VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
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: 1638973
Sex: M
Age: 60
State: GA

Vax Date: 01/20/2021
Onset Date: 01/21/2021
Rec V Date: 08/27/2021
Hospital:

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

Lab Data: Test Date: 20210121; Test Name: TEMPERATURE; Result Unstructured Data: 100.7

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: Temperature of 100.7; chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Temperature of 100.7) and CHILLS (chills) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. No Medical History information was reported. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced PYREXIA (Temperature of 100.7) and CHILLS (chills). At the time of the report, PYREXIA (Temperature of 100.7) and CHILLS (chills) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jan-2021, Body temperature increased: 100.7 Unit not specified. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications provided. Patient took two ibuprofen for his symptoms.

Other Meds:

Current Illness:

ID: 1638974
Sex: F
Age: 75
State:

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

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: Felt warm; Tender; Red Blotches from site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Felt warm), VACCINATION SITE PAIN (Tender) and VACCINATION SITE ERYTHEMA (Red Blotches from site) in a 75-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 at 1:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Felt warm), VACCINATION SITE PAIN (Tender) and VACCINATION SITE ERYTHEMA (Red Blotches from site). At the time of the report, VACCINATION SITE WARMTH (Felt warm), VACCINATION SITE PAIN (Tender) and VACCINATION SITE ERYTHEMA (Red Blotches from site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information not provided.

Other Meds:

Current Illness:

ID: 1638975
Sex: F
Age:
State: FL

Vax Date: 01/12/2021
Onset Date: 01/12/2021
Rec V Date: 08/27/2021
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: arm is red; arm was hot; "but itches like a bug bite."; hardness at the injection site; area has some dots and looks rashy; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm), VACCINATION SITE ERYTHEMA (arm is red), VACCINATION SITE WARMTH (arm was hot), VACCINATION SITE PRURITUS ("but itches like a bug bite.") and VACCINATION SITE INDURATION (hardness at the injection site) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 12-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced VACCINATION SITE PAIN (sore arm). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (arm is red), VACCINATION SITE WARMTH (arm was hot), VACCINATION SITE PRURITUS ("but itches like a bug bite."), VACCINATION SITE INDURATION (hardness at the injection site) and VACCINATION SITE RASH (area has some dots and looks rashy). On 12-Jan-2021, VACCINATION SITE PAIN (sore arm) had not resolved. At the time of the report, VACCINATION SITE ERYTHEMA (arm is red), VACCINATION SITE WARMTH (arm was hot), VACCINATION SITE PRURITUS ("but itches like a bug bite."), VACCINATION SITE INDURATION (hardness at the injection site) and VACCINATION SITE RASH (area has some dots and looks rashy) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.

Other Meds:

Current Illness:

ID: 1638976
Sex: F
Age: 81
State: FL

Vax Date: 01/11/2021
Onset Date: 01/11/2021
Rec V Date: 08/27/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: injection site started itching; arm has been reddish; sore arm; Swollen; A spontaneous report was received from a (Reporter like HCP) concerning a ?81 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events (PT term) list. The patient's medical history was not provided. No relevant concomitant medications were reported. On 11/Jan/2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 039K20A ) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 11/Jan/2021 , The patient experienced the events list (verbatims) Call was transferred from Moderna Customer Care (case #00032052) Caller received 1st dose of the Moderna COVID-19 vaccine on 11JAN2021. She received the shot on her non-dominant (left) arm. Her arm has been reddish, sore, and swollen since she received the vaccine. 2-3 days ago, around 19JAN2021, the injection site started itching and has been extremely itchy since then. None of the reactions have subsided or gotten better. She has been putting ice packs on it and that seems to help with the itching. Consent given for Safety follow-up with patient. Consent given for Safety follow-up with HCP. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. On 11/Jan/2021 date, the outcome of the event(s) was, not resolved

Other Meds: Flonase Allergy Relief; Atorvastatin; Citalopram; Calcium Citrate + D; Centrum A To Zinc; Tramadol; Probiotics NOS; Pantoprazole

Current Illness:

ID: 1638977
Sex: U
Age:
State:

Vax Date: 12/28/2020
Onset Date: 01/08/2021
Rec V Date: 08/27/2021
Hospital:

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

Lab Data: Test Date: 20210108; Test Name: Covid PCR; Result Unstructured Data: Positive; Comments: Positive

Allergies:

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

Symptoms: Covid positive; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid positive) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced COVID-19 (Covid positive). At the time of the report, COVID-19 (Covid positive) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Jan-2021, SARS-CoV-2 test: positive Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1638978
Sex: F
Age:
State:

Vax Date: 02/10/2021
Onset Date:
Rec V Date: 08/27/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: arm pain; cellulitis; A spontaneous report was received from a consumer concerning a female patient of unknown age who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced arm pain and injection site cellulitis. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) for prophylaxis of COVID-19 infection. On Feb-10-2021, after the onset of the events, the patient received their second of two planned doses of mRNA-1273 (lot/batch: 012M20A) for prophylaxis of COVID-19 infection. On 05-Feb-2021, the patient experienced arm pain and injection site cellulitis. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. At the time of this report, the outcome of the event (injection site cellulitis) was resolved. The outcome of the event (arm pain) was unknown. Follow-up received on 11-Feb-2021 included information regarding the second dose of the vaccine and the recovery of the injection site cellulitis.

Other Meds:

Current Illness:

ID: 1638979
Sex: F
Age: 50
State: TX

Vax Date: 01/22/2021
Onset Date: 01/07/2021
Rec V Date: 08/27/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: tested positive on january 15th; sore throat; runny nose; body aches; felt like winded; A spontaneous report was received from a Consumer concerning a 50 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and tested positive with covid 19,the symptoms were sore throat and a runny nose, felt like winded, and also body ache. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date , prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (batch:037K20A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection. On 15 Jan 2021, The patient tested positive with covid 19,the symptoms were sore throat and a runny nose but a week before testing positive the caller reported that felt like winded, it wasn't bad. The sore throat and also body aches appeared when the patient took the test Treatment details are not provided. The second dose of the Moderna COVID 19 Vaccine on January 22nd.Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event(s) tested positive with covid 19,the symptoms were sore throat and a runny nose, felt like winded, and also body ache, was unknown.

Other Meds:

Current Illness:

ID: 1638980
Sex: M
Age:
State:

Vax Date: 01/29/2021
Onset Date:
Rec V Date: 08/27/2021
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: sore arm; A spontaneous report (United States) was received from a Reporter concerning about male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events (PT term) list. The patient's medical history was not provided. No relevant concomitant medications were reported. Patient reported sore arm upon injection No treatment details was provided Action taken with mRNA-1273 in response to the events was not reported.

Other Meds:

Current Illness:

ID: 1638981
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/27/2021
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: Injection site hives; A spontaneous report was received from a Consumer concerning a male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced injection site urticaria. The patient's medical history was not provided. No relevant concomitant medications were reported. On an unknown date, prior to the onset of the events, the patient received their planned dose of mRNA-1273 for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced an allergic reaction kind of hive-like around the injection site. No laboratory details provided. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. At the time of this report, the outcome of the event is not recovered/ resolved.

Other Meds:

Current Illness:

ID: 1638982
Sex: M
Age: 71
State: PA

Vax Date: 02/04/2021
Onset Date: 02/04/2021
Rec V Date: 08/27/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Red; Soreness; A spontaneous report was received from a HCP concerning a 71 years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccination site pain and vaccination site erythema. The patient's medical history was not provided. Relevant concomitant medication was provided as Irbesartan, Pantoprazole, Tamsulosin and Doxycycline. On 04-FEB-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 030L20A) intramuscularly in the Anatomical location which is unknown for prophylaxis of COVID-19 infection. On 04-FEB-2021, The patient experienced the events vaccination site pain and vaccination site erythema. No Lab details provided. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. Recovering, ongoing, not resolved or unknown outcomes: At the time of this report, the outcome of the event(s) (vaccination site pain and vaccination site erythema.) was recovering. The reporter assessed the event(s), [vaccination site pain and vaccination site erythema], as related to study drug.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-011917:Reporter case

Other Meds: IRBESARTAN; PANTOPRAZOLE; TAMSULOSIN; DOXYCYCLINE

Current Illness:

ID: 1638983
Sex: M
Age: 45
State: TX

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 08/27/2021
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: not feeling well; Chill; Fever; Injection site pain; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (not feeling well), CHILLS (Chill), PYREXIA (Fever) and INJECTION SITE PAIN (Injection site pain) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 immunisation. No Medical History information was reported. On 21-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced VACCINATION COMPLICATION (not feeling well), CHILLS (Chill), PYREXIA (Fever) and INJECTION SITE PAIN (Injection site pain). At the time of the report, VACCINATION COMPLICATION (not feeling well), CHILLS (Chill), PYREXIA (Fever) and INJECTION SITE PAIN (Injection site pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant information provided. Treatment included Tylenol and Ibuprofen

Other Meds:

Current Illness:

ID: 1638984
Sex: F
Age:
State: NY

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 08/27/2021
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: Injection site redness; Injection site swollen; Injection site extremely itchy; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Injection site redness), VACCINATION SITE SWELLING (Injection site swollen) and VACCINATION SITE PRURITUS (Injection site extremely itchy) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012620A) for COVID-19 vaccination. No medical history was provided by the reporter. 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 ERYTHEMA (Injection site redness), VACCINATION SITE SWELLING (Injection site swollen) and VACCINATION SITE PRURITUS (Injection site extremely itchy). At the time of the report, VACCINATION SITE ERYTHEMA (Injection site redness), VACCINATION SITE SWELLING (Injection site swollen) and VACCINATION SITE PRURITUS (Injection site extremely itchy) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided. No treatment information provided.

Other Meds:

Current Illness:

ID: 1638985
Sex: M
Age: 68
State: FL

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 08/27/2021
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: muscle tightness in my shoulder up to my neck; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TIGHTNESS (muscle tightness in my shoulder up to my neck) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (no medical history). On 21-Jan-2021 at 11:40 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021 at 12:00 PM, the patient experienced MUSCLE TIGHTNESS (muscle tightness in my shoulder up to my neck). At the time of the report, MUSCLE TIGHTNESS (muscle tightness in my shoulder up to my neck) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. No treatment information was provided. This case was linked to cross link MOD21-11080 (Patient Link).

Other Meds:

Current Illness:

ID: 1638986
Sex: F
Age: 72
State: CA

Vax Date: 01/21/2021
Onset Date: 01/22/2021
Rec V Date: 08/27/2021
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: Diarrhea; glucose also shot up to 208 without eating; light headedness; Cheeks are pink; feeling little abnormal not better than last night; small rash on her injection site; This spontaneous case was reported by a patient and describes the occurrence of DIARRHOEA (Diarrhea), BLOOD GLUCOSE INCREASED (glucose also shot up to 208 without eating), DIZZINESS (light headedness), SKIN DISCOLOURATION (Cheeks are pink) and FEELING ABNORMAL (feeling little abnormal not better than last night) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Heart failure (Due to blockage) in August 2019, Corona virus infection (UK H1 Coronavirus) in March 2018, Pneumonia (she was on oxygen therapy in ICU and took months to recover, almost died.) in March 2018 and Oxygen therapy in March 2018. Concurrent medical conditions included Diabetes, Asthma, Heart disorder (Heart condition, heart damage due to COVID), Myelomalacia and UTI (she is takin Augmentin for her UTI from last 9 days). On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced DIARRHOEA (Diarrhea), BLOOD GLUCOSE INCREASED (glucose also shot up to 208 without eating), DIZZINESS (light headedness), SKIN DISCOLOURATION (Cheeks are pink), FEELING ABNORMAL (feeling little abnormal not better than last night) and VACCINATION SITE RASH (small rash on her injection site). At the time of the report, DIARRHOEA (Diarrhea), BLOOD GLUCOSE INCREASED (glucose also shot up to 208 without eating), DIZZINESS (light headedness), SKIN DISCOLOURATION (Cheeks are pink), FEELING ABNORMAL (feeling little abnormal not better than last night) and VACCINATION SITE RASH (small rash on her 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. Patient takes Blood thinner 3 mg daily concomitantly, and is on Augmentin for her Urinary tract infection for last 9 days, but according to patient she did not have diarrhea with Augmentin. No treatment medications were reported.

Other Meds:

Current Illness: Asthma; Diabetes; Heart disorder (Heart condition, heart damage due to COVID); UTI (she is takin Augmentin for her UTI from last 9 days)

ID: 1638987
Sex: F
Age:
State: NY

Vax Date: 01/13/2021
Onset Date: 01/22/2021
Rec V Date: 08/27/2021
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: itchy rash at the injection site 3 inches in diameter; itchy rash at the injection site 3 inches in diameter; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (itchy rash at the injection site 3 inches in diameter) and VACCINATION SITE PRURITUS (itchy rash at the injection site 3 inches in diameter) 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. On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE RASH (itchy rash at the injection site 3 inches in diameter) and VACCINATION SITE PRURITUS (itchy rash at the injection site 3 inches in diameter). At the time of the report, VACCINATION SITE RASH (itchy rash at the injection site 3 inches in diameter) and VACCINATION SITE PRURITUS (itchy rash at the injection site 3 inches in diameter) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided. No treatment details were reported. This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 23-Jan-2021 and was forwarded to Moderna on 24-Jan-2021. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (itchy rash at the injection site 3 inches in diameter) and VACCINATION SITE PRURITUS (itchy rash at the injection site 3 inches in diameter) 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. On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jan-2021, the patient experienced VACCINATION SITE RASH (itchy rash at the injection site 3 inches in diameter) and VACCINATION SITE PRURITUS (itchy rash at the injection site 3 inches in diameter). At the time of the report, VACCINATION SITE RASH (itchy rash at the injection site 3 inches in diameter) and VACCINATION SITE PRURITUS (itchy rash at the injection site 3 inches in diameter) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided. No treatment details were reported.

Other Meds:

Current Illness:

ID: 1638988
Sex: F
Age: 54
State: FL

Vax Date: 01/13/2021
Onset Date: 01/13/2021
Rec V Date: 08/27/2021
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: felt like when I had the flu; Dark urine/Red urine; Tired; Fever; headache; right lymphedema arm also swelled up; arm pain.; delirious; Kidney pains; wheezy; hot and cold feeling; This spontaneous case was reported by a consumer and describes the occurrence of DELIRIUM (delirious) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Breast cancer and Lymphedema. Concurrent medical conditions included COPD and Immunocompromised. Concomitant products included ALBUTEROL [SALBUTAMOL], BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT), TAMOXIFEN, OXYCODONE HYDROCHLORIDE, PARACETAMOL (PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]) and ALPRAZOLAM (XANAX) for an unknown indication. On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jan-2021, the patient experienced DELIRIUM (delirious) (seriousness criterion medically significant), RENAL PAIN (Kidney pains), WHEEZING (wheezy), FEELING OF BODY TEMPERATURE CHANGE (hot and cold feeling), CHROMATURIA (Dark urine/Red urine), FATIGUE (Tired), PYREXIA (Fever), HEADACHE (headache), LYMPHADENOPATHY (right lymphedema arm also swelled up) and VACCINATION SITE PAIN (arm pain.). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (felt like when I had the flu). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form. At the time of the report, DELIRIUM (delirious), RENAL PAIN (Kidney pains), WHEEZING (wheezy), FEELING OF BODY TEMPERATURE CHANGE (hot and cold feeling), INFLUENZA LIKE ILLNESS (felt like when I had the flu), FATIGUE (Tired), PYREXIA (Fever), HEADACHE (headache), LYMPHADENOPATHY (right lymphedema arm also swelled up) and VACCINATION SITE PAIN (arm pain.) outcome was unknown and CHROMATURIA (Dark urine/Red urine) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Company Comment: 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. Most recent FOLLOW-UP information incorporated above includes: On 19-Aug-2021: Significant follow up received by safety 19-Aug-2021 includes added concomitant medications, treatment medications, added new events, outcome of event red urine changed from unknown to recovered.; 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: ALBUTEROL [SALBUTAMOL]; SYMBICORT; TAMOXIFEN; PERCOCET [OXYCODONE HYDROCHLORIDE;PARACETAMOL]; XANAX

Current Illness: COPD; Immunocompromised

ID: 1638989
Sex: F
Age: 30
State: PA

Vax Date: 02/12/2021
Onset Date: 02/12/2021
Rec V Date: 08/27/2021
Hospital:

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

Lab Data: Test Date: 20210926; Test Name: Pregnancy test; Test Result: Positive ; Result Unstructured Data: Positive; Test Name: Ultrasound; Result Unstructured Data: normal

Allergies:

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

Symptoms: Pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. No Medical History information was reported. On 12-Feb-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 01-Jun-2021. On 12-Feb-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnant). On 12-Feb-2021, MATERNAL EXPOSURE DURING PREGNANCY (Pregnant) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 26-Sep-2021, Pregnancy test: positive (Positive) Positive. On an unknown date, Ultrasound scan: normal (normal) normal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant products were not provided. No treatment information was reported.

Other Meds:

Current Illness:

ID: 1638990
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/27/2021
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: Fatigue; Headache; Diarrhoea; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue), HEADACHE (Headache) and DIARRHOEA (Diarrhoea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FATIGUE (Fatigue), HEADACHE (Headache) and DIARRHOEA (Diarrhoea). At the time of the report, FATIGUE (Fatigue), HEADACHE (Headache) and DIARRHOEA (Diarrhoea) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.

Other Meds:

Current Illness:

ID: 1638991
Sex: F
Age: 46
State: MA

Vax Date: 12/28/2020
Onset Date: 12/28/2020
Rec V Date: 08/27/2021
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: Nerve sensation (finger, nose, toes); chills; pain at injection site (L); headache; fatigue; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of DISCOMFORT (Nerve sensation (finger, nose, toes)), HEADACHE (headache), FATIGUE (fatigue), CHILLS (chills) and VACCINATION SITE PAIN (pain at injection site (L)) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. No Medical History information was reported. On 28-Dec-2020, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Dec-2020, the patient experienced HEADACHE (headache), FATIGUE (fatigue) and VACCINATION SITE PAIN (pain at injection site (L)). On 29-Dec-2020, the patient experienced CHILLS (chills). On 11-Jan-2021, the patient experienced DISCOMFORT (Nerve sensation (finger, nose, toes)). On 01-Jan-2021, CHILLS (chills) had resolved. On 06-Jan-2021, HEADACHE (headache) and FATIGUE (fatigue) had resolved. On 07-Jan-2021, VACCINATION SITE PAIN (pain at injection site (L)) had resolved. On 21-Jan-2021, DISCOMFORT (Nerve sensation (finger, nose, toes)) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided No treatment information provided Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1638992
Sex: F
Age: 72
State: CA

Vax Date: 01/22/2021
Onset Date: 01/22/2021
Rec V Date: 08/27/2021
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: itchiness all over her back and body, itchiness on her spine area; uncomfortable sensation of skin; Itchiness started from injection site; feeling tired; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness all over her back and body, itchiness on her spine area), SKIN DISCOMFORT (uncomfortable sensation of skin), VACCINATION SITE PRURITUS (Itchiness started from injection site) and FATIGUE (feeling tired) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Penicillin allergy. On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced PRURITUS (itchiness all over her back and body, itchiness on her spine area), SKIN DISCOMFORT (uncomfortable sensation of skin), VACCINATION SITE PRURITUS (Itchiness started from injection site) and FATIGUE (feeling tired). At the time of the report, PRURITUS (itchiness all over her back and body, itchiness on her spine area), SKIN DISCOMFORT (uncomfortable sensation of skin), VACCINATION SITE PRURITUS (Itchiness started from injection site) and FATIGUE (feeling tired) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided. No treatment information provided

Other Meds:

Current Illness:

ID: 1638993
Sex: F
Age:
State: FL

Vax Date: 01/16/2021
Onset Date: 01/24/2021
Rec V Date: 08/27/2021
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: continued to grow together; rash on my arm after taking the moderna; Red bumps; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash on my arm after taking the moderna), Red bumps and continued to grow together in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. No medical history is provided, concomitant drugs are provided. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) 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 24-Jan-2021, the patient experienced RASH (rash on my arm after taking the moderna) and Red bumps. On an unknown date, the patient experienced continued to grow together. At the time of the report, RASH (rash on my arm after taking the moderna) was resolving and Red bumps and continued to grow together outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Most recent FOLLOW-UP information incorporated above includes: On 26-Jan-2021: updated concomitant meds, added additional 3 events updated events start date

Other Meds: LIPITOR

Current Illness:

ID: 1638994
Sex: F
Age: 30
State: KS

Vax Date: 01/21/2021
Onset Date: 01/22/2021
Rec V Date: 08/27/2021
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: Could hardly walk; Felt dizzy; Pyrexia; Temperature spiked up to 103; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Pyrexia) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. No Medical History information was reported. On 21-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 PYREXIA (Pyrexia). At the time of the report, PYREXIA (Pyrexia) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. felt like covid-19 in events

Other Meds:

Current Illness:

ID: 1638995
Sex: F
Age:
State: NY

Vax Date: 01/13/2021
Onset Date:
Rec V Date: 08/27/2021
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: her left ear is full; feeling pressure; tinnitus; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of 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 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided. Reporter did not allow further contact.

Other Meds:

Current Illness:

ID: 1638996
Sex: F
Age:
State:

Vax Date: 01/22/2021
Onset Date:
Rec V Date: 08/27/2021
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: Diarrhea; Archy; Chills; Fever; Stomach Pain; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), PAIN (Archy), CHILLS (Chills), PYREXIA (Fever) and ABDOMINAL PAIN UPPER (Stomach Pain) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 22-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 DIARRHOEA (Diarrhea), PAIN (Archy), CHILLS (Chills), PYREXIA (Fever) and ABDOMINAL PAIN UPPER (Stomach Pain). At the time of the report, DIARRHOEA (Diarrhea), PAIN (Archy), CHILLS (Chills), PYREXIA (Fever) and ABDOMINAL PAIN UPPER (Stomach Pain) was resolving. Possible The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment medication include Tylenol for pain. No concomitant medications were provided by reporter. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1638997
Sex: F
Age: 52
State:

Vax Date: 01/04/2021
Onset Date: 01/13/2021
Rec V Date: 08/27/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: a little red dot (several of them) down the side of their arm 2 and a half inches long. Then all the dots binded together; This spontaneous case was reported by a physician and describes the occurrence of VACCINATION SITE RASH (a little red dot (several of them) down the side of their arm 2 and a half inches long. Then all the dots binded together) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included ESTRADIOL, PROGESTERONE and TRAZODONE. On 04-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 13-Jan-2021, the patient experienced VACCINATION SITE RASH (a little red dot (several of them) down the side of their arm 2 and a half inches long. Then all the dots binded together). At the time of the report, VACCINATION SITE RASH (a little red dot (several of them) down the side of their arm 2 and a half inches long. Then all the dots binded together) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments.; 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: ESTRADIOL; PROGESTERONE; TRAZODONE

Current Illness:

ID: 1638998
Sex: F
Age:
State: FL

Vax Date: 01/16/2021
Onset Date: 01/16/2021
Rec V Date: 08/27/2021
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: pain in the arm; headache; A Spontaneous report was received from a Consumer concerning a female patient of unknown age who received a dose of Moderna's COVID-19 vaccine (mRNA-1273) and experienced events, headache, pain in extremity. The patient's medical history was not provided. No relevant concomitant medications were reported. On 26 Jan 2021, the patient received her first of two planned doses of mRNA-1273 (lot/batch:unknown) for prophylaxis of COVID-19 infection. On 26 Jan 2021, the patient reported she had pain in the arm and headache the first day and nothing after that. Laboratory details were not provided. Treatment details were not provided. Action taken with mRNA-1273 in response to the events was not reported. On date of this report, the outcome of the events of patient experiencing events, headache, pain in extremity was recovered/ resolved.

Other Meds:

Current Illness:

ID: 1638999
Sex: F
Age: 75
State:

Vax Date: 01/25/2021
Onset Date: 01/25/2021
Rec V Date: 08/27/2021
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: sore arm; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. No Medical History information was reported. On 25-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm). At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication included oral medication for diabetes No treatment information provided This case was linked to MOD-2021-014421, MOD-2021-014394 (Linked Report).; Sender's Comments: MOD-2021-014421:Same reporter, different patient MOD-2021-014394:Same reporter, different patient

Other Meds:

Current Illness:

ID: 1639000
Sex: M
Age:
State: TX

Vax Date: 01/15/2021
Onset Date:
Rec V Date: 08/27/2021
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: itchiness; raised bubbles in their rash; A spontaneous report (US) was received from a consumer concerning a male patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced itchiness and raised bubbles in the rash. The patient's medical history was not provided. No relevant concomitant medications were reported. 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: unknown) for prophylaxis of COVID-19 infection. The patient experienced itchiness and raised bubbles in the rash. Laboratory details was not provided. No treatment information was provided. Action taken with mRNA-1273 in response to the event was not reported. The outcome of the events was unknown.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-014539:same reporter, different patient

Other Meds:

Current Illness:

ID: 1639001
Sex: F
Age: 71
State: CA

Vax Date: 01/25/2021
Onset Date: 01/26/2021
Rec V Date: 08/27/2021
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; Injection site hurts; Headache; A spontaneous report was received from a (Consumer) concerning a ? 72 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events (fever, injection site hurts, headache) list. The patient's medical history was not provided. No relevant concomitant medications were reported. On 25-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 in the Left Upper Arm for prophylaxis of COVID-19 infection. On 26-JAN-2021, The patient experienced the events list (fever, injection site hurts, headache). Laboratory details was not provided. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. At the time of this report, the outcome of the event(s) (fever, injection site hurts, headache) was . The reporter assessed the event(s), [fever, injection site hurts, headache], as related to study drug.

Other Meds:

Current Illness:

ID: 1639002
Sex: F
Age: 87
State: MD

Vax Date: 01/01/2021
Onset Date:
Rec V Date: 08/27/2021
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: Swollen arm; Rash on the site of the injection; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm) and VACCINATION SITE URTICARIA (Rash on the site of the injection) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In January 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 PERIPHERAL SWELLING (Swollen arm) and VACCINATION SITE URTICARIA (Rash on the site of the injection). At the time of the report, PERIPHERAL SWELLING (Swollen arm) and VACCINATION SITE URTICARIA (Rash on the site of the injection) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.

Other Meds:

Current Illness:

ID: 1639003
Sex: F
Age: 77
State: MA

Vax Date: 02/08/2021
Onset Date: 02/08/2021
Rec V Date: 08/27/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: Vaccination site rash; Vaccination site pruritis; Vaccination site warmth; sore arm; Itchy rash; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy rash) and VACCINATION SITE PRURITUS (Vaccination site pruritis) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Feb-2021, the patient experienced RASH PRURITIC (Itchy rash). On 16-Feb-2021, the patient experienced VACCINATION SITE PRURITUS (Vaccination site pruritis). At the time of the report, RASH PRURITIC (Itchy rash) and VACCINATION SITE PRURITUS (Vaccination site pruritis) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1639004
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/27/2021
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: Shingle outbreak; A spontaneous report was received from a pharmacist concerning a unknown age, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced shingle outbreak. The patient's medical history was not provided by the reporter. Concomitant product use was not provided by the reporter. On unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) via unknown route for prophylaxis of COVID-19 infection. On unknown date, prior to receiving mRNA-1273, the patient experienced shingle outbreak. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event, shingle outbreak considered unknown.

Other Meds:

Current Illness:

ID: 1639005
Sex: M
Age: 85
State: LA

Vax Date: 02/12/2021
Onset Date: 02/13/2021
Rec V Date: 08/27/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: really bad diarrhea; felt like having flu like symptoms; A spontaneous report was received from a consumer, concerning a female patient of 85 years age male patient , who received Moderna's COVID-19 vaccine and experienced diarrohea and flu symptoms The patient's medical history was provided that diabetes and heart conditions. Concomitant product use was not provided by the reporter. Lab data was not provided. Treatment medication was provided that he took pepto bismol. On 12-FEB-2021 prior to the onset of events, the patient received their First dose of mRNA-1273 (batch no. 031M20A )via unknown route to the left arm for COVID-19 infection prophylaxis. Action taken with mRNA-1273 in response to the event was known. The outcome of the event, was considered to be unknown at the time of this report.; Sender's Comments: MOD21-030784:Crosslinked

Other Meds:

Current Illness: Diabetes; Heart rate (heart conditions)

ID: 1639006
Sex: F
Age: 50
State: NY

Vax Date: 02/17/2021
Onset Date: 02/17/2021
Rec V Date: 08/27/2021
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: incredible headaches the entire day; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (incredible headaches the entire day) in a 50-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 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced HEADACHE (incredible headaches the entire day). The patient was treated with PARACETAMOL (TYLENOL) on 17-Feb-2021 for Headache, at a dose of 1 dosage form. At the time of the report, HEADACHE (incredible headaches the entire day) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided.

Other Meds:

Current Illness:

ID: 1639007
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/27/2021
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: late for second dose; Covid-19; A spontaneous report (United states) was received from a pharmacist concerning patient who received Moderna's COVID-19 vaccine (mRNA-1273) late for second dose / Product dose omission issue because the patient developed COVID -19 The patient's medical history was not provided. Concomitant product use was not provided by reporter. The patient was due to receive their second of two planned doses of mRNA-1273 (batch number not provided) on 08 Feb 2021.Due to having COVID, the patient missed the second dose. No treatment information was provided. Action taken with the dose of mRNA-1273 vaccine was unknown. The outcome for the event late for second dose / Product dose omission issue and COVID-19 was considered as unknown.; Reporter's Comments: This report refers to a case of a patient of unknown age and gender wo experienced late for second dose or mRNA-1273 (Inappropriate schedule of vaccine administered) due COVID-19 infection. Based on the known etiology of the disease and the profile of mRNA-1273 vaccine, a causal association between the event and mRNA-1273 is assessed as unlikely.

Other Meds:

Current Illness:

ID: 1639008
Sex: F
Age: 33
State: MA

Vax Date: 01/14/2021
Onset Date: 01/14/2021
Rec V Date: 08/27/2021
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: Test Date: 20210121; Test Name: Amniocentesis; Result Unstructured Data: low; Test Date: 20201101; Test Name: Pregnancy test; Test Result: Positive ; Result Unstructured Data: positive; Test Date: 20210121; Test Name: Ultrasound; Result Unstructured Data: normal; Test Date: 20211228; Test Name: Ultrasound; Result Unstructured Data: normal

Allergies:

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

Symptoms: exposure during pregnancy; muscle soreness at injection site; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of EXPOSURE DURING PREGNANCY (exposure during pregnancy) in a 33-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Alcohol use (Prior use). Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) 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 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 21-Sep-2020 and the estimated date of delivery was 11-Jul-2021. On 14-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the sixteenth week of the pregnancy. The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of UNK dosage form. On 14-Jan-2021, EXPOSURE DURING PREGNANCY (exposure during pregnancy) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Nov-2020, Pregnancy test: positive Positive. On 21-Jan-2021, Amniocentesis: low level 10% of mosaic turner syndrome Low. On 21-Jan-2021, Ultrasound scan: no abnormal findings normal. On 28-Dec-2021, Ultrasound scan: no abnormal findings normal. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. This case was linked to MOD-2021-165269 (Patient Link).

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

Current Illness:

ID: 1639009
Sex: F
Age: 35
State: PA

Vax Date: 02/19/2021
Onset Date: 02/19/2021
Rec V Date: 08/27/2021
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 Date: 20201101; Test Name: positive pregnancy test; Test Result: Positive ; Result Unstructured Data: Positive; Test Name: ultrasound; Result Unstructured Data: normal

Allergies:

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

Symptoms: Vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a patient and describes the occurrence of EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) in a 35-year-old female patient (gravida 2, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. Concurrent medical conditions included Pregnancy (Number of fetuses -1) since 01-Nov-2020. Concomitant products included PRENATAL VITAMINS [ASCORBIC ACID;BETACAROTENE;CALCIUM SULFATE;COLECALCIFEROL;CYANOCOBALAMIN;FERROUS FUMARATE;FOLIC ACID;NICOTINAMIDE;PYRIDOXINE HYDROCHLORIDE;RETINOL ACETATE;RIBOFLAVIN;THIAMINE MONONITRATE;TOCOPHERYL ACETATE;ZINC OXIDE] for Vitamin supplementation. On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. The patient's last menstrual period was on 01-Oct-2020 and the estimated date of delivery was 08-Jul-2021. On 19-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the twentieth week of the pregnancy. On 19-Feb-2021, EXPOSURE DURING PREGNANCY (Vaccine exposure during pregnancy) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Nov-2020, Pregnancy test positive: Positive. On an unknown date, Ultrasound uterus: normal (normal) normal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. no treatment mentioned

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

Current Illness: Pregnancy (Number of fetuses -1)

ID: 1639010
Sex: M
Age: 73
State: NC

Vax Date: 02/01/2021
Onset Date:
Rec V Date: 08/27/2021
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: arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect products included non-company products TREPROSTINIL SODIUM for Pulmonary arterial hypertension and SELEXIPAG (UPTRAVI) for an unknown indication. Concurrent medical conditions included Pulmonary arterial hypertension. Concomitant products included WARFARIN for an unknown indication. On 27-Mar-2019, the patient started TREPROSTINIL SODIUM (unknown route) .6 milligram per millilitre four times per day. In February 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started SELEXIPAG (UPTRAVI) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm soreness). At the time of the report, PAIN IN EXTREMITY (arm soreness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information was not provided Most recent FOLLOW-UP information incorporated above includes: On 26-Apr-2021: NNI- Email ack from reporter

Other Meds: TREPROSTINIL SODIUM; UPTRAVI; WARFARIN

Current Illness: Pulmonary arterial hypertension

ID: 1639011
Sex: M
Age:
State: IN

Vax Date: 02/12/2021
Onset Date: 02/13/2001
Rec V Date: 08/27/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Nauseated; Vomiting a lot; fever chills; Arm was sore; chills; shaking a lot; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nauseated), VOMITING (Vomiting a lot), PYREXIA (fever chills), VACCINATION SITE PAIN (Arm was sore) and CHILLS (chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Diabetic. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Feb-2001, the patient experienced TREMOR (shaking a lot). On 13-Feb-2021, the patient experienced NAUSEA (Nauseated), VOMITING (Vomiting a lot), PYREXIA (fever chills), VACCINATION SITE PAIN (Arm was sore) and CHILLS (chills). At the time of the report, NAUSEA (Nauseated), VOMITING (Vomiting a lot), PYREXIA (fever chills), VACCINATION SITE PAIN (Arm was sore), CHILLS (chills) and TREMOR (shaking a lot) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.

Other Meds:

Current Illness: Diabetic

ID: 1639012
Sex: M
Age: 34
State: IL

Vax Date: 01/23/2021
Onset Date: 01/29/2021
Rec V Date: 08/27/2021
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: feels like hypertension headache; pre flu like symptoms; feels like sickness is approaching / Do not feel well; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEADACHE (feels like hypertension headache), INFLUENZA LIKE ILLNESS (pre flu like symptoms) and MALAISE (feels like sickness is approaching / Do not feel well) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Neck pain. On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced HEADACHE (feels like hypertension headache), INFLUENZA LIKE ILLNESS (pre flu like symptoms) and MALAISE (feels like sickness is approaching / Do not feel well). At the time of the report, HEADACHE (feels like hypertension headache), INFLUENZA LIKE ILLNESS (pre flu like symptoms) and MALAISE (feels like sickness is approaching / Do not feel well) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.

Other Meds:

Current Illness:

ID: 1639013
Sex: F
Age: 75
State: VA

Vax Date: 01/30/2021
Onset Date: 01/30/2021
Rec V Date: 08/27/2021
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: neck pain; pain in my left arm; headache; A spontaneous report was received from a Healthcare Professional concerning a 76? Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events, pain in my left arm, neck pain, and headache. The patient's medical history was not provided. No relevant concomitant medications were reported. On 30 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot batch: 027L20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 31 Jan 2021, the patient experienced the events pain in my left arm. On 3 Feb 2021, the patient experienced the events neck pain. On 30 Jan 2021, the patient experienced the events headache. Action taken with mRNA-1273 in response to the events, pain in my left arm, neck pain, and headache was not reported. On 30 Jan 2021 the outcome of events, headache was resolved. On an unknown date the outcome of events include, pain in my left arm, neck pain was not reported.; Reporter's Comments: This case concerns a 76-year old female patient who received the first dose of mRNA-1273 and experienced non-serious events pain in my left arm, neck pain, and headache. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1639014
Sex: M
Age: 76
State:

Vax Date: 01/18/2021
Onset Date:
Rec V Date: 08/27/2021
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: shoulder was swollen/ shoulder was like puffy; there was a lot of redness there; Blood pressure is elevated; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (shoulder was swollen/ shoulder was like puffy), ERYTHEMA (there was a lot of redness there) and BLOOD PRESSURE INCREASED (Blood pressure is elevated) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included SIMVASTATIN, LOSARTAN, LEVOTHYROXINE, TAMSULOSIN and metroprocol succinate for an unknown indication. On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (shoulder was swollen/ shoulder was like puffy), ERYTHEMA (there was a lot of redness there) and BLOOD PRESSURE INCREASED (Blood pressure is elevated). The patient was treated with DOXYCYCLINE MONOHYDRATE at a dose of 100 milligram. At the time of the report, PERIPHERAL SWELLING (shoulder was swollen/ shoulder was like puffy), ERYTHEMA (there was a lot of redness there) and BLOOD PRESSURE INCREASED (Blood pressure is elevated) 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: SIMVASTATIN; LOSARTAN; LEVOTHYROXINE; TAMSULOSIN; metroprocol succinate

Current Illness:

ID: 1639015
Sex: M
Age: 72
State:

Vax Date: 02/01/2021
Onset Date: 02/02/2021
Rec V Date: 08/27/2021
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: very weak; hardly walk; can't sleep; couldn't stand up; is quite sick; started throwing up; chills; This spontaneous case was reported by a physician and describes the occurrence of ASTHENIA (very weak), GAIT DISTURBANCE (hardly walk), INSOMNIA (can't sleep), ASTHENIA (couldn't stand up) and PYREXIA (is quite sick) in a 72-year-old male 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 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Feb-2021, the patient experienced ASTHENIA (very weak), GAIT DISTURBANCE (hardly walk), INSOMNIA (can't sleep), ASTHENIA (couldn't stand up), PYREXIA (is quite sick), VOMITING (started throwing up) and CHILLS (chills). The patient was treated with ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) at an unspecified dose and frequency. At the time of the report, ASTHENIA (very weak), GAIT DISTURBANCE (hardly walk), INSOMNIA (can't sleep), ASTHENIA (couldn't stand up), PYREXIA (is quite sick), VOMITING (started throwing up) and CHILLS (chills) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. No concomitant medications reported by investigator o No treatment medications provided by the reporter.

Other Meds:

Current Illness:

ID: 1639016
Sex: M
Age:
State: MS

Vax Date: 01/27/2021
Onset Date: 01/28/2021
Rec V Date: 08/27/2021
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: 20210128; Test Name: Body temperature; Test Result: Inconclusive ; Result Unstructured Data: fever of 102 degrees

Allergies:

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

Symptoms: This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 102 degrees) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 09L20A) for COVID-19 vaccination. No Medical History information was reported. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced PYREXIA (Fever of 102 degrees). At the time of the report, PYREXIA (Fever of 102 degrees) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jan-2021, Body temperature: 102 (Inconclusive) fever of 102 degrees. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications reported by investigator No treatment medications provided by the reporter.

Other Meds:

Current Illness:

ID: 1639017
Sex: U
Age:
State:

Vax Date: 01/30/2021
Onset Date:
Rec V Date: 08/27/2021
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: Soreness; Headache; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Soreness) and HEADACHE (Headache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 30-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 PAIN (Soreness) and HEADACHE (Headache). At the time of the report, PAIN (Soreness) and HEADACHE (Headache) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications reported by investigator No treatment medications provided by the reporter. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1639018
Sex: F
Age:
State: MS

Vax Date: 01/27/2021
Onset Date: 01/28/2021
Rec V Date: 08/27/2021
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: Fever; Body aches; Headache; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), MYALGIA (Body aches), HEADACHE (Headache) and NAUSEA (Nausea) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 09L20A) for COVID-19 vaccination. No Medical History information was reported. On 27-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Jan-2021, the patient experienced PYREXIA (Fever), MYALGIA (Body aches), HEADACHE (Headache) and NAUSEA (Nausea). At the time of the report, PYREXIA (Fever), MYALGIA (Body aches), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment or concomitant medications were reported. This case was linked to US-MODERNATX, INC.-MOD-2021-022474, US-MODERNATX, INC.-MOD-2021-047944 (E2B Linked Report). Reporter did not allow further contact; Sender's Comments: US-MODERNATX, INC.-MOD-2021-047944:Crosslinked (MOD21-018119) US-MODERNATX, INC.-MOD-2021-022474:Crosslinked (MOD21-018119)

Other Meds:

Current Illness:

ID: 1639019
Sex: F
Age:
State: MS

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

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

Lab Data:

Allergies:

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

Symptoms: muscle twitches over whole body; Fever; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of MUSCLE TWITCHING (muscle twitches over whole body) and PYREXIA (Fever) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 09L20A) for COVID-19 vaccination. No Medical History information was reported. On 27-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 28-Jan-2021, the patient experienced MUSCLE TWITCHING (muscle twitches over whole body) and PYREXIA (Fever). At the time of the report, MUSCLE TWITCHING (muscle twitches over whole body) and PYREXIA (Fever) 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. Treatment information was not provided. Relevant concomitant medication was not reported. This case was linked to MODERNATX, INC.-MOD-2021-022474, MODERNATX, INC.-MOD-2021-047944 (E2B Linked Report).; Sender's Comments: MODERNATX, INC.-MOD-2021-047944:Crosslinked (MOD21-018071) MODERNATX, INC.-MOD-2021-022474:Crosslinked (MOD21-018071)

Other Meds:

Current Illness:

ID: 1639020
Sex: M
Age:
State: MO

Vax Date: 02/02/2021
Onset Date:
Rec V Date: 08/27/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: chills; fever; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills) and PYREXIA (fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 02-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CHILLS (chills) and PYREXIA (fever). At the time of the report, CHILLS (chills) and PYREXIA (fever) outcome was unknown. No relevant concomitant medications were reported. Treatment details included were not reported. Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded. Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1639021
Sex: F
Age: 82
State: AK

Vax Date: 01/14/2021
Onset Date: 01/29/2021
Rec V Date: 08/27/2021
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: Spot that was running down from the injection site towards my elbow; Redness in the arm at the site; This spontaneous case was reported by a consumer and describes the occurrence of RASH MACULAR (Spot that was running down from the injection site towards my elbow) and VACCINATION SITE ERYTHEMA (Redness in the arm at the site) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure. Concomitant products included ATORVASTATIN for an unknown indication. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Jan-2021, the patient experienced RASH MACULAR (Spot that was running down from the injection site towards my elbow) and VACCINATION SITE ERYTHEMA (Redness in the arm at the site). At the time of the report, RASH MACULAR (Spot that was running down from the injection site towards my elbow) was resolving and VACCINATION SITE ERYTHEMA (Redness in the arm at the site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The caller confirmed that she got the Moderna vaccine on 14-Jan-2021. she stated that she had no initial side effects. On 29-Jan-2021, I noticed a spot that was running down from the injection site towards my elbow. On the 30th the shape of the spot changed into a rectangle 2 by 4 inches. The patient indicated that the spot is lighter in color today and will continue to monitor it. The patient received the Moderna vaccine in the upper left arm on 14-Jan-2021, just before 4:00 PM. The vaccine was given to prevent COVID-19. The lot number an expiration date were unavailable at this time. Most recent FOLLOW-UP information incorporated above includes: On 31-Mar-2021: Report received: Initiative recieved; 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. Further information has been requested.

Other Meds: ATORVASTATIN

Current Illness: Blood pressure

ID: 1639022
Sex: F
Age: 83
State: NJ

Vax Date: 01/15/2021
Onset Date: 01/30/2021
Rec V Date: 08/27/2021
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: started to get little red marks had all red blotches in chest and arm; terrible headache; it was as red as an apple; itched in chest and arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of RASH MACULAR (started to get little red marks had all red blutches in chest and arm), PRURITUS (itched in chest and arm), HEADACHE (terrible headache) and ERYTHEMA (it was as red as an apple) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. Concomitant products included LEVOTHYROXINE and Amadelz for an unknown indication. On 15-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 30-Jan-2021, the patient experienced PRURITUS (itched in chest and arm). On an unknown date, the patient experienced RASH MACULAR (started to get little red marks had all red blutches in chest and arm), HEADACHE (terrible headache) and ERYTHEMA (it was as red as an apple). At the time of the report, RASH MACULAR (started to get little red marks had all red blutches in chest and arm), PRURITUS (itched in chest and arm) and ERYTHEMA (it was as red as an apple) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. Took Benadryl and Triamcinolone acetonide cream. Hydroxycine prescription so that they could sleep better (took it one night). Dermathologist was going to prescribe Prednisone for skin rash but did not try it in the end. Family doctor told them to take Claritin and Zyrteck if it continues. One doctor told them to go to the ER and got an IV steroids if it came back.

Other Meds: LEVOTHYROXINE

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am