chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 41.0
Sex: F
Vaccine: COVID19
Symptoms: Extra dose administered, Speech disorder
Clinical narrative: Patient don't speak too much; Received the second dose twice; This spontaneous case was reported by a pharmacist and describes the occurrence of EXTRA DOSE ADMINISTERED (Received the second dose twice) and SPEECH DISORDER (Patient don't speak too much) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced EXTRA DOSE ADMINISTERED (Received the second dose twice). On an unknown date, the patient experienced SPEECH DISORDER (Patient don't speak too much). On 30-Mar-2021, EXTRA DOSE ADMINISTERED (Received the second dose twice) had resolved. At the time of the report, SPEECH DISORDER (Patient don't speak too much) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter said the patient received the second dose twice, once on the morning and again on the afternoon on 30-Mar-2021. The reporter mentioned that the they had a 24 hour caregiving service and the first caregiver brought the patient on the morning and the second caregiver on the afternoon. The reporter also mentioned the patient don't speak too much.  Reportedly, the reporter was outside of the pharmacy.  No Concomitant product use was reported. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy
Clinical narrative: Swelling lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swelling lymph nodes) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 18-Mar-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 LYMPHADENOPATHY (Swelling lymph nodes). At the time of the report, LYMPHADENOPATHY (Swelling lymph nodes) outcome was unknown. Not Provided      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.  The patient received their first dose on 18-Mar-2021 and developed swelling of the lymph nodes.  No Concomitant product use was reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Herpes zoster, Rash
Clinical narrative: Rash on neck and clavicle bone; Diagonised with Shingles; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Diagonised with Shingles) and RASH (Rash on neck and clavicle bone) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced HERPES ZOSTER (Diagonised with Shingles). On an unknown date, the patient experienced RASH (Rash on neck and clavicle bone). At the time of the report, HERPES ZOSTER (Diagonised with Shingles) and RASH (Rash on neck and clavicle bone) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product information was not provided. Treatment information includes Acyclovir but want to know before she takes it.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: 2nd dose given 59 days after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (2nd dose given 59 days after the 1st dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (2nd dose given 59 days after the 1st dose). On 30-Mar-2021, PRODUCT DOSE OMISSION ISSUE (2nd dose given 59 days after the 1st dose) had resolved.            For mRNA-1273 (Moderna COVID-19 Vaccine) (unknown), the reporter did not provide any causality assessments.  The reporter was calling on behalf of their mother. The reporter mentioned that the patient received their first dose of the Moderna Covid-19 vaccine on 30-Jan-2021. The pharmacy did not get the vaccine supply for their 2nd dose. The patient received their second dose on 30-Mar-2021, 59 days after the 1st dose.   No Concomitant product use was reported. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain upper, COVID-19, Diarrhoea, Hyposmia, SARS-CoV-2 test
Clinical narrative: Lost the sense of smell; Tested positive for COVID-19; COVID-19; Diarrhea; Sstomach ache; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), HYPOSMIA (Lost the sense of smell), ABDOMINAL PAIN UPPER (Sstomach ache), SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19) and DIARRHOEA (Diarrhea) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Sstomach ache) and DIARRHOEA (Diarrhea). On 20-Mar-2021, the patient experienced COVID-19 (COVID-19) and SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19). On 21-Mar-2021, the patient experienced HYPOSMIA (Lost the sense of smell). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, COVID-19 (COVID-19), HYPOSMIA (Lost the sense of smell), ABDOMINAL PAIN UPPER (Sstomach ache), SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19) and DIARRHOEA (Diarrhea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Mar-2021, SARS-CoV-2 test: positive (Positive) Tested positive for COVID-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The reporter was calling on behalf of their husband. The patient received their first dose of the Moderna COVID-19 vaccine on 10-Mar-2021 and then was diagnosed with COVID-19. On 19-Mar-2021, the patient began to have diarrhea and stomachache, and on 20-Mar-2021, the patient tested positive for COVID-19. On 21-Mar-2021, the patient lost the sense of smell.  Concomitant medication included Blood pressure medication. Treatment medication included Tylenol and cough syrup.   This case was linked to MOD21-065375, MOD21-065447 (Patient Link).
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: SARS-CoV-2 test positive
Clinical narrative: Lost the sense of smell; Tested positive for COVID-19; COVID-19; Diarrhea; Sstomach ache; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (COVID-19), HYPOSMIA (Lost the sense of smell), ABDOMINAL PAIN UPPER (Sstomach ache), SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19) and DIARRHOEA (Diarrhea) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Sstomach ache) and DIARRHOEA (Diarrhea). On 20-Mar-2021, the patient experienced COVID-19 (COVID-19) and SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19). On 21-Mar-2021, the patient experienced HYPOSMIA (Lost the sense of smell). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, COVID-19 (COVID-19), HYPOSMIA (Lost the sense of smell), ABDOMINAL PAIN UPPER (Sstomach ache), SARS-COV-2 TEST POSITIVE (Tested positive for COVID-19) and DIARRHOEA (Diarrhea) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Mar-2021, SARS-CoV-2 test: positive (Positive) Tested positive for COVID-19.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The reporter was calling on behalf of their husband. The patient received their first dose of the Moderna COVID-19 vaccine on 10-Mar-2021 and then was diagnosed with COVID-19. On 19-Mar-2021, the patient began to have diarrhea and stomachache, and on 20-Mar-2021, the patient tested positive for COVID-19. On 21-Mar-2021, the patient lost the sense of smell.  Concomitant medication included Blood pressure medication. Treatment medication included Tylenol and cough syrup.   This case was linked to MOD21-065375, MOD21-065447 (Patient Link).
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Product administration error, Underdose
Clinical narrative: Administered the dose to a patient but some leaked out.; Administered the dose to a patient but some leaked out; This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Administered the dose to a patient but some leaked out.) and PRODUCT ADMINISTRATION ERROR (Administered the dose to a patient but some leaked out) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included LOSARTAN and AMLODIPINE for an unknown indication.    On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced UNDERDOSE (Administered the dose to a patient but some leaked out.) and PRODUCT ADMINISTRATION ERROR (Administered the dose to a patient but some leaked out). On 30-Mar-2021, UNDERDOSE (Administered the dose to a patient but some leaked out.) and PRODUCT ADMINISTRATION ERROR (Administered the dose to a patient but some leaked out) 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.   The reporter was a pharmacist who reported that they administered the vaccine dose to a patient, but some leaked out and wanted to know if the patient needs to be re- administered.  No treatment information was provided.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: Patient who has gotten the 2nd dose early; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient who has gotten the 2nd dose early) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient who has gotten the 2nd dose early). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient who has gotten the 2nd dose early) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   The reporter was a pharmacist and reported that they believe one of their patients was given second dose of vaccine early. No detail of patient demography, vaccinated date, anatomical location, Lot number, Date of expiration or any symptom after administration was provided.  No Concomitant product use was reported. No treatment information was provided.  Action taken with mRNA-1273 in response to the event was not applicable.
Age: 34.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Feeling hot, Joint swelling
Clinical narrative: Had chills; Elbowswelled up like a baseball, noticed more swelling; Elbowwarm to the touch; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Elbowswelled up like a baseball, noticed more swelling), FEELING HOT (Elbowwarm to the touch) and CHILLS (Had chills) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced JOINT SWELLING (Elbowswelled up like a baseball, noticed more swelling) and FEELING HOT (Elbowwarm to the touch). On 26-Feb-2021, the patient experienced CHILLS (Had chills). At the time of the report, JOINT SWELLING (Elbowswelled up like a baseball, noticed more swelling) had resolved and FEELING HOT (Elbowwarm to the touch) and CHILLS (Had chills) had not resolved.            The patient visited their primary doctor for this a few weeks ago and was advised to wait it out at that time.  The patient reported it has been almost 6 weeks since they received their vaccination.  No Concomitant product use was reported. Patient has stated that that his elbow swelled up the next morning after getting the shot, and it occurred in his non-dominant arm (the left arm where he received the vaccination). The doctor said it was bursitis and drained it and it did not reoccur.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Follow up received on 07-JUL-2021 and Updated anatomical location of vaccination in product tab. updated Event outcome as Recovered and updated medically confirm of the event.Updated consent declined for further follow up.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dyspnoea, Flushing, Nausea, Paraesthesia
Clinical narrative: Difficulty breathing; Flushing; Prickling/Tingling sensation; vomiting; Strong Smell; Uncomfortable in the back of her Throat, and it moved to her chest; Bad Taste in her mouth/Unusual taste; Jaw was Shaking; Uncomfortable in the chest; Nausea; Sore Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty breathing), FLUSHING (Flushing), PARAESTHESIA (Prickling/Tingling sensation), PAROSMIA (Strong Smell) and THROAT IRRITATION (Uncomfortable in the back of her Throat, and it moved to her chest) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concomitant products included ARMODAFINIL (NUVIGIL) for Narcolepsy, TRAMADOL and BACLOFEN (BACLOPHEN) for Pain, ESTRADIOL for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PAROSMIA (Strong Smell), THROAT IRRITATION (Uncomfortable in the back of her Throat, and it moved to her chest), TASTE DISORDER (Bad Taste in her mouth/Unusual taste), TREMOR (Jaw was Shaking), CHEST DISCOMFORT (Uncomfortable in the chest), NAUSEA (Nausea) and VACCINATION SITE PAIN (Sore Injection Site). On an unknown date, the patient experienced DYSPNOEA (Difficulty breathing), FLUSHING (Flushing), PARAESTHESIA (Prickling/Tingling sensation) and VOMITING (vomiting). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 03-Mar-2021 at a dose of 1 dosage form. On 03-Mar-2021, PAROSMIA (Strong Smell), THROAT IRRITATION (Uncomfortable in the back of her Throat, and it moved to her chest), TASTE DISORDER (Bad Taste in her mouth/Unusual taste), TREMOR (Jaw was Shaking), CHEST DISCOMFORT (Uncomfortable in the chest) and NAUSEA (Nausea) had resolved. On 17-Mar-2021, VACCINATION SITE PAIN (Sore Injection Site) had resolved. At the time of the report, DYSPNOEA (Difficulty breathing), FLUSHING (Flushing) and PARAESTHESIA (Prickling/Tingling sensation) outcome was unknown and VOMITING (vomiting) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include Thyroid replacement for Low thyroid.   Treatment included Antihistamines   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow-up information was received from initial reporter: Patient details updated, concomitant medications and new events were updated.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Parosmia, Taste disorder, Throat irritation, Tremor, Vaccination site pain
Clinical narrative: Difficulty breathing; Flushing; Prickling/Tingling sensation; vomiting; Strong Smell; Uncomfortable in the back of her Throat, and it moved to her chest; Bad Taste in her mouth/Unusual taste; Jaw was Shaking; Uncomfortable in the chest; Nausea; Sore Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty breathing), FLUSHING (Flushing), PARAESTHESIA (Prickling/Tingling sensation), PAROSMIA (Strong Smell) and THROAT IRRITATION (Uncomfortable in the back of her Throat, and it moved to her chest) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concomitant products included ARMODAFINIL (NUVIGIL) for Narcolepsy, TRAMADOL and BACLOFEN (BACLOPHEN) for Pain, ESTRADIOL for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PAROSMIA (Strong Smell), THROAT IRRITATION (Uncomfortable in the back of her Throat, and it moved to her chest), TASTE DISORDER (Bad Taste in her mouth/Unusual taste), TREMOR (Jaw was Shaking), CHEST DISCOMFORT (Uncomfortable in the chest), NAUSEA (Nausea) and VACCINATION SITE PAIN (Sore Injection Site). On an unknown date, the patient experienced DYSPNOEA (Difficulty breathing), FLUSHING (Flushing), PARAESTHESIA (Prickling/Tingling sensation) and VOMITING (vomiting). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 03-Mar-2021 at a dose of 1 dosage form. On 03-Mar-2021, PAROSMIA (Strong Smell), THROAT IRRITATION (Uncomfortable in the back of her Throat, and it moved to her chest), TASTE DISORDER (Bad Taste in her mouth/Unusual taste), TREMOR (Jaw was Shaking), CHEST DISCOMFORT (Uncomfortable in the chest) and NAUSEA (Nausea) had resolved. On 17-Mar-2021, VACCINATION SITE PAIN (Sore Injection Site) had resolved. At the time of the report, DYSPNOEA (Difficulty breathing), FLUSHING (Flushing) and PARAESTHESIA (Prickling/Tingling sensation) outcome was unknown and VOMITING (vomiting) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include Thyroid replacement for Low thyroid.   Treatment included Antihistamines   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow-up information was received from initial reporter: Patient details updated, concomitant medications and new events were updated.
Age: 74.0
Sex: F
Vaccine: COVID19
Symptoms: Vomiting
Clinical narrative: Difficulty breathing; Flushing; Prickling/Tingling sensation; vomiting; Strong Smell; Uncomfortable in the back of her Throat, and it moved to her chest; Bad Taste in her mouth/Unusual taste; Jaw was Shaking; Uncomfortable in the chest; Nausea; Sore Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty breathing), FLUSHING (Flushing), PARAESTHESIA (Prickling/Tingling sensation), PAROSMIA (Strong Smell) and THROAT IRRITATION (Uncomfortable in the back of her Throat, and it moved to her chest) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history information was reported.  Concomitant products included ARMODAFINIL (NUVIGIL) for Narcolepsy, TRAMADOL and BACLOFEN (BACLOPHEN) for Pain, ESTRADIOL for an unknown indication.    On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced PAROSMIA (Strong Smell), THROAT IRRITATION (Uncomfortable in the back of her Throat, and it moved to her chest), TASTE DISORDER (Bad Taste in her mouth/Unusual taste), TREMOR (Jaw was Shaking), CHEST DISCOMFORT (Uncomfortable in the chest), NAUSEA (Nausea) and VACCINATION SITE PAIN (Sore Injection Site). On an unknown date, the patient experienced DYSPNOEA (Difficulty breathing), FLUSHING (Flushing), PARAESTHESIA (Prickling/Tingling sensation) and VOMITING (vomiting). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 03-Mar-2021 at a dose of 1 dosage form. On 03-Mar-2021, PAROSMIA (Strong Smell), THROAT IRRITATION (Uncomfortable in the back of her Throat, and it moved to her chest), TASTE DISORDER (Bad Taste in her mouth/Unusual taste), TREMOR (Jaw was Shaking), CHEST DISCOMFORT (Uncomfortable in the chest) and NAUSEA (Nausea) had resolved. On 17-Mar-2021, VACCINATION SITE PAIN (Sore Injection Site) had resolved. At the time of the report, DYSPNOEA (Difficulty breathing), FLUSHING (Flushing) and PARAESTHESIA (Prickling/Tingling sensation) outcome was unknown and VOMITING (vomiting) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications include Thyroid replacement for Low thyroid.   Treatment included Antihistamines   Most recent FOLLOW-UP information incorporated above includes: On 15-Jul-2021: Follow-up information was received from initial reporter: Patient details updated, concomitant medications and new events were updated.
Age: 46.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Erythema, Tenderness
Clinical narrative: Dizziness; Redness; Tenderness; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness), TENDERNESS (Tenderness) and DIZZINESS (Dizziness) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic (Erythromycin), Allergy to antibiotic (Other mycins), Drug allergy (Hydrocodone) and Drug allergy (codeines).    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced ERYTHEMA (Redness) and TENDERNESS (Tenderness). On 29-Mar-2021, the patient experienced DIZZINESS (Dizziness). At the time of the report, ERYTHEMA (Redness), TENDERNESS (Tenderness) and DIZZINESS (Dizziness) 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.  The patient post receiving their first Moderna vaccine developed redness and tenderness. The patient also experienced dizziness at night.   No Concomitant product use was reported.  No treatment information was provided.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Legs hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Legs hurt) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 29-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced PAIN IN EXTREMITY (Legs hurt). At the time of the report, PAIN IN EXTREMITY (Legs hurt) 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.  The patient post receiving their Moderna dose of vaccine stated that their legs hurt.  No Concomitant product use was reported. No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: arm is very sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm is very sore) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No Medical History was reported).   On 29-Mar-2021, the patient 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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced VACCINATION SITE PAIN (arm is very sore). At the time of the report, VACCINATION SITE PAIN (arm is very sore) outcome was unknown.
Age: 87.0
Sex: M
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 an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN and VITAMINS NOS for an unknown indication.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown.            No treatment was reported. Action taken in response to mRNA-1273 was not applicable. Patient has implanted pacemaker.   This case was linked to MOD-2021-061155, MOD-2021-061159 (E2B Linked Report).; Sender's Comments:  MOD-2021-061155: MOD-2021-061159:
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Interchange of vaccine products
Clinical narrative: Received the first dose of the Pfizer vaccine on 26Feb2021 and on 26Mar2021 received a Moderna vaccine; This spontaneous case was reported by a nurse and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Received the first dose of the Pfizer vaccine on 26Feb2021 and on 26Mar2021 received a Moderna vaccine) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination.     Concomitant products included AMLODIPINE, BUDESONIDE, CALCIUM, VITAMIN D3, LOSARTAN, METOPROLOL, OMEPRAZOLE, SERTRALINE and TRAZODONE for an unknown indication.    On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Mar-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Received the first dose of the Pfizer vaccine on 26Feb2021 and on 26Mar2021 received a Moderna vaccine). On 26-Mar-2021, INTERCHANGE OF VACCINE PRODUCTS (Received the first dose of the Pfizer vaccine on 26Feb2021 and on 26Mar2021 received a Moderna vaccine) 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.   The reporter was calling to report that a patient received their first dose of the Pfizer vaccine on 26-Feb-2021 and on 26-Mar-2021, the patient received a Moderna vaccine.  Concomitant medication used also included 25 mg of sertraline for an unknown indication.  No treatment information was provided.
Age: 29.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: pregnant received Moderna COVID 19 vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (pregnant received Moderna COVID 19 vaccine) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination.     The patient's past medical history included Alcohol use (prior use) on 14-Mar-2021.    On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 23-Feb-2021 and the estimated date of delivery was 28-Nov-2021. On 18-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (pregnant received Moderna COVID 19 vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  third week of the pregnancy.  On 18-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (pregnant received Moderna COVID 19 vaccine) had resolved. Not Provided      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.   Concomitant medication use was unknown Treatment information was unknown
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Fall, Inappropriate schedule of product administration, Joint effusion
Clinical narrative: Next appointment is scheduled past 42 days of first dose/had to delay his second dose; His knee had to be drained of fluid; Fall; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Next appointment is scheduled past 42 days of first dose/had to delay his second dose), JOINT EFFUSION (His knee had to be drained of fluid) and FALL (Fall) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination.     Concomitant products included INSULIN GLARGINE (LANTUS), LISINOPRIL, METFORMIN, DILTIAZEM, OMEPRAZOLE, ROSUVASTATIN, DOXAZOSIN, GLIMEPIRIDE, ACETYLSALICYLIC ACID (BABY ASPIRIN) and RIVAROXABAN (XARELTO) for an unknown indication.    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Next appointment is scheduled past 42 days of first dose/had to delay his second dose), JOINT EFFUSION (His knee had to be drained of fluid) and FALL (Fall). The patient was treated with Surgery (On 19-Mar-2021, the patient had a surgery due to a fall the patient had.) for Fall. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Next appointment is scheduled past 42 days of first dose/had to delay his second dose) had resolved and JOINT EFFUSION (His knee had to be drained of fluid) and FALL (Fall) was resolving.        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.  The reporter was calling on behalf of their husband who received their first dose of Moderna vaccine on 18-Feb-2021. On 19-Mar-2021, the patient had a surgery due to a fall the patient had, so they had to delay their second dose. The patient's knee had to be drained of fluid and now that the patient was recovering well their surgeon stated that the patient was able to receive the second dose on 08-Apr-2021.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Headache, Pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), PAIN (Body aches), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Severe headaches) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced PAIN (Body aches), CHILLS (Chills) and PYREXIA (Fever). On 25-Feb-2021, the patient experienced HEADACHE (Severe headaches). On 02-Mar-2021, the patient experienced DIZZINESS (Dizziness). On 03-Mar-2021, the patient experienced FATIGUE (Tiredness). At the time of the report, DIZZINESS (Dizziness), PAIN (Body aches), CHILLS (Chills), PYREXIA (Fever), HEADACHE (Severe headaches) and FATIGUE (Tiredness) outcome was unknown. No concomitant medications were reported. Treatment details included Tylenol. This case was linked to MOD-2021-064625. Reporter did not allow further contact.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizziness), PAIN (Body aches), CHILLS (Chills), PYREXIA (Fever) and HEADACHE (Severe headaches) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Feb-2021, the patient experienced PAIN (Body aches), CHILLS (Chills) and PYREXIA (Fever). On 25-Feb-2021, the patient experienced HEADACHE (Severe headaches). On 02-Mar-2021, the patient experienced DIZZINESS (Dizziness). On 03-Mar-2021, the patient experienced FATIGUE (Tiredness). At the time of the report, DIZZINESS (Dizziness), PAIN (Body aches), CHILLS (Chills), PYREXIA (Fever), HEADACHE (Severe headaches) and FATIGUE (Tiredness) outcome was unknown. No concomitant medications were reported. Treatment details included Tylenol. This case was linked to MOD-2021-064625. Reporter did not allow further contact.
Age: 22.0
Sex: F
Vaccine: COVID19
Symptoms: Anosmia, Cough, Malaise, SARS-CoV-2 test positive
Clinical narrative: cough; lost sense of smell; tested positive for COVID-19; feel Unwell; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (cough), SARS-COV-2 TEST POSITIVE (tested positive for COVID-19), MALAISE (feel Unwell) and ANOSMIA (lost sense of smell) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Mar-2021, the patient experienced MALAISE (feel Unwell). On 29-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for COVID-19). On an unknown date, the patient experienced COUGH (cough) and ANOSMIA (lost sense of smell). At the time of the report, COUGH (cough), SARS-COV-2 TEST POSITIVE (tested positive for COVID-19), MALAISE (feel Unwell) and ANOSMIA (lost sense of smell) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication not provided.  Treatment medication includes Tylenol and cough syrup.   This case was linked to MOD21-065375, MOD21-065446, MOD-2021-062855, MOD-2021-062855 (Patient Link).
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Feeling abnormal
Clinical narrative: she mentioned she had a hard time getting around; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (she mentioned she had a hard time getting around) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced FEELING ABNORMAL (she mentioned she had a hard time getting around). At the time of the report, FEELING ABNORMAL (she mentioned she had a hard time getting around) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No Concomitant medications were provided No Treatment information provided
Age: 58.0
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 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20ZA and 042L20A.) for COVID-19 vaccination.     Concomitant products included OMEPRAZOLE, HYDROCHLOROTHIAZIDE, SULFAMETHOXAZOLE, TRIMETHOPRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIM) and CITALOPRAM HYDROBROMIDE for an unknown indication.   On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown. Not Provided          No Concomitant medications were provided No Treatment information provided    This case was linked; Sender's Comments:  US-MODERNATX, INC.-second dose
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Burning sensation, Pain in extremity, Pruritus, Skin infection
Clinical narrative: Sore arm; Arm burn; Arm itchy; Like skin infection from the upper arm to the elbow; weakness for about 4 days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), BURNING SENSATION (Arm burn), PRURITUS (Arm itchy), SKIN INFECTION (Like skin infection from the upper arm to the elbow) and ASTHENIA (weakness for about 4 days) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 27-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, the patient experienced ASTHENIA (weakness for about 4 days). On 05-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), BURNING SENSATION (Arm burn), PRURITUS (Arm itchy) and SKIN INFECTION (Like skin infection from the upper arm to the elbow). On 02-Mar-2021, ASTHENIA (weakness for about 4 days) had resolved. At the time of the report, PAIN IN EXTREMITY (Sore arm), BURNING SENSATION (Arm burn), PRURITUS (Arm itchy) and SKIN INFECTION (Like skin infection from the upper arm to the elbow) outcome was unknown.            Treatment Cream with antibiotics. Action taken was not applicable .
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Hyperhidrosis, Nausea
Clinical narrative: SWEATS; CHILLS; HEADACHE; EXHAUSTION; NAUSEOUS; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (SWEATS), CHILLS (CHILLS), HEADACHE (HEADACHE), FATIGUE (EXHAUSTION) and NAUSEA (NAUSEOUS) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Mar-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 HYPERHIDROSIS (SWEATS), CHILLS (CHILLS), HEADACHE (HEADACHE), FATIGUE (EXHAUSTION) and NAUSEA (NAUSEOUS). At the time of the report, HYPERHIDROSIS (SWEATS), CHILLS (CHILLS), HEADACHE (HEADACHE), FATIGUE (EXHAUSTION) and NAUSEA (NAUSEOUS) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were reported. No treatment information was provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site bruising, Vaccination site pain
Clinical narrative: Developed a reddish bruise on injection site; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (Developed a reddish bruise on injection site) and VACCINATION SITE PAIN (Sore arm) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 037B21A) for COVID-19 vaccination.     No medical history provided by reporter.  Concomitant products included MULTIVITAMIN [VITAMINS NOS], CALCIUM, VITAMIN B COMPLEX (B COMPLEX [VITAMIN B COMPLEX]) and LORATADINE for an unknown indication.   On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced VACCINATION SITE BRUISING (Developed a reddish bruise on injection site) and VACCINATION SITE PAIN (Sore arm). At the time of the report, VACCINATION SITE BRUISING (Developed a reddish bruise on injection site) and VACCINATION SITE PAIN (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment information was not provided.   This case was linked to MOD-2021-062141 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 12-May-2021: Follow up document received on 12-May-2021 contains Contact information of patient.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Oral pruritus, Rash, Urticaria, Vaccination site rash
Clinical narrative: Welting on shoulder and face; itching of mouth; Really bad rash all over face and the arm she got the vacicne/rash on left side of face; rash on left side of face; Really bad rash all over face and the arm she got the vacicne; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Welting on shoulder and face), ORAL PRURITUS (itching of mouth), RASH (Really bad rash all over face and the arm she got the vacicne/rash on left side of face), RASH (rash on left side of face) and VACCINATION SITE RASH (Really bad rash all over face and the arm she got the vacicne) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002B21A) for COVID-19 vaccination.     Concurrent medical conditions included Migraine and Asthma. Concomitant products included FLUTICASONE PROPIONATE (FLOVENT) and MONTELUKAST SODIUM (SINGULAIR) for Asthma, RIZATRIPTAN BENZOATE (MAXALT) for Migraine.    On 19-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 URTICARIA (Welting on shoulder and face), ORAL PRURITUS (itching of mouth), RASH (Really bad rash all over face and the arm she got the vacicne/rash on left side of face), RASH (rash on left side of face) and VACCINATION SITE RASH (Really bad rash all over face and the arm she got the vacicne). The patient was treated with PREDNISONE at a dose of 1 dosage form; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form; EPINEPHRINE (EPIPEN) at a dose of 1 dosage form and METHYLPREDNISOLONE (MEDROL DOSEPAK) at a dose of 1 dosage form. On 24-Mar-2021, URTICARIA (Welting on shoulder and face), ORAL PRURITUS (itching of mouth), RASH (Really bad rash all over face and the arm she got the vacicne/rash on left side of face) and RASH (rash on left side of face) had resolved. At the time of the report, VACCINATION SITE RASH (Really bad rash all over face and the arm she got the vacicne) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: Follow-up received on 09-APR-2021.Reporter details was reported. Patient DOB, gender, age was updated.Patient medical history was reported.Lot number and Concomitant medication , treatment medication was reported. Events was reported. Outcome was reported.
Age: 68.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: 2nd dose was scheduled and the patient missed his scheduled 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (2nd dose was scheduled and the patient missed his scheduled 2nd dose) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 21-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (2nd dose was scheduled and the patient missed his scheduled 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (2nd dose was scheduled and the patient missed his scheduled 2nd dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter.  Treatment information was not provided.