chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 71.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Illness, Pain
Clinical narrative: felt sick; ache; tired; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (felt sick), PAIN (ache) and FATIGUE (tired) in a 71-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 event (No significant medical history).   On 24-Mar-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-Mar-2021, the patient experienced ILLNESS (felt sick), PAIN (ache) and FATIGUE (tired). At the time of the report, ILLNESS (felt sick), PAIN (ache) and FATIGUE (tired) outcome was unknown.            Treatment medicines include Tylenol  No Concomitant medications
Age: 76.0
Sex: M
Vaccine: COVID19
Symptoms: Off label use, SARS-CoV-2 test positive
Clinical narrative: received infusion after and now cannot receive the second dose for 90 days; tested positive for covid-19; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (tested positive for covid-19) and OFF LABEL USE (received infusion after and now cannot receive the second dose for 90 days) in a 76-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 event.    On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced SARS-COV-2 TEST POSITIVE (tested positive for covid-19). On 13-Mar-2021, the patient experienced OFF LABEL USE (received infusion after and now cannot receive the second dose for 90 days). At the time of the report, SARS-COV-2 TEST POSITIVE (tested positive for covid-19) and OFF LABEL USE (received infusion after and now cannot receive the second dose for 90 days) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       No Concomitant and treatment medications were reported.   This case was linked to US-MODERNATX, INC.-MOD-2021-069728 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-069728:Wife case
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Fatigue, Lip swelling, Mouth swelling, Pain in extremity, SARS-CoV-2 antibody test
Clinical narrative: left side of his tongue started to itch; tongue slightly swollen; lips got swollen as well on both sides near the edges; pain on arm; swelling of the tongue and mouth; fatigued; This spontaneous case was reported by a consumer and describes the occurrence of TONGUE PRURITUS (left side of his tongue started to itch), SWOLLEN TONGUE (tongue slightly swollen), LIP SWELLING (lips got swollen as well on both sides near the edges), PAIN IN EXTREMITY (pain on arm) and MOUTH SWELLING (swelling of the tongue and mouth) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Asthma since an unknown date. Concurrent medical conditions included Seasonal allergy, Food allergy (all diary products, nuts and fish) and Drug allergy (Demerol allergy). Concomitant products included OLOPATADINE HYDROCHLORIDE for Nasal congestion, FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Seasonal allergy.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced TONGUE PRURITUS (left side of his tongue started to itch), SWOLLEN TONGUE (tongue slightly swollen), LIP SWELLING (lips got swollen as well on both sides near the edges), PAIN IN EXTREMITY (pain on arm), MOUTH SWELLING (swelling of the tongue and mouth) and FATIGUE (fatigued). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 05-Apr-2021, SWOLLEN TONGUE (tongue slightly swollen), PAIN IN EXTREMITY (pain on arm) and MOUTH SWELLING (swelling of the tongue and mouth) had resolved, LIP SWELLING (lips got swollen as well on both sides near the edges) outcome was unknown. At the time of the report, TONGUE PRURITUS (left side of his tongue started to itch) and FATIGUE (fatigued) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, SARS-CoV-2 antibody test: positive (Positive) SARS-CoV-2 antibody test-Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient has an EpiPen that takes everywhere. For the symptoms,patient took Benadryl the day of the vaccine. Patient received treatment of Tylenol the next day for the sore arm.
Age: 39.0
Sex: M
Vaccine: COVID19
Symptoms: Swollen tongue, Tongue pruritus
Clinical narrative: left side of his tongue started to itch; tongue slightly swollen; lips got swollen as well on both sides near the edges; pain on arm; swelling of the tongue and mouth; fatigued; This spontaneous case was reported by a consumer and describes the occurrence of TONGUE PRURITUS (left side of his tongue started to itch), SWOLLEN TONGUE (tongue slightly swollen), LIP SWELLING (lips got swollen as well on both sides near the edges), PAIN IN EXTREMITY (pain on arm) and MOUTH SWELLING (swelling of the tongue and mouth) in a 39-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included Asthma since an unknown date. Concurrent medical conditions included Seasonal allergy, Food allergy (all diary products, nuts and fish) and Drug allergy (Demerol allergy). Concomitant products included OLOPATADINE HYDROCHLORIDE for Nasal congestion, FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for Seasonal allergy.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, the patient experienced TONGUE PRURITUS (left side of his tongue started to itch), SWOLLEN TONGUE (tongue slightly swollen), LIP SWELLING (lips got swollen as well on both sides near the edges), PAIN IN EXTREMITY (pain on arm), MOUTH SWELLING (swelling of the tongue and mouth) and FATIGUE (fatigued). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. On 05-Apr-2021, SWOLLEN TONGUE (tongue slightly swollen), PAIN IN EXTREMITY (pain on arm) and MOUTH SWELLING (swelling of the tongue and mouth) had resolved, LIP SWELLING (lips got swollen as well on both sides near the edges) outcome was unknown. At the time of the report, TONGUE PRURITUS (left side of his tongue started to itch) and FATIGUE (fatigued) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2020, SARS-CoV-2 antibody test: positive (Positive) SARS-CoV-2 antibody test-Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Patient has an EpiPen that takes everywhere. For the symptoms,patient took Benadryl the day of the vaccine. Patient received treatment of Tylenol the next day for the sore arm.
Age: 68.0
Sex: F
Vaccine: COVID19
Symptoms: Pain, Pruritus, Vaccination site mass
Clinical narrative: Injection Site Lump; Itching Moved Around; Body Aches Moved Around; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MASS (Injection Site Lump), PRURITUS (Itching Moved Around) and PAIN (Body Aches Moved Around) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, the patient experienced VACCINATION SITE MASS (Injection Site Lump), PRURITUS (Itching Moved Around) and PAIN (Body Aches Moved Around). On 30-Mar-2021, PRURITUS (Itching Moved Around) and PAIN (Body Aches Moved Around) had resolved. At the time of the report, VACCINATION SITE MASS (Injection Site Lump) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.     Concomitant product use was not provided by the reporter. Treatment information was not provided.   Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Reporter's address and Email address were added.
Age: 51.0
Sex: F
Vaccine: COVID19
Symptoms: COVID-19, Malaise, SARS-CoV-1 test
Clinical narrative: Tested positive for Covid on 24Mar2021; Started to feel sick; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for Covid on 24Mar2021) and MALAISE (Started to feel sick) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007B21A and 046B21A) for COVID-19 vaccination.     Concurrent medical conditions included Cancer (Patient reported history of cancer 3 years ago) since 2018. Concomitant products included ANASTROZOLE from 01-Sep-2018 to an unknown date for Cancer, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) from 01-May-2018 to an unknown date for an unknown indication.   On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Mar-2021, the patient experienced MALAISE (Started to feel sick). On 24-Mar-2021, the patient experienced COVID-19 (Tested positive for Covid on 24Mar2021). At the time of the report, COVID-19 (Tested positive for Covid on 24Mar2021) and MALAISE (Started to feel sick) outcome was unknown. Not Provided    DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, SARS-CoV-1 test: positive (Positive) tested positive for Covid.         Action taken with mRNA-1273 in response to the event was not applicable.  Treatment medication was not provided by the reporter.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jun-2021: Follow up received on  26-jun-2021 include concomitant medication added on anastrozole, aspirin and 2nd dose Vaccine information was added and weight added.
Age: 30.0
Sex: F
Vaccine: COVID19
Symptoms: Maternal exposure during pregnancy
Clinical narrative: maternal exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 028L20A) for COVID-19 vaccination.     Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] and ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for an unknown indication.   On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 04-Jan-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy). On 04-Jan-2021, MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Treatment details not provided.
Sex: F
Vaccine: COVID19
Symptoms: Dizziness, Malaise, Pain, Rash, Urticaria
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of dizziness, malaise (doesn't feel good overall), urticaria, (neck broke-out and HCP said looked like hives), vaccine virus shedding (took one solid week to get the basic side effects to go away) and vaccine positive re-challenge (gotten basic side effects after getting the vaccine) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The occurrence of additional events detailed below. No medical history reported. On Mar 23, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced dizziness, malaise (doesn't feel good overall), urticaria, (neck broke-out and HCP said looked like hives), vaccine virus shedding (took one solid week to get the basic side effects to go away), vaccine positive re-challenge (gotten  basic side effects after getting the vaccine), pain (didn't hurt anymore after 7 days) and rash on her neck. At the time of the report, dizziness, malaise (doesn't feel good overall), urticaria, (neck broke-out and HCP said looked like hives), vaccine virus shedding (took one solid week to get the basic side effects to go away), vaccine positive re-challenge (gotten basic side effects after getting the vaccine), pain (didn't hurt anymore after 7 days) and rash on her neck outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. Treatment: topical cream and medication. Reporter did not allow further contact.
Sex: F
Vaccine: COVID19
Symptoms: Vaccine positive rechallenge, Vaccine virus shedding
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of dizziness, malaise (doesn't feel good overall), urticaria, (neck broke-out and HCP said looked like hives), vaccine virus shedding (took one solid week to get the basic side effects to go away) and vaccine positive re-challenge (gotten basic side effects after getting the vaccine) in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. The occurrence of additional events detailed below. No medical history reported. On Mar 23, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced dizziness, malaise (doesn't feel good overall), urticaria, (neck broke-out and HCP said looked like hives), vaccine virus shedding (took one solid week to get the basic side effects to go away), vaccine positive re-challenge (gotten  basic side effects after getting the vaccine), pain (didn't hurt anymore after 7 days) and rash on her neck. At the time of the report, dizziness, malaise (doesn't feel good overall), urticaria, (neck broke-out and HCP said looked like hives), vaccine virus shedding (took one solid week to get the basic side effects to go away), vaccine positive re-challenge (gotten basic side effects after getting the vaccine), pain (didn't hurt anymore after 7 days) and rash on her neck outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. Treatment: topical cream and medication. Reporter did not allow further contact.
Age: 57.0
Sex: F
Vaccine: COVID19
Symptoms: Tinnitus
Clinical narrative: Tinnitus; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Tinnitus) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination.     No Medical History information was reported.    On 28-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021, the patient experienced TINNITUS (Tinnitus). At the time of the report, TINNITUS (Tinnitus) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 34.0
Sex: F
Vaccine: COVID19
Symptoms: Diarrhoea, Exposure during pregnancy
Clinical narrative: Vaccine administered to pregnant patient; Diarrhea; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine administered to pregnant patient) and DIARRHOEA (Diarrhea) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 25A21A) for COVID-19 vaccination.     Concurrent medical conditions included Depression. Concomitant products included BUPROPION for Depression, MULTIVITAMINS [VITAMINS NOS] for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 04-Jul-2020 and the estimated date of delivery was 23-Apr-2021. On 11-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine administered to pregnant patient) and DIARRHOEA (Diarrhea). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-first week of the pregnancy.  On 11-Feb-2021, EXPOSURE DURING PREGNANCY (Vaccine administered to pregnant patient) had resolved. At the time of the report, DIARRHOEA (Diarrhea) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Treatment information was not provided.  Company Comment: This is a case of product exposure during pregnancy with reported AEs, myalgia, fatigue and diarrhea in a 34 year old patient. Patient will be continued to be monitored for further AEs during her pregnancy.   This case was linked to US-MODERNATX, INC.-MOD-2021-069796 (E2B Linked Report).; Sender's Comments: This is a case of product exposure during pregnancy with reported AEs, myalgia, fatigue and diarrhea in a 34 year old patient. Patient will be continued to be monitored for further AEs during her pregnancy. US-MODERNATX, INC.-MOD-2021-069796:Second dose case
Age: 18.0
Sex: F
Vaccine: COVID19
Symptoms: Lethargy, Nausea
Clinical narrative: Lethargy; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of LETHARGY (Lethargy) and NAUSEA (Nausea) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Family history included COVID-19 (Family had COVID in November 2020.).    On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Apr-2021, the patient experienced LETHARGY (Lethargy) and NAUSEA (Nausea). At the time of the report, LETHARGY (Lethargy) and NAUSEA (Nausea) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       This case was linked to MOD21-071205, MOD21-071243 (E2B Linked Report).; Sender's Comments:  MOD21-071205: MOD21-071243:
Age: 83.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Burning sensation, Dizziness, Gastrooesophageal reflux disease, Vaccination site swelling
Clinical narrative: it felt like really bad acid reflux; weakness; burning sensation; dizziness; vaccination site swelling up; This spontaneous case was reported by a consumer and describes the occurrence of GASTROOESOPHAGEAL REFLUX DISEASE (it felt like really bad acid reflux), ASTHENIA (weakness), BURNING SENSATION (burning sensation), DIZZINESS (dizziness) and VACCINATION SITE SWELLING (vaccination site swelling up) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     Concomitant products included LOVASTATIN, FLUOXETINE and TRAMADOL for an unknown indication.    On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced VACCINATION SITE SWELLING (vaccination site swelling up). On 07-Apr-2021, the patient experienced GASTROOESOPHAGEAL REFLUX DISEASE (it felt like really bad acid reflux), ASTHENIA (weakness), BURNING SENSATION (burning sensation) and DIZZINESS (dizziness). At the time of the report, GASTROOESOPHAGEAL REFLUX DISEASE (it felt like really bad acid reflux), ASTHENIA (weakness), BURNING SENSATION (burning sensation), DIZZINESS (dizziness) and VACCINATION SITE SWELLING (vaccination site swelling up) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.        .
Age: 55.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site pain, Vaccination site pruritus, Vaccination site rash
Clinical narrative: big and itchy rash at the injection site (right arm); big and itchy rash at the injection site (right arm); a bit of pains; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (big and itchy rash at the injection site (right arm)), VACCINATION SITE RASH (big and itchy rash at the injection site (right arm)) and VACCINATION SITE PAIN (a bit of pains) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced VACCINATION SITE PRURITUS (big and itchy rash at the injection site (right arm)), VACCINATION SITE RASH (big and itchy rash at the injection site (right arm)) and VACCINATION SITE PAIN (a bit of pains). At the time of the report, VACCINATION SITE PRURITUS (big and itchy rash at the injection site (right arm)), VACCINATION SITE RASH (big and itchy rash at the injection site (right arm)) and VACCINATION SITE PAIN (a bit of pains) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medications were not reported. Treatment details not provided.   Reporter did not allow further contact   Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: Event outcome updated.
Sex: M
Vaccine: COVID19
Symptoms: Arthralgia, Fatigue
Clinical narrative: joint pain; felt tired; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (joint pain) and FATIGUE (felt tired) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     Concurrent medical conditions included AIDS (diagnosed in the 1980s.).    In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced ARTHRALGIA (joint pain) and FATIGUE (felt tired). At the time of the report, ARTHRALGIA (joint pain) and FATIGUE (felt tired) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant product use was not provided by the reporter. Treatment information was not provided.  Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Cold sweat, Dizziness, Erythema, Eye irritation, Injection site pruritus
Clinical narrative: itching; red mark on her shoulder and was burning and itching; the pain and burning felt like a burn; eye was still irritated; like a rash at the injection site; Vaccination site swelling; left aye turned very red; Injection site itching; Cold sweat; Vaccination site pain/ burning at the injection site; nauseas; Dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), COLD SWEAT (Cold sweat), PRURITUS (itching), ERYTHEMA (red mark on her shoulder and was burning and itching) and PAIN (the pain and burning felt like a burn) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032H20P) 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 ERGOCALCIFEROL (VITAMIN D [ERGOCALCIFEROL]), ZINC and MULTIVITAMINS [VITAMINS NOS] for an unknown indication, FISH OIL, OENOTHERA BIENNIS OIL, TOCOPHERYL ACETATE (OMEGA 3 & 6).    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced DIZZINESS (Dizzy) and NAUSEA (nauseas). On 30-Mar-2021, the patient experienced COLD SWEAT (Cold sweat), INJECTION SITE PRURITUS (Injection site itching) and VACCINATION SITE PAIN (Vaccination site pain/ burning at the injection site). On 01-Apr-2021, the patient experienced OCULAR HYPERAEMIA (left aye turned very red). On 05-Apr-2021, the patient experienced PRURITUS (itching), ERYTHEMA (red mark on her shoulder and was burning and itching), PAIN (the pain and burning felt like a burn), EYE IRRITATION (eye was still irritated), VACCINATION SITE RASH (like a rash at the injection site) and VACCINATION SITE SWELLING (Vaccination site swelling). The patient was treated with ACETAMINOPHEN ongoing since an unknown date at an unspecified dose and frequency. On 06-Apr-2021, OCULAR HYPERAEMIA (left aye turned very red) and EYE IRRITATION (eye was still irritated) outcome was unknown. At the time of the report, DIZZINESS (Dizzy), COLD SWEAT (Cold sweat), PRURITUS (itching), ERYTHEMA (red mark on her shoulder and was burning and itching), PAIN (the pain and burning felt like a burn), INJECTION SITE PRURITUS (Injection site itching), VACCINATION SITE RASH (like a rash at the injection site), NAUSEA (nauseas), VACCINATION SITE PAIN (Vaccination site pain/ burning at the injection site) and VACCINATION SITE SWELLING (Vaccination site swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Nausea, Ocular hyperaemia, Pain, Pruritus, Vaccination site pain
Clinical narrative: itching; red mark on her shoulder and was burning and itching; the pain and burning felt like a burn; eye was still irritated; like a rash at the injection site; Vaccination site swelling; left aye turned very red; Injection site itching; Cold sweat; Vaccination site pain/ burning at the injection site; nauseas; Dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), COLD SWEAT (Cold sweat), PRURITUS (itching), ERYTHEMA (red mark on her shoulder and was burning and itching) and PAIN (the pain and burning felt like a burn) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032H20P) 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 ERGOCALCIFEROL (VITAMIN D [ERGOCALCIFEROL]), ZINC and MULTIVITAMINS [VITAMINS NOS] for an unknown indication, FISH OIL, OENOTHERA BIENNIS OIL, TOCOPHERYL ACETATE (OMEGA 3 & 6).    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced DIZZINESS (Dizzy) and NAUSEA (nauseas). On 30-Mar-2021, the patient experienced COLD SWEAT (Cold sweat), INJECTION SITE PRURITUS (Injection site itching) and VACCINATION SITE PAIN (Vaccination site pain/ burning at the injection site). On 01-Apr-2021, the patient experienced OCULAR HYPERAEMIA (left aye turned very red). On 05-Apr-2021, the patient experienced PRURITUS (itching), ERYTHEMA (red mark on her shoulder and was burning and itching), PAIN (the pain and burning felt like a burn), EYE IRRITATION (eye was still irritated), VACCINATION SITE RASH (like a rash at the injection site) and VACCINATION SITE SWELLING (Vaccination site swelling). The patient was treated with ACETAMINOPHEN ongoing since an unknown date at an unspecified dose and frequency. On 06-Apr-2021, OCULAR HYPERAEMIA (left aye turned very red) and EYE IRRITATION (eye was still irritated) outcome was unknown. At the time of the report, DIZZINESS (Dizzy), COLD SWEAT (Cold sweat), PRURITUS (itching), ERYTHEMA (red mark on her shoulder and was burning and itching), PAIN (the pain and burning felt like a burn), INJECTION SITE PRURITUS (Injection site itching), VACCINATION SITE RASH (like a rash at the injection site), NAUSEA (nauseas), VACCINATION SITE PAIN (Vaccination site pain/ burning at the injection site) and VACCINATION SITE SWELLING (Vaccination site swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 56.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site rash, Vaccination site swelling
Clinical narrative: itching; red mark on her shoulder and was burning and itching; the pain and burning felt like a burn; eye was still irritated; like a rash at the injection site; Vaccination site swelling; left aye turned very red; Injection site itching; Cold sweat; Vaccination site pain/ burning at the injection site; nauseas; Dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), COLD SWEAT (Cold sweat), PRURITUS (itching), ERYTHEMA (red mark on her shoulder and was burning and itching) and PAIN (the pain and burning felt like a burn) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032H20P) 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 ERGOCALCIFEROL (VITAMIN D [ERGOCALCIFEROL]), ZINC and MULTIVITAMINS [VITAMINS NOS] for an unknown indication, FISH OIL, OENOTHERA BIENNIS OIL, TOCOPHERYL ACETATE (OMEGA 3 & 6).    On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Mar-2021, the patient experienced DIZZINESS (Dizzy) and NAUSEA (nauseas). On 30-Mar-2021, the patient experienced COLD SWEAT (Cold sweat), INJECTION SITE PRURITUS (Injection site itching) and VACCINATION SITE PAIN (Vaccination site pain/ burning at the injection site). On 01-Apr-2021, the patient experienced OCULAR HYPERAEMIA (left aye turned very red). On 05-Apr-2021, the patient experienced PRURITUS (itching), ERYTHEMA (red mark on her shoulder and was burning and itching), PAIN (the pain and burning felt like a burn), EYE IRRITATION (eye was still irritated), VACCINATION SITE RASH (like a rash at the injection site) and VACCINATION SITE SWELLING (Vaccination site swelling). The patient was treated with ACETAMINOPHEN ongoing since an unknown date at an unspecified dose and frequency. On 06-Apr-2021, OCULAR HYPERAEMIA (left aye turned very red) and EYE IRRITATION (eye was still irritated) outcome was unknown. At the time of the report, DIZZINESS (Dizzy), COLD SWEAT (Cold sweat), PRURITUS (itching), ERYTHEMA (red mark on her shoulder and was burning and itching), PAIN (the pain and burning felt like a burn), INJECTION SITE PRURITUS (Injection site itching), VACCINATION SITE RASH (like a rash at the injection site), NAUSEA (nauseas), VACCINATION SITE PAIN (Vaccination site pain/ burning at the injection site) and VACCINATION SITE SWELLING (Vaccination site swelling) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.
Age: 78.0
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue, SARS-CoV-2 test positive
Clinical narrative: 90 days since her first dose; Got Covid; This spontaneous case was reported by a consumer and describes the occurrence of SARS-COV-2 TEST POSITIVE (Got Covid) and PRODUCT DOSE OMISSION ISSUE (90 days since her first dose) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025j20-2a) for COVID-19 vaccination.     No Medical History information was reported.    On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced SARS-COV-2 TEST POSITIVE (Got Covid). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (90 days since her first dose). The patient was treated with BAMLANIVIMAB for Symptomatic treatment, at a dose of 1 dosage form. At the time of the report, SARS-COV-2 TEST POSITIVE (Got Covid) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (90 days since her first dose) had resolved. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported.   Most recent FOLLOW-UP information incorporated above includes: On 26-Jun-2021: received on 26-JUN-2021 in which No new information
Age: 58.0
Sex: F
Vaccine: COVID19
Symptoms: Influenza like illness, SARS-CoV-2 test, SARS-CoV-2 test positive, Vaccination site pain
Clinical narrative: flue like symptoms; Covid19 Positive after first vaccination; Pain at the injection arm; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (flue like symptoms), SARS-COV-2 TEST POSITIVE (Covid19 Positive after first vaccination) and VACCINATION SITE PAIN (Pain at the injection arm) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030B21A) for COVID-19 vaccination.     No Medical History information was reported.    On 08-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 08-Mar-2021, the patient experienced VACCINATION SITE PAIN (Pain at the injection arm). On 23-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (flue like symptoms) and SARS-COV-2 TEST POSITIVE (Covid19 Positive after first vaccination). On 31-Mar-2021, INFLUENZA LIKE ILLNESS (flue like symptoms) had resolved. At the time of the report, SARS-COV-2 TEST POSITIVE (Covid19 Positive after first vaccination) and VACCINATION SITE PAIN (Pain at the injection arm) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Mar-2021, SARS-CoV-2 test: positive Positive.     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Product dose omission issue
Clinical narrative: Second dose was not applied in the correct interval; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Second dose was not applied in the correct interval) in a 67-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 medical history reported).    On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Second dose was not applied in the correct interval). On 18-Mar-2021, PRODUCT DOSE OMISSION ISSUE (Second dose was not applied in the correct interval) had resolved.        mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged.       No concomitant medication reported   No treatment medication reported
Age: 48.0
Sex: F
Vaccine: COVID19
Symptoms: Accidental overdose, Anxiety, Feeling abnormal, Tremor
Clinical narrative: Anxiety; hands shaking; feeling of weightlessness/feeling of floating; Invalid dose of 1ml of Moderna Vaccine; This spontaneous case was reported by a nurse and describes the occurrence of ANXIETY (Anxiety), TREMOR (hands shaking), FEELING ABNORMAL (feeling of weightlessness/feeling of floating) and ACCIDENTAL OVERDOSE (Invalid dose of 1ml of Moderna Vaccine) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination.     No medical history was provided by the reporter.  Concurrent medical conditions included Sulfonamide allergy.    On 06-Apr-2021 at 4:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced ANXIETY (Anxiety), TREMOR (hands shaking) and FEELING ABNORMAL (feeling of weightlessness/feeling of floating). 06-Apr-2021, the patient experienced ACCIDENTAL OVERDOSE (Invalid dose of 1ml of Moderna Vaccine). On 06-Apr-2021, ACCIDENTAL OVERDOSE (Invalid dose of 1ml of Moderna Vaccine) had resolved. On 10-Apr-2021, ANXIETY (Anxiety), TREMOR (hands shaking) and FEELING ABNORMAL (feeling of weightlessness/feeling of floating) had resolved.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.   For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Concomitant product use was not provided. Treatment information was not  provided.   This case was linked to MOD21-071039, MOD21-071001, MOD21-070955, MOD21-071038, MOD21-071043, MOD21-071046, MOD21-071048 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: On 26-MAY-2021 a follow up was received, Patient demographics was updated. Batch number of suspect product details was added. Allergic conditions were added. New events were added. Event's start, stop dates and outcome was added. On 22-Jul-2021: A significant follow up was received on 22-JUL-2021 where outcome of the events were updated.; Sender's Comments: This report refers to a case of Accidental overdose, for mRNA-1273, lot # 044A21A,  with no associated AEs. MOD21-071039: MOD21-071001: MOD21-070955: MOD21-071038: MOD21-071043: MOD21-071046: MOD21-071048:
Age: 44.0
Sex: F
Vaccine: COVID19
Symptoms: Paraesthesia oral, Pharyngeal swelling
Clinical narrative: Started to feel Swelling in her throat; Tingling in Tongue; This spontaneous case was reported by a consumer and describes the occurrence of PHARYNGEAL SWELLING (Started to feel Swelling in her throat) and PARAESTHESIA ORAL (Tingling in Tongue) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Mar-2021, the patient experienced PHARYNGEAL SWELLING (Started to feel Swelling in her throat) and PARAESTHESIA ORAL (Tingling in Tongue). The patient was treated with DIPHENHYDRAMINE ongoing since an unknown date for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, PHARYNGEAL SWELLING (Started to feel Swelling in her throat) and PARAESTHESIA ORAL (Tingling in Tongue) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant drug information was not provided. Treatment information included Benadryl.
Age: 87.0
Sex: M
Vaccine: COVID19
Symptoms: Abdominal pain, Back pain
Clinical narrative: Dull achy pain to the right side of abdomen; pain radiated to back; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (Dull achy pain to the right side of abdomen) and BACK PAIN (pain radiated to back) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 015M20A and 002P021A) for COVID-19 vaccination.     Concomitant products included ATORVASTATIN, APIXABAN (ELIQUIS), LEVOTHYROXINE and DOFETILIDE for an unknown indication.   On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced ABDOMINAL PAIN (Dull achy pain to the right side of abdomen) and BACK PAIN (pain radiated to back). The patient was treated with PARACETAMOL (ACETAMINOPHEN EXTRA STRENGTH) ongoing since an unknown date for Symptomatic treatment, at an unspecified dose and frequency. At the time of the report, ABDOMINAL PAIN (Dull achy pain to the right side of abdomen) and BACK PAIN (pain radiated to back) outcome was unknown. Not Provided          Treatment medication includes: Extra Strength Tylenol. Action taken with mRNA-1273 in response to the event was not applicable.
Age: 52.0
Sex: F
Vaccine: COVID19
Symptoms: Rash, Vaccination site pain
Clinical narrative: -2021-069799, MOD21-071455 (E2B Linked Report).; Sender's Comments: Rash (neck,behind  knee,lower back); sore injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash (neck,behind  knee,lower back)) and VACCINATION SITE PAIN (sore injection site arm) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination.     No Medical History information was reported.    On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced RASH (Rash (neck,behind  knee,lower back)) and VACCINATION SITE PAIN (sore injection site arm). At the time of the report, RASH (Rash (neck,behind  knee,lower back)) was resolving and VACCINATION SITE PAIN (sore injection site arm) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to US-MODERNATX, INC.-MOD-2021-069799, MOD21-071455 (E2B Linked Report).; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-069799:Case for second dose MOD21-071455:cross linked case
Age: 35.0
Sex: F
Vaccine: COVID19
Symptoms: Fatigue, Maternal exposure during pregnancy, Pain, Pregnancy test
Clinical narrative: Body ache; Fatigue; Vaccine administered to pregnant patient; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Vaccine administered to pregnant patient), PAIN (Body ache) and FATIGUE (Fatigue) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 25A21A) for COVID-19 vaccination.     The patient's past medical history included Subfertility (Failed to conceive after a year plus of trying. Referred to fertility clinic for IVF.). Previously administered products included for an unreported indication: MARIJUANA from 2008 to 2013, NICOTINE (1 Pack/day- 3mg 60ml/week) from 2009 to February 2020, PHENCYCLIDINE (Daily) from 2012 to 2013 and TDAP. Concurrent medical conditions included Depression since 2020, Alcohol use (1 drink/week) since 2006 and Allergy to plants. Concomitant products included BUPROPION, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), VITAMIN C [ASCORBIC ACID], VITAMIN D [VITAMIN D NOS] and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication.   On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 04-Jul-2020 and the estimated date of delivery was 23-Apr-2021. On 11-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Vaccine administered to pregnant patient). On 11-Mar-2021,  after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced PAIN (Body ache) and FATIGUE (Fatigue). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the  thirty-first week of the pregnancy. The delivery occurred, which was reported as Full-term. For neonate 1, the birth weight was 4026 grams (8lbs 14oz) with an APGAR score of 7 and 9 at (1, 5 minutes). The outcome was reported as Term Birth w/o Complications. Length- 20 cm, Head circumference- 34.29 cm. On 11-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Vaccine administered to pregnant patient) had resolved. On 13-Mar-2021, FATIGUE (Fatigue) had resolved. At the time of the report, PAIN (Body ache) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In September 2020, Pregnancy test: Positive.     For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.   Treatment medications were not reported.   This case was linked to MOD-2021-069764 (Patient Link).
Age: 51.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Decreased appetite, Pain, Pyrexia
Clinical narrative: This spontaneous case reported by a consumer, describes the occurrence of decreased appetite (loss of appetite), pain (body aches), pyrexia (fever) and chills in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 031M20A and 039A21A) for COVID-19 immunization. Concomitant products included vitamins (NOS) for an unknown indication. On Mar 4, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. On Apr 6, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19  vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced decreased appetite (loss of appetite), pain (body aches), pyrexia (fever) and chills. At the time of the report, decreased appetite (loss of appetite), pain (body aches), pyrexia (fever) and chills outcome: unknown.
Age: 67.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Chills, Pyrexia
Clinical narrative: joint pain; chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (joint pain), CHILLS (chills) and PYREXIA (fever) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.   On 06-Apr-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 an unknown date, the patient experienced ARTHRALGIA (joint pain), CHILLS (chills) and PYREXIA (fever). At the time of the report, ARTHRALGIA (joint pain), CHILLS (chills) and PYREXIA (fever) outcome was unknown.            Patient typically has joint pain and took tramadol and meloxicam. Concomitant product use was not provided by the reporter.