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: 1638923
Sex: U
Age:
State:

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

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

Lab Data: Test Name: Body temperature; Result Unstructured Data: 99-100

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: BODY ACHES; MY ARM HURT THE REST OF THE DAY AND NIGHT; HEADACHE; FATIGUE; LOW FEVER (99-100); This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced body aches, my arm hurt the rest of the day and night, headache, fatigue, and low fever (99-100). Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 99-100. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from body aches, my arm hurt the rest of the day and night, headache, fatigue, and low fever (99-100). This report was non-serious.

Other Meds:

Current Illness:

ID: 1638924
Sex: M
Age:
State: NY

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

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: BLOOD CLOTS; This spontaneous report received from a consumer who reported hearing on media platform concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown expiry: unknown) dose, start therapy date were not reported, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced blood clots. As per the reporter "Consumer called for information about blood clots. She mentioned she heard about 1 guy in the media. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of blood clots was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210851596- COVID-19 VACCINE AD26.COV2.S- Blood clots. This event is considered unassessable. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.

Other Meds:

Current Illness:

ID: 1638925
Sex: F
Age:
State: NC

Vax Date:
Onset Date: 08/25/2021
Rec V Date: 08/27/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EL1284
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: SORENESS AND ACHINESS; HIGH FEVER; HEADACHES; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 25-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 25-AUG-2021, the patient experienced soreness and achiness. On 25-AUG-2021, the patient experienced high fever. On 25-AUG-2021, the patient experienced headaches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the high fever, soreness and achiness and headaches was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1638926
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: INJECTIONS STARTED TO COMING OUT FROM NECK AND IF DID NOT RECEIVED VACCINE WOULD BE DEAD; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's concurrent conditions included: numbness. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced injections started to coming out from neck and if did not received vaccine would be dead. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of injections started to coming out from neck and if did not received vaccine would be dead was not reported. This report was non-serious.

Other Meds:

Current Illness: Numbness

ID: 1638927
Sex: M
Age:
State: MA

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

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

Lab Data:

Allergies:

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

Symptoms: NOSE BLEED; This spontaneous report received from a consumer concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced nose bleed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from nose bleed. This report was non-serious.

Other Meds:

Current Illness:

ID: 1638928
Sex: F
Age:
State: SC

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

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

Lab Data:

Allergies:

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

Symptoms: SUSPECTED CLINICAL VACCINATION FAILURE; SUSPECTED COVID-19 INFECTION; This spontaneous report received from a patient concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported) dose was not reported, administered 1 in total on 12-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications were not reported. The patient commented that she recently experienced a breakthrough case of COVID (dates not specified) (coded to suspected covid-19 infection and suspected clinical vaccination failure). As per this report, the patient was recommended to receive the booster shot of vaccine in eight months. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the suspected covid-19 infection and suspected clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report associated with Product Quality compliant and PQC number has been requested.; Sender's Comments: V0: 20210851625-Covid-19 vaccine ad26.cov2.s-Suspected clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS

Other Meds:

Current Illness:

ID: 1638929
Sex: F
Age:
State: MI

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

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: LITTLE BLOOD CLOT ON LEFT LEG NEAR KNEE THE SIZE OF PENNY; ARM SORENESS AT THE INJECTION SITE; This spontaneous report received from a patient concerned a 26 year old female with unspecified ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808982, expiry: 21-SEP-2021) dose was not reported, 1 total, administered on 06-AUG-2021 to right arm for prophylactic vaccination. No concomitant medications were reported. On 07-AUG-2021, the patient experienced arm soreness initially for 3 or 4 days at the injection site. On 25-AUG-2021, the patient experienced little blood clot on left leg near knee the size of a penny. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from arm soreness at the injection site on 10-AUG-2021, and the outcome of little blood clot on left leg near knee the size of penny was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20210851662- Covid-19 vaccine ad26.cov2.s- Little blood clot on left leg near knee the size of penny. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds:

Current Illness:

ID: 1638930
Sex: F
Age:
State: NY

Vax Date:
Onset Date: 03/30/2021
Rec V Date: 08/27/2021
Hospital:

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

Lab Data: Test Date: 202105; Test Name: SARS-CoV-2 antibody test; Result Unstructured Data: keep going up

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: TIRED; HEADACHE; This spontaneous report received from a patient concerned a 72 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1808978, and expiry: 13-JUN-2021) dose was not reported, administered on 29-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 30-MAR-2021, the patient experienced tired. On 30-MAR-2021, the patient experienced headache. Laboratory data (dates unspecified) included: SARS-CoV-2 antibody test (NR: not provided) keep going up. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from tired, and headache on 30-MAR-2021. This report was non-serious.

Other Meds:

Current Illness:

ID: 1638931
Sex: F
Age:
State: NC

Vax Date:
Onset Date: 08/25/2021
Rec V Date: 08/27/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: DRUG ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (17 YEAR OLD); OFF LABEL USE; This spontaneous report received from a health care professional concerned a 17 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1820095, expiry: UNKNOWN) dose was not reported, administered on 25-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-AUG-2021, the patient experienced drug administered to patient of inappropriate age (17 year old). On 25-AUG-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the drug administered to patient of inappropriate age (17 year old) and off label use was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1638932
Sex: F
Age:
State: UT

Vax Date:
Onset Date: 08/25/2021
Rec V Date: 08/27/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: ADMINISTERED THE JANSSEN COVID-19 VACCINE TO A FEMALE PATIENT AND GAVE HER THE ENTIRE VIAL; OFF LABEL USE; This spontaneous report received from a health care professional concerned an adult female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 204A21A, and expiry: 21-SEP-2021) dose was not reported, administered on 25-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-AUG-2021, the patient experienced administered the janssen covid-19 vaccine to a female patient and gave her the entire vial. On 25-AUG-2021, the patient experienced off label use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the administered the janssen covid-19 vaccine to a female patient and gave her the entire vial and off label use was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1638933
Sex: F
Age:
State: MO

Vax Date:
Onset Date: 07/20/2021
Rec V Date: 08/27/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Vaccination site erythema, Vaccination site pruritus, Vaccination site swelling

Symptoms: SEVERE CRUSHING HEADACHE, ON AND OFF HEADACHES OF MILD NATURE AND SLEPT MOST OF THE TIME BECAUSE IT WAS DEBILITATING; This spontaneous report received from a patient concerned a 61 year old female. The patient's weight was 135 pounds, and height was 65 inches. The patient's past medical history included: cigarette smoker, and concurrent conditions included: alcohol user, and non allergy nasal issues, and other pre-existing medical conditions included: The patient had no known allergies, and no history of drug abuse or illicit dug usage. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 207A21A, expiry: 07-AUG-2021) dose was not reported, administered on 20-JUL-2021 for prophylactic vaccination. Concomitant medications included alendronate sodium for non allergy nasal issues, azelastine for non allergy nasal issues, and fluticasone propionate for non allergy nasal issues. On 20-JUL-2021, the patient experienced severe crushing headache, on and off headaches of mild nature and slept most of the time because it was debilitating. Treatment medications (dates unspecified) included: paracetamol, and acetylsalicylic acid/caffeine/paracetamol/salicylamide. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from severe crushing headache, on and off headaches of mild nature and slept most of the time because it was debilitating. This report was non-serious.

Other Meds: FOSAMAX; FLONASE [FLUTICASONE PROPIONATE]; AZELASTINE

Current Illness: Alcohol use (Near beer, social drinker.); Nasal disorder NOS

ID: 1638934
Sex: M
Age:
State: NY

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

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: IN BED ALL WEEK; This spontaneous report received from a patient concerned a 38 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced in bed all week. The action taken with covid-19 vaccine was not applicable. The patient recovered from in bed all week. This report was non-serious.

Other Meds:

Current Illness:

ID: 1638935
Sex: U
Age:
State: NY

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

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

Lab Data:

Allergies:

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

Symptoms: NOSE BLEED; This spontaneous report received from a consumer concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. No concomitant medications were reported. The batch number was not reported and has been requested. On an unspecified date, the patient experienced nose bleed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of nose bleed was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1638936
Sex: F
Age:
State:

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

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 025J20-2A
Dose Series: 1
Vax Route: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Dyspnoea, Fatigue, Feeling abnormal, Head discomfort, Headache

Symptoms: SYMPTOMS OF THYROIDITIS; This spontaneous report received from a patient concerned a female of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient never had thyroid problems before and had not history of autoimmune disorders. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. he batch number was not reported and has been requested. No concomitant medications were reported. On JUL-2021, the patient experienced symptoms of thyroiditis. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of symptoms of thyroiditis was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1638937
Sex: F
Age:
State: AK

Vax Date:
Onset Date: 08/24/2021
Rec V Date: 08/27/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Heart rate decreased, Heart rate increased, Hypertension, Injection site pain, Musculoskeletal chest pain

Symptoms: SWOLLEN LIPS; BUMPS AND HIVES ON FROM HEAD TO REST OF HER BODY; ITCHY; This spontaneous report received from a patient concerned a 39 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: autoimmune disease, non alcoholic, non smoker, allergy to nuts, and allergy to fruits, and other pre-existing medical conditions included: The patient did not have any drug abuse/illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 201A21A, expiry: UNKNOWN) dose was not reported, administered on 23-AUG-2021 18:00 for prophylactic vaccination. No concomitant medications were reported. On 24-AUG-2021, the patient experienced itchy. On 25-AUG-2021, the patient experienced swollen lips. On 25-AUG-2021, the patient experienced bumps and hives on from head to rest of her body. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from itchy, and bumps and hives on from head to rest of her body, and had not recovered from swollen lips. This report was non-serious.

Other Meds:

Current Illness: Abstains from alcohol; Allergy to nuts (Hives and Itchiness); Autoimmune disorder; Fruit allergy (Hives and Itchiness); Non-smoker

ID: 1638938
Sex: M
Age:
State: FL

Vax Date:
Onset Date: 04/06/2021
Rec V Date: 08/27/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: BRUISING; PETECHIAE; This spontaneous report received from a patient concerned a 62 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: non alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient had no history of known allergies and drug abuse or illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 06-APR-2021, the patient experienced bruising. On 06-APR-2021, the patient experienced petechiae. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from bruising, and petechiae. This report was non-serious.

Other Meds:

Current Illness: Abstains from alcohol; Non-smoker

ID: 1638939
Sex: M
Age:
State: MI

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

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

Lab Data: Test Date: 20210412; Test Name: Oxygen saturation; Result Unstructured Data: low; Test Name: COVID-19 virus test; Result Unstructured Data: negative

Allergies:

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

Symptoms: PRESUMED DIAGNOSIS, CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) (COUGH/WHEEZE/COULDN'T BREATHE); This spontaneous report received from a patient concerned a 51 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: non smoker. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unk) dose was not reported, administered on 01-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 02-APR-2021, the patient experienced presumed diagnosis, chronic obstructive pulmonary disease (copd) (cough/wheeze/couldn't breathe). On 12-APR-2021, Laboratory data included: Oxygen saturation (NR: not provided) low. Laboratory data (dates unspecified) included: COVID-19 virus test (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of presumed diagnosis, chronic obstructive pulmonary disease (copd) (cough/wheeze/couldn't breathe) was not reported. This report was non-serious.

Other Meds:

Current Illness: Non-smoker

ID: 1638940
Sex: M
Age:
State: NY

Vax Date:
Onset Date: 04/07/2021
Rec V Date: 08/27/2021
Hospital:

Vax Type: HIBV
Manufacturer: MERCK & CO. INC.
Vax Name: HIB (PEDVAXHIB)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data: Test Name: Antibody test; Result Unstructured Data: High Immunity

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: STAYED IN BED ALL DAY; NAUSEOUS; BAD HEADACHE; This spontaneous report received from a parent concerned a 43 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 07-APR-2021, the patient experienced stayed in bed all day. On 07-APR-2021, the patient experienced nauseous. On 07-APR-2021, the patient experienced bad headache. Laboratory data (dates unspecified) included: Antibody test (NR: not provided) High Immunity. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from stayed in bed all day, nauseous, and bad headache on 07-APR-2021. This report was non-serious. This case, from the same reporter is linked to 20210852035.

Other Meds:

Current Illness:

ID: 1638941
Sex: M
Age:
State: NY

Vax Date:
Onset Date: 04/07/2021
Rec V Date: 08/27/2021
Hospital:

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

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

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: IMMUNITY ALSO HIGH BUT NOT AS HIGH AS WIFE; FEET WERE KILLING HIM; This spontaneous report received from a consumer concerned a 70 year old male. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A expiry: UNKNOWN) dose was not reported, administered on 06-APR-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-APR-2021, the patient experienced feet were killing him. On an unspecified date, the patient experienced immunity also high but not as high as wife. Laboratory data (dates unspecified) included: SARS-CoV-2 antibody test (NR: not provided) High. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from feet were killing him on 07-APR-2021, and the outcome of immunity also high but not as high as wife was not reported. This report was non-serious. This case, from the same reporter is linked to 20210852005.

Other Meds:

Current Illness:

ID: 1638942
Sex: U
Age:
State: SD

Vax Date:
Onset Date: 08/25/2021
Rec V Date: 08/27/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a pharmacist concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1805029 expiry: 23-AUG-2021) dose was not reported, administered on 25-AUG-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-AUG-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1638943
Sex: F
Age:
State: FL

Vax Date:
Onset Date: 03/01/2021
Rec V Date: 08/27/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: Eh9899
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data: Test Date: 202103; Test Name: Blood test; Result Unstructured Data: Normal; Test Date: 20210801; Test Name: Echocardiogram; Result Unstructured Data: Not reported; Test Date: 20210820; Test Name: Blood pressure; Result Unstructured Data: 105/95

Allergies:

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

Symptoms: DIZZINESS; DIFFICULTY CONCENTRATING; BLURRED VISION; DIFFICULTY BREATHING; SWEATS; BLOOD PRESSURE INCREASED; HEADACHE; EXTREME WEAKNESS; NAUSEA; LIGHT SENSITIVITY; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. The patient was previously treated with azithromycin for covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 expiry: 23-AUG-2021) dose was not reported, administered on 19-MAR-2021 10:20 for prophylactic vaccination. No concomitant medications were reported. On MAR-2021, the patient experienced light sensitivity. Laboratory data included: Blood test (NR: not provided) Normal. On 27-MAR-2021, the patient experienced dizziness. On 27-MAR-2021, the patient experienced difficulty concentrating. On 27-MAR-2021, the patient experienced blurred vision. On 27-MAR-2021, the patient experienced difficulty breathing. On 27-MAR-2021, the patient experienced sweats. On 27-MAR-2021, the patient experienced blood pressure increased. On 27-MAR-2021, the patient experienced headache. On 27-MAR-2021, the patient experienced extreme weakness. On 27-MAR-2021, the patient experienced nausea. On 01-AUG-2021, Laboratory data included: Echocardiogram (NR: not provided) Not reported. On 20-AUG-2021, Laboratory data included: Blood pressure (NR: not provided) 105/95. Treatment medications (dates unspecified) included: cyanocobalamin, ondansetron, glyceryl trinitrate, acetylsalicylic acid, and meclozine. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from blurred vision, was recovering from blood pressure increased, and had not recovered from dizziness, headache, difficulty concentrating, nausea, difficulty breathing, extreme weakness, sweats, and light sensitivity. This report was non-serious.

Other Meds:

Current Illness:

ID: 1638944
Sex: F
Age:
State: OK

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

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: ITCHINESS; DIFFICULTY BREATHING; PAIN IN ARM AND LEG; HEADACHE; This spontaneous report received from a consumer concerned a 6 decade old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: drug allergy, diabetes, and swelling, and other pre-existing medical conditions included: Patient had problem with salt and swelling for which she uses diuretic. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on APR-2021 for prophylactic vaccination. The batch number was not reported. The company is unable to perform follow-up to request batch and lot numbers. Concomitant medications included insulin for diabetes. On AUG-2021, the patient experienced itchiness. On AUG-2021, the patient experienced difficulty breathing. On AUG-2021, the patient experienced pain in arm and leg. On AUG-2021, the patient experienced headache. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the pain in arm and leg, headache, itchiness and difficulty breathing was not reported. This report was non-serious.

Other Meds: INSULIN

Current Illness: Diabetes; Drug allergy; Swelling

ID: 1638945
Sex: F
Age:
State: VA

Vax Date:
Onset Date: 08/25/2021
Rec V Date: 08/27/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Dizziness, Injection site pain, Myalgia, Pyrexia

Symptoms: EXPIRED VACCINE ADMINISTERED/ DOSE WAS DRAWN ON 24-AUG-2021 11:00 AND ADMINISTERED ON 25-AUG-2021 13:00; This spontaneous report received from a health care professional concerned a 29 year old female. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 205A21A, expiry: 21-SEP-2021) dose was not reported, administered on 25-AUG-2021 13:00 for prophylactic vaccination. No concomitant medications were reported. On 25-AUG-2021, the patient experienced expired vaccine administered/ dose was drawn on 24-aug-2021 11:00 and administered on 25-aug-2021 13:00. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of expired vaccine administered/ dose was drawn on 24-aug-2021 11:00 and administered on 25-aug-2021 13:00 was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1638946
Sex: F
Age: 60
State: OH

Vax Date: 12/23/2020
Onset Date: 12/24/2020
Rec V Date: 08/27/2021
Hospital:

Vax Type: COVID19
Manufacturer: MODERNA
Vax Name: COVID19 (COVID19 (MODERNA))
Lot: 011L20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: Really bad abdominal pain; Nagging headche; A spontaneous report was received from a healthcare professional, who was also a 60-year-old female patient, who received Moderna's COVID-19 Vaccine and experienced nagging headache and really bad abdominal pain. The patient's medical history was not provided. No concomitant medications were provided. On 23 Dec 2020, prior to the onset of the events, the patient received her first of two planned doses of mRNA-1273 (Batch number 039k20A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 24 Dec 2020, the patient experienced nagging headache. On 25 Dec 2020, she woke up with really bad abdominal pain. Treatment included bismuth subsalicylate. Action taken with mRNA-1273 in response to the events was not provided The outcome of the events nagging headache and really bad abdominal pain was not provided.; Reporter's Comments: This case concerns a 60 year old female patient who experienced events of Abdominal pain and Headache. Abdominal pain occurred 3 days after administration of first of two planned doses of mRNA-1273 (Batch number 039k20A) and Headache occurred 2 days after first of two planned doses of mRNA-1273 (Batch number 039k20A). Very limited information regarding the events has been provided at this time. Based on temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1638947
Sex: F
Age: 51
State:

Vax Date: 12/24/2020
Onset Date: 12/24/2020
Rec V Date: 08/27/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: Limping a bit today only going up the stairs; Trouble going up the stairs with joint pain in her right hip; Pain and soreness in her hip; A spontaneous report was received from a pharmacist, who was a 51 year-old, female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced trouble going up the stairs with joint pain in her right hip, limping a bit today only going up the stairs, and pain and soreness in her hip. The patient's medical history included exercising. No relevant concomitant medications were reported. On 24 Dec 2020 at 11:30 or 12:00, about three hours prior to the events, the patient received her first of two planned doses of mRNA-1273 (batch 039k20a) intramuscularly for prophylaxis of COVID-19 infection. On 24 Dec 2020, around 15:00, the patient noticed she had trouble going up the stairs with joint pain and soreness in her right hip. She did not have any pain or soreness at the injection site, only in her hip. She was limping a bit today only going up the stairs. She had not treated the pain. Action taken with mRNA-1273 in response to the events was not reported. The outcome of the evets trouble going up the stairs with joint pain in her right hip, limping a bit today only going up the stairs, and pain and soreness in her hip were unknown.; Reporter's Comments: This case concerns a 51 year old, female patient. The patient's medical history is not provided. The patient experienced trouble going up the stairs with joint pain in her right hip, limping a bit only going up the stairs, and pain and soreness in her hip. The event occurred on 24 Dec 2020, about 3 hours after the administration of the first dose mRNA-1273. The reporter causality assessment for the event was not provided. The sponsor assessed the event as possibly related to the mRNA-1273 vaccine. Pain of the joint is listed on the company's fact sheet for the healthcare providers. Additional information regarding the patient's medical history and concomitant medications will help to further assess the event of limping.

Other Meds:

Current Illness: Exercise regular

ID: 1638948
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Arthralgia, Chills, Headache, Mobility decreased, Myalgia

Symptoms: Vaccination adverse reaction; 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 VACCINATION COMPLICATION (Vaccination adverse reaction) 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 VACCINATION COMPLICATION (Vaccination adverse reaction). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant medications were reported No treatment medications were reported Amendment version created on 25-Aug-2021, to correct Initial Receipt Date from 16-Jul-2020 to 16-Jul-2021.

Other Meds:

Current Illness:

ID: 1638949
Sex: F
Age: 24
State: TN

Vax Date: 01/06/2021
Onset Date: 01/06/2021
Rec V Date: 08/27/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: Numbness in left hand; sensation like her hand was getting bit or swollen; Face numbness; tingling sensation in her tongue; Headache; A spontaneous report was received from a consumer concerning a 24-year old, female patient who received Moderna's COVID-19 vaccine and experienced headache, numbness in the left hand, sensation of swelling, facial numbness, and tongue tingling. The patient's medical history was not provided. No relevant concomitant medications were reported. On 06 Jan 2021, the patient received their first of two planned doses of mRNA-1273 (lot: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On the evening of 06 Jan 2021, the patient began to experience a headache, numbness in the left hand and face. She also reported having a sensation like her hand was getting big or swelling and tongue tingling. Treatment for the event included diphenhydramine hydrochloride. Action taken with mRNA-1273 in response to the events was not reported. The events, headache, numbness in the left hand, sensation of swelling, and tongue tingling, were considered resolved on 06 Jan 2021. The event, facial numbness, was considered not resolved.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start dates of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1638950
Sex: F
Age: 43
State: GA

Vax Date: 12/31/2020
Onset Date: 01/08/2021
Rec V Date: 08/27/2021
Hospital:

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

Lab Data: Test Date: 20210108; Test Name: CT scan; Result Unstructured Data: lymph nodes were swollen

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: Swollen lymph nodes on my clavicle; A spontaneous report (United States) was received from a nurse concerning a 44-years-old female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and had swollen lymph nodes on clavicle. The patient's medical history was not reported by the reporter. Concomitant medications were not provided. On 31 Dec 2020, prior to the onset of the event, the patient received their first of two planned doses of mRNA-1273 (Lot number: unknown) through intramuscular route at right deltoid for prophylaxis of COVID-19 infection. On 08 Jan 2021, the patient noticed that she had a swollen bump on her clavicle, on the same side as her injection. She had a CT scan on 08 Jan 2021 to determine that her lymph nodes were swollen. She has had no treatment at that time. Treatment for event was reported as none. Action taken with mRNA-1273 in response to the event was unknown. The outcome of event, swollen lymph nodes on clavicle was unknown.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1638951
Sex: F
Age: 74
State: KS

Vax Date: 01/05/2021
Onset Date: 01/05/2021
Rec V Date: 08/27/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Headache, Heart rate increased, Injection site erythema, Injection site pain, Injection site swelling

Symptoms: Diarrhea; No energy; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and ASTHENIA (No energy) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. Concurrent medical conditions included Anxiety (No reported medical history) and Blood pressure. On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced DIARRHOEA (Diarrhea) and ASTHENIA (No energy). At the time of the report, DIARRHOEA (Diarrhea) and ASTHENIA (No energy) 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. This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea) and ASTHENIA (No energy) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. Concurrent medical conditions included Anxiety (No reported medical history) and Blood pressure. On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced DIARRHOEA (Diarrhea) and ASTHENIA (No energy). At the time of the report, DIARRHOEA (Diarrhea) and ASTHENIA (No energy) 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 product use was not provided by the reporter. No treatment information was provided. Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the onset date of the reported events, a causal relationship cannot be excluded.

Other Meds:

Current Illness: Anxiety (No reported medical history); Blood pressure

ID: 1638952
Sex: M
Age:
State:

Vax Date: 01/06/2021
Onset Date: 01/06/2021
Rec V Date: 08/27/2021
Hospital:

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

Lab Data: Test Date: 20210106; Test Name: Blood pressure measurement; Test Result: Inconclusive ; Result Unstructured Data: ten minutes after vaccination; Test Date: 20210106; Test Name: Blood pressure measurement; Test Result: Inconclusive ; Result Unstructured Data: ninety minutes after vaccination; Test Date: 20210106; Test Name: Heart rate; Test Result: Inconclusive ; Result Unstructured Data: ten minutes after vaccination; Test Date: 20210106; Test Name: Heart rate; Test Result: Inconclusive ; Result Unstructured Data: ninety minutes after vaccination; Test Date: 20210106; Test Name: Oxygen saturation; Test Result: Inconclusive ; Result Unstructured Data: thirty minutes after vaccination; Test Date: 20210106; Test Name: Oxygen saturation; Test Result: Inconclusive ; Result Unstructured Data: ninety minutes after vaccination

Allergies:

Symptom List: Nausea

Symptoms: Felt tightness in his throat; Felt soreness in his throat; Very slight associated difficulty breathing; tongue was little swollen; This spontaneous case was reported by a nurse (subsequently medically confirmed) and describes the occurrence of THROAT TIGHTNESS (Felt tightness in his throat), OROPHARYNGEAL PAIN (Felt soreness in his throat), DYSPNOEA (Very slight associated difficulty breathing) and SWOLLEN TONGUE (tongue was little swollen) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (No reported medical history). On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jan-2021, the patient experienced THROAT TIGHTNESS (Felt tightness in his throat), OROPHARYNGEAL PAIN (Felt soreness in his throat), DYSPNOEA (Very slight associated difficulty breathing) and SWOLLEN TONGUE (tongue was little swollen). At the time of the report, THROAT TIGHTNESS (Felt tightness in his throat), OROPHARYNGEAL PAIN (Felt soreness in his throat), DYSPNOEA (Very slight associated difficulty breathing) and SWOLLEN TONGUE (tongue was little swollen) was resolving. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jan-2021, Blood pressure measurement: 164/108 mmHg ten minutes after vaccination and 128/98 mmHg ninety minutes after vaccination. On 06-Jan-2021, Heart rate: 110 heart beats per minute ten minutes after vaccination and 65 heart beats per minute ninety minutes after vaccination. On 06-Jan-2021, Oxygen saturation: 94 percent thirty minutes after vaccination and 96-98 percent ninety minutes after vaccination. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1638953
Sex: M
Age: 80
State: AL

Vax Date: 01/14/2021
Onset Date: 01/17/2021
Rec V Date: 08/27/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: Diarrhea; Dizziness; Sluggish; Cold sweat; Going to passout things were turning black; going back to bed and couldn't make it (too weak)/had to sit on floor; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), SLUGGISHNESS (Sluggish), COLD SWEAT (Cold sweat) and PRESYNCOPE (Going to passout things were turning black) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 14-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 17-Jan-2021, the patient experienced DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), SLUGGISHNESS (Sluggish), COLD SWEAT (Cold sweat), PRESYNCOPE (Going to passout things were turning black) and ASTHENIA (going back to bed and couldn't make it (too weak)/had to sit on floor). At the time of the report, DIARRHOEA (Diarrhea), DIZZINESS (Dizziness), SLUGGISHNESS (Sluggish), COLD SWEAT (Cold sweat), PRESYNCOPE (Going to passout things were turning black) and ASTHENIA (going back to bed and couldn't make it (too weak)/had to sit on floor) outcome was unknown. No concomitant medications were reported. No treatment related information has been reported.; Sender's Comments: Very limited information regarding this events has been provided at this time. Further information has been requested. Company assessed the events to be unlikely related to company product.

Other Meds:

Current Illness:

ID: 1638954
Sex: F
Age:
State: IN

Vax Date: 01/05/2021
Onset Date: 01/05/2021
Rec V Date: 08/27/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: lip swelling; lip tingling; lump in her neck; facial swelling; arm pain; A spontaneous report was received from a physician concerning a 40 year old female patient who experienced arm pain, lip swelling, facial swelling, lip tingling, and lump in her neck with the use of mRNA-1273. The patient's medical history included Ankylosing Spondylitis and on immunosuppression due to her condition. Concomitant medications included hydrocortisone, buprenorphine, diltiazem and duloxetine. Two other drugs were doubtful(Agent not heard properly). On 05 Jan 2021, the patient received the first of two planned doses of mRNA-1273 (Lot # unknown) intramuscularly, for prophylaxis of COVID-19 infection. On the night of 05 Jan 2021, the patient experienced the non-serious event of arm pain, which went away. On 08 Jan 2021, the patient experienced lip swelling and tingling, and a lump in her neck. It was noted the patient is on a lot of medication because her condition is immunosuppressive. The physician inquired if the patient can receive prednisone for reported events and how would it affect the second dose. It was not confirmed whether the patient received treatment with prednisone. Treatment included diphenhydramine hydrochloride and famotidine. Action taken with mRNA-1273 in response to the event was not provided. The event of arm pain recovered on an unspecified date. The events of facial swelling, lip swelling and tingling, and a lump in her neck were not recovered/not resolved.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: HUMERA; BUPRENORPHINE; DILTIAZEM; DULOXETINE

Current Illness: Ankylosing spondylitis; Immunosuppression (due to her condition)

ID: 1638955
Sex: M
Age: 30
State:

Vax Date: 01/06/2021
Onset Date:
Rec V Date: 08/27/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: itching like a bug bite around the injection site; mild red ring about 2cm x 3cm around injection site; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION SITE PRURITUS (itching like a bug bite around the injection site) and VACCINATION SITE ERYTHEMA (mild red ring about 2cm x 3cm around injection site) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 25J20A) for COVID-19 vaccination. No Medical History information was reported. On 06-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PRURITUS (itching like a bug bite around the injection site) and VACCINATION SITE ERYTHEMA (mild red ring about 2cm x 3cm around injection site). At the time of the report, VACCINATION SITE PRURITUS (itching like a bug bite around the injection site) and VACCINATION SITE ERYTHEMA (mild red ring about 2cm x 3cm around injection site) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment related information has been reported.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1638956
Sex: M
Age: 66
State: FL

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

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: joint pain in left arm; pain initially in the right arm which seemed to the at the joints; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (joint pain in left arm) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 04-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On 11-Jan-2021, the patient experienced ARTHRALGIA (joint pain in left arm). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 13-Jan-2021, ARTHRALGIA (joint pain in left arm) had resolved. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1638957
Sex: F
Age:
State: KY

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

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: Dark urine; Confusion/dizziness; Headache; Tingling of the ear; Flu Like Symptoms; Body Aches; Locked Jaw; Confusion/Dizziness; This spontaneous case was reported by a pharmacist and describes the occurrence of CONFUSIONAL STATE (Confusion/dizziness) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The patient's past medical history included Neurological disorder NOS, Tingling and Panic attacks. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CONFUSIONAL STATE (Confusion/dizziness). At the time of the report, CONFUSIONAL STATE (Confusion/dizziness) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment medication not provided. Concomitant medication not provided. Most recent FOLLOW-UP information incorporated above includes: On 13-Apr-2021: No new information received; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1638958
Sex: M
Age:
State: NY

Vax Date: 12/24/2020
Onset Date: 12/31/2020
Rec V Date: 08/27/2021
Hospital:

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

Lab Data: Test Date: 20211231; Test Name: SARS-CoV-2; Test Result: Positive ; Result Unstructured Data: tested positive for COVID 19

Allergies:

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

Symptoms: Little Malaise; Mild symptoms; Tested positive for COVID one week after first dose; This spontaneous case was reported by a physician and describes the occurrence of SARS-COV-2 TEST POSITIVE (Tested positive for COVID one week after first dose), MALAISE (Little Malaise) and VACCINATION COMPLICATION (Mild symptoms) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (no relevant medical history reported). On 24-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2020, the patient experienced SARS-COV-2 TEST POSITIVE (Tested positive for COVID one week after first dose). On an unknown date, the patient experienced MALAISE (Little Malaise) and VACCINATION COMPLICATION (Mild symptoms). At the time of the report, SARS-COV-2 TEST POSITIVE (Tested positive for COVID one week after first dose) outcome was unknown and MALAISE (Little Malaise) and VACCINATION COMPLICATION (Mild symptoms) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 31-Dec-2021, SARS-CoV-2 test: positive (Positive) tested positive for COVID 19. 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.

Other Meds:

Current Illness:

ID: 1638959
Sex: M
Age: 37
State: SD

Vax Date: 01/14/2021
Onset Date: 01/14/2021
Rec V Date: 08/27/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Headache; Local and systemic pain at injection site; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and VACCINATION SITE PAIN (Local and systemic pain at injection site) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. No Medical History information was reported. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jan-2021, the patient experienced HEADACHE (Headache) and VACCINATION SITE PAIN (Local and systemic pain at injection site). At the time of the report, HEADACHE (Headache) and VACCINATION SITE PAIN (Local and systemic pain at injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. The reporter asked if the patient could self administer Tylenol (paracetamol) to treat symptoms.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1638960
Sex: F
Age: 38
State: CA

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

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: diarrhea; pain in eye that wraps around the head; pain in her neck; she is very uncomfortable; feeling dizzy; left breast swollen; left arm swollen; horrible headache; nauseated; site of injection is swollen; so exhausted that she sleeps; This spontaneous case was reported by an other and describes the occurrence of DIZZINESS (feeling dizzy), BREAST SWELLING (left breast swollen), PERIPHERAL SWELLING (left arm swollen), EYE PAIN (pain in eye that wraps around the head) and NECK PAIN (pain in her neck) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (no reported medical history). On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced DIZZINESS (feeling dizzy), BREAST SWELLING (left breast swollen), PERIPHERAL SWELLING (left arm swollen), VACCINATION COMPLICATION (she is very uncomfortable), HEADACHE (horrible headache), NAUSEA (nauseated), VACCINATION SITE SWELLING (site of injection is swollen) and FATIGUE (so exhausted that she sleeps). On 14-Jan-2021, the patient experienced EYE PAIN (pain in eye that wraps around the head) and NECK PAIN (pain in her neck). On an unknown date, the patient experienced DIARRHOEA (diarrhea). At the time of the report, DIZZINESS (feeling dizzy), BREAST SWELLING (left breast swollen), PERIPHERAL SWELLING (left arm swollen), EYE PAIN (pain in eye that wraps around the head), NECK PAIN (pain in her neck), VACCINATION COMPLICATION (she is very uncomfortable), DIARRHOEA (diarrhea), HEADACHE (horrible headache), NAUSEA (nauseated), VACCINATION SITE SWELLING (site of injection is swollen) and FATIGUE (so exhausted that she sleeps) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication were not reported by the reporter. Treatment details not reported by the reporter.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1638961
Sex: F
Age: 64
State: ID

Vax Date: 01/07/2021
Onset Date: 01/14/2021
Rec V Date: 08/27/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Tested positive for Covid; A spontaneous report was received from a consumer concerning herself, a 64 years old female patient, who recieved Moderna's COVID-19 vaccine and tested positive for Covid a week later of vaccination. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. The patient received first of two planned doses of mRNA-1273:[Batch number not provided] on 07-JAN-2021 intramuscularly in the right arm for prophylaxis of COVID-19 infection. The patient was exposed by a side coworker a week ago, lost her smell and taste and tested positive on 14-JAN-2021. Treatment information was not provided. Action taken with mRNA-1273 in response to the event was not provided. The outcome of the event was unknown.

Other Meds:

Current Illness:

ID: 1638962
Sex: F
Age:
State: ND

Vax Date: 01/18/2021
Onset Date: 01/19/2021
Rec V Date: 08/27/2021
Hospital:

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot: EK9231
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data: Test Date: 20210119; Test Name: Body temperature; Result Unstructured Data: Fever 101.6F

Allergies:

Symptom List: Chills, Feeling cold, Feeling hot, Myalgia, Pain

Symptoms: Soreness; Severe back ache; Toes are throbbing and aching; Fever 101.6F; A spontaneous report was received from a consumer concerning a 53-year-old, female patient, who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced soreness, severe back ache, toes are throbbing and aching, fever 101.6F. The patient's medical history, was not provided by the reporter. Concomitant medications were not reported. On 18 Jan 2021, approximately one day prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (Lot number:025120-2A) intramuscularly in the right arm for prophylaxis of COVID-19 infection. On 19 Jan 2021, prior to receiving mRNA-1273, the patient felt soreness, severe back ache, toes are throbbing and aching, fever 101.6F. Treatment for the events included paracetamol and ibuprofen. Action taken with mRNA-1273 in response to the events was not reported. The events,soreness, severe back ache, toes are throbbing and aching, fever 101.6F were considered unknown on 19 Jan 2021.

Other Meds:

Current Illness:

ID: 1638963
Sex: M
Age:
State: AL

Vax Date: 01/16/2021
Onset Date: 01/16/2021
Rec V Date: 08/27/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: Neck pain; Sniffles; Body pain; Injection site pain; This spontaneous case was reported by a health care professional and describes the occurrence of NECK PAIN (Neck pain), RHINORRHOEA (Sniffles), MYALGIA (Body pain) and INJECTION SITE PAIN (Injection site pain) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012N20A) for COVID-19 vaccination. MEDICAL HISTORY (Parent): unknown. No Medical History information was reported. On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Jan-2021, the patient experienced NECK PAIN (Neck pain), RHINORRHOEA (Sniffles), MYALGIA (Body pain) and INJECTION SITE PAIN (Injection site pain). At the time of the report, NECK PAIN (Neck pain), RHINORRHOEA (Sniffles), MYALGIA (Body pain) and INJECTION SITE PAIN (Injection site pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1638964
Sex: F
Age:
State: CA

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

Vax Type: COVID19
Manufacturer: PFIZER\BIONTECH
Vax Name: COVID19 (COVID19 (PFIZER-BIONTECH))
Lot:
Dose Series: 2
Vax Route:
Vax Site:

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Abnormal behaviour, Adverse reaction, Anger, Asthma

Symptoms: Swelling in the joint of her knee replacement and above it in her thigh area; This spontaneous case was reported by a consumer and describes the occurrence of JOINT SWELLING (Swelling in the joint of her knee replacement and above it in her thigh area) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Knee replacement on 08-Sep-2020. On 11-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 JOINT SWELLING (Swelling in the joint of her knee replacement and above it in her thigh area). At the time of the report, JOINT SWELLING (Swelling in the joint of her knee replacement and above it in her thigh area) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Non Significant Follow-up Append; Sender's Comments: Very limited information regarding the event has been provided at this time. However, the patient's history of knee replacement surgery approximately 4 months before receiving the vaccine confounds causality assessment. Further information has been requested.

Other Meds:

Current Illness:

ID: 1638965
Sex: F
Age: 36
State: TX

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

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

Lab Data:

Allergies:

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

Symptoms: Touched it and it was warm; Hard and firm for a week/Injection area hard/Hard elevelated area/Bump; Arm soreness; Injection area slightly red/After putting ice, it was more red (added redness); Swollen; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Touched it and it was warm), VACCINATION SITE INDURATION (Hard and firm for a week/Injection area hard/Hard elevelated area/Bump), VACCINATION SITE ERYTHEMA (Injection area slightly red/After putting ice, it was more red (added redness)), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE PAIN (Arm soreness) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced VACCINATION SITE ERYTHEMA (Injection area slightly red/After putting ice, it was more red (added redness)) and VACCINATION SITE SWELLING (Swollen). On 09-Jan-2021, the patient experienced VACCINATION SITE INDURATION (Hard and firm for a week/Injection area hard/Hard elevelated area/Bump) and VACCINATION SITE PAIN (Arm soreness). On 15-Jan-2021, the patient experienced VACCINATION SITE WARMTH (Touched it and it was warm). On 10-Jan-2021, VACCINATION SITE PAIN (Arm soreness) had resolved. At the time of the report, VACCINATION SITE WARMTH (Touched it and it was warm), VACCINATION SITE INDURATION (Hard and firm for a week/Injection area hard/Hard elevelated area/Bump), VACCINATION SITE ERYTHEMA (Injection area slightly red/After putting ice, it was more red (added redness)) and VACCINATION SITE SWELLING (Swollen) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. Patient used cold compress for treatment.

Other Meds:

Current Illness:

ID: 1638966
Sex: F
Age: 62
State: KY

Vax Date: 01/17/2021
Onset Date: 01/17/2021
Rec V Date: 08/27/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Covid Arm; itchy rash; little knot there; Red rash; HR increased; BP increased; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEART RATE INCREASED (HR increased), BLOOD PRESSURE INCREASED (BP increased), VACCINATION SITE RASH (Covid Arm), RASH PRURITIC (itchy rash) and VACCINATION SITE INDURATION (little knot there) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect products included non-company products Los for an unknown indication and INSULIN LISPRO (HUMALOG) for an unknown indication. Concurrent medical conditions included Diabetes, Hypertension, High cholesterol and Asthma. On 17-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient started Los (unknown route) at an unspecified dose and INSULIN LISPRO (HUMALOG) (unknown route) at an unspecified dose. On 17-Jan-2021, the patient experienced HEART RATE INCREASED (HR increased) and BLOOD PRESSURE INCREASED (BP increased). On 27-Jan-2021, the patient experienced VACCINATION SITE RASH (Covid Arm), RASH PRURITIC (itchy rash), VACCINATION SITE INDURATION (little knot there) and RASH ERYTHEMATOUS (Red rash ). At the time of the report, HEART RATE INCREASED (HR increased) and BLOOD PRESSURE INCREASED (BP increased) had resolved and VACCINATION SITE RASH (Covid Arm), RASH PRURITIC (itchy rash), VACCINATION SITE INDURATION (little knot there) and RASH ERYTHEMATOUS (Red rash ) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Most recent FOLLOW-UP information incorporated above includes: On 05-Feb-2021: No specific follow-up information recorded.

Other Meds:

Current Illness: Diabetes

ID: 1638967
Sex: F
Age: 66
State: TX

Vax Date: 01/08/2021
Onset Date: 01/14/2021
Rec V Date: 08/27/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: he developed bright red rash from shoulder bone to her elbow; injection site is still red; experiencing lot of pain on upper arm left; This spontaneous case was reported by an occupational therapist (subsequently medically confirmed) and describes the occurrence of VACCINATION SITE RASH (he developed bright red rash from shoulder bone to her elbow), VACCINATION SITE ERYTHEMA (injection site is still red) and VACCINATION SITE PAIN (experiencing lot of pain on upper arm left) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037K20A) for COVID-19 vaccination. No Medical History information was reported. On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage form. On 14-Jan-2021, the patient experienced VACCINATION SITE RASH (he developed bright red rash from shoulder bone to her elbow), VACCINATION SITE ERYTHEMA (injection site is still red) and VACCINATION SITE PAIN (experiencing lot of pain on upper arm left). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE RASH (he developed bright red rash from shoulder bone to her elbow), VACCINATION SITE ERYTHEMA (injection site is still red) and VACCINATION SITE PAIN (experiencing lot of pain on upper arm left) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.

Other Meds:

Current Illness:

ID: 1638968
Sex: F
Age:
State: OH

Vax Date: 12/31/2020
Onset Date: 12/31/2020
Rec V Date: 08/27/2021
Hospital:

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

Lab Data: Test Date: 20210109; Test Name: covid-19 test

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Her arm felt like it was going to fall off; Hurt bad for 4 days; chills; body ache; headache; not feeling good; This spontaneous case was reported by a nurse and describes the occurrence of FEELING ABNORMAL (Her arm felt like it was going to fall off), PAIN (Hurt bad for 4 days), CHILLS (chills), PAIN (body ache) and HEADACHE (headache) in a 23-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. The occurrence of additional non-serious events is detailed below. Concomitant products included birth control pills. On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Dec-2020, the patient experienced FEELING ABNORMAL (Her arm felt like it was going to fall off), PAIN (Hurt bad for 4 days), CHILLS (chills), PAIN (body ache), HEADACHE (headache) and FEELING ABNORMAL (not feeling good). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Her arm felt like it was going to fall off), PAIN (Hurt bad for 4 days), CHILLS (chills), PAIN (body ache), HEADACHE (headache) and FEELING ABNORMAL (not feeling good) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Jan-2021, SARS-CoV-2 test (positive-positive positive): positive positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.

Other Meds: birth control pills

Current Illness:

ID: 1638969
Sex: M
Age: 71
State: WA

Vax Date: 01/18/2021
Onset Date: 01/18/2021
Rec V Date: 08/27/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Soreness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Soreness at injection site) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 18-Jan-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021, the patient experienced ARTHRALGIA (Soreness at injection site). At the time of the report, ARTHRALGIA (Soreness at injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported. No treatment information provided.

Other Meds:

Current Illness:

ID: 1638970
Sex: M
Age:
State: CA

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

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: Sore arm; Fatigue; A spontaneous report was received from a (Consumer) concerning an unknown age, male patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced sore arm and fatigue. The patient's medical history was not provided. No relevant concomitant medications were reported. On 13 Jan 2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 41L20A) unknown route and site for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced sore arm and fatigue. Laboratory details not provided. No treatment details were reported. Action taken with mRNA-1273 in response to the events was not reported. At the time of the report, the outcome of the event was unknown.

Other Meds:

Current Illness:

ID: 1638971
Sex: F
Age: 78
State: CO

Vax Date: 01/08/2021
Onset Date: 01/14/2021
Rec V Date: 08/27/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Diarrhoea, Fatigue, Feeling abnormal, Headache

Symptoms: infection at the injection site; long raised red itchy hard spot at injection site and was raised and hot; redness at injection site; injection site itch; A spontaneous report was received from a Consumer concerning a ? 78Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events Infection at the injection site, long raised red itchy hard spot at injection site and was raised and hot and redness at injection site. The patient's medical history was not provided. No relevant concomitant medications were reported. On 08-JAN-2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: unknown) intramuscularly in the Anatomical location unspecified for prophylaxis of COVID-19 infection. On 14-JAN-2021, The patient experienced the events Infection at the injection site, long raised red itchy hard spot at injection site and was raised and hot and redness at injection site. Laboratory details were not provided. Treatment details in narrative include Her neighbor got the vaccine at the same location and they said it was an infection and gave antibiotics. She went to her doctor and he said he would give her antibiotics in case. She is wondering if this is a normal reaction. Action taken with mRNA-1273 in response to the events was not reported. On date, the outcome of the event Infection at the injection site, long raised red itchy hard spot at injection site and was raised and hot and redness at injection site was Not Recovered/Not Resolved. The reporter assessed the events Infection at the injection site, long raised red itchy hard spot at injection site and was raised and hot and redness at injection site related to the study drug was unknown.

Other Meds:

Current Illness:

ID: 1638972
Sex: F
Age: 73
State: FL

Vax Date: 01/15/2021
Onset Date: 01/15/2021
Rec V Date: 08/27/2021
Hospital:

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

Lab Data: Test Date: 20210116; Test Name: Body temperature; Result Unstructured Data: 101

Allergies:

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

Symptoms: chills; fever; soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), PYREXIA (fever) and VACCINATION SITE PAIN (soreness at the injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013L20A) for COVID-19 vaccination. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for Cholesterol, METOPROLOL for Hypertension, MULTIVITAMINS [VITAMINS NOS] for Immune disorder prophylaxis, AMITRIPTYLINE for an unknown indication. On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced CHILLS (chills), PYREXIA (fever) and VACCINATION SITE PAIN (soreness at the injection site). On 17-Jan-2021, CHILLS (chills), PYREXIA (fever) and VACCINATION SITE PAIN (soreness at the injection site) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Jan-2021, Body temperature: 101 degree Farenheit. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient took 2 acetaminophen to treat the symptoms.

Other Meds: MULTIVITAMINS [VITAMINS NOS]; LIPITOR; AMITRIPTYLINE; METOPROLOL

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am