VAERS 2021 Database www.vaers.hhs.gov

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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: 1817197
Sex: F
Age:
State:

Vax Date:
Onset Date: 10/21/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: FEVER; This spontaneous report received from a consumer via a company representative 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 20-OCT-2021 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 21-OCT-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from fever. This report was non-serious.

Other Meds:

Current Illness:

ID: 1817198
Sex: M
Age:
State: MN

Vax Date:
Onset Date: 06/01/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: BLEEDING OF THE GUMS; NOSEBLEED FOR 3 DAYS; CUT THAT WOULDN'T STOP BLEEDING; CHANGE IN TASTE (PEANUT BUTTER DIDN'T TASTE THE SAME); This spontaneous report received from a patient concerned a 46 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: Unk) dose was not reported, administered on 01-JUN-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 01-JUN-2021, the patient experienced bleeding of the gums. On 01-JUN-2021, the patient experienced nosebleed for 3 days. On 01-JUN-2021, the patient experienced cut that wouldn't stop bleeding. On 01-JUN-2021, the patient experienced change in taste (peanut butter didn't taste the same). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from bleeding of the gums, and change in taste (peanut butter didn't taste the same) on 29-JUN-2021, nosebleed for 3 days on 03-JUN-2021, and cut that wouldn't stop bleeding on 02-JUN-2021. This report was non-serious.

Other Meds:

Current Illness:

ID: 1817199
Sex: U
Age:
State:

Vax Date:
Onset Date: 03/01/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: BONES HURT FOR WEEKS; HAVE NOT HAD A GOOD NIGHTS SLEEP; This spontaneous report received from a patient 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 (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAR-2021, the patient experienced bones hurt for weeks. On MAR-2021, the patient experienced have not had a good nights sleep. The action taken with covid-19 vaccine was not applicable. The patient recovered from bones hurt for weeks, and had not recovered from have not had a good nights sleep. This report was non-serious.

Other Meds:

Current Illness:

ID: 1817200
Sex: M
Age:
State: NJ

Vax Date:
Onset Date: 03/17/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data: Test Date: 06/17/2021; Test Name: Skin biopsy; Result Unstructured Data: COVID-19 rash.

Allergies: The patient has no known allergy.

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: This spontaneous report received from a parent concerned a 34-year-old male. The patient's height, and weight not reported. The patient's pre-existing medical conditions included: No known allergy. The patient received COVID-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch/lot# 1805031, expiry: unknown), dose not reported, administered Mar 16, 2021 for immunization. No concomitant medications reported. On Mar 17, 2021, patient experienced soreness in injection arm. On Mar 17, 2021, patient experienced tirednesss. On May 5, 2021, patient experienced severe itchy rash from scalp to foot all over large patches 4-6 inches in width with raised especially on chest and back/COVID-19 rash. On Jun 17, 2021, laboratory data included: Skin biopsy (NR: not provided) COVID rash. On an unspecified date, patient bled from itching (even with the medications). Treatment medications (dates unspecified) included: prednisone, clobetasol propionate and betamethasone dipropionate. The action taken with COVID-19 vaccine ad26.cov2.s: not applicable. The patient recovered from soreness in injection arm, and tirednesss on Mar 18, 2021; but has not recovered from severe itchy rash from scalp to foot all over large patches 4-6 inches in width with raised especially on chest and back/COVID-19 rash, and bled from itching (even with the medications).

Other Meds:

Current Illness:

ID: 1817201
Sex: F
Age:
State: PA

Vax Date:
Onset Date: 10/15/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: HAIR LOSS TO THE POINT OF BALD SPOTS ON SCALP/NOTICED EXCESSIVE HAIR LOSS ON BACK OF HEAD/NEW PATCH OF HAIR MISSING FROM FRONT OF MY HEAD; This spontaneous report received from a patient via a company representative 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 (suspension for injection, route of admin not reported, batch number: 211A21A expiry: UNKNOWN) dose was not reported, administered on 20-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 15-OCT-2021, the patient experienced hair loss to the point of bald spots on scalp/noticed excessive hair loss on back of head/new patch of hair missing from front of my head. The action taken with covid-19 vaccine was not applicable. The outcome of hair loss to the point of bald spots on scalp/noticed excessive hair loss on back of head/new patch of hair missing from front of my head was not reported. This report was non-serious. This case, from the same reporter is linked to 20211046106.

Other Meds:

Current Illness:

ID: 1817202
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: FLOP LIKE A FISH IN PAIN IN HEART; This spontaneous report received from a patient 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 was unable to perform follow-up to request batch/lot number. No concomitant medications were reported. On an unspecified date, the patient experienced flop like a fish in pain in heart. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of flop like a fish in pain in heart was not reported. This report was non-serious.; Sender's Comments: V0- Medical Assessment comment not required as per standard procedure as the case assessed as non-serious.

Other Meds:

Current Illness:

ID: 1817203
Sex: M
Age:
State: AK

Vax Date:
Onset Date: 10/17/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: BODY ACHES; COUGH; NASAL CONGESTION; SNEEZING; CHILLS; WEAKNESS; TIREDNESS; HEADACHES; This spontaneous report received from a patient concerned an 82 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: 212A21A expiry: UNKNOWN) dose was not reported, administered on 13-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-OCT-2021, the patient experienced body aches. On 17-OCT-2021, the patient experienced cough. On 17-OCT-2021, the patient experienced nasal congestion. On 17-OCT-2021, the patient experienced sneezing. On 17-OCT-2021, the patient experienced chills. On 17-OCT-2021, the patient experienced weakness. On 17-OCT-2021, the patient experienced tiredness. On 17-OCT-2021, the patient experienced headaches. The action taken with covid-19 vaccine was not applicable. The patient was recovering from chills, body aches, weakness, cough, tiredness, nasal congestion, headaches, and sneezing. This report was non-serious.

Other Meds:

Current Illness:

ID: 1817205
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: SWELLING OF THE TONGUE; SWELLING OF THE THROAT; 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 (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 swelling of the tongue, and swelling of the throat. The action taken with covid-19 vaccine was not applicable. The outcome of the swelling of the tongue and swelling of the throat was not reported. This report was non-serious. This case, from the same reporter is linked to 20211046395 and 20211039784.

Other Meds:

Current Illness:

ID: 1817206
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: SEVERE SHOULDER PAIN; This spontaneous report received from a consumer 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 severe shoulder pain. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of severe shoulder pain was not reported. This report was non-serious. This case, from the same reporter is linked to 20211046388 and 20211039784.

Other Meds:

Current Illness:

ID: 1817207
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: SICK; WORST FEVER AT NIGHT; 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 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 sick, and worst fever at night. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sick, and the outcome of worst fever at night was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1817208
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: COLD SWEAT; QUITE SEVERE FEVER; This spontaneous report received from a patient 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. 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 cold sweat, and quite severe fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from cold sweat, and quite severe fever. This report was non-serious.

Other Meds:

Current Illness:

ID: 1817209
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: SORE ARM; FATIGUE; 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 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 sore arm, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sore arm and fatigue was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1817210
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: BODY ACHES; CHILLS; 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 not reported, batch number: Unknown expiry: UNKNWON) 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 chills, and body aches. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the chills and body aches was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1817211
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 03/13/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: FELT CRUMMY; DELTOID PAIN/ SORE DELTOID; This spontaneous report received from a patient concerned a 59 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: unknown) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 13-MAR-2021, the patient experienced felt crummy. On 13-MAR-2021, the patient experienced deltoid pain/ sore deltoid. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt crummy, and deltoid pain/ sore deltoid on 14-MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20211047299.

Other Meds:

Current Illness:

ID: 1817212
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: 24 HOURS WITH A TOUGH FEVER; 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 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 24 hours with a tough fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from 24 hours with a tough fever. This report was non-serious.

Other Meds:

Current Illness:

ID: 1817213
Sex: U
Age:
State: OR

Vax Date:
Onset Date: 10/22/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional 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 (suspension for injection, route of admin not reported, batch number: 1821281 expiry: 21-OCT-2021) dose was not reported, administered on 22-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-OCT-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211047333.

Other Meds:

Current Illness:

ID: 1817214
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 03/13/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: MOBILITY ISSUES; CAN NOT SLEEP; CAN NOT MOVE SHOULDER (HER BLOUSE HURTS ON HER SKIN, CAN NOT GET SEATBELT ON)/CAN NOT LIFT BAG; SHOULDER INFLAMMATION; CAN NOT DO MUCH OF WHAT SHE USED TO DO; SEVERE PAIN IN ENTIRE SHOULDER AREA (SUPERFICIAL PAIN AND DEEPER PAIN INSIDE THE SHOULDER, AMPLIFIED PAIN RESPONSE THAT BOTH GROSS AND MORE MINUTE); FELT SICK; INTENSE INJECTION SITE PAIN; FEVER; This spontaneous report received from a consumer concerned a 71 year old female. The patient's height, and weight were not reported. The patient's past medical history included: car accident, and shoulder was hurt. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805020, expiry: UNKNOWN) dose was not reported, administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 13-MAR-2021, the patient experienced severe pain in entire shoulder area (superficial pain and deeper pain inside the shoulder, amplified pain response that both gross and more minute). On 13-MAR-2021, the patient experienced felt sick. On 13-MAR-2021, the patient experienced intense injection site pain. On 13-MAR-2021, the patient experienced fever. On an unspecified date, the patient experienced mobility issues, can not sleep, can not move shoulder (her blouse hurts on her skin, can not get seatbelt on) /can not lift bag, shoulder inflammation, and can not do much of what she used to do. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from felt sick, and fever on 23-MAR-2021, and had not recovered from intense injection site pain, severe pain in entire shoulder area (superficial pain and deeper pain inside the shoulder, amplified pain response that both gross and more minute), can not move shoulder (her blouse hurts on her skin, can not get seatbelt on)/can not lift bag, shoulder inflammation, mobility issues, can not sleep, and can not do much of what she used to do. This report was non-serious. This case, from the same reporter is linked to 20211047262.

Other Meds:

Current Illness:

ID: 1817215
Sex: M
Age:
State: SC

Vax Date:
Onset Date: 10/22/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: INCORRECT PRODUCT STORAGE (VACCINE WAS HELD OUTSIDE OF THE FRIDGE AT ROOM TEMPERATURE FOR 4 HOURS); OUT OF SPECIFICATION PRODUCT USE/ADMINISTRATION ERROR; This spontaneous report received from a pharmacist concerned multiple patients. 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: 1855194, and expiry: 09-APR-2022) dose was not reported, administered on 22-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-OCT-2021, the patient experienced incorrect product storage (vaccine was held outside of the fridge at room temperature for 4 hours). On 22-OCT-2021, the patient experienced out of specification product use/administration error. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the out of specification product use/administration error and incorrect product storage (vaccine was held outside of the fridge at room temperature for 4 hours) was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1817216
Sex: M
Age:
State: OR

Vax Date:
Onset Date: 10/22/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: ADMINISTRATION OF EXPIRED VACCINE; This spontaneous report received from a health care professional concerned a 60 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: 1821281 expiry: 21-OCT-2021) dose was not reported, administered on 22-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 22-OCT-2021, the patient experienced administration of expired vaccine. The action taken with covid-19 vaccine was not applicable. The outcome of administration of expired vaccine was not reported. This report was non-serious. This case, from the same reporter is linked to 20211047292.

Other Meds:

Current Illness:

ID: 1817217
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: CHILLS; BAD FEVER; 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 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/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced chills, and bad fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bad fever and chills was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1817218
Sex: M
Age:
State: CA

Vax Date:
Onset Date: 04/01/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data: Test Date: 202107; Test Name: Blood test; Result Unstructured Data: Negative; Test Date: 202107; Test Name: Diagnostic ultrasound; Result Unstructured Data: No abnormalities found

Allergies:

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

Symptoms: SHARP ACUTE PAIN IN LEFT SIDE OF ABDOMEN IN FRONT AND BACK AS WELL; This spontaneous report received from a patient concerned a 28 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: environmental allergies. 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 18-MAR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On APR-2021, the patient experienced sharp acute pain in left side of abdomen in front and back as well. On JUL-2021, Laboratory data included: Blood test (NR: not provided) Negative, and Diagnostic ultrasound (NR: not provided) No abnormalities found. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from sharp acute pain in left side of abdomen in front and back as well. This report was non-serious.

Other Meds:

Current Illness: Environmental allergy

ID: 1817219
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: BAD FEVER; HEADACHE; This spontaneous report received from a patient via a company representative via a twitter post 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 (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 number. No concomitant medications were reported. On an unspecified date, the patient experienced bad fever, and headache. The action taken with covid-19 vaccine was not applicable. The patient recovered from bad fever, and headache. This report was non-serious.

Other Meds:

Current Illness:

ID: 1817220
Sex: M
Age:
State: TX

Vax Date:
Onset Date: 05/01/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: MUSCLE WASTING; NERVE PAIN; PAIN IN LEFT SHOULDER; STIFFNESS; PAIN; This spontaneous report received from a patient 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 (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on 07-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On MAY-2021, the patient experienced stiffness. On MAY-2021, the patient experienced pain. On an unspecified date, the patient experienced muscle wasting, nerve pain, and pain in left shoulder. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from pain in left shoulder, muscle wasting, and nerve pain, and the outcome of stiffness and pain was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1817221
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: FATIGUE; This spontaneous report received from a patient concerned a 4 decade 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, intramuscular, batch: 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. Non-company suspect drugs included: adalimumab (solution for injection in pre-filled pen, subcutaneous, batch number was not reported) dose, frequency, and therapy dates were not reported for an unspecified indication. No concomitant medications were reported. On an unspecified date, the patient experienced fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable; and action taken with adalimumab was not reported. The patient recovered from fatigue. This report was non-serious.

Other Meds:

Current Illness:

ID: 1817222
Sex: M
Age:
State: TX

Vax Date:
Onset Date: 10/24/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: BLOODY EYE (EYE WITH BUSTED BLOOD, WHITE PART OF RIGHT EYE WAS RED); This spontaneous report received from a patient concerned a 30 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: Unk) dose was not reported, administered on 21-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 24-OCT-2021, the patient experienced bloody eye (eye with busted blood, white part of right eye was red). The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bloody eye (eye with busted blood, white part of right eye was red) was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1817223
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: ALMOST COULD NOT STAND UP; DIZZINESS; This spontaneous report received from a patient via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. The patient was part of the Ensemble trial and received a placebo but then was given the Janssen COVID-19 vaccine after the trial ended. 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 almost could not stand up, and dizziness. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the almost could not stand up and dizziness was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1817224
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: ACHES; CHILLS; FEVER; 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 (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 fever, chills, and aches. The action taken with covid-19 vaccine was not applicable. The patient recovered from fever, chills, and aches. This report was non-serious.

Other Meds:

Current Illness:

ID: 1817225
Sex: U
Age:
State:

Vax Date:
Onset Date: 10/25/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data: Test Name: Blood test; Result Unstructured Data: No blood clots found

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: SWELLING IN LOWER LEGS; This spontaneous report received from a patient 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 (suspension for injection, route of admin not reported, batch number: Unk) 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 25-OCT-2021, the patient experienced swelling in lower legs. Laboratory data (dates unspecified) included: Blood test (NR: not provided) No blood clots found. The action taken with covid-19 vaccine was not applicable. The patient had not recovered from swelling in lower legs. This report was non-serious.

Other Meds:

Current Illness:

ID: 1817226
Sex: F
Age:
State: TN

Vax Date:
Onset Date:
Rec V Date: 10/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: SITE OF INJECTION VERY PAINFUL (COULD NOT SLEEP ON ARM); This spontaneous report received from a consumer concerned a 27 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 (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 and has been requested. No concomitant medications were reported. On an unspecified date, the patient experienced site of injection very painful (could not sleep on arm). The action taken with covid-19 vaccine was not applicable. The patient recovered from site of injection very painful (could not sleep on arm). This report was non-serious. This case, from the same reporter is linked to 20211044978.

Other Meds:

Current Illness:

ID: 1817227
Sex: F
Age: 29
State: NC

Vax Date: 05/09/2021
Onset Date: 05/01/2021
Rec V Date: 10/26/2021
Hospital: Y

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

Lab Data: Test Name: Blood pressure; Result Unstructured Data: little low; Test Date: 20210509; Test Name: Blood pressure; Result Unstructured Data: Drop in Blood Pressure

Allergies:

Symptom List: Nausea

Symptoms: Appendicitis; felt faint; bit of a headache; Difficulty breathing; Chest tightness; Feeling hot; Flushing; Prickling/Tingling; ears were ringing; almost passed out; Irregular heart rate/palpitations/her heart was pounding; Drop in blood Pressure; the patient felt really weird when the first shot was injected into her for about 40 minutes; the patient felt some pain around the injection site; This spontaneous case was reported by a consumer and describes the occurrence of APPENDICITIS (Appendicitis) in a 29-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Irritable bowel syndrome, Anxiety, Blood pressure high, Seasonal allergy (running nose, watery eyes, stuffy nose, itching, sneezing, ect), Food allergy (Diarrhea, abdominal discomfort, gas, pain during digestion), Milk allergy (Symptoms of lactose intolerance. However, cheese and less does not affect patient.), Obesity and Pain. Concomitant products included PARACETAMOL (TYLENOL) for Pain. On 09-May-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-May-2021, the patient experienced PALPITATIONS (Irregular heart rate/palpitations/her heart was pounding) and FEELING ABNORMAL (the patient felt really weird when the first shot was injected into her for about 40 minutes). 09-May-2021, the patient experienced BLOOD PRESSURE DECREASED (Drop in blood Pressure). In May 2021, the patient experienced VACCINATION SITE PAIN (the patient felt some pain around the injection site). On 02-Jun-2021, the patient experienced DYSPNOEA (Difficulty breathing), CHEST DISCOMFORT (Chest tightness), FEELING HOT (Feeling hot), FLUSHING (Flushing) and PARAESTHESIA (Prickling/Tingling). On 03-Jun-2021, the patient experienced APPENDICITIS (Appendicitis) (seriousness criteria hospitalization and medically significant). In June 2021, the patient experienced PRESYNCOPE (almost passed out) and TINNITUS (ears were ringing). On an unknown date, the patient experienced DIZZINESS (felt faint) and HEADACHE (bit of a headache). The patient was hospitalized on sometime in June 2021 due to APPENDICITIS. The patient was treated with Surgery (Apendicectomy) for Appendicitis. On 09-May-2021, BLOOD PRESSURE DECREASED (Drop in blood Pressure) had resolved. On 04-Jun-2021, APPENDICITIS (Appendicitis), PALPITATIONS (Irregular heart rate/palpitations/her heart was pounding), DYSPNOEA (Difficulty breathing), CHEST DISCOMFORT (Chest tightness), FEELING HOT (Feeling hot) and FLUSHING (Flushing) had resolved, PARAESTHESIA (Prickling/Tingling) outcome was unknown. At the time of the report, PRESYNCOPE (almost passed out), FEELING ABNORMAL (the patient felt really weird when the first shot was injected into her for about 40 minutes), DIZZINESS (felt faint), TINNITUS (ears were ringing) and HEADACHE (bit of a headache) outcome was unknown and VACCINATION SITE PAIN (the patient felt some pain around the injection site) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-May-2021, Blood pressure measurement: drop (Low) Drop in Blood Pressure. On an unknown date, Blood pressure measurement: little low (Low) little low. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered APPENDICITIS (Appendicitis) and BLOOD PRESSURE DECREASED (Drop in blood Pressure) to be possibly related. No further causality assessments were provided for PRESYNCOPE (almost passed out), PALPITATIONS (Irregular heart rate/palpitations/her heart was pounding), DYSPNOEA (Difficulty breathing), CHEST DISCOMFORT (Chest tightness), FEELING HOT (Feeling hot), FLUSHING (Flushing), PARAESTHESIA (Prickling/Tingling), FEELING ABNORMAL (the patient felt really weird when the first shot was injected into her for about 40 minutes), DIZZINESS (felt faint), TINNITUS (ears were ringing), VACCINATION SITE PAIN (the patient felt some pain around the injection site) and HEADACHE (bit of a headache). Treatment information was not provided. The patient's body felt like it was going into red alert mode; like it did not like what was in the shot. She felt faint, so the pharmacist took her blood pressure (which was usually on the higher side, because of her weight) and it was super low. Again after 15 minutes, bp was checked. It was a little low, but it was okay for her to go home. She felt some pain around the injection site for the next few days and had a bit of a headache, but that was it. When the patient was taking a shower on 02-Jun-2021, her right lower abdomen started hurting bad. Then that night when she got up to use the bathroom, it hurt so bad that her ears were ringing, and she almost passed out. The morning of 03-Jun-2021, her husband took her to the emergency room, and she was informed that she had appendicitis and it was needed to perform emergency surgery to remove it. Company comment: This case concerns a 29-year-old female patient with no previous relevant medical history, who experienced the unexpected serious event/AESI of Appendicitis and other non serious events after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). The event occurred approximately 25 days after the first dose of Spikevax. The rechallenge for the event Appendicitis is not applicable since appendicectomy was performed. The benefit-risk relationship of Spikevax vaccine is not affected by this report This case was linked to MOD-2021-354676 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 14-Jun-2021: The follow up document was received from the initial reporter: New event blood pressure drop and lab data were added. On 17-Oct-2021: Follow up document received and patient information, allergic reaction, medical history, suspect product batch/lot number, concomitant medication and new events added: palpitations, dyspnoea, chest discomfort, feeling hot, flushing, presyncope, feeling abnormal, dizziness, tinnitus, headache, vaccination site pain.; Sender's Comments: This case concerns a 29-year-old female patient with no previous relevant medical history, who experienced the unexpected serious event/AESI of Appendicitis and other non serious events after Spikevax (mRNA- 1273 vaccine / Moderna COVID-19 Vaccine). The event occurred approximately 25 days after the first dose of Spikevax. The rechallenge for the event Appendicitis is not applicable since appendicectomy was performed. The benefit-risk relationship of Spikevax vaccine is not affected by this report

Other Meds: TYLENOL

Current Illness: Anxiety; Blood pressure high; Food allergy (Diarrhea, abdominal discomfort, gas, pain during digestion); Irritable bowel syndrome; Milk allergy (Symptoms of lactose intolerance. However, cheese and less does not affect patient.); Obesity; Pain; Seasonal allergy (running nose, watery eyes, stuffy nose, itching, sneezing, ect)

ID: 1817228
Sex: M
Age: 16
State: FL

Vax Date: 07/08/2021
Onset Date: 07/10/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: tingling in his feet; he was underage; numbness in his feet; This spontaneous case was reported by a pharmacist and describes the occurrence of HYPOAESTHESIA (numbness in his feet), PARAESTHESIA (tingling in his feet) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (he was underage) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. No Medical History information was reported. On 08-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jul-2021, the patient experienced HYPOAESTHESIA (numbness in his feet). On an unknown date, the patient experienced PARAESTHESIA (tingling in his feet) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (he was underage). On 28-Jul-2021, HYPOAESTHESIA (numbness in his feet) had resolved. At the time of the report, PARAESTHESIA (tingling in his feet) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (he was underage) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was provided by the reporter. The treatment information was not reported. It was reported that the patient received 1st Moderna dose with immunizer not aware of age below 18 until preparing for 2nd dose. After interviewing patient prior to second dose he mentioned tingling in his feet after the 1st vaccine. Resolved before 2nd dose was due. This case was linked to MOD-2021-339395 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow up received and patient demographics updated. event (numbness in his feet) onset date updated. On 01-Oct-2021: Follow up received, reporter contact details/patient birth year updated, event end date added.

Other Meds:

Current Illness:

ID: 1817229
Sex: M
Age: 77
State: TN

Vax Date: 02/05/2021
Onset Date: 08/21/2021
Rec V Date: 10/26/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: leg problem after the 2nd dose; 1st dose 05Feb2021; 2nd dose 21Aug2021; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (leg problem after the 2nd dose) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 039K209) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Feb-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1. On 21-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 05Feb2021; 2nd dose 21Aug2021). On an unknown date, the patient experienced LIMB DISCOMFORT (leg problem after the 2nd dose) (seriousness criterion hospitalization). At the time of the report, LIMB DISCOMFORT (leg problem after the 2nd dose) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose 05Feb2021; 2nd dose 21Aug2021) had resolved. Concomitant medications was not provided by the reporter Treatment information was not provided. On 08-Oct-2021, he again experienced the same leg problem this time more extensive than the 1st one. He was admitted in the hospital for the night. MRI was done and they could not find anything wrong with him. This case concerns Inappropriate schedule of product administration in a 77 year-old male patient with no medical history provided, who experienced the unexpected non-serious event of Limb discomfort. The event of Limb discomfort occurred an unknown number of days after the second dose of mRNA-1273 vaccine. Rechallenge considered positive based on report of reoccurrence of event after third dose. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report. The seriousness criteria of hospitalization is removed for this event since the source document does not support this seriousness criteria. This case was linked to MOD-2021-350768 (Patient Link).; Sender's Comments: This case concerns Inappropriate schedule of product administration in a 77 year-old male patient with no medical history provided, who experienced the unexpected non-serious event of Limb discomfort. The event of Limb discomfort occurred an unknown number of days after the second dose of mRNA-1273 vaccine. Rechallenge considered positive based on report of reoccurrence of event after third dose. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report. The seriousness criteria of hospitalization is removed for this event since the source document does not support this seriousness criteria.

Other Meds:

Current Illness:

ID: 1817230
Sex: M
Age: 42
State: VA

Vax Date: 09/13/2021
Onset Date: 10/12/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Left side of the tongue has canker sores/Canker sores hurt; chest constriction & tightening on left side that could be muscle related/Front of the chest, towards the heart/Probably the chest, that whole area; whole face hurts; has sores in mouth inside cheeks; he has sores in his mouth all around gums; Sore on left side of tongue; Ears are hurting/Left ear hurts, like an ear infection; out of commission & hammered by it; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (chest constriction & tightening on left side that could be muscle related/Front of the chest, towards the heart/Probably the chest, that whole area), FACIAL PAIN (whole face hurts), IMPAIRED WORK ABILITY (out of commission & hammered by it), STOMATITIS (has sores in mouth inside cheeks) and NONINFECTIVE GINGIVITIS (he has sores in his mouth all around gums) in a 42-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 13-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Oct-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced IMPAIRED WORK ABILITY (out of commission & hammered by it). On 14-Oct-2021, the patient experienced CHEST DISCOMFORT (chest constriction & tightening on left side that could be muscle related/Front of the chest, towards the heart/Probably the chest, that whole area), FACIAL PAIN (whole face hurts), STOMATITIS (has sores in mouth inside cheeks), NONINFECTIVE GINGIVITIS (he has sores in his mouth all around gums), GLOSSODYNIA (Sore on left side of tongue) and EAR PAIN (Ears are hurting/Left ear hurts, like an ear infection). On an unknown date, the patient experienced APHTHOUS ULCER (Left side of the tongue has canker sores/Canker sores hurt). On 13-Oct-2021, IMPAIRED WORK ABILITY (out of commission & hammered by it) was resolving. At the time of the report, CHEST DISCOMFORT (chest constriction & tightening on left side that could be muscle related/Front of the chest, towards the heart/Probably the chest, that whole area), FACIAL PAIN (whole face hurts), STOMATITIS (has sores in mouth inside cheeks), NONINFECTIVE GINGIVITIS (he has sores in his mouth all around gums), GLOSSODYNIA (Sore on left side of tongue), EAR PAIN (Ears are hurting/Left ear hurts, like an ear infection) and APHTHOUS ULCER (Left side of the tongue has canker sores/Canker sores hurt) outcome was unknown. No concomitant medication was reported. No treatment medication was reported . Symptom text in narrative included: Patient stated that the chest constriction & tightening is more in left pectoral than around the heart or under his arm Second dose partial lot number was 011F Most recent FOLLOW-UP information incorporated above includes: On 19-Oct-2021: Significant follow up received. First dose batch number, Second dose partial batch number added. New event added

Other Meds:

Current Illness:

ID: 1817231
Sex: M
Age: 18
State: NH

Vax Date: 05/12/2021
Onset Date: 09/01/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: 2-3 days ago, his arm started swelling a little bit/later on, the swelling started, It became two sizes bigger than the other arm; Arm hurted,still hurting, still hurting; couldn't lift his arm,couldn't raise his arm up,couldn't lift anything heavy with that arm; Couldn't lift anything heavy with that arm; blood clot; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (blood clot), VACCINATION SITE SWELLING (2-3 days ago, his arm started swelling a little bit/later on, the swelling started, It became two sizes bigger than the other arm) and PAIN IN EXTREMITY (Arm hurted,still hurting, still hurting) in an 18-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 051C21A and 022D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 12-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In September 2021, the patient experienced THROMBOSIS (blood clot) (seriousness criterion medically significant). On an unknown date, the patient experienced VACCINATION SITE SWELLING (2-3 days ago, his arm started swelling a little bit/later on, the swelling started, It became two sizes bigger than the other arm) (seriousness criterion medically significant), PAIN IN EXTREMITY (Arm hurted,still hurting, still hurting) (seriousness criterion medically significant), MOBILITY DECREASED (couldn't lift his arm,couldn't raise his arm up,couldn't lift anything heavy with that arm) and MUSCULAR WEAKNESS (Couldn't lift anything heavy with that arm). The patient was treated with RIVAROXABAN (XARELTO) for Adverse event, at an unspecified dose and frequency. At the time of the report, THROMBOSIS (blood clot), VACCINATION SITE SWELLING (2-3 days ago, his arm started swelling a little bit/later on, the swelling started, It became two sizes bigger than the other arm), PAIN IN EXTREMITY (Arm hurted,still hurting, still hurting), MOBILITY DECREASED (couldn't lift his arm,couldn't raise his arm up,couldn't lift anything heavy with that arm) and MUSCULAR WEAKNESS (Couldn't lift anything heavy with that arm) outcome was unknown. No relevant concomitant medication information provided. Patient visited hospital in month of September because of swelling. Company Comment: This case concerns an 18-year-old male patient with no relevant medical history, who experienced the unexpected event of Thrombosis. The event occurred approximately 4 months after receiving the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the second dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Sender's Comments: This case concerns an 18-year-old male patient with no relevant medical history, who experienced the unexpected event of Thrombosis. The event occurred approximately 4 months after receiving the second dose of mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was not applicable since only information about the second dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.

Other Meds:

Current Illness:

ID: 1817232
Sex: M
Age: 72
State: FL

Vax Date: 01/05/2021
Onset Date: 01/01/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: little headache; muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (little headache) and MYALGIA (muscle aches) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011120A) for COVID-19 vaccination. No Medical History information was reported. On 05-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In January 2021, the patient experienced HEADACHE (little headache) and MYALGIA (muscle aches). At the time of the report, HEADACHE (little headache) and MYALGIA (muscle aches) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by reporter. The patient was prescribed some medications for two weeks for his blood pressure This case was linked to MOD-2021-353242, MOD-2021-353246.

Other Meds:

Current Illness:

ID: 1817233
Sex: F
Age: 70
State: OH

Vax Date: 10/14/2021
Onset Date: 10/14/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: She's starting to want to itch; Has a rash, it's on her arm (not the one she took the shot at); Also a bit on the arm on the injection, more on the elbow and down; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (She's starting to want to itch), RASH (Has a rash, it's on her arm (not the one she took the shot at)) and VACCINATION SITE RASH (Also a bit on the arm on the injection, more on the elbow and down) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022C21A) for COVID-19 vaccination. The patient's past medical history included Rash. Concurrent medical conditions included Penicillin allergy (Had rashes) and Sulfonamide allergy (Allergic to sulfa . Had rashes). Concomitant products included LISINOPRIL, LEVOTHYROXINE, EZETIMIBE and METOPROLOL for an unknown indication. On 14-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Oct-2021, the patient experienced RASH (Has a rash, it's on her arm (not the one she took the shot at)) and VACCINATION SITE RASH (Also a bit on the arm on the injection, more on the elbow and down). On an unknown date, the patient experienced PRURITUS (She's starting to want to itch). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PRURITUS (She's starting to want to itch) outcome was unknown and RASH (Has a rash, it's on her arm (not the one she took the shot at)) and VACCINATION SITE RASH (Also a bit on the arm on the injection, more on the elbow and down) was resolving. Most recent FOLLOW-UP information incorporated above includes: On 19-Oct-2021: Significant information: Events Outcome reported

Other Meds: LISINOPRIL; LEVOTHYROXINE; EZETIMIBE; METOPROLOL

Current Illness: Penicillin allergy (Had rashes); Sulfonamide allergy (Allergic to sulfa . Had rashes)

ID: 1817234
Sex: F
Age: 61
State: PA

Vax Date: 02/08/2021
Onset Date: 02/01/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: More than 35 days between Moderna Covie-19 vaccines; Eczema on my left arm at the injection site.; Experienced eczema on my right leg/eczema on my right knee/eczema on my right ankle/eczema on my Face; 8 days after first vaccine injection site left arm blew up; 8 days after first vaccine injection site Extremely Red; 8 days after first vaccine injection site hot to the touch; 2 weeks after first injection mouth felt like burnt pizza; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (8 days after first vaccine injection site hot to the touch), ORAL DISCOMFORT (2 weeks after first injection mouth felt like burnt pizza), VACCINATION SITE ECZEMA (Eczema on my left arm at the injection site.), ECZEMA (Experienced eczema on my right leg/eczema on my right knee/eczema on my right ankle/eczema on my Face) and VACCINATION SITE SWELLING (8 days after first vaccine injection site left arm blew up) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. 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 15-Feb-2021, the patient experienced VACCINATION SITE WARMTH (8 days after first vaccine injection site hot to the touch), VACCINATION SITE SWELLING (8 days after first vaccine injection site left arm blew up) and VACCINATION SITE ERYTHEMA (8 days after first vaccine injection site Extremely Red). In February 2021, the patient experienced ORAL DISCOMFORT (2 weeks after first injection mouth felt like burnt pizza). In May 2021, the patient experienced VACCINATION SITE ECZEMA (Eczema on my left arm at the injection site.) and ECZEMA (Experienced eczema on my right leg/eczema on my right knee/eczema on my right ankle/eczema on my Face). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between Moderna Covie-19 vaccines). At the time of the report, VACCINATION SITE WARMTH (8 days after first vaccine injection site hot to the touch), VACCINATION SITE SWELLING (8 days after first vaccine injection site left arm blew up) and VACCINATION SITE ERYTHEMA (8 days after first vaccine injection site Extremely Red) was resolving, ORAL DISCOMFORT (2 weeks after first injection mouth felt like burnt pizza), VACCINATION SITE ECZEMA (Eczema on my left arm at the injection site.) and ECZEMA (Experienced eczema on my right leg/eczema on my right knee/eczema on my right ankle/eczema on my Face) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 35 days between Moderna Covie-19 vaccines) 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. Concomitant medications details were not reported by the reporter. Treatment details was not reported by the reporter. Reported stated that she decided to not to take second Moderna COVID-19 because her doctor told her the side effects related to the second vaccine are even worse.

Other Meds:

Current Illness:

ID: 1817235
Sex: U
Age: 50
State:

Vax Date: 10/06/2021
Onset Date: 10/06/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: dose administered past the 30-day use; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose administered past the 30-day use) in a 50-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 06-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose administered past the 30-day use). On 06-Oct-2021, EXPIRED PRODUCT ADMINISTERED (dose administered past the 30-day use) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. HCP didn't provide information for if the dose administered past the 30-day use by date was the first or second shot Event verbatim stated that updated patient info. No concomitant medications information was reported. No treatment medications were provided.

Other Meds:

Current Illness:

ID: 1817236
Sex: M
Age: 64
State: TX

Vax Date: 10/12/2021
Onset Date:
Rec V Date: 10/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: This morning, he found a bruise around injection site that is about 5 inches spread and 4 inches in diameter.; Next day, he started with full body aches.; It is puffing and sore.; It is puffing and sore.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE BRUISING (This morning, he found a bruise around injection site that is about 5 inches spread and 4 inches in diameter.), MYALGIA (Next day, he started with full body aches.), VACCINATION SITE SWELLING (It is puffing and sore.) and VACCINATION SITE PAIN (It is puffing and sore.) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 091021A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included INSULIN, METFORMIN, LISINOPRIL, ACETYLSALICYLIC ACID (ASPIRIN (E.C.)) and PRAVASTATIN for an unknown indication. On 12-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE BRUISING (This morning, he found a bruise around injection site that is about 5 inches spread and 4 inches in diameter.), MYALGIA (Next day, he started with full body aches.), VACCINATION SITE SWELLING (It is puffing and sore.) and VACCINATION SITE PAIN (It is puffing and sore.). The patient was treated with ACETYLSALICYLIC ACID, CHLORPHENAMINE MALEATE, PHENYLEPHRINE BITARTRATE (ALKA SELTZER PLUS COLD FORMULA) at a dose of 1 dosage form once a day. At the time of the report, VACCINATION SITE BRUISING (This morning, he found a bruise around injection site that is about 5 inches spread and 4 inches in diameter.), MYALGIA (Next day, he started with full body aches.), VACCINATION SITE SWELLING (It is puffing and sore.) and VACCINATION SITE PAIN (It is puffing and sore.) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The action taken with mRNA-1273 (Spikevax) (Unknown) was not applicable

Other Meds: INSULIN; METFORMIN; LISINOPRIL; ASPIRIN (E.C.); PRAVASTATIN

Current Illness:

ID: 1817237
Sex: M
Age:
State: SD

Vax Date:
Onset Date:
Rec V Date: 10/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: doses were administered expired yesterday 14Oct2021; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (doses were administered expired yesterday 14Oct2021) in a 60-year-old male patient 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 EXPIRED PRODUCT ADMINISTERED (doses were administered expired yesterday 14Oct2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (doses were administered expired yesterday 14Oct2021) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was provided. No treatment medication was provided.

Other Meds:

Current Illness:

ID: 1817238
Sex: F
Age: 43
State: FL

Vax Date: 08/02/2021
Onset Date: 08/30/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: felt like she had the flu; felt nauseous; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (felt like she had the flu) and NAUSEA (felt nauseous) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004F21A and 006D21A) for COVID-19 vaccination. No Medical History information was reported. On 02-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Aug-2021, the patient experienced INFLUENZA LIKE ILLNESS (felt like she had the flu) and NAUSEA (felt nauseous). At the time of the report, INFLUENZA LIKE ILLNESS (felt like she had the flu) and NAUSEA (felt nauseous) outcome was unknown. No relevant concomitant medications were reported. No treatment information was provided. This case was linked to MOD-2021-354446 (Patient Link).

Other Meds:

Current Illness:

ID: 1817239
Sex: F
Age: 55
State: FL

Vax Date: 10/01/2021
Onset Date: 10/01/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data: Test Date: 202110; Test Name: Body temperature; Result Unstructured Data: 101.6

Allergies:

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

Symptoms: dry cough; congestion; bone and joint icky; Red rash and a bruise on the injection site; Fever; strong headache; Lot of fatigue; Arm swelling and pain; Arm swelling and pain; Red rash and a bruise on the injection site; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (dry cough), NASAL CONGESTION (congestion), MUSCULOSKELETAL DISCOMFORT (bone and joint icky), VACCINATION SITE BRUISING (Red rash and a bruise on the injection site) and PYREXIA (Fever) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Seasonal allergy. On 01-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In October 2021, the patient experienced COUGH (dry cough), NASAL CONGESTION (congestion), MUSCULOSKELETAL DISCOMFORT (bone and joint icky), VACCINATION SITE BRUISING (Red rash and a bruise on the injection site), PYREXIA (Fever), HEADACHE (strong headache), FATIGUE (Lot of fatigue), VACCINATION SITE PAIN (Arm swelling and pain), VACCINATION SITE SWELLING (Arm swelling and pain) and VACCINATION SITE RASH (Red rash and a bruise on the injection site). At the time of the report, COUGH (dry cough) and NASAL CONGESTION (congestion) had not resolved and MUSCULOSKELETAL DISCOMFORT (bone and joint icky), VACCINATION SITE BRUISING (Red rash and a bruise on the injection site), PYREXIA (Fever), HEADACHE (strong headache), FATIGUE (Lot of fatigue), VACCINATION SITE PAIN (Arm swelling and pain), VACCINATION SITE SWELLING (Arm swelling and pain) and VACCINATION SITE RASH (Red rash and a bruise on the injection site) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In October 2021, Body temperature: 101.6 (High) 101.6. No concomitant medications were provided. Patient stated that having a rare disease and after finish radiation hcp recommended get a 3rd dose. This case was linked to MOD-2021-354688, MOD-2021-354613 (Patient Link).

Other Meds:

Current Illness: Seasonal allergy

ID: 1817240
Sex: M
Age:
State: OK

Vax Date: 05/14/2021
Onset Date: 06/11/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data: Test Name: SARS-CoV-2 test; Test Result: Negative ; Result Unstructured Data: Negative COVID-19 test

Allergies:

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

Symptoms: Does not like the taste of food after 2nd shot; Does not have desire to eat after 2nd shot, does not have any Appetite after 2nd shot; Loosing weight (-59lbs) after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of TASTE DISORDER (Does not like the taste of food after 2nd shot), DECREASED APPETITE (Does not have desire to eat after 2nd shot, does not have any Appetite after 2nd shot) and WEIGHT DECREASED (Loosing weight (-59lbs) after 2nd dose) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 006C21A) for COVID-19 vaccination. The patient's past medical history included Hypoxia, Fibromyalgia, Arthritis, Lumbar pain, Back pain, Scoliosis and Carpal tunnel syndrome. Concurrent medical conditions included Acute respiratory failure, Aortic aneurysm, Spinal stenosis, Barrett's oesophagus, BPH, Cardiomyopathy, COPD, Coronary artery disease, Coronary atherosclerosis, Epilepsy, GERD, Hyperlipidemia, Hypertension, Obesity, Myocardial infarction, Migraine, Neuropathy NOS, Restless leg syndrome, Neurofibromatosis and Sleep apnea. Concomitant products included LEVETIRACETAM, POTASSIUM CHLORIDE, GABAPENTIN, FUROSEMIDE, VALPROATE SEMISODIUM (DIVALPROEX), CARVEDILOL, TAMSULOSIN, PANTOPRAZOLE, BACLOFEN, AMITRIPTYLINE, CLOPIDOGREL, CITALOPRAM, ATORVASTATIN, AMLODIPINE, DICLOFENAC and PRAMIPEXOLE for an unknown indication. On 14-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Jun-2021, the patient experienced TASTE DISORDER (Does not like the taste of food after 2nd shot), DECREASED APPETITE (Does not have desire to eat after 2nd shot, does not have any Appetite after 2nd shot) and WEIGHT DECREASED (Loosing weight (-59lbs) after 2nd dose). On 17-Oct-2021, WEIGHT DECREASED (Loosing weight (-59lbs) after 2nd dose) had resolved. At the time of the report, TASTE DISORDER (Does not like the taste of food after 2nd shot) and DECREASED APPETITE (Does not have desire to eat after 2nd shot, does not have any Appetite after 2nd shot) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative COVID-19 test. No Treatment Information were provided by the reporter Reporter stated that after the second shot, patient does not have any Appetite, patient is loosing weight (He is 5'7" and was 316lbs prior to Vaccination). patient weighs 257 Lbs. now 17OCT2021.patient states that he can taste the food, but does not like the taste any more and has no desire to eat and he is late for the church and can not hang on too long.

Other Meds: LEVETIRACETAM; POTASSIUM CHLORIDE; GABAPENTIN; FUROSEMIDE; DIVALPROEX; CARVEDILOL; TAMSULOSIN; PANTOPRAZOLE; BACLOFEN; AMITRIPTYLINE; CLOPIDOGREL; CITALOPRAM; ATORVASTATIN; AMLODIPINE; DICLOFENAC; PRAMIPEXOLE

Current Illness: Acute respiratory failure; Aortic aneurysm; Barrett's oesophagus; BPH; Cardiomyopathy; COPD; Coronary artery disease; Coronary atherosclerosis; Epilepsy; GERD; Hyperlipidemia; Hypertension; Migraine; Myocardial infarction; Neurofibromatosis; Neuropathy NOS; Obesity; Restless leg syndrome; Sleep apnea; Spinal stenosis

ID: 1817241
Sex: F
Age: 56
State:

Vax Date: 03/10/2021
Onset Date: 04/09/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Arm was sore,Body Aches; Arm was sore,Body Aches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Arm was sore,Body Aches) and VACCINATION SITE PAIN (Arm was sore,Body Aches) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 02FB21A and 040A21A) for COVID-19 vaccination. Concurrent medical conditions included Diabetes. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 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 09-Apr-2021, the patient experienced MYALGIA (Arm was sore,Body Aches) and VACCINATION SITE PAIN (Arm was sore,Body Aches). On 10-Apr-2021, MYALGIA (Arm was sore,Body Aches) and VACCINATION SITE PAIN (Arm was sore,Body Aches) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication listed. No treatment information provided. This case was linked to MOD-2021-355605 (Patient Link).

Other Meds:

Current Illness: Diabetes

ID: 1817242
Sex: U
Age:
State: MA

Vax Date: 10/18/2021
Onset Date: 10/18/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: patient got a dose from and expired vial; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patient got a dose from and expired vial) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination. No Medical History information was reported. On 18-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (patient got a dose from and expired vial). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (patient got a dose from and expired vial) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported. No treatment medication was reported.

Other Meds:

Current Illness:

ID: 1817243
Sex: F
Age: 76
State: NY

Vax Date: 03/02/2021
Onset Date: 05/14/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Cannot lift her arms above her shoulders/can't do anything; Pain in her neck; Pain in her groin; Can't walk because the pain in her legs is horrible/pain went down to the right calf/pain went to the hip/pain in arms; Excruciating pain; Pain in shoulders; >35 days of vaccine admistration 1st dose 02-Mar-2021,2nd dose 14-May-2021; This spontaneous case was reported by a consumer and describes the occurrence of HYPOKINESIA (Cannot lift her arms above her shoulders/can't do anything), NECK PAIN (Pain in her neck), GROIN PAIN (Pain in her groin), PAIN IN EXTREMITY (Can't walk because the pain in her legs is horrible/pain went down to the right calf/pain went to the hip/pain in arms) and PAIN (Excruciating pain) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A and 003A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-May-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (>35 days of vaccine admistration 1st dose 02-Mar-2021,2nd dose 14-May-2021). In July 2021, the patient experienced HYPOKINESIA (Cannot lift her arms above her shoulders/can't do anything), NECK PAIN (Pain in her neck), GROIN PAIN (Pain in her groin), PAIN IN EXTREMITY (Can't walk because the pain in her legs is horrible/pain went down to the right calf/pain went to the hip/pain in arms), PAIN (Excruciating pain) and ARTHRALGIA (Pain in shoulders). The patient was treated with OXYCODONE for Pain, at an unspecified dose and frequency and CANNABIDIOL (CBD OIL) for Pain, at an unspecified dose and frequency. On 14-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (>35 days of vaccine admistration 1st dose 02-Mar-2021,2nd dose 14-May-2021) had resolved. At the time of the report, HYPOKINESIA (Cannot lift her arms above her shoulders/can't do anything), NECK PAIN (Pain in her neck), GROIN PAIN (Pain in her groin), PAIN (Excruciating pain) and ARTHRALGIA (Pain in shoulders) had not resolved and PAIN IN EXTREMITY (Can't walk because the pain in her legs is horrible/pain went down to the right calf/pain went to the hip/pain in arms) was resolving. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not provided. It was reported that patient went to a cardiovascular doctor and had 3 MRIs done and they had not found anything. CBD oil does not help the pain,the only time it gets better is at 5 pm and if she keeps walking, and that only helps her legs.

Other Meds:

Current Illness:

ID: 1817244
Sex: M
Age: 61
State: CA

Vax Date: 04/23/2021
Onset Date:
Rec V Date: 10/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: not pain but,felt different; the right arm was sore/still sore after 4 month/right arm still hurts/still sore; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (not pain but,felt different) and VACCINATION SITE PAIN (the right arm was sore/still sore after 4 month/right arm still hurts/still sore) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 007C21A and 035C21A) for COVID-19 vaccination. Medical history was not provided. On 23-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-May-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 FEELING ABNORMAL (not pain but,felt different) and VACCINATION SITE PAIN (the right arm was sore/still sore after 4 month/right arm still hurts/still sore). At the time of the report, FEELING ABNORMAL (not pain but,felt different) outcome was unknown and VACCINATION SITE PAIN (the right arm was sore/still sore after 4 month/right arm still hurts/still sore) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant drug details were reported. No treatment details were reported. This case was linked to MOD-2021-355773 (Patient Link).

Other Meds:

Current Illness:

ID: 1817245
Sex: U
Age:
State: MS

Vax Date: 10/18/2021
Onset Date: 10/18/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: Vaccine leaked out while being administered; Vaccine leaked out while being administered (the needle must not have been screwed tightly to the syringe); Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of UNDERDOSE (Vaccine leaked out while being administered) and DEVICE CONNECTION ISSUE (Vaccine leaked out while being administered (the needle must not have been screwed tightly to the syringe)) 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 18-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced UNDERDOSE (Vaccine leaked out while being administered) and DEVICE CONNECTION ISSUE (Vaccine leaked out while being administered (the needle must not have been screwed tightly to the syringe)). On 18-Oct-2021, UNDERDOSE (Vaccine leaked out while being administered) and DEVICE CONNECTION ISSUE (Vaccine leaked out while being administered (the needle must not have been screwed tightly to the syringe)) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication of the patient was not reported. No treatment information was provided by the reporter.

Other Meds:

Current Illness:

ID: 1817246
Sex: M
Age: 58
State: CA

Vax Date: 10/15/2021
Onset Date: 10/15/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Accidentally gave a 0.5ml booster shot to NON-immunocompromised patient; This spontaneous case was reported by a nurse and describes the occurrence of EXTRA DOSE ADMINISTERED (Accidentally gave a 0.5ml booster shot to NON-immunocompromised patient) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 076c21a) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included GLIPIZIDE for an unknown indication. On 15-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) .5 ml. On 15-Oct-2021, the patient experienced EXTRA DOSE ADMINISTERED (Accidentally gave a 0.5ml booster shot to NON-immunocompromised patient). On 15-Oct-2021, EXTRA DOSE ADMINISTERED (Accidentally gave a 0.5ml booster shot to NON-immunocompromised patient) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Treatment details were reported. Most recent FOLLOW-UP information incorporated above includes: On 18-Oct-2021: Added Patient initials, Age, gender ,Suspect product details, Concomitant Glipizide.

Other Meds: GLIPIZIDE

Current Illness:

ID: 1817247
Sex: F
Age: 32
State: NJ

Vax Date: 10/14/2021
Onset Date: 10/15/2021
Rec V Date: 10/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Rash was big/ It started small and gradually became bigger/she noticed a lump or a red rash next to the site of injection; Lump or red rash next to the site of injection/the rash was big/rash still there; Redness at the injection site/ It started small and gradually became bigger/growing anymore and getting better; Weakness; Back pain; Chills; Fatigue; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness), BACK PAIN (Back pain), VACCINATION SITE MASS (Rash was big/ It started small and gradually became bigger/she noticed a lump or a red rash next to the site of injection), CHILLS (Chills) and FATIGUE (Fatigue) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 14-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Oct-2021, the patient experienced ASTHENIA (Weakness), BACK PAIN (Back pain), FATIGUE (Fatigue) and MYALGIA (Body aches). 15-Oct-2021, the patient experienced CHILLS (Chills). On 16-Oct-2021, the patient experienced VACCINATION SITE MASS (Rash was big/ It started small and gradually became bigger/she noticed a lump or a red rash next to the site of injection). 16-Oct-2021, the patient experienced VACCINATION SITE RASH (Lump or red rash next to the site of injection/the rash was big/rash still there) and VACCINATION SITE ERYTHEMA (Redness at the injection site/ It started small and gradually became bigger/growing anymore and getting better). On 15-Oct-2021, ASTHENIA (Weakness), BACK PAIN (Back pain), CHILLS (Chills), FATIGUE (Fatigue) and MYALGIA (Body aches) had resolved. At the time of the report, VACCINATION SITE MASS (Rash was big/ It started small and gradually became bigger/she noticed a lump or a red rash next to the site of injection), VACCINATION SITE RASH (Lump or red rash next to the site of injection/the rash was big/rash still there) and VACCINATION SITE ERYTHEMA (Redness at the injection site/ It started small and gradually became bigger/growing anymore and getting better) was resolving. No concomitant and treatment information provided. This case was linked to MOD-2021-355758.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am