VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 10/01/2021
** VAERS DATABASE Last updated: October 1, 2021**
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Manufacturers

Total Manufacturer
187,133MODERNA
33,878JANSSEN
2,321PFIZER\BIONTECH
1,091GLAXOSMITHKLINE BIOLOGICALS
983UNKNOWN MANUFACTURER
363MERCK & CO. INC.
229SEQIRUS, INC.
45DYNAVAX TECHNOLOGIES CORPORATION
41NOVARTIS VACCINES AND DIAGNOSTICS
29SANOFI PASTEUR
18EMERGENT BIOSOLUTIONS
8PAXVAX
7TEVA PHARMACEUTICALS
4PFIZER\WYETH
3BERNA BIOTECH, LTD.
2SMITHKLINE BEECHAM
2INTERCELL AG
2PROTEIN SCIENCES CORPORATION
1CSL LIMITED

Incidents per State

State Total
77,548
AK1,869
AL5,581
AR3,688
AS47
AZ14,288
CA61,984
CO11,665
CT8,149
DC1,663
DE1,807
FL37,749
FM5
GA15,058
GU120
HI2,453
IA4,625
ID2,692
IL20,334
IN24,007
KS4,615
KY7,696
LA4,887
MA14,654
MD12,514
ME3,129
MH11
MI18,739
MN12,528
MO9,710
MP29
MS2,790
MT2,375
NC16,368
ND1,356
NE2,880
NH3,100
NJ17,634
NM3,916
NV4,239
NY34,355
OH19,081
OK6,195
OR8,636
PA23,083
PR2,370
QM2
RI2,088
SC6,411
SD1,212
TN9,131
TX35,174
UT4,273
VA14,937
VI64
VT1,676
WA14,909
WI11,259
WV2,388
WY861
XB5
XL1
XV2

ID: 1543575
Sex: M
Age: 79
State: KY

Vax Date: 01/14/2021
Onset Date: 01/17/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: Vaccination site rash; rash little sore; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Vaccination site rash) and VACCINATION SITE PAIN (rash little sore) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L209) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included ALOGLIPTIN, AMLODIPINE, CHOLECALCIFEROL, CLOTRIMAZOLE, DUPILUMAB (DUPIXENT), LOSARTAN, METFORMIN, MULTVITAMIN & MINERAL, OMEPRAZOLE, ROSUVASTATIN and INSULIN for an unknown indication. On 14-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 RASH (Vaccination site rash) and VACCINATION SITE PAIN (rash little sore). At the time of the report, VACCINATION SITE RASH (Vaccination site rash) was resolving and VACCINATION SITE PAIN (rash little sore) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.

Other Meds: ALOGLIPTIN; AMLODIPINE; CHOLECALCIFEROL; CLOTRIMAZOLE; DUPIXENT; LOSARTAN; METFORMIN; MULTVITAMIN & MINERAL; OMEPRAZOLE; ROSUVASTATIN; INSULIN

Current Illness:

ID: 1543576
Sex: M
Age: 29
State: AZ

Vax Date: 12/23/2020
Onset Date: 01/01/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025L20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: Raynaud's phenomenon; This spontaneous case was reported by a physician and describes the occurrence of RAYNAUD'S PHENOMENON (Raynaud's phenomenon) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. No medical history was provided by the reporter. On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced RAYNAUD'S PHENOMENON (Raynaud's phenomenon). The patient was treated with Physical therapy (Rewarming the limb) for Raynaud's phenomenon. At the time of the report, RAYNAUD'S PHENOMENON (Raynaud's phenomenon) 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. Most recent FOLLOW-UP information incorporated above includes: On 22-Jan-2021: Added patient contact details, Patient demographics. and Route of administration details. Updated treatment details.

Other Meds:

Current Illness:

ID: 1543577
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EL1284
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chest discomfort, Dysphagia, Pain in extremity, Visual impairment

Symptoms: Acquired COVID-19; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (Acquired COVID-19) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. 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 COVID-19 (Acquired COVID-19). At the time of the report, COVID-19 (Acquired COVID-19) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.

Other Meds:

Current Illness:

ID: 1543578
Sex: F
Age: 36
State: VA

Vax Date: 01/19/2021
Onset Date: 01/19/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: unknown
Dose Series: UNK
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Explosive diarrhea; Migraine; Mild diarrhea; Feeling really tired; Nausea; Started to feel extremely cold in veins, like when contrast liquid is injected for an MRI; Tingling on lips; Buzzing or vibration all over body; Mild tachycardia; Slightly elevated blood pressure; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (Started to feel extremely cold in veins, like when contrast liquid is injected for an MRI), PARAESTHESIA ORAL (Tingling on lips), SENSORY DISTURBANCE (Buzzing or vibration all over body), TACHYCARDIA (Mild tachycardia) and BLOOD PRESSURE INCREASED (Slightly elevated blood pressure) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concurrent medical conditions included Anxiety. Concomitant products included LORAZEPAM (ATIVAN), IBUPROFEN (ADVIL [IBUPROFEN]), VITAMINS NOS and ZINC for an unknown indication. 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 FEELING COLD (Started to feel extremely cold in veins, like when contrast liquid is injected for an MRI), PARAESTHESIA ORAL (Tingling on lips), SENSORY DISTURBANCE (Buzzing or vibration all over body), TACHYCARDIA (Mild tachycardia), BLOOD PRESSURE INCREASED (Slightly elevated blood pressure), FATIGUE (Feeling really tired) and NAUSEA (Nausea). On 20-Jan-2021, the patient experienced DIARRHOEA (Mild diarrhea). On 21-Jan-2021, the patient experienced MIGRAINE (Migraine). On 22-Jan-2021, the patient experienced DIARRHOEA (Explosive diarrhea). On 19-Jan-2021, FEELING COLD (Started to feel extremely cold in veins, like when contrast liquid is injected for an MRI), PARAESTHESIA ORAL (Tingling on lips), SENSORY DISTURBANCE (Buzzing or vibration all over body), TACHYCARDIA (Mild tachycardia), BLOOD PRESSURE INCREASED (Slightly elevated blood pressure) and NAUSEA (Nausea) had resolved. On 20-Jan-2021, DIARRHOEA (Mild diarrhea) and FATIGUE (Feeling really tired) had resolved. On 21-Jan-2021, MIGRAINE (Migraine) had resolved. At the time of the report, DIARRHOEA (Explosive diarrhea) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds: ATIVAN; ADVIL [IBUPROFEN]; VITAMINS NOS; ZINC

Current Illness: Anxiety

ID: 1543579
Sex: F
Age: 76
State: SC

Vax Date: 01/13/2021
Onset Date:
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: (Felt like she had a cold) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COPD. On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Arm was swollen, hot, red, itchy), DRY THROAT (dry throat), PAIN IN EXTREMITY (Arm was really sore/both arms got really large, swollen, and hurt), BLISTER (Her arm just got huge, they were blister-looking), NASOPHARYNGITIS (Felt like she had a cold), VACCINATION SITE PRURITUS (Arm was swollen, hot, red, itchy), VACCINATION SITE ERYTHEMA (Arm was swollen, hot, red, itchy), VACCINATION SITE SWELLING (Arm was swollen, hot, red, itchy/both arms got really large, swollen), FATIGUE ("tired, doesn't want to expand energy, general tiredness") and MYALGIA ("bones achy, feel washed out"). The patient was treated with PARACETAMOL (TYLENOL) at a dose of every 6 hours for 3 doses. At the time of the report, VACCINATION SITE WARMTH (Arm was swollen, hot, red, itchy), DRY THROAT (dry throat), PAIN IN EXTREMITY (Arm was really sore/both arms got really large, swollen, and hurt), BLISTER (Her arm just got huge, they were blister-looking), NASOPHARYNGITIS (Felt like she had a cold), VACCINATION SITE PRURITUS (Arm was swollen, hot, red, itchy), VACCINATION SITE ERYTHEMA (Arm was swollen, hot, red, itchy), VACCINATION SITE SWELLING (Arm was swollen, hot, red, itchy/both arms got really large, swollen), FATIGUE ("tired, doesn't want to expand energy, general tiredness") and MYALGIA ("bones achy, feel washed out") outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. In second follow up patient stated that checked vital signs and pulse oximeter level and her oxygen has been normal. This case was linked to MOD-2021-031020 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 12-Jul-2021: Follow up received on 12 Jul 2021. The event verbatim, anatomical location and narrative was updated. An additional event nasopharyngitis was also added. On 19-Jul-2021: Follow-up information received on 19 Jul 2021 contains significant information. added medical history COPD, added events myalgia, fatigue, nasopharyngitis, dry throat.

Other Meds:

Current Illness:

ID: 1543580
Sex: M
Age: 76
State: OH

Vax Date: 01/26/2021
Onset Date: 01/26/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type: FLUC4
Manufacturer: SEQIRUS, INC.
Vax Name: INFLUENZA (SEASONAL) (FLUCELVAX QUADRIVALENT)
Lot: 276563
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Confusional state, Eye inflammation, Headache, Laboratory test

Symptoms: Headache; tiredness; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and FATIGUE (tiredness) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (past medical history not provided). Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), MONTELUKAST SODIUM, FINASTERIDE, CLOPIDOGREL and FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced HEADACHE (Headache) and FATIGUE (tiredness). On 27-Jan-2021, HEADACHE (Headache) and FATIGUE (tiredness) 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. Patient Feels back to Normal and is not worried about the Events No treatment information was reported.; 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: SYMBICORT; MONTELUKAST SODIUM; FINASTERIDE; CLOPIDOGREL; ALLEGRA

Current Illness:

ID: 1543581
Sex: F
Age: 26
State: GA

Vax Date: 01/12/2021
Onset Date: 01/12/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Large swollen rash at injection site; Armpit pain; Pain in lymph nodes in neck and arm; Itchy rash; Red rash; Large swollen rash at injection site; Bruise; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE SWELLING (Large swollen rash at injection site), VACCINATION SITE RASH (Large swollen rash at injection site), AXILLARY PAIN (Armpit pain), CONTUSION (Bruise) and LYMPH NODE PAIN (Pain in lymph nodes in neck and arm) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Pregnancy (Denies pregnancy, as she is on ortho tricyclin). Concomitant products included ARTEMISININ (TRICYCLINE) for Oral contraceptive. On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced CONTUSION (Bruise). On 18-Jan-2021, the patient experienced VACCINATION SITE RASH (Large swollen rash at injection site). On 20-Jan-2021, the patient experienced VACCINATION SITE SWELLING (Large swollen rash at injection site), AXILLARY PAIN (Armpit pain), LYMPH NODE PAIN (Pain in lymph nodes in neck and arm), RASH PRURITIC (Itchy rash) and RASH ERYTHEMATOUS (Red rash). At the time of the report, VACCINATION SITE SWELLING (Large swollen rash at injection site), VACCINATION SITE RASH (Large swollen rash at injection site), AXILLARY PAIN (Armpit pain), CONTUSION (Bruise), LYMPH NODE PAIN (Pain in lymph nodes in neck and arm), RASH PRURITIC (Itchy rash) and RASH ERYTHEMATOUS (Red rash) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. Concomitant medication included ortho tricyclin.

Other Meds: TRICYCLINE

Current Illness:

ID: 1543582
Sex: M
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Patient received first dose of the vaccine 4 weeks ago, and he was tested positive for COVID-19 infection 10 days later; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of COVID-19 (Patient received first dose of the vaccine 4 weeks ago, and he was tested positive for COVID-19 infection 10 days later) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced COVID-19 (Patient received first dose of the vaccine 4 weeks ago, and he was tested positive for COVID-19 infection 10 days later). At the time of the report, COVID-19 (Patient received first dose of the vaccine 4 weeks ago, and he was tested positive for COVID-19 infection 10 days later) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided. No concomitant medication was provided.

Other Meds:

Current Illness:

ID: 1543583
Sex: F
Age: 59
State: OH

Vax Date: 01/14/2021
Onset Date: 01/14/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: Heavy flushing coming over her; Lightheaded; Dizzy; General feeling of being unwell; The injection site was red; Injection site the size of a quarter; Injection site spread to the size of a coffee can lid; It looked bruised; She wondered if she had cellulitis; the lymph nodes in injection site were swollen; A Spontaneous report was received from Non healthcare professional concerning a 59 year old, female patient who received Moderna's COVID-19 Vaccine (mRNA-1273) and experienced lightheaded, dizzy, fast heart rate of 80-90, The injection site was red, Injection site the size of a quarter, lymph nodes in injection site were swollen The patient's medical history, as reported include Have had anaphylaxis shock with chemo allergic reactions.fibromyalgia - muscle ache every day, nausea, Diabetic. Low vit D and concomitant medications Cyclobenzaprine, Pioglitazone 30mg a day, Probiotic daily, Atorvastatin, Benadryl when needed, Colestipol two a day, Losartan potassium, Metformin 1000 two a day, Nebivolol at night, Vit D3, Tylenol or Aleve if needed. On 14 JAN 2021, the patient received their one dose of the two planned doses of COVID-19 Vaccine (mRNA-1273) intramuscularly in the left arm for prophylaxis of COVID-19 infection and had a reaction to the first dose that thinks it maybe an allergic reaction. Within a couple of minutes, she felt like a heavy flushing coming over her. She stayed for 30 mins to get checked up and then went away. She also felt lightheaded and dizzy and had a fast heart rate of 80-90. She had a general feeling of being unwell. These went away in an hour, and she is used to feeling like that and nauseous. She usually has vertigo episodes The injection site was also red and the size of a quarter, but then it spread to the size of a coffee can lid. For the next 10 days it kept getting lighter, maybe because she is fair skinned, it looked bruised. She wondered if she had cellulitis. Also, the lymph nodes in injection site were swollen. No treatment information is provided Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event is resolved/recovered

Other Meds: PIOGLITAZONE; PROBIOTIC [BIFIDOBACTERIUM LACTIS]; ATORVASTATIN; BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]; COLESTIPOL; CYCLOBENZAPRINE; LOSARTAN POTASSIUM; METFORMIN [METFORMIN HYDROCHLORIDE]; NEBIVOLOL; VITAMIN D3

Current Illness: Allergy (anaphylaxis shock with chemo + allergic reactions.); Diabetes; Fibromyalgia (fibromyalgia - muscle ache every day)

ID: 1543584
Sex: F
Age: 29
State: AL

Vax Date: 12/28/2020
Onset Date: 12/28/2020
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J201A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Pregnancy at time of Vaccination; Headache; Sore Arm; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy at time of Vaccination), MYALGIA (Sore Arm) and HEADACHE (Headache) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 042L20A) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy (Sulfa). Concomitant products included FLUTICASONE from 01-Jan-2017 to an unknown date for Seasonal allergy, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication. On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 27-Nov-2020 and the estimated date of delivery was 22-Sep-2021. On 28-Dec-2020, the patient experienced MYALGIA (Sore Arm). On 29-Dec-2020, the patient experienced HEADACHE (Headache). On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy at time of Vaccination). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the fourth week of the pregnancy. On 30-Dec-2020, MYALGIA (Sore Arm) and HEADACHE (Headache) had resolved. At the time of the report, EXPOSURE DURING PREGNANCY (Pregnancy at time of Vaccination) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication Prenatal vitamins, Fluticasone. Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Added patient relevant history (Allergy) details, Concomitant medications

Other Meds: PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]; FLUTICASONE

Current Illness: Drug allergy (Sulfa)

ID: 1543585
Sex: F
Age: 55
State: MA

Vax Date: 12/30/2020
Onset Date:
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling

Symptoms: lymph node enlargement; Left breat was heavier than right; If I press around the lining by the chest or sternum, it hurts; Sprain; Felt some swelling on the lining of the brest; This spontaneous case was reported by a nurse and describes the occurrence of LYMPHADENOPATHY (lymph node enlargement), CHEST PAIN (If I press around the lining by the chest or sternum, it hurts), LIGAMENT SPRAIN (Sprain) and BREAST SWELLING (Felt some swelling on the lining of the brest) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. Concurrent medical conditions included Hypertension. On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On an unknown date, the patient experienced LYMPHADENOPATHY (lymph node enlargement), CHEST PAIN (If I press around the lining by the chest or sternum, it hurts), LIGAMENT SPRAIN (Sprain) and BREAST SWELLING (Felt some swelling on the lining of the brest). At the time of the report, LYMPHADENOPATHY (lymph node enlargement), CHEST PAIN (If I press around the lining by the chest or sternum, it hurts), LIGAMENT SPRAIN (Sprain) and BREAST SWELLING (Felt some swelling on the lining of the brest) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: mmHg Inconclusive. On an unknown date, Computerised tomogram: negative Negative. On an unknown date, Electrocardiogram: Inconclusive. On an unknown date, Fibrin D dimer: high ng/mL (High) The D-Dimer was elevated which indicated a chance for DVT. On an unknown date, X-ray: (Inconclusive) The X-ray taken was unclear. 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 treatment information was provided. No concomitant medication was provided.

Other Meds:

Current Illness: Hypertension

ID: 1543586
Sex: F
Age: 75
State: MO

Vax Date: 01/14/2021
Onset Date: 01/15/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039k20a
Dose Series: 1
Vax Route: SYR
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: woke up spitting up clear, thick mucous like liquid; chills; tingling down her leg like a blood clot; heart was racing; sore arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ORAL DISCHARGE (woke up spitting up clear, thick mucous like liquid), CHILLS (chills), PARAESTHESIA (tingling down her leg like a blood clot), PALPITATIONS (heart was racing) and PAIN IN EXTREMITY (sore arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Thrombosis since an unknown date and Vertigo since an unknown date. Concomitant products included WARFARIN SODIUM (COUMADIN), LORATADINE (LORATADIN) and OXYCODONE HYDROCHLORIDE (OXYCONTIN) for an unknown indication. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 15-Jan-2021, the patient experienced ORAL DISCHARGE (woke up spitting up clear, thick mucous like liquid), CHILLS (chills), PARAESTHESIA (tingling down her leg like a blood clot), PALPITATIONS (heart was racing) and PAIN IN EXTREMITY (sore arm). At the time of the report, ORAL DISCHARGE (woke up spitting up clear, thick mucous like liquid), CHILLS (chills), PARAESTHESIA (tingling down her leg like a blood clot), PALPITATIONS (heart was racing) and PAIN IN EXTREMITY (sore arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided.

Other Meds: COUMADIN; LORATADIN; OXYCONTIN

Current Illness: Thrombosis; Vertigo

ID: 1543587
Sex: F
Age: 29
State: TX

Vax Date: 02/09/2021
Onset Date: 02/09/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Blood pressure decreased, Chest pain, Chills, Confusional state, Decreased appetite

Symptoms: Pregnant; This spontaneous prospective pregnancy case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 29-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The patient's past medical history included Pregnancy from January 2017 to 04-Oct-2017. Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] from 08-Feb-2021 to an unknown date for an unknown indication. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 21-Dec-2020 and the estimated date of delivery was 27-Sep-2021. On 09-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the seventh week of the pregnancy. On 09-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jan-2021, Pregnancy test: positive (Positive) positive. 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 treatment information was provided. No concomitant medication was provided.

Other Meds: PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS

Current Illness:

ID: 1543588
Sex: F
Age:
State: CT

Vax Date: 01/15/2021
Onset Date: 01/15/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20-2A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Dyspnoea, Fatigue, Feeling abnormal, Head discomfort, Headache

Symptoms: very swollen arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (very swollen arm) in a 54-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 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced PERIPHERAL SWELLING (very swollen arm). At the time of the report, PERIPHERAL SWELLING (very swollen arm) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. No concomitant medication was provided.

Other Meds:

Current Illness:

ID: 1543589
Sex: M
Age: 58
State: TX

Vax Date: 01/05/2021
Onset Date: 01/05/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Heart rate decreased, Heart rate increased, Hypertension, Injection site pain, Musculoskeletal chest pain

Symptoms: Bronchitis; flu; lost taste; This spontaneous case was reported by a consumer and describes the occurrence of BRONCHITIS (Bronchitis), INFLUENZA (flu) and AGEUSIA (lost taste) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. No Medical History information was reported. On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced BRONCHITIS (Bronchitis), INFLUENZA (flu) and AGEUSIA (lost taste). At the time of the report, BRONCHITIS (Bronchitis), INFLUENZA (flu) and AGEUSIA (lost taste) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Jan-2021, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. No concomitant medication was provided.

Other Meds:

Current Illness:

ID: 1543590
Sex: F
Age: 30
State: OH

Vax Date: 12/30/2020
Onset Date: 12/30/2020
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Nausea, Pain, Pain in extremity, Paraesthesia oral, Pyrexia

Symptoms: The patient's past medical history included Melanoma in August 2015 and Alcohol abuse (1 drink every couple of months) from 2021 to 2020. Concurrent medical conditions included Pregnant since 20-Sep-2020. Concomitant products included PYRIDOXINE HYDROCHLORIDE (B6) and DOXYLAMINE SUCCINATE (UNISOM [DOXYLAMINE SUCCINATE]) for Nausea, CHORIOGONADOTROPIN ALFA (OVIDREL [CHORIOGONADOTROPIN ALFA]) from 19-Sep-2020 to an unknown date and LETROZOLE from 07-Sep-2020 to 11-Sep-2020 for Subfertility, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), FOLIC ACID (FOLIC) and IRON for an unknown indication. On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 03-Sep-2020 and the estimated date of delivery was 15-Jun-2021. On 28-Jan-2021, the patient experienced FATIGUE (fatigue), ARTHRALGIA (arthralgia), MYALGIA (myalgia) and HEADACHE (headache). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the twentieth week of the pregnancy. The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 29-Jan-2021, FATIGUE (fatigue), ARTHRALGIA (arthralgia), MYALGIA (myalgia) and HEADACHE (headache) had resolved. At the time of the report, MATERNAL EXPOSURE DURING PREGNANCY (maternal exposure during pregnancy) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-Dec-2020, Gestational diabetes:. On 17-Dec-2020, Prenatal screening test: normal (normal) normal. On 26-Jan-2021, Ultrasound uterus: normal (normal) 20 week ultrasound normal.. On 24-Feb-2021, Gestational diabetes: normal (normal) normal. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment medication Tylenol Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Updated Patient demographics, LMP, Delivery due date.Added lab data (NIPT,1-h-OGTT), Medical history (Melanoma).Added sub-fertility drugs(Ovidrel and Letrozole).Updated route of administration and start date for all concomitants, stop date and indication for both B6 and unisom medications.Added patient info (prior alcohol use).

Other Meds: PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]; FOLIC; B6; OVIDREL [CHORIOGONADOTROPIN ALFA]; LETROZOLE; UNISOM [DOXYLAMINE SUCCINATE]; IRON

Current Illness: Pregnant

ID: 1543591
Sex: F
Age:
State: NJ

Vax Date: 01/06/2021
Onset Date: 01/21/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type: DTAPHEPBIP
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: DTAP + HEPB + IPV (PEDIARIX)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: SARS-CoV-2 antibody test, SARS-CoV-2 test negative

Symptoms: really bad headache; some sinus congestion; sneezing; Tested positive for COVID 19; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of HEADACHE (really bad headache) and COVID-19 (Tested positive for COVID 19) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. Concurrent medical conditions included RA. Concomitant products included TOFACITINIB CITRATE (XELJANZ) for Rheumatoid arthritis. On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 21-Jan-2021, the patient experienced COVID-19 (Tested positive for COVID 19). On an unknown date, the patient experienced HEADACHE (really bad headache). At the time of the report, HEADACHE (really bad headache) and COVID-19 (Tested positive for COVID 19) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2021, SARS-CoV-2 test positive: positive Positive. 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 treatment information was provided. No concomitant medication was provided.

Other Meds: XELJANZ

Current Illness: RA

ID: 1543592
Sex: F
Age: 76
State: IL

Vax Date: 01/13/2021
Onset Date: 01/13/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type: HIBV
Manufacturer: MERCK & CO. INC.
Vax Name: HIB (PEDVAXHIB)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Patch at the injection site that looks like sunburn; Soreness in the arm; A spontaneous report was received from a (Consumer) concerning a ? 76 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events (PT term) list. The patient's medical history was not provided. No relevant concomitant medications were reported. On 22/Jan/2021 date or an unknown date, The patient experienced the events list (verbatims) Per voicemail received: 76-year-old female Caller received the Moderna vaccine on 13Jan2021, all I had was a "little soreness in the arm. As of this morning, 22Jan2021, "I have a patch at the site of the injection." "About 2X4 inches," that "looks like a sunburn." Caller stated, It's not bothering me, I just wanted to report that "I'm having apparently a reaction to the vaccine." ****************************** Patient left another voicemail responding to the callback attempted. Upon callback, patient confirmed information provided in voicemail that was originally made. The reaction lasted about two days and it's back to looking normal. She took no medications in regards to her reaction and has no other questions at this time. Consent given to Safety for follow-up. 25JAN2021 No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported.

Other Meds:

Current Illness:

ID: 1543593
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/11/2021
Hospital:

Vax Type: PNC13
Manufacturer: PFIZER\WYETH
Vax Name: PNEUMO (PREVNAR13)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: redness and swelling to the arm; redness and swelling to the arm; large sinus pressure; This spontaneous case was reported by a consumer and describes the occurrence of the first episode of VACCINATION SITE ERYTHEMA (redness and swelling to the arm), the second episode of VACCINATION SITE ERYTHEMA (redness and swelling to the arm) and PARANASAL SINUS DISCOMFORT (large sinus pressure) in a patient of an unknown age and gender 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 the first episode of VACCINATION SITE ERYTHEMA (redness and swelling to the arm), the second episode of VACCINATION SITE ERYTHEMA (redness and swelling to the arm) and PARANASAL SINUS DISCOMFORT (large sinus pressure). At the time of the report, last episode of VACCINATION SITE ERYTHEMA (redness and swelling to the arm) and PARANASAL SINUS DISCOMFORT (large sinus pressure) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.; 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: 1543594
Sex: F
Age:
State:

Vax Date: 01/14/2021
Onset Date: 01/14/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type: RV1
Manufacturer: GLAXOSMITHKLINE BIOLOGICALS
Vax Name: ROTAVIRUS (ROTARIX)
Lot:
Dose Series: 1
Vax Route: PO
Vax Site: MO

Lab Data:

Allergies:

Symptom List: Blood pressure increased, Chest discomfort, Heart rate increased

Symptoms: tachycardia; severe weakness; numbness; lightheadedness; sweaty; itchy around her neck; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of TACHYCARDIA (tachycardia), ASTHENIA (severe weakness), HYPOAESTHESIA (numbness), DIZZINESS (lightheadedness) and HYPERHIDROSIS (sweaty) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included LEVOTHYROXINE for an unknown indication. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced TACHYCARDIA (tachycardia), ASTHENIA (severe weakness), HYPOAESTHESIA (numbness), DIZZINESS (lightheadedness), HYPERHIDROSIS (sweaty) and PRURITUS (itchy around her neck). On 14-Jan-2021, TACHYCARDIA (tachycardia), ASTHENIA (severe weakness) and DIZZINESS (lightheadedness) had resolved. At the time of the report, HYPOAESTHESIA (numbness), HYPERHIDROSIS (sweaty) and PRURITUS (itchy around her neck) outcome was unknown. 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. No treatment information was provided. No concomitant medication was provided.

Other Meds: LEVOTHYROXINE

Current Illness:

ID: 1543596
Sex: F
Age: 21
State: NJ

Vax Date: 08/04/2021
Onset Date: 08/08/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: Eh9899
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies: Penicillin allergy

Symptom List: Injection site erythema, Injection site pruritus, Injection site swelling, Lymph node pain, Lymphadenopathy

Symptoms: Fatigue and arm pain the day of, tapering off in the days following (arm pain was bad enough that arm could barely be lifted without pain). Shortness of breath and chest tightness after about three days following vaccine.

Other Meds: CBD Oil, 3mg daily

Current Illness:

ID: 1543597
Sex: F
Age: 60
State: NJ

Vax Date: 01/23/2021
Onset Date: 01/23/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: injection site hard; injection site a little red; injection site sore; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INDURATION (injection site hard), VACCINATION SITE ERYTHEMA (injection site a little red), VACCINATION SITE PAIN (injection site sore) and HEADACHE (headache) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. Concurrent medical conditions included Cholesterol and Blood pressure (High blood pressure patient. On meds but unspecified.). Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) for an unknown indication. On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced VACCINATION SITE INDURATION (injection site hard), VACCINATION SITE ERYTHEMA (injection site a little red), VACCINATION SITE PAIN (injection site sore) and HEADACHE (headache). At the time of the report, VACCINATION SITE INDURATION (injection site hard), VACCINATION SITE ERYTHEMA (injection site a little red), VACCINATION SITE PAIN (injection site sore) and HEADACHE (headache) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medicines also include water pill and medicines for cholesterol and high blood pressure. No treatment medication information was provided. Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: NNI

Other Meds: ZOLOFT

Current Illness: Blood pressure (High blood pressure patient. On meds but unspecified.); Cholesterol

ID: 1543598
Sex: F
Age: 69
State: WY

Vax Date: 01/09/2021
Onset Date: 01/12/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Dizziness, Injection site pain, Myalgia, Pyrexia

Symptoms: pain went from her neck to eye; dizziness, needs to use the wall to walk down the hall; severe headaches; pain went from her neck to eye; A spontaneous report was received from a consumer concerning a 69 years old female patient who received Moderna's Covid 19 vaccine and experienced severe headaches, pain from her neck to eye and dizziness. The patient's medical history was not provided.No relevant concomitant medications were provided. The patient received their first of two planned doses of mRNA-1273 (Batch number: 037K20A), intramuscularly,in her left arm on 9-Jan-2021. On 12-Jan-2021, the patient experienced severe headache. The patient also stated that pain went from her neck to eye.She also experienced dizziness and she needs to use the wall for aid as she walks down the hall.( Dizziness ensued once she lays down) Lab data was not provided. Treatment information included Ibuprofen. Action taken with mRNA-1273 in response to the events was not provided. The outcome of the event was unknown.

Other Meds:

Current Illness:

ID: 1543599
Sex: M
Age: 71
State: OK

Vax Date: 01/14/2021
Onset Date: 01/14/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011L20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: COVID-19 Diagnoses; Sickness; Soreness and pain in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Soreness and pain in the injection site), ILLNESS (Sickness) and COVID-19 (COVID-19 Diagnoses) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L2OA) for COVID-19 vaccination. No Medical History information was reported. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE PAIN (Soreness and pain in the injection site). On 21-Jan-2021, the patient experienced ILLNESS (Sickness). On 22-Jan-2021, the patient experienced COVID-19 (COVID-19 Diagnoses). At the time of the report, VACCINATION SITE PAIN (Soreness and pain in the injection site), ILLNESS (Sickness) and COVID-19 (COVID-19 Diagnoses) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. No concomitant medication was provided.

Other Meds:

Current Illness:

ID: 1543600
Sex: F
Age:
State: OH

Vax Date: 01/21/2021
Onset Date: 01/22/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. No concomitant medication was provided.

Other Meds:

Current Illness:

ID: 1543601
Sex: M
Age: 74
State: IN

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Arthralgia, Chills, Headache, Mobility decreased, Myalgia

Symptoms: On my right ankle about a 4" batch of red rash. Rash is smooth and not itching.; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (On my right ankle about a 4" batch of red rash. Rash is smooth and not itching.) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. Concomitant products included HYDROCODONE, FUROSEMIDE, ESCITALOPRAM, AMLODIPINE, LISINOPRIL, MIRABEGRON, OMEPRAZOLE, ERGOCALCIFEROL, EZETIMIBE and RIVAROXABAN 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-Jan-2021, the patient experienced RASH ERYTHEMATOUS (On my right ankle about a 4" batch of red rash. Rash is smooth and not itching.). At the time of the report, RASH ERYTHEMATOUS (On my right ankle about a 4" batch of red rash. Rash is smooth and not itching.) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Event outcome updated as recovered.

Other Meds: HYDROCODONE; FUROSEMIDE; ESCITALOPRAM; AMLODIPINE; LISINOPRIL; MIRABEGRON; OMEPRAZOLE; ERGOCALCIFEROL; EZETIMIBE; RIVAROXABAN

Current Illness:

ID: 1543602
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: Something that could be considered a side effect; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of ADVERSE EVENT FOLLOWING IMMUNISATION (Something that could be considered a side effect) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT FOLLOWING IMMUNISATION (Something that could be considered a side effect). At the time of the report, ADVERSE EVENT FOLLOWING IMMUNISATION (Something that could be considered a side effect) outcome was unknown. 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. No treatment information was provided. No concomitant medication was provided.

Other Meds:

Current Illness:

ID: 1543603
Sex: F
Age: 70
State: FL

Vax Date: 01/20/2021
Onset Date: 01/20/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: arm became swollen to the elbow; Hurts at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (arm became swollen to the elbow) and INJECTION SITE PAIN (Hurts at injection site) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012620A) for COVID-19 vaccination. 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 PERIPHERAL SWELLING (arm became swollen to the elbow) and INJECTION SITE PAIN (Hurts at injection site). At the time of the report, PERIPHERAL SWELLING (arm became swollen to the elbow) and INJECTION SITE PAIN (Hurts at injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. No concomitant medication was provided.

Other Meds:

Current Illness:

ID: 1543604
Sex: F
Age: 59
State:

Vax Date: 01/14/2021
Onset Date: 01/22/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Headache, Heart rate increased, Injection site erythema, Injection site pain, Injection site swelling

Symptoms: they can only feel where the injection was by slightly pressing on it; redness and itching at the site of the injection; redness and itching at the site of the injection; hat localize area is warm to the touch; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE INDURATION (they can only feel where the injection was by slightly pressing on it), VACCINATION SITE ERYTHEMA (redness and itching at the site of the injection), VACCINATION SITE PRURITUS (redness and itching at the site of the injection) and VACCINATION SITE WARMTH (hat localize area is warm to the touch) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. Concurrent medical conditions included Cholesterol. On 14-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 VACCINATION SITE ERYTHEMA (redness and itching at the site of the injection), VACCINATION SITE PRURITUS (redness and itching at the site of the injection) and VACCINATION SITE WARMTH (hat localize area is warm to the touch). On an unknown date, the patient experienced VACCINATION SITE INDURATION (they can only feel where the injection was by slightly pressing on it). At the time of the report, VACCINATION SITE INDURATION (they can only feel where the injection was by slightly pressing on it), VACCINATION SITE ERYTHEMA (redness and itching at the site of the injection), VACCINATION SITE PRURITUS (redness and itching at the site of the injection) and VACCINATION SITE WARMTH (hat localize area is warm to the touch) outcome was unknown. 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. No treatment information was provided. No concomitant medication was provided.

Other Meds:

Current Illness: Cholesterol

ID: 1543605
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: right face was swelling up; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (right face was swelling up) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SWELLING FACE (right face was swelling up). At the time of the report, SWELLING FACE (right face was swelling up) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided. No treatment information provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1543606
Sex: F
Age: 40
State:

Vax Date: 02/08/2021
Onset Date: 02/08/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: UNK
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: sore arm; pregnancy; This spontaneous prospective pregnancy case was reported by a physician and describes the occurrence of VACCINATION SITE PAIN (sore arm) and EXPOSURE DURING PREGNANCY (pregnancy) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication. On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 31-Mar-2021. On 08-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore arm) and EXPOSURE DURING PREGNANCY (pregnancy). On 08-Feb-2021, EXPOSURE DURING PREGNANCY (pregnancy) had resolved. At the time of the report, VACCINATION SITE PAIN (sore arm) 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 treatment information provided. Most recent FOLLOW-UP information incorporated above includes: On 10-Feb-2021: Internal review on 21-JUL-2021resulted in update of birth type and fetal outcome was updated.

Other Meds: PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]

Current Illness:

ID: 1543607
Sex: F
Age: 73
State: CO

Vax Date: 01/09/2021
Onset Date: 01/18/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: Rash around the injection site and slightly above it; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Rash around the injection site and slightly above it) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included ACICLOVIR SODIUM (ACYCLOVIR ABBOTT VIAL) and HYDROCHLOROTHIAZIDE, LOSARTAN POTASSIUM (LOSARTAN HCTZ) for an unknown indication. On 09-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 VACCINATION SITE RASH (Rash around the injection site and slightly above it). At the time of the report, VACCINATION SITE RASH (Rash around the injection site and slightly above it) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Additional concomitant medication included supplements (unspecified). Most recent FOLLOW-UP information incorporated above includes: On 15-Apr-2021: Reporter did not follow up with HCP- she received second dose in other arm and did not have any event.

Other Meds: ACYCLOVIR ABBOTT VIAL; LOSARTAN HCTZ

Current Illness:

ID: 1543608
Sex: U
Age:
State: IA

Vax Date:
Onset Date:
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011j20a
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Dizziness, Nausea, Pain, Tachycardia

Symptoms: Hardness at injection site, 8 days post injection; Redness at injection site, 8 days post injection; Swelling at injection site, 8 days post injection; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE INDURATION (Hardness at injection site, 8 days post injection), VACCINATION SITE ERYTHEMA (Redness at injection site, 8 days post injection) and VACCINATION SITE SWELLING (Swelling at injection site, 8 days post injection) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE INDURATION (Hardness at injection site, 8 days post injection), VACCINATION SITE ERYTHEMA (Redness at injection site, 8 days post injection) and VACCINATION SITE SWELLING (Swelling at injection site, 8 days post injection). At the time of the report, VACCINATION SITE INDURATION (Hardness at injection site, 8 days post injection), VACCINATION SITE ERYTHEMA (Redness at injection site, 8 days post injection) and VACCINATION SITE SWELLING (Swelling at injection site, 8 days post 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. The patient's concomitant medication was not reported. The patient's treatment medication was not reported. Most recent FOLLOW-UP information incorporated above includes: On 18-Mar-2021: TCR added- No answer On 07-Apr-2021: TCR added- Spoke with HCP and she refused follow-up.

Other Meds:

Current Illness:

ID: 1543609
Sex: F
Age: 38
State: CA

Vax Date: 01/05/2021
Onset Date:
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: Pregnant; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant) in a 38-year-old female patient (gravida 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 042L20A and 011L20A) for COVID-19 vaccination. Concurrent medical conditions included Ehlers-Danlos syndrome, Anxiety since 2003, Depression since 2003 and Herpes NOS. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]), VALACYCLOVIR [VALACICLOVIR] and ESCITALOPRAM OXALATE (LEXAPRO) for an unknown indication. On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 05-Jan-2021 and the estimated date of delivery was 12-Oct-2021. On an unknown date, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the fourth week of the pregnancy. At the time of the report, EXPOSURE DURING PREGNANCY (Pregnant) had resolved. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Feb-2021, Pregnancy test: positive (Positive) Positive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information provided.

Other Meds: PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]; VALACYCLOVIR [VALACICLOVIR]; LEXAPRO

Current Illness: Anxiety; Depression; Ehlers-Danlos syndrome; Herpes NOS

ID: 1543610
Sex: F
Age:
State: IL

Vax Date:
Onset Date: 02/18/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: red line in her arm; raised; hot; scattered bumps; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red line in her arm), VACCINATION SITE SWELLING (raised), VACCINATION SITE WARMTH (hot) and VACCINATION SITE MASS (scattered bumps) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Osteoarthritis and Fibromyalgia. Concomitant products included ATORVASTATIN for Cholesterol, DULOXETINE for Fibromyalgia, LEVOTHYROXINE for Hypothyroidism, ETODOLAC for Osteoarthritis, CALCIUM CARBONATE (OSCAL [CALCIUM CARBONATE]) for Supplementation therapy, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) for an unknown indication. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (red line in her arm), VACCINATION SITE SWELLING (raised), VACCINATION SITE WARMTH (hot) and VACCINATION SITE MASS (scattered bumps). At the time of the report, VACCINATION SITE ERYTHEMA (red line in her arm), VACCINATION SITE SWELLING (raised), VACCINATION SITE WARMTH (hot) and VACCINATION SITE MASS (scattered bumps) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Reporter did not allow further contact

Other Meds: OSCAL [CALCIUM CARBONATE]; DULOXETINE; ETODOLAC; LEVOTHYROXINE; ATORVASTATIN; ASPIRIN (E.C.)

Current Illness: Fibromyalgia; Osteoarthritis

ID: 1543611
Sex: F
Age: 32
State: MD

Vax Date: 01/06/2021
Onset Date: 01/06/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type: UNK
Manufacturer: UNKNOWN MANUFACTURER
Vax Name: VACCINE NOT SPECIFIED (NO BRAND NAME)
Lot:
Dose Series: UNK
Vax Route: SYR
Vax Site: UN

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site induration, Injection site pruritus, Injection site swelling, Myalgia

Symptoms: pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (pregnant) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. No medical history was provided by the reporter. On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 14-Dec-2020 and the estimated date of delivery was 20-Sep-2021. On 06-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (pregnant). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the third week of the pregnancy. At the time of the report, EXPOSURE DURING PREGNANCY (pregnant) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. No concomitant medications were provided. No treatment information provided.

Other Meds:

Current Illness:

ID: 1543612
Sex: M
Age:
State: CO

Vax Date: 01/20/2021
Onset Date: 01/23/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Cough, Limb discomfort, Pain, SARS-CoV-2 test positive

Symptoms: Nausea; Headache; Fever; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea), HEADACHE (Headache) and PYREXIA (Fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 20-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, the patient experienced NAUSEA (Nausea), HEADACHE (Headache) and PYREXIA (Fever). At the time of the report, NAUSEA (Nausea), HEADACHE (Headache) and PYREXIA (Fever) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided. No treatment information provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1543613
Sex: F
Age:
State:

Vax Date: 01/19/2021
Onset Date: 01/19/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: instantly started bleeding after getting the shot; bump on the arm; Bruise; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE (instantly started bleeding after getting the shot), VACCINATION SITE MASS (bump on the arm) and VACCINATION SITE BRUISING (Bruise) in a 69-year-old female patient 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) (unknown route) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE HAEMORRHAGE (instantly started bleeding after getting the shot), VACCINATION SITE MASS (bump on the arm) and VACCINATION SITE BRUISING (Bruise). At the time of the report, VACCINATION SITE HAEMORRHAGE (instantly started bleeding after getting the shot), VACCINATION SITE MASS (bump on the arm) and VACCINATION SITE BRUISING (Bruise) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided. No treatment information provided. Most recent FOLLOW-UP information incorporated above includes: On 08-Jun-2021: Follow up document is received on 08-JUN-2021 and it doesn't have any new information

Other Meds:

Current Illness:

ID: 1543614
Sex: U
Age:
State:

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011J20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site erythema, Injection site pain, Injection site swelling

Symptoms: Visual disturbance; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of VISUAL IMPAIRMENT (Visual disturbance) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced VISUAL IMPAIRMENT (Visual disturbance). At the time of the report, VISUAL IMPAIRMENT (Visual disturbance) 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 relevant concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1543615
Sex: F
Age: 32
State: NJ

Vax Date: 02/09/2021
Onset Date: 02/09/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EK9231
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Chills, Feeling cold, Feeling hot, Myalgia, Pain

Symptoms: Pregnant and received Moderna COVID vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received Moderna COVID vaccine) in a 32-year-old female patient (gravida 3, para 2) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. Concurrent medical conditions included Hay fever. Concomitant products included PRENATAL + DHA for an unknown indication. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 28-Nov-2020 and the estimated date of delivery was 04-Sep-2021. On 09-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received Moderna COVID vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the tenth week of the pregnancy. On 09-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant and received Moderna COVID vaccine) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. There was no treatment medication reported. No maternal history of subfertility was reported. No family history of congenital anomalies/genetic disease was reported. No complications or acute illnesses during this pregnancy to date were reported. On an unknown date in Nov-2016, it was reported that 1st pregnancy ended with live, full-term birth. On an unknown date in Nov-2019, it was reported that 2st pregnancy ended with live, full-term birth.

Other Meds: PRENATAL + DHA

Current Illness:

ID: 1543616
Sex: M
Age: 58
State: TX

Vax Date: 12/29/2020
Onset Date:
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: Sore throat; Runny nose; Sore Arm; A little rash around the shot; Shoulders ached; Fever; Cold Chills; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Runny nose), VACCINATION SITE PAIN (Sore Arm), VACCINATION SITE RASH (A little rash around the shot) and ARTHRALGIA (Shoulders ached) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1. On an unknown date, the patient experienced OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Runny nose), VACCINATION SITE PAIN (Sore Arm), VACCINATION SITE RASH (A little rash around the shot), ARTHRALGIA (Shoulders ached), PYREXIA (Fever) and CHILLS (Cold Chills). At the time of the report, OROPHARYNGEAL PAIN (Sore throat), RHINORRHOEA (Runny nose), ARTHRALGIA (Shoulders ached), PYREXIA (Fever) and CHILLS (Cold Chills) outcome was unknown and VACCINATION SITE PAIN (Sore Arm) and VACCINATION SITE RASH (A little rash around the shot) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided. No treatment information provided.

Other Meds:

Current Illness:

ID: 1543617
Sex: F
Age: 26
State: TX

Vax Date: 12/23/2020
Onset Date: 12/23/2020
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 2
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Abnormal behaviour, Adverse reaction, Anger, Asthma

Symptoms: Elevated WBC; Body was red; Lips swelling; Itching; Allergic reaction; Migraine; Tachycardia; Hives/Red spots on skin; Myalgia; Chills; Vomits; Headache; Vaccination site pain; This spontaneous case was reported by a physician assistant and describes the occurrence of MIGRAINE (Migraine), TACHYCARDIA (Tachycardia), URTICARIA (Hives/Red spots on skin), LIP SWELLING (Lips swelling) and WHITE BLOOD CELL COUNT INCREASED (Elevated WBC) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Previously administered products included for an unreported indication: GARDASIL 9 (Dose 3/3 and Route i.m) on 03-Dec-2020. Concurrent medical conditions included Drug allergy (methimazole), Hives (Skin Allergy) since 22-Jan-2021 and Hypothyroidism (Recent changes: High levels, Medication increased) since 2016. Concomitant products included LEVOTHYROXINE for Hypothyroidism, CONTRACEPTIVES and NORETHINDRONE ACETATE for an unknown indication. On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Dec-2020, the patient experienced VACCINATION SITE PAIN (Vaccination site pain). On 20-Jan-2021, the patient experienced MIGRAINE (Migraine), TACHYCARDIA (Tachycardia), URTICARIA (Hives/Red spots on skin), MYALGIA (Myalgia), CHILLS (Chills), VOMITING (Vomits) and HEADACHE (Headache). On 22-Jan-2021 at 1:00 AM, the patient experienced HYPERSENSITIVITY (Allergic reaction). On 01-Feb-2021, the patient experienced LIP SWELLING (Lips swelling) and PRURITUS (Itching). On an unknown date, the patient experienced WHITE BLOOD CELL COUNT INCREASED (Elevated WBC) and ERYTHEMA (Body was red). The patient was treated with METHYLPREDNISOLONE (MEDROL DOSEPAK) (oral) for Symptomatic treatment, at a dose of 4 mg. On 23-Dec-2020, VACCINATION SITE PAIN (Vaccination site pain) had resolved. On 31-Jan-2021, MIGRAINE (Migraine), TACHYCARDIA (Tachycardia), MYALGIA (Myalgia), VOMITING (Vomits) and HEADACHE (Headache) had resolved, CHILLS (Chills) had resolved with sequelae. On 10-Feb-2021, PRURITUS (Itching) had resolved. At the time of the report, URTICARIA (Hives/Red spots on skin), LIP SWELLING (Lips swelling), WHITE BLOOD CELL COUNT INCREASED (Elevated WBC) and ERYTHEMA (Body was red) outcome was unknown and HYPERSENSITIVITY (Allergic reaction) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Follow-up received on 17-JUN-2021: updated reporter details, added patient details, medical history, Concomitant medications, treatment medication and event

Other Meds: LEVOTHYROXINE; CONTRACEPTIVES; NORETHINDRONE ACETATE

Current Illness: Drug allergy (methimazole); Hives (Skin Allergy); Hypothyroidism (Recent changes: High levels, Medication increased)

ID: 1543618
Sex: F
Age: 31
State: MN

Vax Date: 02/10/2021
Onset Date: 02/10/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Consciousness fluctuating, Crying, Dry skin, Epistaxis, Headache

Symptoms: Pregnant at the time of vaccination; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE TIMING UNSPECIFIED (Pregnant at the time of vaccination) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. Concurrent medical conditions included Penicillin allergy. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 01-Oct-2020 to an unknown date for an unknown indication. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 25-Oct-2020 and the estimated date of delivery was 02-Aug-2021. On 10-Feb-2021, the patient experienced MATERNAL EXPOSURE TIMING UNSPECIFIED (Pregnant at the time of vaccination). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the fifteenth week of the pregnancy. At the time of the report, MATERNAL EXPOSURE TIMING UNSPECIFIED (Pregnant at the time of vaccination) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Nov-2020, Pregnancy test: positive (Positive) Positive. 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: PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]

Current Illness: Penicillin allergy

ID: 1543619
Sex: F
Age:
State:

Vax Date: 01/12/2021
Onset Date:
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Hypotonia, Lethargy, Respiratory rate decreased, Screaming, Skin warm

Symptoms: reaction of my whole arm going numb; reaction is growing; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (reaction of my whole arm going numb) and CONDITION AGGRAVATED (reaction is growing) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. On 12-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 HYPOAESTHESIA (reaction of my whole arm going numb) and CONDITION AGGRAVATED (reaction is growing). At the time of the report, HYPOAESTHESIA (reaction of my whole arm going numb) and CONDITION AGGRAVATED (reaction is growing) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided. No treatment information provided.

Other Meds:

Current Illness:

ID: 1543620
Sex: F
Age: 78
State: CO

Vax Date: 01/12/2021
Onset Date: 01/12/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 026LZOA
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: Arm red; Arm swollen; Arm a little tender; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Arm a little tender), VACCINATION SITE ERYTHEMA (Arm red) and VACCINATION SITE SWELLING (Arm swollen) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20-A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included SALBUTAMOL SULFATE (INHALERIN) and Eye vitamins for an unknown indication. On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Jan-2021, the patient experienced VACCINATION SITE PAIN (Arm a little tender). On 21-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Arm red) and VACCINATION SITE SWELLING (Arm swollen). At the time of the report, VACCINATION SITE PAIN (Arm a little tender), VACCINATION SITE ERYTHEMA (Arm red) and VACCINATION SITE SWELLING (Arm swollen) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment medication included Benadryl at an unknown dose and frequency via an unknown route. Reporter did not allow further contact

Other Meds: INHALERIN; Eye vitamins

Current Illness:

ID: 1543621
Sex: F
Age: 82
State: NJ

Vax Date: 01/18/2021
Onset Date: 01/19/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Doesn't feel well; Feeling funny in the top of her stomach with lots of gases; Nauseated; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), VACCINATION COMPLICATION (Doesn't feel well), FLATULENCE (Feeling funny in the top of her stomach with lots of gases) and NAUSEA (Nauseated) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. Concomitant products included METFORMIN, AMLODIPINE, METOPROLOL, ATORVASTATIN CALCIUM (LIPITOR), ACETYLSALICYLIC ACID (BABY ASPIRIN), INSULIN GLARGINE (LANTUS), VITAMINS NOS and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication. On 18-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 PAIN IN EXTREMITY (Sore arm). On 22-Jan-2021, the patient experienced VACCINATION COMPLICATION (Doesn't feel well), FLATULENCE (Feeling funny in the top of her stomach with lots of gases) and NAUSEA (Nauseated). The patient was treated with ESOMEPRAZOLE MAGNESIUM (NEXIUM [ESOMEPRAZOLE MAGNESIUM]) for Adverse event, at a dose of UNK dosage form. On 21-Jan-2021, PAIN IN EXTREMITY (Sore arm) had resolved. At the time of the report, VACCINATION COMPLICATION (Doesn't feel well), FLATULENCE (Feeling funny in the top of her stomach with lots of gases) and NAUSEA (Nauseated) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Oxygen saturation: 98 % normal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Additional concomitant medical included glucoride (1mg, twice a day). The patient received treatment with inhaler (indication unspecified).

Other Meds: METFORMIN; AMLODIPINE; METOPROLOL; LIPITOR; BABY ASPIRIN; LANTUS; VITAMINS NOS; SYNTHROID

Current Illness:

ID: 1543622
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Back pain, Cold sweat, Headache, Nausea, Vomiting

Symptoms: have precipitated a cervical radiculopathy that she had in the past ;really classic and really bad; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of CONDITION AGGRAVATED (have precipitated a cervical radiculopathy that she had in the past ;really classic and really bad) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Cervical radiculopathy (The patient had this event in the past). 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 CONDITION AGGRAVATED (have precipitated a cervical radiculopathy that she had in the past ;really classic and really bad). At the time of the report, CONDITION AGGRAVATED (have precipitated a cervical radiculopathy that she had in the past ;really classic and really bad) outcome was unknown. 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 medication was not reported. Treatment medication was not reported. Within hours of getting the vaccine, it seems to have precipitated a cervical radiculopathy that she had in the past, really classic and really bad.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1543623
Sex: F
Age:
State: MA

Vax Date: 01/10/2021
Onset Date: 01/08/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025j20-2A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: Swelling glands at neck, chest, groin, and under arm; JOINT PAIN; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of ARTHRALGIA (JOINT PAIN) and LYMPHADENOPATHY (Swelling glands at neck, chest, groin, and under arm) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L2OA) for COVID-19 vaccination. The patient's past medical history included COVID-19 from March 2020 to April 2020. On 10-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced ARTHRALGIA (JOINT PAIN). On 11-Jan-2021, the patient experienced LYMPHADENOPATHY (Swelling glands at neck, chest, groin, and under arm). At the time of the report, ARTHRALGIA (JOINT PAIN) and LYMPHADENOPATHY (Swelling glands at neck, chest, groin, and under arm) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2021, Blood test: normal (normal) normal. 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 medication was not reported. Treatment medication was not reported.

Other Meds:

Current Illness:

ID: 1543624
Sex: F
Age:
State: OH

Vax Date: 02/01/2021
Onset Date: 02/02/2021
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Diarrhoea, Fatigue, Feeling abnormal, Headache

Symptoms: Swelling around the injection site; arm soreness; Pain; redness around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness), VACCINATION SITE PAIN (Pain), VACCINATION SITE ERYTHEMA (redness around the injection site) and VACCINATION SITE SWELLING (Swelling around 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 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 1. On 02-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm soreness), VACCINATION SITE PAIN (Pain) and VACCINATION SITE ERYTHEMA (redness around the injection site). On an unknown date, the patient experienced VACCINATION SITE SWELLING (Swelling around the injection site). At the time of the report, PAIN IN EXTREMITY (arm soreness), VACCINATION SITE PAIN (Pain) and VACCINATION SITE ERYTHEMA (redness around the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was provided by the reporter. No treatment medication was provided by the reporter.

Other Meds:

Current Illness:

ID: 1543625
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/11/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 037K20A
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Hot flush, Myalgia, Nausea, Tension headache

Symptoms: Felt soreness on his arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Felt soreness on his arm) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history provided). 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 VACCINATION SITE PAIN (Felt soreness on his arm). At the time of the report, VACCINATION SITE PAIN (Felt soreness on his arm) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. No concomitant information provided. No treatment information 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:

Total 2021 VAERS Injuries: 636,615

Page last modified: 03 October 2021 5:28pm