VAERS 2021 Database www.vaers.hhs.gov

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VAERS Updated: 11/12/2021
** VAERS DATABASE Last updated: November 12, 2021**
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Manufacturers

Total Manufacturer
199,106MODERNA
36,710JANSSEN
5,381PFIZER\BIONTECH
2,555GLAXOSMITHKLINE BIOLOGICALS
1,469UNKNOWN MANUFACTURER
897MERCK & CO. INC.
627SEQIRUS, INC.
112DYNAVAX TECHNOLOGIES CORPORATION
91SANOFI PASTEUR
75NOVARTIS VACCINES AND DIAGNOSTICS
40EMERGENT BIOSOLUTIONS
14PAXVAX
12TEVA PHARMACEUTICALS
12PROTEIN SCIENCES CORPORATION
9PFIZER\WYETH
4BERNA BIOTECH, LTD.
4SMITHKLINE BEECHAM
3INTERCELL AG
1MEDIMMUNE VACCINES, INC.
1CSL LIMITED

COVID19 Lot Number

VAX LOT Total
2S9CL7,949
7,473
2,547
1,506
1,187
1,051
1,049
s0294561,043
866
IMM209861
816
UT7065MA766
657
579
U62828AA563
557
538
U6737AA516
515
S034636506
4F472471
458
P100253275449
444
276563436
429
418
4BH32414
MENVEO404
PP9L5362
UJ446AA337
319
306
290
271
49TM3270
R1B252M253
4F472179
933622147
C5763AA144
CW3116134
3Y7NL126
UNK114
113
ARBA141A105
104
103
96
300057A90
79
1F4EB73
R1B743M62
56
UJ090AA55
51
UH894AB46
45
UNK44
UNK42
42
EJ168638
Unknown36
35
34
32
32
26
el128424
24
A115A22
22
EN620222
21
UNK20
20
19
Z127A19
19
17
JEV18K95E15
12
111798PI12
10
A739088
No batch number8
3333324181078
6
6
TAR356
5
5
U6935AA5
UNK5
4
unknown4
3
2
55RB72
2
2
2
2
2
U7124AA2
JEV18A68E2
2
ABYB05BA1
1
1
1
1
AMVA436A1
1
1
TJ3521
A130A; VIS give1
1
U7140BB1
1
1
SP UP016AA1
1
1808P08802/ESV01
037K20A300,947
EL1284288,578
57,766
1,432

Incidents per State

State Total
82,750
CA62,821
FL38,209
TX36,512
NY34,921
PA23,646
IN23,622
IL20,597
MI19,590
OH19,426
NJ18,413
NC16,769
GA15,932
WA15,351
VA15,234
MA14,876
AZ14,206
MN12,940
MD12,656
CO11,908
WI11,425
MO10,240
TN9,685
OR8,768
KY8,437
CT8,300
SC6,700
OK6,293
AL5,692
LA5,025
IA4,825
KS4,821
UT4,637
NV4,374
NM3,967
AR3,807
ME3,161
NH3,096
NE2,918
MS2,859
ID2,785
WV2,469
HI2,459
PR2,417
MT2,414
RI2,076
DE1,868
AK1,830
VT1,734
DC1,715
ND1,388
SD1,269
WY866
GU118
VI69
AS47
MP29
MH8
XB6
FM4
QM3
XV2
XL1

ID: 1631267
Sex: F
Age: 88
State: WI

Vax Date: 01/31/2021
Onset Date: 02/01/2021
Rec V Date: 08/25/2021
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: hot rash; Chills; Fever; Fatigue; rash from shoulder to elbow; rash on arm; itchy rash on arm; redness; soreness; A spontaneous report was received from a consumer concerning a 88-years-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events redness, soreness, rash on arm, itchy rash on arm, hot rash, swollen rash, chills, fever, fatigue, rash from shoulder to elbow. The patient's medical history was not provided. No relevant concomitant medications were reported. On 31 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 007M20A or MRN4544) intramuscularly for prophylaxis of COVID-19 infection. On 1 Feb 2021, the patient experienced the event(s) redness, soreness. On 8 Feb 2021, the patient experienced the event(s) rash on arm, itchy rash on arm. On an unknown date, the patient experienced the event(s) hot rash, swollen rash, chills, fever, fatigue. On 14 Feb 2021, the patient experienced the event(s) rash from shoulder to elbow. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event(s), redness, soreness, rash on arm, itchy rash on arm, hot rash, swollen rash, chills, fever, fatigue, rash from shoulder to elbow was unknown.

Other Meds:

Current Illness:

ID: 1631268
Sex: M
Age:
State: SD

Vax Date: 01/04/2021
Onset Date: 01/01/2021
Rec V Date: 08/25/2021
Hospital:

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

Lab Data: Test Date: 202101; Test Name: Covid-19 test; Test Result: Positive ; Result Unstructured Data: Positive

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: Got covid-19 after vaccination; A spontaneous report was received from other health professional concerning a male patient of unspecified age who received Moderna's COVID-19 vaccine (mRNA-1273) and tested positive for covid-19. The patient's medical history and concomitant medication were not reported. On 04-Jan-2021 prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) via intramuscular route for prophylaxis of COVID-19 infection. A few days after the vaccine administration, the patient had sore throat, cough and body aches. Hence, on 08-Jan-2021, he went to the physician and had a strep test and covid-19 test. He did not have strep; but, however, he was positive for covid-19. No treatment information was provided. Action taken with the mRNA-1273 in response to the event was not provided. The outcome of event got covid-19 after vaccination was considered unknown.; Reporter's Comments: Based on the current available information and the mechanism of action of mRNA-1237 vaccine, the event of COVID-19 is assessed as unlikely related.

Other Meds:

Current Illness:

ID: 1631269
Sex: M
Age:
State: CT

Vax Date: 01/16/2021
Onset Date:
Rec V Date: 08/25/2021
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: developed a lump under his armpit; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (developed a lump under his armpit) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. No Medical History information was reported. On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (developed a lump under his armpit). At the time of the report, LYMPHADENOPATHY (developed a lump under his armpit) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication were provided by reporter Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1631270
Sex: M
Age:
State: FL

Vax Date: 01/24/2021
Onset Date: 01/24/2021
Rec V Date: 08/25/2021
Hospital:

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

Lab Data: Test Date: 20210125; Test Name: TEMPERATURE; Result Unstructured Data: increased

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: stomach upset; fever; cold; chills; Muscle stiffness; vomiting; diarrhea; Headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headaches), PYREXIA (fever), NASOPHARYNGITIS (cold), CHILLS (chills) and MUSCULOSKELETAL STIFFNESS (Muscle stiffness) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hypertension and Allergy (Allergic to Amoxicillin, Sodium-penicillin, oxycodone, and outside things.). Concomitant products included LORATADINE for Allergy, METOPROLOL for Hypertension, AMLODIPINE BESILATE (PRODIPINE). On 24-Jan-2021 at 1:15 PM, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced HEADACHE (Headaches), NASOPHARYNGITIS (cold), CHILLS (chills), MUSCULOSKELETAL STIFFNESS (Muscle stiffness), VOMITING (vomiting) and DIARRHOEA (diarrhea). On 25-Jan-2021, the patient experienced PYREXIA (fever). On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (stomach upset). On 24-Jan-2021, HEADACHE (Headaches) outcome was unknown, MUSCULOSKELETAL STIFFNESS (Muscle stiffness) had resolved. At the time of the report, PYREXIA (fever), NASOPHARYNGITIS (cold), CHILLS (chills), ABDOMINAL DISCOMFORT (stomach upset) and VOMITING (vomiting) had resolved and DIARRHOEA (diarrhea) outcome was unknown. For Callers mother and husband this symptom appeared after taking Moderna's COVID 19 vaccine. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 25-Jan-2021, Body temperature increased: 101 degree f. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. As treatment for the events she has also taken Tylenol. This case was linked to MOD-2021-017362, MOD-2021-018532 (Patient Link).

Other Meds: METOPROLOL; LORATADINE; PRODIPINE

Current Illness: Allergy (Allergic to Amoxicillin, Sodium-penicillin, oxycodone, and outside things.); Hypertension

ID: 1631271
Sex: F
Age: 70
State: TX

Vax Date: 12/31/2020
Onset Date:
Rec V Date: 08/25/2021
Hospital:

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

Lab Data: Test Name: Body temperature; Result Unstructured Data: 100F fever was reported

Allergies:

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

Symptoms: sore arm; Neck and stomach were burning like fever; fever 100F; This spontaneous case was reported by a consumer and describes the occurrence of SKIN WARM (Neck and stomach were burning like fever), PYREXIA (fever 100F) and PAIN IN EXTREMITY (sore arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 043L20A) for COVID-19 vaccination. No Medical History information was reported. On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SKIN WARM (Neck and stomach were burning like fever), PYREXIA (fever 100F) and PAIN IN EXTREMITY (sore arm). At the time of the report, SKIN WARM (Neck and stomach were burning like fever), PYREXIA (fever 100F) and PAIN IN EXTREMITY (sore arm) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: body temperature 100F fever was reported. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not reported Treatment for the events were acetaminophen included

Other Meds:

Current Illness:

ID: 1631272
Sex: M
Age: 30
State: NV

Vax Date: 12/30/2020
Onset Date: 01/04/2021
Rec V Date: 08/25/2021
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: Test Date: 20210104; Test Name: SARS-COV-2; Test Result: Positive ; Result Unstructured Data: Severe acute respiratory syndrome

Allergies:

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

Symptoms: tested postive for covid-19 after 1st dose; This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (tested postive for covid-19 after 1st dose) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K02A) for COVID-19 vaccination. No Medical History information was reported. On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jan-2021, the patient experienced COVID-19 (tested postive for covid-19 after 1st dose). On 16-Jan-2021, COVID-19 (tested postive for covid-19 after 1st dose) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jan-2021, Severe acute respiratory syndrome: 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. Concomitant medications used by the patient was not reported. No Treatment details was provided.

Other Meds:

Current Illness:

ID: 1631273
Sex: M
Age: 77
State: TX

Vax Date: 12/31/2020
Onset Date:
Rec V Date: 08/25/2021
Hospital:

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

Lab Data: Test Name: Body temperature; Result Unstructured Data: 100F

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Neck and stomach were burning like fever; sore; fever 100F; This spontaneous case was reported by a consumer and describes the occurrence of SKIN WARM (Neck and stomach were burning like fever), PAIN IN EXTREMITY (sore) and PYREXIA (fever 100F) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025L20A and 043L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SKIN WARM (Neck and stomach were burning like fever), PAIN IN EXTREMITY (sore) and PYREXIA (fever 100F). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, SKIN WARM (Neck and stomach were burning like fever), PAIN IN EXTREMITY (sore) and PYREXIA (fever 100F) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: body temperature 100F was reported.. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information include Tylenol.Concomitant medications were not reported. This case was linked to MOD-2021-018772 (Patient Link).

Other Meds:

Current Illness:

ID: 1631274
Sex: M
Age: 37
State: NY

Vax Date: 01/08/2021
Onset Date: 02/05/2021
Rec V Date: 08/25/2021
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: back pain; pain in neck; pain in jaw; numbness in hand; can not clench his hand; fever; Chills; dizziness; flu like symptoms; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Feb-2021 and was forwarded to Moderna on 20-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), INFLUENZA LIKE ILLNESS (flu like symptoms), BACK PAIN (back pain), NECK PAIN (pain in neck) and PAIN IN JAW (pain in jaw) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced DIZZINESS (dizziness), INFLUENZA LIKE ILLNESS (flu like symptoms), PYREXIA (fever) and CHILLS. On 10-Feb-2021, the patient experienced BACK PAIN (back pain), NECK PAIN (pain in neck), PAIN IN JAW (pain in jaw), HYPOAESTHESIA (numbness in hand) and JOINT STIFFNESS (can not clench his hand). At the time of the report, DIZZINESS (dizziness), INFLUENZA LIKE ILLNESS (flu like symptoms), BACK PAIN (back pain), NECK PAIN (pain in neck), PAIN IN JAW (pain in jaw), HYPOAESTHESIA (numbness in hand), JOINT STIFFNESS (can not clench his hand), PYREXIA (fever) and CHILLS outcome was unknown. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1631275
Sex: F
Age: 67
State: AK

Vax Date: 01/21/2021
Onset Date: 01/26/2021
Rec V Date: 08/25/2021
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: Entire arm became sore; deltoid muscle was inflammed; It was hot to touch (deltoid muscle); Arm puffed up and swollen; bright red like a sunburn (deltoid muscle); This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Entire arm became sore), PERIPHERAL SWELLING (Arm puffed up and swollen), VACCINATION SITE INFLAMMATION (deltoid muscle was inflammed), VACCINATION SITE WARMTH (It was hot to touch (deltoid muscle)) and VACCINATION SITE ERYTHEMA (bright red like a sunburn (deltoid muscle)) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 21-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 PAIN IN EXTREMITY (Entire arm became sore), PERIPHERAL SWELLING (Arm puffed up and swollen), VACCINATION SITE INFLAMMATION (deltoid muscle was inflammed), VACCINATION SITE WARMTH (It was hot to touch (deltoid muscle)) and VACCINATION SITE ERYTHEMA (bright red like a sunburn (deltoid muscle)). The patient was treated with DICLOFENAC (VOLTAREN [DICLOFENAC]) at a dose of 50 mg. At the time of the report, PAIN IN EXTREMITY (Entire arm became sore) had not resolved and PERIPHERAL SWELLING (Arm puffed up and swollen), VACCINATION SITE INFLAMMATION (deltoid muscle was inflammed), VACCINATION SITE WARMTH (It was hot to touch (deltoid muscle)) and VACCINATION SITE ERYTHEMA (bright red like a sunburn (deltoid muscle)) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. This case was linked to MOD-2021-029752, MOD-2021-029752 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 27-Feb-2021: Follow-up added on 27-Feb-2021 included: Additional AEs added. Outcome of pain in arm updated.

Other Meds:

Current Illness:

ID: 1631276
Sex: F
Age: 57
State: NE

Vax Date: 12/31/2020
Onset Date: 01/03/2021
Rec V Date: 08/25/2021
Hospital:

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

Lab Data: Test Name: CT; Result Unstructured Data: Negative brain normal

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Hypoaesthesia; Tingling; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of HYPOAESTHESIA (Hypoaesthesia) and PARAESTHESIA (Tingling) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The patient's past medical history included No adverse event. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), ATORVASTATIN, ANASTROZOLE (ARIMIDEX) and HYDROCHLOROTHIAZIDE, OLMESARTAN MEDOXOMIL (OLMESARTAN + HIDROCLOROTIAZIDA) for an unknown indication. On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jan-2021, the patient experienced HYPOAESTHESIA (Hypoaesthesia) and PARAESTHESIA (Tingling). At the time of the report, HYPOAESTHESIA (Hypoaesthesia) and PARAESTHESIA (Tingling) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram head: ct scan Negative brain 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. Treatment for the event included Carbamazepine .

Other Meds: BABY ASPIRIN; ATORVASTATIN; ARIMIDEX; OLMESARTAN + HIDROCLOROTIAZIDA

Current Illness:

ID: 1631277
Sex: F
Age: 45
State: NJ

Vax Date: 02/06/2021
Onset Date:
Rec V Date: 08/25/2021
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: mark on her arm at injection site; Weakness; Dizziness; injection site is big; (mark) is red; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE BRUISING (mark on her arm at injection site), ASTHENIA (Weakness), DIZZINESS (Dizziness), INJECTION SITE SWELLING (injection site is big) and INJECTION SITE ERYTHEMA ((mark) is red) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE BRUISING (mark on her arm at injection site), ASTHENIA (Weakness), DIZZINESS (Dizziness), INJECTION SITE SWELLING (injection site is big) and INJECTION SITE ERYTHEMA ((mark) is red). At the time of the report, INJECTION SITE BRUISING (mark on her arm at injection site), ASTHENIA (Weakness), DIZZINESS (Dizziness) and INJECTION SITE SWELLING (injection site is big) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications are provided. No treatment information reported.

Other Meds:

Current Illness:

ID: 1631278
Sex: F
Age: 45
State:

Vax Date: 01/18/2021
Onset Date: 01/18/2021
Rec V Date: 08/25/2021
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: arm started to swell up; red circle below injection site; itchy below injection site; the are is warm to touch; fatigue; arm was tender and sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was tender and sore), PERIPHERAL SWELLING (arm started to swell up), INJECTION SITE ERYTHEMA (red circle below injection site), INJECTION SITE PRURITUS (itchy below injection site) and INJECTION SITE WARMTH (the are is warm to touch) in a 45-year-old female adult exposed to mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L2DA) , while the parent received the product for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 18-Jan-2021, the parent received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 18-Jan-2021, the adult was diagnosed with PAIN IN EXTREMITY (arm was tender and sore). On 26-Jan-2021, the adult was diagnosed with PERIPHERAL SWELLING (arm started to swell up), INJECTION SITE ERYTHEMA (red circle below injection site), INJECTION SITE PRURITUS (itchy below injection site), INJECTION SITE WARMTH (the are is warm to touch) and FATIGUE (fatigue). The Adult was exposed to mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy. On 20-Jan-2021, PAIN IN EXTREMITY (arm was tender and sore) had resolved. At the time of the report, PERIPHERAL SWELLING (arm started to swell up), INJECTION SITE ERYTHEMA (red circle below injection site), INJECTION SITE PRURITUS (itchy below injection site), INJECTION SITE WARMTH (the are is warm to touch) and FATIGUE (fatigue) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant conmeds reported. Treatment provided: Benadryl (diphenhydramine) and Tylenol (paracetamol).

Other Meds:

Current Illness:

ID: 1631279
Sex: U
Age: 48
State: NY

Vax Date: 01/14/2021
Onset Date:
Rec V Date: 08/25/2021
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: Chills; icky feelings; Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness), CHILLS (Chills) and VACCINATION COMPLICATION (icky feelings) in a 48-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event. Concomitant products included INFLIXIMAB (REMICADE). On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On an unknown date, the patient experienced PAIN IN EXTREMITY (Arm soreness), CHILLS (Chills) and VACCINATION COMPLICATION (icky feelings). At the time of the report, PAIN IN EXTREMITY (Arm soreness) outcome was unknown. Reporter did not allow further contact

Other Meds: REMICADE

Current Illness:

ID: 1631280
Sex: F
Age: 77
State: FL

Vax Date: 01/16/2021
Onset Date: 01/24/2021
Rec V Date: 08/25/2021
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: infection at the site of injection; itchy - at the site of injection; redness - at the site of injection - size of nickel; swelling - at the site of injection; hot to the touch - at the site of injection; A spontaneous report (United States) was received from a consumer who is a 77-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced redness - at the site of injection - size of nickel/size of softball, swelling - at the site of injection, hot to the touch - at the site of injection, itchy - at the site of injection, infection at the site of injection. The patient's medical history was not provided. Concomitant medications reported were Synthroid, Premarin, Xanax, Escitalopram, Losartan, Supplements, Vitamins for unknown indication. On 16-Jan-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 01J20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 24-Jan-2021, the patient experienced the events redness - at the site of injection - size of nickel. swelling - at the site of injection, hot to the touch - at the site of injection, itchy - at the site of injection. On 25-Jan-2021, the patient experienced the increase in the redness - at the site of injection - size of softball. On 26-Jan-2021, the patient was seen by a HCP who suspected a vaccine site infection and provided treatment. Treatment details included an unspecified antibiotic and an unspecified topical ointment Action taken with mRNA-1273 in response to the events was not available. The outcome of events , vaccination site warmth, vaccination site infection, vaccination site erythema, vaccination site swelling and vaccination site pruritus were unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: SYNTHROID; PREMARIN; XANAX; ESCITALOPRAM; LOSARTAN; Supplements; VITAMINS A & D

Current Illness:

ID: 1631281
Sex: U
Age: 73
State: MD

Vax Date: 01/27/2021
Onset Date: 02/02/2021
Rec V Date: 08/25/2021
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: Herpes sore; A spontaneous report was received from a Healthcare Professional concerning a 74-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events herpes sore outbreak. The patient's medical history was not provided. No relevant concomitant medications were reported. On 27 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (unknown Batch Number) intramuscularly in his left deltoid for prophylaxis of COVID-19 infection. On 2 Feb 2021, the patient experienced the events herpes sore. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. On 3 Feb 2021 the outcome of events herpes sore was not reported.

Other Meds:

Current Illness:

ID: 1631282
Sex: M
Age: 79
State:

Vax Date: 01/27/2021
Onset Date: 01/28/2021
Rec V Date: 08/25/2021
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: Dry cough; Little fatigue; A spontaneous report was received from a Consumer concerning a 79? Years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events, dry cough, little fatigue. The patient's medical history was not provided. Concomitant medications reported were Medication for cholesterol, Medication for high blood pressure for drug use for unknown indication. On 27 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot batch: Not provided) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 28 Jan 2021, the patient experienced the events, dry cough. little fatigue. Treatment details included Toprol, 1FEB2021 JGrilloBalboa Action taken with mRNA-1273 in response to the events, dry cough, little fatigue was not reported. On an unknown date the outcome of events include, dry cough, little fatigue was not reported.

Other Meds: Medication for high blood pressure; Medication for cholesterol

Current Illness:

ID: 1631283
Sex: M
Age:
State: NJ

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
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: Shaking; Chills; Headache; Myalgia; Fatigue; A spontaneous report was received from a healthcare professional concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events shaking, chills, headache, myalgia, fatigue. The patient's medical history was not provided. No relevant concomitant medications were reported. On unknown date, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced the event(s) shaking, chills, headache, myalgia, fatigue. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event(s), shaking, chills, headache, myalgia, fatigue was unknown.

Other Meds:

Current Illness:

ID: 1631284
Sex: F
Age: 66
State:

Vax Date: 01/23/2021
Onset Date: 01/23/2021
Rec V Date: 08/25/2021
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: Still itchy; still swollen (little bit); slight temp; arm started to swell up really big; itch; Soreness at the vaccination site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Still itchy), PERIPHERAL SWELLING (arm started to swell up really big), PRURITUS (itch), SWELLING (still swollen (little bit)) and PYREXIA (slight temp) in a 66-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 information was reported by reporter. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) 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 PAIN (Soreness at the vaccination site). On 30-Jan-2021, the patient experienced PERIPHERAL SWELLING (arm started to swell up really big), PRURITUS (itch) and PYREXIA (slight temp). On 02-Feb-2021, the patient experienced PRURITUS (Still itchy) and SWELLING (still swollen (little bit)). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, PRURITUS (Still itchy), PERIPHERAL SWELLING (arm started to swell up really big), PRURITUS (itch), SWELLING (still swollen (little bit)), PYREXIA (slight temp) and VACCINATION SITE PAIN (Soreness at the vaccination site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.

Other Meds: LEXAPRO

Current Illness:

ID: 1631285
Sex: F
Age: 77
State: NY

Vax Date: 01/19/2021
Onset Date: 01/19/2021
Rec V Date: 08/25/2021
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: vaccination site was red; swollen; warm; itchy; a little lump formed; arm was sore; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of INJECTION SITE ERYTHEMA (vaccination site was red), VACCINATION SITE SWELLING (swollen), INJECTION SITE WARMTH (warm), INJECTION SITE PRURITUS (itchy) and VACCINATION SITE MASS (a little lump formed) in a 77-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 No adverse event (No medical reported history). On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE PAIN (arm was sore). On 26-Jan-2021, the patient experienced INJECTION SITE PRURITUS (itchy) and VACCINATION SITE MASS (a little lump formed). On 27-Jan-2021, the patient experienced INJECTION SITE ERYTHEMA (vaccination site was red), VACCINATION SITE SWELLING (swollen) and INJECTION SITE WARMTH (warm). At the time of the report, INJECTION SITE ERYTHEMA (vaccination site was red), VACCINATION SITE SWELLING (swollen), INJECTION SITE WARMTH (warm), INJECTION SITE PRURITUS (itchy), VACCINATION SITE MASS (a little lump formed) and VACCINATION SITE PAIN (arm was sore) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. patient have given antihistamine but unknown no concomitant medication provided

Other Meds:

Current Illness:

ID: 1631286
Sex: U
Age: 78
State: FL

Vax Date: 01/26/2021
Onset Date:
Rec V Date: 08/25/2021
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: Ankle started to hurt; It went into his leg a little bit; hurt to walk on; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Ankle started to hurt), PAIN IN EXTREMITY (It went into his leg a little bit) and GAIT DISTURBANCE (hurt to walk on) in a 78-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. The patient's past medical history included Gout. Concomitant products included METFORMIN, GLIMEPIRIDE and RIVAROXABAN (XARELTO). On 26-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 ARTHRALGIA (Ankle started to hurt), PAIN IN EXTREMITY (It went into his leg a little bit) and GAIT DISTURBANCE (hurt to walk on). Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Most recent FOLLOW-UP information incorporated above includes: On 01-Feb-2021: No specific follow-up information recorded.

Other Meds: METFORMIN; GLIMEPIRIDE; XARELTO

Current Illness:

ID: 1631287
Sex: F
Age: 58
State: GA

Vax Date: 01/20/2021
Onset Date:
Rec V Date: 08/25/2021
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:

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

Symptoms: injection site swelling; injection site knot; skin tightening; extreme soreness; fever; headaches; fatigue; blotchy redness; injection site redness; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (injection site swelling), INJECTION SITE ABSCESS (injection site knot), SUBCUTANEOUS ABSCESS (skin tightening), PAIN (extreme soreness) and PYREXIA (fever) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE SWELLING (injection site swelling), INJECTION SITE ABSCESS (injection site knot), SUBCUTANEOUS ABSCESS (skin tightening), PAIN (extreme soreness), PYREXIA (fever), HEADACHE (headaches), FATIGUE (fatigue), RASH MACULAR (blotchy redness) and INJECTION SITE ERYTHEMA (injection site redness). At the time of the report, INJECTION SITE SWELLING (injection site swelling), INJECTION SITE ABSCESS (injection site knot), SUBCUTANEOUS ABSCESS (skin tightening), PAIN (extreme soreness), PYREXIA (fever), HEADACHE (headaches), FATIGUE (fatigue), RASH MACULAR (blotchy redness) and INJECTION SITE ERYTHEMA (injection site redness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. Treatment details included Took ibuprofen for symptoms the first day, then switched to Tylenol 500mg x 2 B.I.D. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1631288
Sex: M
Age: 40
State: GA

Vax Date: 01/13/2021
Onset Date: 01/13/2021
Rec V Date: 08/25/2021
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: Developed rash on legs that spread up his legs to his arm; Legs itch; Rash at the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRURITUS (Legs itch), RASH (Developed rash on legs that spread up his legs to his arm) and INJECTION SITE RASH (Rash at the injection site) in a 41-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. No Medical History information was reported. On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced INJECTION SITE RASH (Rash at the injection site). On 18-Jan-2021, the patient experienced PRURITUS (Legs itch). On 19-Jan-2021, the patient experienced RASH (Developed rash on legs that spread up his legs to his arm). The patient was treated with PREDNISONE on 29-Jan-2021 at an unspecified dose and frequency; FAMOTIDINE on 29-Jan-2021 at an unspecified dose and frequency and CETIRIZINE on 29-Jan-2021 at an unspecified dose and frequency. At the time of the report, PRURITUS (Legs itch), RASH (Developed rash on legs that spread up his legs to his arm) and INJECTION SITE RASH (Rash at the injection site) was resolving. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported The patient went to a doctor and was confirmed to have a typical drug allergic reaction. He was given a steroid shot (unknown) and prescribed with Prednisone, Famotidine and Cetirizine

Other Meds:

Current Illness:

ID: 1631289
Sex: F
Age:
State: AL

Vax Date:
Onset Date: 02/04/2021
Rec V Date: 08/25/2021
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: Having a little bit of queasiness; Her lymph node was swollen; cannot move left arm at all - the arm she got her shot in.; Knot in her left arm; excruciating pain in her left arm, so bad she can't even lift her arm; Her left arm was swollen at the site; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Having a little bit of queasiness), VACCINATION SITE LYMPHADENOPATHY (Her lymph node was swollen), VACCINATION SITE MOVEMENT IMPAIRMENT (cannot move left arm at all - the arm she got her shot in.), VACCINATION SITE MASS (Knot in her left arm) and VACCINATION SITE PAIN (excruciating pain in her left arm, so bad she can't even lift her arm) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced NAUSEA (Having a little bit of queasiness), VACCINATION SITE LYMPHADENOPATHY (Her lymph node was swollen), VACCINATION SITE MOVEMENT IMPAIRMENT (cannot move left arm at all - the arm she got her shot in.), VACCINATION SITE MASS (Knot in her left arm), VACCINATION SITE PAIN (excruciating pain in her left arm, so bad she can't even lift her arm) and VACCINATION SITE SWELLING (Her left arm was swollen at the site). At the time of the report, NAUSEA (Having a little bit of queasiness), VACCINATION SITE LYMPHADENOPATHY (Her lymph node was swollen), VACCINATION SITE MOVEMENT IMPAIRMENT (cannot move left arm at all - the arm she got her shot in.), VACCINATION SITE MASS (Knot in her left arm), VACCINATION SITE PAIN (excruciating pain in her left arm, so bad she can't even lift her arm) and VACCINATION SITE SWELLING (Her left arm was swollen at the site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient was taking concomitant medications including medicines for blood pressure and thyroid Treatment details included Tylenol, Asper cream, Heating pad. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1631290
Sex: F
Age:
State: MA

Vax Date: 01/26/2021
Onset Date: 01/27/2021
Rec V Date: 08/25/2021
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: hives at the injection site; fever (100.1?F); This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE URTICARIA (hives at the injection site) and PYREXIA (fever (100.1?F)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). On 26-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced VACCINATION SITE URTICARIA (hives at the injection site) and PYREXIA (fever (100.1?F)). At the time of the report, VACCINATION SITE URTICARIA (hives at the injection site) and PYREXIA (fever (100.1?F)) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1631291
Sex: M
Age: 76
State: FL

Vax Date: 01/15/2021
Onset Date: 01/15/2021
Rec V Date: 08/25/2021
Hospital:

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

Lab Data: Test Date: 20210117; Test Name: covid; Test Result: Positive ; Result Unstructured Data: positive

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: lightheaded; positive COVID test; no appetite; A spontaneous report was received from a consumer concerning a 76-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and tested positive for covid test 2 days later and had lightheadedness and no appetite after few days of vaccination. The patient's medical history was not provided. Concomitant medications included Cimzia, methotrexate. On 15 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 013L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 17 Jan 2021, the patient experienced Covid-19. On 15 Jan 2021, the patient experienced the event no appetite (decreased appetite) and On 22 Jan 2021, the patient experienced lightheadedness (dizziness). On 20 Jan 2021 infusion Bamlanivimab was received as treatment medication. Action taken with mRNA-1273 in response to the events was unknown. The outcome of the reported events Sar CoV -2 positive, dizziness and decreased appetite was unknown.; Reporter's Comments: This case concerns a 76-year-old male who experienced a serious unexpected event of COVID-19 along with NS events of unexpected dizziness and decreased appetite. Event onset occurred on Day 3 after the first dose of mRNA-1273. Treatment included bamlanivimab. Event outcomes unknown. Based on 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: CIMZIA; METHOTREXATE

Current Illness:

ID: 1631292
Sex: F
Age:
State: PA

Vax Date: 01/28/2021
Onset Date: 12/31/2020
Rec V Date: 08/25/2021
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: Malaise; Headache; Nausea; reactions to the vaccine; Vertigo; Balance issue; dizzy sensation; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (reactions to the vaccine), MALAISE (Malaise), VERTIGO (Vertigo), BALANCE DISORDER (Balance issue) and DIZZINESS (dizzy sensation) in a 35-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. No Medical History information was reported. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2020, the patient experienced ADVERSE EVENT (reactions to the vaccine), VERTIGO (Vertigo), BALANCE DISORDER (Balance issue) and DIZZINESS (dizzy sensation). On 28-Jan-2021, the patient experienced MALAISE (Malaise), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, ADVERSE EVENT (reactions to the vaccine) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 27-Jan-2021: No specific follow-up information recorded.

Other Meds:

Current Illness:

ID: 1631293
Sex: F
Age: 80
State:

Vax Date: 01/29/2021
Onset Date: 01/30/2021
Rec V Date: 08/25/2021
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: eyelids were swollen; eyes were all red; felt like sand in the left eye; little bruise on the injection site; numbness on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (little bruise on the injection site), INJECTION SITE HYPOAESTHESIA (numbness on the injection site), OCULAR HYPERAEMIA (eyes were all red), OCULAR DISCOMFORT (felt like sand in the left eye) and SWELLING OF EYELID (eyelids were swollen) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concomitant products included INSULIN INJECTION, LISINOPRIL, PRAVASTATIN and OMEPRAZOLE for an unknown indication. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced VACCINATION SITE BRUISING (little bruise on the injection site) and INJECTION SITE HYPOAESTHESIA (numbness on the injection site). On 02-Feb-2021, the patient experienced OCULAR HYPERAEMIA (eyes were all red) and OCULAR DISCOMFORT (felt like sand in the left eye). On an unknown date, the patient experienced SWELLING OF EYELID (eyelids were swollen). On 03-Feb-2021, VACCINATION SITE BRUISING (little bruise on the injection site), OCULAR HYPERAEMIA (eyes were all red), OCULAR DISCOMFORT (felt like sand in the left eye) and SWELLING OF EYELID (eyelids were swollen) had resolved. At the time of the report, INJECTION SITE HYPOAESTHESIA (numbness on the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds: INSULIN INJECTION; LISINOPRIL; PRAVASTATIN; OMEPRAZOLE

Current Illness:

ID: 1631294
Sex: F
Age: 81
State: CA

Vax Date: 01/16/2021
Onset Date: 01/26/2021
Rec V Date: 08/25/2021
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: rash on arm has faded but is still there; rash on arm is warm at times; red rash on arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (rash on arm is warm at times), VACCINATION SITE ERYTHEMA (red rash on arm) and VACCINATION SITE RASH (rash on arm has faded but is still there) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included AMLODIPINE, CYANOCOBALAMIN, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE (VITAMIN B 1-6-12) and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication. On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, the patient experienced VACCINATION SITE WARMTH (rash on arm is warm at times) and VACCINATION SITE ERYTHEMA (red rash on arm). On 02-Feb-2021, the patient experienced VACCINATION SITE RASH (rash on arm has faded but is still there). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (rash on arm is warm at times), VACCINATION SITE ERYTHEMA (red rash on arm) and VACCINATION SITE RASH (rash on arm has faded but is still there) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The rash on arm had faded but was still there. Treatment included diphenhydramine and ice. Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.

Other Meds: AMLODIPINE; VITAMIN B 1-6-12; VITAMIN D 2000

Current Illness:

ID: 1631295
Sex: F
Age: 84
State:

Vax Date: 01/26/2021
Onset Date: 01/27/2021
Rec V Date: 08/25/2021
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: Fever; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Jan-2021 and was forwarded to Moderna on 28-Jan-2021. This spontaneous case was reported by an other caregiver and describes the occurrence of PYREXIA (Fever) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information includes Tylenol 650 mg. No relevant concomitant medications were reported.

Other Meds:

Current Illness:

ID: 1631296
Sex: F
Age: 40
State: AZ

Vax Date: 01/23/2021
Onset Date: 01/23/2021
Rec V Date: 08/25/2021
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: tachycardia up to 140 resting HR; Blood pressure 180/98; super dizzy; super weak; tingling in hands and feet; hotness in left arm at the injection site; hotness in left shoulder; hotness in left neck; headache; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (tachycardia up to 140 resting HR), BLOOD PRESSURE INCREASED (Blood pressure 180/98), DIZZINESS (super dizzy), ASTHENIA (super weak) and PARAESTHESIA (tingling in hands and feet) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included LISDEXAMFETAMINE MESILATE (VYVANSE) 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 TACHYCARDIA (tachycardia up to 140 resting HR), BLOOD PRESSURE INCREASED (Blood pressure 180/98), DIZZINESS (super dizzy), ASTHENIA (super weak), PARAESTHESIA (tingling in hands and feet), VACCINATION SITE WARMTH (hotness in left arm at the injection site), MUSCULOSKELETAL DISCOMFORT (hotness in left shoulder), MUSCULOSKELETAL DISCOMFORT (hotness in left neck) and HEADACHE (headache). On 23-Jan-2021, TACHYCARDIA (tachycardia up to 140 resting HR) and BLOOD PRESSURE INCREASED (Blood pressure 180/98) had resolved. On 26-Jan-2021, HEADACHE (headache) had resolved. At the time of the report, DIZZINESS (super dizzy), ASTHENIA (super weak), PARAESTHESIA (tingling in hands and feet), VACCINATION SITE WARMTH (hotness in left arm at the injection site), MUSCULOSKELETAL DISCOMFORT (hotness in left shoulder) and MUSCULOSKELETAL DISCOMFORT (hotness in left neck) 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. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: VYVANSE

Current Illness:

ID: 1631297
Sex: F
Age: 74
State: IL

Vax Date: 01/26/2021
Onset Date: 01/29/2021
Rec V Date: 08/25/2021
Hospital:

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

Lab Data: Test Name: INR; Result Unstructured Data: 5.8

Allergies:

Symptom List: Injection site pain

Symptoms: INR 5.8; A spontaneous report was received from a non healthcare professional concerning a 75-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced International normalised ratio increased as 5.8. The patient's medical history was not provided. Concomitant medications reported were Warfarin used for atrial fibrillation. On 26 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: Unknown) intramuscularly for prophylaxis of COVID-19 infection. On 29 Jan 2021, 3 days after vaccination the patient experienced International normalised ratio increased as 5.8. The patient called her health care professional and they took her off warfarin and was taken to the hospital. The hospital read her International normalised ratio to be 5.8 and then held the warfarin for 3 days and now she was back to her normal International normalised ratio. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. On an unknown date the outcome of International normalised ratio increased as 5.8 was recovered.

Other Meds: WARFARIN

Current Illness: Atrial fibrillation

ID: 1631298
Sex: F
Age:
State:

Vax Date: 01/15/2021
Onset Date: 01/01/2021
Rec V Date: 08/25/2021
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: Large red plaque on arm; Not able to lift arm; Severe pain shooting from ear and neck to pinky finger; Arm a rash, 6 inch circle; Fever; Lethargy; Pain localized to arm; Severe Diarrhea; Nausea; This spontaneous case was reported by a physician and describes the occurrence of LETHARGY (Lethargy), DIARRHOEA (Severe Diarrhea), PAIN (Pain localized to arm), ERYTHEMA (Large red plaque on arm) and INJECTED LIMB MOBILITY DECREASED (Not able to lift arm) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 007M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-Jan-2021, the patient experienced LETHARGY (Lethargy), PAIN (Pain localized to arm) and PYREXIA (Fever). In January 2021, the patient experienced DIARRHOEA (Severe Diarrhea) and NAUSEA (Nausea). On 23-Jan-2021, the patient experienced ERYTHEMA (Large red plaque on arm), INJECTED LIMB MOBILITY DECREASED (Not able to lift arm), PAIN IN EXTREMITY (Severe pain shooting from ear and neck to pinky finger) and RASH (Arm a rash, 6 inch circle). The patient was treated with IBUPROFEN at an unspecified dose and frequency. In January 2021, LETHARGY (Lethargy), PAIN (Pain localized to arm), ERYTHEMA (Large red plaque on arm), PAIN IN EXTREMITY (Severe pain shooting from ear and neck to pinky finger) and PYREXIA (Fever) had resolved. At the time of the report, DIARRHOEA (Severe Diarrhea), INJECTED LIMB MOBILITY DECREASED (Not able to lift arm), RASH (Arm a rash, 6 inch circle) and NAUSEA (Nausea) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product information was not provided. Treatment information includes ice and heat. Most recent FOLLOW-UP information incorporated above includes: On 08-Apr-2021: No specific follow-up information recorded.

Other Meds:

Current Illness:

ID: 1631299
Sex: M
Age:
State: CA

Vax Date: 02/02/2021
Onset Date: 02/02/2021
Rec V Date: 08/25/2021
Hospital:

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

Lab Data: Test Name: Fast heart rate; Test Result: Inconclusive ; Result Unstructured Data: 80bpm; Test Name: resting heart rate; Test Result: Inconclusive ; Result Unstructured Data: 50bpm

Allergies:

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

Symptoms: dizziness; difficulty of breathing; fast heart rate 80bpm; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizziness), DYSPNOEA (difficulty of breathing) and HEART RATE INCREASED (fast heart rate 80bpm) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. No Medical History information was reported. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced DIZZINESS (dizziness), DYSPNOEA (difficulty of breathing) and HEART RATE INCREASED (fast heart rate 80bpm). At the time of the report, DIZZINESS (dizziness), DYSPNOEA (difficulty of breathing) and HEART RATE INCREASED (fast heart rate 80bpm) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: (Inconclusive) 80bpm and (Inconclusive) 50bpm. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient Experienced dizziness, difficulty of breathing and fast heart rate:80bpm. According to the patient his resting heart rate is only 50bpm.

Other Meds:

Current Illness:

ID: 1631300
Sex: F
Age: 70
State: NY

Vax Date: 02/10/2021
Onset Date: 02/22/2021
Rec V Date: 08/25/2021
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: Can not move the arm; Itchy arm; Red arm; Swollen arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Can not move the arm), VACCINATION SITE PRURITUS (Itchy arm), VACCINATION SITE ERYTHEMA (Red arm) and VACCINATION SITE SWELLING (Swollen arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for COVID-19 vaccination. No Medical History information was reported. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Feb-2021, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Can not move the arm), VACCINATION SITE PRURITUS (Itchy arm), VACCINATION SITE ERYTHEMA (Red arm) and VACCINATION SITE SWELLING (Swollen arm). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Can not move the arm), VACCINATION SITE PRURITUS (Itchy arm), VACCINATION SITE ERYTHEMA (Red arm) and VACCINATION SITE SWELLING (Swollen arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1631301
Sex: U
Age:
State: TN

Vax Date:
Onset Date:
Rec V Date: 08/25/2021
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: Platelet count of zero; This spontaneous case was reported by a physician and describes the occurrence of PLATELET COUNT DECREASED (Platelet count of zero) in an 82-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PLATELET COUNT DECREASED (Platelet count of zero). At the time of the report, PLATELET COUNT DECREASED (Platelet count of zero) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine), the reporter did not provide any causality assessments. Treatment and concomitant medications were not provided.

Other Meds:

Current Illness:

ID: 1631302
Sex: F
Age: 83
State: FL

Vax Date: 02/16/2021
Onset Date: 02/16/2021
Rec V Date: 08/25/2021
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: cant lift arm past 45 degrees; arm sore/pain in left arm at the injection site; A spontaneous report (United States) was received from a healthcare professional concerning a 83-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm sore/vaccination site pain, cant lift arm past 45 degrees/muscular weakness. The patient's medical history included a mastectomy ten years ago. No relevant concomitant medications were reported. On an unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route for prophylaxis of COVID-19 infection. On 16 Feb 2021, prior to the onset of the events the patient received second of two planned doses of mRNA-1273 (lot/batch: unknown) via unknown route in the left arm for prophylaxis of COVID-19 infection. On 16 Feb 2021, the patient experienced the events, arm sore, cant lift arm past 45 degrees. The patient could take other hand and use it to assist in order to raise left arm, but cannot lift higher than 45 degrees without assistance Treatment details included Tylenol. The patient received both the doses of mRNA-1273 prior to the events, therefore action taken against the drug in response to the events was not applicable. The outcome of events, arm sore, cant lift arm past 45 degrees was unknown.

Other Meds:

Current Illness:

ID: 1631303
Sex: F
Age:
State: NJ

Vax Date: 01/28/2021
Onset Date: 01/28/2021
Rec V Date: 08/25/2021
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: shortness of breath; sore arm; fatigue; joint pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (sore arm), FATIGUE (fatigue), ARTHRALGIA (joint pain) and DYSPNOEA (shortness of breath) 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 Pneumonia and Asthma. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 1. On 28-Jan-2021, the patient experienced PAIN (sore arm), FATIGUE (fatigue) and ARTHRALGIA (joint pain). On 29-Jan-2021, the patient experienced DYSPNOEA (shortness of breath). At the time of the report, PAIN (sore arm), FATIGUE (fatigue), ARTHRALGIA (joint pain) and DYSPNOEA (shortness of breath) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Most recent FOLLOW-UP information incorporated above includes: On 29-Jan-2021: No specific follow-up information recorded.

Other Meds:

Current Illness:

ID: 1631304
Sex: F
Age: 79
State: AL

Vax Date: 01/20/2021
Onset Date: 01/20/2021
Rec V Date: 08/25/2021
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: Burning; itching; fever; soreness at site of injection; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning), PRURITUS (itching), PYREXIA (fever) and INJECTION SITE PAIN (soreness at site of injection) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for an unknown indication. No Medical History information was reported. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 20-Jan-2021, the patient experienced BURNING SENSATION (Burning), PRURITUS (itching), PYREXIA (fever) and INJECTION SITE PAIN (soreness at site of injection). At the time of the report, BURNING SENSATION (Burning), PRURITUS (itching), PYREXIA (fever) and INJECTION SITE PAIN (soreness at site of injection) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1631305
Sex: F
Age:
State: NY

Vax Date: 01/05/2021
Onset Date:
Rec V Date: 08/25/2021
Hospital:

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

Lab Data: Test Name: Covid-19; Test Result: Positive ; Result Unstructured Data: date - unknown

Allergies:

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

Symptoms: Cold; Covid-19; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of NASOPHARYNGITIS (Cold) and COVID-19 (Covid-19) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. not provided) 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (Cold) and COVID-19 (Covid-19). At the time of the report, NASOPHARYNGITIS (Cold) and COVID-19 (Covid-19) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: positive date - unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.

Other Meds:

Current Illness:

ID: 1631306
Sex: F
Age:
State: PA

Vax Date: 02/12/2021
Onset Date: 02/13/2021
Rec V Date: 08/25/2021
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: Red circle around the injection site; Painful at injection site; Itchy at injection site; Rash in the neck, face and chest; CHILLS; arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (arm soreness), VACCINATION SITE PAIN (Painful at injection site), VACCINATION SITE PRURITUS (Itchy at injection site), RASH (Rash in the neck, face and chest) and CHILLS (CHILLS) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced VACCINATION SITE PAIN (arm soreness). On 22-Feb-2021, the patient experienced VACCINATION SITE PAIN (Painful at injection site), VACCINATION SITE PRURITUS (Itchy at injection site), RASH (Rash in the neck, face and chest) and CHILLS (CHILLS). On 23-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Red circle around the injection site). On 14-Feb-2021, VACCINATION SITE PAIN (arm soreness) had resolved. At the time of the report, VACCINATION SITE PAIN (Painful at injection site), VACCINATION SITE PRURITUS (Itchy at injection site) and VACCINATION SITE ERYTHEMA (Red circle around the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.

Other Meds:

Current Illness:

ID: 1631307
Sex: U
Age:
State: CT

Vax Date: 02/16/2021
Onset Date: 02/17/2021
Rec V Date: 08/25/2021
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: itching/burning from neck down to chest; rash is not red or bumpy; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching/burning from neck down to chest) and RASH (rash is not red or bumpy) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. Co-suspect products included non-company products DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL N) for an unknown indication and CORTISONE for an unknown indication. The patient's past medical history included No adverse event. On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient started DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL N) (unknown route) at an unspecified dose and CORTISONE (unknown route) at an unspecified dose. On 17-Feb-2021, the patient experienced PRURITUS (itching/burning from neck down to chest) and RASH (rash is not red or bumpy). At the time of the report, PRURITUS (itching/burning from neck down to chest) and RASH (rash is not red or bumpy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.

Other Meds:

Current Illness:

ID: 1631308
Sex: F
Age:
State:

Vax Date: 01/15/2021
Onset Date:
Rec V Date: 08/25/2021
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: swelling around collar bone that may or may not be due to vaccine; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BONE SWELLING (swelling around collar bone that may or may not be due to vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. No Medical History information was reported. On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced BONE SWELLING (swelling around collar bone that may or may not be due to vaccine). At the time of the report, BONE SWELLING (swelling around collar bone that may or may not be due to vaccine) had resolved.

Other Meds:

Current Illness:

ID: 1631309
Sex: F
Age:
State: MD

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 08/25/2021
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: Swollen arm Near the Injection Site; Sore Arm Near the Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swollen arm Near the Injection Site) and VACCINATION SITE PAIN (Sore Arm Near the Injection Site) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Diabetes. Concomitant products included INSULIN for Diabetes mellitus. 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 VACCINATION SITE SWELLING (Swollen arm Near the Injection Site) and VACCINATION SITE PAIN (Sore Arm Near the Injection Site). On 25-Jan-2021, VACCINATION SITE SWELLING (Swollen arm Near the Injection Site) and VACCINATION SITE PAIN (Sore Arm Near the Injection Site) had resolved. Treatment medication included Tylenol. This case was linked to US-MODERNATX, INC.-MOD-2021-020539 (Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-020539:Same patient, 2nd dose

Other Meds: INSULIN

Current Illness: Diabetes

ID: 1631310
Sex: F
Age:
State: IN

Vax Date: 12/30/2020
Onset Date: 01/02/2021
Rec V Date: 08/25/2021
Hospital:

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

Lab Data: Test Date: 20210102; Test Name: COVID-19; Test Result: Positive ; Result Unstructured Data: COVID positive

Allergies:

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

Symptoms: Tested Covid-19 positive; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of COVID-19 (Tested Covid-19 positive) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No medical history reported.). On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Jan-2021, the patient experienced COVID-19 (Tested Covid-19 positive). At the time of the report, COVID-19 (Tested Covid-19 positive) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Jan-2021, COVID-19: positive (Positive) COVID positive. 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. No relevant concomitant medications were reported. Treatment for the events was unknown.

Other Meds:

Current Illness:

ID: 1631311
Sex: F
Age: 83
State: FL

Vax Date: 02/08/2021
Onset Date: 02/16/2021
Rec V Date: 08/25/2021
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: Cold; Congestion; Bad Cough; Body Aches; Headache; Joint Pain; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (Cold), NASAL CONGESTION (Congestion), COUGH (Bad Cough), PAIN (Body Aches) and HEADACHE (Headache) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced NASOPHARYNGITIS (Cold), NASAL CONGESTION (Congestion), COUGH (Bad Cough), PAIN (Body Aches), HEADACHE (Headache), ARTHRALGIA (Joint Pain) and FATIGUE (Fatigue). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and CHLORPHENAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PARACETAMOL, PSEUDOEPHEDRINE HYDROCHLORIDE (ROBITUSSIN TOTAL COUGH, COLD & FLU EXTR.STR.N) at an unspecified dose and frequency. At the time of the report, NASOPHARYNGITIS (Cold), NASAL CONGESTION (Congestion), COUGH (Bad Cough), PAIN (Body Aches), HEADACHE (Headache), ARTHRALGIA (Joint Pain) and FATIGUE (Fatigue) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1631312
Sex: F
Age:
State:

Vax Date: 01/19/2021
Onset Date:
Rec V Date: 08/25/2021
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: rash or hives on my left arm where I had my shot; rash or hives on my left arm where I had my shot; This spontaneous case was reported by a patient and describes the occurrence of INJECTION SITE URTICARIA (rash or hives on my left arm where I had my shot) and INJECTION SITE RASH (rash or hives on my left arm where I had my shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE URTICARIA (rash or hives on my left arm where I had my shot) and INJECTION SITE RASH (rash or hives on my left arm where I had my shot). At the time of the report, INJECTION SITE URTICARIA (rash or hives on my left arm where I had my shot) and INJECTION SITE RASH (rash or hives on my left arm where I had my shot) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. Treatment information was not provided. Company comment: 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.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1631313
Sex: M
Age: 61
State: OH

Vax Date: 01/05/2021
Onset Date:
Rec V Date: 08/25/2021
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: Test Date: 20210115; Test Name: SARS-COV-2 test; Test Result: Positive ; Result Unstructured Data: positive

Allergies:

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

Symptoms: tested positive for COVID-19; A spontaneous report was received from a health care provider concerning a 61 year old, male patient who developed COVID-19. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 05-JAN-2021, approximately 7 days prior to the onset of the symptoms, the patient received their first of two planned doses of mRNA-1273 (Batch number: 039K20A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection. On 13-JAN-2021, the patient started showing symptoms of COVID-19 after being exposed on the weekend of 09-10-JAN-2021. On 15-JAN-2021, the patient tested positive for COVID-19. The patient is still symptomatic and has a second dose scheduled for 02-FEB-2021. Treatment information was not provided. Action taken with mRNA-1273 in response to the event(s) was not provided/unknown. The event(s), COVID-19, was considered recovering/resolving. Follow up: Follow-up received on 28-JAN-2021 included HCP was given the 1st dose of the vaccine on 05Jan2021 (with 2nd dose scheduled on 02Feb2021) at a health care facility. He had it on his R deltoid. He was exposed to a Covid-19 positive case the weekend of 19-10Jan2021. He started to develop symptoms of Covid-19 on 13Jan2021 and tested positive on 15Jan2021. He is still currently symptomatic. Consent to follow up obtained.

Other Meds:

Current Illness: COVID-19 (symptoms still ongoing)

ID: 1631314
Sex: F
Age: 31
State:

Vax Date: 12/29/2020
Onset Date: 12/29/2020
Rec V Date: 08/25/2021
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: Test Date: 20201016; Test Name: Pregnancy test; Test Result: Positive ; Result Unstructured Data: Positive

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: Had arm pain when got vaccine; Pregnancy; This spontaneous prospective pregnancy case was reported by a physician (subsequently medically confirmed) and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnancy) and VACCINATION SITE PAIN (Had arm pain when got vaccine) in a 31-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025J202A and 029L20A) for COVID-19 vaccination. Concurrent medical conditions included Allergy NOS. Concomitant products included LORATADINE for Allergy, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication. On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-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 20-Sep-2020 and the estimated date of delivery was 27-Jun-2021. On 29-Dec-2020, the patient experienced EXPOSURE DURING PREGNANCY (Pregnancy). On an unknown date, the patient experienced VACCINATION SITE PAIN (Had arm pain when got vaccine). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the fourteenth week of the pregnancy. On 26-Jan-2021, EXPOSURE DURING PREGNANCY (Pregnancy) had resolved. At the time of the report, VACCINATION SITE PAIN (Had arm pain when got vaccine) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Oct-2020, Pregnancy test: positive (Positive) Positive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. This case concerns a 31 year-old, female patient, who is pregnant and experienced an event of exposure during pregnancy after receiving her second dose of mRNA-1273 vaccine 3 months after she had a positive pregnancy test. Also, she experienced an event of arm pain (vaccination site pain). 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. Further information has been requested.; Sender's Comments: This case concerns a 31 year-old, female patient, who is pregnant and experienced an event of exposure during pregnancy after receiving her second dose of mRNA-1273 vaccine 3 months after she had a positive pregnancy test. Also, she experienced an event of arm pain (vaccination site pain). 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. Further information has been requested.

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

Current Illness: Allergy NOS

ID: 1631315
Sex: F
Age: 93
State: NY

Vax Date: 01/14/2021
Onset Date: 01/14/2021
Rec V Date: 08/25/2021
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: red circle; itchy; heavy; stiff; warm; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (heavy), MUSCULOSKELETAL STIFFNESS (stiff), INJECTION SITE WARMTH (warm), ERYTHEMA (red circle) and PRURITUS (itchy) in a 93-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. Concomitant products included METOPROLOL, ROSUVASTATIN and ACETYLSALICYLIC ACID (BABY ASPIRIN) 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 LIMB DISCOMFORT (heavy), MUSCULOSKELETAL STIFFNESS (stiff) and INJECTION SITE WARMTH (warm). On 25-Jan-2021, the patient experienced ERYTHEMA (red circle) and PRURITUS (itchy). At the time of the report, LIMB DISCOMFORT (heavy), MUSCULOSKELETAL STIFFNESS (stiff), INJECTION SITE WARMTH (warm), ERYTHEMA (red circle) and PRURITUS (itchy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. Treatment details included Advil. Reporter did not allow further contact

Other Meds: METOPROLOL; ROSUVASTATIN; BABY ASPIRIN

Current Illness:

ID: 1631316
Sex: F
Age: 28
State: TX

Vax Date: 01/29/2021
Onset Date:
Rec V Date: 08/25/2021
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: arm pain; arm itchy/itchy is getting bigger and getting worse; really bad, like a welts; poilus skin; really hurt at the injection site; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (arm pain), PRURITUS (arm itchy/itchy is getting bigger and getting worse), URTICARIA (really bad, like a welts), PRURITUS (poilus skin) and VACCINATION SITE PAIN (really hurt at the injection site) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. No Medical History information was reported. On 29-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 PAIN IN EXTREMITY (arm pain), PRURITUS (arm itchy/itchy is getting bigger and getting worse), URTICARIA (really bad, like a welts), PRURITUS (poilus skin) and VACCINATION SITE PAIN (really hurt at the injection site). At the time of the report, PAIN IN EXTREMITY (arm pain), PRURITUS (arm itchy/itchy is getting bigger and getting worse), URTICARIA (really bad, like a welts), PRURITUS (poilus skin) and VACCINATION SITE PAIN (really hurt at the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am