chrisvoncsefalvay/vaers-narrative-generation huggingface dataset:
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, Dental care, Dizziness, Fatigue, Headache
Clinical narrative: Headache; Pain from her lower back on the right side to her toe; Nose was burning, she could smell burn and her "fingertips burning; Head eyes and nose itching; Right hand completely frozen; Joint pain up to upper arm; Dental work done; Sore arm/Pain from her upper right arm; Fatigue; Blurry vision; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), DIZZINESS (Dizziness), PAIN (Pain from her lower back on the right side to her toe), FATIGUE (Fatigue) and VISION BLURRED (Blurry vision) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011B21A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided y the reporter.  Concomitant products included COLESEVELAM, ROSUVASTATIN, FAMCICLOVIR, Omeprazole, GABAPENTIN (GABAPENTIN "PCD"), METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE MONOHYDRATE (JANUMET), FEXOFENADINE HYDROCHLORIDE (ALLEGRA), ZINC, ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-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 DIZZINESS (Dizziness), FATIGUE (Fatigue), VISION BLURRED (Blurry vision) and MYALGIA (Sore arm/Pain from her upper right arm). On 05-Apr-2021, the patient experienced DENTAL CARE (Dental work done). On 14-Apr-2021, the patient experienced PAIN (Pain from her lower back on the right side to her toe), SKIN BURNING SENSATION (Nose was burning, she could smell burn and her "fingertips burning), PRURITUS (Head eyes and nose itching), INJECTED LIMB MOBILITY DECREASED (Right hand completely frozen) and ARTHRALGIA (Joint pain up to upper arm). On an unknown date, the patient experienced HEADACHE (Headache). On 03-Apr-2021, DIZZINESS (Dizziness), VISION BLURRED (Blurry vision) and MYALGIA (Sore arm/Pain from her upper right arm) had resolved, FATIGUE (Fatigue) outcome was unknown. At the time of the report, HEADACHE (Headache), PAIN (Pain from her lower back on the right side to her toe), SKIN BURNING SENSATION (Nose was burning, she could smell burn and her "fingertips burning), PRURITUS (Head eyes and nose itching), DENTAL CARE (Dental work done), INJECTED LIMB MOBILITY DECREASED (Right hand completely frozen) and ARTHRALGIA (Joint pain up to upper arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Cold water, aloe vera, cold showers, Benadry, Tylenol, Hydroxyzine, Allergy patches, cold pack were used as treatments.   This case was linked to MOD-2021-089500 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Injected limb mobility decreased, Myalgia, Pain, Pruritus, Skin burning sensation
Clinical narrative: Headache; Pain from her lower back on the right side to her toe; Nose was burning, she could smell burn and her "fingertips burning; Head eyes and nose itching; Right hand completely frozen; Joint pain up to upper arm; Dental work done; Sore arm/Pain from her upper right arm; Fatigue; Blurry vision; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), DIZZINESS (Dizziness), PAIN (Pain from her lower back on the right side to her toe), FATIGUE (Fatigue) and VISION BLURRED (Blurry vision) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011B21A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided y the reporter.  Concomitant products included COLESEVELAM, ROSUVASTATIN, FAMCICLOVIR, Omeprazole, GABAPENTIN (GABAPENTIN "PCD"), METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE MONOHYDRATE (JANUMET), FEXOFENADINE HYDROCHLORIDE (ALLEGRA), ZINC, ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-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 DIZZINESS (Dizziness), FATIGUE (Fatigue), VISION BLURRED (Blurry vision) and MYALGIA (Sore arm/Pain from her upper right arm). On 05-Apr-2021, the patient experienced DENTAL CARE (Dental work done). On 14-Apr-2021, the patient experienced PAIN (Pain from her lower back on the right side to her toe), SKIN BURNING SENSATION (Nose was burning, she could smell burn and her "fingertips burning), PRURITUS (Head eyes and nose itching), INJECTED LIMB MOBILITY DECREASED (Right hand completely frozen) and ARTHRALGIA (Joint pain up to upper arm). On an unknown date, the patient experienced HEADACHE (Headache). On 03-Apr-2021, DIZZINESS (Dizziness), VISION BLURRED (Blurry vision) and MYALGIA (Sore arm/Pain from her upper right arm) had resolved, FATIGUE (Fatigue) outcome was unknown. At the time of the report, HEADACHE (Headache), PAIN (Pain from her lower back on the right side to her toe), SKIN BURNING SENSATION (Nose was burning, she could smell burn and her "fingertips burning), PRURITUS (Head eyes and nose itching), DENTAL CARE (Dental work done), INJECTED LIMB MOBILITY DECREASED (Right hand completely frozen) and ARTHRALGIA (Joint pain up to upper arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Cold water, aloe vera, cold showers, Benadry, Tylenol, Hydroxyzine, Allergy patches, cold pack were used as treatments.   This case was linked to MOD-2021-089500 (Patient Link).
Age: 63.0
Sex: F
Vaccine: COVID19
Symptoms: Vision blurred
Clinical narrative: Headache; Pain from her lower back on the right side to her toe; Nose was burning, she could smell burn and her "fingertips burning; Head eyes and nose itching; Right hand completely frozen; Joint pain up to upper arm; Dental work done; Sore arm/Pain from her upper right arm; Fatigue; Blurry vision; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), DIZZINESS (Dizziness), PAIN (Pain from her lower back on the right side to her toe), FATIGUE (Fatigue) and VISION BLURRED (Blurry vision) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011B21A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     No medical history was provided y the reporter.  Concomitant products included COLESEVELAM, ROSUVASTATIN, FAMCICLOVIR, Omeprazole, GABAPENTIN (GABAPENTIN "PCD"), METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE MONOHYDRATE (JANUMET), FEXOFENADINE HYDROCHLORIDE (ALLEGRA), ZINC, ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication.   On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-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 DIZZINESS (Dizziness), FATIGUE (Fatigue), VISION BLURRED (Blurry vision) and MYALGIA (Sore arm/Pain from her upper right arm). On 05-Apr-2021, the patient experienced DENTAL CARE (Dental work done). On 14-Apr-2021, the patient experienced PAIN (Pain from her lower back on the right side to her toe), SKIN BURNING SENSATION (Nose was burning, she could smell burn and her "fingertips burning), PRURITUS (Head eyes and nose itching), INJECTED LIMB MOBILITY DECREASED (Right hand completely frozen) and ARTHRALGIA (Joint pain up to upper arm). On an unknown date, the patient experienced HEADACHE (Headache). On 03-Apr-2021, DIZZINESS (Dizziness), VISION BLURRED (Blurry vision) and MYALGIA (Sore arm/Pain from her upper right arm) had resolved, FATIGUE (Fatigue) outcome was unknown. At the time of the report, HEADACHE (Headache), PAIN (Pain from her lower back on the right side to her toe), SKIN BURNING SENSATION (Nose was burning, she could smell burn and her "fingertips burning), PRURITUS (Head eyes and nose itching), DENTAL CARE (Dental work done), INJECTED LIMB MOBILITY DECREASED (Right hand completely frozen) and ARTHRALGIA (Joint pain up to upper arm) outcome was unknown.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Cold water, aloe vera, cold showers, Benadry, Tylenol, Hydroxyzine, Allergy patches, cold pack were used as treatments.   This case was linked to MOD-2021-089500 (Patient Link).
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Blood pressure measurement, Body temperature, Dizziness, Fatigue
Clinical narrative: Fever of 103; Headache; muscle ache; Weakness; extremely tired; dizziness; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 103), HEADACHE (Headache), MYALGIA (muscle ache), ASTHENIA (Weakness) and FATIGUE (extremely tired) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 24-Oct-2020 and Ileostomy on 02-Oct-2016. Concomitant products included GABAPENTIN from 15-Aug-2010 to an unknown date, DIAZEPAM from 13-Jul-2010 to an unknown date, BACLOFEN from 15-Aug-2020 to an unknown date, LEVOTHYROXINE and LOSARTAN from 12-Jul-2010 to an unknown date for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced PYREXIA (Fever of 103), HEADACHE (Headache), MYALGIA (muscle ache), ASTHENIA (Weakness), FATIGUE (extremely tired), DIZZINESS (dizziness) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever of 103), HEADACHE (Headache), MYALGIA (muscle ache), ASTHENIA (Weakness), FATIGUE (extremely tired), DIZZINESS (dizziness) and NAUSEA (nausea) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Oct-2020, Viral test: positive the patient has been diagnosed with positive for COVID-19. In 2021, Blood pressure measurement: 164/90 (abnormal) 164/90. In 2021, Body temperature: 101.2 (abnormal) 101.2, 102.9 (abnormal) 102.9 and 103 (abnormal) 103. In 2021, Heart rate: 122 (abnormal) 122.         vaccine doses has been injected via Shoulder The patient had no Allergies to medications, food, and other products.   This case was linked to US-MODERNATX, INC.-MOD-2021-089510 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow up received on 26-May-2021 contains non-significant information contact information updated. On 25-Jul-2021: Updated Reporter details, updated Patient demographics, added lab test, added Vaccine Facility information, Suspect product anatomical location has been updated, added Concomitant drugs, added Adverse Event start date, Outcome updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089510:Dose 1
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Heart rate, Myalgia, Nausea, Pyrexia
Clinical narrative: Fever of 103; Headache; muscle ache; Weakness; extremely tired; dizziness; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 103), HEADACHE (Headache), MYALGIA (muscle ache), ASTHENIA (Weakness) and FATIGUE (extremely tired) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 24-Oct-2020 and Ileostomy on 02-Oct-2016. Concomitant products included GABAPENTIN from 15-Aug-2010 to an unknown date, DIAZEPAM from 13-Jul-2010 to an unknown date, BACLOFEN from 15-Aug-2020 to an unknown date, LEVOTHYROXINE and LOSARTAN from 12-Jul-2010 to an unknown date for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced PYREXIA (Fever of 103), HEADACHE (Headache), MYALGIA (muscle ache), ASTHENIA (Weakness), FATIGUE (extremely tired), DIZZINESS (dizziness) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever of 103), HEADACHE (Headache), MYALGIA (muscle ache), ASTHENIA (Weakness), FATIGUE (extremely tired), DIZZINESS (dizziness) and NAUSEA (nausea) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Oct-2020, Viral test: positive the patient has been diagnosed with positive for COVID-19. In 2021, Blood pressure measurement: 164/90 (abnormal) 164/90. In 2021, Body temperature: 101.2 (abnormal) 101.2, 102.9 (abnormal) 102.9 and 103 (abnormal) 103. In 2021, Heart rate: 122 (abnormal) 122.         vaccine doses has been injected via Shoulder The patient had no Allergies to medications, food, and other products.   This case was linked to US-MODERNATX, INC.-MOD-2021-089510 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow up received on 26-May-2021 contains non-significant information contact information updated. On 25-Jul-2021: Updated Reporter details, updated Patient demographics, added lab test, added Vaccine Facility information, Suspect product anatomical location has been updated, added Concomitant drugs, added Adverse Event start date, Outcome updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089510:Dose 1
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Viral test
Clinical narrative: Fever of 103; Headache; muscle ache; Weakness; extremely tired; dizziness; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 103), HEADACHE (Headache), MYALGIA (muscle ache), ASTHENIA (Weakness) and FATIGUE (extremely tired) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included COVID-19 on 24-Oct-2020 and Ileostomy on 02-Oct-2016. Concomitant products included GABAPENTIN from 15-Aug-2010 to an unknown date, DIAZEPAM from 13-Jul-2010 to an unknown date, BACLOFEN from 15-Aug-2020 to an unknown date, LEVOTHYROXINE and LOSARTAN from 12-Jul-2010 to an unknown date for an unknown indication.   On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced PYREXIA (Fever of 103), HEADACHE (Headache), MYALGIA (muscle ache), ASTHENIA (Weakness), FATIGUE (extremely tired), DIZZINESS (dizziness) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever of 103), HEADACHE (Headache), MYALGIA (muscle ache), ASTHENIA (Weakness), FATIGUE (extremely tired), DIZZINESS (dizziness) and NAUSEA (nausea) had resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Oct-2020, Viral test: positive the patient has been diagnosed with positive for COVID-19. In 2021, Blood pressure measurement: 164/90 (abnormal) 164/90. In 2021, Body temperature: 101.2 (abnormal) 101.2, 102.9 (abnormal) 102.9 and 103 (abnormal) 103. In 2021, Heart rate: 122 (abnormal) 122.         vaccine doses has been injected via Shoulder The patient had no Allergies to medications, food, and other products.   This case was linked to US-MODERNATX, INC.-MOD-2021-089510 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow up received on 26-May-2021 contains non-significant information contact information updated. On 25-Jul-2021: Updated Reporter details, updated Patient demographics, added lab test, added Vaccine Facility information, Suspect product anatomical location has been updated, added Concomitant drugs, added Adverse Event start date, Outcome updated.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089510:Dose 1
Sex: M
Vaccine: COVID19
Symptoms: Diarrhoea, Pain in extremity
Clinical narrative: sore arm; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and DIARRHOEA (diarrhea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination.     No Medical History information was reported.    On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and DIARRHOEA (diarrhea). Not Provided          This case was linked to MOD21-081406, MOD21-081427 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: No specific follow-up information recorded.; Sender's Comments:  MOD21-081406: MOD21-081427:for his brother , follow up
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Body temperature, Chills, Dizziness, Ear pain, Fatigue
Clinical narrative: left injection arm soreness; Felt dizzy; Ear pain; Covid arm; chills; Tiredness; headache; lymph node under the left injection arm was swollen; fever of 103F; sore left arm at injection site; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (left injection arm soreness), DIZZINESS (Felt dizzy), EAR PAIN (Ear pain), VACCINATION SITE REACTION (Covid arm) and CHILLS (chills) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included IBD (Microscopic Colitis) since 01-Jan-2021. Concomitant products included ATORVASTATIN for Hypercholesterolemia, BIFIDOBACTERIUM INFANTIS (ALIGN) for IBD, HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE HCTZ) for Vertigo, VITAMIN D3 for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced PAIN IN EXTREMITY (left injection arm soreness), DIZZINESS (Felt dizzy), EAR PAIN (Ear pain), VACCINATION SITE REACTION (Covid arm), CHILLS (chills), FATIGUE (Tiredness), HEADACHE (headache), LYMPHADENOPATHY (lymph node under the left injection arm was swollen), PYREXIA (fever of 103F) and VACCINATION SITE PAIN (sore left arm at injection site). The patient was treated with PARACETAMOL (TYLENOL) (oral) for Fever, at a dose of 500 milligram and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (topical) for Rash, at an unspecified dose and frequency. On 19-Apr-2021, PAIN IN EXTREMITY (left injection arm soreness), DIZZINESS (Felt dizzy), EAR PAIN (Ear pain), VACCINATION SITE REACTION (Covid arm), CHILLS (chills), FATIGUE (Tiredness), HEADACHE (headache), LYMPHADENOPATHY (lymph node under the left injection arm was swollen) and PYREXIA (fever of 103F) had resolved and VACCINATION SITE PAIN (sore left arm at injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Apr-2021, Body temperature: 103 (High) High.         The patient alternated between Advil and Tylenol for reducing fever.   This case was linked to US-MODERNATX, INC.-MOD-2021-089677 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 29-May-2021: Updates concomitant product use and treatment medication use. Updated event start date and stop date.Updated patient's medical history.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089677:Crosse linked
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Headache, Lymphadenopathy, Pain in extremity, Pyrexia, Vaccination site pain
Clinical narrative: left injection arm soreness; Felt dizzy; Ear pain; Covid arm; chills; Tiredness; headache; lymph node under the left injection arm was swollen; fever of 103F; sore left arm at injection site; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (left injection arm soreness), DIZZINESS (Felt dizzy), EAR PAIN (Ear pain), VACCINATION SITE REACTION (Covid arm) and CHILLS (chills) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included IBD (Microscopic Colitis) since 01-Jan-2021. Concomitant products included ATORVASTATIN for Hypercholesterolemia, BIFIDOBACTERIUM INFANTIS (ALIGN) for IBD, HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE HCTZ) for Vertigo, VITAMIN D3 for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced PAIN IN EXTREMITY (left injection arm soreness), DIZZINESS (Felt dizzy), EAR PAIN (Ear pain), VACCINATION SITE REACTION (Covid arm), CHILLS (chills), FATIGUE (Tiredness), HEADACHE (headache), LYMPHADENOPATHY (lymph node under the left injection arm was swollen), PYREXIA (fever of 103F) and VACCINATION SITE PAIN (sore left arm at injection site). The patient was treated with PARACETAMOL (TYLENOL) (oral) for Fever, at a dose of 500 milligram and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (topical) for Rash, at an unspecified dose and frequency. On 19-Apr-2021, PAIN IN EXTREMITY (left injection arm soreness), DIZZINESS (Felt dizzy), EAR PAIN (Ear pain), VACCINATION SITE REACTION (Covid arm), CHILLS (chills), FATIGUE (Tiredness), HEADACHE (headache), LYMPHADENOPATHY (lymph node under the left injection arm was swollen) and PYREXIA (fever of 103F) had resolved and VACCINATION SITE PAIN (sore left arm at injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Apr-2021, Body temperature: 103 (High) High.         The patient alternated between Advil and Tylenol for reducing fever.   This case was linked to US-MODERNATX, INC.-MOD-2021-089677 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 29-May-2021: Updates concomitant product use and treatment medication use. Updated event start date and stop date.Updated patient's medical history.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089677:Crosse linked
Age: 61.0
Sex: F
Vaccine: COVID19
Symptoms: Vaccination site reaction
Clinical narrative: left injection arm soreness; Felt dizzy; Ear pain; Covid arm; chills; Tiredness; headache; lymph node under the left injection arm was swollen; fever of 103F; sore left arm at injection site; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (left injection arm soreness), DIZZINESS (Felt dizzy), EAR PAIN (Ear pain), VACCINATION SITE REACTION (Covid arm) and CHILLS (chills) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     Concurrent medical conditions included IBD (Microscopic Colitis) since 01-Jan-2021. Concomitant products included ATORVASTATIN for Hypercholesterolemia, BIFIDOBACTERIUM INFANTIS (ALIGN) for IBD, HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE HCTZ) for Vertigo, VITAMIN D3 for an unknown indication.   On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced PAIN IN EXTREMITY (left injection arm soreness), DIZZINESS (Felt dizzy), EAR PAIN (Ear pain), VACCINATION SITE REACTION (Covid arm), CHILLS (chills), FATIGUE (Tiredness), HEADACHE (headache), LYMPHADENOPATHY (lymph node under the left injection arm was swollen), PYREXIA (fever of 103F) and VACCINATION SITE PAIN (sore left arm at injection site). The patient was treated with PARACETAMOL (TYLENOL) (oral) for Fever, at a dose of 500 milligram and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (topical) for Rash, at an unspecified dose and frequency. On 19-Apr-2021, PAIN IN EXTREMITY (left injection arm soreness), DIZZINESS (Felt dizzy), EAR PAIN (Ear pain), VACCINATION SITE REACTION (Covid arm), CHILLS (chills), FATIGUE (Tiredness), HEADACHE (headache), LYMPHADENOPATHY (lymph node under the left injection arm was swollen) and PYREXIA (fever of 103F) had resolved and VACCINATION SITE PAIN (sore left arm at injection site) outcome was unknown.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Apr-2021, Body temperature: 103 (High) High.         The patient alternated between Advil and Tylenol for reducing fever.   This case was linked to US-MODERNATX, INC.-MOD-2021-089677 (E2B Linked Report).   Most recent FOLLOW-UP information incorporated above includes: On 29-May-2021: Updates concomitant product use and treatment medication use. Updated event start date and stop date.Updated patient's medical history.; Sender's Comments:  US-MODERNATX, INC.-MOD-2021-089677:Crosse linked
Age: 27.0
Sex: M
Vaccine: COVID19
Symptoms: Chills, Fatigue, Headache, Injection site pain, Myalgia
Clinical narrative: fatigue; sore arm at injection site; chills; body aches; headache; This spontaneous case was reported by an other health professional and describes the occurrence of FATIGUE (fatigue), INJECTION SITE PAIN (sore arm at injection site), CHILLS (chills), MYALGIA (body aches) and HEADACHE (headache) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 011J20A) for COVID-19 vaccination.     Concurrent medical conditions included Allergy to plants. Concomitant products included MELATONIN for Sleep deprivation.   On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced FATIGUE (fatigue), INJECTION SITE PAIN (sore arm at injection site), CHILLS (chills), MYALGIA (body aches) and HEADACHE (headache). On 25-Apr-2021, FATIGUE (fatigue), INJECTION SITE PAIN (sore arm at injection site), CHILLS (chills), MYALGIA (body aches) and HEADACHE (headache) had resolved.        For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.   Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: other relevant history, concomitant drug, dose details of suspect drug,  events and their outcomes were added
Sex: F
Vaccine: COVID19
Symptoms: Headache
Clinical narrative: Headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headaches) 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 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced HEADACHE (Headaches). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, HEADACHE (Headaches) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.       Concomitant medications were not reported. Treatment details include acetaminophen and that helps some
Age: 71.0
Sex: F
Vaccine: COVID19
Symptoms: Chills, Fatigue
Clinical narrative: CHILLS; Feeling very tired; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (CHILLS) and FATIGUE (Feeling very tired) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination.     Concomitant products included METFORMIN for an unknown indication.   On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced CHILLS (CHILLS) and FATIGUE (Feeling very tired). At the time of the report, CHILLS (CHILLS) and FATIGUE (Feeling very tired) outcome was unknown. Not Provided          concomitant medicine: blood pressure pill and cholesterol pills Treatment information as not reported.
Sex: F
Vaccine: COVID19
Symptoms: Chills, Dizziness, Erythema, Feeling hot, Induration
Clinical narrative: Arm was swollen the size of a fist; Real hard; Real hot like you can light a cigarette off it; Fire engine red; Itch real bad; Light headedness; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm was swollen the size of a fist), INDURATION (Real hard), FEELING HOT (Real hot like you can light a cigarette off it), ERYTHEMA (Fire engine red) and PRURITUS (Itch real bad) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced PERIPHERAL SWELLING (Arm was swollen the size of a fist), INDURATION (Real hard), FEELING HOT (Real hot like you can light a cigarette off it), ERYTHEMA (Fire engine red), PRURITUS (Itch real bad), DIZZINESS (Light headedness) and CHILLS (Chills). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Arm was swollen the size of a fist), INDURATION (Real hard), FEELING HOT (Real hot like you can light a cigarette off it), ERYTHEMA (Fire engine red), PRURITUS (Itch real bad), DIZZINESS (Light headedness) and CHILLS (Chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Peripheral swelling, Pruritus
Clinical narrative: Arm was swollen the size of a fist; Real hard; Real hot like you can light a cigarette off it; Fire engine red; Itch real bad; Light headedness; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm was swollen the size of a fist), INDURATION (Real hard), FEELING HOT (Real hot like you can light a cigarette off it), ERYTHEMA (Fire engine red) and PRURITUS (Itch real bad) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced PERIPHERAL SWELLING (Arm was swollen the size of a fist), INDURATION (Real hard), FEELING HOT (Real hot like you can light a cigarette off it), ERYTHEMA (Fire engine red), PRURITUS (Itch real bad), DIZZINESS (Light headedness) and CHILLS (Chills). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Arm was swollen the size of a fist), INDURATION (Real hard), FEELING HOT (Real hot like you can light a cigarette off it), ERYTHEMA (Fire engine red), PRURITUS (Itch real bad), DIZZINESS (Light headedness) and CHILLS (Chills) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.
Sex: F
Vaccine: COVID19
Symptoms: Abdominal pain upper, Chills, Constipation, Diarrhoea, Influenza like illness
Clinical narrative: Constipation; Muscle pain; Stomach cramps; Flu like symptoms; Chills; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach cramps), CONSTIPATION (Constipation) and INFLUENZA LIKE ILLNESS (Flu like symptoms) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 26-Mar-2021, the patient experienced CHILLS (Chills) and DIARRHOEA (Diarrhea). On 22-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach cramps) and INFLUENZA LIKE ILLNESS (Flu like symptoms). On an unknown date, the patient experienced CONSTIPATION (Constipation) and MYALGIA (Muscle pain). At the time of the report, CHILLS (Chills), DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach cramps), CONSTIPATION (Constipation), INFLUENZA LIKE ILLNESS (Flu like symptoms) and MYALGIA (Muscle pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.     Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Myalgia
Clinical narrative: Constipation; Muscle pain; Stomach cramps; Flu like symptoms; Chills; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach cramps), CONSTIPATION (Constipation) and INFLUENZA LIKE ILLNESS (Flu like symptoms) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.   On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 26-Mar-2021, the patient experienced CHILLS (Chills) and DIARRHOEA (Diarrhea). On 22-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach cramps) and INFLUENZA LIKE ILLNESS (Flu like symptoms). On an unknown date, the patient experienced CONSTIPATION (Constipation) and MYALGIA (Muscle pain). At the time of the report, CHILLS (Chills), DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach cramps), CONSTIPATION (Constipation), INFLUENZA LIKE ILLNESS (Flu like symptoms) and MYALGIA (Muscle pain) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.     Reporter did not allow further contact
Sex: F
Vaccine: COVID19
Symptoms: Asthenia, Headache, Pyrexia, Retinal migraine, Visual impairment
Clinical narrative: visual migraine; visual issues; saw black floaters that turned into black zigzag lines in her visual field which lasted 10 minutes; experienced a fever 99.8; weakness; slight headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (experienced a fever 99.8), ASTHENIA (weakness), HEADACHE (slight headache), VISUAL IMPAIRMENT (visual issues) and VITREOUS FLOATERS (saw black floaters that turned into black zigzag lines in her visual field which lasted 10 minutes) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PYREXIA (experienced a fever 99.8), ASTHENIA (weakness) and HEADACHE (slight headache). On 03-Apr-2021, the patient experienced VISUAL IMPAIRMENT (visual issues) and VITREOUS FLOATERS (saw black floaters that turned into black zigzag lines in her visual field which lasted 10 minutes). On 26-Apr-2021, the patient experienced RETINAL MIGRAINE (visual migraine). On 01-Apr-2021, PYREXIA (experienced a fever 99.8) and ASTHENIA (weakness) had resolved, HEADACHE (slight headache) outcome was unknown. On 03-Apr-2021, VISUAL IMPAIRMENT (visual issues) and VITREOUS FLOATERS (saw black floaters that turned into black zigzag lines in her visual field which lasted 10 minutes) had resolved. At the time of the report, RETINAL MIGRAINE (visual migraine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-090202 (Patient Link).
Sex: F
Vaccine: COVID19
Symptoms: Vitreous floaters
Clinical narrative: visual migraine; visual issues; saw black floaters that turned into black zigzag lines in her visual field which lasted 10 minutes; experienced a fever 99.8; weakness; slight headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (experienced a fever 99.8), ASTHENIA (weakness), HEADACHE (slight headache), VISUAL IMPAIRMENT (visual issues) and VITREOUS FLOATERS (saw black floaters that turned into black zigzag lines in her visual field which lasted 10 minutes) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below.     The patient's past medical history included No adverse event.    On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PYREXIA (experienced a fever 99.8), ASTHENIA (weakness) and HEADACHE (slight headache). On 03-Apr-2021, the patient experienced VISUAL IMPAIRMENT (visual issues) and VITREOUS FLOATERS (saw black floaters that turned into black zigzag lines in her visual field which lasted 10 minutes). On 26-Apr-2021, the patient experienced RETINAL MIGRAINE (visual migraine). On 01-Apr-2021, PYREXIA (experienced a fever 99.8) and ASTHENIA (weakness) had resolved, HEADACHE (slight headache) outcome was unknown. On 03-Apr-2021, VISUAL IMPAIRMENT (visual issues) and VITREOUS FLOATERS (saw black floaters that turned into black zigzag lines in her visual field which lasted 10 minutes) had resolved. At the time of the report, RETINAL MIGRAINE (visual migraine) outcome was unknown. Not Provided      The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       This case was linked to MOD-2021-090202 (Patient Link).
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Arthralgia, COVID-19, Fear, Hypotension, Mobility decreased
Clinical narrative: scared to receive her 2nd vaccine; shoulder pain at injection site; muscle pain; joint pain; severe at times where she could hardly get out of bed to get to the restroom; This spontaneous case was reported by a consumer and describes the occurrence of FEAR (scared to receive her 2nd vaccine), VACCINATION SITE PAIN (shoulder pain at injection site), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and MOBILITY DECREASED (severe at times where she could hardly get out of bed to get to the restroom) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     The patient's past medical history included Emergency care examination abnormal (Patient tested positive for COVID-19  in nov2020 and went to the emergency department because her blood pressure went very low.) in November 2020 and Fluid replacement NOS (Patient received fluids in the emergency department.) in November 2020.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced VACCINATION SITE PAIN (shoulder pain at injection site), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and MOBILITY DECREASED (severe at times where she could hardly get out of bed to get to the restroom). On an unknown date, the patient experienced FEAR (scared to receive her 2nd vaccine). On 16-Apr-2021, VACCINATION SITE PAIN (shoulder pain at injection site), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and MOBILITY DECREASED (severe at times where she could hardly get out of bed to get to the restroom) had resolved. At the time of the report, FEAR (scared to receive her 2nd vaccine) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, COVID-19: positive (Positive) Positive. In November 2020, Hypotension: low (Low) Blood pressure went very low..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  Treatment information was not provided.    Reporter did not allow further contact
Age: 86.0
Sex: F
Vaccine: COVID19
Symptoms: Myalgia, Vaccination site pain
Clinical narrative: scared to receive her 2nd vaccine; shoulder pain at injection site; muscle pain; joint pain; severe at times where she could hardly get out of bed to get to the restroom; This spontaneous case was reported by a consumer and describes the occurrence of FEAR (scared to receive her 2nd vaccine), VACCINATION SITE PAIN (shoulder pain at injection site), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and MOBILITY DECREASED (severe at times where she could hardly get out of bed to get to the restroom) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination.     The patient's past medical history included Emergency care examination abnormal (Patient tested positive for COVID-19  in nov2020 and went to the emergency department because her blood pressure went very low.) in November 2020 and Fluid replacement NOS (Patient received fluids in the emergency department.) in November 2020.    On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced VACCINATION SITE PAIN (shoulder pain at injection site), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and MOBILITY DECREASED (severe at times where she could hardly get out of bed to get to the restroom). On an unknown date, the patient experienced FEAR (scared to receive her 2nd vaccine). On 16-Apr-2021, VACCINATION SITE PAIN (shoulder pain at injection site), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and MOBILITY DECREASED (severe at times where she could hardly get out of bed to get to the restroom) had resolved. At the time of the report, FEAR (scared to receive her 2nd vaccine) had not resolved.      DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, COVID-19: positive (Positive) Positive. In November 2020, Hypotension: low (Low) Blood pressure went very low..     The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.  Treatment information was not provided.    Reporter did not allow further contact
Age: 54.0
Sex: F
Vaccine: COVID19
Symptoms: Alopecia, Erythema, Nausea, Pyrexia
Clinical narrative: Hair loss; Fever; Nausea; Redness in their right arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness in their right arm), ALOPECIA (Hair loss), PYREXIA (Fever) and NAUSEA (Nausea) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination.     Concomitant products included LEVOTHYROXINE for an unknown indication.    On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 02-Apr-2021, the patient experienced ERYTHEMA (Redness in their right arm), PYREXIA (Fever) and NAUSEA (Nausea). On 08-Apr-2021, the patient experienced ALOPECIA (Hair loss). On 05-Apr-2021, ERYTHEMA (Redness in their right arm), PYREXIA (Fever) and NAUSEA (Nausea) had resolved. At the time of the report, ALOPECIA (Hair loss) outcome was unknown.        The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.       Concomitant medication also included Vitamins. No treatment medication was reported.   Most recent FOLLOW-UP information incorporated above includes: On 12-Jun-2021: Follow up received on 12-JUN-2021 contains no new information.