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: 1643041
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: i got my firs dose of de vaccine on april 14.. and didnt get the second; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (i got my firs dose of de vaccine on april 14.. and didnt get the second) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (i got my firs dose of de vaccine on april 14.. and didnt get the second). At the time of the report, PRODUCT DOSE OMISSION ISSUE (i got my firs dose of de vaccine on april 14. and didnt get the second) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided. No treatment details were provided.

Other Meds:

Current Illness:

ID: 1643042
Sex: F
Age: 57
State: TN

Vax Date: 06/22/2021
Onset Date:
Rec V Date: 08/28/2021
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: Headache; Fever; Chills; body aches and her arm is sore; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (body aches and her arm is sore) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination. No Medical History information was reported. On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (body aches and her arm is sore). At the time of the report, HEADACHE (Headache), PYREXIA (Fever), CHILLS (Chills) and MYALGIA (body aches and her arm is sore) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant medications were reported. No Treatment medication were given.

Other Meds:

Current Illness:

ID: 1643043
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: Test Name: Temperature; Test Result: Inconclusive ; Result Unstructured Data: 100.5

Allergies:

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

Symptoms: Really bad stomach ache; Really bad chills/Can't stop shivering; Some vomiting; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (Really bad stomach ache), CHILLS (Really bad chills/Can't stop shivering) and VOMITING (Some vomiting) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was reported by reporter. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN UPPER (Really bad stomach ache), CHILLS (Really bad chills/Can't stop shivering) and VOMITING (Some vomiting). At the time of the report, ABDOMINAL PAIN UPPER (Really bad stomach ache), CHILLS (Really bad chills/Can't stop shivering) and VOMITING (Some vomiting) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.5 (Inconclusive) 100.5. No concomitant and treatment medications are provided. Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow up received on 23-Jun-2021, No new information. Patient Denied to Consent to Follow up.

Other Meds:

Current Illness:

ID: 1643044
Sex: F
Age: 55
State: LA

Vax Date: 01/11/2021
Onset Date: 06/15/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210619; Test Name: COVID-19 Test; Test Result: Positive ; Result Unstructured Data: Positive (Rapid Molecular Nasal Swab)

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Suspected Covid-19; Feeling bad; Loss sense of smell.; Diarrhea; Muscle ache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (Suspected Covid-19), FEELING ABNORMAL (Feeling bad), ANOSMIA (Loss sense of smell.), DIARRHOEA (Diarrhea) and MYALGIA (Muscle ache) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Type 2 diabetes mellitus since 2010 and Cardiomyopathy since 2020. Concomitant products included METFORMIN HYDROCHLORIDE (METFORMIN XR), DULAGLUTIDE (TRULICITY), ROSUVASTATIN CALCIUM (CRESTOR), CARVEDILOL (COREG) and VALSARTAN (DIOVAN) for an unknown indication. On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Jun-2021, the patient experienced FEELING ABNORMAL (Feeling bad) and ANOSMIA (Loss sense of smell.). On 19-Jun-2021, the patient experienced SUSPECTED COVID-19 (Suspected Covid-19). On an unknown date, the patient experienced DIARRHOEA (Diarrhea), MYALGIA (Muscle ache) and FATIGUE (Fatigue). At the time of the report, SUSPECTED COVID-19 (Suspected Covid-19), FEELING ABNORMAL (Feeling bad), ANOSMIA (Loss sense of smell.), DIARRHOEA (Diarrhea), MYALGIA (Muscle ache) and FATIGUE (Fatigue) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Jun-2021, SARS-CoV-2 test: positive (Positive) Positive (Rapid Molecular Nasal Swab). After getting suspected for COVID-19 the patient was quarantined for 10 days. Treatment medication was not provided. Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Significant follow up, patient demographics, medical history, concomitant and treatment medications and new events were updated.

Other Meds: METFORMIN XR; TRULICITY; CRESTOR; COREG; DIOVAN

Current Illness: Cardiomyopathy; Type 2 diabetes mellitus

ID: 1643045
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: just had second shot and im Really sick; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (just had second shot and im Really sick) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 ILLNESS (just had second shot and im Really sick). At the time of the report, ILLNESS (just had second shot and im Really sick) outcome was unknown. Concomitant product usage were not provided. Treatment details were not provided.

Other Meds:

Current Illness:

ID: 1643046
Sex: F
Age: 61
State: WI

Vax Date: 03/13/2021
Onset Date: 04/10/2021
Rec V Date: 08/28/2021
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: 202104; Test Name: Body temperature; Result Unstructured Data: High

Allergies:

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

Symptoms: sluggish; Body aches; fatigue; fever; This spontaneous case was reported by a patient and describes the occurrence of SLUGGISHNESS (sluggish), MYALGIA (Body aches), FATIGUE (fatigue) and PYREXIA (fever) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 001B21A) for COVID-19 vaccination. Concurrent medical conditions included Pollen allergy (Reaction- Sneezing, watery eyes.) since 1970, Allergic reaction to antibiotics (Rash) since 2005, Allergic reaction to bee sting (cellulitis) since August 2010, Allergy to molds (Reaction- Sneezing, watery eyes.) since 1970 and Seasonal allergy (Reaction- Sneezing, watery eyes.) since 1970. Concomitant products included MULTIVITAMIN [VITAMINS NOS], COLECALCIFEROL (D3), FISH OIL (OMEGA 3 [FISH OIL]), VACCINIUM MACROCARPON (CRANBERRY EXTRACT [VACCINIUM MACROCARPON]) and CURCUMA LONGA (TURMERIC [CURCUMA LONGA]) for an unknown indication. On 13-Mar-2021 at 11:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Apr-2021 at 11:15 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Apr-2021, the patient experienced SLUGGISHNESS (sluggish), MYALGIA (Body aches), FATIGUE (fatigue) and PYREXIA (fever). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 11-Apr-2021, MYALGIA (Body aches) and PYREXIA (fever) had resolved. On 12-Apr-2021, SLUGGISHNESS (sluggish) and FATIGUE (fatigue) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In April 2021, Body temperature: 102 (High) High. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. This case was linked to MOD-2021-062244 (Patient Link).

Other Meds: MULTIVITAMIN [VITAMINS NOS]; D3; OMEGA 3 [FISH OIL]; CRANBERRY EXTRACT [VACCINIUM MACROCARPON]; TURMERIC [CURCUMA LONGA]

Current Illness: Allergic reaction to antibiotics (Rash); Allergic reaction to bee sting (cellulitis); Allergy to molds (Reaction- Sneezing, watery eyes.); Pollen allergy (Reaction- Sneezing, watery eyes.); Seasonal allergy (Reaction- Sneezing, watery eyes.)

ID: 1643047
Sex: F
Age: 68
State: NY

Vax Date: 03/17/2021
Onset Date: 03/17/2021
Rec V Date: 08/28/2021
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: arm was sore; red and warm arm; red and warm arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore), ERYTHEMA (red and warm arm) and FEELING HOT (red and warm arm) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A..A (illegible) and 031A21B) for COVID-19 vaccination. No medical history reported by the reporter. Concomitant products included ATORVASTATIN, METOPROLOL TARTRATE, HYDROCHLOROTHIAZIDE, LISINOPRIL (LISINOPRIL/HCTZ), DESVENLAFAXINE SUCCINATE MONOHYDRATE (PRISTIQ) and SEMAGLUTIDE (OZEMPIC) for an unknown indication. On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm was sore), ERYTHEMA (red and warm arm) and FEELING HOT (red and warm arm). At the time of the report, PAIN IN EXTREMITY (arm was sore), ERYTHEMA (red and warm arm) and FEELING HOT (red and warm arm) outcome was unknown. Treatment details were not provided. This case was linked to MOD-2021-231407 (Patient Link).

Other Meds: ATORVASTATIN; METOPROLOL TARTRATE; LISINOPRIL/HCTZ; PRISTIQ; OZEMPIC

Current Illness:

ID: 1643048
Sex: F
Age:
State:

Vax Date: 04/22/2021
Onset Date: 05/02/2021
Rec V Date: 08/28/2021
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: Blood work; Test Result: Inconclusive ; Result Unstructured Data: Unknown

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Muscle twitches; This spontaneous case was reported by a patient and describes the occurrence of MUSCLE TWITCHING (Muscle twitches) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-May-2021, the patient experienced MUSCLE TWITCHING (Muscle twitches). At the time of the report, MUSCLE TWITCHING (Muscle twitches) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: unknown (Inconclusive) Unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant medication information was reported. No treatment medication information was reported. Patient developed muscle twitches and other symptoms similar to Syndrome. They did blood work and treated her. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1643049
Sex: F
Age: 47
State: NC

Vax Date: 06/21/2021
Onset Date: 06/21/2021
Rec V Date: 08/28/2021
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: 20210621; Test Name: body temperature

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: felt like she had Covid again; sweating; chills; headache; been sick; felt all the aches; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (been sick), HYPERHIDROSIS (sweating), SYMPTOM RECURRENCE (felt like she had Covid again), MYALGIA (felt all the aches) and CHILLS (chills) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 in 2020. On 21-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jun-2021, the patient experienced ILLNESS (been sick) and MYALGIA (felt all the aches). On 22-Jun-2021, the patient experienced HYPERHIDROSIS (sweating), CHILLS (chills) and HEADACHE (headache). On 21-Jul-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced SYMPTOM RECURRENCE (felt like she had Covid again). At the time of the report, ILLNESS (been sick), HYPERHIDROSIS (sweating), SYMPTOM RECURRENCE (felt like she had Covid again), MYALGIA (felt all the aches), CHILLS (chills) and HEADACHE (headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jun-2021, Body temperature: 100.6f High. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Concomitant and treatment medications were provided.

Other Meds:

Current Illness:

ID: 1643050
Sex: M
Age: 34
State: MI

Vax Date: 05/19/2021
Onset Date: 05/19/2021
Rec V Date: 08/28/2021
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: cold sweats; kidney pain; This spontaneous case was reported by a consumer and describes the occurrence of COLD SWEAT (cold sweats) and RENAL PAIN (kidney pain) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-May-2021, the patient experienced COLD SWEAT (cold sweats) and RENAL PAIN (kidney pain). On 20-May-2021, COLD SWEAT (cold sweats) and RENAL PAIN (kidney pain) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. Concomitant medications were not provided. Treatment information was not reported. This case was linked to MOD-2021-232335 (Patient Link).

Other Meds:

Current Illness:

ID: 1643051
Sex: M
Age: 34
State: MI

Vax Date: 05/19/2021
Onset Date: 05/19/2021
Rec V Date: 08/28/2021
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: Dry heaves; Kidney pain; Felt like he was burning up; Body shakes throughout the night that were cold and hot; Fatigue; Vomiting; Headache behind the eyes; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of RETCHING (Dry heaves), RENAL PAIN (Kidney pain), FEELING HOT (Felt like he was burning up), FEELING OF BODY TEMPERATURE CHANGE (Body shakes throughout the night that were cold and hot) and MYALGIA (Body aches) in a 34-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. No Medical History information was reported. On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-May-2021, the patient experienced MYALGIA (Body aches). On 17-Jun-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced RETCHING (Dry heaves), RENAL PAIN (Kidney pain), FEELING HOT (Felt like he was burning up), FEELING OF BODY TEMPERATURE CHANGE (Body shakes throughout the night that were cold and hot), FATIGUE (Fatigue), VOMITING (Vomiting) and HEADACHE (Headache behind the eyes). On 20-May-2021, MYALGIA (Body aches) had resolved. On 18-Jun-2021, RETCHING (Dry heaves), RENAL PAIN (Kidney pain), FEELING HOT (Felt like he was burning up), VOMITING (Vomiting) and HEADACHE (Headache behind the eyes) had resolved. On 22-Jun-2021, FATIGUE (Fatigue) had resolved. At the time of the report, FEELING OF BODY TEMPERATURE CHANGE (Body shakes throughout the night that were cold and hot) had resolved. No concomitant medications were reported. No treatment information was provided. This case was linked to MOD-2021-232322 (Patient Link).

Other Meds:

Current Illness:

ID: 1643052
Sex: F
Age: 56
State: NJ

Vax Date: 01/12/2021
Onset Date: 02/11/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210211; Test Name: elevated blood pressure; Result Unstructured Data: high; Test Name: ct scan; Test Result: Inconclusive ; Result Unstructured Data: inconclusive; Test Name: dvt; Test Result: Inconclusive ; Result Unstructured Data: inconclusive; Test Date: 20210213; Test Name: Fibrin D dimer increased; Result Unstructured Data: 1.6

Allergies:

Symptom List: Rash, Urticaria

Symptoms: I could not breathe/shortness of breath; I had palpitations; still have trouble going up the stairs; This spontaneous case was reported by a pharmacist and describes the occurrence of DYSPNOEA (I could not breathe/shortness of breath), PALPITATIONS (I had palpitations) and GAIT DISTURBANCE (still have trouble going up the stairs) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B20A and 016M20A) for COVID-19 vaccination. No Medical History information was reported. On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Feb-2021, the patient experienced DYSPNOEA (I could not breathe/shortness of breath), PALPITATIONS (I had palpitations) and GAIT DISTURBANCE (still have trouble going up the stairs). At the time of the report, DYSPNOEA (I could not breathe/shortness of breath), PALPITATIONS (I had palpitations) and GAIT DISTURBANCE (still have trouble going up the stairs) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 11-Feb-2021, Blood pressure increased: high (High) high. On 13-Feb-2021, Fibrin D dimer increased (Unknown-1.6): high (High) 1.6. On an unknown date, Computerised tomogram: inconclusive (Inconclusive) inconclusive. On an unknown date, Deep vein thrombosis: inconclusive (Inconclusive) inconclusive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The concomitant history was not reported .The treatment history was not provided. the lab tests conducted are DVT, CT scan of lungs , nuclear tests with no data. Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: follow up received on 23-jun-21 with non significant information

Other Meds:

Current Illness:

ID: 1643053
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: havent been feeling myself lately; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (havent been feeling myself lately) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FEELING ABNORMAL (havent been feeling myself lately). At the time of the report, FEELING ABNORMAL (havent been feeling myself lately) outcome was unknown. No concomitant medications was reported. No treatment drug details was reported.

Other Meds:

Current Illness:

ID: 1643054
Sex: F
Age: 39
State: PA

Vax Date: 05/01/2021
Onset Date: 06/23/2021
Rec V Date: 08/28/2021
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: fever; chills; Vaccination site pain; Difficulty sleeping; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills), VACCINATION SITE PAIN (Vaccination site pain) and INSOMNIA (Difficulty sleeping) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jun-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 received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 23-Jun-2021, the patient experienced PYREXIA (fever), CHILLS (chills), VACCINATION SITE PAIN (Vaccination site pain) and INSOMNIA (Difficulty sleeping). At the time of the report, PYREXIA (fever), CHILLS (chills), VACCINATION SITE PAIN (Vaccination site pain) and INSOMNIA (Difficulty sleeping) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment medication provided by reporter. No concomitant medication provided by reporter.

Other Meds:

Current Illness:

ID: 1643055
Sex: F
Age:
State: FL

Vax Date: 12/31/2020
Onset Date: 01/27/2021
Rec V Date: 08/28/2021
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: Arm mobility was restricted; My left arm was very painful at injection site; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (Arm mobility was restricted) and VACCINATION SITE PAIN (My left arm was very painful at injection site) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20Ai and 011L20A) for COVID-19 vaccination. The patient's past medical history included Herpes simplex from 01-Jan-2021 to 02-Mar-2021. Concurrent medical conditions included Penicillin allergy, Hypothyroidism since 1983 and Essential hypertension since 2018. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID) from 1989 to an unknown date, LIOTHYRONINE SODIUM (CYTOMEL) from 1995 to an unknown date and OLMESARTAN from 2018 to an unknown date 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 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced MOBILITY DECREASED (Arm mobility was restricted) and VACCINATION SITE PAIN (My left arm was very painful at injection site). On 31-Jan-2021, MOBILITY DECREASED (Arm mobility was restricted) and VACCINATION SITE PAIN (My left arm was very painful at injection site) had resolved. No treatment information was provided. This case was linked to MOD-2021-002194 (Patient Link).

Other Meds: SYNTHROID; CYTOMEL; OLMESARTAN

Current Illness: Essential hypertension; Hypothyroidism; Penicillin allergy

ID: 1643056
Sex: U
Age:
State:

Vax Date: 03/23/2021
Onset Date: 06/23/2021
Rec V Date: 08/28/2021
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: Why would i get a black eye from my second dose; This spontaneous case was reported by a consumer and describes the occurrence of EYE CONTUSION (Why would i get a black eye from my second dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The patient's past medical history included No adverse reaction. On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jun-2021, the patient experienced EYE CONTUSION (Why would i get a black eye from my second dose). At the time of the report, EYE CONTUSION (Why would i get a black eye from my second dose) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided. No treatment was reported

Other Meds:

Current Illness:

ID: 1643057
Sex: U
Age:
State:

Vax Date: 06/22/2021
Onset Date:
Rec V Date: 08/28/2021
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: Extremely tired; Headache; Sore; 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 FATIGUE (Extremely tired), HEADACHE (Headache) and MYALGIA (Sore) 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 22-Jun-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 FATIGUE (Extremely tired), HEADACHE (Headache) and MYALGIA (Sore). The patient was treated with NAPROXEN SODIUM (ALEVE) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, FATIGUE (Extremely tired), HEADACHE (Headache) and MYALGIA (Sore) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Follow-Up received on 21-JUL-2021 and does not contain any new information.; Sender's Comments: This is an invalid case due to no identifiable patient. However, 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: 1643058
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: today all my joints ache; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (today all my joints ache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (today all my joints ache). The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds:

Current Illness:

ID: 1643059
Sex: F
Age: 42
State: PA

Vax Date: 05/07/2021
Onset Date: 06/19/2021
Rec V Date: 08/28/2021
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: missed second vaccine window / haven't received 2nd dosage what should I do?; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed second vaccine window / haven't received 2nd dosage what should I do?) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed second vaccine window / haven't received 2nd dosage what should I do?). On 19-Jun-2021, PRODUCT DOSE OMISSION ISSUE (missed second vaccine window / haven't received 2nd dosage what should I do?) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information was not provided. List of concomitant medication were not given. Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: NNI

Other Meds:

Current Illness:

ID: 1643060
Sex: M
Age:
State:

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

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

Lab Data: Test Name: Body Temperature; Result Unstructured Data: High

Allergies:

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

Symptoms: My son in law got his second shot yesterday and is now running a temp of 105; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (My son in law got his second shot yesterday and is now running a temp of 105) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 PYREXIA (My son in law got his second shot yesterday and is now running a temp of 105). At the time of the report, PYREXIA (My son in law got his second shot yesterday and is now running a temp of 105) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 105 (High) High. No concomitant medications were provided by the reporter. No treatment medications were provided by the reporter.

Other Meds:

Current Illness:

ID: 1643061
Sex: M
Age: 68
State: MD

Vax Date: 03/04/2021
Onset Date: 03/20/2021
Rec V Date: 08/28/2021
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: Not Received a Second Dose (About 3 months post first shot); Ski Accident after first dose; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Not Received a Second Dose (About 3 months post first shot)) and ACCIDENT (Ski Accident after first dose) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Accident (ski accident) since 20-Mar-2021. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced ACCIDENT (Ski Accident after first dose). On 23-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Not Received a Second Dose (About 3 months post first shot)). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Not Received a Second Dose (About 3 months post first shot)) and ACCIDENT (Ski Accident after first dose) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment medication provided by reporter. No concomitant medication provided by reporter.

Other Meds:

Current Illness: Accident (ski accident)

ID: 1643062
Sex: F
Age:
State: NY

Vax Date: 03/20/2021
Onset Date:
Rec V Date: 08/28/2021
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: more than 35 days from 1st vaccination; COVID-19; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (more than 35 days from 1st vaccination) and COVID-19 (COVID-19) 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 20-Mar-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 PRODUCT DOSE OMISSION ISSUE (more than 35 days from 1st vaccination) and COVID-19 (COVID-19). At the time of the report, PRODUCT DOSE OMISSION ISSUE (more than 35 days from 1st vaccination) and COVID-19 (COVID-19) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Relevant concomitant medications were not reported. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1643063
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: tingling; cold sensation in feet; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in feet) and PERIPHERAL COLDNESS (cold sensation in feet) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (tingling in feet) and PERIPHERAL COLDNESS (cold sensation in feet). At the time of the report, PARAESTHESIA (tingling in feet) and PERIPHERAL COLDNESS (cold sensation in feet) had not resolved. No concomitant medications reported. No treatment information was provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1643064
Sex: F
Age: 51
State: FL

Vax Date: 04/02/2021
Onset Date: 04/02/2021
Rec V Date: 08/28/2021
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: Patient received 1st dose 2Apr2021 did not receive 2nd dose because she could not get in touch with the vaccination site; This spontaneous case was reported by a patient and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient received 1st dose 2Apr2021 did not receive 2nd dose because she could not get in touch with the vaccination site) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046A21A) for COVID-19 vaccination. No Medical History information was reported. On 02-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient received 1st dose 2Apr2021 did not receive 2nd dose because she could not get in touch with the vaccination site). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient received 1st dose 2Apr2021 did not receive 2nd dose because she could not get in touch with the vaccination site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1643065
Sex: U
Age:
State: SC

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: 11 patients received doses of temperature excursion; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (11 patients received doses of temperature excursion) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) 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 PRODUCT TEMPERATURE EXCURSION ISSUE (11 patients received doses of temperature excursion). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (11 patients received doses of temperature excursion) had resolved. 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 concomitant medications were reported No treatment information was reported This case was linked to US-MODERNATX (E2B Linked Report). This case was linked to MOD-2021-232457, MOD-2021-232457 (Patient Link).; Sender's Comments: US-MODERNATX:irms

Other Meds:

Current Illness:

ID: 1643066
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: muscle pain; sharp thigh cramping; right upper shoulder blade; headaches; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (muscle pain), MUSCLE SPASMS (sharp thigh cramping), ARTHRALGIA (right upper shoulder blade) and HEADACHE (headaches) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (muscle pain), MUSCLE SPASMS (sharp thigh cramping), ARTHRALGIA (right upper shoulder blade) and HEADACHE (headaches). At the time of the report, MYALGIA (muscle pain), MUSCLE SPASMS (sharp thigh cramping), ARTHRALGIA (right upper shoulder blade) and HEADACHE (headaches) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds:

Current Illness:

ID: 1643067
Sex: U
Age:
State:

Vax Date: 03/02/2021
Onset Date: 03/07/2021
Rec V Date: 08/28/2021
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: rash all over my face and neck; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash all over my face and neck) 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 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Mar-2021, the patient experienced RASH (rash all over my face and neck). At the time of the report, RASH (rash all over my face and neck) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication given. No treatment information provided.

Other Meds:

Current Illness:

ID: 1643068
Sex: F
Age: 69
State: GA

Vax Date: 01/14/2021
Onset Date:
Rec V Date: 08/28/2021
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: Arthritis Pain improved; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Arthritis Pain improved) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 030M20A) for COVID-19 vaccination. The patient's past medical history included Knee replacement on 27-Apr-2021. Concomitant products included ETANERCEPT (ENBREL), METHOTREXATE, HYALURONATE SODIUM (EUFLEXXA), CENTRUM SILVER +50, CHONDROITIN SULFATE SODIUM, GLUCOSAMINE HYDROCHLORIDE (GLUCOSAMINE/CHONDROITIN [CHONDROITIN SULFATE SODIUM;GLUCOSAMINE HYDROCHLORIDE]), CALCIUM, ZINGIBER OFFICINALE ROOT (GINGER ROOT EXTRACT), FOLIC ACID, CINNAMOMUM CASSIA BARK, THIOCTIC ACID (CINNAMON ALPHA LIPOIC ACID), BIFIDOBACTERIUM BIFIDUM, BIFIDOBACTERIUM LONGUM, LACTOBACILLUS GASSERI (PHILLIPS COLON HEALTH), OMEPRAZOLE, ROSUVASTATIN, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), VITAMIN D3 and TOCOPHEROL (VITAMIN E [TOCOPHEROL]) 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 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Arthritis Pain improved). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Arthritis Pain improved) outcome was unknown. Treatment information was not provided.

Other Meds: ENBREL; METHOTREXATE; EUFLEXXA; CENTRUM SILVER +50; GLUCOSAMINE/CHONDROITIN [CHONDROITIN SULFATE SODIUM;GLUCOSAMINE HYDROCHLORIDE]; CALCIUM; GINGER ROOT EXTRACT; FOLIC ACID; CINNAMON ALPHA LIPOIC ACID; PHILLIPS COLON HEALTH; OMEPRAZOLE; ROS

Current Illness:

ID: 1643069
Sex: F
Age:
State: OH

Vax Date: 01/20/2021
Onset Date:
Rec V Date: 08/28/2021
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: Got COVID-19; Did not get second dose yet; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Got COVID-19) and PRODUCT DOSE OMISSION ISSUE (Did not get second dose yet) in an 81-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 20-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 COVID-19 (Got COVID-19) and PRODUCT DOSE OMISSION ISSUE (Did not get second dose yet). The patient was treated with PLASMA at a dose of 1 dosage form. At the time of the report, COVID-19 (Got COVID-19) and PRODUCT DOSE OMISSION ISSUE (Did not get second dose yet) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant drugs are provided. No treatment information was given.

Other Meds:

Current Illness:

ID: 1643070
Sex: U
Age:
State: TX

Vax Date: 06/21/2021
Onset Date: 06/21/2021
Rec V Date: 08/28/2021
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: Estimated 30 patients received vaccines from expired vial.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Estimated 30 patients received vaccines from expired vial.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination. No Medical History information was reported. On 21-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Estimated 30 patients received vaccines from expired vial.). On 22-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Estimated 30 patients received vaccines from expired vial.) 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. Cross linked with MOD21-114724 No Concomitant and treatment medications were provided. Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: NNI Follow up received/ No adverse event reported

Other Meds:

Current Illness:

ID: 1643071
Sex: M
Age:
State: MO

Vax Date: 05/25/2021
Onset Date: 06/22/2021
Rec V Date: 08/28/2021
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: 8 patients received a dose from a vial that was expired / vial was taken out of the refrigerator at 4:14pm on Monday 21JUN2021 and punctured and kept at room temperature / received doses from the same via yesterday 22JUN2021 between 9am and 6:19pm; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (8 patients received a dose from a vial that was expired / vial was taken out of the refrigerator at 4:14pm on Monday 21JUN2021 and punctured and kept at room temperature / received doses from the same via yesterday 22JUN2021 between 9am and 6:19pm) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049C21A) for COVID-19 vaccination. No Medical History information was reported. On 25-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (8 patients received a dose from a vial that was expired / vial was taken out of the refrigerator at 4:14pm on Monday 21JUN2021 and punctured and kept at room temperature / received doses from the same via yesterday 22JUN2021 between 9am and 6:19pm). At the time of the report, EXPIRED PRODUCT ADMINISTERED (8 patients received a dose from a vial that was expired / vial was taken out of the refrigerator at 4:14pm on Monday 21JUN2021 and punctured and kept at room temperature / received doses from the same via yesterday 22JUN2021 between 9am and 6:19pm) 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 are provided. treatment to the events not provided. 8 patients received a dose from a vial that was expired, Pharmacist states the vial was taken out of the refrigerator at 4:14pm on Monday 21JUN2021 and punctured and kept at room temperature. Some patients received doses from the same vial yesterday 22JUN2021 between 9am and 6:19pm. Of the 8 patients, 6 received the vaccine within 24 hours and 2 patients received it about 26 hours after it was punctured at room temperature. Caller states that none of the patients have reported any adverse events.

Other Meds:

Current Illness:

ID: 1643072
Sex: U
Age:
State:

Vax Date: 04/01/2021
Onset Date: 06/20/2021
Rec V Date: 08/28/2021
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: This spontaneous case reported by a consumer, describes the occurrence of back pain (pain moved to part of right-side of back), pain in extremity (pain in right hand/pain moved to the whole arm) and arthralgia (pain moved to shoulder) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. April 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Jun 20, 2021, patient experienced pain in extremity (pain in right hand/pain moved to the whole arm). On Jun 23, 2021, patient experienced back pain (pain moved to part of right-side of back) and arthralgia (pain moved to shoulder). At the time of the report, back pain (pain moved to part of right-side of back), pain in extremity (pain in right hand/pain moved to the whole arm) and arthralgia (pain moved to shoulder) outcome: unknown. No concomitant medication or treatment information provided.

Other Meds:

Current Illness:

ID: 1643073
Sex: F
Age: 76
State: MA

Vax Date: 04/14/2021
Onset Date: 04/14/2021
Rec V Date: 08/28/2021
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: Stiffness; Swelling; Left shoulder became sore; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiffness), SWELLING (Swelling) and ARTHRALGIA (Left shoulder became sore) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination. No Medical History information was reported. On 14-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness), SWELLING (Swelling) and ARTHRALGIA (Left shoulder became sore). At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiffness), SWELLING (Swelling) and ARTHRALGIA (Left shoulder became sore) outcome was unknown. No concomitant medications was reported. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 13-Aug-2021: Non significant FU- updated Mailing Address

Other Meds:

Current Illness:

ID: 1643074
Sex: F
Age:
State: MI

Vax Date: 05/24/2021
Onset Date: 06/22/2021
Rec V Date: 08/28/2021
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: Leg was cramping; Felt a little warm; Didn't feel well; Heart was racing; Had trouble trying to catch a breath; Immediately go to the bathroom and had diarrhoea; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Didn't feel well), PALPITATIONS (Heart was racing), DYSPNOEA (Had trouble trying to catch a breath), DIARRHOEA (Immediately go to the bathroom and had diarrhoea) and MUSCLE SPASMS (Leg was cramping) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A and 022C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Jun-2021, the patient experienced MALAISE (Didn't feel well), PALPITATIONS (Heart was racing), DYSPNOEA (Had trouble trying to catch a breath) and DIARRHOEA (Immediately go to the bathroom and had diarrhoea). On 23-Jun-2021, the patient experienced MUSCLE SPASMS (Leg was cramping) and FEELING HOT (Felt a little warm). On 22-Jun-2021, MALAISE (Didn't feel well), PALPITATIONS (Heart was racing), DYSPNOEA (Had trouble trying to catch a breath) and DIARRHOEA (Immediately go to the bathroom and had diarrhoea) outcome was unknown. At the time of the report, MUSCLE SPASMS (Leg was cramping) and FEELING HOT (Felt a little warm) outcome was unknown. No concomitant medications were provided. No treatment details were provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1643075
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: get sick from the second shot two weeks after getting it; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (get sick from the second shot two weeks after getting it) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 ILLNESS (get sick from the second shot two weeks after getting it). At the time of the report, ILLNESS (get sick from the second shot two weeks after getting it) outcome was unknown. It has reported that patient had taken the second shot two weeks ago. No concomitant medications were reported. No treatment medication was reported.

Other Meds:

Current Illness:

ID: 1643076
Sex: M
Age: 64
State: NJ

Vax Date: 04/28/2021
Onset Date:
Rec V Date: 08/28/2021
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: flu-like symptoms; sweats; fever; chills; body aches; This spontaneous case was reported by a pharmacist and describes the occurrence of INFLUENZA LIKE ILLNESS (flu-like symptoms), HYPERHIDROSIS (sweats), PYREXIA (fever), CHILLS (chills) and MYALGIA (body aches) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022B21A and 022B21A) for COVID-19 vaccination. The patient's past medical history included Skin cancer and Chemotherapy in 2018. Concurrent medical conditions included High cholesterol. Concomitant products included ROSUVASTATIN for High cholesterol. On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 26-May-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 INFLUENZA LIKE ILLNESS (flu-like symptoms), HYPERHIDROSIS (sweats), PYREXIA (fever), CHILLS (chills) and MYALGIA (body aches). At the time of the report, INFLUENZA LIKE ILLNESS (flu-like symptoms), HYPERHIDROSIS (sweats), PYREXIA (fever), CHILLS (chills) and MYALGIA (body aches) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.

Other Meds: ROSUVASTATIN

Current Illness: High cholesterol

ID: 1643077
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: Knee has gotten worse; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Knee has gotten worse) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Arthritis (She had been diagnosed with arthritis of the knee years ago.). On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 ARTHRALGIA (Knee has gotten worse). At the time of the report, ARTHRALGIA (Knee has gotten worse) outcome was unknown. No concomitant product use was provided by the reporter. Treatment information was not provided. The consumer stated that she was having a knee replacement surgery in September 2021 due to arthritis. The patient received 2nd dose of Vaccination in February 2021.

Other Meds:

Current Illness: Arthritis (She had been diagnosed with arthritis of the knee years ago.)

ID: 1643078
Sex: M
Age: 47
State: FL

Vax Date: 06/22/2021
Onset Date: 06/23/2021
Rec V Date: 08/28/2021
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: stiff neck / really stiff neck; felt really bad; 103 fever / fever; bowel movement that really smelled, nasty like sludge; queasy; real dizzy; fell asleep three times since I've been home; heart rate is elevated; I feel pounding in my chest; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (stiff neck / really stiff neck), FEELING ABNORMAL (felt really bad), PYREXIA (103 fever / fever), ABNORMAL FAECES (bowel movement that really smelled, nasty like sludge) and NAUSEA (queasy) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jun-2021, the patient experienced MUSCULOSKELETAL STIFFNESS (stiff neck / really stiff neck), FEELING ABNORMAL (felt really bad), PYREXIA (103 fever / fever), ABNORMAL FAECES (bowel movement that really smelled, nasty like sludge), NAUSEA (queasy), DIZZINESS (real dizzy), SOMNOLENCE (fell asleep three times since I've been home), HEART RATE INCREASED (heart rate is elevated) and PALPITATIONS (I feel pounding in my chest). The patient was treated with PARACETAMOL (TYLENOL) on 23-Jun-2021 at an unspecified dose and frequency. At the time of the report, MUSCULOSKELETAL STIFFNESS (stiff neck / really stiff neck), FEELING ABNORMAL (felt really bad), PYREXIA (103 fever / fever), ABNORMAL FAECES (bowel movement that really smelled, nasty like sludge), NAUSEA (queasy), DIZZINESS (real dizzy), SOMNOLENCE (fell asleep three times since I've been home), HEART RATE INCREASED (heart rate is elevated) and PALPITATIONS (I feel pounding in my chest) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Concomitant Medications was provided by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow-up information received on 23-JUN-2021 contains no significant information.

Other Meds:

Current Illness:

ID: 1643079
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: arm pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 PAIN IN EXTREMITY (arm pain). At the time of the report, PAIN IN EXTREMITY (arm pain) outcome was unknown. No concomitant medications information was reported. No treatment medications were provided.

Other Meds:

Current Illness:

ID: 1643080
Sex: M
Age: 78
State: CA

Vax Date: 03/01/2021
Onset Date:
Rec V Date: 08/28/2021
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: Pain is not deliberating, but annoying; injection site is still sore. He says that it is sore enough that he cannot sleep on that side. He says; He says he has sore muscle feeling; This spontaneous case was reported by a consumer and describes the occurrence of IRRITABILITY (Pain is not deliberating, but annoying), VACCINATION SITE PAIN (injection site is still sore. He says that it is sore enough that he cannot sleep on that side. He says) and MYALGIA (He says he has sore muscle feeling) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 01-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced IRRITABILITY (Pain is not deliberating, but annoying), VACCINATION SITE PAIN (injection site is still sore. He says that it is sore enough that he cannot sleep on that side. He says) and MYALGIA (He says he has sore muscle feeling). At the time of the report, IRRITABILITY (Pain is not deliberating, but annoying), VACCINATION SITE PAIN (injection site is still sore. He says that it is sore enough that he cannot sleep on that side. He says) and MYALGIA (He says he has sore muscle feeling) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not provided. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1643081
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: This spontaneous case reported by a consumer, describes the occurrence of illness (got sick after 2nd shot) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced illness (got sick after 2nd shot). At the time of the report, illness (got sick after 2nd shot) outcome: unknown. No concomitant medication or treatment information reported. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): not applicable.

Other Meds:

Current Illness:

ID: 1643082
Sex: U
Age:
State:

Vax Date: 04/28/2021
Onset Date:
Rec V Date: 08/28/2021
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: I recieved my first dose 4/28 is it to late for second?; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (I recieved my first dose 4/28 is it to late for second?) 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 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (I recieved my first dose 4/28 is it to late for second?). At the time of the report, PRODUCT DOSE OMISSION ISSUE (I recieved my first dose 4/28 is it to late for second?) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No information regarding corrective treatment was reported by the patient.

Other Meds:

Current Illness:

ID: 1643083
Sex: M
Age: 16
State:

Vax Date: 05/19/2021
Onset Date: 05/19/2021
Rec V Date: 08/28/2021
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: 16 year old received both doses of Moderna vaccine, no side effects reported; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received both doses of Moderna vaccine, no side effects reported) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A and 037C21A) for COVID-19 vaccination. No Medical History information was reported. On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received both doses of Moderna vaccine, no side effects reported). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (16 year old received both doses of Moderna vaccine, no side effects reported) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and 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: 1643084
Sex: F
Age: 52
State: AL

Vax Date: 04/29/2021
Onset Date: 04/29/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: sinus infection; dizziness/ dizziness that hasn't let up/ I bend over, I'm dizzy/I reach up to get something, I'm dizzy; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS POSTURAL (dizziness/ dizziness that hasn't let up/ I bend over, I'm dizzy/I reach up to get something, I'm dizzy) and SINUSITIS ( sinus infection) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 007B21A) for COVID-19 vaccination. The patient's past medical history included Hiatal hernia and Chest pain. On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Apr-2021, the patient experienced DIZZINESS POSTURAL (dizziness/ dizziness that hasn't let up/ I bend over, I'm dizzy/I reach up to get something, I'm dizzy). On an unknown date, the patient experienced SINUSITIS ( sinus infection). The patient was treated with AMOXICILLIN for Sinus infection, at a dose of 1 dosage form; CEFTRIAXONE SODIUM (ROCEPHIN) for Sinus infection, at a dose of 1 dosage form and MECLIZINE [MECLOZINE] for Dizziness, at a dose of 1 dosage form. At the time of the report, DIZZINESS POSTURAL (dizziness/ dizziness that hasn't let up/ I bend over, I'm dizzy/I reach up to get something, I'm dizzy) had not resolved and SINUSITIS ( sinus infection) had resolved. Action taken with mRNA 1273 in response to event was not applicable. Patient Concomitant medication includes unspecified blood pressure medication,unspecified cholesterol medication,unspecified allergy pill,acid reflux medication. This case was linked to MOD-2021-234035, MOD-2021-234035 (Patient Link).

Other Meds:

Current Illness:

ID: 1643085
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: Numbness in the arm; Tenderness; Hard to move my arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in the arm), TENDERNESS (Tenderness) and MOBILITY DECREASED (Hard to move my arm) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Numbness in the arm), TENDERNESS (Tenderness) and MOBILITY DECREASED (Hard to move my arm). At the time of the report, HYPOAESTHESIA (Numbness in the arm), TENDERNESS (Tenderness) and MOBILITY DECREASED (Hard to move my arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. Treatment information was not provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1643086
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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; chill; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), MYALGIA (body aches) and CHILLS (chill) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever), MYALGIA (body aches) and CHILLS (chill). At the time of the report, PYREXIA (fever), MYALGIA (body aches) and CHILLS (chill) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitants were provided. No medical history was provided.

Other Meds:

Current Illness:

ID: 1643087
Sex: F
Age:
State: TX

Vax Date: 06/18/2021
Onset Date: 06/18/2021
Rec V Date: 08/28/2021
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 Name: COVID-19 PCR test; Test Result: Positive ; Result Unstructured Data: positive

Allergies:

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

Symptoms: second dose of vaccine 14 days after she would be tested negative for Covid.; SARS-CoV-2 test; a fever that came and went; fatigue; loss of appetite; a cough; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (loss of appetite), COUGH (a cough), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose of vaccine 14 days after she would be tested negative for Covid.), SARS-COV-2 TEST (SARS-CoV-2 test) and PYREXIA (a fever that came and went) in a 95-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 18-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jun-2021, the patient experienced DECREASED APPETITE (loss of appetite), COUGH (a cough), PYREXIA (a fever that came and went) and FATIGUE (fatigue). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose of vaccine 14 days after she would be tested negative for Covid.) and SARS-COV-2 TEST (SARS-CoV-2 test). On 20-Jun-2021, PYREXIA (a fever that came and went) had resolved. At the time of the report, DECREASED APPETITE (loss of appetite), COUGH (a cough), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose of vaccine 14 days after she would be tested negative for Covid.), SARS-COV-2 TEST (SARS-CoV-2 test) and FATIGUE (fatigue) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Relevant concomitant medications were not reported. Treatment medication was not provided. Most recent FOLLOW-UP information incorporated above includes: On 21-Jul-2021: Updated reporter email . Event COVID 19

Other Meds:

Current Illness:

ID: 1643088
Sex: F
Age: 61
State: CA

Vax Date: 06/22/2021
Onset Date: 06/23/2021
Rec V Date: 08/28/2021
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: Excessive perspiration; Pus emiting from vagina; Pus emiting from rectum; left leg and arm were edematous - edema left ankle; Warmth sensation came over my body; Burning lower back pain; Legs are kinda tingly, tingly BLE, tingling in arm; Numbness in hip and groin area ,pelvic area down to toes; This case was initially received via Regulatory Authority (Reference number: 21-114868) on 23-Jun-2021. The most recent information was received on 23-Jun-2021 and was forwarded to Moderna on 23-Jun-2021. This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Warmth sensation came over my body), BACK PAIN (Burning lower back pain), PARAESTHESIA (Legs are kinda tingly, tingly BLE, tingling in arm), HYPOAESTHESIA (Numbness in hip and groin area ,pelvic area down to toes) and OEDEMA PERIPHERAL (left leg and arm were edematous - edema left ankle) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040821A) for COVID-19 immunization. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Diverticulosis since 21-Jun-2020, Seasonal allergy, Penicillin allergy and UTI since 21-Jun-2021. Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) from 18-Jun-2012 to an unknown date for Allergy, CYANOCOBALAMIN (B12 1000 SR) from 21-Jan-2021 to 15-Jun-2021 for an unknown indication. On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jun-2021, the patient experienced BURNING SENSATION (Warmth sensation came over my body), BACK PAIN (Burning lower back pain), PARAESTHESIA (Legs are kinda tingly, tingly BLE, tingling in arm) and HYPOAESTHESIA (Numbness in hip and groin area ,pelvic area down to toes). On 25-Jun-2021, the patient experienced OEDEMA PERIPHERAL (left leg and arm were edematous - edema left ankle). On 17-Jul-2021, the patient experienced VAGINAL DISCHARGE (Pus emiting from vagina) and DISCHARGE (Pus emiting from rectum). On an unknown date, the patient experienced HYPERHIDROSIS (Excessive perspiration). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency and CIPROFLOXACIN (CIPRO [CIPROFLOXACIN]) ongoing since an unknown date for Edema, at an unspecified dose and frequency. At the time of the report, BURNING SENSATION (Warmth sensation came over my body), BACK PAIN (Burning lower back pain), PARAESTHESIA (Legs are kinda tingly, tingly BLE, tingling in arm), HYPOAESTHESIA (Numbness in hip and groin area ,pelvic area down to toes), OEDEMA PERIPHERAL (left leg and arm were edematous - edema left ankle), VAGINAL DISCHARGE (Pus emiting from vagina), DISCHARGE (Pus emiting from rectum) and HYPERHIDROSIS (Excessive perspiration) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient is expecting the 2nd dose of vaccine on 27 JUL 2021. Concomitant Medications were not provided by the reporter. Treatment information was not provided by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Follow up received contains significant information: Reporter information, patient information such as DOB, age, gender, medical history such as historical condition, vaccine information added. On 22-Jul-2021: Follow up received contains significant information : medical history added, concomitant medication added On 02-Aug-2021: Follow-up information received contains Significant information Medical information and Concomitant medication and treatment medication added, events added and dose 1 batch number information added and patient demographic information added.

Other Meds: ALLEGRA; B12 1000 SR

Current Illness: Diverticulosis; Penicillin allergy; Seasonal allergy; UTI

ID: 1643089
Sex: F
Age: 61
State: CA

Vax Date: 06/22/2021
Onset Date: 06/23/2021
Rec V Date: 08/28/2021
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: Warmth sensation came over her body; Burning lower back pain; Her legs feel tingly; Arms hurt; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Warmth sensation came over her body), BACK PAIN (Burning lower back pain), PARAESTHESIA (Her legs feel tingly) and PAIN IN EXTREMITY (Arms hurt) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Diverticulosis. Concomitant products included FEXOFENADINE HYDROCHLORIDE (ALLEGRA) for an unknown indication. On 22-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jun-2021, the patient experienced FEELING HOT (Warmth sensation came over her body), BACK PAIN (Burning lower back pain), PARAESTHESIA (Her legs feel tingly) and PAIN IN EXTREMITY (Arms hurt). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at a dose of 1 dosage form. At the time of the report, FEELING HOT (Warmth sensation came over her body), BACK PAIN (Burning lower back pain), PARAESTHESIA (Her legs feel tingly) and PAIN IN EXTREMITY (Arms hurt) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds: ALLEGRA

Current Illness: Diverticulosis

ID: 1643090
Sex: M
Age: 73
State: TN

Vax Date: 02/08/2021
Onset Date: 02/08/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: felt like he had the flu; felt sick; Headache; fever; Aches; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (felt like he had the flu), ILLNESS (felt sick), HEADACHE (Headache), PYREXIA (fever) and MYALGIA (Aches) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. No Medication history was reported by the provider. Concomitant products included CHLORPHENAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE (CORICIDIN HBP COUGH & COLD), PARACETAMOL (TYLENOL) and NAPROXEN SODIUM (ALEVE) for an unknown indication. 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 INFLUENZA LIKE ILLNESS (felt like he had the flu), ILLNESS (felt sick), HEADACHE (Headache), PYREXIA (fever) and MYALGIA (Aches). On 13-Feb-2021, INFLUENZA LIKE ILLNESS (felt like he had the flu), ILLNESS (felt sick), PYREXIA (fever) and MYALGIA (Aches) had resolved. At the time of the report, HEADACHE (Headache) was resolving. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No Treatment medications were reported. This case was linked to MOD-2021-232713 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 23-Jun-2021: Added demographic details- age, gender and Date of birth

Other Meds: CORICIDIN HBP COUGH & COLD; TYLENOL; ALEVE

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am