chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature increased, Chills, Delusion, Feeling of body temperature change, Hyperhidrosis
Clinical narrative: Flue like symptoms but only stronger; system completely blocked; Sweats; Took it's clothes off because it was cold and hot; Delusional because of the fever; Rash on the arm; Chills, Shivering; Fever of 40°C; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flue like symptoms but only stronger), UNEVALUABLE EVENT (system completely blocked), HYPERHIDROSIS (Sweats), FEELING OF BODY TEMPERATURE CHANGE (Took it's clothes off because it was cold and hot) and DELUSION (Delusional because of the fever) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in July 2020. Concurrent medical conditions included Hypertension.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flue like symptoms but only stronger), UNEVALUABLE EVENT (system completely blocked), HYPERHIDROSIS (Sweats), FEELING OF BODY TEMPERATURE CHANGE (Took it's clothes off because it was cold and hot), DELUSION (Delusional because of the fever), RASH (Rash on the arm), CHILLS (Chills, Shivering) and PYREXIA (Fever of 40°C). At the time of the report, INFLUENZA LIKE ILLNESS (Flue like symptoms but only stronger), UNEVALUABLE EVENT (system completely blocked), HYPERHIDROSIS (Sweats), FEELING OF BODY TEMPERATURE CHANGE (Took it's clothes off because it was cold and hot), DELUSION (Delusional because of the fever), RASH (Rash on the arm), CHILLS (Chills, Shivering) and PYREXIA (Fever of 40°C) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature increased: 40 degree Celsius (Inconclusive) 40°C.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was doing ok at the time of report.  Products known to have been used by the patient, within two weeks prior to the event, included unspecified blood pressure pills. No treatment information was provided.   This case was linked to MOD-2021-049333 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Clinical course information.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, Pyrexia, Rash, Unevaluable event
Clinical narrative: Flue like symptoms but only stronger; system completely blocked; Sweats; Took it's clothes off because it was cold and hot; Delusional because of the fever; Rash on the arm; Chills, Shivering; Fever of 40°C; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flue like symptoms but only stronger), UNEVALUABLE EVENT (system completely blocked), HYPERHIDROSIS (Sweats), FEELING OF BODY TEMPERATURE CHANGE (Took it's clothes off because it was cold and hot) and DELUSION (Delusional because of the fever) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038K20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 in July 2020. Concurrent medical conditions included Hypertension.   On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Flue like symptoms but only stronger), UNEVALUABLE EVENT (system completely blocked), HYPERHIDROSIS (Sweats), FEELING OF BODY TEMPERATURE CHANGE (Took it's clothes off because it was cold and hot), DELUSION (Delusional because of the fever), RASH (Rash on the arm), CHILLS (Chills, Shivering) and PYREXIA (Fever of 40°C). At the time of the report, INFLUENZA LIKE ILLNESS (Flue like symptoms but only stronger), UNEVALUABLE EVENT (system completely blocked), HYPERHIDROSIS (Sweats), FEELING OF BODY TEMPERATURE CHANGE (Took it's clothes off because it was cold and hot), DELUSION (Delusional because of the fever), RASH (Rash on the arm), CHILLS (Chills, Shivering) and PYREXIA (Fever of 40°C) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature increased: 40 degree Celsius (Inconclusive) 40°C.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient was doing ok at the time of report.  Products known to have been used by the patient, within two weeks prior to the event, included unspecified blood pressure pills. No treatment information was provided.   This case was linked to MOD-2021-049333 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Clinical course information.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Bladder pain, Pain in extremity
Clinical narrative: Bladder pain; arm pain; This spontaneous case was reported by a consumer and describes the occurrence of BLADDER PAIN (Bladder pain) and PAIN IN EXTREMITY (arm pain) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included Bladder cancer in June 2020. Concomitant products included OLODATEROL HYDROCHLORIDE, TIOTROPIUM BROMIDE MONOHYDRATE (STIOLTO RESPIMAT) for an unknown indication.   On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 09-Mar-2021, the patient experienced BLADDER PAIN (Bladder pain) and PAIN IN EXTREMITY (arm pain). On 15-Mar-2021, BLADDER PAIN (Bladder pain) had resolved. At the time of the report, PAIN IN EXTREMITY (arm pain) outcome was unknown.            Most recent FOLLOW-UP information incorporated above includes: On 08-May-2021: No significant information was received. On 08-May-2021: Outcome of bladder pain updated.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination site pain
Clinical narrative: Develop a swelling in the lymph node area; Armpit was tender and sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Armpit was tender and sore) and LYMPHADENOPATHY (Develop a swelling in the lymph node area) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION SITE PAIN (Armpit was tender and sore). On 14-Mar-2021, the patient experienced LYMPHADENOPATHY (Develop a swelling in the lymph node area). At the time of the report, VACCINATION SITE PAIN (Armpit was tender and sore) and LYMPHADENOPATHY (Develop a swelling in the lymph node area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported. The patient did not take any treatment medication.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Oropharyngeal pain
Clinical narrative: Soreness in throat; Headache; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Soreness in throat) and HEADACHE (Headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ATORVASTATIN CALCIUM (LIPITOR) and GLIPIZIDE for an unknown indication.    On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced OROPHARYNGEAL PAIN (Soreness in throat) and HEADACHE (Headache). On 15-Jan-2021, OROPHARYNGEAL PAIN (Soreness in throat) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medication was provided.  No medical history information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 06-Jul-2021: No new information.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Fatigue, Lymphadenopathy, Malaise
Clinical narrative: Felt lymph node under left arm on; Felt like she was getting sick; Mild chills; Dizzy; Felt fatigued; Super sleepy; Really tired; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Super sleepy), MALAISE (Felt like she was getting sick), CHILLS (Mild chills), DIZZINESS (Dizzy) and LYMPHADENOPATHY (Felt lymph node under left arm on) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Morphine allergy).    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced SOMNOLENCE (Super sleepy) and FATIGUE (Really tired). On 12-Mar-2021, the patient experienced MALAISE (Felt like she was getting sick), CHILLS (Mild chills), DIZZINESS (Dizzy) and FATIGUE (Felt fatigued). On 14-Mar-2021, the patient experienced LYMPHADENOPATHY (Felt lymph node under left arm on). At the time of the report, SOMNOLENCE (Super sleepy), MALAISE (Felt like she was getting sick), CHILLS (Mild chills), DIZZINESS (Dizzy), LYMPHADENOPATHY (Felt lymph node under left arm on), FATIGUE (Really tired) and FATIGUE (Felt fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Sex: F
Vaccine: COVID19
Symptoms: Somnolence
Clinical narrative: Felt lymph node under left arm on; Felt like she was getting sick; Mild chills; Dizzy; Felt fatigued; Super sleepy; Really tired; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Super sleepy), MALAISE (Felt like she was getting sick), CHILLS (Mild chills), DIZZINESS (Dizzy) and LYMPHADENOPATHY (Felt lymph node under left arm on) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Drug allergy (Morphine allergy).    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, the patient experienced SOMNOLENCE (Super sleepy) and FATIGUE (Really tired). On 12-Mar-2021, the patient experienced MALAISE (Felt like she was getting sick), CHILLS (Mild chills), DIZZINESS (Dizzy) and FATIGUE (Felt fatigued). On 14-Mar-2021, the patient experienced LYMPHADENOPATHY (Felt lymph node under left arm on). At the time of the report, SOMNOLENCE (Super sleepy), MALAISE (Felt like she was getting sick), CHILLS (Mild chills), DIZZINESS (Dizzy), LYMPHADENOPATHY (Felt lymph node under left arm on), FATIGUE (Really tired) and FATIGUE (Felt fatigued) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 80.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Pain in extremity
Clinical narrative: Diarrhea; Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm) and DIARRHOEA in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     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 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm). On 01-Mar-2021, the patient experienced DIARRHOEA. On 01-Mar-2021, PAIN IN EXTREMITY (Sore Arm) had resolved. On 02-Mar-2021, DIARRHOEA had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.  No treatment details were provided.
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lip erythema, Lip swelling, Swollen tongue, Tachycardia
Clinical narrative: Sudden tachycardia; Tongue swollen; Tongue red and burned; Lips swollen; Lips red and burned; Headache; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Sudden tachycardia), SWOLLEN TONGUE (Tongue swollen), TONGUE ERYTHEMA (Tongue red and burned), LIP SWELLING (Lips swollen) and LIP ERYTHEMA (Lips red and burned) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Jan-2021, the patient experienced TACHYCARDIA (Sudden tachycardia), SWOLLEN TONGUE (Tongue swollen), TONGUE ERYTHEMA (Tongue red and burned), LIP SWELLING (Lips swollen), LIP ERYTHEMA (Lips red and burned) and HEADACHE (Headache). The patient was treated with IBUPROFEN for Pain relief, at a dose of 1 dosage form. At the time of the report, TACHYCARDIA (Sudden tachycardia), SWOLLEN TONGUE (Tongue swollen), LIP SWELLING (Lips swollen) and HEADACHE (Headache) was resolving and TONGUE ERYTHEMA (Tongue red and burned) and LIP ERYTHEMA (Lips red and burned) had not resolved. Not Provided
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Tongue erythema
Clinical narrative: Sudden tachycardia; Tongue swollen; Tongue red and burned; Lips swollen; Lips red and burned; Headache; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (Sudden tachycardia), SWOLLEN TONGUE (Tongue swollen), TONGUE ERYTHEMA (Tongue red and burned), LIP SWELLING (Lips swollen) and LIP ERYTHEMA (Lips red and burned) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Jan-2021, the patient experienced TACHYCARDIA (Sudden tachycardia), SWOLLEN TONGUE (Tongue swollen), TONGUE ERYTHEMA (Tongue red and burned), LIP SWELLING (Lips swollen), LIP ERYTHEMA (Lips red and burned) and HEADACHE (Headache). The patient was treated with IBUPROFEN for Pain relief, at a dose of 1 dosage form. At the time of the report, TACHYCARDIA (Sudden tachycardia), SWOLLEN TONGUE (Tongue swollen), LIP SWELLING (Lips swollen) and HEADACHE (Headache) was resolving and TONGUE ERYTHEMA (Tongue red and burned) and LIP ERYTHEMA (Lips red and burned) had not resolved. Not Provided
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Burning sensation, Myalgia, Pain in extremity, Pyrexia
Clinical narrative: Felt burn; Her arm hurt badly, achy; Muscle pain; Joint pain; Fever; This spontaneous case was reported by an other health care professional and describes the occurrence of BURNING SENSATION (Felt burn), PAIN IN EXTREMITY (Her arm hurt badly, achy), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 18-Dec-2020.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, the patient experienced BURNING SENSATION (Felt burn), PAIN IN EXTREMITY (Her arm hurt badly, achy), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and PYREXIA (Fever). At the time of the report, BURNING SENSATION (Felt burn), PAIN IN EXTREMITY (Her arm hurt badly, achy), MYALGIA (Muscle pain), ARTHRALGIA (Joint pain) and PYREXIA (Fever) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   No relevant concomitant medications were reported.   Treatment information was not provided.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity, Pruritus
Clinical narrative: Sore arm; itching; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and PRURITUS (itching) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030A21A and 030A21A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder NOS and Hypertension.   On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 12-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and PRURITUS (itching). The patient was treated with TALC (BABY POWDER [TALC]) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm) and PRURITUS (itching) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications included unspecified thyroid and high blood pressure medications.   This case was linked to MOD-2021-135592 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Follow-up information received on 05 May 2021.Added second dose details and updated outcome of events.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache
Clinical narrative: Felt tired; Headache; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Felt tired) and HEADACHE (Headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced FATIGUE (Felt tired) and HEADACHE (Headache). At the time of the report, FATIGUE (Felt tired) and HEADACHE (Headache) outcome was unknown.        mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged.       For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessment.  Concomitant product use was not provided by the reporter. No treatment information was provided.   This case was linked to MOD-2021-044373 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Inappropriate schedule of product administration
Clinical narrative: 37 days of interval between two doses; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (37 days of interval between two doses) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No reported medical history).   On 10-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 15-Feb-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (37 days of interval between two doses). On 15-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (37 days of interval between two doses) had resolved. Not Provided          Most recent FOLLOW-UP information incorporated above includes: On 09-Apr-2021: No new information; Sender's Comments: This report refers to a case of Inappropriate Schedule Of Product Administration for mRNA-1273 (Lot number: Unknown) with no associated AEs.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Fatigue, Vaccination site erythema, Vaccination site pain, Vaccination site pruritus
Clinical narrative: dizzy spells; Feelings of vertigo; itching at injection site; fatigue; redness at injection site; pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy spells), VERTIGO (Feelings of vertigo), VACCINATION SITE PRURITUS (itching at injection site), FATIGUE (fatigue) and VACCINATION SITE ERYTHEMA (redness at injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Vertigo (During peri-menopause patient experienced occasional bouts of vertigo. These disappeared after menopause). Concurrent medical conditions included Drug allergy (Sulfa drugs), Penicillin allergy and Hypothyroidism since 01-Jan-1978. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and LIOTHYRONINE SODIUM (CYTOMEL) for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced DIZZINESS (dizzy spells), VERTIGO (Feelings of vertigo), VACCINATION SITE PRURITUS (itching at injection site), FATIGUE (fatigue), VACCINATION SITE ERYTHEMA (redness at injection site) and VACCINATION SITE PAIN (pain at injection site). On 18-Mar-2021, DIZZINESS (dizzy spells) and VERTIGO (Feelings of vertigo) had resolved. At the time of the report, VACCINATION SITE PRURITUS (itching at injection site), FATIGUE (fatigue), VACCINATION SITE ERYTHEMA (redness at injection site) and VACCINATION SITE PAIN (pain at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Reporter Email Address was added patient race Height and weight was added allergy medical history and current condition was added Outcome of the events was added from unknown to Recovered concomitant drug added 2nd dose info was added
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Vertigo
Clinical narrative: dizzy spells; Feelings of vertigo; itching at injection site; fatigue; redness at injection site; pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy spells), VERTIGO (Feelings of vertigo), VACCINATION SITE PRURITUS (itching at injection site), FATIGUE (fatigue) and VACCINATION SITE ERYTHEMA (redness at injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Vertigo (During peri-menopause patient experienced occasional bouts of vertigo. These disappeared after menopause). Concurrent medical conditions included Drug allergy (Sulfa drugs), Penicillin allergy and Hypothyroidism since 01-Jan-1978. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) and LIOTHYRONINE SODIUM (CYTOMEL) for an unknown indication.    On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Mar-2021, the patient experienced DIZZINESS (dizzy spells), VERTIGO (Feelings of vertigo), VACCINATION SITE PRURITUS (itching at injection site), FATIGUE (fatigue), VACCINATION SITE ERYTHEMA (redness at injection site) and VACCINATION SITE PAIN (pain at injection site). On 18-Mar-2021, DIZZINESS (dizzy spells) and VERTIGO (Feelings of vertigo) had resolved. At the time of the report, VACCINATION SITE PRURITUS (itching at injection site), FATIGUE (fatigue), VACCINATION SITE ERYTHEMA (redness at injection site) and VACCINATION SITE PAIN (pain at injection site) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Reporter Email Address was added patient race Height and weight was added allergy medical history and current condition was added Outcome of the events was added from unknown to Recovered concomitant drug added 2nd dose info was added
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Blood glucose decreased, Chills, Malaise, Pain, Tremor
Clinical narrative: chills and achey; low blood sugar, shaking not feeling good; low blood sugar, shaking not feeling good; Shaking; chills and achey; This spontaneous case was reported by a consumer and describes the occurrence of BLOOD GLUCOSE DECREASED (low blood sugar, shaking not feeling good), MALAISE (low blood sugar, shaking not feeling good), TREMOR (Shaking), PAIN (chills and achey) and CHILLS (chills and achey) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination.     No medical history was provided.  Concomitant products included PARACETAMOL (TYLENOL), PROBIOTICS NOS, MULTIVITAMIN [VITAMINS NOS], COLECALCIFEROL (D3), CALCIUM, BRIOBACEPT (BRIO), FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), SEMAGLUTIDE (OZEMPIC), EMPAGLIFLOZIN (JARDIANCE), IRBESARTAN, INSULIN, INSULIN LISPRO (HUMALOG), INSULIN GLARGINE (BASAGLAR), TORSEMIDE and POTASSIUM CHLORIDE for an unknown indication.    On 04-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, the patient experienced CHILLS (chills and achey). On 09-Mar-2021, the patient experienced BLOOD GLUCOSE DECREASED (low blood sugar, shaking not feeling good), MALAISE (low blood sugar, shaking not feeling good) and TREMOR (Shaking). On 10-Mar-2021, the patient experienced PAIN (chills and achey). On 05-Mar-2021, CHILLS (chills and achey) outcome was unknown. At the time of the report, BLOOD GLUCOSE DECREASED (low blood sugar, shaking not feeling good), MALAISE (low blood sugar, shaking not feeling good), TREMOR (Shaking) and PAIN (chills and achey) outcome was unknown.            Concomitant medications included Pepcid, Nexium, Digestive Enzymes and Centrum silver. Patient took two Tylenol for treatment.   Reporter did not allow further contact
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Diarrhoea
Clinical narrative: Stomach ache; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Stomach ache) and DIARRHOEA (Diarrhea) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 12-Mar-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 15-Mar-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach ache) and DIARRHOEA (Diarrhea). At the time of the report, ABDOMINAL PAIN UPPER (Stomach ache) and DIARRHOEA (Diarrhea) outcome was unknown.            No treatment medication were provided. No concomitant medication were provided. Action taken for Moderna COVID-19 Vaccine was not applicable.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Aphonia, Bronchitis, Chills, Cough, Dyspnoea
Clinical narrative: loss of voice; bronchitis; coughing that was not going away; shortness of breath; cold; had chills; This spontaneous case was reported by a consumer and describes the occurrence of APHONIA (loss of voice), BRONCHITIS (bronchitis), COUGH (coughing that was not going away), DYSPNOEA (shortness of breath) and NASOPHARYNGITIS (cold) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced APHONIA (loss of voice), BRONCHITIS (bronchitis), COUGH (coughing that was not going away), DYSPNOEA (shortness of breath), NASOPHARYNGITIS (cold) and CHILLS (had chills). The patient was treated with GUAIFENESIN (MUCINEX) for Cough, at an unspecified dose and frequency. At the time of the report, APHONIA (loss of voice), BRONCHITIS (bronchitis), COUGH (coughing that was not going away), DYSPNOEA (shortness of breath), NASOPHARYNGITIS (cold) and CHILLS (had chills) outcome was unknown.            Concomitant medications were not provided. Mucinex for the cough but it seems not to be helping a lot. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event was not applicable.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 22-May-2021: Indication added for suspect drug, Partial onset date added for all events.
Age: 74.0
Sex: M
Vaccine: COVID19
Symptoms: Nasopharyngitis
Clinical narrative: loss of voice; bronchitis; coughing that was not going away; shortness of breath; cold; had chills; This spontaneous case was reported by a consumer and describes the occurrence of APHONIA (loss of voice), BRONCHITIS (bronchitis), COUGH (coughing that was not going away), DYSPNOEA (shortness of breath) and NASOPHARYNGITIS (cold) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 029A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.   On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced APHONIA (loss of voice), BRONCHITIS (bronchitis), COUGH (coughing that was not going away), DYSPNOEA (shortness of breath), NASOPHARYNGITIS (cold) and CHILLS (had chills). The patient was treated with GUAIFENESIN (MUCINEX) for Cough, at an unspecified dose and frequency. At the time of the report, APHONIA (loss of voice), BRONCHITIS (bronchitis), COUGH (coughing that was not going away), DYSPNOEA (shortness of breath), NASOPHARYNGITIS (cold) and CHILLS (had chills) outcome was unknown.            Concomitant medications were not provided. Mucinex for the cough but it seems not to be helping a lot. The patient received both scheduled doses of mRNA-1273 prior to the event; therefore, action taken with the drug in response to the event was not applicable.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 22-May-2021: Indication added for suspect drug, Partial onset date added for all events.
Age: 49.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site mass, Vaccination site rash
Clinical narrative: small bumps on arm near injection site; muscle pain; Rash on arm; A spontaneous report was received from a consumer concerning a 49-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced myalgia (muscle pain), vaccination site mass, and vaccination site rash (rash on arm).   The patient's medical history was not provided. No relevant concomitant medications were reported.  On 9 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 03421A) Intramuscularly for prophylaxis of COVID-19 infection.  On 9 Mar 2021, the patient experienced rash on arm, small bumps on arm near injection site and muscle pain.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of events was unknown. Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 79.0
Sex: M
Vaccine: COVID19
Symptoms: Feeling abnormal, Rash erythematous, Vaccination site erythema, Vaccination site rash, Vaccination site warmth
Clinical narrative: It just felt weird; the side effect started 09MAR2021 he noticed a red rash about the size a tennis ball; The rash didn't itch , it felt little warm, the actual skin wasn't raised at all.; It has faded now to a very light pink color. Still discolored a little bit, not the way it was when he first noticed it ; It was about two colors brighter then a tomato; The rash is located Below the injection on my Upper left arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (It just felt weird), RASH ERYTHEMATOUS (the side effect started 09MAR2021 he noticed a red rash about the size a tennis ball), VACCINATION SITE WARMTH (The rash didn't itch , it felt little warm, the actual skin wasn't raised at all.), VACCINATION SITE ERYTHEMA (It has faded now to a very light pink color. Still discolored a little bit, not the way it was when he first noticed it ; It was about two colors brighter then a tomato) and VACCINATION SITE RASH (The rash is located Below the injection on my Upper left arm) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (It just felt weird), RASH ERYTHEMATOUS (the side effect started 09MAR2021 he noticed a red rash about the size a tennis ball), VACCINATION SITE WARMTH (The rash didn't itch , it felt little warm, the actual skin wasn't raised at all.), VACCINATION SITE ERYTHEMA (It has faded now to a very light pink color. Still discolored a little bit, not the way it was when he first noticed it ; It was about two colors brighter then a tomato) and VACCINATION SITE RASH (The rash is located Below the injection on my Upper left arm). At the time of the report, FEELING ABNORMAL (It just felt weird), RASH ERYTHEMATOUS (the side effect started 09MAR2021 he noticed a red rash about the size a tennis ball), VACCINATION SITE WARMTH (The rash didn't itch , it felt little warm, the actual skin wasn't raised at all.), VACCINATION SITE ERYTHEMA (It has faded now to a very light pink color. Still discolored a little bit, not the way it was when he first noticed it ; It was about two colors brighter then a tomato) and VACCINATION SITE RASH (The rash is located Below the injection on my Upper left arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided. Treatment details were not provided.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Asthenia, Feeding disorder, Myalgia, Nausea
Clinical narrative: upset stomach; no energy; could not eat; smell sensitivity; muscle pain; nausea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (upset stomach), ASTHENIA (no energy), FEEDING DISORDER (could not eat), PAROSMIA (smell sensitivity) and MYALGIA (muscle pain) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included OLANZAPINE, LOSARTAN, LORATADINE, PARACETAMOL (TYLENOL), ATORVASTATIN, AMLODIPINE and OMEPRAZOLE for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced ABDOMINAL DISCOMFORT (upset stomach), ASTHENIA (no energy), FEEDING DISORDER (could not eat), PAROSMIA (smell sensitivity), MYALGIA (muscle pain) and NAUSEA (nausea). On 03-Mar-2021, ABDOMINAL DISCOMFORT (upset stomach), ASTHENIA (no energy), FEEDING DISORDER (could not eat), PAROSMIA (smell sensitivity), MYALGIA (muscle pain) and NAUSEA (nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. Other relevant medication history included flu.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Parosmia
Clinical narrative: upset stomach; no energy; could not eat; smell sensitivity; muscle pain; nausea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (upset stomach), ASTHENIA (no energy), FEEDING DISORDER (could not eat), PAROSMIA (smell sensitivity) and MYALGIA (muscle pain) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided by the reporter.  Concomitant products included OLANZAPINE, LOSARTAN, LORATADINE, PARACETAMOL (TYLENOL), ATORVASTATIN, AMLODIPINE and OMEPRAZOLE for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced ABDOMINAL DISCOMFORT (upset stomach), ASTHENIA (no energy), FEEDING DISORDER (could not eat), PAROSMIA (smell sensitivity), MYALGIA (muscle pain) and NAUSEA (nausea). On 03-Mar-2021, ABDOMINAL DISCOMFORT (upset stomach), ASTHENIA (no energy), FEEDING DISORDER (could not eat), PAROSMIA (smell sensitivity), MYALGIA (muscle pain) and NAUSEA (nausea) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment information was provided. Other relevant medication history included flu.
Age: 87.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Flatulence
Clinical narrative: EXPLOSIVE DIARRHEA; GAS; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (EXPLOSIVE DIARRHEA) and FLATULENCE (GAS) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-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 DIARRHOEA (EXPLOSIVE DIARRHEA) and FLATULENCE (GAS). At the time of the report, DIARRHOEA (EXPLOSIVE DIARRHEA) and FLATULENCE (GAS) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported.  No treatment information was provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Hyperhidrosis
Clinical narrative: sweating at night; chills; headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating at night), CHILLS (chills) and HEADACHE (headache) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (no reported medical history). Concomitant products included LOSARTAN for an unknown indication.    On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Mar-2021, the patient experienced HYPERHIDROSIS (sweating at night), CHILLS (chills) and HEADACHE (headache). At the time of the report, HYPERHIDROSIS (sweating at night) and CHILLS (chills) had not resolved and HEADACHE (headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Treatment medication included fluticasone.
Age: 85.0
Sex: M
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in an 85-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No concomitant medications were reported.  No laboratory details were  provided.  No treatment medications were reported.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling
Clinical narrative: Injection site became swollen; Injection site red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Injection site became swollen) and VACCINATION SITE ERYTHEMA (Injection site red) 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 05-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, the patient experienced VACCINATION SITE SWELLING (Injection site became swollen) and VACCINATION SITE ERYTHEMA (Injection site red). At the time of the report, VACCINATION SITE SWELLING (Injection site became swollen) and VACCINATION SITE ERYTHEMA (Injection site red) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 60.0
Sex: M
Vaccine: COVID19
Symptoms: Balance disorder, Dizziness, Nausea
Clinical narrative: Dizzy; Feeling off balance; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), BALANCE DISORDER (Feeling off balance) and NAUSEA (Nausea) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination.   No Medical History information was reported.    On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, the patient experienced DIZZINESS (Dizzy), BALANCE DISORDER (Feeling off balance) and NAUSEA (Nausea). At the time of the report, DIZZINESS (Dizzy), BALANCE DISORDER (Feeling off balance) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. No treatment information was provided.
Age: 60.0
Sex: F
Vaccine: COVID19
Symptoms: Hypersomnia, Pain, Pyrexia
Clinical narrative: in bed for over 12 hours; fever; achy; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSOMNIA (in bed for over 12 hours), PYREXIA (fever) and PAIN (achy) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 841120A) for COVID-19 vaccination.     No relevant medical history reported.  Concomitant products included ZOLPIDEM for an unknown indication.   On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced HYPERSOMNIA (in bed for over 12 hours), PYREXIA (fever) and PAIN (achy). At the time of the report, HYPERSOMNIA (in bed for over 12 hours), PYREXIA (fever) and PAIN (achy) outcome was unknown. Not Provided          Treatment medication not reported. Action taken with mRNA-1273 was not applicable.
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Injection site pain
Clinical narrative: pain at injection (left); This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 15-Mar-2021 and was forwarded to Moderna on 15-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (pain at injection (left)) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 026A21A) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 13-Mar-2021, the patient experienced INJECTION SITE PAIN (pain at injection (left)). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, INJECTION SITE PAIN (pain at injection (left)) outcome was unknown. Not Provided          no concomitant medication provided.  Action taken with mRNA-1273 in response to the events was not Applicable.   Most recent FOLLOW-UP information incorporated above includes: On 11-May-2021: Contact details updated.
Age: 72.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Vaccination site pain
Clinical narrative: Fever; Chills; soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills) and VACCINATION SITE PAIN (soreness at the injection site) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 036A21A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 on 15-Nov-2020.   On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 2 dosage form. On 09-Mar-2021, the patient experienced PYREXIA (Fever), CHILLS (Chills) and VACCINATION SITE PAIN (soreness at the injection site). At the time of the report, PYREXIA (Fever), CHILLS (Chills) and VACCINATION SITE PAIN (soreness at the injection site) outcome was unknown.            No Concomitant Medications were provided. No Treatment History was provided.