chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Asthenia, Fatigue
Clinical narrative: feeling really tired; feeling run down; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (feeling really tired) and ASTHENIA (feeling run down) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010821A) for COVID-19 vaccination.     The patient's past medical history included No adverse event. Concomitant products included LISINOPRIL, CARVEDILOL, MONTELUKAST, ROSUVASTATIN, SALBUTAMOL (ALBUTEROL HFA), TIOTROPIUM BROMIDE (SPIRIVA) and BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for an unknown indication.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Feb-2021, the patient experienced FATIGUE (feeling really tired) and ASTHENIA (feeling run down). At the time of the report, FATIGUE (feeling really tired) and ASTHENIA (feeling run down) outcome was unknown.      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021:  Patient denied to fill ADR and denied for further follow up. No further follow up required.
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Influenza like illness, Pain in extremity, Peripheral swelling
Clinical narrative: swollen arm; painful arm; flu-like symptoms; red arm; horrible headache; exhausted; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen arm), PAIN IN EXTREMITY (painful arm), INFLUENZA LIKE ILLNESS (flu-like symptoms), VACCINATION SITE ERYTHEMA (red arm) and HEADACHE (horrible headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced PERIPHERAL SWELLING (swollen arm), PAIN IN EXTREMITY (painful arm), INFLUENZA LIKE ILLNESS (flu-like symptoms), VACCINATION SITE ERYTHEMA (red arm), HEADACHE (horrible headache) and FATIGUE (exhausted). At the time of the report, PERIPHERAL SWELLING (swollen arm), PAIN IN EXTREMITY (painful arm), INFLUENZA LIKE ILLNESS (flu-like symptoms), VACCINATION SITE ERYTHEMA (red arm), HEADACHE (horrible headache) and FATIGUE (exhausted) 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 concomitant medications were reported.  It was reported that the patient took acetaminophen for the adverse events.  Upon internal review on 21-May-2021, the ague was corrected to unknown.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Event outcomes updated.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema
Clinical narrative: swollen arm; painful arm; flu-like symptoms; red arm; horrible headache; exhausted; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen arm), PAIN IN EXTREMITY (painful arm), INFLUENZA LIKE ILLNESS (flu-like symptoms), VACCINATION SITE ERYTHEMA (red arm) and HEADACHE (horrible headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 27-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced PERIPHERAL SWELLING (swollen arm), PAIN IN EXTREMITY (painful arm), INFLUENZA LIKE ILLNESS (flu-like symptoms), VACCINATION SITE ERYTHEMA (red arm), HEADACHE (horrible headache) and FATIGUE (exhausted). At the time of the report, PERIPHERAL SWELLING (swollen arm), PAIN IN EXTREMITY (painful arm), INFLUENZA LIKE ILLNESS (flu-like symptoms), VACCINATION SITE ERYTHEMA (red arm), HEADACHE (horrible headache) and FATIGUE (exhausted) 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 concomitant medications were reported.  It was reported that the patient took acetaminophen for the adverse events.  Upon internal review on 21-May-2021, the ague was corrected to unknown.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Event outcomes updated.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Sciatica, Swollen tongue
Clinical narrative: She was in pain because she had a sciatica issue; feels like her tongue is swollen; This spontaneous case was reported by a consumer and describes the occurrence of SWOLLEN TONGUE (feels like her tongue is swollen) and SCIATICA (She was in pain because she had a sciatica issue) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination.     Concurrent medical conditions included Diabetic. Concomitant products included INSULIN, LOSARTAN, OMEPRAZOLE, MONTELUKAST and CETIRIZINE HYDROCHLORIDE (CETRIZINE) for an unknown indication.    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 SWOLLEN TONGUE (feels like her tongue is swollen). On 01-Mar-2021, the patient experienced SCIATICA (She was in pain because she had a sciatica issue). At the time of the report, SWOLLEN TONGUE (feels like her tongue is swollen) and SCIATICA (She was in pain because she had a sciatica issue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.  No treatment details were reported.
Age: 38.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Neck pain, Pain in extremity
Clinical narrative: nitially on the neck; currently on her lower legs; joint pains; A spontaneous report was received from a healthcare professional concerning a 38-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events joint pains. initially on the neck then in other joints and currently on her lower legs.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 6 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On Feb 2021, the patient experienced the event(s) joint pains. initially on the neck then in other joints and currently on her lower legs  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), joint pains,initially on the neck then in other joints and currently on her lower legs was unknown.
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness
Clinical narrative: dizziness; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 20-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 DIZZINESS (dizziness). At the time of the report, DIZZINESS (dizziness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant history and concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: No specific follow-up information recorded.
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Vaccination complication, Vomiting
Clinical narrative: All the side effects listed except for Anaphylaxis, swelling of the lymph nodes and vomiting; All the side effects listed except for Anaphylaxis, swelling of the lymph nodes and vomiting; All the side effects listed except for Anaphylaxis, swelling of the lymph nodes and vomiting; A spontaneous report (United States) was received from a consumer concerning a 68-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events all the side effects listed except for anaphylaxis, swelling of the lymph nodes and vomiting.  The patient's medical history was not provided. Concomitant medications reported were Blood pressure medications, Antidepressant medications, Anxiety medications for drug use for unknown indication.  On 1 Mar 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On 2 Mar 2021, the patient experienced the event(s) all the side effects listed except for anaphylaxis, swelling of the lymph nodes and vomiting.  Treatment details included None.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), all the side effects listed except for anaphylaxis, swelling of the lymph nodes and vomiting was unknown.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Erythema, Fatigue, Feeling hot, Headache
Clinical narrative: coughing and throwing up green stuff which was mucus; felt dizzy; couldn't get my head right because my neck was hurting; Felt like my body was on fire; My whole body was red; my glands swelled up, lymph nodes between my shoulder and neck are still swollen; fever up to 100.1 -100.4degF; aches and pain; really bad headache; felt like I lost all my energy; A spontaneous report was received from a consumer concerning a 72-years old, female patient who experienced the events coughing, myalgia, pyrexia, dizziness, neck pain, headache, erythema, feeling hot, fatigue and lymphadenopathy.  The patient's medical history was not provided.  Concomitant product use was not reported.  On 25 Feb 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch: 002A21A) in the left arm for prophylaxis of COVID-19 infection.    On 25 Feb 2021, few hours after vaccination the patient was coughing and throwing up green stuff which was mucus. The patient experienced aches and pain, fever up to 100.1  100.4 deg F, dizziness. The patient also reported neck pain, really bad headache, whole body was red, felt like her body was on fire, glands swollen, lymph nodes between her shoulder and neck got swollen and she felt loss of energy. The patient took Tylenol for headache.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of the events coughing, myalgia, pyrexia, dizziness, neck pain, headache, erythema, feeling hot, fatigue and lymphadenopathy are still ongoing.
Age: 72.0
Sex: F
Vaccine: COVID19
Symptoms: Lymphadenopathy, Myalgia, Neck pain, Productive cough, Pyrexia
Clinical narrative: coughing and throwing up green stuff which was mucus; felt dizzy; couldn't get my head right because my neck was hurting; Felt like my body was on fire; My whole body was red; my glands swelled up, lymph nodes between my shoulder and neck are still swollen; fever up to 100.1 -100.4degF; aches and pain; really bad headache; felt like I lost all my energy; A spontaneous report was received from a consumer concerning a 72-years old, female patient who experienced the events coughing, myalgia, pyrexia, dizziness, neck pain, headache, erythema, feeling hot, fatigue and lymphadenopathy.  The patient's medical history was not provided.  Concomitant product use was not reported.  On 25 Feb 2021, prior to the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch: 002A21A) in the left arm for prophylaxis of COVID-19 infection.    On 25 Feb 2021, few hours after vaccination the patient was coughing and throwing up green stuff which was mucus. The patient experienced aches and pain, fever up to 100.1  100.4 deg F, dizziness. The patient also reported neck pain, really bad headache, whole body was red, felt like her body was on fire, glands swollen, lymph nodes between her shoulder and neck got swollen and she felt loss of energy. The patient took Tylenol for headache.  Action taken with mRNA-1273 in response to the events was not applicable.  The outcome of the events coughing, myalgia, pyrexia, dizziness, neck pain, headache, erythema, feeling hot, fatigue and lymphadenopathy are still ongoing.
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Pain in extremity, Vaccination site erythema, Vaccination site induration, Vaccination site pain
Clinical narrative: a lot of pain under her arm in the underneath underarm in the gland area; area around the vaccination site has a red circle; warm sensation (around vaccination site); burning sensation (around vaccination site); a little itch (around vaccination site); the area around the vaccine site looking rash looking like a hive; the area around the vaccine site looking rash raised; arm was sore; A spontaneous report was received from a consumer concerning a 45-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm was sore, a lot of pain under her arm in the underneath underarm in the gland area, area around the vaccination site has a red circle, warm sensation (around vaccination site), burning sensation (around vaccination site), a little itch (around vaccination site), the area around the vaccine site looking rash looking like a hive, the area around the vaccine site looking rash raised.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 22 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 013M20a) via unknown route for prophylaxis of COVID-19 infection.  On 22 Feb 2021, the patient experienced the event(s) arm was sore. On 2021, the patient experienced the event(s) a lot of pain under her arm in the underneath underarm in the gland area, area around the vaccination site has a red circle, warm sensation (around vaccination site), burning sensation (around vaccination site), a little itch (around vaccination site), the area around the vaccine site looking rash looking like a hive, the area around the vaccine site looking rash raised.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  On 24 Feb 2021 the outcome of event(s), arm was sore was resolved. The outcome of event(s), a lot of pain under her arm in the underneath underarm in the gland area, area around the vaccination site has a red circle, warm sensation (around vaccination site), burning sensation (around vaccination site), a little itch (around vaccination site), the area around the vaccine site looking rash looking like a hive, the area around the vaccine site looking rash raised was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pruritus, Vaccination site rash, Vaccination site warmth
Clinical narrative: a lot of pain under her arm in the underneath underarm in the gland area; area around the vaccination site has a red circle; warm sensation (around vaccination site); burning sensation (around vaccination site); a little itch (around vaccination site); the area around the vaccine site looking rash looking like a hive; the area around the vaccine site looking rash raised; arm was sore; A spontaneous report was received from a consumer concerning a 45-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm was sore, a lot of pain under her arm in the underneath underarm in the gland area, area around the vaccination site has a red circle, warm sensation (around vaccination site), burning sensation (around vaccination site), a little itch (around vaccination site), the area around the vaccine site looking rash looking like a hive, the area around the vaccine site looking rash raised.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 22 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 013M20a) via unknown route for prophylaxis of COVID-19 infection.  On 22 Feb 2021, the patient experienced the event(s) arm was sore. On 2021, the patient experienced the event(s) a lot of pain under her arm in the underneath underarm in the gland area, area around the vaccination site has a red circle, warm sensation (around vaccination site), burning sensation (around vaccination site), a little itch (around vaccination site), the area around the vaccine site looking rash looking like a hive, the area around the vaccine site looking rash raised.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.  On 24 Feb 2021 the outcome of event(s), arm was sore was resolved. The outcome of event(s), a lot of pain under her arm in the underneath underarm in the gland area, area around the vaccination site has a red circle, warm sensation (around vaccination site), burning sensation (around vaccination site), a little itch (around vaccination site), the area around the vaccine site looking rash looking like a hive, the area around the vaccine site looking rash raised was unknown.
Age: 36.0
Sex: F
Vaccine: COVID19
Symptoms: Chest discomfort, Dizziness, Fatigue, Nausea
Clinical narrative: stomach feeling funky; Dizziness; Fatigue and run down; Nausea; heat on the chest with discomfort; A spontaneous report was received from a consumer concerning a 36-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events dizziness, fatigue and run down, nausea, heat on the chest with discomfort, stomach feeling funky.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 26 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 014M20A) intramuscularly for prophylaxis of COVID-19 infection.  On 27 Feb 2021, the patient experienced the event(s) dizziness, fatigue and run down, nausea, heat on the chest with discomfort. On 28 Feb 2021, the patient experienced the event(s) stomach feeling funky.  Treatment details included Meltrin.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), dizziness, fatigue and run down, nausea, heat on the chest with discomfort, stomach feeling funky was unknown.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain, Rhinorrhoea
Clinical narrative: runny nose; aching; Feeling Tired; Headache; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (runny nose), PAIN (aching), FATIGUE (Feeling Tired) and HEADACHE (Headache) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029AZ1A) for COVID-19 vaccination.     Concurrent medical conditions included Thyroid disorder, Diabetes mellitus and Hypertension. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), EMPAGLIFLOZIN, METFORMIN and HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN HCTZ) for an unknown indication.    On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, the patient experienced RHINORRHOEA (runny nose), PAIN (aching), FATIGUE (Feeling Tired) and HEADACHE (Headache). At the time of the report, RHINORRHOEA (runny nose), PAIN (aching), FATIGUE (Feeling Tired) and HEADACHE (Headache) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No treatment medications were reported.   Reporter did not allow further contact
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Pyrexia, Vaccination site pain
Clinical narrative: Intense joint pain in both hips (right one worse); Pain in the injection site; Fever; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Pain in the injection site), PYREXIA (Fever) and ARTHRALGIA (Intense joint pain in both hips (right one worse)) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A22A) for COVID-19 vaccination.     No Medical History information was reported.   On 25-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain in the injection site) and PYREXIA (Fever). On 02-Mar-2021, the patient experienced ARTHRALGIA (Intense joint pain in both hips (right one worse)). At the time of the report, VACCINATION SITE PAIN (Pain in the injection site) outcome was unknown and PYREXIA (Fever) and ARTHRALGIA (Intense joint pain in both hips (right one worse)) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   This case was linked to MOD-2021-020412 (Link).   Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: Follow Up  received on 14-JUN-2021 contains Reporter Phone Number,Updated outcome of the Events Pyrexia, Arthralgia to Not Recovered/Not Resolved
Sex: M
Vaccine: COVID19
Symptoms: Adverse reaction, Mobility decreased, Pain in extremity
Clinical narrative: Side effects; Barely could get out of bed, trouble straightening up, homebound for 4-5 days; Left leg pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ADVERSE REACTION (Side effects), PAIN IN EXTREMITY (Left leg pain) and MOBILITY DECREASED (Barely could get out of bed, trouble straightening up, homebound for 4-5 days) 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 02-Mar-2021, the patient experienced PAIN IN EXTREMITY (Left leg pain). On an unknown date, the patient experienced ADVERSE REACTION (Side effects) and MOBILITY DECREASED (Barely could get out of bed, trouble straightening up, homebound for 4-5 days). At the time of the report, ADVERSE REACTION (Side effects), PAIN IN EXTREMITY (Left leg pain) and MOBILITY DECREASED (Barely could get out of bed, trouble straightening up, homebound for 4-5 days) outcome was unknown.            No concomitant medication was provided. No treatment information provided.  The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was considered to be not applicable.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Follow up was received on 30 April 2021. Patient demographics and new events ( pain in extremity and mobility decreased ) were added.
Age: 75.0
Sex: F
Vaccine: COVID19
Symptoms: Anxiety, Dysgeusia, Injection site pain, Speech disorder, Swollen tongue
Clinical narrative: Tongue swelled up and was very tender; Speech impairment; Metalic taste; Anxious; Tender arm of the injection site; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Mar-2021 and was forwarded to Moderna on 02-Mar-2021.    This spontaneous case was reported by a consumer and describes the occurrence of SPEECH DISORDER (Speech impairment), DYSGEUSIA (Metalic taste) and ANXIETY (Anxious) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination.     Concurrent medical conditions included High cholesterol, Hypertension, Hypothyroidism, Osteoporosis (Imrpoved to Osteopenia 12/2019) and Breast cancer. Concomitant products included TAMOXIFEN from 12-Jul-2017 to an unknown date for Breast cancer, ROSUVASTATIN for Cholesterol, LISINOPRIL for Hypertension, LEVOTHYROXINE for Hypothyroidism, DENOSUMAB (PROLIA) for Osteoporosis.   On 17-Feb-2021, the patient 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 received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 17-Feb-2021, the patient experienced ANXIETY (Anxious). On 26-Feb-2021, the patient experienced SPEECH DISORDER (Speech impairment) and DYSGEUSIA (Metalic taste). On 28-Feb-2021, SPEECH DISORDER (Speech impairment) and DYSGEUSIA (Metalic taste) had resolved. At the time of the report, ANXIETY (Anxious) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.       No treatment medication was provided. Action taken with mRNA-1273 in response to the event was unknown   Most recent FOLLOW-UP information incorporated above includes: On 15-May-2021: Add patient demographics. Add medical history, concomitant products, dose 2 information. Add events like anxiety and metallic taste.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Pain in extremity
Clinical narrative: Dizzy ("Lightheaded"); sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and DIZZINESS (Dizzy ("Lightheaded")) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). On 27-Feb-2021, the patient experienced DIZZINESS (Dizzy ("Lightheaded")). At the time of the report, PAIN IN EXTREMITY (sore arm) and DIZZINESS (Dizzy ("Lightheaded")) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.
Age: 76.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia
Clinical narrative: joint pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (joint pain) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, the patient experienced ARTHRALGIA (joint pain). At the time of the report, ARTHRALGIA (joint pain) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.
Age: 66.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Pyrexia, Rash
Clinical narrative: fever; chills; rashes; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills) and RASH (rashes) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 16M220A) for COVID-19 vaccination.     No Medical History information was reported.    On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced PYREXIA (fever), CHILLS (chills) and RASH (rashes). At the time of the report, PYREXIA (fever), CHILLS (chills) and RASH (rashes) 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: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Headache, Induration, Joint range of motion decreased, Neck pain
Clinical narrative: Neck pain; Headache; Chills; Fever; Hardness on bicep; Pain at injection; Hot to touch; A knot on arm; Could not raise arm above head; Minimal pain; Minimal swelling; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Minimal pain), SWELLING (Minimal swelling), VACCINATION SITE MASS (A knot on arm), JOINT RANGE OF MOTION DECREASED (Could not raise arm above head) and NECK PAIN (Neck pain) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes.    On 18-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced PAIN (Minimal pain) and SWELLING (Minimal swelling). On 27-Feb-2021, the patient experienced VACCINATION SITE MASS (A knot on arm), JOINT RANGE OF MOTION DECREASED (Could not raise arm above head), VACCINATION SITE WARMTH (Hot to touch) and VACCINATION SITE PAIN (Pain at injection). On 02-Mar-2021, the patient experienced INDURATION (Hardness on bicep). On an unknown date, the patient experienced NECK PAIN (Neck pain), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, PAIN (Minimal pain), SWELLING (Minimal swelling), VACCINATION SITE MASS (A knot on arm), JOINT RANGE OF MOTION DECREASED (Could not raise arm above head), NECK PAIN (Neck pain), VACCINATION SITE PAIN (Pain at injection), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown and VACCINATION SITE WARMTH (Hot to touch) and INDURATION (Hardness on bicep) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medication use of diabetes med  was reported Treatment information also includes, ice.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Contact information updated
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pyrexia, Swelling, Vaccination site mass, Vaccination site pain
Clinical narrative: Neck pain; Headache; Chills; Fever; Hardness on bicep; Pain at injection; Hot to touch; A knot on arm; Could not raise arm above head; Minimal pain; Minimal swelling; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Minimal pain), SWELLING (Minimal swelling), VACCINATION SITE MASS (A knot on arm), JOINT RANGE OF MOTION DECREASED (Could not raise arm above head) and NECK PAIN (Neck pain) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes.    On 18-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced PAIN (Minimal pain) and SWELLING (Minimal swelling). On 27-Feb-2021, the patient experienced VACCINATION SITE MASS (A knot on arm), JOINT RANGE OF MOTION DECREASED (Could not raise arm above head), VACCINATION SITE WARMTH (Hot to touch) and VACCINATION SITE PAIN (Pain at injection). On 02-Mar-2021, the patient experienced INDURATION (Hardness on bicep). On an unknown date, the patient experienced NECK PAIN (Neck pain), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, PAIN (Minimal pain), SWELLING (Minimal swelling), VACCINATION SITE MASS (A knot on arm), JOINT RANGE OF MOTION DECREASED (Could not raise arm above head), NECK PAIN (Neck pain), VACCINATION SITE PAIN (Pain at injection), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown and VACCINATION SITE WARMTH (Hot to touch) and INDURATION (Hardness on bicep) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medication use of diabetes med  was reported Treatment information also includes, ice.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Contact information updated
Age: 65.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: Neck pain; Headache; Chills; Fever; Hardness on bicep; Pain at injection; Hot to touch; A knot on arm; Could not raise arm above head; Minimal pain; Minimal swelling; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Minimal pain), SWELLING (Minimal swelling), VACCINATION SITE MASS (A knot on arm), JOINT RANGE OF MOTION DECREASED (Could not raise arm above head) and NECK PAIN (Neck pain) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Diabetes.    On 18-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced PAIN (Minimal pain) and SWELLING (Minimal swelling). On 27-Feb-2021, the patient experienced VACCINATION SITE MASS (A knot on arm), JOINT RANGE OF MOTION DECREASED (Could not raise arm above head), VACCINATION SITE WARMTH (Hot to touch) and VACCINATION SITE PAIN (Pain at injection). On 02-Mar-2021, the patient experienced INDURATION (Hardness on bicep). On an unknown date, the patient experienced NECK PAIN (Neck pain), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, PAIN (Minimal pain), SWELLING (Minimal swelling), VACCINATION SITE MASS (A knot on arm), JOINT RANGE OF MOTION DECREASED (Could not raise arm above head), NECK PAIN (Neck pain), VACCINATION SITE PAIN (Pain at injection), HEADACHE (Headache), CHILLS (Chills) and PYREXIA (Fever) outcome was unknown and VACCINATION SITE WARMTH (Hot to touch) and INDURATION (Hardness on bicep) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       concomitant medication use of diabetes med  was reported Treatment information also includes, ice.   Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: Contact information updated
Sex: F
Vaccine: COVID19
Symptoms: Wrong product administered
Clinical narrative: her first shot was Moderna and her second shot was Pfizer; A spontaneous report was received from a reporter like a health care professional concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and second dose was pfizer.   The patient's medication history was not reported. Concomitant medications not provided.  On an unknown date, prior to the onset of the events, the patient received the first of the two planned doses of mRNA-1273 (lot/batch unknown) in the anatomical location for prophylaxis  of COVID-19 infection.  On an unknown date,following the vaccine administration the patient had her first shot Moderna and her second shot was Pfizer.  No symptoms reported. No treatment information provided.  The outcome of the event was unknown.  Action taken with mRNA-1273 in response to the events was unknown.; Reporter's Comments: This report refers to a case of wrong vaccine administered  for mRNA-1273, lot # unknown with no associated AEs.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Asthenia
Clinical narrative: weakness; pain in the right hip; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (weakness) and ARTHRALGIA (pain in the right hip) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced ASTHENIA (weakness) and ARTHRALGIA (pain in the right hip). At the time of the report, ASTHENIA (weakness) and ARTHRALGIA (pain in the right hip) had resolved.            Treatment medication was not provided.  Concomitant medication was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Additional information included outcome of the events.
Sex: F
Vaccine: COVID19
Symptoms: Contusion, Vaccination site induration, Vaccination site pruritus, Vaccination site swelling
Clinical narrative: "feels bruised inside"; swelling on the injection site; hard; itching; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION ("feels bruised inside"), VACCINATION SITE SWELLING (swelling on the injection site), VACCINATION SITE INDURATION (hard) and VACCINATION SITE PRURITUS (itching) 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 27-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, the patient experienced CONTUSION ("feels bruised inside"), VACCINATION SITE SWELLING (swelling on the injection site), VACCINATION SITE INDURATION (hard) and VACCINATION SITE PRURITUS (itching). At the time of the report, CONTUSION ("feels bruised inside"), VACCINATION SITE SWELLING (swelling on the injection site), VACCINATION SITE INDURATION (hard) and VACCINATION SITE PRURITUS (itching) outcome was unknown.            No relevant concomitant medications were reported. No treatment information was provided.
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue, Influenza like illness, Myalgia, Pain in extremity
Clinical narrative: body ache; joint ache; lot of fatigue, was so so tired; had fever but no much fever; like flu; lot of mucous in the throat and nose; arm really sore; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (like flu), RHINORRHOEA (lot of mucous in the throat and nose), PAIN IN EXTREMITY (arm really sore), MYALGIA (body ache) and ARTHRALGIA (joint ache) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension (using Blood pressure medication).   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm really sore). On 27-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (like flu), RHINORRHOEA (lot of mucous in the throat and nose), MYALGIA (body ache), ARTHRALGIA (joint ache), FATIGUE (lot of fatigue, was so so tired) and PYREXIA (had fever but no much fever). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event following immunisation, at an unspecified dose and frequency. On 28-Feb-2021, INFLUENZA LIKE ILLNESS (like flu), RHINORRHOEA (lot of mucous in the throat and nose), PAIN IN EXTREMITY (arm really sore), MYALGIA (body ache), ARTHRALGIA (joint ache) and PYREXIA (had fever but no much fever) had resolved and FATIGUE (lot of fatigue, was so so tired) outcome was unknown.            Relevant concomitant medications included Blood pressure medication
Age: 81.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia, Rhinorrhoea
Clinical narrative: body ache; joint ache; lot of fatigue, was so so tired; had fever but no much fever; like flu; lot of mucous in the throat and nose; arm really sore; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (like flu), RHINORRHOEA (lot of mucous in the throat and nose), PAIN IN EXTREMITY (arm really sore), MYALGIA (body ache) and ARTHRALGIA (joint ache) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 004M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Hypertension (using Blood pressure medication).   On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm really sore). On 27-Feb-2021, the patient experienced INFLUENZA LIKE ILLNESS (like flu), RHINORRHOEA (lot of mucous in the throat and nose), MYALGIA (body ache), ARTHRALGIA (joint ache), FATIGUE (lot of fatigue, was so so tired) and PYREXIA (had fever but no much fever). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event following immunisation, at an unspecified dose and frequency. On 28-Feb-2021, INFLUENZA LIKE ILLNESS (like flu), RHINORRHOEA (lot of mucous in the throat and nose), PAIN IN EXTREMITY (arm really sore), MYALGIA (body ache), ARTHRALGIA (joint ache) and PYREXIA (had fever but no much fever) had resolved and FATIGUE (lot of fatigue, was so so tired) outcome was unknown.            Relevant concomitant medications included Blood pressure medication
Sex: M
Vaccine: COVID19
Symptoms: Discharge, Fluid retention, Induration, Peripheral swelling, Rash
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FLUID RETENTION (FLUID RETENTION), PERIPHERAL SWELLING (LEGS, THIGH, CALF ARE SO SWOLLEN), INDURATION (HARD AS A WATERMELON), DISCHARGE (BROKE OUT IN SMELLY DICHARGE) and VACCINATION SITE WARMTH (WARM TO TOUCH) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FLUID RETENTION (FLUID RETENTION), PERIPHERAL SWELLING (LEGS, THIGH, CALF ARE SO SWOLLEN), INDURATION (HARD AS A WATERMELON), DISCHARGE (BROKE OUT IN SMELLY DICHARGE), VACCINATION SITE WARMTH (WARM TO TOUCH) and RASH (BROKE OUT IN SMELLY DICHARGE RASH ALL OVER HIS BODY). The patient was treated with BACITRACIN ZINC, GRAMICIDIN, POLYMYXIN B SULFATE (TRIPLE ANTIBIOTIC [BACITRACIN ZINC;GRAMICIDIN;POLYMYXIN B SULFATE]) (topical) ongoing since an unknown date for Adverse event following immunisation, at an unspecified dose and frequency. At the time of the report, FLUID RETENTION (FLUID RETENTION), PERIPHERAL SWELLING (LEGS, THIGH, CALF ARE SO SWOLLEN), INDURATION (HARD AS A WATERMELON), DISCHARGE (BROKE OUT IN SMELLY DICHARGE), VACCINATION SITE WARMTH (WARM TO TOUCH) and RASH (BROKE OUT IN SMELLY DICHARGE RASH ALL OVER HIS BODY) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   This case was linked to MOD-2021-101565 (Patient Link).
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site warmth
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of FLUID RETENTION (FLUID RETENTION), PERIPHERAL SWELLING (LEGS, THIGH, CALF ARE SO SWOLLEN), INDURATION (HARD AS A WATERMELON), DISCHARGE (BROKE OUT IN SMELLY DICHARGE) and VACCINATION SITE WARMTH (WARM TO TOUCH) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No Medical History information was reported.    On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FLUID RETENTION (FLUID RETENTION), PERIPHERAL SWELLING (LEGS, THIGH, CALF ARE SO SWOLLEN), INDURATION (HARD AS A WATERMELON), DISCHARGE (BROKE OUT IN SMELLY DICHARGE), VACCINATION SITE WARMTH (WARM TO TOUCH) and RASH (BROKE OUT IN SMELLY DICHARGE RASH ALL OVER HIS BODY). The patient was treated with BACITRACIN ZINC, GRAMICIDIN, POLYMYXIN B SULFATE (TRIPLE ANTIBIOTIC [BACITRACIN ZINC;GRAMICIDIN;POLYMYXIN B SULFATE]) (topical) ongoing since an unknown date for Adverse event following immunisation, at an unspecified dose and frequency. At the time of the report, FLUID RETENTION (FLUID RETENTION), PERIPHERAL SWELLING (LEGS, THIGH, CALF ARE SO SWOLLEN), INDURATION (HARD AS A WATERMELON), DISCHARGE (BROKE OUT IN SMELLY DICHARGE), VACCINATION SITE WARMTH (WARM TO TOUCH) and RASH (BROKE OUT IN SMELLY DICHARGE RASH ALL OVER HIS BODY) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No relevant concomitant medications were reported.   This case was linked to MOD-2021-101565 (Patient Link).
Age: 79.0
Sex: F
Vaccine: COVID19
Symptoms: Oral herpes
Clinical narrative: Cold sore in mouth, right side of lip; This spontaneous case was reported by a patient and describes the occurrence of ORAL HERPES (Cold sore in mouth, right side of lip) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No adverse event history).    On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced ORAL HERPES (Cold sore in mouth, right side of lip). At the time of the report, ORAL HERPES (Cold sore in mouth, right side of lip) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-032370 (Patient Link).   Reporter did not allow further contact; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.