chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Lip swelling, Off label use, Swelling
Clinical narrative: Swelling in her upper lip; Swelling above the upper lip; Not immunocompromised, got her third dose; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (Swelling in her upper lip), SWELLING (Swelling above the upper lip) and OFF LABEL USE (Not immunocompromised, got her third dose) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 052E21A, 030M20A and 042L20A) for COVID-19 vaccination.     No medical history was provided.  Concomitant products included HYALURONIC ACID (RESTYLANE) for an unknown indication.   On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Aug-2021, the patient experienced OFF LABEL USE (Not immunocompromised, got her third dose). On 27-Aug-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LIP SWELLING (Swelling in her upper lip) and SWELLING (Swelling above the upper lip). On 25-Aug-2021, OFF LABEL USE (Not immunocompromised, got her third dose) had resolved. On 31-Aug-2021, LIP SWELLING (Swelling in her upper lip) and SWELLING (Swelling above the upper lip) had resolved.            Treatment information was not provided.
Sex: U
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Heart rate, Tachycardia
Clinical narrative: Tachycardia; Experienced dizziness; Weakness; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Tachycardia), DIZZINESS (Experienced dizziness) and ASTHENIA (Weakness) 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 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 TACHYCARDIA (Tachycardia), DIZZINESS (Experienced dizziness) and ASTHENIA (Weakness). At the time of the report, TACHYCARDIA (Tachycardia), DIZZINESS (Experienced dizziness) and ASTHENIA (Weakness) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Mar-2021, Heart rate: high (High) tachycardia.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not provided.  Treatment medication was not provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, SARS-CoV-2 test
Clinical narrative: Already 6 weeks since first dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Already 6 weeks since first dose) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037C21A) for COVID-19 vaccination.     The patient's past medical history included Exposure to COVID-19.    On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jul-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Already 6 weeks since first dose). On 21-Jul-2021, PRODUCT DOSE OMISSION ISSUE (Already 6 weeks since first dose) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Sep-2021, SARS-CoV-2 test: negative (Negative) Negative.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant product information was provided.  Treatment information was not provided.   Patient received first dose of Moderna vaccine on 21Jul2021 (Lot number: 037C21A) and was scheduled for her second dose on 01Sep2021, but it was cancelled due to bad weather. Patient was exposed to COVID and got tested on 01Sep2021. Results were negative.
Age: 16.0
Sex: M
Vaccine: COVID19
Symptoms: Product administered to patient of inappropriate age
Clinical narrative: Vaccine given to a 16 year old; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine given to a 16 year old) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Aug-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine given to a 16 year old). On 30-Aug-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine given to a 16 year old) 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. No treatment medication were provided.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Nasal congestion, Nasopharyngitis, Pain in extremity, Rhinorrhoea, Secretion discharge
Clinical narrative: Mucus in throat; Catching a cold; Congested; Nose running; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of SECRETION DISCHARGE (Mucus in throat), NASOPHARYNGITIS (Catching a cold), NASAL CONGESTION (Congested), RHINORRHOEA (Nose running) and PAIN IN EXTREMITY (Sore arm) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939901) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Aug-2021, the patient experienced SECRETION DISCHARGE (Mucus in throat), NASOPHARYNGITIS (Catching a cold), NASAL CONGESTION (Congested), RHINORRHOEA (Nose running) and PAIN IN EXTREMITY (Sore arm). The patient was treated with PARACETAMOL (TYLENOL) for Myalgia, at an unspecified dose and frequency. At the time of the report, SECRETION DISCHARGE (Mucus in throat) had not resolved and NASOPHARYNGITIS (Catching a cold), NASAL CONGESTION (Congested), RHINORRHOEA (Nose running) and PAIN IN EXTREMITY (Sore arm) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medication was not provided Treatment information include throat lozenges and drinks tea with honey.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: More than 35 days after the first dose without receiving the second dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days after the first dose without receiving the second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days after the first dose without receiving the second dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days after the first dose without receiving the second dose) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication was reported.  No treatment history was reported.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: She didn't get her second dose one month after her 1st dose/ it was past the recommended time; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (She didn't get her second dose one month after her 1st dose/ it was past the recommended time) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received 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 (She didn't get her second dose one month after her 1st dose/ it was past the recommended time). At the time of the report, PRODUCT DOSE OMISSION ISSUE (She didn't get her second dose one month after her 1st dose/ it was past the recommended time) 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 medications were provided. No Treatment medications were provided.
Age: 73.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, Pruritus, Rash, Swelling
Clinical narrative: itching; Swollen; burning; full body rash including face; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching), SWELLING (Swollen), BURNING SENSATION (burning) and RASH (full body rash including face) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.  On 07-Aug-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 PRURITUS (itching), SWELLING (Swollen), BURNING SENSATION (burning) and RASH (full body rash including face). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itching, Swelling, Burning sensation and Rash all over, at an unspecified dose and frequency. At the time of the report, PRURITUS (itching), SWELLING (Swollen), BURNING SENSATION (burning) and RASH (full body rash including face) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   No concomitant medication information was provided.  She was scheduled to get the 2nd dose on 04-Sept-2021.
Age: 99.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Patient was administered the first dose of Moderna vaccine in April 21 but did not get the second dose (since 5 months ago); This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient was administered the first dose of Moderna vaccine in April 21 but did not get the second dose (since 5 months ago)) in a 99-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes and Cardiac arrest (heart condition (pace maker  and defibrillator)).    On 21-Apr-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 DOSE OMISSION ISSUE (Patient was administered the first dose of Moderna vaccine in April 21 but did not get the second dose (since 5 months ago)). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient was administered the first dose of Moderna vaccine in April 21 but did not get the second dose (since 5 months ago)) had resolved.            No Concomitant medications was provided.  No Treatment medications was provided.   Reporter did not allow further contact
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Feeling abnormal, Inappropriate schedule of product administration, Influenza like illness
Clinical narrative: Achy all over, like I have the flu; Felt kind of lousy; About 2 hours in, arm got really sore, entire arm hurt to the bone, all night long. achy all over.; Chills; sore on Especially the lymph nodes on the left side; Lymph nodes were tender; The patient received her second dose on 02Mar2021 and third dose on 01Sep2021; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Achy all over, like I have the flu), FEELING ABNORMAL (Felt kind of lousy), MYALGIA (About 2 hours in, arm got really sore, entire arm hurt to the bone, all night long. achy all over.), CHILLS (Chills) and LYMPH NODE PAIN ( sore on Especially the lymph nodes on the left side) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received her second dose on 02Mar2021 and third dose on 01Sep2021). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Achy all over, like I have the flu), FEELING ABNORMAL (Felt kind of lousy), MYALGIA (About 2 hours in, arm got really sore, entire arm hurt to the bone, all night long. achy all over.), CHILLS (Chills), LYMPH NODE PAIN ( sore on Especially the lymph nodes on the left side) and LYMPHADENOPATHY (Lymph nodes were tender). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) on 02-Sep-2021 for Adverse event, at an unspecified dose and frequency. On 01-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received her second dose on 02Mar2021 and third dose on 01Sep2021) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (Achy all over, like I have the flu), FEELING ABNORMAL (Felt kind of lousy), MYALGIA (About 2 hours in, arm got really sore, entire arm hurt to the bone, all night long. achy all over.), CHILLS (Chills), LYMPH NODE PAIN ( sore on Especially the lymph nodes on the left side) and LYMPHADENOPATHY (Lymph nodes were tender) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.7 (High) Temperature was 99.7. Then it went away, and the patient felt kind of lousy..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   This case was linked to MOD-2021-306517 (Patient Link).
Age: 50.0
Sex: F
Vaccine: COVID19
Symptoms: Lymph node pain, Lymphadenopathy, Myalgia
Clinical narrative: Achy all over, like I have the flu; Felt kind of lousy; About 2 hours in, arm got really sore, entire arm hurt to the bone, all night long. achy all over.; Chills; sore on Especially the lymph nodes on the left side; Lymph nodes were tender; The patient received her second dose on 02Mar2021 and third dose on 01Sep2021; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Achy all over, like I have the flu), FEELING ABNORMAL (Felt kind of lousy), MYALGIA (About 2 hours in, arm got really sore, entire arm hurt to the bone, all night long. achy all over.), CHILLS (Chills) and LYMPH NODE PAIN ( sore on Especially the lymph nodes on the left side) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 062E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 01-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received her second dose on 02Mar2021 and third dose on 01Sep2021). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Achy all over, like I have the flu), FEELING ABNORMAL (Felt kind of lousy), MYALGIA (About 2 hours in, arm got really sore, entire arm hurt to the bone, all night long. achy all over.), CHILLS (Chills), LYMPH NODE PAIN ( sore on Especially the lymph nodes on the left side) and LYMPHADENOPATHY (Lymph nodes were tender). The patient was treated with IBUPROFEN (ADVIL 12 HOUR) on 02-Sep-2021 for Adverse event, at an unspecified dose and frequency. On 01-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The patient received her second dose on 02Mar2021 and third dose on 01Sep2021) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (Achy all over, like I have the flu), FEELING ABNORMAL (Felt kind of lousy), MYALGIA (About 2 hours in, arm got really sore, entire arm hurt to the bone, all night long. achy all over.), CHILLS (Chills), LYMPH NODE PAIN ( sore on Especially the lymph nodes on the left side) and LYMPHADENOPATHY (Lymph nodes were tender) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.7 (High) Temperature was 99.7. Then it went away, and the patient felt kind of lousy..     For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were reported.   This case was linked to MOD-2021-306517 (Patient Link).
Age: 40.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: receiving 2nd dose 13 days after the 1st one; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (receiving 2nd dose 13 days after the 1st one) in a 40-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027b21a and 027b21a) for COVID-19 vaccination.     No Medical History information was reported.   On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (receiving 2nd dose 13 days after the 1st one). On 02-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (receiving 2nd dose 13 days after the 1st one) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided.  No Treatment medications were provided.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Memory impairment, Nervousness, Speech disorder, Tremor, Vaccination complication
Clinical narrative: she hasn't been well since she took the vaccine/don't feel like myself; forget things/have a hard time remembering things when I talk; not talking normal/speech problems; she has the internal shakes/ shakiness/I have the shakes; she's not herself /nervousness in her system/have the jitters all the time; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (she hasn't been well since she took the vaccine/don't feel like myself), MEMORY IMPAIRMENT (forget things/have a hard time remembering things when I talk), SPEECH DISORDER (not talking normal/speech problems), TREMOR (she has the internal shakes/ shakiness/I have the shakes) and NERVOUSNESS (she's not herself /nervousness in her system/have the jitters all the time) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053E21A and 078C21A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Aug-2021, the patient experienced VACCINATION COMPLICATION (she hasn't been well since she took the vaccine/don't feel like myself), MEMORY IMPAIRMENT (forget things/have a hard time remembering things when I talk), SPEECH DISORDER (not talking normal/speech problems), TREMOR (she has the internal shakes/ shakiness/I have the shakes) and NERVOUSNESS (she's not herself /nervousness in her system/have the jitters all the time). At the time of the report, VACCINATION COMPLICATION (she hasn't been well since she took the vaccine/don't feel like myself), MEMORY IMPAIRMENT (forget things/have a hard time remembering things when I talk), SPEECH DISORDER (not talking normal/speech problems), TREMOR (she has the internal shakes/ shakiness/I have the shakes) and NERVOUSNESS (she's not herself /nervousness in her system/have the jitters all the time) outcome was unknown.            No concomitant medications provided. No treatment medications provided.   This case was linked to MOD-2021-306606 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 02-Sep-2021: Follow up received on  02-SEP-2021 contains non-significant information.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Vaccination site pain, Vaccination site rash
Clinical narrative: Arm is very sore 7/10 painscale; Its all around injection site flat rash, not itchy/like a big well; Headache; Extremely tired; Tender to touch; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm is very sore 7/10 painscale), VACCINATION SITE RASH (Its all around injection site flat rash, not itchy/like a big well), HEADACHE (Headache), FATIGUE (Extremely tired) and VACCINATION SITE PAIN (Tender to touch) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023C21A and 047B21A) for COVID-19 vaccination.     Concomitant products included VITAMIN B12 (CYANOCOBALAMIN AND ANALOGUES), ASCORBIC ACID (VITAMIN C FORMULA), FOLIC ACID (FOLATE) and MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 08-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Sep-2021, the patient experienced PAIN IN EXTREMITY (Arm is very sore 7/10 painscale), VACCINATION SITE RASH (Its all around injection site flat rash, not itchy/like a big well), HEADACHE (Headache), FATIGUE (Extremely tired) and VACCINATION SITE PAIN (Tender to touch). At the time of the report, PAIN IN EXTREMITY (Arm is very sore 7/10 painscale), VACCINATION SITE RASH (Its all around injection site flat rash, not itchy/like a big well), HEADACHE (Headache), FATIGUE (Extremely tired) and VACCINATION SITE PAIN (Tender to touch) outcome was unknown.            Treatment medication was  not reported.
Sex: U
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Interchange of vaccine products
Clinical narrative: Inappropriate schedule of vaccine administered; Interchange of vaccine products; 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 (Inappropriate schedule of vaccine administered) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) in a  patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 30-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products). On 30-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and INTERCHANGE OF VACCINE PRODUCTS (Interchange of vaccine products) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Relevant concomitant medications were not reported.  The treatment information was  not provided.  It was reported that total five patients who were immune compromised, and took Moderna third dose on 30-Aug-2021.They got their two shots  of Pfizer previously, one of them got second Pfizer shot on 25-AUG-2021 and took Moderna Booster after five days.   Reporter did not allow further contact
Sex: U
Vaccine: COVID19
Symptoms: Ligament sprain
Clinical narrative: Twisted my ankle; This spontaneous case was reported by a consumer and describes the occurrence of LIGAMENT SPRAIN (Twisted my ankle) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LIGAMENT SPRAIN (Twisted my ankle). At the time of the report, LIGAMENT SPRAIN (Twisted my ankle) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medication reported. No treatment medication reported.  Patient queried about taking Advil (ibuprofen).
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenitis
Clinical narrative: Infection in lymph node right after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENITIS (Infection in lymph node right after vaccination) in a female patient of an unknown age who received mRNA-1273 (COVID 19 Vaccine Moderna) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (COVID 19 Vaccine Moderna) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENITIS (Infection in lymph node right after vaccination). At the time of the report, LYMPHADENITIS (Infection in lymph node right after vaccination) outcome was unknown.        The action taken with mRNA-1273 (COVID 19 Vaccine Moderna) (Unknown) was unknown.       No concomitant medication information was provided.  No treatment medication were provided.
Age: 26.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19, Product dose omission issue
Clinical narrative: gotten covid a week ago; Received the first dose 5 weeks ago/supposed to get the second dose last week but they rescheduled it because he forgot.; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (gotten covid a week ago) and PRODUCT DOSE OMISSION ISSUE (Received the first dose 5 weeks ago/supposed to get the second dose last week but they rescheduled it because he forgot.) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COVID-19 (gotten covid a week ago) and PRODUCT DOSE OMISSION ISSUE (Received the first dose 5 weeks ago/supposed to get the second dose last week but they rescheduled it because he forgot.). At the time of the report, COVID-19 (gotten covid a week ago) was resolving and PRODUCT DOSE OMISSION ISSUE (Received the first dose 5 weeks ago/supposed to get the second dose last week but they rescheduled it because he forgot.) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant and treatment medication was reported by patient.
Age: 28.0
Sex: F
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 20 days after first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (20 days after first dose) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 062E21A and 088D21A) for COVID-19 vaccination.     No Medical History information was reported.   On 11-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (20 days after first dose). On 02-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (20 days after first dose) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No Concomitant medication was reported.  No treatment medications were reported
Sex: M
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: now he is dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (now he is dizzy) 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 03-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Sep-2021, the patient experienced DIZZINESS (now he is dizzy). At the time of the report, DIZZINESS (now he is dizzy) had not resolved.            No concomitant medications were mentioned. No treatment details were reported. Upon reading the FAQ on side effects and advising to call their HCP or go the nearest hospital, caller disconnected the call. No other details were provided.
Age: 37.0
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration, Pain in extremity, Pyrexia
Clinical narrative: Little pain in my arm/arm soreness; Slight Fever; It has been about 7 months since I received my first dose of the Moderna COVID-19 vaccine (only received one dose thus far); This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Little pain in my arm/arm soreness), PYREXIA (Slight Fever) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (It has been about 7 months since I received my first dose of the Moderna COVID-19 vaccine (only received one dose thus far)) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On an unknown date, the patient experienced PAIN IN EXTREMITY (Little pain in my arm/arm soreness), PYREXIA (Slight Fever) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (It has been about 7 months since I received my first dose of the Moderna COVID-19 vaccine (only received one dose thus far)). In 2021, PYREXIA (Slight Fever) had resolved. At the time of the report, PAIN IN EXTREMITY (Little pain in my arm/arm soreness) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (It has been about 7 months since I received my first dose of the Moderna COVID-19 vaccine (only received one dose thus far)) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.  Treatment medications were not reported.
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Fatigue, Maternal exposure during pregnancy, Oropharyngeal pain
Clinical narrative: Sore throat; Some diarrhea; Tired; Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant), OROPHARYNGEAL PAIN (Sore throat), DIARRHOEA (Some diarrhea) and FATIGUE (Tired) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 23-Mar-2021 and the estimated date of delivery was 01-Jan-2022. On 02-Sep-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). On 03-Sep-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), DIARRHOEA (Some diarrhea) and FATIGUE (Tired). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  twenty-third week of the pregnancy.  On 02-Sep-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. At the time of the report, OROPHARYNGEAL PAIN (Sore throat), DIARRHOEA (Some diarrhea) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided.  After receiving the vaccine the patient had a sore throat, been tired, and had some diarrhea. She had been drinking water and resting to try and help with her symptoms.  This report refers to a case of maternal exposure during pregnancy for mRNA-1273 with associated AEs reported as oropharyngeal pain, diarrhoea and fatigue in a 28-year-old female patient. The patient experienced the events on the same day as mRNA-1273 administration. Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded. Therefore, causality is assessed as possibly related.; Sender's Comments: This report refers to a case of maternal exposure during pregnancy for mRNA-1273 with associated AEs reported as oropharyngeal pain, diarrhoea and fatigue in a 28-year-old female patient. The patient experienced the events on the same day as mRNA-1273 administration. Based on the current available information and temporal association between the use of the product and the onset date of the events, a causal relationship cannot be excluded. Therefore, causality is assessed as possibly related.
Sex: U
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: side effects last; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effects last) 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 VACCINATION COMPLICATION (side effects last). At the time of the report, VACCINATION COMPLICATION (side effects last) outcome was unknown.            No concomitant medications were reported.  No treatment medications were reported.    Reporter did not allow further contact
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal discomfort, Dizziness, Inappropriate schedule of product administration, Joint swelling, Nausea
Clinical narrative: Inappropriate schedule of vaccine administered; swelling on arm from the second dose,; both ankles are swelling up,feet swollen up pretty bad in the ankles; dizziness; sick stomach; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling on arm from the second dose,), JOINT SWELLING (both ankles are swelling up,feet swollen up pretty bad in the ankles), DIZZINESS (dizziness), ABDOMINAL DISCOMFORT (sick stomach) and NAUSEA (nausea) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C021A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure. Concomitant products included LISINOPRIL, AMLODIPINE and DILTIAZEM for Blood pressure abnormal, TRAMADOL for Pain, PANTOPRAZOLE for Stomach discomfort, PRAVASTATIN for an unknown indication.   On 18-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Sep-2021, the patient experienced PERIPHERAL SWELLING (swelling on arm from the second dose,), JOINT SWELLING (both ankles are swelling up,feet swollen up pretty bad in the ankles), DIZZINESS (dizziness), ABDOMINAL DISCOMFORT (sick stomach) and NAUSEA (nausea). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, PERIPHERAL SWELLING (swelling on arm from the second dose,), DIZZINESS (dizziness), ABDOMINAL DISCOMFORT (sick stomach), NAUSEA (nausea) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved and JOINT SWELLING (both ankles are swelling up,feet swollen up pretty bad in the ankles) had not resolved.            No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-307512 (Patient Link).
Age: 59.0
Sex: M
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Inappropriate schedule of vaccine administered; swelling on arm from the second dose,; both ankles are swelling up,feet swollen up pretty bad in the ankles; dizziness; sick stomach; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling on arm from the second dose,), JOINT SWELLING (both ankles are swelling up,feet swollen up pretty bad in the ankles), DIZZINESS (dizziness), ABDOMINAL DISCOMFORT (sick stomach) and NAUSEA (nausea) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C021A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Blood pressure. Concomitant products included LISINOPRIL, AMLODIPINE and DILTIAZEM for Blood pressure abnormal, TRAMADOL for Pain, PANTOPRAZOLE for Stomach discomfort, PRAVASTATIN for an unknown indication.   On 18-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Sep-2021, the patient experienced PERIPHERAL SWELLING (swelling on arm from the second dose,), JOINT SWELLING (both ankles are swelling up,feet swollen up pretty bad in the ankles), DIZZINESS (dizziness), ABDOMINAL DISCOMFORT (sick stomach) and NAUSEA (nausea). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). At the time of the report, PERIPHERAL SWELLING (swelling on arm from the second dose,), DIZZINESS (dizziness), ABDOMINAL DISCOMFORT (sick stomach), NAUSEA (nausea) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved and JOINT SWELLING (both ankles are swelling up,feet swollen up pretty bad in the ankles) had not resolved.            No concomitant medications were reported.  No treatment medications were reported.   This case was linked to MOD-2021-307512 (Patient Link).
Sex: U
Vaccine: COVID19
Symptoms: Abnormal dreams, Therapeutic response unexpected
Clinical narrative: More vivid dreams/the dreams are so surreal; memory is sharper; This spontaneous case was reported by a consumer and describes the occurrence of ABNORMAL DREAMS (More vivid dreams/the dreams are so surreal) and THERAPEUTIC RESPONSE UNEXPECTED (memory is sharper) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABNORMAL DREAMS (More vivid dreams/the dreams are so surreal) and THERAPEUTIC RESPONSE UNEXPECTED (memory is sharper). At the time of the report, ABNORMAL DREAMS (More vivid dreams/the dreams are so surreal) and THERAPEUTIC RESPONSE UNEXPECTED (memory is sharper) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Sex: U
Vaccine: COVID19
Symptoms: Illness
Clinical narrative: getting sick; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (getting sick) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (getting sick). At the time of the report, ILLNESS (getting sick) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Patient stated that she talked to a couple people of her age that had Covid and the vaccine and had terrible  experience of getting sick again.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Burning sensation, COVID-19, Vaccination site pain
Clinical narrative: I got COVID; It started with my nose burning; sore arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (I got COVID), BURNING SENSATION (It started with my nose burning) and VACCINATION SITE PAIN (sore arm at the injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011D21A) for COVID-19 vaccination.     No Medical History information was reported.    On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Aug-2021, the patient experienced VACCINATION SITE PAIN (sore arm at the injection site). On 17-Aug-2021, the patient experienced COVID-19 (I got COVID) and BURNING SENSATION (It started with my nose burning). At the time of the report, COVID-19 (I got COVID), BURNING SENSATION (It started with my nose burning) and VACCINATION SITE PAIN (sore arm at the injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medication was provided.  The patient had a sore arm at the injection site.   On 17-Aug-2021, the patient had positive diagnosis of Covid-19. "My test came back positive." "It started with my nose burning. I thought I had a sinus infection. I had congestion, a fever for 2-3 days" (she didn't take her temperature), "and I lost taste and smell for just a few days."  No treatment information was provided.  Company Comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.
Age: 47.0
Sex: F
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: Patient received expired 3rd dose of the Moderna vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received expired 3rd dose of the Moderna vaccine) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 31-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received expired 3rd dose of the Moderna vaccine). On 31-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Patient received expired 3rd dose of the Moderna vaccine) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications were provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: some kind of reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (some kind of reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (some kind of reaction). At the time of the report, VACCINATION SITE REACTION (some kind of reaction) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. No Treatment medications were reported.
Age: 83.0
Sex: M
Vaccine: COVID19
Symptoms: Influenza, Pain, Renal disorder, Respiratory disorder, Thirst
Clinical narrative: Trouble in his kidneys; pain; Feeling like he has the flu; Terrible thirsty; Breathing problems; This spontaneous case was reported by a consumer and describes the occurrence of RENAL DISORDER (Trouble in his kidneys), PAIN (pain), INFLUENZA (Feeling like he has the flu), THIRST (Terrible thirsty) and RESPIRATORY DISORDER (Breathing problems) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 52921a) for COVID-19 vaccination.     Concomitant products included "10-20 meds" and "asthma medication" for an unknown indication.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Sep-2021, the patient experienced RENAL DISORDER (Trouble in his kidneys), PAIN (pain), INFLUENZA (Feeling like he has the flu), THIRST (Terrible thirsty) and RESPIRATORY DISORDER (Breathing problems). At the time of the report, RENAL DISORDER (Trouble in his kidneys), PAIN (pain), INFLUENZA (Feeling like he has the flu), THIRST (Terrible thirsty) and RESPIRATORY DISORDER (Breathing problems) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.  Treatment information was not reported.