chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 52.0
Sex: M
Vaccine: COVID19
Symptoms: Back pain, Hypoaesthesia, Peripheral coldness
Clinical narrative: Numbness in the left side of the body and he cannot feel anything in his left side; Left foot feels cold; Back pain; This spontaneous case was reported by a nurse and describes the occurrence of HYPOAESTHESIA (Numbness in the left side of the body and he cannot feel anything in his left side), PERIPHERAL COLDNESS (Left foot feels cold) and BACK PAIN (Back pain) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017B21A and 046B21A) for COVID-19 immunisation.     No medication history was provided.  Concurrent medical conditions included Allergic reaction to antibiotics (Keflex).   On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Apr-2021, the patient experienced HYPOAESTHESIA (Numbness in the left side of the body and he cannot feel anything in his left side), PERIPHERAL COLDNESS (Left foot feels cold) and BACK PAIN (Back pain). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Symptomatic treatment, at an unspecified dose and frequency and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) ongoing since an unknown date for Vitamin supplementation, at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (Numbness in the left side of the body and he cannot feel anything in his left side), PERIPHERAL COLDNESS (Left foot feels cold) and BACK PAIN (Back pain) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant medication use was unknown   This case was linked to MOD-2021-155226 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Medication allergies have been added. HCP contact information (fax no.) has been added. On 24-Jun-2021: Non-Significant Follow-up added
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Pain in extremity
Clinical narrative: Tired; Arm hurt; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 20-May-2021 and was forwarded to Moderna on 20-May-2021.    This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm hurt) and FATIGUE (Tired) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 00621A) 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 PAIN IN EXTREMITY (Arm hurt) and FATIGUE (Tired). At the time of the report, PAIN IN EXTREMITY (Arm hurt) and FATIGUE (Tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided. Treatment medications were unknown.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling
Clinical narrative: Swelling of hands; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swelling of hands) 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 17-May-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 an unknown date, the patient experienced PERIPHERAL SWELLING (Swelling of hands). At the time of the report, PERIPHERAL SWELLING (Swelling of hands) outcome was unknown.            Concomitant product use was not provided.  Treatment information was not provided.  Action taken with mRNA-1273 in response to the events was  not applicable.   Reporter did not allow further contact
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: didn't receive the second dose >42 days; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (didn't receive the second dose >42 days) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 25-Jan-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 (didn't receive the second dose >42 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (didn't receive the second dose >42 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   No concomitant medication was provided.  No treatment details were provided.
Age: 21.0
Sex: M
Vaccine: COVID19
Symptoms: Chest pain, Myalgia, Pain
Clinical narrative: weird pain right beneath chest  in upper part  of ribs; had pain whenever turn back , lift or push out of the bed; pain right beneath chest  in upper part  of ribs and also right behind the back; body sore/  body ache; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (weird pain right beneath chest  in upper part  of ribs), PAIN (had pain whenever turn back , lift or push out of the bed), PAIN (pain right beneath chest  in upper part  of ribs and also right behind the back) and MYALGIA (body sore/  body ache) in a 21-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026c21a) for COVID-19 vaccination.     No Medical History information was reported.    On 12-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (weird pain right beneath chest  in upper part  of ribs), PAIN (had pain whenever turn back , lift or push out of the bed), PAIN (pain right beneath chest  in upper part  of ribs and also right behind the back) and MYALGIA (body sore/  body ache). At the time of the report, CHEST PAIN (weird pain right beneath chest  in upper part  of ribs), PAIN (had pain whenever turn back , lift or push out of the bed), PAIN (pain right beneath chest  in upper part  of ribs and also right behind the back) and MYALGIA (body sore/  body ache) outcome was unknown.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: bigger in size/; warm to touch; feeling ache; having real red arm at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (warm to touch), PAIN (feeling ache), VACCINATION SITE ERYTHEMA (having real red arm at injection site) and VACCINATION SITE SWELLING (bigger in size/) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, the patient experienced VACCINATION SITE WARMTH (warm to touch), PAIN (feeling ache) and VACCINATION SITE ERYTHEMA (having real red arm at injection site). On an unknown date, the patient experienced VACCINATION SITE SWELLING (bigger in size/). At the time of the report, VACCINATION SITE WARMTH (warm to touch), PAIN (feeling ache), VACCINATION SITE ERYTHEMA (having real red arm at injection site) and VACCINATION SITE SWELLING (bigger in size/) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were provided. No treatment medications were provided.   Reporter did not allow further contact
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Haven't received second dose/Missed step 2 of moderna vaccine; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Haven't received second dose/Missed step 2 of moderna vaccine) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022M20A) for COVID-19 vaccination.     Concurrent medical conditions included Type II diabetes mellitus, Hyperlipidemia, Hypothyroidism, Parkinson's disease, Major depression, Allergy to antibiotic (Sulfa.) and Allergy to antibiotic (Tetracyclines.). Concomitant products included LEVOTHYROXINE SODIUM (LEVOTHYROXIN) for Hypothyroidism, VALPROATE SEMISODIUM (DEPAKOTE) for Major depression, VENLAFAXINE HYDROCHLORIDE (EFFEXOR) for Major depressive disorder, ASA for Prophylaxis, METFORMIN for Type II diabetes mellitus.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Haven't received second dose/Missed step 2 of moderna vaccine). On 01-Apr-2021, PRODUCT DOSE OMISSION ISSUE (Haven't received second dose/Missed step 2 of moderna vaccine) 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 considered PRODUCT DOSE OMISSION ISSUE (Haven't received second dose/Missed step 2 of moderna vaccine) to be not related.    No treatment medication was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-154614 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Patient demographic details, medical history, allergy information, concomitant medications added.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-154614:same reporter case
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Decreased activity, Fatigue, Headache, Illness, Myalgia
Clinical narrative: Real sick; Couldn't really move; Fatigue; Headache; Sore feet and hands and body aches; Pain in the arm; Swelling and pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in the arm), PERIPHERAL SWELLING (Swelling and pain in the arm), ILLNESS (Real sick), DECREASED ACTIVITY (Couldn't really move) and MYALGIA (Sore feet and hands and body aches) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History Information was Reported.     On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021, the patient experienced PAIN IN EXTREMITY (pain in the arm), PERIPHERAL SWELLING (Swelling and pain in the arm), MYALGIA (Sore feet and hands and body aches) and HEADACHE (Headache). On 20-May-2021, the patient experienced FATIGUE (Fatigue). On an unknown date, the patient experienced ILLNESS (Real sick) and DECREASED ACTIVITY (Couldn't really move). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (pain in the arm), PERIPHERAL SWELLING (Swelling and pain in the arm), ILLNESS (Real sick), MYALGIA (Sore feet and hands and body aches), FATIGUE (Fatigue) and HEADACHE (Headache) was resolving and DECREASED ACTIVITY (Couldn't really move) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Med Info Agent: No concomitant medication were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-154410 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: FUP TCR included additional events and updated outcome of the events.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-154410:Patient's wife
Age: 54.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity, Peripheral swelling
Clinical narrative: Real sick; Couldn't really move; Fatigue; Headache; Sore feet and hands and body aches; Pain in the arm; Swelling and pain in the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in the arm), PERIPHERAL SWELLING (Swelling and pain in the arm), ILLNESS (Real sick), DECREASED ACTIVITY (Couldn't really move) and MYALGIA (Sore feet and hands and body aches) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History Information was Reported.     On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-May-2021, the patient experienced PAIN IN EXTREMITY (pain in the arm), PERIPHERAL SWELLING (Swelling and pain in the arm), MYALGIA (Sore feet and hands and body aches) and HEADACHE (Headache). On 20-May-2021, the patient experienced FATIGUE (Fatigue). On an unknown date, the patient experienced ILLNESS (Real sick) and DECREASED ACTIVITY (Couldn't really move). The patient was treated with IBUPROFEN at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (pain in the arm), PERIPHERAL SWELLING (Swelling and pain in the arm), ILLNESS (Real sick), MYALGIA (Sore feet and hands and body aches), FATIGUE (Fatigue) and HEADACHE (Headache) was resolving and DECREASED ACTIVITY (Couldn't really move) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Med Info Agent: No concomitant medication were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-154410 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: FUP TCR included additional events and updated outcome of the events.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-154410:Patient's wife
Sex: F
Vaccine: COVID19
Symptoms: Dysstasia, Fatigue, Vertigo
Clinical narrative: could not stand up after 2nd dose; strong vertigos after 2nd dose; great fatigue after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of DYSSTASIA (could not stand up after 2nd dose), VERTIGO (strong vertigos after 2nd dose) and FATIGUE (great fatigue after 2nd 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 18-May-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 an unknown date, the patient experienced DYSSTASIA (could not stand up after 2nd dose), VERTIGO (strong vertigos after 2nd dose) and FATIGUE (great fatigue after 2nd dose). At the time of the report, DYSSTASIA (could not stand up after 2nd dose), VERTIGO (strong vertigos after 2nd dose) and FATIGUE (great fatigue after 2nd dose) outcome was unknown.            Concomitant medication list was not provided. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not applicable.   This case was linked to CH-MODERNATX, INC.-MOD-2021-154325, CH-MODERNATX, INC.-MOD-2021-154241, CH-MODERNATX, INC.-MOD-2021-155361, CH-MODERNATX, INC.-MOD-2021-155504 (E2B Linked Report).; Sender's Comments:  CH-MODERNATX, INC.-MOD-2021-154325: CH-MODERNATX, INC.-MOD-2021-154241: CH-MODERNATX, INC.-MOD-2021-155361: CH-MODERNATX, INC.-MOD-2021-155504:
Age: 57.0
Sex: M
Vaccine: COVID19, COVID19
Symptoms: Product administration error
Clinical narrative: Received Pfizer vaccine for second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT ADMINISTRATION ERROR (Received Pfizer vaccine for second dose) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048BZ1A) for COVID-19 vaccination.    Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination.    No medical history was provided by the reporter.  Concomitant products included DULAGLUTIDE (TRULICITY), GLIPIZIDE and METFORMIN for an unknown indication.   On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage form. On 19-May-2021, the patient experienced PRODUCT ADMINISTRATION ERROR (Received Pfizer vaccine for second dose). On 19-May-2021, PRODUCT ADMINISTRATION ERROR (Received Pfizer vaccine for second dose) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: 62 days since she had the first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (62 days since she had the first 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 15-May-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 (62 days since she had the first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (62 days since she had the first dose) 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 treatment information was provided. No concomitant medication were reported.  The patient would be 62 days since had the first dose. Pharmacist did not had any more information about the patient because the patient got the first dose from another location.   Reporter did not allow further contact
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: 2nd dose not administered on day 58 after the first dose; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (2nd dose not administered on day 58 after the first dose) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 24-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 PRODUCT DOSE OMISSION ISSUE (2nd dose not administered on day 58 after the first dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (2nd dose not administered on day 58 after the first dose) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   no concomitant medications are reported.
Age: 50.0
Sex: U
Vaccine: COVID19
Symptoms: Expired product administered
Clinical narrative: administered past the 12 hour mark,administered at 3:20pm yesterday 19may2021 and restarted and administrated this am 20may2021; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered past the 12 hour mark,administered at 3:20pm yesterday 19may2021 and restarted and administrated this am 20may2021) in a 50-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 immunisation.     No Medical History information was reported.    On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered past the 12 hour mark,administered at 3:20pm yesterday 19may2021 and restarted and administrated this am 20may2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered past the 12 hour mark,administered at 3:20pm yesterday 19may2021 and restarted and administrated this am 20may2021) 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.   Concomitant medication history not provided. Treatment information was unknown.
Sex: M
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: The consumers son had side effects that were over in a day; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (The consumers son had side effects that were over in a day) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (The consumers son had side effects that were over in a day). At the time of the report, VACCINATION COMPLICATION (The consumers son had side effects that were over in a day) outcome was unknown.            no concomitant drugs and treatment medications was provided.   This case was linked to US-MODERNATX, INC.-MOD-2021-155334, US-MODERNATX, INC.-MOD-2021-155959 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-155334:Sister's Case US-MODERNATX, INC.-MOD-2021-155959:Same reporter
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Tinea infection, Vaccination site pruritus
Clinical narrative: Look like a ringworm; Itching at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching at the injection site) and TINEA INFECTION (Look like a ringworm) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 017B21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concomitant products included METFORMIN for Diabetic.    On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRURITUS (Itching at the injection site) and TINEA INFECTION (Look like a ringworm). At the time of the report, PRURITUS (Itching at the injection site) and TINEA INFECTION (Look like a ringworm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment drugs were reported. Safety consent to follow up with the patient received
Age: 23.0
Sex: F
Vaccine: COVID19
Symptoms: Hot flush, Vaccination site mass
Clinical narrative: lump in the left arm; hot flashes almost immediately after receiving the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HOT FLUSH (hot flashes almost immediately after receiving the vaccine) and VACCINATION SITE MASS (lump in the left arm) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, the patient experienced HOT FLUSH (hot flashes almost immediately after receiving the vaccine). On 20-May-2021, the patient experienced VACCINATION SITE MASS (lump in the left arm). On 12-May-2021, HOT FLUSH (hot flashes almost immediately after receiving the vaccine) had resolved. At the time of the report, VACCINATION SITE MASS (lump in the left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   NO CONCOMITANT MEDICATION WERE USED. NO TREATMENT DRUGS WERE GIVEN
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus
Clinical narrative: A few days after the first vaccine, her left arm was itchy; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PRURITUS (A few days after the first vaccine, her left arm was itchy) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029KC0A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetes, Heart disease, unspecified and Asthma.    On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (A few days after the first vaccine, her left arm was itchy). At the time of the report, VACCINATION SITE PRURITUS (A few days after the first vaccine, her left arm was itchy) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No concomitant medications provided. No treatment information is provided.   This case was linked to MOD-2021-083149 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Therapeutic response unexpected
Clinical narrative: No longer tired and her hair has grown back; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (No longer tired and her hair has grown back) 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 COVID-19 (COVID made her tired and her hair started to fall out.).   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 THERAPEUTIC RESPONSE UNEXPECTED (No longer tired and her hair has grown back). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (No longer tired and her hair has grown back) outcome was unknown.            No concomitant medications were provided. Treatment medications were unknown. Action taken with mRNA-1273 in response to the events was not applicable.
Sex: U
Vaccine: COVID19
Symptoms: Product temperature excursion issue
Clinical narrative: Doses administered from vial with affected temperature excursion; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered from vial with affected temperature excursion) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered from vial with affected temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Doses administered from vial with affected temperature excursion) 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.   Concomitant medications were not provided.  Reporter states that 2,340 doses experienced temperature excursion intended to be stored in freezer.
Sex: F
Vaccine: COVID19
Symptoms: Cyst, Dermatitis contact, Pain, Pruritus, Rash erythematous
Clinical narrative: "contact rash" on her forearm; left forearm. which was red with scratches,; 3 itchy bumps on the left forearm.; felt like something bit her in the arm/ painful stinging; scratching her forearm about a foot from the injection site and 2 inches from the crook of her arm/itching all over/ Started again the next day, all over the body, but no rash; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of PAIN (felt like something bit her in the arm/ painful stinging), PRURITUS (scratching her forearm about a foot from the injection site and 2 inches from the crook of her arm/itching all over/ Started again the next day, all over the body, but no rash), CYST (3 itchy bumps on the left forearm.), DERMATITIS CONTACT ("contact rash" on her forearm) and RASH ERYTHEMATOUS (left forearm. which was red with scratches,) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination.     No Medical History information was reported.    On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced PAIN (felt like something bit her in the arm/ painful stinging) and PRURITUS (scratching her forearm about a foot from the injection site and 2 inches from the crook of her arm/itching all over/ Started again the next day, all over the body, but no rash). On 07-May-2021, the patient experienced CYST (3 itchy bumps on the left forearm.). On 13-May-2021, the patient experienced DERMATITIS CONTACT ("contact rash" on her forearm) and RASH ERYTHEMATOUS (left forearm. which was red with scratches,). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) at an unspecified dose and frequency. On 16-May-2021, DERMATITIS CONTACT ("contact rash" on her forearm) outcome was unknown. At the time of the report, PAIN (felt like something bit her in the arm/ painful stinging), PRURITUS (scratching her forearm about a foot from the injection site and 2 inches from the crook of her arm/itching all over/ Started again the next day, all over the body, but no rash), CYST (3 itchy bumps on the left forearm.) and RASH ERYTHEMATOUS (left forearm. which was red with scratches,) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications was provided.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (I started getting shooting pains in the arm that I got the injection in) 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 09-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 20-May-2021, the patient experienced VACCINATION SITE PAIN (I started getting shooting pains in the arm that I got the injection in). At the time of the report, VACCINATION SITE PAIN (I started getting shooting pains in the arm that I got the injection in) outcome was unknown. No concomitant medication details were reported. Most recent FOLLOW-UP information incorporated above includes: On 30-Jun-2021: Follow-up information received on 30-JUN-2021 contains No New Information.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Headache, Thinking abnormal
Clinical narrative: losing train of thought; constant headache in the right side of his head, even to the touch; constant fatigue; This spontaneous case was reported by a pharmacist and describes the occurrence of THINKING ABNORMAL (losing train of thought), HEADACHE (constant headache in the right side of his head, even to the touch) and FATIGUE (constant fatigue) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination.     The patient's past medical history included Diabetes since an unknown date. Concomitant products included METFORMIN for Diabetes.    On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, the patient experienced THINKING ABNORMAL (losing train of thought), HEADACHE (constant headache in the right side of his head, even to the touch) and FATIGUE (constant fatigue). At the time of the report, THINKING ABNORMAL (losing train of thought), HEADACHE (constant headache in the right side of his head, even to the touch) and FATIGUE (constant fatigue) 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.   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Breast pain, Chest pain, Chills, Dizziness, Myalgia
Clinical narrative: This spontaneous case reported by a pharmacist, describes the occurrence of breast pain, chest pain, dizziness, chills and nausea in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunisation. The occurrence of additional events detailed below. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced breast pain, chest pain, dizziness, chills, nausea and myalgia (muscle pain/underarm pain). At the time of the report, breast pain, chest pain, dizziness, chills, nausea and myalgia (muscle pain/underarm pain) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. Reporter did not allow further contact.
Sex: F
Vaccine: COVID19
Symptoms: Nausea
Clinical narrative: This spontaneous case reported by a pharmacist, describes the occurrence of breast pain, chest pain, dizziness, chills and nausea in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunisation. The occurrence of additional events detailed below. No medical history reported. On an unknown date, patient received a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced breast pain, chest pain, dizziness, chills, nausea and myalgia (muscle pain/underarm pain). At the time of the report, breast pain, chest pain, dizziness, chills, nausea and myalgia (muscle pain/underarm pain) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. The reporter did not provide any causality assessments, concomitant medication or treatment information. Reporter did not allow further contact.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Off label use, Rash, Rash erythematous, Rash pruritic, Urticaria
Clinical narrative: Her original due date of Dose 2 was 05May2021 but it scheduled for 20May2021; rash on right ankle, spread upward to leg; rash as being slightly pruritic; rash as being slightly red; red bumps above the skin; This spontaneous case was reported by a patient and describes the occurrence of RASH PRURITIC (rash as being slightly pruritic), RASH ERYTHEMATOUS (rash as being slightly red), URTICARIA (red bumps above the skin), OFF LABEL USE (Her original due date of Dose 2 was 05May2021 but it scheduled for 20May2021) and RASH (rash on right ankle, spread upward to leg) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039A21A) for COVID-19 vaccination.     No medical history provided.     On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Apr-2021, the patient experienced RASH PRURITIC (rash as being slightly pruritic), RASH ERYTHEMATOUS (rash as being slightly red), URTICARIA (red bumps above the skin) and RASH (rash on right ankle, spread upward to leg). On an unknown date, the patient experienced OFF LABEL USE (Her original due date of Dose 2 was 05May2021 but it scheduled for 20May2021). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL ALLERGY [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of 10 days of bendadryl, 25 mg tablet daily; FAMOTIDINE (PEPCID [FAMOTIDINE]) at a dose of Pepcid, twice a day and CORTICOSTEROIDS (STEROIDS) from 27-Apr-2021 to 06-May-2021 at a dose of 10 day regime of Steroid taper. On 11-May-2021, RASH PRURITIC (rash as being slightly pruritic), URTICARIA (red bumps above the skin) and RASH (rash on right ankle, spread upward to leg) had resolved. At the time of the report, OFF LABEL USE (Her original due date of Dose 2 was 05May2021 but it scheduled for 20May2021) 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 provided. The patient stated that original date of Dose 2 was 05May2021,but was scheduled on 20May2021.   This case was linked to US-MODERNATX, INC.-MOD-2021-155649 (Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-155649:Cluster case
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Device connection issue, Underdose
Clinical narrative: syringe was not attached tight enough; vaccine leaked during giving the shot because the syringe was not attached tight enough; This spontaneous case was reported by a consumer and describes the occurrence of DEVICE CONNECTION ISSUE (syringe was not attached tight enough) and UNDERDOSE (vaccine leaked during giving the shot because the syringe was not attached tight enough) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, the patient experienced DEVICE CONNECTION ISSUE (syringe was not attached tight enough) and UNDERDOSE (vaccine leaked during giving the shot because the syringe was not attached tight enough). At the time of the report, DEVICE CONNECTION ISSUE (syringe was not attached tight enough) and UNDERDOSE (vaccine leaked during giving the shot because the syringe was not attached tight enough) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       The reporter also mentioned he has not having any symptoms but his friends experience it.  Treatment information was not provided by reporter.   Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: No new information.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Fatigue, Inappropriate schedule of product administration, Myalgia
Clinical narrative: Loss of appetite; Aches; chills; Fatigue; Undisclosed reaction after receiving the 2nd dose; Second dose administered within 1 month; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Undisclosed reaction after receiving the 2nd dose), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered within 1 month), DECREASED APPETITE (Loss of appetite), MYALGIA (Aches) and CHILLS (chills) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered within 1 month). On an unknown date, the patient experienced VACCINATION COMPLICATION (Undisclosed reaction after receiving the 2nd dose), DECREASED APPETITE (Loss of appetite), MYALGIA (Aches), CHILLS (chills) and FATIGUE (Fatigue). On 17-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered within 1 month) had resolved. At the time of the report, VACCINATION COMPLICATION (Undisclosed reaction after receiving the 2nd dose), DECREASED APPETITE (Loss of appetite), MYALGIA (Aches), CHILLS (chills) and FATIGUE (Fatigue) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable. Concomitant drug was not reported. Treatment details was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Additional information was received from the initial reporter: Date of second dose was updated and vaccine batch number added. Ne events Myalgia, Decreased appetite, Chills Fatigue and Inappropriate schedule of product administration were added.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination complication
Clinical narrative: Loss of appetite; Aches; chills; Fatigue; Undisclosed reaction after receiving the 2nd dose; Second dose administered within 1 month; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Undisclosed reaction after receiving the 2nd dose), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered within 1 month), DECREASED APPETITE (Loss of appetite), MYALGIA (Aches) and CHILLS (chills) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026A21) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered within 1 month). On an unknown date, the patient experienced VACCINATION COMPLICATION (Undisclosed reaction after receiving the 2nd dose), DECREASED APPETITE (Loss of appetite), MYALGIA (Aches), CHILLS (chills) and FATIGUE (Fatigue). On 17-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose administered within 1 month) had resolved. At the time of the report, VACCINATION COMPLICATION (Undisclosed reaction after receiving the 2nd dose), DECREASED APPETITE (Loss of appetite), MYALGIA (Aches), CHILLS (chills) and FATIGUE (Fatigue) outcome was unknown.            Action taken with mRNA-1273 in response to the event was not applicable. Concomitant drug was not reported. Treatment details was not reported.   Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Additional information was received from the initial reporter: Date of second dose was updated and vaccine batch number added. Ne events Myalgia, Decreased appetite, Chills Fatigue and Inappropriate schedule of product administration were added.
Age: 89.0
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: Received two doses of Pfizer vaccine and was accidentally given the MODERNA vaccine instead of the shingles vaccine today; This spontaneous case was reported by a pharmacist and describes the occurrence of WRONG PRODUCT ADMINISTERED (Received two doses of Pfizer vaccine and was accidentally given the MODERNA vaccine instead of the shingles vaccine today) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036C21A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-May-2021, the patient experienced WRONG PRODUCT ADMINISTERED (Received two doses of Pfizer vaccine and was accidentally given the MODERNA vaccine instead of the shingles vaccine today). At the time of the report, WRONG PRODUCT ADMINISTERED (Received two doses of Pfizer vaccine and was accidentally given the MODERNA vaccine instead of the shingles vaccine today) 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.
Sex: F
Vaccine: COVID19
Symptoms: Intentional product use issue
Clinical narrative: More than 5 month after 1 dose/ was not able to get 2nd vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (More than 5 month after 1 dose/ was not able to get 2nd vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation.     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 INTENTIONAL PRODUCT USE ISSUE (More than 5 month after 1 dose/ was not able to get 2nd vaccine). At the time of the report, INTENTIONAL PRODUCT USE ISSUE (More than 5 month after 1 dose/ was not able to get 2nd vaccine) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was temporarily withheld on an unknown date.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   No concomitant medications were provided. Treatment medications were unknown.  The reporter stated that the patient was not able to get 2nd vaccine due to unforeseen circumstances.