chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Dizziness, Feeling abnormal, Headache, Malaise
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain/soreness at injection site), VACCINATION SITE SWELLING (swelling at injection site), HEADACHE (headache), ASTHENIA (low energy) and MALAISE (Not feeling good) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. Concomitant products included CETIRIZINE HYDROCHLORIDE (ALLER TEC), LISINOPRIL and VITAMIN D3. On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE PAIN (pain/soreness at injection site) and VACCINATION SITE SWELLING (swelling at injection site). On 29-Jan-2021, the patient experienced HEADACHE (headache), ASTHENIA (low energy), MALAISE (Not feeling good), DIZZINESS (dizzy), FEELING ABNORMAL (foggy headed), TREMOR (shaky) and NECK PAIN (neck is a little achy). At the time of the report, VACCINATION SITE PAIN (pain/soreness at injection site) and VACCINATION SITE SWELLING (swelling at injection site) was resolving and HEADACHE (headache), ASTHENIA (low energy), MALAISE (Not feeling good), DIZZINESS (dizzy), FEELING ABNORMAL (foggy headed), TREMOR (shaky) and NECK PAIN (neck is a little achy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment of these events were not provided.
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Neck pain, Tremor, Vaccination site pain, Vaccination site swelling
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain/soreness at injection site), VACCINATION SITE SWELLING (swelling at injection site), HEADACHE (headache), ASTHENIA (low energy) and MALAISE (Not feeling good) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. Concomitant products included CETIRIZINE HYDROCHLORIDE (ALLER TEC), LISINOPRIL and VITAMIN D3. On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced VACCINATION SITE PAIN (pain/soreness at injection site) and VACCINATION SITE SWELLING (swelling at injection site). On 29-Jan-2021, the patient experienced HEADACHE (headache), ASTHENIA (low energy), MALAISE (Not feeling good), DIZZINESS (dizzy), FEELING ABNORMAL (foggy headed), TREMOR (shaky) and NECK PAIN (neck is a little achy). At the time of the report, VACCINATION SITE PAIN (pain/soreness at injection site) and VACCINATION SITE SWELLING (swelling at injection site) was resolving and HEADACHE (headache), ASTHENIA (low energy), MALAISE (Not feeling good), DIZZINESS (dizzy), FEELING ABNORMAL (foggy headed), TREMOR (shaky) and NECK PAIN (neck is a little achy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment of these events were not provided.
Sex: F
Vaccine: COVID19
Symptoms: Adverse reaction
Clinical narrative: terrible reaction that lasted almost a week, 5-6 days; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE REACTION (terrible reaction that lasted almost a week, 5-6 days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No Historical Conditions were Reported.).    On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced ADVERSE REACTION (terrible reaction that lasted almost a week, 5-6 days). At the time of the report, ADVERSE REACTION (terrible reaction that lasted almost a week, 5-6 days) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       No concomitant medications were provided.  No treatment medications were provided.; Sender's Comments: Very limited information regarding this event has been provided at this time.  Further information has been requested.
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Eye swelling, Lip swelling, Pain in extremity, Pyrexia
Clinical narrative: Sore arm; Eyes swelled up; Lips swelled up; Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of EYE SWELLING (Eyes swelled up), LIP SWELLING (Lips swelled up), PAIN IN EXTREMITY (Sore arm), PYREXIA (Fever) and CHILLS (Chills) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032120A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 (COVID pneumonia) in September 2020.    On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced PYREXIA (Fever) and CHILLS (Chills). On 23-Jan-2021, the patient experienced EYE SWELLING (Eyes swelled up) and LIP SWELLING (Lips swelled up). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, EYE SWELLING (Eyes swelled up), LIP SWELLING (Lips swelled up), PYREXIA (Fever) and CHILLS (Chills) was resolving and 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 provided.  Treatment for the event included diphenhydramine (Benadryl)   Most recent FOLLOW-UP information incorporated above includes: On 25-Jan-2021: New event Sore arm reported.
Age: 50.0
Sex: M
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site rash
Clinical narrative: Rash at the injection site; Pain at the injection site/painful at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash at the injection site) and VACCINATION SITE PAIN (Pain at the injection site/painful at the injection site) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination.     No Medical History information was reported.   On 23-Jan-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jan-2021, the patient experienced VACCINATION SITE RASH (Rash at the injection site) and VACCINATION SITE PAIN (Pain at the injection site/painful at the injection site). At the time of the report, VACCINATION SITE RASH (Rash at the injection site) and VACCINATION SITE PAIN (Pain at the injection site/painful at the injection site) had resolved. Not Provided          No relevant concomitant medications were reported. No treatment information was provided.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: Follow-up received on 10-JUN-2021 and outcomes provided by reporter, 2nd dose taken and no event after 2 nd dose. Reporter not interested in further FU.
Age: 77.0
Sex: F
Vaccine: COVID19
Symptoms: Back pain, Headache, Pruritus, Vaccination site urticaria
Clinical narrative: Mid back pain; Itchy neck; 6-7 welts on the right arm where the vaccine was injected; Headache; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Mid back pain), PRURITUS (Itchy neck), VACCINATION SITE URTICARIA (6-7 welts on the right arm where the vaccine was injected) and HEADACHE (Headache) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced BACK PAIN (Mid back pain), PRURITUS (Itchy neck), VACCINATION SITE URTICARIA (6-7 welts on the right arm where the vaccine was injected) and HEADACHE (Headache). The patient was treated with PARACETAMOL (TYLENOL) on 27-Jan-2021 for Pain, at an unspecified dose and frequency. At the time of the report, BACK PAIN (Mid back pain), PRURITUS (Itchy neck), VACCINATION SITE URTICARIA (6-7 welts on the right arm where the vaccine was injected) and HEADACHE (Headache) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not provided by the reporter.  events occured about an hour after receiving the vaccine and that the patient used Tylenol to try to alleviate the pain, but it did not work.   Most recent FOLLOW-UP information incorporated above includes: On 10-Jul-2021: Follow-up information received on 10-Jul-2021, contains significant information. Updated event outcome as Recovered/Resolved.
Sex: M
Vaccine: COVID19
Symptoms: Injection site movement impairment, Pain in extremity
Clinical narrative: he can´t move his arm; arm pain; A spontaneous report was received from a consumer, concerning a male patient of unspecified age, who arm pain/pain in extremity and couldn't move his arm/injection site movement impairment.  The patient's medical history was not provided. Concomitant product use was not provided by the reporter.  On 31 Jan 2021, prior to the onset of events, the patient received their first of two planned doses of mRNA-1273 (lot number unknown) intramuscularly for COVID-19 infection prophylaxis.  Beginning on 01FEB2021, the patient began experiencing arm pain and that he couldn't move his arm.    Treatment of these events were not reported.  Action taken with mRNA-1273 in response to the event was unknown.  The outcome of the events, pain in extremity and injection site movement impairment were considered unknown.
Sex: F
Vaccine: COVID19
Symptoms: Pain in extremity
Clinical narrative: Sore arm; This spontaneous case was reported by an other health care professional and describes the occurrence of PAIN IN EXTREMITY (Sore arm) 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 03-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 04-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). At the time of the report, PAIN IN EXTREMITY (Sore arm) had not resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.   Reporter did not allow further contact
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site erythema, Vaccination site swelling, Vaccination site warmth
Clinical narrative: Injection site shaped like triangle, raised in a tennis ball shape; Injection site was red; injection site was warm; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE SWELLING (Injection site shaped like triangle, raised in a tennis ball shape), VACCINATION SITE ERYTHEMA (Injection site was red) and VACCINATION SITE WARMTH (injection site was warm) in a 55-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 (No adverse event history). Concomitant products included IBUPROFEN (MOTRIN [IBUPROFEN]).    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (Injection site shaped like triangle, raised in a tennis ball shape), VACCINATION SITE ERYTHEMA (Injection site was red) and VACCINATION SITE WARMTH (injection site was warm). At the time of the report, VACCINATION SITE SWELLING (Injection site shaped like triangle, raised in a tennis ball shape), VACCINATION SITE ERYTHEMA (Injection site was red) and VACCINATION SITE WARMTH (injection site was warm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   There was no treatment for these events.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Alanine aminotransferase increased, Arthralgia, Blood uric acid, C-reactive protein, Mean platelet volume
Clinical narrative: I had severe knee pains and overall joint pain. I had blood and urine work ordered by doctor.
Age: 24.0
Sex: M
Vaccine: COVID19
Symptoms: Mean platelet volume normal
Clinical narrative: I had severe knee pains and overall joint pain. I had blood and urine work ordered by doctor.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Discomfort, Fatigue, Headache, Hypoaesthesia, Muscular weakness
Clinical narrative: Starting the 8th of this month, I am experiencing extreme fatigue. I also had a headache started in the evening on Aug 8th lasted for days 24 hours a day. Ibuprofen or acetaminophen help with discomfort. Starting the 11th of this month, I am experiencing palpitations, a feeling on pins, tingling throughout my body and numbness in my face, hands and toes. This is extremely uncomfortable; it feels like my legs are going to give out on me.
Age: 45.0
Sex: F
Vaccine: COVID19
Symptoms: Palpitations, Paraesthesia
Clinical narrative: Starting the 8th of this month, I am experiencing extreme fatigue. I also had a headache started in the evening on Aug 8th lasted for days 24 hours a day. Ibuprofen or acetaminophen help with discomfort. Starting the 11th of this month, I am experiencing palpitations, a feeling on pins, tingling throughout my body and numbness in my face, hands and toes. This is extremely uncomfortable; it feels like my legs are going to give out on me.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Abdominal discomfort, Chills, Diarrhoea, Fatigue, Headache
Clinical narrative: Diarrhea; GI symptoms; fatigued; Nausea; Headache; chills; right arm soreness; muscle soreness; righ arm soreness at the injection site; broke out in hives that were on her stomach; This spontaneous case was reported by a nurse and describes the occurrence of DIARRHOEA (Diarrhea), ABDOMINAL DISCOMFORT (GI symptoms), PAIN IN EXTREMITY (right arm soreness), URTICARIA (broke out in hives that were on her stomach) and FATIGUE (fatigued) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Essential tremor, Eczema, Vitiligo, Connective tissue disorder (undifferentiated), Drug allergy, Adhesive tape allergy, Allergy (Lactose), Allergy (Hibiclens) and Rosacea. Concomitant products included AZELAIC ACID for Rosacea, WOMEN MULTI and KETOCONAZOLE for an unknown indication.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced MYALGIA (muscle soreness) and VACCINATION SITE PAIN (righ arm soreness at the injection site). On 30-Dec-2020, the patient experienced PAIN IN EXTREMITY (right arm soreness). On 01-Jan-2021, the patient experienced DIARRHOEA (Diarrhea), ABDOMINAL DISCOMFORT (GI symptoms), FATIGUE (fatigued), NAUSEA (Nausea), HEADACHE (Headache) and CHILLS (chills). On an unknown date, the patient experienced URTICARIA (broke out in hives that were on her stomach). On 04-Jan-2021, NAUSEA (Nausea) had resolved. At the time of the report, DIARRHOEA (Diarrhea), ABDOMINAL DISCOMFORT (GI symptoms), PAIN IN EXTREMITY (right arm soreness), URTICARIA (broke out in hives that were on her stomach), FATIGUE (fatigued), HEADACHE (Headache), CHILLS (chills), MYALGIA (muscle soreness) and VACCINATION SITE PAIN (righ arm soreness at the injection site) had resolved.        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 assessments.   Per follow-up source, it was noted that the patient contacted her PCP and she was advised to see an allergist prior to receiving the second vaccine dose.  No further information was provided.   Treatment information was not reported.   This case was linked to MOD-2021-163093 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Updates include additional event, medical history and concomitant medication use.
Age: 39.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Nausea, Pain in extremity, Urticaria, Vaccination site pain
Clinical narrative: Diarrhea; GI symptoms; fatigued; Nausea; Headache; chills; right arm soreness; muscle soreness; righ arm soreness at the injection site; broke out in hives that were on her stomach; This spontaneous case was reported by a nurse and describes the occurrence of DIARRHOEA (Diarrhea), ABDOMINAL DISCOMFORT (GI symptoms), PAIN IN EXTREMITY (right arm soreness), URTICARIA (broke out in hives that were on her stomach) and FATIGUE (fatigued) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included Essential tremor, Eczema, Vitiligo, Connective tissue disorder (undifferentiated), Drug allergy, Adhesive tape allergy, Allergy (Lactose), Allergy (Hibiclens) and Rosacea. Concomitant products included AZELAIC ACID for Rosacea, WOMEN MULTI and KETOCONAZOLE for an unknown indication.    On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced MYALGIA (muscle soreness) and VACCINATION SITE PAIN (righ arm soreness at the injection site). On 30-Dec-2020, the patient experienced PAIN IN EXTREMITY (right arm soreness). On 01-Jan-2021, the patient experienced DIARRHOEA (Diarrhea), ABDOMINAL DISCOMFORT (GI symptoms), FATIGUE (fatigued), NAUSEA (Nausea), HEADACHE (Headache) and CHILLS (chills). On an unknown date, the patient experienced URTICARIA (broke out in hives that were on her stomach). On 04-Jan-2021, NAUSEA (Nausea) had resolved. At the time of the report, DIARRHOEA (Diarrhea), ABDOMINAL DISCOMFORT (GI symptoms), PAIN IN EXTREMITY (right arm soreness), URTICARIA (broke out in hives that were on her stomach), FATIGUE (fatigued), HEADACHE (Headache), CHILLS (chills), MYALGIA (muscle soreness) and VACCINATION SITE PAIN (righ arm soreness at the injection site) had resolved.        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 assessments.   Per follow-up source, it was noted that the patient contacted her PCP and she was advised to see an allergist prior to receiving the second vaccine dose.  No further information was provided.   Treatment information was not reported.   This case was linked to MOD-2021-163093 (Patient Link).   Most recent FOLLOW-UP information incorporated above includes: On 24-May-2021: Updates include additional event, medical history and concomitant medication use.
Age: 75.0
Sex: M
Vaccine: COVID19
Symptoms: Rash
Clinical narrative: Rash in the groin area; This spontaneous case was reported by a non-health professional (subsequently medically confirmed) and describes the occurrence of RASH (Rash in the groin area) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse reaction.    On 26-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On 28-Jan-2021, the patient experienced RASH (Rash in the groin area). At the time of the report, RASH (Rash in the groin area) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD21-15665 (Patient Link).   Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pruritus, Injection site swelling
Clinical narrative: Injection site itching; Injection site swelling; Injection site redness; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (Injection site itching), INJECTION SITE SWELLING (Injection site swelling) and INJECTION SITE ERYTHEMA (Injection site redness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     The patient's past medical history included No adverse event.    On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PRURITUS (Injection site itching), INJECTION SITE SWELLING (Injection site swelling) and INJECTION SITE ERYTHEMA (Injection site redness). At the time of the report, INJECTION SITE PRURITUS (Injection site itching), INJECTION SITE SWELLING (Injection site swelling) and INJECTION SITE ERYTHEMA (Injection site redness) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Age: 69.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Injection site pain, Sinus headache
Clinical narrative: Sinus was mess up; Soreness at injection site; Chills; This spontaneous case was reported by a consumer and describes the occurrence of SINUS HEADACHE (Sinus was mess up), INJECTION SITE PAIN (Soreness at injection site) and CHILLS (Chills) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination.     The patient's past medical history included COVID-19 in November 2020. Concurrent medical conditions included Asthma.    On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced SINUS HEADACHE (Sinus was mess up), INJECTION SITE PAIN (Soreness at injection site) and CHILLS (Chills). At the time of the report, SINUS HEADACHE (Sinus was mess up), INJECTION SITE PAIN (Soreness at injection site) and CHILLS (Chills) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient is currently on muscle relaxant, pain medication, asthma and oxygen machine.
Age: 64.0
Sex: F
Vaccine: COVID19
Symptoms: Ocular hyperaemia
Clinical narrative: eyes is is blood shot red eye; A spontaneous report was received from a consumer concerning a Drug Start Date-1956-1-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events eyes is is blood shot red eye.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On , prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: ) via unknown route for prophylaxis of COVID-19 infection. On 22 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: Unknown) via unknown route for prophylaxis of COVID-19 infection.  On 22 Feb 2021, the patient experienced the event(s) eyes is is blood shot red eye.  Treatment details included None.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), eyes is is blood shot red eye was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Injection site erythema, Injection site pain, Injection site pruritus, Injection site warmth
Clinical narrative: Site of injection, great big round circle size of half dollar that is hot; Injection site itchy; Injection site red; Injection site painful to the touch; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Site of injection, great big round circle size of half dollar that is hot), INJECTION SITE PRURITUS (Injection site itchy), INJECTION SITE ERYTHEMA (Injection site red) and INJECTION SITE PAIN (Injection site painful to the touch) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to antibiotic.    On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE WARMTH (Site of injection, great big round circle size of half dollar that is hot), INJECTION SITE PRURITUS (Injection site itchy), INJECTION SITE ERYTHEMA (Injection site red) and INJECTION SITE PAIN (Injection site painful to the touch). At the time of the report, INJECTION SITE WARMTH (Site of injection, great big round circle size of half dollar that is hot), INJECTION SITE PRURITUS (Injection site itchy), INJECTION SITE ERYTHEMA (Injection site red) and INJECTION SITE PAIN (Injection site painful to the touch) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided/unknown by the reporter. The patient's daughter, who is a Health Care Professional, told her to see her doctor for cephalexin in case the reaction got worse.   Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Follow up received on 15-Apr-2021 included no new information.
Age: 82.0
Sex: F
Vaccine: COVID19
Symptoms: Pruritus, Rash, Rash erythematous
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (red rash), PRURITUS (itches) and RASH (Rash spread) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history reported). No concomitant medication provided. No information about Treatment received. On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced RASH ERYTHEMATOUS (red rash), PRURITUS (itches) and RASH (Rash spread). At the time of the report, RASH ERYTHEMATOUS (red rash), PRURITUS (itches) and RASH (Rash spread) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Flushing, Rash papular, Rash pruritic, Vaccination site pain
Clinical narrative: This spontaneous case was reported by a nurse and describes the occurrence of FLUSHING (Face was flushed), DIZZINESS (Dizziness), RASH PRURITIC (Very itchy all over where the rashes are, scalp is itchy also), RASH PAPULAR (Rash is like many small red red bumps all over upper body) and VACCINATION SITE PAIN (Soreness at injection site) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The patient's past medical history included Sinus infection. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced FLUSHING (Face was flushed), DIZZINESS (Dizziness), RASH PRURITIC (Very itchy all over where the rashes are, scalp is itchy also), RASH PAPULAR (Rash is like many small red red bumps all over upper body) and VACCINATION SITE PAIN (Soreness at injection site). At the time of the report, FLUSHING (Face was flushed), DIZZINESS (Dizziness), RASH PRURITIC (Very itchy all over where the rashes are, scalp is itchy also), RASH PAPULAR (Rash is like many small red red bumps all over upper body) and VACCINATION SITE PAIN (Soreness at injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. This patient was on antibiotics NOS for a sinus infection up until Tuesday, 26-Jan-2021. She developed a rash on her back, chest, upper abdomen, to the side of the abdomen and a little bit on her face. She took loratadine, which cleared up the rash on her chest and face, but when the effect wore off, the rash came back. The rash on her back seemed to be getting worse. The rash on her abdominal area seemed to be clearing. Treatment included loratadine and topical hydrocortisone cream.
Sex: F
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Tested positive to COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive to COVID-19) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination.     The patient's past medical history included No adverse event (No medical history reported).    On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced COVID-19 (Tested positive to COVID-19). At the time of the report, COVID-19 (Tested positive to COVID-19) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No relevant concomitant medications were reported. Treatment information was not provided.
Sex: F
Vaccine: COVID19
Symptoms: Stomatitis
Clinical narrative: Mouth Sores; A spontaneous report was received from a consumer concerning a 71-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events mouth sores.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 16 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) Mouth Sores.  Treatment details included Salt Water Gargles.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), mouth sores was unknown.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Axillary pain, Chills, Headache, Lymphadenopathy
Clinical narrative: their neck and their upper arm were also affected; palpable left axillary lymph nodes; the swelling had reached the left supraclavicular; axillary tenderness; body ache; chills; fever; headache; joint pain; This spontaneous case was reported by a physician and describes the occurrence of CHILLS (chills), PYREXIA (fever), HEADACHE (headache), ARTHRALGIA (joint pain) and LYMPHADENOPATHY (palpable left axillary lymph nodes) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J202A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Autoimmune disorder NOS. Concomitant products included MONTELUKAST SODIUM (SINGULAIR), FEXOFENADINE HYDROCHLORIDE (ALLEGRA), PEPSIN and DICLOFENAC SODIUM (VOLTAREN EX).    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced CHILLS (chills), PYREXIA (fever), HEADACHE (headache), ARTHRALGIA (joint pain) and PAIN (body ache). On 21-Jan-2021, the patient experienced AXILLARY PAIN (axillary tenderness). On 22-Jan-2021, the patient experienced LYMPHADENOPATHY (palpable left axillary lymph nodes) and SWELLING (the swelling had reached the left supraclavicular). On 24-Jan-2021, the patient experienced PERIPHERAL SWELLING (their neck and their upper arm were also affected). On 18-Jan-2021, ARTHRALGIA (joint pain) and PAIN (body ache) had resolved. On 29-Jan-2021, PYREXIA (fever) had resolved. At the time of the report, CHILLS (chills), HEADACHE (headache), LYMPHADENOPATHY (palpable left axillary lymph nodes), AXILLARY PAIN (axillary tenderness), SWELLING (the swelling had reached the left supraclavicular) and PERIPHERAL SWELLING (their neck and their upper arm were also affected) was resolving.        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.   Treatment of these events included ibuprofen and acetaminophen.
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Peripheral swelling, Pyrexia, Swelling
Clinical narrative: their neck and their upper arm were also affected; palpable left axillary lymph nodes; the swelling had reached the left supraclavicular; axillary tenderness; body ache; chills; fever; headache; joint pain; This spontaneous case was reported by a physician and describes the occurrence of CHILLS (chills), PYREXIA (fever), HEADACHE (headache), ARTHRALGIA (joint pain) and LYMPHADENOPATHY (palpable left axillary lymph nodes) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J202A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Autoimmune disorder NOS. Concomitant products included MONTELUKAST SODIUM (SINGULAIR), FEXOFENADINE HYDROCHLORIDE (ALLEGRA), PEPSIN and DICLOFENAC SODIUM (VOLTAREN EX).    On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced CHILLS (chills), PYREXIA (fever), HEADACHE (headache), ARTHRALGIA (joint pain) and PAIN (body ache). On 21-Jan-2021, the patient experienced AXILLARY PAIN (axillary tenderness). On 22-Jan-2021, the patient experienced LYMPHADENOPATHY (palpable left axillary lymph nodes) and SWELLING (the swelling had reached the left supraclavicular). On 24-Jan-2021, the patient experienced PERIPHERAL SWELLING (their neck and their upper arm were also affected). On 18-Jan-2021, ARTHRALGIA (joint pain) and PAIN (body ache) had resolved. On 29-Jan-2021, PYREXIA (fever) had resolved. At the time of the report, CHILLS (chills), HEADACHE (headache), LYMPHADENOPATHY (palpable left axillary lymph nodes), AXILLARY PAIN (axillary tenderness), SWELLING (the swelling had reached the left supraclavicular) and PERIPHERAL SWELLING (their neck and their upper arm were also affected) was resolving.        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.   Treatment of these events included ibuprofen and acetaminophen.
Sex: F
Vaccine: COVID19
Symptoms: Tachycardia
Clinical narrative: This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (rapid heart beat) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. Concurrent medical conditions included Asthma. Concomitant products included SALBUTAMOL SULFATE (PROAIR [SALBUTAMOL SULFATE]) for Asthma. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jan-2021, the patient experienced TACHYCARDIA (rapid heart beat). On 31-Jan-2021, TACHYCARDIA (rapid heart beat) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment for the event not reported.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site lymphadenopathy
Clinical narrative: Swollen lymph nodes under right arm; A spontaneous report (United States) was received from a consumer concerning herself a 56-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced swollen lymph nodes under right arm/ vaccination site lymphadenopathy.  The patient's medical history was not provided. Products known to have been used by the patient, within two weeks prior to the event, included diltiazem and bupropion hydrochloride.   On 20 Feb 2021, prior to the onset of the event, the patient received their second of two planned doses of mRNA-1273 (batch: 023M20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection.  On an unspecified date, the patient experienced swollen lymph nodes under right arm. Treatment information was not provided.   Action taken with mRNA-1273 in response to the event was not reported.  The outcome of event, swollen lymph nodes under right arm was unknown.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: COVID-19
Clinical narrative: Tested positive for Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for Covid) in a 65-year-old male elderly exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013C20A) , while the parent received the product for COVID-19 vaccination.    MEDICAL HISTORY (Parent): Unknown.     MEDICAL HISTORY (Patient): Medical history and concomitant medication were not reported.    On 19-Jan-2021, the parent received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the parent received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 28-Jan-2021, the elderly was diagnosed with COVID-19 (Tested positive for Covid). The Elderly was exposed to mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy.  At the time of the report, COVID-19 (Tested positive for Covid) had not resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       On Unknown day in Feb,2021 patient received the 2nd dose of mRNA-1273 (Moderna COVID-19 Vaccine) No relevant concomitant medications were reported.  Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Additional information received On 01-Jul-2021: Follow up
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Cough, Dyspnoea, Feeling of body temperature change, Headache
Clinical narrative: nasty cough; slight headache; slight temperature; chills around the neck/chills around shoulders; feeling hot/cold; shortness of breath; A spontaneous report was received from a healthcare professional concerning a 64-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events nasty cough, slight headache, slight temperature, chills around the neck, chills around shoulders, feeling hot cold, shortness of breath.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 13 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 105M20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) nasty cough, slight headache, slight temperature, chills around the neck, chills around shoulders, feeling hot cold, shortness of breath.  Treatment details included Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), nasty cough, slight headache, slight temperature, chills around the neck, chills around shoulders, feeling hot cold, shortness of breath was unknown.
Age: 65.0
Sex: M
Vaccine: COVID19
Symptoms: Pyrexia
Clinical narrative: nasty cough; slight headache; slight temperature; chills around the neck/chills around shoulders; feeling hot/cold; shortness of breath; A spontaneous report was received from a healthcare professional concerning a 64-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events nasty cough, slight headache, slight temperature, chills around the neck, chills around shoulders, feeling hot cold, shortness of breath.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 13 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 105M20A) via unknown route in the left arm for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) nasty cough, slight headache, slight temperature, chills around the neck, chills around shoulders, feeling hot cold, shortness of breath.  Treatment details included Tylenol.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), nasty cough, slight headache, slight temperature, chills around the neck, chills around shoulders, feeling hot cold, shortness of breath was unknown.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Headache, Pain in extremity, Pyrexia, Vaccination site erythema
Clinical narrative: A red , big and hot circle of 2 inches of diameter at the injection site; Swelling at injection; Fever; Headache; A red , big and hot circle of 2 inches of diameter at the injection site; Pain in arm; She was in bed for 3 days due to events; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (A red , big and hot circle of 2 inches of diameter at the injection site), PAIN IN EXTREMITY (Pain in arm), VACCINATION SITE ERYTHEMA (A red , big and hot circle of 2 inches of diameter at the injection site), VACCINATION SITE SWELLING (Swelling at injection) and PYREXIA (Fever) in a 63-year-old female patient 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 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE WARMTH (A red , big and hot circle of 2 inches of diameter at the injection site), VACCINATION SITE ERYTHEMA (A red , big and hot circle of 2 inches of diameter at the injection site), VACCINATION SITE SWELLING (Swelling at injection), PYREXIA (Fever) and HEADACHE (Headache). On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in arm) and FATIGUE (She was in bed for 3 days due to events). At the time of the report, VACCINATION SITE WARMTH (A red , big and hot circle of 2 inches of diameter at the injection site), VACCINATION SITE ERYTHEMA (A red , big and hot circle of 2 inches of diameter at the injection site), PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown and PAIN IN EXTREMITY (Pain in arm), VACCINATION SITE SWELLING (Swelling at injection) and FATIGUE (She was in bed for 3 days due to events) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: New events provided; reporter information updated; outcome of event swelling at injection updated; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site swelling, Vaccination site warmth
Clinical narrative: A red , big and hot circle of 2 inches of diameter at the injection site; Swelling at injection; Fever; Headache; A red , big and hot circle of 2 inches of diameter at the injection site; Pain in arm; She was in bed for 3 days due to events; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (A red , big and hot circle of 2 inches of diameter at the injection site), PAIN IN EXTREMITY (Pain in arm), VACCINATION SITE ERYTHEMA (A red , big and hot circle of 2 inches of diameter at the injection site), VACCINATION SITE SWELLING (Swelling at injection) and PYREXIA (Fever) in a 63-year-old female patient 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 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, the patient experienced VACCINATION SITE WARMTH (A red , big and hot circle of 2 inches of diameter at the injection site), VACCINATION SITE ERYTHEMA (A red , big and hot circle of 2 inches of diameter at the injection site), VACCINATION SITE SWELLING (Swelling at injection), PYREXIA (Fever) and HEADACHE (Headache). On an unknown date, the patient experienced PAIN IN EXTREMITY (Pain in arm) and FATIGUE (She was in bed for 3 days due to events). At the time of the report, VACCINATION SITE WARMTH (A red , big and hot circle of 2 inches of diameter at the injection site), VACCINATION SITE ERYTHEMA (A red , big and hot circle of 2 inches of diameter at the injection site), PYREXIA (Fever) and HEADACHE (Headache) outcome was unknown and PAIN IN EXTREMITY (Pain in arm), VACCINATION SITE SWELLING (Swelling at injection) and FATIGUE (She was in bed for 3 days due to events) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant product use was not provided. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 04-Jun-2021: New events provided; reporter information updated; outcome of event swelling at injection updated; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.
Age: 45.0
Sex: M
Vaccine: COVID19
Symptoms: Lymphadenopathy, Pain in extremity, Sinus pain
Clinical narrative: sore arm; sinus problems; swollen lymph nodes; A spontaneous report was received from a consumer concerning a 45-years-old  patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events sore arm, sinus problems, swollen lymph nodes.  The patient's medical history was not provided. No relevant concomitant medications were reported.  On 25 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection.  On an unknown date, the patient experienced the event(s) Sore Arm, Sinus Problems, Swollen Lymph Nodes.  No treatment information was provided.  Action taken with mRNA-1273 in response to the events was not reported.   The outcome of event(s), sore arm, sinus problems, swollen lymph nodes was unknown.