXTRA DOSE ADMINISTERED (three doses of the Moderna vaccine given) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A, 047B21A and 048C21A) for COVID-19 vaccination.     Concurrent medical conditions included Fibromyalgia, Hypertension, Hyperthyroidism and Hyperlipidemia.   On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jul-2021, 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 EXTRA DOSE ADMINISTERED (three doses of the Moderna vaccine given). At the time of the report, EXTRA DOSE ADMINISTERED (three doses of the Moderna vaccine given) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant and treatment information provided by the reporter.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Second dose of vaccine given greater than 35 days; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose of vaccine given greater than 35 days) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047A21A) for COVID-19 vaccination.     Concurrent medical conditions included Dementia. Concomitant products included LORAZEPAM (ATIVAN) from 23-Mar-2021 to an unknown date for Anxiety, DOCUSATE SODIUM, SENNOSIDE A+B (SENNA PLUS [DOCUSATE SODIUM;SENNOSIDE A+B]) from 23-Mar-2021 to an unknown date for Constipation, SERTRALINE HYDROCHLORIDE (ZOLOFT) from 23-Mar-2021 to an unknown date for Depression, AMMONIUM LACTATE (AMLACTIN) from 24-Mar-2021 to an unknown date for Dry skin, AMLODIPINE from 28-Apr-2021 to an unknown date for Hypertension, ACETAMINOPHEN from 28-Apr-2021 to an unknown date for Pain, VITAMIN D3 from 23-Mar-2021 to an unknown date for Vitamin D deficiency.   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Jun-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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose of vaccine given greater than 35 days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose of vaccine given greater than 35 days) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Amlodipine is on hold if Systolic Blood Pressure less than 110.  Treatment product details not provided.   Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Follow up received on 02-AUG-2021 contain no new information.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Product identification number issue
Clinical narrative: dose from vial missing NDC; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT IDENTIFICATION NUMBER ISSUE (dose from vial missing NDC) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) 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 an unknown date, the patient experienced PRODUCT IDENTIFICATION NUMBER ISSUE (dose from vial missing NDC). At the time of the report, PRODUCT IDENTIFICATION NUMBER ISSUE (dose from vial missing NDC) 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 relevant concomitant medications were reported.  It was reported that vials with missing NCD came from another location since they would not use them, so the exact shipping information was unknown.  Upon visual inspection the vials  were fine and were transfered with the proper storage and arrived frozen.  No treatment information was provided.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose, Blood pressure measurement, Dizziness, Dry mouth, Dysgeusia
Clinical narrative: Dry mouth; Metal taste; Blood pressure high; Dizzy; Nausea; Weird sensation felt like water was running down her arm; Swollen arm/swelling left hand; Extreme thirst; Vertigo, swiminess; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo, swiminess), PARAESTHESIA (Weird sensation felt like water was running down her arm), PERIPHERAL SWELLING (Swollen arm/swelling left hand), THIRST (Extreme thirst) and DRY MOUTH (Dry mouth) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Aortic valve stenosis and insufficiency, Chronic sinusitis, Carpal tunnel syndrome and Mitral valve prolapse. Concurrent medical conditions included Hypertension, Kidney disorder, Migraine, Asthma, Type 2 diabetes mellitus and Stenosis. Concomitant products included TYRAMINE and MONOSODIUM GLUTAMATE for Migraine.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced VERTIGO (Vertigo, swiminess) and HEADACHE (Headache). On 22-Feb-2021, the patient experienced THIRST (Extreme thirst). On an unknown date, the patient experienced PARAESTHESIA (Weird sensation felt like water was running down her arm), PERIPHERAL SWELLING (Swollen arm/swelling left hand), DRY MOUTH (Dry mouth), DYSGEUSIA (Metal taste), HYPERTENSION (Blood pressure high), DIZZINESS (Dizzy) and NAUSEA (Nausea). At the time of the report, VERTIGO (Vertigo, swiminess), PARAESTHESIA (Weird sensation felt like water was running down her arm), PERIPHERAL SWELLING (Swollen arm/swelling left hand) and HEADACHE (Headache) had resolved and THIRST (Extreme thirst), DRY MOUTH (Dry mouth), DYSGEUSIA (Metal taste), HYPERTENSION (Blood pressure high), DIZZINESS (Dizzy) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Feb-2021, Blood glucose: increased (High) Increased. On 22-Feb-2021, Blood pressure measurement: high (High) blood pressure had risen.     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.   On 22Feb2021 patients cardiologist noticed that her blood pressure had risen and had to add a new medication and increase her existing one. No treatment information was provided.   This case was linked to MOD-2021-280076 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Aug-2021: Follow Up information was received on 25-Aug-2021 and events,relevant medical history and concomitant medications were added.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Hypertension, Nausea, Paraesthesia, Peripheral swelling
Clinical narrative: Dry mouth; Metal taste; Blood pressure high; Dizzy; Nausea; Weird sensation felt like water was running down her arm; Swollen arm/swelling left hand; Extreme thirst; Vertigo, swiminess; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo, swiminess), PARAESTHESIA (Weird sensation felt like water was running down her arm), PERIPHERAL SWELLING (Swollen arm/swelling left hand), THIRST (Extreme thirst) and DRY MOUTH (Dry mouth) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Aortic valve stenosis and insufficiency, Chronic sinusitis, Carpal tunnel syndrome and Mitral valve prolapse. Concurrent medical conditions included Hypertension, Kidney disorder, Migraine, Asthma, Type 2 diabetes mellitus and Stenosis. Concomitant products included TYRAMINE and MONOSODIUM GLUTAMATE for Migraine.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced VERTIGO (Vertigo, swiminess) and HEADACHE (Headache). On 22-Feb-2021, the patient experienced THIRST (Extreme thirst). On an unknown date, the patient experienced PARAESTHESIA (Weird sensation felt like water was running down her arm), PERIPHERAL SWELLING (Swollen arm/swelling left hand), DRY MOUTH (Dry mouth), DYSGEUSIA (Metal taste), HYPERTENSION (Blood pressure high), DIZZINESS (Dizzy) and NAUSEA (Nausea). At the time of the report, VERTIGO (Vertigo, swiminess), PARAESTHESIA (Weird sensation felt like water was running down her arm), PERIPHERAL SWELLING (Swollen arm/swelling left hand) and HEADACHE (Headache) had resolved and THIRST (Extreme thirst), DRY MOUTH (Dry mouth), DYSGEUSIA (Metal taste), HYPERTENSION (Blood pressure high), DIZZINESS (Dizzy) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Feb-2021, Blood glucose: increased (High) Increased. On 22-Feb-2021, Blood pressure measurement: high (High) blood pressure had risen.     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.   On 22Feb2021 patients cardiologist noticed that her blood pressure had risen and had to add a new medication and increase her existing one. No treatment information was provided.   This case was linked to MOD-2021-280076 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Aug-2021: Follow Up information was received on 25-Aug-2021 and events,relevant medical history and concomitant medications were added.
Age: 70.0
Sex: F
Vaccine: COVID19
Symptoms: Thirst, Vertigo
Clinical narrative: Dry mouth; Metal taste; Blood pressure high; Dizzy; Nausea; Weird sensation felt like water was running down her arm; Swollen arm/swelling left hand; Extreme thirst; Vertigo, swiminess; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo, swiminess), PARAESTHESIA (Weird sensation felt like water was running down her arm), PERIPHERAL SWELLING (Swollen arm/swelling left hand), THIRST (Extreme thirst) and DRY MOUTH (Dry mouth) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Aortic valve stenosis and insufficiency, Chronic sinusitis, Carpal tunnel syndrome and Mitral valve prolapse. Concurrent medical conditions included Hypertension, Kidney disorder, Migraine, Asthma, Type 2 diabetes mellitus and Stenosis. Concomitant products included TYRAMINE and MONOSODIUM GLUTAMATE for Migraine.    On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced VERTIGO (Vertigo, swiminess) and HEADACHE (Headache). On 22-Feb-2021, the patient experienced THIRST (Extreme thirst). On an unknown date, the patient experienced PARAESTHESIA (Weird sensation felt like water was running down her arm), PERIPHERAL SWELLING (Swollen arm/swelling left hand), DRY MOUTH (Dry mouth), DYSGEUSIA (Metal taste), HYPERTENSION (Blood pressure high), DIZZINESS (Dizzy) and NAUSEA (Nausea). At the time of the report, VERTIGO (Vertigo, swiminess), PARAESTHESIA (Weird sensation felt like water was running down her arm), PERIPHERAL SWELLING (Swollen arm/swelling left hand) and HEADACHE (Headache) had resolved and THIRST (Extreme thirst), DRY MOUTH (Dry mouth), DYSGEUSIA (Metal taste), HYPERTENSION (Blood pressure high), DIZZINESS (Dizzy) and NAUSEA (Nausea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Feb-2021, Blood glucose: increased (High) Increased. On 22-Feb-2021, Blood pressure measurement: high (High) blood pressure had risen.     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.   On 22Feb2021 patients cardiologist noticed that her blood pressure had risen and had to add a new medication and increase her existing one. No treatment information was provided.   This case was linked to MOD-2021-280076 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 25-Aug-2021: Follow Up information was received on 25-Aug-2021 and events,relevant medical history and concomitant medications were added.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Chills, Feeling hot, Myalgia, Pain
Clinical narrative: It has a burning sensation; pain sensation; feels warm to touch; I noticed a red lesion at the site of the injection; sore arm for 3/4 days; occasional chills; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (It has a burning sensation), PAIN (pain sensation), FEELING HOT (feels warm to touch), MYALGIA (sore arm for 3/4 days) and CHILLS (occasional chills) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jul-2021, the patient experienced MYALGIA (sore arm for 3/4 days) and CHILLS (occasional chills). On 07-Aug-2021, the patient experienced VACCINATION SITE ERYTHEMA (I noticed a red lesion at the site of the injection). On 08-Aug-2021, the patient experienced BURNING SENSATION (It has a burning sensation), PAIN (pain sensation) and FEELING HOT (feels warm to touch). At the time of the report, BURNING SENSATION (It has a burning sensation), PAIN (pain sensation), FEELING HOT (feels warm to touch) and VACCINATION SITE ERYTHEMA (I noticed a red lesion at the site of the injection) outcome was unknown and MYALGIA (sore arm for 3/4 days) and CHILLS (occasional chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant history was not reported. The treatment history was not provided.
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: It has a burning sensation; pain sensation; feels warm to touch; I noticed a red lesion at the site of the injection; sore arm for 3/4 days; occasional chills; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (It has a burning sensation), PAIN (pain sensation), FEELING HOT (feels warm to touch), MYALGIA (sore arm for 3/4 days) and CHILLS (occasional chills) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jul-2021, the patient experienced MYALGIA (sore arm for 3/4 days) and CHILLS (occasional chills). On 07-Aug-2021, the patient experienced VACCINATION SITE ERYTHEMA (I noticed a red lesion at the site of the injection). On 08-Aug-2021, the patient experienced BURNING SENSATION (It has a burning sensation), PAIN (pain sensation) and FEELING HOT (feels warm to touch). At the time of the report, BURNING SENSATION (It has a burning sensation), PAIN (pain sensation), FEELING HOT (feels warm to touch) and VACCINATION SITE ERYTHEMA (I noticed a red lesion at the site of the injection) outcome was unknown and MYALGIA (sore arm for 3/4 days) and CHILLS (occasional chills) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       The concomitant history was not reported. The treatment history was not provided.
Age: 69.0
Sex: F
Vaccine: COVID19
Symptoms: Diplopia, Headache, Migraine, Nervous system disorder
Clinical narrative: Migraine; Double vision; Has been having neurological problems; really bad headache; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (Migraine), DIPLOPIA (Double vision), NERVOUS SYSTEM DISORDER (Has been having neurological problems) and HEADACHE (really bad headache) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 610M20A) for COVID-19 vaccination.     The patient's past medical history included Breast cancer (She had breast cancer 17 years ago .). Concurrent medical conditions included Myelodysplasia and Osteopenia. Concomitant products included EPOETIN ALFA (PROCRIT) and CITALOPRAM for an unknown indication.   On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MIGRAINE (Migraine), DIPLOPIA (Double vision), NERVOUS SYSTEM DISORDER (Has been having neurological problems) and HEADACHE (really bad headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, MIGRAINE (Migraine), DIPLOPIA (Double vision) and NERVOUS SYSTEM DISORDER (Has been having neurological problems) outcome was unknown and HEADACHE (really bad headache) had not resolved.            This case was linked to MOD-2021-281173 (Patient Link).   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: follow up received it contains no new information.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A and 025L20A) for COVID-19 vaccination.     Concurrent medical conditions included Tendinitis (In her elbow) and CIDP (Diagnosed for 20 years). Concomitant products included LEVOTHYROXINE, ALPRAZOLAM and OMEPRAZOLE for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Feb-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.            patient got a steroid shot for the tendinitis in her elbow2 hours before getting the second dose of vaccine. Concomitant medications include Supplements. No treatment medication were provided.   This case was linked to MOD-2021-286520 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Swelling
Clinical narrative: had swelling of her whole body from her head down to her toes; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (had swelling of her whole body from her head down to her toes) 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 10-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Aug-2021, the patient experienced SWELLING (had swelling of her whole body from her head down to her toes). At the time of the report, SWELLING (had swelling of her whole body from her head down to her toes) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant and treatment medications were not reported.
Age: 39.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Expired vaccine used; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 39-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Jul-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 EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) 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.    concomitant medications are not provided by the reporter  no treatment information provided   This case was linked to MOD21-126929 (Patient Link).
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Heavy menstrual bleeding, Menstrual disorder, Paraesthesia, Rash
Clinical narrative: her period started a week earlier; her period was heavier than usual; tingling in arm and hand while driving; Had a head to toe rash/head to toe rash with welts; This spontaneous case was reported by an other health care professional and describes the occurrence of MENSTRUAL DISORDER (her period started a week earlier), HEAVY MENSTRUAL BLEEDING (her period was heavier than usual), PARAESTHESIA (tingling in arm and hand while driving) and RASH (Had a head to toe rash/head to toe rash with welts) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 059E21A) for COVID-19 vaccination.     Concurrent medical conditions included Erythromelalgia. Concomitant products included DULOXETINE HYDROCHLORIDE (CYMBALTA), ACETYLSALICYLIC ACID (ASPIRIN ACTIV), AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL), MOMETASONE FUROATE (ASMANEX HFA) and LEVOSALBUTAMOL TARTRATE (XOPENEX HFA) for an unknown indication.    On 31-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RASH (Had a head to toe rash/head to toe rash with welts). On an unknown date, the patient experienced MENSTRUAL DISORDER (her period started a week earlier), HEAVY MENSTRUAL BLEEDING (her period was heavier than usual) and PARAESTHESIA (tingling in arm and hand while driving). At the time of the report, MENSTRUAL DISORDER (her period started a week earlier), HEAVY MENSTRUAL BLEEDING (her period was heavier than usual), PARAESTHESIA (tingling in arm and hand while driving) and RASH (Had a head to toe rash/head to toe rash with welts) 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.   Patient also took concomitant medications of Cranberry Pill and Antiarin. No treatment medications are provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Follow Up received on 30-AUg-2021 contains additional primary reporter and mentioned additional AE contact.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Expired product administered, Inappropriate schedule of product administration, Myalgia, Pain in extremity
Clinical narrative: This spontaneous case was reported by a pharmacist and describes the occurrence of DIZZINESS (Lightheadedness), PAIN IN EXTREMITY (Sore arm), MYALGIA (Muscle soreness), EXPIRED PRODUCT ADMINISTERED (gave patient a dose from an expired vial) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose taken on 23-Mar-2021, third dose taken on 18-Aug-2021) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination. The patient's past medical history included Hypertension (constant for a while). Concurrent medical conditions included Drug allergy (Allergy to Prevacid, reaction is chest pain.), SLE nephritis since 24-Jun-2021, Tension headache (once a week usually, can't recall (tension type headache)) since 28-Feb-2021 and Knee pain. Concomitant products included FLUOXETINE for Depression, TRAZODONE for Tension headache, MYCOPHENOLATE MOFETIL (MYCOPHENOLATE), HYDROXYCHLOROQUINE, PREDNISONE, SPIRONOLACTONE, ARIPIPRAZOLE (ABILIFY), VITAMIN D [VITAMIN D NOS] and FOLIC ACID for an unknown indication.On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (gave patient a dose from an expired vial). On 19-Aug-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and MYALGIA (Muscle soreness). On an unknown date, the patient experienced DIZZINESS (Lightheadedness) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose taken on 23-Mar-2021, third dose taken on 18-Aug-2021). On 18-Aug-2021, EXPIRED PRODUCT ADMINISTERED (gave patient a dose from an expired vial) had resolved. On 21-Aug-2021, DIZZINESS (Lightheadedness) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm) and MYALGIA (Muscle soreness) had not resolved and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose taken on 23-Mar-2021, third dose taken on 18-Aug-2021) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Reported that the pharmacist believes the patient must have had some type of transplant. Reported that the patient hadn't taken any medications to alleviate symptoms. This case was linked to MOD-2021-293779, MOD-2021-293783 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 22-Aug-2021: Patient demographic details, medical history, concurrent conditions, concomitant medications were added. First dose and second dose details and events were updated.