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: 1790256
Sex: F
Age: 67
State: NC

Vax Date: 01/30/2021
Onset Date:
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: primary said she thought I had gotten covid before I got the second shot; This spontaneous case was reported by a nurse and describes the occurrence of SUSPECTED COVID-19 (primary said she thought I had gotten covid before I got the second shot) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032620A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included CALCIUM, VITAMIN D NOS, ACETYLSALICYLIC ACID (ASPIRIN 81), ATORVASTATIN CALCIUM (LIPITOR), CYANOCOBALAMIN (B12 [CYANOCOBALAMIN]), ESCITALOPRAM OXALATE (LEXAPRO), FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]), LORATADINE (CLARITIN [LORATADINE]), MONTELUKAST SODIUM (SINGULAIR), OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) and DENOSUMAB (PROLIA) for an unknown indication. On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced SUSPECTED COVID-19 (primary said she thought I had gotten covid before I got the second shot). At the time of the report, SUSPECTED COVID-19 (primary said she thought I had gotten covid before I got the second shot) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment information was provided This case was linked to MOD-2021-341159 (Patient Link).; Sender's Comments: This case concerns a 68 year old female with no reported medical history , who experienced the unexpected event of Suspected Covid 19 which occurred on an unknown date after vaccination with the 1st dose of mRNA-1273 (Moderna). The rechallenge is not applicable since only information of the 1st dose is reported. The age of the patient may be considered as a confounder( since the elderly group are prone to Covid 19 infection) for this case. The benefit-risk relationship of mRNA-1273 (Moderna ) is not affected by this report.

Other Meds: CALCIUM; VITAMIN D NOS; ASPIRIN 81; LIPITOR; B12 [CYANOCOBALAMIN]; LEXAPRO; FLONASE [FLUTICASONE PROPIONATE]; CLARITIN [LORATADINE]; SINGULAIR; PROTONIX [OMEPRAZOLE]; PROLIA

Current Illness:

ID: 1790257
Sex: M
Age: 56
State:

Vax Date: 06/24/2021
Onset Date:
Rec V Date: 10/16/2021
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: weight gain; swelling; This spontaneous case was reported by an other health care professional and describes the occurrence of OBESITY (weight gain) and SWELLING (swelling) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Anxiety and Obesity. Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) from 15-Feb-2021 to an unknown date and BUSPIRONE HYDROCHLORIDE (BUSPAR) from 12-Mar-2021 to an unknown date for Anxiety, SILDENAFIL CITRATE (VIAGRA) for Pulmonary hypertension. On 24-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jul-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 OBESITY (weight gain) and SWELLING (swelling). At the time of the report, OBESITY (weight gain) and SWELLING (swelling) outcome was unknown. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment medication details were reported. This case was linked to MOD-2021-326423 (Patient Link).

Other Meds: ZOLOFT; BUSPAR; VIAGRA

Current Illness: Anxiety; Obesity

ID: 1790258
Sex: U
Age:
State: GA

Vax Date: 10/02/2021
Onset Date: 10/02/2021
Rec V Date: 10/16/2021
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: Dose administered after manufacture date of expiry; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacture date of expiry) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039821A) for COVID-19 vaccination. No Medical History information was reported. On 02-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacture date of expiry). On 02-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered after manufacture date of expiry) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided. Moderna cannot guarantee patients received full protection against the COVID-19 Virus. Most recent FOLLOW-UP information incorporated above includes: On 07-Oct-2021: Follow up received and contains non significant information.

Other Meds:

Current Illness:

ID: 1790259
Sex: F
Age: 90
State: TX

Vax Date: 01/18/2021
Onset Date: 10/01/2021
Rec V Date: 10/16/2021
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: Covid-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid-19) in a 91-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 18-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Oct-2021, the patient experienced COVID-19 (Covid-19). At the time of the report, COVID-19 (Covid-19) outcome was unknown. Treatment included: Regeneron. No Concomitant medications were reported.; Sender's Comments: This report concerns a 91 year old female patient with no relevant medical history who experienced non-serious unexpected event of COVID-19 infection. The event occurred approximately 8 months after vaccination with second dose of mRNA-1273. The re-challenge is not applicable as the event happened after the second dose. The outcome of the event is unknown at the time of this report. The benefit-risk relationship of mRNA-1273 is not affected by this report. There is incomplete information about the second dose of the vaccine and the latency between the doses.

Other Meds:

Current Illness:

ID: 1790260
Sex: F
Age: 71
State: CT

Vax Date: 04/27/2021
Onset Date: 04/27/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: This spontaneous case reported by a consumer, describes the occurrence of vaccination site discolouration (black and blue mark at injection site on left arm), diarrhea and pyrexia (fever every morning for 3 weeks) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine, batch/lot# 025821A and 044A21A) for COVID-19 immunization. No medical history reported. On Mar 30, 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 27, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Apr 27, 2021, patient experienced vaccination site discolouration (black and blue mark at injection site on left arm), diarrhea and pyrexia (fever every morning for 3 weeks). At the time of the report, vaccination site discolouration (black and blue mark at injection site on left arm), diarrhea and pyrexia (fever every morning for 3 weeks) outcome: unknown. No concomitant medications or treatment information reported. The patient stated the black and blue mark went away after 2 weeks and then came back in late September. This case linked to MOD-2021-066619 (patient link).

Other Meds:

Current Illness:

ID: 1790261
Sex: M
Age: 15
State: UT

Vax Date: 10/04/2021
Onset Date: 10/04/2021
Rec V Date: 10/16/2021
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: Vaccine administered to an underage patient.; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to an underage patient.) in a 15-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination. No Medical History information was reported. On 04-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Oct-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to an underage patient.). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine administered to an underage patient.) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1790262
Sex: F
Age: 67
State: GA

Vax Date: 03/03/2021
Onset Date: 03/30/2021
Rec V Date: 10/16/2021
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: range of motion is limited at times; Lots of morning stiffness upon waking up; arm (right arm) continued to hurt from shoulder down through my hand; Body Aches; extreme chills; right arm aches / arm (right arm) continued to hurt,My right arm aches even now as I am sending you this email. Can't stand for it to get cold, cold air causes it to ache worse; Limited movement; Flare in Sinuses; Asthma conditions; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (right arm aches / arm (right arm) continued to hurt,My right arm aches even now as I am sending you this email. Can't stand for it to get cold, cold air causes it to ache worse), MOBILITY DECREASED (Limited movement), SINUSITIS (Flare in Sinuses), ASTHMA (Asthma conditions) and JOINT RANGE OF MOTION DECREASED (range of motion is limited at times) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039A21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Lymphedema (history of lymphedema in left arm which she was swelling & lumps under left arm for about 3 years.), Sinusitis (Flare in sinuses) and Asthma aggravated (Flare in asthma). On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced PAIN IN EXTREMITY (right arm aches / arm (right arm) continued to hurt,My right arm aches even now as I am sending you this email. Can't stand for it to get cold, cold air causes it to ache worse), MOBILITY DECREASED (Limited movement), SINUSITIS (Flare in Sinuses), ASTHMA (Asthma conditions), MUSCULOSKELETAL STIFFNESS (Lots of morning stiffness upon waking up), ARTHRALGIA (arm (right arm) continued to hurt from shoulder down through my hand), MYALGIA (Body Aches) and CHILLS (extreme chills). On 30-Sep-2021, the patient experienced JOINT RANGE OF MOTION DECREASED (range of motion is limited at times). At the time of the report, PAIN IN EXTREMITY (right arm aches / arm (right arm) continued to hurt,My right arm aches even now as I am sending you this email. Can't stand for it to get cold, cold air causes it to ache worse) had not resolved, MOBILITY DECREASED (Limited movement), JOINT RANGE OF MOTION DECREASED (range of motion is limited at times), MUSCULOSKELETAL STIFFNESS (Lots of morning stiffness upon waking up), ARTHRALGIA (arm (right arm) continued to hurt from shoulder down through my hand), MYALGIA (Body Aches) and CHILLS (extreme chills) outcome was unknown and SINUSITIS (Flare in Sinuses) and ASTHMA (Asthma conditions) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant medications were provided Treatment medication were not reported. Most recent FOLLOW-UP information incorporated above includes: On 07-Oct-2021: Significant follow up received on 07-0ct-2021 and vaccine dose details, relevant history, Additional events updated.

Other Meds:

Current Illness: Lymphedema (history of lymphedema in left arm which she was swelling & lumps under left arm for about 3 years.)

ID: 1790263
Sex: F
Age:
State: CA

Vax Date: 03/30/2021
Onset Date: 03/30/2021
Rec V Date: 10/16/2021
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: Antibody test; Test Result: Negative ; Result Unstructured Data: IgG and IgM, negative, was explained patient has zero antibodies; Test Name: Antibody test; Test Result: Negative ; Result Unstructured Data: IgG and IgM, negative

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: arm was sore; she was probably in bed with overwhelming low energy; general achiness; vertigo/ vertigo was pretty severe/ vertigo was on and off; she thinks she received expired vaccine; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was sore), ASTHENIA (she was probably in bed with overwhelming low energy), PAIN (general achiness), VERTIGO (vertigo/ vertigo was pretty severe/ vertigo was on and off) and EXPIRED PRODUCT ADMINISTERED (she thinks she received expired vaccine) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (she thinks she received expired vaccine). On 03-Apr-2021, the patient experienced VERTIGO (vertigo/ vertigo was pretty severe/ vertigo was on and off). On an unknown date, the patient experienced PAIN IN EXTREMITY (arm was sore), ASTHENIA (she was probably in bed with overwhelming low energy) and PAIN (general achiness). On 30-Mar-2021, EXPIRED PRODUCT ADMINISTERED (she thinks she received expired vaccine) had resolved. In August 2021, VERTIGO (vertigo/ vertigo was pretty severe/ vertigo was on and off) had resolved. At the time of the report, PAIN IN EXTREMITY (arm was sore), ASTHENIA (she was probably in bed with overwhelming low energy) and PAIN (general achiness) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: negative (Negative) IgG and IgM, negative, was explained patient has zero antibodies and negative (Negative) IgG and IgM, negative. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications was reported. Patient had to use medication for the vertigo.

Other Meds:

Current Illness:

ID: 1790264
Sex: F
Age: 73
State: PA

Vax Date: 03/19/2021
Onset Date: 03/20/2021
Rec V Date: 10/16/2021
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: lack of appetite; lack of energy; diarrhea; Aches/ pains; nausea; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (lack of appetite), ASTHENIA (lack of energy), DIARRHOEA (diarrhea), MYALGIA (Aches/ pains) and NAUSEA (nausea) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Mar-2021, the patient experienced DECREASED APPETITE (lack of appetite), ASTHENIA (lack of energy), DIARRHOEA (diarrhea), MYALGIA (Aches/ pains), NAUSEA (nausea), PYREXIA (fever) and CHILLS (chills). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, DECREASED APPETITE (lack of appetite), ASTHENIA (lack of energy), DIARRHOEA (diarrhea), MYALGIA (Aches/ pains), NAUSEA (nausea), PYREXIA (fever) and CHILLS (chills) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The concomitant medication was not reported. Patient quit smoking 14 years ago. This case was linked to MOD-2021-341298 (Patient Link).

Other Meds:

Current Illness:

ID: 1790265
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Name: covid-19 virus test; Test Result: Positive ; Result Unstructured Data: Positive

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Runny nose; This spontaneous case was reported by a nurse and describes the occurrence of RHINORRHOEA (Runny nose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (Runny nose). At the time of the report, RHINORRHOEA (Runny nose) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient completed his 3 doses of Moderna COVID vaccine as well around June or July. No relevant concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1790266
Sex: U
Age:
State: CA

Vax Date: 10/02/2021
Onset Date: 10/02/2021
Rec V Date: 10/16/2021
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: administered an expired vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered an expired vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination. No Medical History information was reported. On 02-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered an expired vaccine). On 02-Oct-2021, EXPIRED PRODUCT ADMINISTERED (administered an expired vaccine) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication details were not reported by the reporter. Treatment details was not reported by the reporter.

Other Meds:

Current Illness:

ID: 1790267
Sex: F
Age:
State: UT

Vax Date: 09/15/2021
Onset Date: 10/04/2021
Rec V Date: 10/16/2021
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: wife to get the doses in less than a month.; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (wife to get the doses in less than a month.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 15-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (wife to get the doses in less than a month.). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (wife to get the doses in less than a month.) outcome was unknown. No concomitant and treatment medication were reported.

Other Meds:

Current Illness:

ID: 1790268
Sex: F
Age: 73
State: PA

Vax Date: 03/19/2021
Onset Date: 04/17/2021
Rec V Date: 10/16/2021
Hospital: Y

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

Lab Data: Test Name: Chest X-ray; Result Unstructured Data: golf ball sized mass; Test Date: 20210706; Test Name: biopsy lung; Result Unstructured Data: Lung adenocarcinoma

Allergies:

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

Symptoms: The tumor is now growing around her trachea and esophagus; hepatoid adenocarcinoma of the lung; The tumor is now growing around her trachea and esophagus; C. diff; The tumor is now growing around her trachea and esophagus; seizures; edema from the tumors in her head.; took imaging showing 3 tumors in her; coughing up blood; shortness of breath; Fever; Chills; aches / pain; lack of appetite; lack of energy; Nausea; Diarrhea; felt super sick again; couldn't get out of bed; This spontaneous case was reported by a consumer and describes the occurrence of LUNG ADENOCARCINOMA (hepatoid adenocarcinoma of the lung), SEIZURE (seizures), BRAIN OEDEMA (edema from the tumors in her head.), METASTASES TO TRACHEA (The tumor is now growing around her trachea and esophagus), PYREXIA (Fever), CHILLS (Chills), PAIN (aches / pain), DECREASED APPETITE (lack of appetite), ASTHENIA (lack of energy), NAUSEA (Nausea), DIARRHOEA (Diarrhea), ILLNESS (felt super sick again), BEDRIDDEN (couldn't get out of bed), HAEMOPTYSIS (coughing up blood), DYSPNOEA (shortness of breath), TRACHEAL NEOPLASM (The tumor is now growing around her trachea and esophagus), CLOSTRIDIUM DIFFICILE COLITIS (C. diff), METASTASES TO OESOPHAGUS (The tumor is now growing around her trachea and esophagus) and BRAIN NEOPLASM (took imaging showing 3 tumors in her) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 045A21A) for COVID-19 vaccination. The patient's past medical history included Ex-smoker (Patient had quit smoking 14 years ago.). On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-Apr-2021, the patient experienced PYREXIA (Fever) (seriousness criteria hospitalization, medically significant and life threatening), CHILLS (Chills) (seriousness criteria hospitalization, medically significant and life threatening), PAIN (aches / pain) (seriousness criteria hospitalization, medically significant and life threatening), DECREASED APPETITE (lack of appetite) (seriousness criteria hospitalization, medically significant and life threatening), ASTHENIA (lack of energy) (seriousness criteria hospitalization, medically significant and life threatening), NAUSEA (Nausea) (seriousness criteria hospitalization, medically significant and life threatening), DIARRHOEA (Diarrhea) (seriousness criteria hospitalization, medically significant and life threatening), ILLNESS (felt super sick again) (seriousness criteria hospitalization, disability, medically significant and life threatening) and BEDRIDDEN (couldn't get out of bed) (seriousness criteria hospitalization, disability, medically significant and life threatening). In May 2021, the patient experienced HAEMOPTYSIS (coughing up blood) (seriousness criteria hospitalization, disability, medically significant and life threatening) and DYSPNOEA (shortness of breath) (seriousness criteria hospitalization, disability, medically significant and life threatening). On 06-Jul-2021, the patient experienced BRAIN NEOPLASM (took imaging showing 3 tumors in her) (seriousness criteria hospitalization, disability, medically significant and life threatening). On 04-Oct-2021, the patient experienced SEIZURE (seizures) (seriousness criteria hospitalization, disability, medically significant and life threatening) and BRAIN OEDEMA (edema from the tumors in her head.) (seriousness criteria hospitalization, disability, medically significant and life threatening). On an unknown date, the patient experienced LUNG ADENOCARCINOMA (hepatoid adenocarcinoma of the lung) (seriousness criteria hospitalization, disability, medically significant and life threatening), METASTASES TO TRACHEA (The tumor is now growing around her trachea and esophagus) (seriousness criteria hospitalization, disability, medically significant and life threatening), TRACHEAL NEOPLASM (The tumor is now growing around her trachea and esophagus) (seriousness criteria hospitalization, disability, medically significant and life threatening), CLOSTRIDIUM DIFFICILE COLITIS (C. diff) (seriousness criteria hospitalization, disability, medically significant and life threatening) and METASTASES TO OESOPHAGUS (The tumor is now growing around her trachea and esophagus) (seriousness criteria hospitalization, disability, medically significant and life threatening). The patient was treated with METRONIDAZOLE (FLAGYL [METRONIDAZOLE]) for C.difficile colitis, at an unspecified dose and frequency; FENTANYL for Pain, at an unspecified dose and frequency and PEMBROLIZUMAB (KEYTRUDA) for Adverse reaction, at an unspecified dose and frequency. At the time of the report, LUNG ADENOCARCINOMA (hepatoid adenocarcinoma of the lung), SEIZURE (seizures), BRAIN OEDEMA (edema from the tumors in her head.), METASTASES TO TRACHEA (The tumor is now growing around her trachea and esophagus), PYREXIA (Fever), CHILLS (Chills), PAIN (aches / pain), DECREASED APPETITE (lack of appetite), ASTHENIA (lack of energy), NAUSEA (Nausea), DIARRHOEA (Diarrhea), ILLNESS (felt super sick again), BEDRIDDEN (couldn't get out of bed), HAEMOPTYSIS (coughing up blood), DYSPNOEA (shortness of breath), TRACHEAL NEOPLASM (The tumor is now growing around her trachea and esophagus), CLOSTRIDIUM DIFFICILE COLITIS (C. diff), METASTASES TO OESOPHAGUS (The tumor is now growing around her trachea and esophagus) and BRAIN NEOPLASM (took imaging showing 3 tumors in her) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jul-2021, Biopsy lung: lung adenocarcinoma (abnormal) Lung adenocarcinoma. On an unknown date, Chest X-ray: golf ball sized mass (abnormal) golf ball sized mass. No concomitant medication reported. Patient's HCP prescribed her antibiotics, which did not help and on returning a week later she received a Chest X-ray which showed a golf ball sized mass. She then went to a cancer center post 06 Jul 2021 where they biopsied the mass in her lung, and took image showing 3 tumors in her brain. She was told she had limited treatment options, but started radiation for the 3 spots on her brain and chemotherapy for the mass on her lung. She also tried using Keytruda and immunology treatments. The cancer is a hepatoid adenocarcinoma of the lung. The tumor was growing around her trachea and esophagus. The neurologist in the ER said that the seizures were a result of edema from the tumors in her head. She continued to be in the ER and had been placed on a breathing tube. Patient had quit smoking 14 years ago. Company Comment: This case concerns a 74 year old female patient with medical history of ex-smoker, who experienced serious unexpected events of lung adenocarcinoma, metastases to trachea, metastases to esophagus , brain tumor and seizure after second dose of mRNA-1273. The events occurred approximately 2 months after second dose. The re-challenge is not applicable as we are not expecting another dose. The events were considered related to the product as per the reporter's assessment. The benefit-risk relationship of Spikevax in not affected by this report. This case was linked to MOD-2021-341271.; Sender's Comments: This case concerns a 74 year old female patient with medical history of ex-smoker, who experienced serious unexpected events of lung adenocarcinoma, metastases to trachea, metastases to esophagus , brain tumor and seizure after second dose of mRNA-1273. The events occurred approximately 2 months after second dose. The re-challenge is not applicable as we are not expecting another dose. The events were considered related to the product as per the reporter's assessment. The benefit-risk relationship of in not affected by this report.

Other Meds:

Current Illness:

ID: 1790269
Sex: M
Age: 72
State: CA

Vax Date: 02/12/2021
Onset Date: 09/16/2021
Rec V Date: 10/16/2021
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: Venous stasis ulcer; This spontaneous case was reported by a consumer and describes the occurrence of SKIN ULCER (Venous stasis ulcer) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 031M20A) for COVID-19 vaccination. Previously administered products included for an unreported indication: FLUZONE HIGH DOSE QUADRIVALENT (route Intramuscular,Body site left deltoid and dose 1) on 09-Sep-2021. Concurrent medical conditions included Hypertensive heart disease (controlled via medication) since 11-Jul-2008, Sleep apnea (controlled by Bi-PAP) since 20-Aug-2009, Obesity (losing weight) since 15-Jul-2004, Seronegative rheumatoid arthritis (increased dosage of methotrexate) since 07-Feb-2019, Osteoarthritis (increased dosage of methotrexate) since 07-Feb-2019 and Adhesive tape allergy. Concomitant products included FOLIC ACID for Anaemia, DULOXETINE, ACETAMINOPHEN, GLUCOSAMINE and CHONDROITIN for Arthritis, POTASSIUM CHLORIDE for Electrolyte substitution therapy, NIACIN for High cholesterol, FAMOTIDINE for Hyperchlorhydria, ATENOLOL, DILTIAZEM, MINOXIDIL, OLMESARTAN MEDOXOMIL and TORSEMIDE for Hypertension, ZOLPIDEM TARTRATE (ZOLPIDEM TARTRATE ACTAVIS) for Insomnia, MOMETASONE FUROATE (MOMETASONE FUROATE CIPLA) for Nasal congestion, METHOTREXATE for Rheumatoid arthritis, MONTELUKAST SODIUM for Rhinitis allergic, MULTIVITAMIN & MINERAL, VITAMIN D3 and VITAMIN C [ASCORBIC ACID] for an unknown indication. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Sep-2021, the patient experienced SKIN ULCER (Venous stasis ulcer). The patient was treated with CARMELLOSE SODIUM (DUODERM CGF [CARMELLOSE SODIUM]) for Venous stasis ulcer, at an unspecified dose and frequency. At the time of the report, SKIN ULCER (Venous stasis ulcer) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. This case was linked to MOD-2021-338635 (Patient Link).

Other Meds: ATENOLOL; DILTIAZEM; DULOXETINE; FAMOTIDINE; FOLIC ACID; METHOTREXATE; MINOXIDIL; MOMETASONE FUROATE CIPLA; MONTELUKAST SODIUM; NIACIN; OLMESARTAN MEDOXOMIL; POTASSIUM CHLORIDE; TORSEMIDE; ZOLPIDEM TARTRATE ACTAVIS; ACETAMINOPHEN; GLUCOSAMI

Current Illness: Adhesive tape allergy; Hypertensive heart disease (controlled via medication); Obesity (losing weight); Osteoarthritis (increased dosage of methotrexate); Seronegative rheumatoid arthritis (increased dosage of methotrexate); Sleep apnea (controlled by Bi-PAP)

ID: 1790270
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
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: received a dose of moderna after the BUD (beyond use date); This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a dose of Moderna after the BUD (beyond use date)) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a dose of moderna after the BUD (beyond use date)). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received a dose of moderna after the BUD (beyond use date)) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were provided. No treatment medications were provided.

Other Meds:

Current Illness:

ID: 1790271
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: weird symptoms; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (weird symptoms) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced VACCINATION COMPLICATION (weird symptoms). At the time of the report, VACCINATION COMPLICATION (weird symptoms) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1790272
Sex: F
Age: 40
State: IA

Vax Date: 09/29/2021
Onset Date: 09/30/2021
Rec V Date: 10/16/2021
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: Her left armpit felt painful/she has pain under her left arm, there was like a little nodule/ size of a golf ball under her left armpit/ Her lymph nodes are swollen; left ovary cramping/left ovary painful/left ovary felt like it wanted to burst; This spontaneous case was reported by a consumer and describes the occurrence of ADNEXA UTERI PAIN (left ovary cramping/left ovary painful/left ovary felt like it wanted to burst) and LYMPHADENOPATHY (Her left armpit felt painful/she has pain under her left arm, there was like a little nodule/ size of a golf ball under her left armpit/ Her lymph nodes are swollen) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination. The patient's past medical history included Tubectomy (tubes tied years ago, no possibility of a pregnancy.). On 29-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Sep-2021, the patient experienced ADNEXA UTERI PAIN (left ovary cramping/left ovary painful/left ovary felt like it wanted to burst). On 03-Oct-2021, the patient experienced LYMPHADENOPATHY (Her left armpit felt painful/she has pain under her left arm, there was like a little nodule/ size of a golf ball under her left armpit/ Her lymph nodes are swollen). On 02-Oct-2021, ADNEXA UTERI PAIN (left ovary cramping/left ovary painful/left ovary felt like it wanted to burst) had resolved. At the time of the report, LYMPHADENOPATHY (Her left armpit felt painful/she has pain under her left arm, there was like a little nodule/ size of a golf ball under her left armpit/ Her lymph nodes are swollen) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication information were provided. No treatment information provided.

Other Meds:

Current Illness:

ID: 1790273
Sex: M
Age: 27
State:

Vax Date: 03/30/2021
Onset Date: 04/28/2021
Rec V Date: 10/16/2021
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: Patient reports his EENT diagnosed him with autoimmune condition called rare relapsing polychondritis.; nose swollen insanely; nose cartilage was broken; nose cartilage gets inflamed; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of POLYCHONDRITIS (Patient reports his EENT diagnosed him with autoimmune condition called rare relapsing polychondritis.) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 0211321A and 009C21A)) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Relapsing polychondritis since 29-Apr-2021. On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Apr-2021, the patient experienced PYREXIA (fever) and CHILLS (chills). On 29-Apr-2021, the patient experienced SWELLING (nose swollen insanely), CARTILAGE INJURY (nose cartilage was broken) and NASAL INFLAMMATION (nose cartilage gets inflamed). On an unknown date, the patient experienced POLYCHONDRITIS (Patient reports his EENT diagnosed him with autoimmune condition called rare relapsing polychondritis.) (seriousness criterion medically significant). The patient was treated with METHOTREXATE ongoing since an unknown date for Relapsing polychondritis, at an unspecified dose and frequency and PREDNISONE ongoing since an unknown date for Relapsing polychondritis, at an unspecified dose and frequency. At the time of the report, POLYCHONDRITIS (Patient reports his EENT diagnosed him with autoimmune condition called rare relapsing polychondritis.), PYREXIA (fever), CHILLS (chills), SWELLING (nose swollen insanely), CARTILAGE INJURY (nose cartilage was broken) and NASAL INFLAMMATION (nose cartilage gets inflamed) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was mentioned. Company Comment: This case concerns a 27-year-old male patient with relevant medical history of relapsing polychondritis, who experienced the unexpected serious event of Polychondritis and non-serious events of swelling, Nasal inflammation and Cartilage injury and pyrexia.The events occurred unknown days after the second dose of Spikevax. The rechallenge is not applicable since the event occurred after the second dose and no details were provided about the first dose. The benefit-risk relationship of Spikevax is not affected by this report.; Sender's Comments: This case concerns a 27-year-old male patient with relevant medical history of relapsing polychondritis, who experienced the unexpected serious event of Polychondritis and non-serious events of swelling, Nasal inflammation and Cartilage injury and pyrexia.The events occurred unknown days after the second dose of Spikevax. The rechallenge is not applicable since the event occurred after the second dose and no details were provided about the first dose. The benefit-risk relationship of Spikevax is not affected by this report.

Other Meds:

Current Illness: Relapsing polychondritis

ID: 1790274
Sex: M
Age: 34
State: TX

Vax Date: 03/12/2021
Onset Date:
Rec V Date: 10/16/2021
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: cold; shivering; low-grade fever; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold), CHILLS (shivering) and PYREXIA (low-grade fever) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008B21A and 031A21A) for COVID-19 vaccination. Concurrent medical conditions included Asthma. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced NASOPHARYNGITIS (cold), CHILLS (shivering) and PYREXIA (low-grade fever). At the time of the report, NASOPHARYNGITIS (cold), CHILLS (shivering) and PYREXIA (low-grade fever) outcome was unknown. Concomitant: Inhaler for asthma No treatment information was provided This case was linked to MOD-2021-341921 (Patient Link).

Other Meds:

Current Illness: Asthma

ID: 1790275
Sex: M
Age: 34
State: TX

Vax Date: 03/12/2021
Onset Date: 10/03/2021
Rec V Date: 10/16/2021
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: He had cold; He was shivering/cold shivers; He had low-grade fever; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (He had cold), CHILLS (He was shivering/cold shivers) and PYREXIA (He had low-grade fever) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019F21A, 008B21A and 031A21A) for COVID-19 vaccination. Concurrent medical conditions included Asthma. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 13-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Oct-2021, the patient experienced NASOPHARYNGITIS (He had cold), CHILLS (He was shivering/cold shivers) and PYREXIA (He had low-grade fever). At the time of the report, NASOPHARYNGITIS (He had cold) and PYREXIA (He had low-grade fever) was resolving and CHILLS (He was shivering/cold shivers) had not resolved. Concomitant drug included inhaler for asthma. Treatment medications were not provided. It was reported that patient was not feeling as bad. This case was linked to MOD-2021-341881 (Patient Link).

Other Meds:

Current Illness: Asthma

ID: 1790276
Sex: F
Age:
State: VA

Vax Date: 02/19/2021
Onset Date:
Rec V Date: 10/16/2021
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: fell on her back/fell on the back of her head; has a lot of pain from the fall; muscle pain from the fall; This spontaneous case was reported by a consumer and describes the occurrence of FALL (fell on her back/fell on the back of her head), PAIN (has a lot of pain from the fall) and MYALGIA (muscle pain from the fall) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 19-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FALL (fell on her back/fell on the back of her head), PAIN (has a lot of pain from the fall) and MYALGIA (muscle pain from the fall). At the time of the report, FALL (fell on her back/fell on the back of her head), PAIN (has a lot of pain from the fall) and MYALGIA (muscle pain from the fall) outcome was unknown. No concomitant medications were reported No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1790277
Sex: F
Age: 22
State: MI

Vax Date: 10/04/2021
Onset Date: 10/04/2021
Rec V Date: 10/16/2021
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: receiving dose from an expired Moderna COVID19 vaccine vial; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (receiving dose from an expired Moderna COVID19 vaccine vial) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037b21a) for COVID-19 vaccination. No Medical History information was reported. On 04-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (receiving dose from an expired Moderna COVID19 vaccine vial). On 04-Oct-2021, EXPIRED PRODUCT ADMINISTERED (receiving dose from an expired Moderna COVID19 vaccine vial) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant medications were provided. Reporter stated that 4 doses of 1 expired vial of the Moderna COVID19 vaccine were administered No Treatment medications were provided.

Other Meds:

Current Illness:

ID: 1790278
Sex: U
Age:
State: NJ

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
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: throwing up; 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 VOMITING (throwing up) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Arthritis. On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VOMITING (throwing up). At the time of the report, VOMITING (throwing up) outcome was unknown. The concomitant medications included medication shots. No treatment medications were reported.

Other Meds:

Current Illness: Arthritis

ID: 1790279
Sex: M
Age: 86
State: MI

Vax Date: 10/04/2021
Onset Date: 10/04/2021
Rec V Date: 10/16/2021
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: Invalid dose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Oct-2021 and was forwarded to Moderna on 05-Oct-2021. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Invalid dose) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. Previously administered products included for an unreported indication: INFLUENZA VACCINE (Lot number 323626) on 27-Sep-2021. On 04-Oct-2021 at 8:35 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Invalid dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Invalid dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications reported. No treatment medications reported. The invalid dose of Moderna was pulled out of the freezer on Friday October 1st, 2021. The invalid dose of Moderna expired on Sunday October 3, 2021. The Invalid dose of Moderna was administered on Monday October 4, 2021 at 0835 in the morning into this patient's left arm. Most recent FOLLOW-UP information incorporated above includes: On 07-Oct-2021: Follow up received: Added new reporter, historical vaccine Influenza AIIV4 added, patient route of administration Intramuscular added.

Other Meds:

Current Illness:

ID: 1790280
Sex: M
Age: 81
State: IL

Vax Date: 01/01/2021
Onset Date:
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: Sore injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore injection site arm) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (Sore injection site arm). At the time of the report, VACCINATION SITE PAIN (Sore injection site arm) outcome was unknown. No concomitant medications were provided. No treatment medications were provided.

Other Meds:

Current Illness:

ID: 1790281
Sex: M
Age: 54
State: MO

Vax Date: 10/04/2021
Onset Date:
Rec V Date: 10/16/2021
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: arm hurts; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurts) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination. Concurrent medical conditions included Back pain. On 04-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (arm hurts). At the time of the report, PAIN IN EXTREMITY (arm hurts) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. Treatment medication was not provided by the reporter.

Other Meds:

Current Illness: Back pain

ID: 1790282
Sex: M
Age: 61
State: IA

Vax Date: 03/12/2021
Onset Date:
Rec V Date: 10/16/2021
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: Woke up in middle of night and Still not sleeping well; Not eating well; Felt unwell; Muscle pain; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Woke up in middle of night and Still not sleeping well), DECREASED APPETITE (Not eating well), MALAISE (Felt unwell), MYALGIA (Muscle pain) and FATIGUE (Fatigue) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045C21A, 029A21A and 001B21A) for COVID-19 vaccination. Concurrent medical conditions included Immunocompromised. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INSOMNIA (Woke up in middle of night and Still not sleeping well), DECREASED APPETITE (Not eating well), MALAISE (Felt unwell), MYALGIA (Muscle pain) and FATIGUE (Fatigue). The patient was treated with AZELASTINE at an unspecified dose and frequency. At the time of the report, INSOMNIA (Woke up in middle of night and Still not sleeping well), DECREASED APPETITE (Not eating well), MALAISE (Felt unwell), MYALGIA (Muscle pain) and FATIGUE (Fatigue) outcome was unknown. No concomitant medications were reported. This case was linked to MOD-2021-342370 (Patient Link).

Other Meds:

Current Illness: Immunocompromised

ID: 1790283
Sex: F
Age: 37
State: TX

Vax Date: 09/15/2021
Onset Date: 09/16/2021
Rec V Date: 10/16/2021
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: 20210822; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: She tested positive for COVID-19 disease

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: she still feels heavy in her chest; She was coughing while talking; Chest hurt; Ovaries area Hurting; Sweats; Heart palpitation; Swollen Lymph nodes in the neck; Hurting Lymph nodes in the neck; Headache; She started heving Chills; Body aches; This spontaneous case was reported by a patient and describes the occurrence of CHEST DISCOMFORT (she still feels heavy in her chest), COUGH (She was coughing while talking), CHEST PAIN (Chest hurt), ADNEXA UTERI PAIN (Ovaries area Hurting) and HYPERHIDROSIS (Sweats) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 (She tested positive for COVID-19 disease two weeks prior to vaccination with COVID-19 symptoms, Night sweats and muscle pain) from 22-Aug-2021 to 01-Sep-2021. On 15-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, the patient experienced COUGH (She was coughing while talking), CHEST PAIN (Chest hurt), ADNEXA UTERI PAIN (Ovaries area Hurting), HYPERHIDROSIS (Sweats), PALPITATIONS (Heart palpitation), LYMPHADENOPATHY (Swollen Lymph nodes in the neck), LYMPH NODE PAIN (Hurting Lymph nodes in the neck), HEADACHE (Headache), CHILLS (She started heving Chills) and MYALGIA (Body aches). On an unknown date, the patient experienced CHEST DISCOMFORT (she still feels heavy in her chest). At the time of the report, CHEST DISCOMFORT (she still feels heavy in her chest) had not resolved, COUGH (She was coughing while talking), CHEST PAIN (Chest hurt), ADNEXA UTERI PAIN (Ovaries area Hurting), HYPERHIDROSIS (Sweats), LYMPHADENOPATHY (Swollen Lymph nodes in the neck), LYMPH NODE PAIN (Hurting Lymph nodes in the neck), HEADACHE (Headache), CHILLS (She started heving Chills) and MYALGIA (Body aches) outcome was unknown and PALPITATIONS (Heart palpitation) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Aug-2021, SARS-CoV-2 test: positive (Positive) She tested positive for COVID-19 disease. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment details were reported. Patient reported that her doctor (Urgent care) told her that she got her COVID-19 vaccine too early after COVID-19 disease. She does not have a medical history of heart disease.

Other Meds:

Current Illness:

ID: 1790284
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
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: night sweats; This spontaneous case was reported by a consumer and describes the occurrence of NIGHT SWEATS (night sweats) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NIGHT SWEATS (night sweats). At the time of the report, NIGHT SWEATS (night sweats) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported by the reporter. No treatment information provided.

Other Meds:

Current Illness:

ID: 1790285
Sex: F
Age: 83
State: IL

Vax Date: 09/02/2021
Onset Date: 09/02/2021
Rec V Date: 10/16/2021
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: feels very tired/extremely fatigued/feels tired all the time; muscle pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Oct-2021 and was forwarded to Moderna on 05-Oct-2021. This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (feels very tired/extremely fatigued/feels tired all the time) and MYALGIA (muscle pain) in an 83-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 02-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 3 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 02-Sep-2021, the patient experienced FATIGUE (feels very tired/extremely fatigued/feels tired all the time) and MYALGIA (muscle pain). At the time of the report, FATIGUE (feels very tired/extremely fatigued/feels tired all the time) and MYALGIA (muscle pain) outcome was unknown. Caller is calling regarding their mother who took the third Moderna COVID-19 vaccine shot on 02Sep2021t as she is immunocompromised. There had passed 5 months and a week between the 2nd and the 3rd shot. She still feels very tired since that date. The caller does not have their mother's card so more details of the doses could not be gathered. The patient had blood tests done to check what could be happening but everything came back normal. country after the shot. Concomitant medication use was unknown Treatment information was unknown

Other Meds:

Current Illness:

ID: 1790286
Sex: F
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: Severe fever; Fatigue; Headache; Cold sores; This literature-study case was reported in a literature article and describes the occurrence of PYREXIA (Severe fever), FATIGUE (Fatigue), HEADACHE (Headache) and ORAL HERPES (Cold sores) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. LITERATURE REFERENCE: Safety of COVID-19 vaccination in immune-deficient patients receiving supplemental immunoglobulin therapies. Immunol. 2021;41(7):1527-30. Concurrent medical conditions included Common variable immunodeficiency. Concomitant products included IMMUNOGLOBULINS NOS for Common variable immunodeficiency. 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 PYREXIA (Severe fever) (seriousness criterion medically significant), FATIGUE (Fatigue) (seriousness criterion medically significant), HEADACHE (Headache) (seriousness criterion medically significant) and ORAL HERPES (Cold sores) (seriousness criterion medically significant). At the time of the report, PYREXIA (Severe fever), FATIGUE (Fatigue), HEADACHE (Headache) and ORAL HERPES (Cold sores) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered PYREXIA (Severe fever), FATIGUE (Fatigue), HEADACHE (Headache) and ORAL HERPES (Cold sores) to be possibly related. No treatment was provided. An associated condition Enteropathy was mentioned. Deidentified patient information was provided for 37 patients from 24 RA members from primarily academic medical centers. For the final analysis, 25 patients had complete survey information regarding reaction to an initial dose and 22 had complete information for both the first and second doses. Patient characteristics demonstrated that 68.0% (17/25) of patients were female, 96.0% (24/25) were White and 20.0% (5/25) were identified as Hispanic or Latino. The most common diagnosis was common variable immunodeficiency (CVID) in 72.0% (18/25 patients), and 1 patient each was reported with secondary hypogammaglobulinemia due to use of rituximab, X-linked agammaglobulinemia (XLA), severe combined immune deficiency (SCID) due to adenosine deaminase deficiency following gene therapy, Hyper-IgE syndrome, ataxia telangiectasia with hypogammaglobulinemia, CD25 deficiency (compound heterozygote), and combined immunodeficiency (CID) with hypogammaglobulinemia. Injection site pain and fatigue were the most frequently reported symptoms after both doses. COVID-19 vaccines appear safe and well tolerated in patients with immunodeficiency who are receiving supplemental immunoglobulin therapy. This case concerns a 29-year-old female patient, with reported medical history of common variable immunodeficiency, who experienced the unexpected events of pyrexia, fatigue, headache and oral herpes. The events occurred following an unspecified date after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not unknown as second dose details was not disclosed. Causality for the reported event was not provided by the reporter. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) not affected by this report. Event seriousness assessed as as medically significant. However, there was no information in the source docum This case was linked to MOD-2021-342156, MOD-2021-342334, MOD-2021-342335, MOD-2021-342336, MOD-2021-342337, MOD-2021-342338, MOD-2021-342339, MOD-2021-342340, MOD-2021-342341, MOD-2021-342342, MOD-2021-342343, MOD-2021-342344, MOD-2021-342345 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 06-Oct-2021: Follow up received by safety 07-OCT-2021 included an Email with FTA received from Regulatory Authority team and does not contain any new information.; Sender's Comments: This case concerns a 29-year-old female patient, with reported medical history of common variable immunodeficiency, who experienced the unexpected events of pyrexia, fatigue, headache and oral herpes. The events occurred following an unspecified date after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not unknown as second dose details was not disclosed. Causality for the reported event was not provided by the reporter. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) not affected by this report. Event seriousness assessed as as medically significant. However, there was no information in the source document supporting that criteria.

Other Meds: Immunoglobulins NOS

Current Illness: Common variable immunodeficiency

ID: 1790287
Sex: F
Age: 54
State: CA

Vax Date: 02/03/2021
Onset Date: 03/01/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), CHILLS (Chills) and VACCINATION SITE PAIN (Extreme sudden onset pain/discomfort in the arm that the injection occurred/random sudden onset of pain in the upper left arm where the vaccines were given.) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 015M20A) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy (sulfa), Food allergy (Oat), Food allergy (possibly some nuts), Asthma (asthma (since childhood)) and Arthritis. Concomitant products included CETIRIZINE HYDROCHLORIDE for Allergy, CHONDROITIN SULFATE, GLUCOSAMINE SULFATE (GLUCOSAMINE & CHONDROITIN SULFATE) for Arthritis, FLUTICASONE PROPIONATE, SALMETEROL XINAFOATE (ADVAIR) and SALBUTAMOL (VENTOLINE [SALBUTAMOL]) for Asthma, ALBUTEROL [SALBUTAMOL] and VITAMIN C [ASCORBIC ACID] for an unknown indication. On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced PYREXIA (Fever) and CHILLS (Chills). In May 2021, the patient experienced VACCINATION SITE PAIN (Extreme sudden onset pain/discomfort in the arm that the injection occurred/random sudden onset of pain in the upper left arm where the vaccines were given.). The patient was treated with ACETAMINOPHEN in March 2021 for Chills and Fever, at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever), CHILLS (Chills) and VACCINATION SITE PAIN (Extreme sudden onset pain/discomfort in the arm that the injection occurred/random sudden onset of pain in the upper left arm where the vaccines were given.) outcome was unknown. The patient reported that the pain in the arm of injection comes in severely and goes away. This was not triggered by any activities and was very localized. Pain sometimes occurring a few times in a day or week, or once every few weeks also there have been times when I've grabbed my arm as if to sooth the area as one might after being punched, was reported Most recent FOLLOW-UP information incorporated above includes: On 11-Oct-2021: Follow up document received on 11-OCT-21 contains patient demographics(race, patient height and weight and medical history include arthritis updated. Concomitant drugs updated except Advair and albuterol.

Other Meds: ADVAIR; ALBUTEROL [SALBUTAMOL]; VENTOLINE [SALBUTAMOL]; CETIRIZINE HYDROCHLORIDE; GLUCOSAMINE & CHONDROITIN SULFATE; VITAMIN C [ASCORBIC ACID]

Current Illness: Arthritis; Asthma (asthma (since childhood)); Drug allergy (sulfa); Food allergy (possibly some nuts); Food allergy (Oat)

ID: 1790288
Sex: M
Age: 61
State: IA

Vax Date: 03/12/2021
Onset Date:
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: had flu like symptoms; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (had flu like symptoms) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. No Medical History information was reported. On 12-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (had flu like symptoms). At the time of the report, INFLUENZA LIKE ILLNESS (had flu like symptoms) 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. This case was linked to MOD-2021-342263 (Patient Link).

Other Meds:

Current Illness:

ID: 1790289
Sex: F
Age: 34
State: NC

Vax Date: 09/17/2021
Onset Date: 10/01/2021
Rec V Date: 10/16/2021
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: Received both doses only 2 weeks apart; Both doses were expired; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received both doses only 2 weeks apart) and EXPIRED PRODUCT ADMINISTERED (Both doses were expired) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 047A21A and 002A21A) for COVID-19 vaccination. No Medical History information was reported. On 17-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received both doses only 2 weeks apart) and EXPIRED PRODUCT ADMINISTERED (Both doses were expired). On 01-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received both doses only 2 weeks apart) and EXPIRED PRODUCT ADMINISTERED (Both doses were expired) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The patient received the 2 doses with less than 25 days apart, and both of them were expired. No concomitant medications were reported. No treatment information was reported This case was linked to MOD-2021-343937 (Patient Link).

Other Meds:

Current Illness:

ID: 1790291
Sex: M
Age: 42
State: MA

Vax Date: 10/13/2021
Onset Date: 10/14/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: None

Allergies: None

Symptom List: Erythema, Pruritus

Symptoms: Swelling in the left armpit large and painful enough on the second night to wake me up Minor body aches

Other Meds: None

Current Illness: None

ID: 1790292
Sex: F
Age: 44
State:

Vax Date: 03/02/2021
Onset Date:
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: pretty affected by the first two doses/it was very hard; diarrhea for 10 days; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (pretty affected by the first two doses/it was very hard) and DIARRHOEA (diarrhea for 10 days) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029A21A) for COVID-19 vaccination. "No medical history was provided by the reporter.". Concomitant products included HYDROXYZINE EMBONATE (HYDROXYZINE PAMOATE) for Anxiety, TRAZODONE for Sleep disorder. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (pretty affected by the first two doses/it was very hard) and DIARRHOEA (diarrhea for 10 days). At the time of the report, VACCINATION COMPLICATION (pretty affected by the first two doses/it was very hard) outcome was unknown and DIARRHOEA (diarrhea for 10 days) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment information was provided. This case was linked to MOD-2021-342423 (Patient Link).

Other Meds: TRAZODONE; HYDROXYZINE PAMOATE

Current Illness:

ID: 1790293
Sex: F
Age: 73
State: IN

Vax Date: 01/21/2021
Onset Date: 02/18/2021
Rec V Date: 10/16/2021
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: For about 2 days, all I wanted to do was sleep.; Felt really fatigued; Blinding headache; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (For about 2 days, all I wanted to do was sleep.), HEADACHE (Blinding headache) and FATIGUE (Felt really fatigued) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 029K20A) for COVID-19 vaccination. The patient's past medical history included Blood pressure low (The patient was on a ventilator for about a week because her blood pressure was 40) and Pacemaker insertion (cardiac). Concurrent medical conditions included Bradycardia. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Feb-2021, the patient experienced HEADACHE (Blinding headache). On 19-Feb-2021, the patient experienced SOMNOLENCE (For about 2 days, all I wanted to do was sleep.) and FATIGUE (Felt really fatigued). At the time of the report, SOMNOLENCE (For about 2 days, all I wanted to do was sleep.), HEADACHE (Blinding headache) and FATIGUE (Felt really fatigued) outcome was unknown. No concomitant medications were provided. No treatment medications were reported.

Other Meds:

Current Illness: Bradycardia

ID: 1790294
Sex: F
Age: 44
State:

Vax Date: 03/30/2021
Onset Date:
Rec V Date: 10/16/2021
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: pretty affected by the first two doses/it was very hard; felt weak; arm was weak; chills; headache for almost a month; fatigue; soreness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (pretty affected by the first two doses/it was very hard), ASTHENIA (felt weak), MUSCULAR WEAKNESS (arm was weak), CHILLS (chills) and HEADACHE (headache for almost a month) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008B21A) 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 TRAZODONE and HYDROXYZINE EMBONATE (HYDROXYZINE PAMOATE) for an unknown indication. On 30-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (pretty affected by the first two doses/it was very hard), ASTHENIA (felt weak), MUSCULAR WEAKNESS (arm was weak), CHILLS (chills), HEADACHE (headache for almost a month), FATIGUE (fatigue) and MYALGIA (soreness). At the time of the report, VACCINATION COMPLICATION (pretty affected by the first two doses/it was very hard), ASTHENIA (felt weak) and MUSCULAR WEAKNESS (arm was weak) outcome was unknown and CHILLS (chills), HEADACHE (headache for almost a month), FATIGUE (fatigue) and MYALGIA (soreness) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. This case was linked to MOD-2021-342395 (Patient Link).

Other Meds: TRAZODONE; HYDROXYZINE PAMOATE

Current Illness:

ID: 1790295
Sex: F
Age: 66
State: UT

Vax Date: 09/02/2021
Onset Date: 09/02/2021
Rec V Date: 10/16/2021
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: left skin pigmentation very dark, dark brown, almost like a sunburn; reaction in the arm where vaccine was injected; very hot; very red; Patient will not get 2nd dose as HCP recommended; tremors in the legs; tremors in the legs have been gradually getting worse; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (tremors in the legs), PIGMENTATION DISORDER (left skin pigmentation very dark, dark brown, almost like a sunburn), VACCINATION SITE REACTION (reaction in the arm where vaccine was injected), VACCINATION SITE WARMTH (very hot ) and CONDITION AGGRAVATED (tremors in the legs have been gradually getting worse) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. Concomitant products included LEVOTHYROXINE and VITAMINS NOS for an unknown indication. On 02-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Sep-2021, the patient experienced TREMOR (tremors in the legs), CONDITION AGGRAVATED (tremors in the legs have been gradually getting worse) and PRODUCT DOSE OMISSION ISSUE (Patient will not get 2nd dose as HCP recommended). On an unknown date, the patient experienced PIGMENTATION DISORDER (left skin pigmentation very dark, dark brown, almost like a sunburn), VACCINATION SITE REACTION (reaction in the arm where vaccine was injected), VACCINATION SITE WARMTH (very hot ) and VACCINATION SITE ERYTHEMA (very red). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, TREMOR (tremors in the legs), PIGMENTATION DISORDER (left skin pigmentation very dark, dark brown, almost like a sunburn) and CONDITION AGGRAVATED (tremors in the legs have been gradually getting worse) had not resolved and VACCINATION SITE REACTION (reaction in the arm where vaccine was injected), VACCINATION SITE WARMTH (very hot ), VACCINATION SITE ERYTHEMA (very red) and PRODUCT DOSE OMISSION ISSUE (Patient will not get 2nd dose as HCP recommended) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was withdrawn on an unknown date.

Other Meds: LEVOTHYROXINE; VITAMINS NOS

Current Illness:

ID: 1790296
Sex: M
Age: 61
State: AZ

Vax Date: 08/28/2021
Onset Date: 09/28/2021
Rec V Date: 10/16/2021
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: hardly sleep/I sleep about 3 hours a night; can't get comfortable; if I'm not freezing to death, then I'm roasting alive; extremely sensitive to bright light/if I go out in the sun, I'm blinded; it hurts bad; He hasn't gone to work since then. He can't drive his truck, which is what he does for a living; joints are killing me/shoulders, lower back, hips; feeling like crap; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (feeling like crap), INSOMNIA (hardly sleep/I sleep about 3 hours a night), DISCOMFORT (can't get comfortable), FEELING OF BODY TEMPERATURE CHANGE (if I'm not freezing to death, then I'm roasting alive) and PHOTOPHOBIA (extremely sensitive to bright light/if I go out in the sun, I'm blinded) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 28-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Sep-2021, the patient experienced MALAISE (feeling like crap). On an unknown date, the patient experienced INSOMNIA (hardly sleep/I sleep about 3 hours a night), DISCOMFORT (can't get comfortable), FEELING OF BODY TEMPERATURE CHANGE (if I'm not freezing to death, then I'm roasting alive), PHOTOPHOBIA (extremely sensitive to bright light/if I go out in the sun, I'm blinded), PAIN (it hurts bad), IMPAIRED WORK ABILITY (He hasn't gone to work since then. He can't drive his truck, which is what he does for a living) and ARTHRALGIA (joints are killing me/shoulders, lower back, hips). The patient was treated with PARACETAMOL (TYLENOL) on 28-Sep-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, MALAISE (feeling like crap), INSOMNIA (hardly sleep/I sleep about 3 hours a night), DISCOMFORT (can't get comfortable), FEELING OF BODY TEMPERATURE CHANGE (if I'm not freezing to death, then I'm roasting alive), PHOTOPHOBIA (extremely sensitive to bright light/if I go out in the sun, I'm blinded), PAIN (it hurts bad), IMPAIRED WORK ABILITY (He hasn't gone to work since then. He can't drive his truck, which is what he does for a living) and ARTHRALGIA (joints are killing me/shoulders, lower back, hips) had not resolved. No concomitant medications were reported. The patient had driven trucks for 40 years, that all took away from him. The patient could no longer do what he was doing. The thing had got him terrified.

Other Meds:

Current Illness:

ID: 1790297
Sex: F
Age: 58
State: CO

Vax Date: 02/08/2021
Onset Date: 10/04/2021
Rec V Date: 10/16/2021
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: diagnosed with Covid; Lack of efficacy; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (diagnosed with Covid) and DRUG INEFFECTIVE (Lack of efficacy) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 03M20A) for COVID-19 vaccination. No Medical History information was reported. On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Oct-2021, the patient experienced COVID-19 (diagnosed with Covid) and DRUG INEFFECTIVE (Lack of efficacy). The patient was treated with REMDESIVIR on 05-Oct-2021 for COVID-19, at a dose of Infusion. At the time of the report, COVID-19 (diagnosed with Covid) outcome was unknown and DRUG INEFFECTIVE (Lack of efficacy) had resolved. Concomitant medications were not provided. This case concerns a 58-year-old, female patient with no reported medical history, who experienced the unexpected non-serious and AESI event of COVID-19. Drug ineffective was also reported. The event occurred 6 months and 4 days after second dose of Spikevax. The rechallenge was not applicable as no additional dose is expected to be given. The benefit-risk relationship of Spikevax is not affected by this report.; Sender's Comments: This case concerns a 58-year-old, female patient with no reported medical history, who experienced the unexpected non-serious and AESI event of COVID-19. Drug ineffective was also reported. The event occurred 6 months and 4 days after second dose of Spikevax. The rechallenge was not applicable as no additional dose is expected to be given. The benefit-risk relationship of Spikevax is not affected by this report.

Other Meds:

Current Illness:

ID: 1790298
Sex: M
Age: 24
State: MI

Vax Date: 10/04/2021
Onset Date: 10/04/2021
Rec V Date: 10/16/2021
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: Receiving dose from an expired Moderna COVID19 vaccine vial; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (receiving dose from an expired Moderna COVID19 vaccine vial) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037b21a) for COVID-19 vaccination. No Medical History information was reported. On 04-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (receiving dose from an expired Moderna COVID19 vaccine vial). On 04-Oct-2021, EXPIRED PRODUCT ADMINISTERED (receiving dose from an expired Moderna COVID19 vaccine vial) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported. No treatment medication use was reported.

Other Meds:

Current Illness:

ID: 1790299
Sex: F
Age: 51
State: TX

Vax Date: 10/01/2021
Onset Date: 10/02/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Name: SARS-CoV-2 test; Test Result: Negative ; Result Unstructured Data: Negative

Allergies:

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

Symptoms: Eyes are teary; Can't tolerate light; Pain in her eyes; Her throat is irritated; Can't move much; Started to feel her feet very cold; Very very weak; Feels her throat closes; Her breathing gets a little heavy; Pain in all her body / When she goes to sleep is like laying on a bed of nails; Very dizzy/a lot of dizziness; Stomach ache that expanded, it was very strange/very bad stomach ache on 05 Oct/pain in her stomach; Diarrhea; Arthritis in one shoulder and this made it worse; Bad nausea/a lot of nausea; A lot of joint pain/pain in her joints on 04 Oct 2021; headache/pain in her head; This spontaneous case was reported by a consumer and describes the occurrence of THROAT IRRITATION (Her throat is irritated), HYPOKINESIA (Can't move much), PERIPHERAL COLDNESS (Started to feel her feet very cold), ASTHENIA (Very very weak) and THROAT TIGHTNESS (Feels her throat closes) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 on 06-Aug-2021. Concurrent medical conditions included Arthritis. On 01-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Oct-2021, the patient experienced ARTHRALGIA (A lot of joint pain/pain in her joints on 04 Oct 2021) and HEADACHE (headache/pain in her head). On 04-Oct-2021, the patient experienced PERIPHERAL COLDNESS (Started to feel her feet very cold), ASTHENIA (Very very weak), THROAT TIGHTNESS (Feels her throat closes), DYSPNOEA (Her breathing gets a little heavy), DIZZINESS (Very dizzy/a lot of dizziness), ABDOMINAL PAIN UPPER (Stomach ache that expanded, it was very strange/very bad stomach ache on 05 Oct/pain in her stomach), DIARRHOEA (Diarrhea), CONDITION AGGRAVATED (Arthritis in one shoulder and this made it worse), NAUSEA (Bad nausea/a lot of nausea) and MYALGIA (Pain in all her body / When she goes to sleep is like laying on a bed of nails). On 05-Oct-2021, the patient experienced THROAT IRRITATION (Her throat is irritated) and HYPOKINESIA (Can't move much). On an unknown date, the patient experienced LACRIMATION INCREASED (Eyes are teary), PHOTOPHOBIA (Can't tolerate light) and EYE PAIN (Pain in her eyes). At the time of the report, THROAT IRRITATION (Her throat is irritated), HYPOKINESIA (Can't move much), PERIPHERAL COLDNESS (Started to feel her feet very cold), ASTHENIA (Very very weak), THROAT TIGHTNESS (Feels her throat closes), DYSPNOEA (Her breathing gets a little heavy), LACRIMATION INCREASED (Eyes are teary), PHOTOPHOBIA (Can't tolerate light), EYE PAIN (Pain in her eyes), DIZZINESS (Very dizzy/a lot of dizziness), ABDOMINAL PAIN UPPER (Stomach ache that expanded, it was very strange/very bad stomach ache on 05 Oct/pain in her stomach), DIARRHOEA (Diarrhea), CONDITION AGGRAVATED (Arthritis in one shoulder and this made it worse), NAUSEA (Bad nausea/a lot of nausea), ARTHRALGIA (A lot of joint pain/pain in her joints on 04 Oct 2021), HEADACHE (headache/pain in her head) and MYALGIA (Pain in all her body / When she goes to sleep is like laying on a bed of nails) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. No treatment information was reported. Company comment: This case concerns a 51-year-old female patient with no relevant medical history, who experienced the expected event of Arthralgia. The event occurred one day after receiving the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the first dose was disclosed. The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 07-Oct-2021: Follow-up received on 08 Oct 2021 contains no new information.; Sender's Comments: This case concerns a 51-year-old female patient with no relevant medical history, who experienced the expected event of Arthralgia. The event occurred one day after receiving the first dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the first dose was disclosed. The event is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.

Other Meds:

Current Illness: Arthritis

ID: 1790300
Sex: M
Age: 65
State: CO

Vax Date: 10/04/2021
Onset Date: 10/04/2021
Rec V Date: 10/16/2021
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: Pharmacist gave patients expired doses of Moderna COVID-19; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist gave patients expired doses of Moderna COVID-19) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040B21A) for COVID-19 vaccination. No Medical History information was reported. On 04-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist gave patients expired doses of Moderna COVID-19). On 04-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Pharmacist gave patients expired doses of Moderna COVID-19) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. patient was monitored for 15 min after and had no symptoms. No concomitant medications was reported. No treatment drug details was reported.

Other Meds:

Current Illness:

ID: 1790301
Sex: F
Age:
State: NY

Vax Date: 09/18/2021
Onset Date: 09/19/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Name: body temperature; Result Unstructured Data: 100.3 F

Allergies:

Symptom List: Vomiting

Symptoms: flu like symptoms; nocturnal limb pain, legs, arms, nocturnal pain stops in the day time but night disturbed with pain; she got nocturnal limb pain in her legs, arms, and buttocks; developed low grade fever; aches and pains/ nocturnal myalgia; This spontaneous case was reported by a physician and describes the occurrence of INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN IN EXTREMITY (nocturnal limb pain, legs, arms, nocturnal pain stops in the day time but night disturbed with pain), MUSCULOSKELETAL PAIN (she got nocturnal limb pain in her legs, arms, and buttocks), PYREXIA (developed low grade fever) and MYALGIA (aches and pains/ nocturnal myalgia) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 18-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Sep-2021, the patient experienced INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN IN EXTREMITY (nocturnal limb pain, legs, arms, nocturnal pain stops in the day time but night disturbed with pain), MUSCULOSKELETAL PAIN (she got nocturnal limb pain in her legs, arms, and buttocks), PYREXIA (developed low grade fever) and MYALGIA (aches and pains/ nocturnal myalgia). The patient was treated with PARACETAMOL (TYLENOL) on 19-Sep-2021 for Pain, at a dose of 1300 milligram and OXYCODONE on 19-Sep-2021 for Pain, at a dose of 5 milligram. At the time of the report, INFLUENZA LIKE ILLNESS (flu like symptoms), PAIN IN EXTREMITY (nocturnal limb pain, legs, arms, nocturnal pain stops in the day time but night disturbed with pain), MUSCULOSKELETAL PAIN (she got nocturnal limb pain in her legs, arms, and buttocks) and PYREXIA (developed low grade fever) outcome was unknown and MYALGIA (aches and pains/ nocturnal myalgia) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.3 (abnormal) 100.3 F. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitants medications was reported. The nocturnal pain stopped in the day time but at night she was disturbed with pain Tylenol together with Oxycodone,gave her sleep relief, event low grade fever lasted for one week noted. Most recent FOLLOW-UP information incorporated above includes: On 07-Oct-2021: Event (nocturnal myalgia) outcome updated.

Other Meds:

Current Illness:

ID: 1790302
Sex: M
Age: 14
State: MS

Vax Date: 08/31/2021
Onset Date: 08/31/2021
Rec V Date: 10/16/2021
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: The patient did not receive a second dose of the Moderna COVID-19 vaccine as of 05OCT2021, 35 days past first dose.; A fourteen year old patient was administered a single dose of the Moderna COVID-19 vaccine.; This spontaneous case was reported by an other health care professional and describes the occurrence of OFF LABEL USE (A fourteen year old patient was administered a single dose of the Moderna COVID-19 vaccine.) and PRODUCT DOSE OMISSION ISSUE (The patient did not receive a second dose of the Moderna COVID-19 vaccine as of 05OCT2021, 35 days past first dose.) in a 14-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. No Medical History information was reported. On 31-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Aug-2021, the patient experienced OFF LABEL USE (A fourteen year old patient was administered a single dose of the Moderna COVID-19 vaccine.). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (The patient did not receive a second dose of the Moderna COVID-19 vaccine as of 05OCT2021, 35 days past first dose.). On 31-Aug-2021, OFF LABEL USE (A fourteen year old patient was administered a single dose of the Moderna COVID-19 vaccine.) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (The patient did not receive a second dose of the Moderna COVID-19 vaccine as of 05OCT2021, 35 days past first dose.) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. Treatment information was not provided. The second dose was not yet administered. Patient did not report any symptoms or side effects after receiving the vaccine. Most recent FOLLOW-UP information incorporated above includes: On 09-Oct-2021: Follow up information received on 11-OCT-2021 included ethnicity and race of the patient.

Other Meds:

Current Illness:

ID: 1790303
Sex: M
Age:
State: CA

Vax Date: 07/01/2021
Onset Date: 10/03/2021
Rec V Date: 10/16/2021
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: Bells Palsy/can not eat and can not drink, can not smile, can not sleep, can not close their left eye; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Bells Palsy/can not eat and can not drink, can not smile, can not sleep, can not close their left eye) 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. In July 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) (unknown route) 1 dosage form. On 03-Oct-2021, the patient experienced BELL'S PALSY (Bells Palsy/can not eat and can not drink, can not smile, can not sleep, can not close their left eye) (seriousness criterion medically significant). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency and VALACICLOVIR for Adverse event, at an unspecified dose and frequency. At the time of the report, BELL'S PALSY (Bells Palsy/can not eat and can not drink, can not smile, can not sleep, can not close their left eye) outcome was unknown. Concomitant medications were not reported. The patient was also prescribed with some eye ointment, an eye patch at night to keep the eye shut and some eye drops for daytime.; Sender's Comments: This case refers to a male patient of unknown age with no relevant medical history who experienced the expected event of Bell's Palsy approximately 3 months after the second dose of Moderna COVID-19 Vaccine. Rechallenge was assessed as not applicable since limited information on the first dose was provided. No causality assessment was provided by the reporter. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.

Other Meds:

Current Illness:

ID: 1790304
Sex: F
Age: 47
State: CA

Vax Date: 01/25/2021
Onset Date:
Rec V Date: 10/16/2021
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: light flu symptoms after first dose; This spontaneous case was reported by a nurse and describes the occurrence of INFLUENZA LIKE ILLNESS (light flu symptoms after first dose) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. Concurrent medical conditions included Autoimmune disorder. Concomitant products included CORTICOSTEROIDS for Autoimmune disorder NOS. On 25-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 INFLUENZA LIKE ILLNESS (light flu symptoms after first dose). At the time of the report, INFLUENZA LIKE ILLNESS (light flu symptoms after first dose) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment medications were reported for first dose events. This case was linked to MOD-2021-342720 (Patient Link).

Other Meds: CORTICOSTEROIDS

Current Illness: Autoimmune disorder

ID: 1790305
Sex: F
Age: 49
State: MN

Vax Date: 09/22/2021
Onset Date: 09/22/2021
Rec V Date: 10/16/2021
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: Since yesterday (04Oct2021), her face has started tingling; Fatigue went away a week after.; On same day, she had stuffy nose; She had slight headache,All of those symptoms went away; She was fatigued,She was very tired,Fatigue went away a week after; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Oct-2021 and was forwarded to Moderna on 05-Oct-2021. This spontaneous case was reported by a consumer and describes the occurrence of NASAL CONGESTION (On same day, she had stuffy nose), PARAESTHESIA (Since yesterday (04Oct2021), her face has started tingling), HEADACHE (She had slight headache,All of those symptoms went away), FATIGUE (She was fatigued,She was very tired,Fatigue went away a week after) and FATIGUE (Fatigue went away a week after.) in a 49-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 046C21A) for COVID-19 vaccination. No Medical History information was reported. On 22-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 22-Sep-2021, the patient experienced NASAL CONGESTION (On same day, she had stuffy nose), HEADACHE (She had slight headache,All of those symptoms went away) and FATIGUE (She was fatigued,She was very tired,Fatigue went away a week after). On 30-Sep-2021, the patient experienced FATIGUE (Fatigue went away a week after.). On 04-Oct-2021, the patient experienced PARAESTHESIA (Since yesterday (04Oct2021), her face has started tingling). The patient was treated with EUCALYPTUS GLOBULUS OIL, MENTHOL (HALLS) for Adverse event, at an unspecified dose and frequency and IRON for Adverse event, at an unspecified dose and frequency. At the time of the report, NASAL CONGESTION (On same day, she had stuffy nose), PARAESTHESIA (Since yesterday (04Oct2021), her face has started tingling), HEADACHE (She had slight headache,All of those symptoms went away), FATIGUE (She was fatigued,She was very tired,Fatigue went away a week after) and FATIGUE (Fatigue went away a week after.) 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. Concomitant medications included Blood pressure medicine and Diabetes medicine Patient took Treatment with Halls, Vicks Vapor rub, Iron tablets

Other Meds:

Current Illness:

ID: 1790306
Sex: F
Age: 19
State: KY

Vax Date: 10/05/2021
Onset Date: 10/05/2021
Rec V Date: 10/16/2021
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: Received expired dose of the vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired dose of the vaccine) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. No Medical History information was reported. On 05-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired dose of the vaccine). On 05-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received expired dose of the vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication details was provided. No treatment medication details was provided. This case was linked to MOD-2021-342886 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 07-Oct-2021: Follow up received, contains no new information.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am