VAERS 2021 Database www.vaers.hhs.gov

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VAERS Updated: 10/01/2021
** VAERS DATABASE Last updated: October 1, 2021**
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Manufacturers

Total Manufacturer

Incidents per State

State Total
72,296
AK1,638
AL5,339
AR3,412
AS44
AZ13,316
CA58,147
CO11,002
CT7,824
DC1,626
DE1,670
FL36,235
FM3
GA13,429
GU82
HI2,195
IA4,332
ID2,473
IL19,261
IN22,568
KS4,284
KY6,945
LA4,714
MA13,886
MD11,901
ME2,997
MH8
MI17,865
MN11,345
MO8,919
MP30
MS2,676
MT2,147
NC15,401
ND1,273
NE2,732
NH2,859
NJ17,232
NM3,702
NV4,071
NY32,763
OH18,072
OK5,940
OR7,954
PA22,457
PR2,104
QM2
RI1,911
SC6,055
SD1,133
TN8,691
TX34,122
UT4,023
VA13,944
VI49
VT1,661
WA13,811
WI10,395
WV2,220
WY805
XB5
XL1
XV2

ID: 1551173
Sex: F
Age: 67
State: TX

Vax Date: 01/20/2021
Onset Date: 01/21/2021
Rec V Date: 08/13/2021
Hospital:

Vax Type:
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Lab Data:

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Symptom List:

Symptoms: Developed an itchy rash on her back and HCP diagnosed it as shingles; Warm at the injection site; 3" diameter area that is raised,firm at the injection site; Red at the injection site; Right arm was a little sore; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of HERPES ZOSTER (Developed an itchy rash on her back and HCP diagnosed it as shingles), PAIN IN EXTREMITY (Right arm was a little sore), VACCINATION SITE WARMTH (Warm at the injection site), VACCINATION SITE INFLAMMATION (3" diameter area that is raised,firm at the injection site) and VACCINATION SITE ERYTHEMA (Red at the injection site) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The patient's past medical history included Shingles (The caller stated that she was having symptoms of getting shingles prior to the Moderna COVID-19 vaccine.) in January 2021. Previously administered products included for an unreported indication: ZOSTAVAX. Concurrent medical conditions included Drug allergy (Allergic to Propylthiouracil. She also has a lot of drug sensitivity but didnot list them.). On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 21-Jan-2021, the patient experienced PAIN IN EXTREMITY (Right arm was a little sore). On 26-Jan-2021, the patient experienced HERPES ZOSTER (Developed an itchy rash on her back and HCP diagnosed it as shingles), VACCINATION SITE WARMTH (Warm at the injection site), VACCINATION SITE INFLAMMATION (3" diameter area that is raised,firm at the injection site) and VACCINATION SITE ERYTHEMA (Red at the injection site). At the time of the report, HERPES ZOSTER (Developed an itchy rash on her back and HCP diagnosed it as shingles), PAIN IN EXTREMITY (Right arm was a little sore), VACCINATION SITE WARMTH (Warm at the injection site), VACCINATION SITE INFLAMMATION (3" diameter area that is raised,firm at the injection site) and VACCINATION SITE ERYTHEMA (Red at the injection site) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. Treatment details included ibuprofen.

Other Meds:

Current Illness: Drug allergy (Allergic to Propylthiouracil. She also has a lot of drug sensitivity but didnot list them.)

ID: 1551174
Sex: F
Age:
State:

Vax Date: 01/27/2021
Onset Date: 01/27/2021
Rec V Date: 08/13/2021
Hospital:

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Symptom List:

Symptoms: really bad reaction; didn't feel like she could move; Feeling strange; Fever; Extreme fatigue; Horrible headache, piercing; Pain in the eyes and nose; Pain in nose; Heart racing; Flushed cheeks; This spontaneous case was reported by a consumer and describes the occurrence of FLUSHING (Flushed cheeks), VACCINATION COMPLICATION (really bad reaction), HYPOKINESIA (didn't feel like she could move), FEELING ABNORMAL (Feeling strange) and PALPITATIONS (Heart racing) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 in March 2020. Concurrent medical conditions included Cholesterol and Hypertension. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced FLUSHING (Flushed cheeks) and PALPITATIONS (Heart racing). On 28-Jan-2021, the patient experienced PYREXIA (Fever), FATIGUE (Extreme fatigue), HEADACHE (Horrible headache, piercing), EYE PAIN (Pain in the eyes and nose) and RHINALGIA (Pain in nose). On an unknown date, the patient experienced VACCINATION COMPLICATION (really bad reaction), HYPOKINESIA (didn't feel like she could move) and FEELING ABNORMAL (Feeling strange). At the time of the report, FLUSHING (Flushed cheeks), PALPITATIONS (Heart racing), PYREXIA (Fever), FATIGUE (Extreme fatigue), HEADACHE (Horrible headache, piercing), EYE PAIN (Pain in the eyes and nose) and RHINALGIA (Pain in nose) had resolved and VACCINATION COMPLICATION (really bad reaction), HYPOKINESIA (didn't feel like she could move) and FEELING ABNORMAL (Feeling strange) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1551175
Sex: F
Age: 70
State:

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 08/13/2021
Hospital:

Vax Type:
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Lab Data:

Allergies:

Symptom List:

Symptoms: A little raised area in the middle and it look like an insenct bite right in the area where got injection; Scratching their arm; There was a large roundish area 14 inches in diameter; Hive like raised area at the injection site; Little bit of soreness; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE REACTION (A little raised area in the middle and it look like an insenct bite right in the area where got injection), VACCINATION SITE PRURITUS (Scratching their arm), VACCINATION SITE SWELLING (There was a large roundish area 14 inches in diameter), MYALGIA (Little bit of soreness) and VACCINATION SITE URTICARIA (Hive like raised area at the injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 11A21A) for COVID-19 vaccination. The patient's past medical history included Osteoporosis on 08-May-2017. Concurrent medical conditions included Hypertension since 26-Mar-2015. Concomitant products included MIRTAZAPINE (REMERON) from 30-Mar-2021 to an unknown date, TELMISARTAN from 30-Mar-2021 to an unknown date, AZELASTINE from 22-Oct-2020 to an unknown date, CICLOSPORIN (RESTASIS) from 26-Mar-2015 to an unknown date, CALCIUM from 26-Mar-2015 to an unknown date, ASCORBIC ACID, ERGOCALCIFEROL, NICOTINAMIDE, RETINOL PALMITATE, RIBOFLAVIN, THIAMINE MONONITRATE (MULTIVITAMIN 6) from 09-Feb-2012 to an unknown date, MAGNESIUM, FISH OIL (OMEGA 3 [FISH OIL]), CURCUMA LONGA (TURMERIC [CURCUMA LONGA]), ZINC, BIOTIN and CALCIUM CARBONATE (TUMS EXTRA STRENGTH) for an unknown indication. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Jan-2021, the patient experienced MYALGIA (Little bit of soreness). On 28-Jan-2021, the patient experienced VACCINATION SITE REACTION (A little raised area in the middle and it look like an insenct bite right in the area where got injection), VACCINATION SITE PRURITUS (Scratching their arm), VACCINATION SITE SWELLING (There was a large roundish area 14 inches in diameter) and VACCINATION SITE URTICARIA (Hive like raised area at the injection site). On 30-Jan-2021, VACCINATION SITE REACTION (A little raised area in the middle and it look like an insenct bite right in the area where got injection), VACCINATION SITE PRURITUS (Scratching their arm), VACCINATION SITE SWELLING (There was a large roundish area 14 inches in diameter), MYALGIA (Little bit of soreness) and VACCINATION SITE URTICARIA (Hive like raised area at the injection site) 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. Relevant concomitant medications also included blood pressure medicines. Treatment details included Topical cortisone. Most recent FOLLOW-UP information incorporated above includes: On 25-May-2021: ADR Form

Other Meds: REMERON; TELMISARTAN; AZELASTINE; RESTASIS; CALCIUM; MULTIVITAMIN 6; MAGNESIUM; OMEGA 3 [FISH OIL]; TURMERIC [CURCUMA LONGA]; ZINC; BIOTIN; TUMS EXTRA STRENGTH

Current Illness: Hypertension

ID: 1551176
Sex: F
Age: 67
State: WA

Vax Date: 01/20/2021
Onset Date: 01/20/2021
Rec V Date: 08/13/2021
Hospital:

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Symptoms: Tired; Tenderness; Redness; Fatigue; Pain at injection (left); Rash; Bruise; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CONTUSION (Bruise), TENDERNESS (Tenderness), RASH (Rash), ERYTHEMA (Redness) and FATIGUE (Fatigue) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced CONTUSION (Bruise), RASH (Rash), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Pain at injection (left)). On 28-Jan-2021, the patient experienced TENDERNESS (Tenderness) and ERYTHEMA (Redness). On 30-Jan-2021, the patient experienced FATIGUE (Tired). On 23-Jan-2021, CONTUSION (Bruise), FATIGUE (Fatigue) and VACCINATION SITE PAIN (Pain at injection (left)) had resolved. On 27-Jan-2021, RASH (Rash) had resolved. On 01-Feb-2021, TENDERNESS (Tenderness) and ERYTHEMA (Redness) had resolved. At the time of the report, FATIGUE (Tired) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. Treatment details included neosporin ointment, lidocaine and recommended getting vaccine in different arm.

Other Meds:

Current Illness:

ID: 1551177
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/13/2021
Hospital:

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Symptoms: I broke out in a really bad rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH (I broke out in a really bad rash) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (I broke out in a really bad rash). At the time of the report, RASH (I broke out in a really bad rash) 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.

Other Meds:

Current Illness:

ID: 1551178
Sex: F
Age: 63
State:

Vax Date: 01/29/2021
Onset Date: 01/30/2021
Rec V Date: 08/13/2021
Hospital:

Vax Type:
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Symptoms: This spontaneous case was reported by a physician and describes the occurrence of CHILLS (Chills), FATIGUE (Fatigue), HEADACHE (Headache) and PAIN (Very very sore arm that was hard to even raise) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. Concurrent medical conditions included Cervical pain. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced CHILLS (Chills), FATIGUE (Fatigue), HEADACHE (Headache) and PAIN (Very very sore arm that was hard to even raise). On 31-Jan-2021, CHILLS (Chills), FATIGUE (Fatigue), HEADACHE (Headache) and PAIN (Very very sore arm that was hard to even raise) had resolved. Not Provided. 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 medications included pain medications for chronic cervical pain management. No treatment information was provided.

Other Meds:

Current Illness: Cervical pain

ID: 1551179
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/13/2021
Hospital:

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Symptoms: adverse effects; A spontaneous report was received from a consumer concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced adverse effects. The patient's medical history was not provided. No relevant concomitant medications were reported. On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: UNKNOWN) via unknown route for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced adverse effects (not specified). No lab data was provided. Treatment details was unknown. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events-adverse effects was considered to be unknown.; Reporter's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1551180
Sex: F
Age: 65
State: PA

Vax Date: 01/29/2021
Onset Date: 01/30/2021
Rec V Date: 08/13/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
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Vax Site:

Lab Data:

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Symptom List:

Symptoms: feeling shaky and runned out, just weak like having the flu; 101.4?F fever; headache; Dry cough; Short of Breath; severe itching like a bee sting; pain, and aches terrible terrible aches,the aches lasted 24 hours; the arm is still swollen and red half way down to the arm from the injection site; red half way down to the arm from the injection site; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (feeling shaky and runned out, just weak like having the flu), COUGH (Dry cough), SWELLING (the arm is still swollen and red half way down to the arm from the injection site), DYSPNOEA (Short of Breath) and PRURITUS (severe itching like a bee sting) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Influenza B virus infection from 18-Jan-2021 to 25-Jan-2021. Concurrent medical conditions included Blood pressure raised (High blood pressure.). Concomitant products included ASA, ESTRADIOL (ESTRACE), GLICLAZIDE (DIAZIDE [GLICLAZIDE]), DILTIAZEM HYDROCHLORIDE (CARDIZEM [DILTIAZEM HYDROCHLORIDE]) and POTASSIUM CHLORIDE for an unknown indication. On 29-Jan-2021 at 3:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021 at 11:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Jan-2021, the patient experienced SWELLING (the arm is still swollen and red half way down to the arm from the injection site), MYALGIA (pain, and aches terrible terrible aches,the aches lasted 24 hours) and INJECTION SITE ERYTHEMA (red half way down to the arm from the injection site). On 01-Feb-2021, the patient experienced COUGH (Dry cough) and DYSPNOEA (Short of Breath). In February 2021, the patient experienced PRURITUS (severe itching like a bee sting). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (feeling shaky and runned out, just weak like having the flu), PYREXIA (101.4?F fever) and HEADACHE (headache). On 31-Jan-2021, MYALGIA (pain, and aches terrible terrible aches,the aches lasted 24 hours) had resolved. On 02-Feb-2021, COUGH (Dry cough) and DYSPNOEA (Short of Breath) had resolved. In February 2021, SWELLING (the arm is still swollen and red half way down to the arm from the injection site) and INJECTION SITE ERYTHEMA (red half way down to the arm from the injection site) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (feeling shaky and runned out, just weak like having the flu), PRURITUS (severe itching like a bee sting), PYREXIA (101.4?F fever) and HEADACHE (headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 101.4 (High) Fahrenheit. The patient was treated with Tylenol (acetaminophen) every 46 hours. Action taken with mRNA-1273 in response to events was not applicable. Company Comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. This case was linked to MOD-2021-102250. Most recent FOLLOW-UP information incorporated above includes: On 03-May-2021: Additional information received and reporter details, patient demographics, Med history,concomitant medication, event and outcome updated.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.

Other Meds: ASA; ESTRACE; DIAZIDE [GLICLAZIDE]; CARDIZEM [DILTIAZEM HYDROCHLORIDE]; POTASSIUM CHLORIDE

Current Illness: Blood pressure raised (High blood pressure.)

ID: 1551181
Sex: F
Age:
State: VT

Vax Date: 01/15/2021
Onset Date: 01/16/2021
Rec V Date: 08/13/2021
Hospital:

Vax Type:
Manufacturer:
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Lab Data:

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Symptom List:

Symptoms: Throat pain; Swollen tonsils; Swollen neck lymph nodes (opposite side of the injection0; Fever; Vertigo; Headache; Nauseous; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (Vertigo), OROPHARYNGEAL PAIN (Throat pain), TONSILLAR HYPERTROPHY (Swollen tonsils), HEADACHE (Headache) and NAUSEA (Nauseous) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced VERTIGO (Vertigo), HEADACHE (Headache), NAUSEA (Nauseous) and PYREXIA (Fever). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Throat pain), TONSILLAR HYPERTROPHY (Swollen tonsils) and LYMPHADENOPATHY (Swollen neck lymph nodes (opposite side of the injection0). On 16-Jan-2021, NAUSEA (Nauseous) had resolved. On 18-Jan-2021, VERTIGO (Vertigo), HEADACHE (Headache) and PYREXIA (Fever) had resolved. At the time of the report, OROPHARYNGEAL PAIN (Throat pain), TONSILLAR HYPERTROPHY (Swollen tonsils) and LYMPHADENOPATHY (Swollen neck lymph nodes (opposite side of the injection0) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: increased (High) increased. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. no concomitant drugs included no treatment drugs included Most recent FOLLOW-UP information incorporated above includes: On 03-Feb-2021: follow up received contain no significant information

Other Meds:

Current Illness:

ID: 1551182
Sex: M
Age:
State: FL

Vax Date: 01/30/2021
Onset Date: 02/01/2021
Rec V Date: 08/13/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: Eyelids irritation; A spontaneous report was received from a 72-year-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced eyelids irritation. The patient's medical history was not provided. No relevant concomitant medications were reported. On 30 Jan 2021, approximately three days prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (latch number: 013L20A) for prophylaxis of COVID-19 infection. On 01 Feb 2021, the patient experienced eyelids irritation. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not applicable. The outcome of event eyelids irritation was not reported.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1551183
Sex: F
Age: 51
State: NJ

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 08/13/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
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Vax Route:
Vax Site:

Lab Data:

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Symptom List:

Symptoms: developed a rash that looked like shingles; ache on the left side of my buttocks; Headache; Bodyaches; chills; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL PAIN (ache on the left side of my buttocks), RASH (developed a rash that looked like shingles), MYALGIA (Bodyaches), CHILLS (chills) and HEADACHE (Headache) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). Concomitant products included MULTIVITAMIN [VITAMINS NOS] and VITAMIN B12 NOS (VITAMIN B 12 [VITAMIN B12 NOS]) for an unknown indication. On 21-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jan-2021, the patient experienced MYALGIA (Bodyaches) and CHILLS (chills). On 22-Jan-2021, the patient experienced HEADACHE (Headache). On 24-Jan-2021, the patient experienced MUSCULOSKELETAL PAIN (ache on the left side of my buttocks). On 29-Jan-2021, the patient experienced RASH (developed a rash that looked like shingles). At the time of the report, MUSCULOSKELETAL PAIN (ache on the left side of my buttocks), RASH (developed a rash that looked like shingles), MYALGIA (Bodyaches), CHILLS (chills) and HEADACHE (Headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. No treatment information was provided.

Other Meds: MULTIVITAMIN [VITAMINS NOS]; VITAMIN B 12 [VITAMIN B12 NOS]

Current Illness:

ID: 1551184
Sex: F
Age: 23
State: OH

Vax Date: 01/25/2021
Onset Date: 01/23/2021
Rec V Date: 08/13/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

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Symptom List:

Symptoms: pins and needles in legs; lips started to swell; throat became a little swollen; face swelling; couldn't eat for two days; nauseated; chills; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (pins and needles in legs), LIP SWELLING (lips started to swell), PHARYNGEAL SWELLING (throat became a little swollen), SWELLING FACE (face swelling) and FEEDING DISORDER (couldn't eat for two days) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Jan-2021, the patient experienced PARAESTHESIA (pins and needles in legs), LIP SWELLING (lips started to swell), PHARYNGEAL SWELLING (throat became a little swollen), SWELLING FACE (face swelling), FEEDING DISORDER (couldn't eat for two days), NAUSEA (nauseated), CHILLS (chills) and MYALGIA (muscle aches). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and IBUPROFEN (MOTRIN [IBUPROFEN]) at an unspecified dose and frequency. On 25-Jan-2021, PARAESTHESIA (pins and needles in legs), LIP SWELLING (lips started to swell), PHARYNGEAL SWELLING (throat became a little swollen), SWELLING FACE (face swelling), FEEDING DISORDER (couldn't eat for two days), NAUSEA (nauseated), CHILLS (chills) and MYALGIA (muscle aches) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication include birth control and steroids. Most recent FOLLOW-UP information incorporated above includes: On 15-Jun-2021: Follow up contains Concomitant details was updated, second dose details updated.

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Current Illness:

ID: 1551185
Sex: M
Age: 67
State: FL

Vax Date: 01/13/2021
Onset Date: 01/13/2021
Rec V Date: 08/13/2021
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Symptoms: General ill feeling; cough; Malaise; depressed; Fatigue; Joint pain; Chills; Local pain at the injection site; Wave of ill feeling in his lower throat (below the voice box); This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Wave of ill feeling in his lower throat (below the voice box)), FEELING ABNORMAL (General ill feeling), COUGH (cough), MALAISE (Malaise) and DEPRESSION (depressed) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J20A and 029K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Insomnia, GERD, Hypertension, Atrial fibrillation, Dyslipidemia and Allergic rhinitis. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for Atrial fibrillation, AMLODIPINE for Blood pressure high, FENOFIBRATE for Dyslipidemia, BISOPROLOL for Hypertension, ZOLPIDEM for Insomnia. On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 13-Jan-2021, the patient experienced OROPHARYNGEAL PAIN (Wave of ill feeling in his lower throat (below the voice box)), MALAISE (Malaise), DEPRESSION (depressed), FATIGUE (Fatigue), ARTHRALGIA (Joint pain), CHILLS (Chills) and VACCINATION SITE PAIN (Local pain at the injection site). On an unknown date, the patient experienced FEELING ABNORMAL (General ill feeling) and COUGH (cough). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL PAIN (Wave of ill feeling in his lower throat (below the voice box)), FEELING ABNORMAL (General ill feeling), COUGH (cough), FATIGUE (Fatigue), ARTHRALGIA (Joint pain) and CHILLS (Chills) outcome was unknown and MALAISE (Malaise), DEPRESSION (depressed) and VACCINATION SITE PAIN (Local pain at the injection site) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: No specific follow-up information recorded.

Other Meds: FENOFIBRATE; AMLODIPINE; BISOPROLOL; ZOLPIDEM; ASPIRIN (E.C.)

Current Illness: Allergic rhinitis; GERD; Hypertension; Insomnia

ID: 1551186
Sex: F
Age: 52
State: IL

Vax Date: 01/28/2021
Onset Date:
Rec V Date: 08/13/2021
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Symptoms: woke up right palm was orange; cuticles were orange too; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (woke up right palm was orange) and NAIL DISCOLOURATION (cuticles were orange too) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination. No Medical History information was reported. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SKIN DISCOLOURATION (woke up right palm was orange) and NAIL DISCOLOURATION (cuticles were orange too). At the time of the report, SKIN DISCOLOURATION (woke up right palm was orange) and NAIL DISCOLOURATION (cuticles were orange too) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1551187
Sex: F
Age: 70
State: CA

Vax Date: 01/22/2021
Onset Date: 01/22/2021
Rec V Date: 08/13/2021
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Symptoms: Little soreness; Rash; Itching; Slight red mark that its growing; Arm swelled; Little sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Little sore arm), PAIN (Little soreness), RASH (Rash), VACCINATION SITE PRURITUS (Itching) and VACCINATION SITE ERYTHEMA (Slight red mark that its growing) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 22-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced PAIN IN EXTREMITY (Little sore arm). On 30-Jan-2021, the patient experienced PAIN (Little soreness), RASH (Rash), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE ERYTHEMA (Slight red mark that its growing) and VACCINATION SITE SWELLING (Arm swelled). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 23-Jan-2021, PAIN IN EXTREMITY (Little sore arm) had resolved. At the time of the report, PAIN (Little soreness), VACCINATION SITE PRURITUS (Itching), VACCINATION SITE ERYTHEMA (Slight red mark that its growing) and VACCINATION SITE SWELLING (Arm swelled) had resolved and RASH (Rash) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication reported Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Events outcome was updated, treatment using acetaminophen was reported.

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Current Illness:

ID: 1551188
Sex: F
Age:
State: MI

Vax Date: 01/21/2021
Onset Date: 01/29/2021
Rec V Date: 08/13/2021
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Symptoms: Almost looked like cellulitis; Completely swollen about the side of a baseball; Arm was hot red; Arm was really hot; It was itching; Rash; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE CELLULITIS (Almost looked like cellulitis), VACCINATION SITE SWELLING (Completely swollen about the side of a baseball), VACCINATION SITE ERYTHEMA (Arm was hot red), VACCINATION SITE WARMTH (Arm was really hot) and VACCINATION SITE PRURITUS (It was itching) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced VACCINATION SITE CELLULITIS (Almost looked like cellulitis), VACCINATION SITE SWELLING (Completely swollen about the side of a baseball), VACCINATION SITE ERYTHEMA (Arm was hot red), VACCINATION SITE WARMTH (Arm was really hot), VACCINATION SITE PRURITUS (It was itching) and VACCINATION SITE RASH (Rash). At the time of the report, VACCINATION SITE CELLULITIS (Almost looked like cellulitis), VACCINATION SITE SWELLING (Completely swollen about the side of a baseball), VACCINATION SITE ERYTHEMA (Arm was hot red), VACCINATION SITE WARMTH (Arm was really hot), VACCINATION SITE PRURITUS (It was itching) and VACCINATION SITE RASH (Rash) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication were provided by reporter No treatment were reported

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Current Illness:

ID: 1551189
Sex: F
Age: 73
State: CO

Vax Date: 01/22/2021
Onset Date: 01/22/2021
Rec V Date: 08/13/2021
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Symptoms: area is a 3 inch x 5 inch patch on muscle around the injection site; njection site became itchy; injection site became warm; fever; pink at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), VACCINATION SITE ERYTHEMA (pink at injection site), VACCINATION SITE PRURITUS (njection site became itchy), VACCINATION SITE WARMTH (injection site became warm) and VACCINATION SITE RASH (area is a 3 inch x 5 inch patch on muscle around the injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. Concurrent medical conditions included Leukaemia. Concomitant products included natural hormone replacement, LEVOTHYROXINE, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), PROBIOTIC 10, sambucol elderberry gummy and super beet chew for an unknown indication. On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced PYREXIA (fever) and VACCINATION SITE ERYTHEMA (pink at injection site). On 01-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (njection site became itchy) and VACCINATION SITE WARMTH (injection site became warm). On 02-Feb-2021, the patient experienced VACCINATION SITE RASH (area is a 3 inch x 5 inch patch on muscle around the injection site). At the time of the report, PYREXIA (fever), VACCINATION SITE ERYTHEMA (pink at injection site) and VACCINATION SITE WARMTH (injection site became warm) had resolved and VACCINATION SITE PRURITUS (njection site became itchy) and VACCINATION SITE RASH (area is a 3 inch x 5 inch patch on muscle around the injection site) had not resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment: Advil

Other Meds: natural hormone replacement; LEVOTHYROXINE; VITAMIN D 2000; PROBIOTIC 10; sambucol elderberry gummy; super beet chew

Current Illness: Leukaemia

ID: 1551190
Sex: F
Age: 67
State: AL

Vax Date: 01/20/2021
Onset Date: 01/25/2021
Rec V Date: 08/13/2021
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Symptoms: like a cold; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (like a cold) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. Concurrent medical conditions included Osteoporosis and Penicillin allergy. Concomitant products included RALOXIFENE HYDROCHLORIDE (EVISTA) for Osteoporosis. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced NASOPHARYNGITIS (like a cold). At the time of the report, NASOPHARYNGITIS (like a cold) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, Coronavirus test: positive (Positive) positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment medications were provided by the reporter.

Other Meds: EVISTA

Current Illness: Osteoporosis; Penicillin allergy

ID: 1551191
Sex: F
Age: 61
State: FL

Vax Date: 01/15/2021
Onset Date: 01/15/2021
Rec V Date: 08/13/2021
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Symptoms: did not feel dizzy, she could not walk straight or "elegantly"), TENSION (the next day she was completely wired for a 24-36hr period), MIGRAINE (She took a nap and woke up with a migrane) and COUGH (cough) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was reported. Concomitant products included LANSOPRAZOLE and LEVOTHYROXINE for an unknown indication. On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced DRY THROAT (2 minutes later her throat went completely dry she did not feel that she could not breathe, she was able to drink water), GAIT INABILITY (she started to walk, and even though she did not feel dizzy, she could not walk straight or "elegantly") and NAUSEA (The first 10 minutes felt mild nauseosness). On 16-Jan-2021, the patient experienced TENSION (the next day she was completely wired for a 24-36hr period). On 17-Jan-2021, the patient experienced MIGRAINE (She took a nap and woke up with a migrane) and VOMITING (Ended up vomiting). On an unknown date, the patient experienced COUGH (cough). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Sleep problem, at an unspecified dose and frequency. On 15-Jan-2021, NAUSEA (The first 10 minutes felt mild nauseosness) had resolved. On 17-Jan-2021, TENSION (the next day she was completely wired for a 24-36hr period), MIGRAINE (She took a nap and woke up with a migrane) and VOMITING (Ended up vomiting) had resolved. At the time of the report, DRY THROAT (2 minutes later her throat went completely dry she did not feel that she could not breathe, she was able to drink water) and GAIT INABILITY (she started to walk, and even though she did not feel dizzy, she could not walk straight or "elegantly") was resolving and COUGH (cough) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99 (High) 99 degree Fahrenheit. Action taken with mRNA-1273 in response to the event was not applicable. This case was linked to MOD-2021-219219, MOD-2021-219219 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 12-Jun-2021: Added event, lab data and dosage information.

Other Meds: LANSOPRAZOLE; LEVOTHYROXINE

Current Illness:

ID: 1551192
Sex: F
Age:
State: TX

Vax Date: 02/01/2021
Onset Date: 02/01/2021
Rec V Date: 08/13/2021
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Symptoms: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), GAIT DISTURBANCE (Could barely walk into her house), MALAISE (Not feeling well), ASTHENIA (Felt weak) and HEADACHE (Headache) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 in December 2020. On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 02-Feb-2021, the patient experienced GAIT DISTURBANCE (Could barely walk into her house), MALAISE (Not feeling well), ASTHENIA (Felt weak), HEADACHE (Headache), PYREXIA (Body temperature at 102.5), MYALGIA (Muscle ache) and CHILLS (Chills). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Sore arm), GAIT DISTURBANCE (Could barely walk into her house), MALAISE (Not feeling well), ASTHENIA (Felt weak), HEADACHE (Headache), PYREXIA (Body temperature at 102.5), MYALGIA (Muscle ache) and CHILLS (Chills) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2021, Body temperature: 102.5 (High) High. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported.

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Current Illness:

ID: 1551193
Sex: F
Age: 67
State: NY

Vax Date: 01/27/2021
Onset Date: 01/28/2021
Rec V Date: 08/13/2021
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Symptoms: Strong stomach pain; Brain fog; Shoulder pain; slight fever that rose to 102.5 F; nausea; extreme fatigue; Pain in injection spot; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of ABDOMINAL PAIN (Strong stomach pain), FEELING ABNORMAL (Brain fog), ARTHRALGIA (Shoulder pain), PYREXIA (slight fever that rose to 102.5 F) and NAUSEA (nausea) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 on 30-Mar-2020. Previously administered products included for an unreported indication: SHINGRIX (Slight fever and flu-like symptoms after the second shringrix 50 mcg vaccination.) in January 2020. Concurrent medical conditions included Thyroid disorder NOS since 2002, heart palpitation since 2016, Blood pressure high since 2017 and High cholesterol since 2012. Concomitant products included LOSARTAN and ACETYLSALICYLIC ACID (ASPIRIN 81) for Blood pressure increased, SIMVASTATIN for High cholesterol, LEVOTHYROXINE for Hypothyroidism, ATENOLOL for Palpitations. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced ABDOMINAL PAIN (Strong stomach pain), FEELING ABNORMAL (Brain fog), ARTHRALGIA (Shoulder pain), PYREXIA (slight fever that rose to 102.5 F), NAUSEA (nausea), FATIGUE (extreme fatigue) and INJECTION SITE PAIN (Pain in injection spot). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and IBUPROFEN at an unspecified dose and frequency. On 29-Jan-2021, ABDOMINAL PAIN (Strong stomach pain), FEELING ABNORMAL (Brain fog), ARTHRALGIA (Shoulder pain), PYREXIA (slight fever that rose to 102.5 F), NAUSEA (nausea), FATIGUE (extreme fatigue) and INJECTION SITE PAIN (Pain in injection spot) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jan-2021, Body temperature: 102.5 f (High) 102.5 F. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. This case was linked to MOD-2021-158001 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 21-May-2021: Vaccine adverse event reporting form was received. Updated medical history, concomitant medications, treatment and events.

Other Meds: LEVOTHYROXINE; SIMVASTATIN; LOSARTAN; ASPIRIN 81; ATENOLOL

Current Illness: Blood pressure high; High cholesterol; Thyroid disorder NOS

ID: 1551194
Sex: F
Age: 49
State: UT

Vax Date: 01/14/2021
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Rec V Date: 08/13/2021
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Symptoms: Stiff neck on the same side of the injection; A spontaneous report was received from a Healthcare Professional concerning a 49-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced the event of stiff neck on the same side of the injection. The patient's medical history was not provided. No relevant concomitant medications were reported. On 14 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 029L20A) intramuscularly in right arm for prophylaxis of COVID-19 infection. On unspecified date, the patient experienced stiff neck on the same side of the injection. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. On 03 Feb 2021 the outcome of events stiff neck on the same side of the injection was reported not resolved.; Reporter's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.

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Current Illness:

ID: 1551195
Sex: F
Age: 72
State: NC

Vax Date: 01/21/2021
Onset Date: 01/28/2021
Rec V Date: 08/13/2021
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Symptoms: swelling went down to elbow; very hard and very itchy with 2 inch diameter; Redness/very red; swelling/kinda puffy; This spontaneous case was reported by a health care professional and describes the occurrence of JOINT SWELLING (swelling went down to elbow), VACCINATION SITE PRURITUS (very hard and very itchy with 2 inch diameter), VACCINATION SITE ERYTHEMA (Redness/very red) and VACCINATION SITE SWELLING (swelling/kinda puffy) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure. Concomitant products included AMLODIPINE for Blood pressure. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (very hard and very itchy with 2 inch diameter), VACCINATION SITE ERYTHEMA (Redness/very red) and VACCINATION SITE SWELLING (swelling/kinda puffy). On 30-Jan-2021, the patient experienced JOINT SWELLING (swelling went down to elbow). The patient was treated with IBUPROFEN on 29-Jan-2021 at an unspecified dose and frequency. At the time of the report, JOINT SWELLING (swelling went down to elbow) had resolved and VACCINATION SITE PRURITUS (very hard and very itchy with 2 inch diameter), VACCINATION SITE ERYTHEMA (Redness/very red) and VACCINATION SITE SWELLING (swelling/kinda puffy) had not 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.

Other Meds: AMLODIPINE

Current Illness: Blood pressure

ID: 1551196
Sex: F
Age: 67
State: GA

Vax Date: 01/19/2021
Onset Date: 01/30/2021
Rec V Date: 08/13/2021
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Symptoms: cough; shortness breath; high temperature; diarrhea; nausea; vomiting; This spontaneous case was reported by a patient and describes the occurrence of COUGH (cough), DYSPNOEA (shortness breath), PYREXIA (high temperature), DIARRHOEA (diarrhea) and NAUSEA (nausea) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012120A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced COUGH (cough), DYSPNOEA (shortness breath), PYREXIA (high temperature), DIARRHOEA (diarrhea), NAUSEA (nausea) and VOMITING (vomiting). At the time of the report, COUGH (cough), DYSPNOEA (shortness breath), PYREXIA (high temperature), DIARRHOEA (diarrhea), NAUSEA (nausea) and VOMITING (vomiting) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications reported were blood pressure, anti-depressive, cholesterol and allergies pills. No treatment medications were provided by the reporter.; 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.

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Current Illness:

ID: 1551197
Sex: F
Age: 79
State:

Vax Date: 01/25/2021
Onset Date:
Rec V Date: 08/13/2021
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Symptom List:

Symptoms: itchy; big lump; her arm was very sore; This spontaneous case was reported by a consumer and describes the occurrence of in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concomitant products included MESALAMINE for an unknown indication. On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency and IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds: MESALAMINE

Current Illness:

ID: 1551198
Sex: F
Age: 62
State: MD

Vax Date: 01/07/2021
Onset Date: 01/07/2021
Rec V Date: 08/13/2021
Hospital:

Vax Type:
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Lab Data:

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Symptom List:

Symptoms: redness (Started at the spot of injection and then started to go down. It has her hand size this redness); had pain Started at the spot of injection; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE ERYTHEMA (redness (Started at the spot of injection and then started to go down. It has her hand size this redness)) and VACCINATION SITE PAIN (had pain Started at the spot of injection) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. No Medical History information was reported. On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced VACCINATION SITE PAIN (had pain Started at the spot of injection). On 08-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (redness (Started at the spot of injection and then started to go down. It has her hand size this redness)). At the time of the report, VACCINATION SITE ERYTHEMA (redness (Started at the spot of injection and then started to go down. It has her hand size this redness)) and VACCINATION SITE PAIN (had pain Started at the spot of injection) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were provided by the reporter.

Other Meds:

Current Illness:

ID: 1551199
Sex: F
Age: 85
State: NV

Vax Date: 01/23/2021
Onset Date:
Rec V Date: 08/13/2021
Hospital:

Vax Type:
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Lab Data:

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Symptom List:

Symptoms: Red upper arm that is itchy and swollen and blotchy; Red upper arm that is itchy and swollen and blotchy; Red upper arm that is itchy and swollen and blotchy; Red upper arm that is itchy and swollen and blotchy; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Red upper arm that is itchy and swollen and blotchy), VACCINATION SITE PRURITUS (Red upper arm that is itchy and swollen and blotchy), VACCINATION SITE ERYTHEMA (Red upper arm that is itchy and swollen and blotchy) and VACCINATION SITE SWELLING (Red upper arm that is itchy and swollen and blotchy) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. No Medical History information was reported. On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH MACULAR (Red upper arm that is itchy and swollen and blotchy), VACCINATION SITE PRURITUS (Red upper arm that is itchy and swollen and blotchy), VACCINATION SITE ERYTHEMA (Red upper arm that is itchy and swollen and blotchy) and VACCINATION SITE SWELLING (Red upper arm that is itchy and swollen and blotchy). At the time of the report, RASH MACULAR (Red upper arm that is itchy and swollen and blotchy), VACCINATION SITE PRURITUS (Red upper arm that is itchy and swollen and blotchy), VACCINATION SITE ERYTHEMA (Red upper arm that is itchy and swollen and blotchy) and VACCINATION SITE SWELLING (Red upper arm that is itchy and swollen and blotchy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment information was not provided. Concomitant product use was unknown by the reporter.; 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.

Other Meds:

Current Illness:

ID: 1551200
Sex: F
Age: 26
State: TX

Vax Date: 01/02/2021
Onset Date: 01/31/2021
Rec V Date: 08/13/2021
Hospital:

Vax Type:
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Symptom List:

Symptoms: arm was swollen, very red and very hard, hot to the touch, the size of their hand and; hey have limited range movement with their arm, and when they try to move it is painful; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm was swollen, very red and very hard, hot to the touch, the size of their hand and) and DYSKINESIA (hey have limited range movement with their arm, and when they try to move it is painful) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 007M20A) 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) (Intramuscular) 1 dosage form. On 30-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 31-Jan-2021, the patient experienced PERIPHERAL SWELLING (arm was swollen, very red and very hard, hot to the touch, the size of their hand and) and DYSKINESIA (hey have limited range movement with their arm, and when they try to move it is painful). At the time of the report, PERIPHERAL SWELLING (arm was swollen, very red and very hard, hot to the touch, the size of their hand and) and DYSKINESIA (hey have limited range movement with their arm, and when they try to move it is painful) outcome was unknown. Not Provided No relevant concomitant medications were reported. Treatment details included none

Other Meds:

Current Illness:

ID: 1551201
Sex: M
Age: 66
State: MI

Vax Date: 01/26/2021
Onset Date:
Rec V Date: 08/13/2021
Hospital:

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Symptom List:

Symptoms: (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LIMB INJURY (Got a cut on their hand). At the time of the report, LIMB INJURY (Got a cut on their hand) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication list was not provided. Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1551202
Sex: F
Age:
State: TX

Vax Date: 01/08/2021
Onset Date:
Rec V Date: 08/13/2021
Hospital:

Vax Type:
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Symptom List:

Symptoms: Just a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Just a sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Just a sore arm). At the time of the report, PAIN IN EXTREMITY (Just a sore arm) outcome was unknown. Not Provided

Other Meds:

Current Illness:

ID: 1551203
Sex: F
Age:
State: NM

Vax Date: 01/01/2021
Onset Date: 02/02/2021
Rec V Date: 08/13/2021
Hospital:

Vax Type:
Manufacturer:
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Lab Data:

Allergies:

Symptom List:

Symptoms: Has a 100.0 fever, chills, headache, body ache, and soreness at injection site.; Has a 100.0 fever, chills, headache, body ache, and soreness at injection site; Has a 100.0 fever, chills, headache, body ache, and soreness at injection site; Has a 100.0 fever, chills, headache, body ache, and soreness at injection site; Has a 100.0 fever, chills, headache, body ache, and soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Has a 100.0 fever, chills, headache, body ache, and soreness at injection site.), CHILLS (Has a 100.0 fever, chills, headache, body ache, and soreness at injection site), HEADACHE (Has a 100.0 fever, chills, headache, body ache, and soreness at injection site), MYALGIA (Has a 100.0 fever, chills, headache, body ache, and soreness at injection site) and INJECTION SITE PAIN (Has a 100.0 fever, chills, headache, body ache, and soreness at injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No Medical History information was reported. On 01-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. On 02-Feb-2021, the patient experienced PYREXIA (Has a 100.0 fever, chills, headache, body ache, and soreness at injection site.), CHILLS (Has a 100.0 fever, chills, headache, body ache, and soreness at injection site), HEADACHE (Has a 100.0 fever, chills, headache, body ache, and soreness at injection site), MYALGIA (Has a 100.0 fever, chills, headache, body ache, and soreness at injection site) and INJECTION SITE PAIN (Has a 100.0 fever, chills, headache, body ache, and soreness at injection site). At the time of the report, PYREXIA (Has a 100.0 fever, chills, headache, body ache, and soreness at injection site.), CHILLS (Has a 100.0 fever, chills, headache, body ache, and soreness at injection site), HEADACHE (Has a 100.0 fever, chills, headache, body ache, and soreness at injection site), MYALGIA (Has a 100.0 fever, chills, headache, body ache, and soreness at injection site) and INJECTION SITE PAIN (Has a 100.0 fever, chills, headache, body ache, and soreness at injection site) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Feb-2021, Body temperature: 100 (Inconclusive) 100.0. Action taken with mRNA-1273 in response to the events was not applicable. No concomitant medications were reported. No treatment medications were reported. Most recent FOLLOW-UP information incorporated above includes: On 19-Apr-2021: Follow up received on 19APR2021, No new information and patient stated that she was feeling fine.

Other Meds:

Current Illness:

ID: 1551204
Sex: F
Age:
State: NC

Vax Date: 02/04/2021
Onset Date: 02/04/2021
Rec V Date: 08/13/2021
Hospital:

Vax Type:
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Symptom List:

Symptoms: Weakness; Fast Heartbeat; Dizziness; believes she is experiencing a severe allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), HEART RATE INCREASED (Fast Heartbeat), DIZZINESS (Dizziness) and HYPERSENSITIVITY (believes she is experiencing a severe allergic reaction) 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 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced ASTHENIA (Weakness), HEART RATE INCREASED (Fast Heartbeat), DIZZINESS (Dizziness) and HYPERSENSITIVITY (believes she is experiencing a severe allergic reaction). At the time of the report, ASTHENIA (Weakness), HEART RATE INCREASED (Fast Heartbeat), DIZZINESS (Dizziness) and HYPERSENSITIVITY (believes she is experiencing a severe allergic reaction) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1551205
Sex: F
Age:
State: ID

Vax Date:
Onset Date:
Rec V Date: 08/13/2021
Hospital:

Vax Type:
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Symptoms: Had lack of taste; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (Had lack of taste) 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 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 AGEUSIA (Had lack of taste). At the time of the report, AGEUSIA (Had lack of taste) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. No treatment information was provided. Based on the current available information and temporal association between the use of the product and the start date of this event, 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 this event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1551206
Sex: F
Age:
State: TX

Vax Date: 01/22/2021
Onset Date: 01/26/2021
Rec V Date: 08/13/2021
Hospital:

Vax Type:
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Symptom List:

Symptoms: Red blotch reaction; Itching; Injection site is warmer that the rest of her arm; Arm is red for about 4 inches by 2 inches at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Red blotch reaction), PRURITUS (Itching), VACCINATION SITE WARMTH (Injection site is warmer that the rest of her arm) and VACCINATION SITE ERYTHEMA (Arm is red for about 4 inches by 2 inches at the injection site) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. Concomitant products included ATENOLOL and CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM WITH VITAMIN D 3) for an unknown indication. On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced RASH MACULAR (Red blotch reaction), PRURITUS (Itching), VACCINATION SITE WARMTH (Injection site is warmer that the rest of her arm) and VACCINATION SITE ERYTHEMA (Arm is red for about 4 inches by 2 inches at the injection site). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at a dose of 1 dosage form and IBUPROFEN at a dose of 1 dosage form. At the time of the report, RASH MACULAR (Red blotch reaction), PRURITUS (Itching), VACCINATION SITE WARMTH (Injection site is warmer that the rest of her arm) and VACCINATION SITE ERYTHEMA (Arm is red for about 4 inches by 2 inches at the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds: ATENOLOL; CALCIUM WITH VITAMIN D 3

Current Illness:

ID: 1551207
Sex: F
Age: 77
State: VA

Vax Date: 01/21/2021
Onset Date: 01/27/2021
Rec V Date: 08/13/2021
Hospital:

Vax Type:
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Lab Data:

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Symptom List:

Symptoms: Itching/ Round circle at injection site; Redness at injection site; Pain at injection site (R); Hot to touch at injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot to touch at injection site), VACCINATION SITE PRURITUS (Itching/ Round circle at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Pain at injection site (R)) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. Concurrent medical conditions included Shellfish allergy. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Hot to touch at injection site) and VACCINATION SITE PAIN (Pain at injection site (R)). On 29-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itching/ Round circle at injection site) and VACCINATION SITE ERYTHEMA (Redness at injection site). On 02-Feb-2021, VACCINATION SITE PRURITUS (Itching/ Round circle at injection site) had resolved. At the time of the report, VACCINATION SITE WARMTH (Hot to touch at injection site), VACCINATION SITE ERYTHEMA (Redness at injection site) and VACCINATION SITE PAIN (Pain at injection site (R)) 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. Most recent FOLLOW-UP information incorporated above includes: On 05-May-2021: Patient was feeling okay at the time of this report.

Other Meds:

Current Illness: Shellfish allergy

ID: 1551208
Sex: M
Age: 69
State: CA

Vax Date: 01/28/2021
Onset Date: 01/30/2021
Rec V Date: 08/13/2021
Hospital:

Vax Type:
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Symptoms: Difficulty breathing; Fast heartbeat; Little bit of nausea; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Difficulty breathing), HEART RATE INCREASED (Fast heartbeat) and NAUSEA (Little bit of nausea) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. No Medical History information was reported. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced DYSPNOEA (Difficulty breathing), HEART RATE INCREASED (Fast heartbeat) and NAUSEA (Little bit of nausea). At the time of the report, DYSPNOEA (Difficulty breathing), HEART RATE INCREASED (Fast heartbeat) and NAUSEA (Little bit of nausea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications was reported. No treatment details was reported.

Other Meds:

Current Illness:

ID: 1551209
Sex: F
Age:
State: MS

Vax Date: 01/27/2021
Onset Date: 01/28/2021
Rec V Date: 08/13/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
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Lab Data:

Allergies:

Symptom List:

Symptoms: Body aches; Temperature of 101.3; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), PYREXIA (Temperature of 101.3) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 09L20A) for COVID-19 vaccination. No Medical History information was reported. On 27-Jan-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 28-Jan-2021, the patient experienced PAIN (Body aches), PYREXIA (Temperature of 101.3) and HEADACHE (Headache). At the time of the report, PAIN (Body aches), PYREXIA (Temperature of 101.3) and HEADACHE (Headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.3 (Inconclusive) temperature of 101.3. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. concomitant medications were not provided. Treatment information was not provided. This case was linked to US-MODERNATX, INC.-MOD-2021-022474, US-MODERNATX, INC.-MOD-2021-047944 (E2B Linked Report).; 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. Further information has been requested US-MODERNATX, INC.-MOD-2021-047944:Crosslinked (MOD21-018102) US-MODERNATX, INC.-MOD-2021-022474:Crosslinked (MOD21-018102)

Other Meds:

Current Illness:

ID: 1551210
Sex: F
Age:
State: NV

Vax Date: 02/02/2021
Onset Date:
Rec V Date: 08/13/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
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Lab Data:

Allergies:

Symptom List:

Symptoms: Tension; Back pain; This spontaneous case was reported by a consumer and describes the occurrence of TENSION (Tension) and BACK PAIN (Back pain) 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 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TENSION (Tension) and BACK PAIN (Back pain). At the time of the report, TENSION (Tension) and BACK PAIN (Back pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment details was not reported. No concomitant medication was reported.

Other Meds:

Current Illness:

ID: 1551211
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/13/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
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Lab Data:

Allergies:

Symptom List:

Symptoms: Swelling of the face; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (Swelling of the face) 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 an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SWELLING FACE (Swelling of the face). At the time of the report, SWELLING FACE (Swelling of the face) outcome was unknown. Not Provided concomitant medications were not reported. Treatment information was not provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the onset of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1551212
Sex: F
Age: 37
State: NJ

Vax Date: 01/15/2021
Onset Date: 01/22/2021
Rec V Date: 08/13/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
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Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: injection site reaction; Arm started to feel warm; Itchy arm; reaction grew 6 inches in diameter and looked like hives; A spontaneous report was received from a 38-year-old female patient concerning herself who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced a delayed skin reaction, injection site warmth, pruritus and urticaria. The patient's medical history included allergies and she had an epinephrine pen in case of any severe allergic reaction. On 15 Jan 2021, approximately seven days prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number:026L20A) intramuscularly for prophylaxis of COVID-19 infection. On 22 Jan 2021, the patient experienced what she described as "Covid arm". The patient's arm felt warm and itchy and the reaction grew 6 inches in diameter and looked like hives. Treatment for the events included diphenhydramine, acetaminophen, and a warm compress. Action taken with mRNA-1273 in response to the events resolved. The outcome of the events injection site reaction, arm started to feel warm, itchy, reaction grew 6 inches in diameter, looked like hives were considered resolved on 24 Jan 2021.; Reporter'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.

Other Meds:

Current Illness: Allergy NOS

ID: 1551213
Sex: F
Age: 67
State: TX

Vax Date: 12/30/2020
Onset Date: 12/31/2020
Rec V Date: 08/13/2021
Hospital:

Vax Type:
Manufacturer:
Vax Name:
Lot:
Dose Series:
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List:

Symptoms: very faint pink rash shaped as a band that was 2 inches wide and about 1 inch below the injection site; just a little itchy; This spontaneous case was reported by a consumer and describes the occurrence of RASH (very faint pink rash shaped as a band that was 2 inches wide and about 1 inch below the injection site) and PRURITUS (just a little itchy) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure, Cholesterol, Hypothyroidism, GERD, Anxiety and Sleep disorder NOS. Concomitant products included ALPRAZOLAM for Anxiety, QUETIAPINE FUMARATE (SEROQUEL) for Sleep disorder NOS. On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Dec-2020, the patient experienced RASH (very faint pink rash shaped as a band that was 2 inches wide and about 1 inch below the injection site) and PRURITUS (just a little itchy). At the time of the report, RASH (very faint pink rash shaped as a band that was 2 inches wide and about 1 inch below the injection site) and PRURITUS (just a little itchy) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Current condition includes blood pressure, cholesterol, hypothyroidism and Gastroesophageal reflux disease, anxiety, sleep. Concomitant medications were medicine for her blood pressure, cholesterol, hypothyroidism and Gastroesophageal reflux disease, Alprazolam for her anxiety and Seroquel for sleep. Treatment details included For the symptoms: Kenalog cream.,

Other Meds: ALPRAZOLAM; SEROQUEL

Current Illness:

ID: 1551214
Sex: F
Age: 75
State: TX

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 08/13/2021
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Symptoms: Pretty red and concerning on Sunday morning/ It has not spread and it has dimmed in redness; Her arm was warm on Saturday; Her arm was tender; Sore to the touch after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Sore to the touch after vaccination), FEELING HOT (Her arm was warm on Saturday), TENDERNESS (Her arm was tender) and ERYTHEMA (Pretty red and concerning on Sunday morning/ It has not spread and it has dimmed in redness) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination. The patient's past medical history included Mastectomy (Patient previously had a double mastectomy and does not have lymph nodes in her left arm.). On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced PAIN (Sore to the touch after vaccination) and TENDERNESS (Her arm was tender). On 30-Jan-2021, the patient experienced FEELING HOT (Her arm was warm on Saturday). On 31-Jan-2021, the patient experienced ERYTHEMA (Pretty red and concerning on Sunday morning/ It has not spread and it has dimmed in redness). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 1 dosage form and BISABOLOL, CERESIN, PARAFFIN SOFT, PARAFFIN, LIQUID, WOOL ALCOHOLS (AQUAPHOR HEALING) (topical) for Adverse event, at a dose of 1 dosage form. At the time of the report, PAIN (Sore to the touch after vaccination), FEELING HOT (Her arm was warm on Saturday), TENDERNESS (Her arm was tender) and ERYTHEMA (Pretty red and concerning on Sunday morning/ It has not spread and it has dimmed in redness) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient does not have lymph nodes in her left arm. No Concomitant medication was received by the patient. Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Follow up received on 21-APR-2021: contains Non-Significant information.Added reporter contact detail Fax number. On 12-Jul-2021: Follow up received and outcome updated to be Recovered/Resolved

Other Meds:

Current Illness:

ID: 1551215
Sex: F
Age:
State: NV

Vax Date: 01/19/2021
Onset Date:
Rec V Date: 08/13/2021
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Symptoms: Rash; Redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Rash) and VACCINATION SITE ERYTHEMA (Redness at the injection site) 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 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH (Rash) and VACCINATION SITE ERYTHEMA (Redness at the injection site). At the time of the report, RASH (Rash) and VACCINATION SITE ERYTHEMA (Redness at the injection site) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1551216
Sex: F
Age: 64
State: CA

Vax Date: 01/17/2021
Onset Date: 01/17/2021
Rec V Date: 08/13/2021
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Symptoms: Itchiness at the injection site; Redness at the injection site; Soreness at the injection site; Redness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (Itchiness at the injection site), VACCINATION SITE ERYTHEMA (Redness at the injection site), VACCINATION SITE PAIN (Soreness at the injection site) and INJECTION SITE ERYTHEMA (Redness at the injection site) in a 64-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 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jan-2021, the patient experienced VACCINATION SITE PAIN (Soreness at the injection site) and INJECTION SITE ERYTHEMA (Redness at the injection site). On 25-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itchiness at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site). On 19-Jan-2021, VACCINATION SITE PAIN (Soreness at the injection site) and INJECTION SITE ERYTHEMA (Redness at the injection site) had resolved. At the time of the report, VACCINATION SITE PRURITUS (Itchiness at the injection site) and VACCINATION SITE ERYTHEMA (Redness at the injection site) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. It was reported that the itchiness has diminished and the redness has lightened up. No concomitant medications were reported. No treatment medications were reported. Most recent FOLLOW-UP information incorporated above includes: On 04-Jul-2021: Follow-up received on 04-JUL-2021 and contains no new information

Other Meds:

Current Illness:

ID: 1551217
Sex: F
Age:
State: PA

Vax Date: 02/02/2021
Onset Date: 02/02/2021
Rec V Date: 08/13/2021
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Symptoms: Sore arm; Sore arm and pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) and PAIN (Sore arm and pain) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. No Medical History information was reported. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore arm) and PAIN (Sore arm and pain). On 03-Feb-2021, PAIN IN EXTREMITY (Sore arm) and PAIN (Sore arm and pain) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds:

Current Illness:

ID: 1551218
Sex: M
Age: 73
State: NY

Vax Date: 01/18/2021
Onset Date: 01/25/2021
Rec V Date: 08/13/2021
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Symptoms: a little bit of a lighter rash; it felt like there was a lump underneath; This spontaneous case was reported by a consumer and describes the occurrence of RASH (a little bit of a lighter rash) and VACCINATION SITE SWELLING (it felt like there was a lump underneath) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. No Medical History information was reported. On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced RASH (a little bit of a lighter rash) and VACCINATION SITE SWELLING (it felt like there was a lump underneath). At the time of the report, RASH (a little bit of a lighter rash) and VACCINATION SITE SWELLING (it felt like there was a lump underneath) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. Treatment details included a quarter of a Benadryl and probably a little of Cortisone cream. Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.

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Current Illness:

ID: 1551219
Sex: F
Age: 66
State:

Vax Date: 01/30/2021
Onset Date: 01/30/2021
Rec V Date: 08/13/2021
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Symptoms: Arm Pain; Achiness; Anxious; Rapid Heart Beat; Heart Felt like dropping out of her chest; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (Rapid Heart Beat), PALPITATIONS (Heart Felt like dropping out of her chest), PAIN IN EXTREMITY (Arm Pain), PAIN (Achiness) and ANXIETY DISORDER (Anxious) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. No Medical History information was reported. On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced HEART RATE INCREASED (Rapid Heart Beat) and PALPITATIONS (Heart Felt like dropping out of her chest). On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm Pain), PAIN (Achiness) and ANXIETY DISORDER (Anxious). At the time of the report, HEART RATE INCREASED (Rapid Heart Beat), PALPITATIONS (Heart Felt like dropping out of her chest), PAIN IN EXTREMITY (Arm Pain), PAIN (Achiness) and ANXIETY DISORDER (Anxious) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1551220
Sex: F
Age: 73
State: NV

Vax Date: 01/18/2021
Onset Date: 01/18/2021
Rec V Date: 08/13/2021
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Symptoms: Flush; Bruising on the site; Chills; Difficulty of breathing; Itchiness; Body aches; Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness), FLUSHING (Flush), DYSPNOEA (Difficulty of breathing), PRURITUS (Itchiness) and PAIN (Body aches) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included Ambien Sleepin Aid for Sleep disorder NOS. On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness) and PAIN (Body aches). On 28-Jan-2021, the patient experienced DYSPNOEA (Difficulty of breathing) and PRURITUS (Itchiness). On 29-Jan-2021, the patient experienced FLUSHING (Flush), VACCINATION SITE BRUISING (Bruising on the site) and CHILLS (Chills). On 19-Jan-2021, PAIN (Body aches) had resolved. At the time of the report, PAIN IN EXTREMITY (Arm soreness) and DYSPNOEA (Difficulty of breathing) had resolved and FLUSHING (Flush), PRURITUS (Itchiness), VACCINATION SITE BRUISING (Bruising on the site) and CHILLS (Chills) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds: Ambien Sleepin Aid

Current Illness:

ID: 1551221
Sex: F
Age: 69
State: AZ

Vax Date: 01/11/2021
Onset Date: 01/11/2021
Rec V Date: 08/13/2021
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Symptoms: Just 3 days before my second injection I completely lost my taste; low-grade fever; Facial flushing; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm), FLUSHING (Facial flushing), AGEUSIA (Just 3 days before my second injection I completely lost my taste) and PYREXIA (low-grade fever) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. Concurrent medical conditions included Allergy to antibiotic (Allergic to Cephalosporins: resulted in hives.), Allergy to antibiotic (Allergic to Bactrim.), Drug allergy (Allergic to Sulfa.), Iodine allergy, Allergy to antibiotic (Allergic to Erythromycin.), Allergy to antibiotic (Allergic to Cipro.), Drug allergy (Allergic to Prednisone.) and Allergy to antibiotic (Resulted in Urticaria, Swollen tongue.). Concomitant products included NADOLOL (CORGARD), ATORVASTATIN CALCIUM (LIPITOR) and RALOXIFENE HYDROCHLORIDE (EVISTA) for an unknown indication. On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore arm). On 27-Jan-2021, the patient experienced FLUSHING (Facial flushing) and PYREXIA (low-grade fever). On an unknown date, the patient experienced AGEUSIA (Just 3 days before my second injection I completely lost my taste). At the time of the report, VACCINATION SITE PAIN (sore arm), FLUSHING (Facial flushing), AGEUSIA (Just 3 days before my second injection I completely lost my taste) and PYREXIA (low-grade fever) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.2 - 99.5 (Inconclusive) 99.2 - 99.5. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. This case was linked to MOD-2021-245849 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 05-Jul-2021: Follow-up received on 05-JUL-2021 : Lab data, Concomitant medications, Events Outcome were Updated.

Other Meds: CORGARD; LIPITOR; EVISTA

Current Illness: Allergy to antibiotic (Resulted in Urticaria, Swollen tongue.); Allergy to antibiotic (Allergic to Erythromycin.); Allergy to antibiotic (Allergic to Cipro.); Allergy to antibiotic (Allergic to Cephalosporins: resulted in hives.); Allergy to antibiotic (Allergic to Bactrim.); Drug allergy (Allergic to Sulfa.); Drug allergy (Allergic to Prednisone.); Iodine allergy

ID: 1551222
Sex: F
Age: 40
State: IA

Vax Date: 01/19/2021
Onset Date: 01/19/2021
Rec V Date: 08/13/2021
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Symptoms: Rash at the injection site; sore arm; Rash, redness at injection site; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Rash, redness at injection site), VACCINATION SITE PAIN (Sore arm), VACCINATION SITE PAIN (sore arm) and VACCINATION SITE RASH (Rash at the injection site) in a 40-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 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE PAIN (Sore arm). On 01-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Rash, redness at injection site) and VACCINATION SITE PAIN (sore arm). On an unknown date, the patient experienced VACCINATION SITE RASH (Rash at the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (Rash, redness at injection site), VACCINATION SITE PAIN (Sore arm), VACCINATION SITE PAIN (sore arm) and VACCINATION SITE RASH (Rash at the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 599,999

Page last modified: 03 October 2021 5:28pm