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: 1634953
Sex: F
Age:
State: NY

Vax Date: 01/20/2021
Onset Date: 01/20/2021
Rec V Date: 08/26/2021
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 Name: Heart Rate; Result Unstructured Data: low

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: wasn't able to really exercise, started to feel feverish, ill, wasn't able to work; body ache; nauseous; fever 102.2 ?F; joint pain; chills; fatigue; pain under armpit; became increadibly ill; lymph node pain; headache; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of MALAISE (became increadibly ill), HEART RATE (low hear rate), LYMPH NODE PAIN (lymph node pain), HEADACHE (headache) and MALAISE (wasn't able to really exercise, started to feel feverish, ill, wasn't able to work) in a 34-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 COVID-19 (Had Covid-19 infection in March 2020.) in March 2020. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced MALAISE (became increadibly ill), LYMPH NODE PAIN (lymph node pain), HEADACHE (headache), PAIN (body ache), NAUSEA (nauseous), PYREXIA (fever 102.2 ?F), ARTHRALGIA (joint pain), CHILLS (chills), FATIGUE (fatigue) and AXILLARY PAIN (pain under armpit). On an unknown date, the patient experienced HEART RATE (low hear rate) and MALAISE (wasn't able to really exercise, started to feel feverish, ill, wasn't able to work). On 22-Jan-2021, MALAISE (became increadibly ill), PAIN (body ache), PYREXIA (fever 102.2 ?F), ARTHRALGIA (joint pain) and CHILLS (chills) had resolved. At the time of the report, LYMPH NODE PAIN (lymph node pain), MALAISE (wasn't able to really exercise, started to feel feverish, ill, wasn't able to work), NAUSEA (nauseous), FATIGUE (fatigue) and AXILLARY PAIN (pain under armpit) outcome was unknown and HEADACHE (headache) 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. Patient is 5 months Post Partum and not Breast feeding. Treatment Medicines include Motrin and Tylenol

Other Meds:

Current Illness:

ID: 1634954
Sex: F
Age: 34
State: AL

Vax Date: 01/06/2021
Onset Date: 01/07/2021
Rec V Date: 08/26/2021
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: Flu like symptoms; Body aches; Headaches; Low fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Body aches), HEADACHE (Headaches) and PYREXIA (Low fever) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Body aches), HEADACHE (Headaches) and PYREXIA (Low fever). On 09-Jan-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms), PAIN (Body aches), HEADACHE (Headaches) and PYREXIA (Low fever) 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 reported. No treatment medications were provided by the reporter.

Other Meds:

Current Illness:

ID: 1634955
Sex: F
Age:
State: MS

Vax Date: 01/27/2021
Onset Date: 01/28/2021
Rec V Date: 08/26/2021
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: itching; Muscle spasms; body aches; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itching), MUSCLE SPASMS (Muscle spasms), PAIN (body aches) and FATIGUE (fatigue) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced PRURITUS (itching), MUSCLE SPASMS (Muscle spasms), PAIN (body aches) and FATIGUE (fatigue). At the time of the report, PRURITUS (itching), MUSCLE SPASMS (Muscle spasms), PAIN (body aches) and FATIGUE (fatigue) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were provided by the reporter. This case was linked to US-MODERNATX, INC.-MOD-2021-022474, US-MODERNATX, INC.-MOD-2021-047944 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-047944:Crosslinked (MOD21-018111) US-MODERNATX, INC.-MOD-2021-022474:Crosslinked (MOD21-018111)

Other Meds:

Current Illness:

ID: 1634956
Sex: M
Age: 69
State: NJ

Vax Date: 01/05/2021
Onset Date:
Rec V Date: 08/26/2021
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: little pain at site of injection; headache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (little pain at site of injection) and HEADACHE (headache) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (little pain at site of injection) and HEADACHE (headache). At the time of the report, VACCINATION SITE PAIN (little pain at site of injection) and HEADACHE (headache) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1634957
Sex: M
Age: 66
State: AK

Vax Date: 01/02/2021
Onset Date: 01/03/2021
Rec V Date: 08/26/2021
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: 2021; Test Name: Blood test; Result Unstructured Data: Low.HCT level has been low.

Allergies:

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

Symptoms: Diarrhea; HCT level has been low; Patient states that his butt hurt.; tired; Soreness in the arm; A spontaneous report (United States) was received from a Consumer concerning a 66 years old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events soreness in the arm(Pain in extremity), tired(Fatigue), diarrhea, patient states that his butt hurt(Musculoskeletal pain), hct level has been low(Haematocrit decreased). The patient's medical history was not provided. No relevant concomitant medications were reported. On 2 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 arm for prophylaxis of COVID-19 infection. On 3 Jan 2021, the patient experienced the events soreness in the arm. tired. On an unknown date, the patient experienced the events Diarrhea. Patient states that his butt hurt., HCT level has been low. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. On an unknown date the outcome of events, soreness in the arm, tired, diarrhea, patient states that his butt hurt, hct level has been lowwas not reported.

Other Meds:

Current Illness:

ID: 1634958
Sex: M
Age: 93
State: MI

Vax Date: 01/20/2021
Onset Date:
Rec V Date: 08/26/2021
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: minor soreness at the injection site; minor tenderness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (minor soreness at the injection site) and VACCINATION SITE PAIN (minor tenderness at the injection site) in a 93-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. Concurrent medical conditions included Cholesterol and Glaucoma. Concomitant products included IBUPROFEN for Pain. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (minor soreness at the injection site) and VACCINATION SITE PAIN (minor tenderness at the injection site). At the time of the report, VACCINATION SITE PAIN (minor soreness at the injection site) and VACCINATION SITE PAIN (minor tenderness at the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant information provided. No treatment information provided.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.

Other Meds: IBUPROFEN

Current Illness: Cholesterol; Glaucoma

ID: 1634959
Sex: F
Age: 78
State: AZ

Vax Date: 01/20/2021
Onset Date: 01/20/2021
Rec V Date: 08/26/2021
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: Swelling; Red area; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE SWELLING (Swelling) and INJECTION SITE ERYTHEMA (Red area) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy (beta blockers and other drugs). Concomitant products included DILTIAZEM, APIXABAN (ELIQUIS), FLECAINIDE, ALENDRONATE SODIUM (FOSAMAX), PANTOPRAZOLE SODIUM SESQUIHYDRATE (PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE]) and TELMISARTAN (MICARDIS) for an unknown indication. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced INJECTION SITE SWELLING (Swelling) and INJECTION SITE ERYTHEMA (Red area). At the time of the report, INJECTION SITE SWELLING (Swelling) and INJECTION SITE ERYTHEMA (Red area) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was reported.

Other Meds: DILTIAZEM; ELIQUIS; FLECAINIDE; FOSAMAX; PROTONIX [PANTOPRAZOLE SODIUM SESQUIHYDRATE]; MICARDIS

Current Illness:

ID: 1634960
Sex: F
Age: 79
State: AR

Vax Date: 02/01/2021
Onset Date: 02/01/2021
Rec V Date: 08/26/2021
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: big bruise at injection site; some pain during the night; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (some pain during the night) and INJECTION SITE BRUISING (big bruise at injection site) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, the patient experienced PAIN (some pain during the night). On 02-Feb-2021, the patient experienced INJECTION SITE BRUISING (big bruise at injection site). At the time of the report, PAIN (some pain during the night) and INJECTION SITE BRUISING (big bruise at injection site) outcome was unknown. Not provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Products known to have been used by the patient were medicines for high blood pressure, to help her urinate and for "palpitations" of the heart. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1634961
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
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: Hospital; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Feb-2021 and was forwarded to Moderna on 04-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of NOSOCOMIAL INFECTION (Hospital) 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 an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced NOSOCOMIAL INFECTION (Hospital). At the time of the report, NOSOCOMIAL INFECTION (Hospital) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1634962
Sex: M
Age: 41
State: IL

Vax Date: 01/22/2021
Onset Date: 01/23/2021
Rec V Date: 08/26/2021
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: chest pain; shortness of breath; HEADACHE; CHILLS; A spontaneous report was received from a Consumer concerning a 41-years-old male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events headache, chills, chest pain, shortness of breath. The patient's medical history was not provided. Concomitant medications reported were Supplements for unknown indication. On 22 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 arm for prophylaxis of COVID-19 infection. On 23 Jan 2021, the patient experienced the event(s) headache . On 23 Jan 2021, the patient experienced the event(s) chills . On 23 Jan 2021, the patient experienced the event(s) chest pain . On 23 Jan 2021, the patient experienced the event(s) shortness of breath. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event(s), headache was unknown.The outcome of event(s), chills was unknown.The outcome of event(s), chest pain was unknown.The outcome of event(s), shortness of breath was unknown..

Other Meds: Supplements

Current Illness:

ID: 1634963
Sex: F
Age: 74
State:

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 08/26/2021
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: Arm was really sore and hurting when I touched; arm was really red; Feeling itching; Hardness; A spontaneous report was received from a Healthcare Professional concerning a 74-years-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events arm was really sore, really red, hurting when touched, still have redness today after 12 days, itching, hardness. The patient's medical history was not provided. No relevant concomitant medications were reported. On 21 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 043L20A) intramuscularly for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced arm was really sore, really red, hurting when touched, still have redness today after 12 days, On 21 Jan 2021, the patient experienced itching, hardness. Treatment details not ncluded Action taken with mRNA-1273 in response to the events was not reported. The outcome of events arm was really sore, really red, hurting when touched,still have redness today after 12 days,itching, hardness as unknown..

Other Meds:

Current Illness:

ID: 1634964
Sex: M
Age: 81
State: NJ

Vax Date: 01/27/2021
Onset Date:
Rec V Date: 08/26/2021
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: mild chills; soreness near the injection site; temperature of 100.3; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHILLS (mild chills), VACCINATION SITE PAIN (soreness near the injection site) and PYREXIA (temperature of 100.3) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Arthritis (arthritis pain). Concomitant products included NAPROXEN SODIUM (ALEVE) for Arthritis, METFORMIN and ATORVASTATIN CALCIUM (ATORVASTIN) for an unknown indication. On 27-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced CHILLS (mild chills), VACCINATION SITE PAIN (soreness near the injection site) and PYREXIA (temperature of 100.3). At the time of the report, CHILLS (mild chills), VACCINATION SITE PAIN (soreness near the injection site) and PYREXIA (temperature of 100.3) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. CONCOMITANT MEDICATION INCLUDE WATER PILL,METFORMIN,ATORVASTIN

Other Meds: ALEVE; METFORMIN; ATORVASTIN

Current Illness:

ID: 1634965
Sex: F
Age: 78
State: MD

Vax Date: 01/19/2021
Onset Date: 01/19/2021
Rec V Date: 08/26/2021
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: swelling of the upper arm up to the shoulder; he injection site began to itch profusely (terrible itching); intense redness on the arm; pain on her arm; soreness on the arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PERIPHERAL SWELLING (swelling of the upper arm up to the shoulder), VACCINATION SITE PRURITUS (he injection site began to itch profusely (terrible itching)), PAIN IN EXTREMITY (soreness on the arm), ERYTHEMA (intense redness on the arm) and HEADACHE (pain on her arm) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event. Concomitant products included METFORMIN, ATORVASTATIN CALCIUM (LIPITOR), MULTIVITAMIN & MINERAL, CYANOCOBALAMIN (B12 1000 SR), CALCIUM, MAGNESIUM and ZINC for an unknown indication. On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced PAIN IN EXTREMITY (soreness on the arm). On 22-Jan-2021, the patient experienced PERIPHERAL SWELLING (swelling of the upper arm up to the shoulder), VACCINATION SITE PRURITUS (he injection site began to itch profusely (terrible itching)), ERYTHEMA (intense redness on the arm) and HEADACHE (pain on her arm). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE, PARACETAMOL, PHENYLEPHRINE HYDROCHLORIDE (BENADRYL ALLERGY & COLD) at a dose of 1 dosage form. At the time of the report, PERIPHERAL SWELLING (swelling of the upper arm up to the shoulder), VACCINATION SITE PRURITUS (he injection site began to itch profusely (terrible itching)), PAIN IN EXTREMITY (soreness on the arm), ERYTHEMA (intense redness on the arm) and HEADACHE (pain on her arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds: METFORMIN; LIPITOR; MULTIVITAMIN & MINERAL; B12 1000 SR; CALCIUM; MAGNESIUM; ZINC

Current Illness:

ID: 1634966
Sex: M
Age: 75
State: WI

Vax Date: 01/22/2021
Onset Date: 02/19/2021
Rec V Date: 08/26/2021
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: It is very tender; Swelling and puffing; It is very sore when in motion; Awaken with arthralgia right elbow; Sleepiness; Fatigue; This spontaneous case was reported by a health care professional and describes the occurrence of SOMNOLENCE (Sleepiness), TENDERNESS (It is very tender), SWELLING (Swelling and puffing), PAIN (It is very sore when in motion) and FATIGUE (Fatigue) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 030L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included ACETYLSALICYLIC ACID, CAFFEINE, CARBINOXAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE (CAPRAMIN [ACETYLSALICYLIC ACID;CAFFEINE;CARBINOXAMINE MALEATE;PHENYLEPHRINE HYDROCHLORIDE]), ATORVASTATIN, METOPROLOL, DOFETILIDE (TIKOSYN), RIVAROXABAN (XARELTO) and OMEPRAZOLE for an unknown indication. On 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Feb-2021, the patient experienced SOMNOLENCE (Sleepiness) and FATIGUE (Fatigue). On 22-Feb-2021, the patient experienced TENDERNESS (It is very tender), SWELLING (Swelling and puffing), PAIN (It is very sore when in motion) and ARTHRALGIA (Awaken with arthralgia right elbow). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. On 19-Feb-2021, SOMNOLENCE (Sleepiness) and FATIGUE (Fatigue) had resolved. At the time of the report, TENDERNESS (It is very tender), SWELLING (Swelling and puffing), PAIN (It is very sore when in motion) and ARTHRALGIA (Awaken with arthralgia right elbow) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. This case was linked to MODERNATX, INC.-MOD-2021-020521 (E2B Linked Report).; Sender's Comments: MODERNATX, INC.-MOD-2021-020521:Same patient, 1st dose

Other Meds: CAPRAMIN [ACETYLSALICYLIC ACID;CAFFEINE;CARBINOXAMINE MALEATE;PHENYLEPHRINE HYDROCHLORIDE]; ATORVASTATIN; METOPROLOL; TIKOSYN; XARELTO; OMEPRAZOLE.

Current Illness:

ID: 1634967
Sex: F
Age: 57
State: KS

Vax Date: 03/01/2021
Onset Date: 03/01/2021
Rec V Date: 08/26/2021
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: Sore arm; Body aches/ Muscle aches/ Pain; Headache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Mar-2021 and was forwarded to Moderna on 02-Mar-2021. This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm), MYALGIA (Body aches/ Muscle aches/ Pain) and HEADACHE (Headache) in a 57-year-old female 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 01-Mar-2021, the patient experienced PAIN IN EXTREMITY (Sore arm), MYALGIA (Body aches/ Muscle aches/ Pain) and HEADACHE (Headache). At the time of the report, PAIN IN EXTREMITY (Sore arm), MYALGIA (Body aches/ Muscle aches/ Pain) and HEADACHE (Headache) outcome was unknown. Patient received 2nd Moderna vaccine 01Mar2021 on left arm. She had body aches, pain, muscle aches, a sore arm, and a headache. She wanted to know if she could take an aspirin.

Other Meds:

Current Illness:

ID: 1634968
Sex: M
Age: 72
State: CO

Vax Date: 01/26/2021
Onset Date: 01/27/2021
Rec V Date: 08/26/2021
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: 2021; Test Name: covid-19; Test Result: Positive ; Result Unstructured Data: positive

Allergies:

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

Symptoms: Next day woke up with shiver; Couldn't get out of bed; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Next day woke up with shiver) and FATIGUE (Couldn't get out of bed) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. Concurrent medical conditions included Thyroid disorder NOS, Prostate adenoma and Kidney disorder. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced CHILLS (Next day woke up with shiver) and FATIGUE (Couldn't get out of bed). At the time of the report, CHILLS (Next day woke up with shiver) and FATIGUE (Couldn't get out of bed) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, COVID-19: positive Positive.

Other Meds:

Current Illness: Kidney disorder; Prostate adenoma; Thyroid disorder NOS

ID: 1634969
Sex: M
Age: 51
State: NC

Vax Date: 01/26/2021
Onset Date: 01/26/2021
Rec V Date: 08/26/2021
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: sore arm; lethargic; weak; tired; achy; not feel well; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), LETHARGY (lethargic), ASTHENIA (weak), FATIGUE (tired) and PAIN (achy) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunisation. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced PAIN IN EXTREMITY (sore arm), LETHARGY (lethargic), ASTHENIA (weak), FATIGUE (tired), PAIN (achy) and MALAISE (not feel well). At the time of the report, PAIN IN EXTREMITY (sore arm), LETHARGY (lethargic), ASTHENIA (weak), FATIGUE (tired), PAIN (achy) and MALAISE (not feel well) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment and concomitant medications were not provided by reporter.

Other Meds:

Current Illness:

ID: 1634970
Sex: F
Age:
State: GA

Vax Date: 01/16/2021
Onset Date: 01/19/2021
Rec V Date: 08/26/2021
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: arm was red like the size of a baseball and it itched; itching a little bit; red spot with a circle around where got injection; This spontaneous case was reported by a physician (subsequently medically confirmed) and describes the occurrence of RASH PRURITIC (arm was red like the size of a baseball and it itched), PRURITUS (itching a little bit) and VACCINATION SITE ERYTHEMA (red spot with a circle around where got injection) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 028L20A) for COVID-19 vaccination. No Medical History was provided by the reporter. On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced RASH PRURITIC (arm was red like the size of a baseball and it itched), PRURITUS (itching a little bit) and VACCINATION SITE ERYTHEMA (red spot with a circle around where got injection). The patient was treated with CORTISONE for Adverse event, at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (arm was red like the size of a baseball and it itched) and PRURITUS (itching a little bit) had resolved and VACCINATION SITE ERYTHEMA (red spot with a circle around where got injection) 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. Concomitant product use was not provided by the reporter.

Other Meds:

Current Illness:

ID: 1634971
Sex: M
Age:
State:

Vax Date: 01/24/2021
Onset Date: 01/24/2021
Rec V Date: 08/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: redness; pain in the injection site; itchiness; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchiness), ERYTHEMA (redness) and PAIN (pain in the injection site) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. unknown) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jan-2021, the patient experienced PRURITUS (itchiness). On an unknown date, the patient experienced ERYTHEMA (redness) and PAIN (pain in the injection site). At the time of the report, PRURITUS (itchiness), ERYTHEMA (redness) and PAIN (pain in the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1634972
Sex: F
Age: 78
State: MD

Vax Date: 02/16/2021
Onset Date: 02/16/2021
Rec V Date: 08/26/2021
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: Erythema; Dizziness; Developed, within 20 minutes, quick, fast heartbeat up to 120 beats per minute; Had some irregularity; This spontaneous case was reported by a physician and describes the occurrence of HEART RATE INCREASED (Developed, within 20 minutes, quick, fast heartbeat up to 120 beats per minute), HEART RATE IRREGULAR (Had some irregularity), ERYTHEMA (Erythema) and DIZZINESS (Dizziness) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 16-Feb-2021 at 10:55 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced HEART RATE INCREASED (Developed, within 20 minutes, quick, fast heartbeat up to 120 beats per minute) and HEART RATE IRREGULAR (Had some irregularity). On 17-Feb-2021, the patient experienced ERYTHEMA (Erythema) and DIZZINESS (Dizziness). At the time of the report, HEART RATE INCREASED (Developed, within 20 minutes, quick, fast heartbeat up to 120 beats per minute), HEART RATE IRREGULAR (Had some irregularity), ERYTHEMA (Erythema) and DIZZINESS (Dizziness) 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 reported. No treatment information provided. Most recent FOLLOW-UP information incorporated above includes: On 25-Feb-2021: No specific follow-up information recorded.

Other Meds:

Current Illness:

ID: 1634973
Sex: M
Age:
State: AL

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
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: 32 hours later, broke out in rash on my chest between the nipples; small rash between my nipples like a pimple; This spontaneous case was reported by a consumer and describes the occurrence of RASH (32 hours later, broke out in rash on my chest between the nipples) and RASH (small rash between my nipples like a pimple) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J20A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included SIMVASTATIN (ZOCOR) and RIVAROXABAN (XARELTO) 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 RASH (32 hours later, broke out in rash on my chest between the nipples) and RASH (small rash between my nipples like a pimple). At the time of the report, RASH (32 hours later, broke out in rash on my chest between the nipples) and RASH (small rash between my nipples like a pimple) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.

Other Meds: ZOCOR; XARELTO

Current Illness:

ID: 1634974
Sex: M
Age: 65
State:

Vax Date: 01/26/2021
Onset Date:
Rec V Date: 08/26/2021
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: Severe Headache; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Severe Headache) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Severe Headache). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Headache, at an unspecified dose and frequency. At the time of the report, HEADACHE (Severe Headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported.

Other Meds:

Current Illness:

ID: 1634975
Sex: F
Age: 88
State: OH

Vax Date: 01/26/2021
Onset Date: 01/26/2021
Rec V Date: 08/26/2021
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: Feeling hot; diarrhea; cramping; Chills; headache; Teeth hurting; Sore arm; a lot of itching; red mark(size of a quarter) at injection site; A spontaneous report (United States) was received from a consumer concerning a 88-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events chills, headache, teeth hurting, sore arm, a lot of itching, red mark(size of a quarter) at injection site, diarrhea, cramping. The patient's medical history was not provided. Concomitant medications reported were HBP Medication, Allergy Medication, Antianxiety Medication ,vitamins(centrum silver),vitamin D,calcium+Z for drug use for unknown indication. On 26 Jan 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 26 Jan 2021, the patient experienced the event(s) chills, headache, teeth hurting, sore arm, a lot of itching, red mark(size of a quarter) at injection site. On 4 Feb 2021, the patient experienced the event(s) diarrhea, cramping. Treatment details included Tylenol. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event(s), chills, headache, teeth hurting, sore arm, a lot of itching, red mark(size of a quarter) at injection site was unknown and the event diarrhea, cramping was resolving. Based on MSA comment Feeling hot coded to Vaccination site warm, Pain in extremity coded to Vaccination site pain and Injection site erythema coded to Vaccination site erythema

Other Meds:

Current Illness:

ID: 1634976
Sex: F
Age:
State:

Vax Date: 01/23/2021
Onset Date: 01/24/2021
Rec V Date: 08/26/2021
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: A redness at the injection site; It is raised at the injection site; it is itchy at the injection site; Feeling hot; A spontaneous report was received from a consumer concerning a 54-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events vaccination site erythema, vaccination site pruritus ans vaccination site swelling. The patient's medical history was not provided. No relevant concomitant medications were provided. On 23 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 007M20A) via unknown route in right hip for prophylaxis of COVID-19 infection. On the next day 24 Jan 2021 patient developed a redness at the injection site, it was raised and itchy . No treatment details were reported. Action taken with mRNA-1273 in response to the events was unknown. The outcome of event(s), redness at the injection site, it was raised and itchy were considered as not recovered. Based on MSA comment, Feeling hot coded as Vaccination site warmth

Other Meds:

Current Illness:

ID: 1634977
Sex: F
Age: 58
State: TX

Vax Date: 01/20/2021
Onset Date: 01/20/2021
Rec V Date: 08/26/2021
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: it's warm to the touch; there's still some hardness to it; it was bright red; their arm was 2 by 3 inches red; it was raised; it was painful; did not feet well; chest was tight; it was itchy; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (their arm was 2 by 3 inches red), PERIPHERAL SWELLING (it was raised), PRURITUS (it was itchy), PAIN IN EXTREMITY (it was painful) and MALAISE (did not feet well) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Penicillin allergy. Concomitant products included FENOFIBRATE and LEVOTHYROXINE SODIUM (SYNTHROID) for an unknown indication. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Jan-2021, the patient experienced PRURITUS (it was itchy), MALAISE (did not feet well) and CHEST DISCOMFORT (chest was tight). On 28-Jan-2021, the patient experienced ERYTHEMA (their arm was 2 by 3 inches red), PERIPHERAL SWELLING (it was raised), PAIN IN EXTREMITY (it was painful) and VACCINATION SITE ERYTHEMA (it was bright red). On an unknown date, the patient experienced VACCINATION SITE WARMTH (it's warm to the touch) and VACCINATION SITE INDURATION (there's still some hardness to it). At the time of the report, ERYTHEMA (their arm was 2 by 3 inches red), PERIPHERAL SWELLING (it was raised), PRURITUS (it was itchy), PAIN IN EXTREMITY (it was painful), MALAISE (did not feet well), CHEST DISCOMFORT (chest was tight) and VACCINATION SITE ERYTHEMA (it was bright red) had not resolved and VACCINATION SITE WARMTH (it's warm to the touch) and VACCINATION SITE INDURATION (there's still some hardness to it) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. In treatment Topical steroid cream and increased the dosing of Sertac.

Other Meds: FENOFIBRATE; SYNTHROID

Current Illness:

ID: 1634978
Sex: F
Age: 79
State: FL

Vax Date: 02/15/2021
Onset Date: 02/16/2021
Rec V Date: 08/26/2021
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: A little hard at injection site; A little itchy at injection site; A little sore where the injection site was; little red at injection site; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE INDURATION (A little hard at injection site), INJECTION SITE PRURITUS (A little itchy at injection site), INJECTION SITE PAIN (A little sore where the injection site was) and INJECTION SITE ERYTHEMA (little red at injection site) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Feb-2021, the patient experienced INJECTION SITE INDURATION (A little hard at injection site), INJECTION SITE PRURITUS (A little itchy at injection site), INJECTION SITE PAIN (A little sore where the injection site was) and INJECTION SITE ERYTHEMA (little red at injection site). At the time of the report, INJECTION SITE INDURATION (A little hard at injection site), INJECTION SITE PRURITUS (A little itchy at injection site), INJECTION SITE PAIN (A little sore where the injection site was) and INJECTION SITE ERYTHEMA (little red at injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient reported that it was a little red where the injection site occurred, it was little itchy where the injection site occurred, and it was little hard where the injection site occurred. Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: TCR Received: patient she says she is all good and doesn't want frutherfollow up.

Other Meds:

Current Illness:

ID: 1634979
Sex: F
Age: 70
State: TX

Vax Date: 02/01/2021
Onset Date: 02/03/2021
Rec V Date: 08/26/2021
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: body aches; weakness; chills; headaches; fever of 102.5; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (body aches), ASTHENIA (weakness), CHILLS (chills), HEADACHE (headaches) and PYREXIA (fever of 102.5) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. Concomitant products included ATORVASTATIN and LEVOTHYROXINE for an unknown indication. On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Feb-2021, the patient experienced PAIN (body aches), ASTHENIA (weakness), CHILLS (chills), HEADACHE (headaches) and PYREXIA (fever of 102.5). At the time of the report, PAIN (body aches), ASTHENIA (weakness), CHILLS (chills), HEADACHE (headaches) and PYREXIA (fever of 102.5) 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. Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Chills, headache and fever are consistent with the known safety profile of mRNA-1273.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Chills, headache and fever are consistent with the known safety profile of mRNA-1273.

Other Meds: ATORVASTATIN; LEVOTHYROXINE

Current Illness:

ID: 1634980
Sex: M
Age: 48
State: PA

Vax Date: 02/15/2021
Onset Date: 02/15/2021
Rec V Date: 08/26/2021
Hospital:

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

Lab Data: Test Date: 20210216; Test Name: COVID-19 test; Test Result: Positive ; Result Unstructured Data: positive

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: Tested positive for COVID-19; Diarrhea; Rash; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID-19), DIARRHOEA (Diarrhea), RASH (Rash) and FATIGUE (Fatigue) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. Concurrent medical conditions included COVID-19 since 16-Feb-2021 and No adverse event. On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 15-Feb-2021, the patient experienced DIARRHOEA (Diarrhea), RASH (Rash) and FATIGUE (Fatigue). On 16-Feb-2021, the patient experienced COVID-19 (Tested positive for COVID-19). On 18-Feb-2021, DIARRHOEA (Diarrhea), RASH (Rash) and FATIGUE (Fatigue) had resolved. At the time of the report, COVID-19 (Tested positive for COVID-19) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Feb-2021, SARS-CoV-2 test: positive (Positive) positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. This case was linked to MOD-2021-096144 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 22-Apr-2021: Not specified On 29-Apr-2021: contact information updated

Other Meds:

Current Illness: COVID-19

ID: 1634981
Sex: F
Age: 77
State: VT

Vax Date: 02/10/2021
Onset Date: 02/10/2021
Rec V Date: 08/26/2021
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: big, itchy patches all over both of my legs; site of the injection was really hot, red, and itchy; site of the injection was really hot, red, and itchy; site of the injection was really hot, red, and itchy; Little lump; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE MASS (Little lump), PRURITUS (big, itchy patches all over both of my legs), VACCINATION SITE WARMTH (site of the injection was really hot, red, and itchy), VACCINATION SITE PRURITUS (site of the injection was really hot, red, and itchy) and VACCINATION SITE ERYTHEMA (site of the injection was really hot, red, and itchy) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. No Medical History information was reported. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, the patient experienced VACCINATION SITE MASS (Little lump). On 18-Feb-2021, the patient experienced VACCINATION SITE WARMTH (site of the injection was really hot, red, and itchy), VACCINATION SITE PRURITUS (site of the injection was really hot, red, and itchy) and VACCINATION SITE ERYTHEMA (site of the injection was really hot, red, and itchy). On an unknown date, the patient experienced PRURITUS (big, itchy patches all over both of my legs). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 22-Feb-2021 at an unspecified dose and frequency. At the time of the report, VACCINATION SITE MASS (Little lump), VACCINATION SITE WARMTH (site of the injection was really hot, red, and itchy), VACCINATION SITE PRURITUS (site of the injection was really hot, red, and itchy) and VACCINATION SITE ERYTHEMA (site of the injection was really hot, red, and itchy) outcome was unknown and PRURITUS (big, itchy patches all over both of my legs) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. This case was linked to MOD-2021-096058 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: The event pruritis outcome was changed from unknown to not recovered.

Other Meds:

Current Illness:

ID: 1634982
Sex: F
Age: 68
State:

Vax Date: 02/19/2021
Onset Date: 02/19/2021
Rec V Date: 08/26/2021
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: fever; chills; achy all over; painful arm at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever), CHILLS (chills), PAIN (achy all over) and VACCINATION SITE PAIN (painful arm at the injection site) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. No Medical History was provided by the reporter. On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced PYREXIA (fever), CHILLS (chills), PAIN (achy all over) and VACCINATION SITE PAIN (painful arm at the injection site). At the time of the report, PYREXIA (fever), CHILLS (chills), PAIN (achy all over) and VACCINATION SITE PAIN (painful arm at the injection site) outcome was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1634983
Sex: M
Age: 78
State: AR

Vax Date: 01/20/2021
Onset Date: 02/25/2021
Rec V Date: 08/26/2021
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: Body Temperature; Result Unstructured Data: 100 F

Allergies:

Symptom List: Injection site pain

Symptoms: Patient felt sleepy; fever (100F); chills; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Patient felt sleepy), PYREXIA (fever (100F)), CHILLS (chills) and FATIGUE (fatigue) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022M20A and 042L20A) 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-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 25-Feb-2021, the patient experienced SOMNOLENCE (Patient felt sleepy), PYREXIA (fever (100F)), CHILLS (chills) and FATIGUE (fatigue). On 25-Feb-2021, PYREXIA (fever (100F)) had resolved. At the time of the report, SOMNOLENCE (Patient felt sleepy), CHILLS (chills) and FATIGUE (fatigue) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100 f (High) 100 F. Action taken with mRNA 1273 in response to event was not applicable. No concomitant medications reported. No treatment medications were provided

Other Meds:

Current Illness:

ID: 1634984
Sex: F
Age: 79
State: FL

Vax Date: 01/08/2021
Onset Date: 01/08/2021
Rec V Date: 08/26/2021
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: my shoulder blew up; it hurt when I touched it; had an allergic reaction to the shot; I can almost feel a little bit of hardness.; Past weekend, I woke up with something in my eye. My nose and my eyes tearing. I went through; 5 days after the shot, I felt symptoms of COVID.; it is sensitive to touch; arm was swelled, injection site swelled up for 2 weeks; red, not blood red but pink red. It was 2.5 inch below the injection site; Med Info Agent: Update to case number MOD21-16065 Per the contact on 22JUL2021, She has received 2 phone calls but was unable to understand the caller. She recognized the call was from moderna and received a number "MOD021-0256." Today they called back again, it was staff, she said she wanted to send me some kind of a form by email, but did not have my address. She received the both doses of the moderna covid-19 vaccine by injection to the left arm on 8JAN2021 (lot number 025J20A) and 5FEB2021 (lot number 028L20A). She originally called after the first dose because she had questions after she took the first shot. Swelling in her arm for a while, and it looked like an egg. She took the second shot and everything was fine. Her shoulder blew up, got swollen. It hurt when she touched it. It was like half of a ping pong ball. She thought she possibly had an allergic reaction to the shot and was worried about getting the second dose. The swelling did not go down until 1 month later. A doctor friend of her told her not to worry. She has a history of immune problems. Consented to follow up by safety. Caller does not want any additional personal information shared to anyone outside Moderna. Discussed sending information to the FDA and CDC through the VAERS program which she consented to as long as name and email are not included.

Other Meds:

Current Illness: Allergy multiple (Mild allergies to everything); Alopecia (Autoimmune disease); Lichen sclerosis atrophicus (Autoimmune disease); Penicillin allergy (two days after taking penicillin, she had black dots all over her body); Sclerosis multiple (Autoimmune disease)

ID: 1634986
Sex: F
Age: 66
State: TX

Vax Date: 12/30/2020
Onset Date: 01/27/2021
Rec V Date: 08/26/2021
Hospital:

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

Lab Data: Test Date: 20210127; Test Name: Body temperature

Allergies:

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

Symptoms: pain in arm; No appetite for a couple of days.; Swelling from my elbow to my shoulder; Entire site is hot; Angry red patch an inch below the injection site; chills; vaccination site swelling; This spontaneous case was reported by a patient and describes the occurrence of PAIN IN EXTREMITY (pain in arm), DECREASED APPETITE (No appetite for a couple of days.), SWELLING (Swelling from my elbow to my shoulder), VACCINATION SITE WARMTH (Entire site is hot) and VACCINATION SITE ERYTHEMA (Angry red patch an inch below the injection site) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041l20a and 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included B12 deficiency anemia and Angioplasty (HEART ANGIOPLASTY) on 19-Mar-2019. Previously administered products included for an unreported indication: B12 1000 SR on 02-Dec-2020. Concurrent medical conditions included Tetanus, Milk allergy, Allergy NOS (OFF INSECT SPRAY) and Blood pressure high since 15-Mar-2019. Concomitant products included LOSARTAN from 19-Mar-2019 to an unknown date and METOPROLOL from 19-Mar-2019 to an unknown date for Blood pressure high, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) from 19-Mar-2021 to an unknown date for Heart disorder, PARACETAMOL (TYLENOL) and FLUTICASONE for an unknown indication. On 30-Dec-2020 at 2:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jan-2021, the patient experienced PAIN IN EXTREMITY (pain in arm), DECREASED APPETITE (No appetite for a couple of days.), SWELLING (Swelling from my elbow to my shoulder), VACCINATION SITE WARMTH (Entire site is hot), VACCINATION SITE ERYTHEMA (Angry red patch an inch below the injection site), CHILLS (chills) and VACCINATION SITE SWELLING (vaccination site swelling). On 02-Feb-2021, SWELLING (Swelling from my elbow to my shoulder) and VACCINATION SITE WARMTH (Entire site is hot) had resolved. On 10-Feb-2021, PAIN IN EXTREMITY (pain in arm), DECREASED APPETITE (No appetite for a couple of days.), VACCINATION SITE ERYTHEMA (Angry red patch an inch below the injection site), CHILLS (chills) and VACCINATION SITE SWELLING (vaccination site swelling) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-Jan-2021, Body temperature: 101.4 f High. Treatment medications included Tylenol This case was linked to MOD21-15908, MOD-2021-025534 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 07-Apr-2021: Follow up received on 07-APR-2021 and added Med History updated and outcome of events updated

Other Meds: TYLENOL; LOSARTAN; METOPROLOL; ASPIRIN (E.C.); FLUTICASONE

Current Illness: Allergy NOS (OFF INSECT SPRAY); Blood pressure high; Milk allergy; Tetanus

ID: 1634987
Sex: M
Age: 47
State: NJ

Vax Date: 01/25/2021
Onset Date: 01/26/2021
Rec V Date: 08/26/2021
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: swollen under his armpit (on the same arm of the injection); Felt tired; This spontaneous case was reported by a health care professional and describes the occurrence of FATIGUE (Felt tired) and LYMPHADENOPATHY (swollen under his armpit (on the same arm of the injection)) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 25-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-2021, the patient experienced FATIGUE (Felt tired). On 28-Jan-2021, the patient experienced LYMPHADENOPATHY (swollen under his armpit (on the same arm of the injection)). At the time of the report, FATIGUE (Felt tired) and LYMPHADENOPATHY (swollen under his armpit (on the same arm of the injection)) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information provided. Concomitant medications not provided. Most recent FOLLOW-UP information incorporated above includes: On 28-Jan-2021: No new information added

Other Meds:

Current Illness:

ID: 1634988
Sex: F
Age: 69
State: TN

Vax Date: 01/01/2021
Onset Date: 01/01/2021
Rec V Date: 08/26/2021
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: Patient experienced redness at the injection site after her first vaccine done; This spontaneous case was reported by a non-health professional and describes the occurrence of VACCINATION SITE ERYTHEMA (Patient experienced redness at the injection site after her first vaccine done) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. No relevant medical history was reported. No relevant concomitant medications reported. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In January 2021, the patient experienced VACCINATION SITE ERYTHEMA (Patient experienced redness at the injection site after her first vaccine done). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE ERYTHEMA (Patient experienced redness at the injection site after her first vaccine done) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. treatment medication include antihistamine and Tylenol. This case was linked to MOD-2021-026810 (Patient Link).

Other Meds:

Current Illness:

ID: 1634989
Sex: M
Age:
State: FL

Vax Date: 02/11/2021
Onset Date: 02/14/2021
Rec V Date: 08/26/2021
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: 20210214; Test Name: blood test; Result Unstructured Data: normal; Test Date: 20210214; Test Name: CT scan; Result Unstructured Data: Normal

Allergies:

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

Symptoms: severe dizziness; nausea; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (severe dizziness) and NAUSEA (nausea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029K20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No adverse event reported). On 11-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Feb-2021, the patient experienced DIZZINESS (severe dizziness) and NAUSEA (nausea). On 14-Feb-2021, DIZZINESS (severe dizziness) and NAUSEA (nausea) had resolved. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Feb-2021, Blood test normal: normal. On 14-Feb-2021, Computerised tomogram: Normal.

Other Meds:

Current Illness:

ID: 1634990
Sex: F
Age: 87
State: CT

Vax Date: 01/26/2021
Onset Date: 01/31/2021
Rec V Date: 08/26/2021
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: Arm broke out on what looks like a sunburnt, it's red from the injection site down to the elbow; Shortness of breath; A spontaneous report was received from a consumer concerning a 87 year old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced shortness of breath/dyspnoea and arm broke out on what looks like a sunburnt, it's red from the injection site down to the elbow/erythema. The patient's medical history was not provided by the reporter. Concomitant medications included blood pressure medication and vitamins. On 26 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (Lot number: 029L20A) via an unknown route in the left arm for prophylaxis of COVID-19 infection. On 31 Jan 2021, fifth day of injection, the patient started experiencing shortness of breath that lasted two days. On 05 Feb 2021, tenth day of injection the patient's arm broke out on what looks like a sunburnt, it's red from the injection site down to the elbow. Treatment for the events were reported as none. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the event shortness of breath was reported as resolved on 02 Feb 2021. The outcome of the event arm broke out on what looks like a sunburnt, it's red from the injection site down to the elbow was unknown.

Other Meds: VITAMINS [ASCORBIC ACID;ERGOCALCIFEROL;NICOTINAMIDE;RETINOL;RIBOFLAVIN;THIAMINE HYDROCHLORIDE]

Current Illness:

ID: 1634991
Sex: F
Age: 76
State: GA

Vax Date: 01/18/2021
Onset Date: 01/19/2021
Rec V Date: 08/26/2021
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: Fungal infection/Rash/ large rash under right breast; Small rash at injection site; Arm was sore; This spontaneous case was reported by a health care professional (subsequently medically confirmed) and describes the occurrence of FUNGAL SKIN INFECTION (Fungal infection/Rash/ large rash under right breast), VACCINATION SITE PAIN (Arm was sore) and VACCINATION SITE RASH (Small rash at injection site) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L20A and 012L20A) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy (Sulfa). On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 19-Jan-2021, the patient experienced VACCINATION SITE PAIN (Arm was sore). On 25-Jan-2021, the patient experienced FUNGAL SKIN INFECTION (Fungal infection/Rash/ large rash under right breast) and VACCINATION SITE RASH (Small rash at injection site). At the time of the report, FUNGAL SKIN INFECTION (Fungal infection/Rash/ large rash under right breast) had resolved and VACCINATION SITE PAIN (Arm was sore) and VACCINATION SITE RASH (Small rash at injection site) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered VACCINATION SITE RASH (Small rash at injection site) to be possibly related. No further causality assessments were provided for FUNGAL SKIN INFECTION (Fungal infection/Rash/ large rash under right breast) and VACCINATION SITE PAIN (Arm was sore). Concomitant product use was not provided by the reporter. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: updated medically confirmed to yes, patient medical history, suspect product details and event details.

Other Meds:

Current Illness:

ID: 1634992
Sex: M
Age: 73
State: MI

Vax Date: 01/28/2021
Onset Date: 02/25/2021
Rec V Date: 08/26/2021
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: Nausea all night long; headache; feels weak; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (Nausea all night long), HEADACHE (headache) and FATIGUE (feels weak) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007M20A and 010A21A) for COVID-19 vaccination. No Medical History information was reported. On 28-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 ml. On 25-Feb-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to at an unspecified dose. On 25-Feb-2021, the patient experienced NAUSEA (Nausea all night long), HEADACHE (headache) and FATIGUE (feels weak). At the time of the report, NAUSEA (Nausea all night long), HEADACHE (headache) and FATIGUE (feels weak) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. This case was linked to US-MODERNATX, INC.-MOD-2021-027674 (E2B Linked Report). Reporter did not allow further contact; Sender's Comments: US-MODERNATX, INC.-MOD-2021-027674:FU completed on both crosslinked cases

Other Meds:

Current Illness:

ID: 1634993
Sex: F
Age:
State: LA

Vax Date: 02/25/2021
Onset Date: 02/25/2021
Rec V Date: 08/26/2021
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: Soreness around the injection site with pressure; Headache; Soreness; A spontaneous report was received from a consumer concerning a female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events soreness around the injection site with pressure, headache The patient's medical history covid-19, stroke were provided by the reporter. Concomitant medications metoprolol 50 mg, gabapentin 600mg, lodopine 5mg, atorvastatin 40mg, clopidogrel bisulfate, hydrochlorothiazide, losartan 100 mg were reported. On 25 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: 006M20A) via unknown route in his left arm for prophylaxis of COVID-19 infection. On 25 Feb 2021, the patient experienced the events soreness on arm injected with pressure and headaches. Treatment included calcium, woman's multi vitamin, bare aspirin 81mg , ibuprofen was provided by the reporter. Action taken with mRNA-1273 in response to the events was unknown. The outcome of events, soreness on arm injected with pressure and headaches were unknown at the time of this report.

Other Meds: METOPROLOL - 1 A PHARMA; GABAPENTIN; LODOPINE; ATORVASTATIN +PHARMA; CLOPIDOGREL BISULFATE; HYDROCHLOROTHIAZIDE; LOSARTAN "AGP"

Current Illness: Sleep apnea.

ID: 1634994
Sex: M
Age: 73
State: MA

Vax Date: 02/25/2021
Onset Date: 02/25/2021
Rec V Date: 08/26/2021
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: clearing his throat constantly; pressure in the bridge of his nose; This spontaneous case was reported by a consumer and describes the occurrence of THROAT CLEARING (clearing his throat constantly) and NASAL DISCOMFORT (pressure in the bridge of his nose) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002A21A) for COVID-19 vaccination. No Medical History information was reported. On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, the patient experienced THROAT CLEARING (clearing his throat constantly) and NASAL DISCOMFORT (pressure in the bridge of his nose). At the time of the report, THROAT CLEARING (clearing his throat constantly) and NASAL DISCOMFORT (pressure in the bridge of his nose) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.

Other Meds:

Current Illness:

ID: 1634995
Sex: F
Age:
State: NJ

Vax Date: 02/26/2021
Onset Date: 02/26/2021
Rec V Date: 08/26/2021
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: Red and raised bump on tongue; This spontaneous case was reported by a consumer and describes the occurrence of TONGUE DISORDER (Red and raised bump on tongue) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. No Medical History information was reported. On 26-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, the patient experienced TONGUE DISORDER (Red and raised bump on tongue). At the time of the report, TONGUE DISORDER (Red and raised bump on tongue) outcome was unknown. no concomitant medications are provided. treatment to the event not reported. she went to the doctor and it was a blood blister on the tongue. Action taken with mRNA-1273 in response to the event was not applicable. She advised that no further follow-up is needed. Most recent FOLLOW-UP information incorporated above includes: On 29-Apr-2021: Additional information is received it does not contain any new information.

Other Meds:

Current Illness:

ID: 1634996
Sex: M
Age:
State:

Vax Date: 02/13/2021
Onset Date: 02/21/2021
Rec V Date: 08/26/2021
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: rash all over his trunk area; This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash all over his trunk area) 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 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, the patient experienced RASH (rash all over his trunk area). At the time of the report, RASH (rash all over his trunk area) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds:

Current Illness:

ID: 1634997
Sex: F
Age: 81
State: NY

Vax Date: 02/18/2021
Onset Date: 03/18/2021
Rec V Date: 08/26/2021
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: Had Chills 2 months later; Felt off; This spontaneous case was reported by a nurse and describes the occurrence of FEELING ABNORMAL (Felt off) and CHILLS (Had Chills 2 months later) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032M20A and 024M20A) for COVID-19 vaccination. Concomitant products included ATORVASTATIN, POTASSIUM CHLORIDE, AMLODIPINE, METOPROLOL, TRIAMTERENE, LEVOTHYROXINE SODIUM (SYNTHROID), VITAMIN D3, ASCORBIC ACID (VITAMIN C ACID), ASCORBIC ACID, CALCIUM, MINERALS NOS, RETINOL, TOCOPHERYL ACETATE, VITAMIN B NOS, VITAMINS NOS, ZINC (CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS NOS;ZINC]), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), THIAMINE DISULFIDE (BIOGEN [THIAMINE DISULFIDE]) and OMEPRAZOLE for an unknown indication. On 18-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Mar-2021, the patient experienced FEELING ABNORMAL (Felt off). In May 2021, the patient experienced CHILLS (Had Chills 2 months later). At the time of the report, FEELING ABNORMAL (Felt off) and CHILLS (Had Chills 2 months later) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment medications were unknown. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events are not applicable. This case was linked to MOD-2021-132132 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 14-May-2021: Second dose vaccine information (Start date, Lot number and Route of administration) updated. On 18-MAR-2021 new event "Felt off" added. New event "Chills" added.

Other Meds: ATORVASTATIN; POTASSIUM CHLORIDE; AMLODIPINE; METOPROLOL; TRIAMTERENE; SYNTHROID; VITAMIN D3; VITAMIN C ACID; CENTRUM SILVER [ASCORBIC ACID;CALCIUM;MINERALS NOS;RETINOL;TOCOPHERYL ACETATE;VITAMIN B NOS;VITAMINS; ASPIRIN (E.C.); BIOGEN [THIA

Current Illness:

ID: 1634998
Sex: U
Age:
State: FL

Vax Date: 02/25/2021
Onset Date: 02/01/2021
Rec V Date: 08/26/2021
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: sore arm; dizzy; headache; muscle ache; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 27-Feb-2021 and was forwarded to Moderna on 27-Feb-2021. 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 IN EXTREMITY (sore arm), DIZZINESS (dizzy), HEADACHE (headache) and MYALGIA (muscle 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 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced PAIN IN EXTREMITY (sore arm), DIZZINESS (dizzy), HEADACHE (headache) and MYALGIA (muscle ache). At the time of the report, PAIN IN EXTREMITY (sore arm), DIZZINESS (dizzy), HEADACHE (headache) and MYALGIA (muscle ache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds:

Current Illness:

ID: 1634999
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
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: Body ache; Fever; chills; exhaustion; This spontaneous case was reported by a patient and describes the occurrence of MYALGIA (Body ache), PYREXIA (Fever), CHILLS (chills) and FATIGUE (exhaustion) 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 MYALGIA (Body ache), PYREXIA (Fever), CHILLS (chills) and FATIGUE (exhaustion). At the time of the report, MYALGIA (Body ache), PYREXIA (Fever), CHILLS (chills) and FATIGUE (exhaustion) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.

Other Meds:

Current Illness:

ID: 1635000
Sex: M
Age: 37
State: MI

Vax Date: 02/12/2021
Onset Date: 02/16/2021
Rec V Date: 08/26/2021
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: Plaque Psoriasis flare up; A spontaneous report was received from a Healthcare Professional concerning about his son in law a 37-years-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events as plaque psoriasis flare up. The patient's medical history was not provided. Concomitant medications reported were Otezla oral solid, Prednisolone oral solid for drug use for unknown indication. On 12 FEB 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly for prophylaxis of COVID-19 infection. On 16 Feb 2021, the patient experienced the events plaque psoriasis flare up. Treatment details included Prescription Medications:, Otzela-chronic psoriasis, Prednisolone 15mg daily. Action taken with mRNA-1273 in response to the events was not reported. On an unknown date the outcome of events, plaque psoriasis flare up was not reported.

Other Meds: OTEZLA; PREDNISOLONE

Current Illness:

ID: 1635001
Sex: F
Age:
State: WV

Vax Date: 01/08/2010
Onset Date:
Rec V Date: 08/26/2021
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: very very lil sore on her right arm; neighbors got sick; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (very very lil sore on her right arm) and SICK RELATIVE (neighbors got sick) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 007M20A) for COVID-19 vaccination. No Medical History information was reported. On 08-Jan-2010, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Feb-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 PAIN IN EXTREMITY (very very lil sore on her right arm) and SICK RELATIVE (neighbors got sick). At the time of the report, PAIN IN EXTREMITY (very very lil sore on her right arm) and SICK RELATIVE (neighbors got sick) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.

Other Meds:

Current Illness:

ID: 1635002
Sex: F
Age: 66
State: VA

Vax Date: 02/01/2021
Onset Date: 02/01/2021
Rec V Date: 08/26/2021
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: headache; redness is coming back; it's warm to the touch; face started getting blotches; lips were tingling; welt on their arm; skin was crawling; blured vision; Eyes felt gritty; fogginess; This spontaneous case was reported by a consumer and describes the occurrence of VISION BLURRED (fogginess), VISION BLURRED (blured vision), FOREIGN BODY SENSATION IN EYES (Eyes felt gritty), URTICARIA (welt on their arm) and FORMICATION (skin was crawling) in a 66-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. Co-suspect product included non-company product HYDROXYZINE for an unknown indication. The patient's past medical history included Hashimoto's disease since an unknown date and Asthma since an unknown date. Concomitant products included MONTELUKAST for Asthma, LEVOTHYROXINE SODIUM (SYNTHROID) for Hashimoto's disease, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and CYANOCOBALAMIN, PYRIDOXINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE (VITAMIN B 1-6-12) for an unknown indication. On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started HYDROXYZINE (unknown route) at an unspecified dose. On 01-Feb-2021, the patient experienced VISION BLURRED (fogginess). On 02-Feb-2021, the patient experienced VISION BLURRED (blured vision), FOREIGN BODY SENSATION IN EYES (Eyes felt gritty) and FORMICATION (skin was crawling). On 06-Feb-2021, the patient experienced URTICARIA (welt on their arm), RASH MACULAR (face started getting blotches) and PARAESTHESIA ORAL (lips were tingling). On 15-Feb-2021, the patient experienced ERYTHEMA (redness is coming back) and VACCINATION SITE WARMTH (it's warm to the touch). On an unknown date, the patient experienced HEADACHE (headache). The patient was treated with CLINDAMYCIN for Infection, at an unspecified dose and frequency and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at an unspecified dose and frequency. At the time of the report, VISION BLURRED (fogginess), VISION BLURRED (blured vision), FOREIGN BODY SENSATION IN EYES (Eyes felt gritty), URTICARIA (welt on their arm), FORMICATION (skin was crawling), RASH MACULAR (face started getting blotches), PARAESTHESIA ORAL (lips were tingling), ERYTHEMA (redness is coming back), VACCINATION SITE WARMTH (it's warm to the touch) and HEADACHE (headache) 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: SYNTHROID; MONTELUKAST; VITAMIN D 2000; VITAMIN B 1-6-12; HYDROXYZINE

Current Illness: Asthma; Hashimoto's disease

ID: 1635003
Sex: U
Age: 70
State: PA

Vax Date: 02/04/2021
Onset Date: 02/12/2021
Rec V Date: 08/26/2021
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: sole of feet burning; rash on knee up both legs; pimple on legs; Pain in injection site; Red ring near injection; This spontaneous case was reported by a consumer and describes the occurrence of ACNE (pimple on legs), BURNING SENSATION (sole of feet burning), RASH (rash on knee up both legs), VACCINATION SITE PAIN (Pain in injection site) and VACCINATION SITE ERYTHEMA (Red ring near injection) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030L20A) for COVID-19 vaccination. Concurrent medical conditions included Insect bite allergy. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, the patient experienced VACCINATION SITE PAIN (Pain in injection site) and VACCINATION SITE ERYTHEMA (Red ring near injection). On 14-Feb-2021, the patient experienced ACNE (pimple on legs) and RASH (rash on knee up both legs). On an unknown date, the patient experienced BURNING SENSATION (sole of feet burning). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, ACNE (pimple on legs), BURNING SENSATION (sole of feet burning), RASH (rash on knee up both legs), VACCINATION SITE PAIN (Pain in injection site) and VACCINATION SITE ERYTHEMA (Red ring near injection) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient took Ice on sole of feet.

Other Meds:

Current Illness: Insect bite allergy

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am