VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 11/12/2021
** VAERS DATABASE Last updated: November 12, 2021**
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Manufacturers

Total Manufacturer
199,106MODERNA
36,710JANSSEN
5,381PFIZER\BIONTECH
2,555GLAXOSMITHKLINE BIOLOGICALS
1,469UNKNOWN MANUFACTURER
897MERCK & CO. INC.
627SEQIRUS, INC.
112DYNAVAX TECHNOLOGIES CORPORATION
91SANOFI PASTEUR
75NOVARTIS VACCINES AND DIAGNOSTICS
40EMERGENT BIOSOLUTIONS
14PAXVAX
12TEVA PHARMACEUTICALS
12PROTEIN SCIENCES CORPORATION
9PFIZER\WYETH
4BERNA BIOTECH, LTD.
4SMITHKLINE BEECHAM
3INTERCELL AG
1MEDIMMUNE VACCINES, INC.
1CSL LIMITED

COVID19 Lot Number

VAX LOT Total
2S9CL7,949
7,473
2,547
1,506
1,187
1,051
1,049
s0294561,043
866
IMM209861
816
UT7065MA766
657
579
U62828AA563
557
538
U6737AA516
515
S034636506
4F472471
458
P100253275449
444
276563436
429
418
4BH32414
MENVEO404
PP9L5362
UJ446AA337
319
306
290
271
49TM3270
R1B252M253
4F472179
933622147
C5763AA144
CW3116134
3Y7NL126
UNK114
113
ARBA141A105
104
103
96
300057A90
79
1F4EB73
R1B743M62
56
UJ090AA55
51
UH894AB46
45
UNK44
UNK42
42
EJ168638
Unknown36
35
34
32
32
26
el128424
24
A115A22
22
EN620222
21
UNK20
20
19
Z127A19
19
17
JEV18K95E15
12
111798PI12
10
A739088
No batch number8
3333324181078
6
6
TAR356
5
5
U6935AA5
UNK5
4
unknown4
3
2
55RB72
2
2
2
2
2
U7124AA2
JEV18A68E2
2
ABYB05BA1
1
1
1
1
AMVA436A1
1
1
TJ3521
A130A; VIS give1
1
U7140BB1
1
1
SP UP016AA1
1
1808P08802/ESV01
037K20A300,947
EL1284288,578
57,766
1,432

Incidents per State

State Total
82,750
CA62,821
FL38,209
TX36,512
NY34,921
PA23,646
IN23,622
IL20,597
MI19,590
OH19,426
NJ18,413
NC16,769
GA15,932
WA15,351
VA15,234
MA14,876
AZ14,206
MN12,940
MD12,656
CO11,908
WI11,425
MO10,240
TN9,685
OR8,768
KY8,437
CT8,300
SC6,700
OK6,293
AL5,692
LA5,025
IA4,825
KS4,821
UT4,637
NV4,374
NM3,967
AR3,807
ME3,161
NH3,096
NE2,918
MS2,859
ID2,785
WV2,469
HI2,459
PR2,417
MT2,414
RI2,076
DE1,868
AK1,830
VT1,734
DC1,715
ND1,388
SD1,269
WY866
GU118
VI69
AS47
MP29
MH8
XB6
FM4
QM3
XV2
XL1

Date Died:

ID: 1827177
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/29/2021
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: DEATH; This spontaneous report received from a consumer 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, 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 death. On an unspecified date, the patient died from unknown cause of death. It was unknown if the autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. This report was serious (Death).; Sender's Comments: V0: 20211053420-Covid-19 vaccine ad26.cov2.s - Death. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH

Other Meds:

Current Illness:

ID: 1827178
Sex: F
Age:
State:

Vax Date:
Onset Date: 03/01/2021
Rec V Date: 10/29/2021
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: AWFUL; FELT LIKE HIT BY A BUS; COULD NOT SLEEP THAT NIGHT; SORE; CHILLS; FEVER; 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 ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose was not reported, administered on MAR-2021 for prophylactic vaccination. 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 MAR-2021, the patient experienced awful. On MAR-2021, the patient experienced felt like hit by a bus. On MAR-2021, the patient experienced could not sleep that night. On MAR-2021, the patient experienced sore. On MAR-2021, the patient experienced chills. On MAR-2021, the patient experienced fever. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the awful, felt like hit by a bus, fever, chills, could not sleep that night and sore was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1827179
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/29/2021
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: VERY MILD REACTIONS; This spontaneous report received from a patient 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: Unknown) dose, start therapy date were not reported for prophylactic vaccination. 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 very mild reactions. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of very mild reactions was not reported. This report was non-serious. This case, from the same reporter is linked to 20211055553 and 20211055777.

Other Meds:

Current Illness:

ID: 1827180
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/29/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: PAIN ALL THE TIME; FEEL A DIFFERENCE IN BODY; MUSCLES STIFF 24-7; CONSTANTLY COLD; MUSCLES ARE ALWAYS SORE 24-7; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient never had flu and never got cold never wore a jersey or jacket. 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 pain all the time, feel a difference in body, muscles stiff 24-7, constantly cold, and muscles are always sore 24-7. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from muscles are always sore 24-7, muscles stiff 24-7, pain all the time, and constantly cold, and the outcome of feel a difference in body was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1827181
Sex: M
Age:
State: FL

Vax Date:
Onset Date: 10/26/2021
Rec V Date: 10/29/2021
Hospital:

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

Lab Data: Test Date: 20211027; Test Name: Body temperature; Result Unstructured Data: 105 F; Test Date: 20211027; Test Name: Body temperature; Result Unstructured Data: 102 F; Test Date: 20211027; Test Name: Body temperature; Result Unstructured Data: 103 F

Allergies:

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

Symptoms: SWEATING; CHILLS; HEADACHE; FEVER; CHEST PAIN; LITTLE DIZZY, BUT NOTHING TOO CRAZY; BODY ACHES; This spontaneous report received from a patient concerned a 50 year old male. The patient's weight was 188 pounds, and height was 68 inches. The patient's concurrent conditions included: disabled veteran (multiple chronic conditions), penicillin allergy, sulfa allergy, bee sting allergy, non smoker, and non alcoholic, and other pre-existing medical conditions included: Patient had no drug abuse and illicit drug use. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 042A21A, expiry: 19-SEP-2022) dose was not reported, administered on 26-OCT-2021 14:30 for prophylactic vaccination. No concomitant medications were reported. On 26-OCT-2021, the patient experienced chest pain. On 26-OCT-2021, the patient experienced little dizzy, but nothing too crazy. On 26-OCT-2021, the patient experienced body aches. On 26-OCT-2021, the patient experienced chills. On 26-OCT-2021, the patient experienced headache. On 26-OCT-2021, the patient experienced fever. On 27-OCT-2021, the patient experienced sweating. Laboratory data included: Body temperature (NR: not provided) 105 F, 103 F, 102 F. Treatment medications included: paracetamol. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chest pain, and little dizzy, but nothing too crazy on 26-OCT-2021, had not recovered from body aches, headache, and fever, and the outcome of chills and sweating was not reported. This report was non-serious.

Other Meds:

Current Illness: Abstains from alcohol; Allergic reaction to bee sting; Disability; Non-smoker; Penicillin allergy; Sulfonamide allergy

ID: 1827182
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/29/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: VACCINE BREAKTHROUGH INFECTION; SUSPECTED CLINICAL VACCINATION FAILURE; This spontaneous report received from a patient via a company representative via Social Media 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 and expiry: Unknown) dose was not reported, frequency 1 total 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 numbers. No concomitant medications were reported. On an unspecified date, the patient experienced Vaccine breakthrough infection (suspected Clinical vaccination failure). It was reported that "FYI 3 of us in my family and friends group had a breakthrough infection and we all had the J&J vaccine. So I don't think it's just the compromised but the J&J appears weak". The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the vaccine breakthrough infection and suspected Clinical vaccination failure was not reported. This report was serious (Other Medically Important Condition). This report was associated with product quality complaint: 90000199535.; Sender's Comments: V0: 20211055243- Covid-19 vaccine ad26.cov2.s- Vaccine breakthrough infection. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s). 20211055243-Covid-19 vaccine ad26.cov2.s- Suspected clinical vaccination failure. This event is considered not related. The event has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event than the drug. Specifically: SPECIAL SITUATIONS

Other Meds:

Current Illness:

ID: 1827183
Sex: M
Age:
State: MN

Vax Date:
Onset Date:
Rec V Date: 10/29/2021
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: A LOT OF BODY ACHES; CHILLS; TIRED; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced a lot of body aches, chills, and tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the a lot of body aches, tired and chills was not reported. This report was non-serious. This case, from the same reporter is linked to 20211055339.

Other Meds:

Current Illness:

ID: 1827184
Sex: F
Age:
State: NY

Vax Date:
Onset Date: 09/24/2021
Rec V Date: 10/29/2021
Hospital:

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

Lab Data: Test Name: Colonoscopy; Result Unstructured Data: Unknown

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: BOWEL SOUNDS EVEN WHEN SHE IS NOT HUNGRY; COULD NOT SLEEP; INTENSIVE STOMACH PAIN ON THE RIGHT, LEFT SIDE AND IN THE MIDDLE; DID NOT HAVE BOWEL MOVEMENT; COULD NOT GET OUT OF BED; HEADACHE; LOW-GRADE FEVER; This spontaneous report received from a patient concerned a 70 year old female. The patient's height, and weight were not reported. The patient's past medical history included: did colonoscopy and broke into rash (less rash), and concurrent conditions included: non alcoholic, and non smoker, and other pre-existing medical conditions included: The patient had no drug abuse or illicit drug usage. The patient experienced hives and rash severe all over her body and red and inflamed when treated with sulfamethoxazole/trimethoprim for drug used for unknown indication. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 212A21A expiry: 21-DEC-2021) dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 24-SEP-2021, the patient experienced could not get out of bed. On 24-SEP-2021, the patient experienced headache. On 24-SEP-2021, the patient experienced low-grade fever. On 27-SEP-2021, the patient experienced intensive stomach pain on the right, left side and in the middle. On 27-SEP-2021, the patient experienced did not have bowel movement. On 27-OCT-2021, the patient experienced could not sleep. On an unspecified date, the patient experienced bowel sounds even when she is not hungry. Laboratory data (dates unspecified) included: Colonoscopy (NR: not provided) Unknown. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from could not get out of bed, headache, and low-grade fever on 26-SEP-2021, was recovering from intensive stomach pain on the right, left side and in the middle, and did not have bowel movement, and the outcome of bowel sounds even when she is not hungry and could not sleep was not reported. This report was non-serious.

Other Meds:

Current Illness: Abstains from alcohol; Non-smoker

ID: 1827185
Sex: U
Age:
State:

Vax Date:
Onset Date: 10/01/2021
Rec V Date: 10/29/2021
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: OVERALL SORENESS; ARM WAS A KILLER; HEADACHE; BIT TIRED; 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 was not reported, administered on 26-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 OCT-2021, the patient experienced overall soreness. On OCT-2021, the patient experienced arm was a killer. On OCT-2021, the patient experienced headache. On OCT-2021, the patient experienced bit tired. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the bit tired, headache, overall soreness and arm was a killer was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1827186
Sex: M
Age:
State: MS

Vax Date:
Onset Date:
Rec V Date: 10/29/2021
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: ONLY SWEATS; CHILLS; This spontaneous report received from a consumer concerned an 83 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: immune issue. 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 10-MAR-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 only sweats, and chills. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the only sweats and chills was not reported. This report was non-serious.

Other Meds:

Current Illness: Immune system disorder

ID: 1827187
Sex: F
Age:
State:

Vax Date:
Onset Date: 03/01/2021
Rec V Date: 10/29/2021
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: SICK FROM THE J AND J BUT ONLY FOR 20 HOURS; 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 ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose was not reported, administered on MAR-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 MAR-2021, the patient experienced sick from the j and j but only for 20 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sick from the j and j but only for 20 hours on MAR-2021. This report was non-serious. This case, from the same reporter is linked to 20211055134 and 20211055777.

Other Meds:

Current Illness:

ID: 1827188
Sex: F
Age:
State:

Vax Date:
Onset Date: 10/01/2021
Rec V Date: 10/29/2021
Hospital:

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

Lab Data: Test Date: 202110; Test Name: Electrocardiogram; Result Unstructured Data: Blood little thicker than normal; Test Date: 202110; Test Name: Heart rate; Result Unstructured Data: 96-100 bpm; Test Date: 202110; Test Name: Diagnostic procedure NOS; Result Unstructured Data: Blood little thicker than normal; Test Date: 20211021; Test Name: Body temperature; Result Unstructured Data: Fever of 99

Allergies:

Symptom List: Rash, Urticaria

Symptoms: MUSCLE ACHES; FATIGUE; SLIGHT FEVER OF 99; HEADACHE; CHILLS; ARM PAIN; HEART RATE WENT UP TO 96-100 BPM/ELEVATED RESTING HEART RATE; BLOOD THICKER THAN NORMAL; SWOLLEN ARM; BURNING SENSATION ON LEFT SHOULDER, GOING UP INTO ARM AND UP THE NECK, AND INTO THE JAW; BURNING SENSATION TO THE SIDE OF BREAST; PAIN; This spontaneous report received from a consumer concerned a 60 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: heart murmur. 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 OCT-2021, the patient experienced heart rate went up to 96-100 bpm/elevated resting heart rate. On OCT-2021, the patient experienced blood thicker than normal. On OCT-2021, the patient experienced swollen arm. On OCT-2021, the patient experienced burning sensation on left shoulder, going up into arm and up the neck, and into the jaw. On OCT-2021, the patient experienced burning sensation to the side of breast. On OCT-2021, the patient experienced arm pain. On OCT-2021, the patient experienced pain. Laboratory data included: Diagnostic procedure NOS (NR: not provided) Blood little thicker than normal, Electrocardiogram (NR: not provided) Blood little thicker than normal, and Heart rate (NR: not provided) 96-100 bpm. On 21-OCT-2021, the patient experienced chills. On 21-OCT-2021, the patient experienced muscle aches. On 21-OCT-2021, the patient experienced fatigue. On 21-OCT-2021, the patient experienced slight fever of 99. On 21-OCT-2021, the patient experienced headache. Laboratory data included: Body temperature (NR: not provided) Fever of 99. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from pain, had not recovered from heart rate went up to 96-100 bpm/elevated resting heart rate, arm pain, and swollen arm, and the outcome of slight fever of 99, chills, headache, fatigue, muscle aches, burning sensation on left shoulder, going up into arm and up the neck, and into the jaw, blood thicker than normal and burning sensation to the side of breast was not reported. This report was non-serious.

Other Meds:

Current Illness: Heart murmur

ID: 1827189
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/29/2021
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: SLEEPY; SUPER AWFUL; BODY ACHES; BAD FEVER; 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 sleepy, super awful, body aches, bad fever, and fatigue. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the sleepy, super awful, body aches, bad fever and fatigue was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1827190
Sex: M
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 10/29/2021
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: CHILLS; FEVER FOR ABOUT 3 HOURS; This spontaneous report received from a consumer via a company representative concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced chills, and fever for about 3 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from chills, and fever for about 3 hours. This report was non-serious. This case, from the same reporter is linked to 20211055553 and 20211055134.

Other Meds:

Current Illness:

ID: 1827191
Sex: F
Age:
State: OH

Vax Date:
Onset Date: 09/21/2021
Rec V Date: 10/29/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: SORE ARM; TWITCHING OF ARM/MINOR TWITCHING ALL OVER THE BODY(FEET, LEGS, BACK); This spontaneous report received from a patient concerned a 41 year old female. The patient's weight was 112 pounds, and height was 60.5 inches. 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: 211A21A expiry: UNKNOWN) dose was not reported, administered on 20-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 21-SEP-2021, the patient experienced twitching of arm/minor twitching all over the body (feet, legs, back). On an unspecified date, the patient experienced sore arm. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from sore arm, and had not recovered from twitching of arm/minor twitching all over the body(feet, legs, back). This report was non-serious.

Other Meds:

Current Illness:

ID: 1827192
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/29/2021
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: FELT A BIT DOWN FOR ABOUT 12 HOURS; HEADACHE; 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 headache, and felt a bit down for about 12 hours. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from headache, and felt a bit down for about 12 hours. This report was non-serious.

Other Meds:

Current Illness:

ID: 1827193
Sex: F
Age: 33
State: MA

Vax Date: 03/25/2021
Onset Date: 03/25/2021
Rec V Date: 10/29/2021
Hospital:

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

Lab Data: Test Date: 20210331; Test Name: Glucose challenge; Result Unstructured Data: Normal; Test Date: 20211002; Test Name: Pregnancy test; Test Result: Positive ; Result Unstructured Data: Positive; Test Date: 20210303; Test Name: Ultrasound; Result Unstructured Data: Normal

Allergies:

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

Symptoms: rapid delivery; I was pregnant (3rd trimester both covid vaccine doses); This spontaneous retrospective pregnancy case was reported by a consumer and describes the occurrence of MATERNAL EXPOSURE DURING PREGNANCY (I was pregnant (3rd trimester both covid vaccine doses)) and PRECIPITATE LABOUR (rapid delivery) in a 34-year-old female patient (gravida 1, para 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 011J20A) for COVID-19 vaccination. Concurrent medical conditions included Polycystic ovary. Concomitant products included MULTI VITAMIN [ASCORBIC ACID;COLECALCIFEROL;NICOTINAMIDE;PANTHENOL;PYRIDOXINE HYDROCHLORIDE;RETINOL PALMITATE;RIBOFLAVIN;THIAMINE HYDROCHLORIDE;TOCOPHERYL ACETATE]. On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 14-Jun-2021. On 25-Mar-2021, the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (I was pregnant (3rd trimester both covid vaccine doses)). On an unknown date, the patient experienced PRECIPITATE LABOUR (rapid delivery). The vaginal delivery occurred on 16-Jun-2021, which was reported as Full-term. For neonate 1, the birth weight was 4044 grams (8lbs 15oz) with an APGAR score of 7 and 9 at (1, 5 minutes). The outcome was reported as Delivered NOS. Patient delivered a healthy baby on 16-JUN-2021 (two days past due date). On 25-Mar-2021, MATERNAL EXPOSURE DURING PREGNANCY (I was pregnant (3rd trimester both covid vaccine doses)) had resolved. At the time of the report, PRECIPITATE LABOUR (rapid delivery) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 03-Mar-2021, Ultrasound scan: normal (normal) Normal. On 31-Mar-2021, Blood glucose: normal (normal) Normal. On 02-Oct-2021, Pregnancy test: positive (Positive) Positive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication list was not provided. Treatment information was not provided. Patient delivered a healthy baby on 16-JUN-2021 (two days past due date). Company Comment: This case concerns a 34-year-old, female patient with medical history of polycystic ovary, who experienced the non serious events of maternal exposure during pregnancy and precipitate labour. The patient received both vaccine doses at 3rd trimester of pregnancy (28th and 32nd gestational week). The vaginal delivery occurred on 16-Jun-2021, which was reported as Full-term.Patient delivered a healthy baby on 16-JUN-2021 (two days past due date). For neonate, the birth weight was 4044 grams (8lbs 15oz) with an APGAR score of 7 and 9 at (1, 5 minutes). The benefit-risk relationship of Moderna COVID-19 Vaccine in not affected by this report. This case was linked to MOD-2021-357824 (Parent-Child Link). See case MOD-2021-357824 for details regarding the child case. Most recent FOLLOW-UP information incorporated above includes: On 19-Oct-2021: Significant Follow up-Pregnancy outcome form received, event added, child case created; Sender's Comments: This case concerns a 34-year-old, female patient with medical history of polycystic ovary, who experienced the non serious events of maternal exposure during pregnancy and precipitate labour. The patient received both vaccine doses at 3rd trimester of pregnancy (28th and 32nd gestational week). The vaginal delivery occurred on 16-Jun-2021, which was reported as Full-term.Patient delivered a healthy baby on 16-JUN-2021 (two days past due date). For neonate, the birth weight was 4044 grams (8lbs 15oz) with an APGAR score of 7 and 9 at (1, 5 minutes). The benefit-risk relationship of Moderna COVID-19 Vaccine in not affected by this report.

Other Meds: MULTI VITAMIN [ASCORBIC ACID;COLECALCIFEROL;NICOTINAMIDE;PANTHENOL;PYRIDOXINE HYDROCHLORIDE;RETINOL

Current Illness: Polycystic ovary

ID: 1827194
Sex: M
Age: 79
State: LA

Vax Date: 04/01/2021
Onset Date:
Rec V Date: 10/29/2021
Hospital: Y

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

Lab Data: Test Name: Blood pressure; Result Unstructured Data: Blood pressure 145/115 high; Test Name: CT scan.; Result Unstructured Data: diagnosed with left embolism in left lung; Test Name: Heart rate; Result Unstructured Data: Heart rate 130-140 high, Heart Rate of 150+

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: left embolism in left lung; High BP / m Blood Pressure of 145/115; This spontaneous case was reported by a consumer and describes the occurrence of PULMONARY EMBOLISM (left embolism in left lung) and HYPERTENSION (High BP / m Blood Pressure of 145/115) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 017B21A) for COVID-19 vaccination. The patient's past medical history included Surgery (Patient had a prior medical history of double by pass surgery) and AFib (patient was a not an a-fib patient anymore but takes medications as prophylactic.). Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN), LOSARTAN, PRAVASTATIN, OMEPRAZOLE, AMLODIPINE BESYLATE and COLECALCIFEROL (VITAMIN D 3) for an unknown indication. On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PULMONARY EMBOLISM (left embolism in left lung) (seriousness criteria hospitalization, medically significant and life threatening) and HYPERTENSION (High BP / m Blood Pressure of 145/115) (seriousness criterion hospitalization). The patient was hospitalized from 14-Oct-2021 to sometime in October 2021 due to HYPERTENSION and PULMONARY EMBOLISM. The patient was treated with ISOSORBIDE MONONITRATE for Adverse event, at an unspecified dose and frequency; BUDESONIDE for Adverse event, at an unspecified dose and frequency; IPRATROPIUM for Adverse event, at an unspecified dose and frequency; SALBUTAMOL SULFATE (ALBUTEROL [SALBUTAMOL SULFATE]) for Adverse event, at an unspecified dose and frequency; PANTOPRAZOLE SODIUM for Adverse event, at an unspecified dose and frequency; LOSARTAN POTASSIUM for Adverse event, at an unspecified dose and frequency; ASPIRIN [ACETYLSALICYLIC ACID] for Adverse event, at an unspecified dose and frequency; SALBUTAMOL SULFATE (VENTOLIN HFA) for Adverse event, at an unspecified dose and frequency; PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency and ENOXAPARIN SODIUM for Adverse event, at an unspecified dose and frequency. On 14-Oct-2021, PULMONARY EMBOLISM (left embolism in left lung) and HYPERTENSION (High BP / m Blood Pressure of 145/115) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 145/115 (High) Blood pressure 145/115 high. On an unknown date, Computerised tomogram: abnormal (abnormal) diagnosed with left embolism in left lung. On an unknown date, Heart rate: 130-140 (High) Heart rate 130-140 high, Heart Rate of 150+. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient reported that he experienced high blood pressure and high heart rate. he was hospitalized On 14 Oct-2021 for 2 days and then discharged on 3rd day. Company Comment: This case concerns a 79-year-old male patient with a history of atrial fibrillation and double bypass surgery, who experienced the unexpected, serious (hospitalization, life threatening and medically significant) events of Pulmonary embolism and hypertension. The events occurred approximately 6 after the first dose of mRNA-1273 and 5 after the second dose of mRNA-1273. The rechallenge was not applicable. The medical history of atrial fibrillation and double bypass surgery are confounders. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 79-year-old male patient with a history of atrial fibrillation and double bypass surgery, who experienced the unexpected, serious (hospitalization, life threatening and medically significant) events of Pulmonary embolism and hypertension. The events occurred approximately 6 after the first dose of mRNA-1273 and 5 after the second dose of mRNA-1273. The rechallenge was not applicable. The medical history of atrial fibrillation and double bypass surgery are confounders. The benefit-risk relationship of mRNA-1273 is not affected by this report.

Other Meds: BABY ASPIRIN; LOSARTAN; PRAVASTATIN; OMEPRAZOLE; AMLODIPINE BESYLATE; VITAMIN D 3

Current Illness:

ID: 1827195
Sex: F
Age:
State: AL

Vax Date: 01/19/2021
Onset Date:
Rec V Date: 10/29/2021
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: Body Aches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Body Aches) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042l20a) for COVID-19 vaccination. Concurrent medical conditions included Shellfish allergy (Allergy to Shell) and Arthritis since 1984. On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (Body Aches). At the time of the report, MYALGIA (Body Aches) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant and treatment information was reported by reporter. The 3 shot gave me ? 9 hours body aches all my body aches like if I had the flu..Gone the next day. This case was linked to MOD-2021-287530 (Patient Link).; Sender's Comments: This is a case of a 81 year old female with relevant medical history of arthritis, who experienced a non-serious , expected event of myalgia which occurred on an unknown period of time with vaccination with the first dose of mRNA -1273 (Moderna). The re-challenge for this case is unknown . The benefit-risk relationship of mRNA-1273 (Moderna ) is not affected by this report.

Other Meds:

Current Illness: Arthritis; Shellfish allergy (Allergy to Shell)

ID: 1827196
Sex: F
Age: 42
State: NY

Vax Date: 04/02/2021
Onset Date:
Rec V Date: 10/29/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: Biopsy; Result Unstructured Data: autoimmune disease following vaccination: Urticarial vasculitis; Test Date: 2021; Test Name: Blood test; Result Unstructured Data: autoimmune disease following vaccination: Urticarial vasculitis; Test Date: 2021; Test Name: Mammography; Test Result: Negative ; Result Unstructured Data: all tests came out negative for cancer

Allergies:

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

Symptoms: Had to stop working because of her symptoms; Joint pain in her hands and her shoulders,skin and joints affected; Muscle pain; Urticarial vasculitis; One bruise got infected and got cellulitis; Warm and swelled bruising in her legs like phlebitis; Horrible pain; Very severe and painful urticaria on all the body; All the body with bruises and swelling; Warm and swelled bruising; Swelled lymphatics glands on her throat,swelling on her throat; Eye pain; Buzzing in her ears; Stomach acid; Ear pain; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIAL VASCULITIS (Urticarial vasculitis) and CELLULITIS (One bruise got infected and got cellulitis) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014c21a and 025b21a) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was reported by the reporter. Concomitant products included LIDOCAINE for Muscle pain and Joint pain, IBUPROFEN (MOTRIN [IBUPROFEN]) and IRON for an unknown indication. On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced URTICARIAL VASCULITIS (Urticarial vasculitis) (seriousness criterion medically significant). 2021, the patient experienced CELLULITIS (One bruise got infected and got cellulitis) (seriousness criterion medically significant), CONTUSION (Warm and swelled bruising in her legs like phlebitis), PAIN (Horrible pain), URTICARIA (Very severe and painful urticaria on all the body), SWELLING (All the body with bruises and swelling), FEELING HOT (Warm and swelled bruising), PHARYNGEAL SWELLING (Swelled lymphatics glands on her throat,swelling on her throat), EYE PAIN (Eye pain), TINNITUS (Buzzing in her ears), HYPERCHLORHYDRIA (Stomach acid), EAR PAIN (Ear pain), ARTHRALGIA (Joint pain in her hands and her shoulders,skin and joints affected) and MYALGIA (Muscle pain). On an unknown date, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Had to stop working because of her symptoms). At the time of the report, URTICARIAL VASCULITIS (Urticarial vasculitis), CELLULITIS (One bruise got infected and got cellulitis), CONTUSION (Warm and swelled bruising in her legs like phlebitis), PAIN (Horrible pain), URTICARIA (Very severe and painful urticaria on all the body), SWELLING (All the body with bruises and swelling), FEELING HOT (Warm and swelled bruising), PHARYNGEAL SWELLING (Swelled lymphatics glands on her throat,swelling on her throat), EYE PAIN (Eye pain), TINNITUS (Buzzing in her ears), HYPERCHLORHYDRIA (Stomach acid), EAR PAIN (Ear pain), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Had to stop working because of her symptoms), ARTHRALGIA (Joint pain in her hands and her shoulders,skin and joints affected) and MYALGIA (Muscle pain) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Biopsy: abnormal (abnormal) autoimmune disease following vaccination: Urticarial vasculitis. In 2021, Blood test: abnormal (abnormal) autoimmune disease following vaccination: Urticarial vasculitis. In 2021, Mammogram: negative (Negative) all tests came out negative for cancer. 20 days after vaccination had warm and swelled bruising in legs like phlebitis, horrible pain, very severe and painful urticaria on all body, one bruise got infected and got cellulitis, all body with bruises and swelling, joint pain in hands and shoulders, swelled lymphatics glands on throat, eye and ear pain, buzzing in ears, stomach acid, muscle and joint pain, swelling on throat. Patient had no protein inside body and no organ was affected. Experiencing symptoms since more than 4-5 month and skin and joints were affected. Had mammography as HCPs thought it was cancer and after that a blood clot because of vaccine but all tests came out negative. HCPs didn't know what patient had until all body had bruises and swelling, performed blood tests and biopsy. Taking antihistamines for stomach acid, antiallergics and not receiving treatment right now, HCP thought about corticoids. This spontaneous report concerns a 43 year old female patient with no relevant medical history who experienced the serious unexpected events of urticarial vasculitis and cellulitis. The events occurred approximately 20 days after receiving the second dose of mRNA-1273. The patient received both the first and second dose of vaccine at appropriate dosing interval (about 28 days). The patient experienced bruising all over the body, swelling, myalgia, arthralgia, painful urticaria, eye pain, ear pain, tinnitus, hyperchlorhydria, throat swelling, and cellulitis (reported as one of the bruise was infected). Mammography for cancer and the test for blood clot was found to be negative. The diagnosis of urticarial vasculitis was made based on the biopsy report. The patient additionally reported that she had to stop working because of the symptoms (captured as activities of daily living impaired). Re-challenge was not applicable as the events happened after the second dose and no additional dosing will be given. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This spontaneous report concerns a 43 year old female patient with no relevant medical history who experienced the serious unexpected events of urticarial vasculitis and cellulitis. The events occurred approximately 20 days after receiving the second dose of mRNA-1273. The patient received both the first and second dose of vaccine at appropriate dosing interval (about 28 days). The patient experienced bruising all over the body, swelling, myalgia, arthralgia, painful urticaria, eye pain, ear pain, tinnitus, hyperchlorhydria, throat swelling, and cellulitis (reported as one of the bruise was infected). Mammography for cancer and the test for blood clot was found to be negative. The diagnosis of urticarial vasculitis was made based on the biopsy report. The patient additionally reported that she had to stop working because of the symptoms (captured as activities of daily living impaired). Re-challenge was not applicable as the events happened after the second dose and no additional dosing will be given. The benefit-risk relationship of mRNA-1273 is not affected by this report.

Other Meds: LIDOCAINE; MOTRIN [IBUPROFEN]; IRON

Current Illness:

ID: 1827197
Sex: F
Age: 25
State: PA

Vax Date: 09/26/2021
Onset Date: 09/26/2021
Rec V Date: 10/29/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Like a third degree sunburn; Maternal exposure during breast feeding; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Like a third degree sunburn) and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939906) for COVID-19 vaccination. No Medical History information was reported. On 26-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Sep-2021, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding). On 04-Oct-2021, the patient experienced RASH ERYTHEMATOUS (Like a third degree sunburn). On 26-Sep-2021, MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) had resolved. At the time of the report, RASH ERYTHEMATOUS (Like a third degree sunburn) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication provided by reporter. No treatment medication provided by reporter. Patient delivered a baby on 19-Sep-2021.Other than delivering a baby and having the shot nothing else was new. The rash was on her chest, stomach, arms and face. She stated it was not on her legs, butt or back. Her obstetrician told her the rash could have been as a result of the mixture of the epidural, hormones and vaccine. She states she was still in the process of healing as she was regenerating new skin. The rash was similar to a third degree sunburn. The caller received the injection into the muscle of her right, upper arm at the facility. Company Comment: This case concerns a 25 year old breastfeeding female with no other reported history who experienced the non-serious, unlisted AESI of Maternal exposure during breastfeeding the day of dose 1 of mRNA-1273. Re-challenge is unknown as no information on dose 2 is reported. Benefit-risk relationship of mRNA-1237 is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 18-Oct-2021: Follow up received on 18-Oct-2021 and updated Reporter's Detail, Patient initial , Patient DOB, gender, New event and Dosage detail were updated.; Sender's Comments: This case concerns a 25 year old breastfeeding female with no other reported history who experienced the non-serious, unlisted AESI of Maternal exposure during breastfeeding the day of dose 1 of mRNA-1273. Re-challenge is unknown as no information on dose 2 is reported. Benefit-risk relationship of mRNA-1237 is not affected by this report.

Other Meds:

Current Illness:

ID: 1827198
Sex: F
Age: 24
State: NC

Vax Date: 09/01/2021
Onset Date: 09/01/2021
Rec V Date: 10/29/2021
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: Maternal exposure during breast feeding; had a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (had a sore arm) and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036B21A) for COVID-19 vaccination. No Medical History information was reported. On 01-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Sep-2021, the patient experienced PAIN IN EXTREMITY (had a sore arm). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding). At the time of the report, PAIN IN EXTREMITY (had a sore arm) and MATERNAL EXPOSURE DURING BREAST FEEDING (Maternal exposure during breast feeding) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not provided by reporter. Treatment information was not provided by reporter. Patient's weight was 200 COMPANY COMMENT: This case concerns a 25 year old breastfeeding female with no reported history who experienced the non-serious, unlisted AESI of Maternal exposure during breastfeeding and the event Pain in extremity the day of dose 1 of mRNA-1273. Re-challenge is positive for pain in extremity as it recurred with dose 2. Benefit-risk relationship of mRNA-1273 is not affected by this report. This case was linked to MOD-2021-355915 (Parent-Child Link). This case was linked to MOD-2021-356130 (Patient Link). See case MOD-2021-355915 for details regarding the child case.; Sender's Comments: This case concerns a 25 year old breastfeeding female with no reported history who experienced the non-serious, unlisted AESI of Maternal exposure during breastfeeding and the event Pain in extremity the day of dose 1 of mRNA-1273. Re-challenge is positive for pain in extremity as it recurred with dose 2. Benefit-risk relationship of mRNA-1273 is not affected by this report.

Other Meds:

Current Illness:

ID: 1827199
Sex: M
Age: 66
State: NE

Vax Date: 10/01/2021
Onset Date: 10/02/2021
Rec V Date: 10/29/2021
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: Woke up with pillow sweat for the first days; A bad rash/Rash is getting worst; Rash is painful; Lymph node sore; Shingles; Rash under arm/ Then it got worst; Feeling very sick/he has been sick for 24 days since getting first dose; Pain when took a deep breath; Right hand was numb; Middle finger got really cold; Right elbow swollen; Knee swollen; Waves of nausea; Injection site was pretty sore/still lot of arm pain, feel where the injection was; Hard breathing; Vision started going down; No energy/Still no energy; Felt very bad; A headache/still having headache; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Felt very bad), DYSPNOEA (Hard breathing), VISUAL IMPAIRMENT (Vision started going down), ASTHENIA (No energy/Still no energy) and JOINT SWELLING (Right elbow swollen) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Rheumatoid arthritis, Arthritis and Gout, unspecified (Gout problems.). Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) and PREDNISONE for an unknown indication. On 01-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Oct-2021, the patient experienced FEELING ABNORMAL (Felt very bad) and HEADACHE (A headache/still having headache). On 03-Oct-2021, the patient experienced DYSPNOEA (Hard breathing), VISUAL IMPAIRMENT (Vision started going down) and ASTHENIA (No energy/Still no energy). On 04-Oct-2021, the patient experienced JOINT SWELLING (Right elbow swollen), JOINT SWELLING (Knee swollen), NAUSEA (Waves of nausea) and INJECTION SITE PAIN (Injection site was pretty sore/still lot of arm pain, feel where the injection was). On 05-Oct-2021, the patient experienced HYPOAESTHESIA (Right hand was numb) and PERIPHERAL COLDNESS (Middle finger got really cold). On 09-Oct-2021, the patient experienced PAINFUL RESPIRATION (Pain when took a deep breath). On 11-Oct-2021, the patient experienced MALAISE (Feeling very sick/he has been sick for 24 days since getting first dose). On 13-Oct-2021, the patient experienced RASH (Rash under arm/ Then it got worst). On 15-Oct-2021, the patient experienced HERPES ZOSTER (Shingles). On an unknown date, the patient experienced HYPERHIDROSIS (Woke up with pillow sweat for the first days), RASH (A bad rash/Rash is getting worst), RASH (Rash is painful) and LYMPH NODE PAIN (Lymph node sore). At the time of the report, FEELING ABNORMAL (Felt very bad), DYSPNOEA (Hard breathing), VISUAL IMPAIRMENT (Vision started going down), JOINT SWELLING (Right elbow swollen), JOINT SWELLING (Knee swollen), HYPOAESTHESIA (Right hand was numb), PERIPHERAL COLDNESS (Middle finger got really cold), PAINFUL RESPIRATION (Pain when took a deep breath), HERPES ZOSTER (Shingles), HYPERHIDROSIS (Woke up with pillow sweat for the first days), RASH (Rash is painful), RASH (Rash under arm/ Then it got worst) and LYMPH NODE PAIN (Lymph node sore) outcome was unknown and ASTHENIA (No energy/Still no energy), MALAISE (Feeling very sick/he has been sick for 24 days since getting first dose), RASH (A bad rash/Rash is getting worst), HEADACHE (A headache/still having headache), NAUSEA (Waves of nausea) and INJECTION SITE PAIN (Injection site was pretty sore/still lot of arm pain, feel where the injection was) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment medication were provided. 9-Oct-2021 - Patient experienced nausea 10-Oct-2021- Patient still had a little bit of nausea On 11-Oct-2021 the patient also experienced a spot on his back which he thought that he had a bug bite. Most recent FOLLOW-UP information incorporated above includes: On 22-Oct-2021: Reporter email ID updated, Current condition added, Outcome of event Feeling sick updated from unknown to Not recovered.

Other Meds: BABY ASPIRIN; PREDNISONE

Current Illness: Arthritis; Gout, unspecified (Gout problems.); Rheumatoid arthritis

ID: 1827200
Sex: F
Age: 69
State: GA

Vax Date: 01/14/2021
Onset Date: 09/21/2021
Rec V Date: 10/29/2021
Hospital:

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

Lab Data: Test Date: 20211015; Test Name: Alanine aminotransferase; Result Unstructured Data: 22 IU/L -normal; Test Date: 20211015; Test Name: Albumin globulin ratio; Result Unstructured Data: 1.6 - normal; Test Date: 20211015; Test Name: Aspartate aminotransferase; Result Unstructured Data: 22 IU/L - Normal; Test Date: 20211015; Test Name: Basophils; Result Unstructured Data: 0.1?10E3/uL - normal Normal range- 0 to 0?10E3/uL; Test Date: 20211015; Test Name: Blood Albumin; Result Unstructured Data: 4.5 g/dL -normal; Test Date: 20211015; Test Name: Alkaline phosphatase; Result Unstructured Data: 81 IU/L - Normal; Test Date: 20211015; Test Name: Blood bilirubin; Result Unstructured Data: 0.3 mg/dL -Normal; Test Date: 20211015; Test Name: Blood Calcium; Result Unstructured Data: 10.2 mg/dL -Normal; Test Date: 20211015; Test Name: Blood chloride; Result Unstructured Data: 103 mmol/L -normal; Test Date: 20211015; Test Name: Blood creatinine; Result Unstructured Data: 0.83 mg/dL; Test Date: 20211015; Test Name: Blood Glucose; Result Unstructured Data: 92 mg/dL-Normal; Test Date: 20211015; Test Name: Blood potassium; Result Unstructured Data: 5.5 mmol/L -High; Test Date: 20211015; Test Name: Blood urea; Result Unstructured Data: 9 mg/dL-Normal; Test Date: 20211015; Test Name: Blood urea nitrogen/creatinine ratio; Result Unstructured Data: Decreased; Test Date: 20211015; Test Name: Carbon Dioxide; Result Unstructured Data: 10.2 mg/dL -Normal; Test Date: 20211015; Test Name: C-reactive protien; Result Unstructured Data: 9mg/L - Normal; Test Date: 20211015; Test Name: Eosinophils; Result Unstructured Data: 0.3?10E3/uL- normal Normal range is 0?10E3/uL; Test Date: 20211015; Test Name: Total Globulin; Result Unstructured Data: 2.9 g/dL -Normal; Test Date: 20211015; Test Name: GFR; Result Unstructured Data: 72 mL/min/1.73 Normal range is > 59mL/min/1.73; Test Date: 20211015; Test Name: Hematocrit; Result Unstructured Data: 38.4%- Normal; Test Date: 20211015; Test Name: Haemoglobin; Result Unstructured Data: 12.6 g/dL -Normal; Test Date: 20211015; Test Name: hepatitis b surface antibody; Test Result: Negative ; Result Unstructured Data: Non reactive - inconsistent with immunity, less than 10mlU/ml.; Test Date: 20211015; Test Name: hepatitis b surface antigen; Test Result: Negative ; Result Unstructured Data: negative; Test Date: 20211015; Test Name: Hepatitis C antibody; Result Unstructured Data: <0.1 s/co ratio; Test Date: 20211015; Test Name: Hepatitis C virus; Test Result: Negative ; Result Unstructured Data: Negative; Test Date: 20211015; Test Name: granulocytes; Result Unstructured Data: 0.0?10E3/uL- normal; Test Date: 20211015; Test Name: Lymphocytes; Result Unstructured Data: 1.5?10E3/uL -Normal Normal range is 0-3?10E3/uL; Test Date: 20211015; Test Name: MCH; Result Unstructured Data: 31.7 pg- normal; Test Date: 20211015; Test Name: MCHC; Result Unstructured Data: 32.8 g/dL- normal; Test Date: 20211015; Test Name: MCV; Result Unstructured Data: 97 fL - normal; Test Date: 20211015; Test Name: Monocytes; Result Unstruc

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: Chills after the 3rd dose; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills after the 3rd dose) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050E21A, 012L20A and 030M20A) for COVID-19 vaccination. The patient's past medical history included Knee replacement on 27-Apr-2021. Concurrent medical conditions included Rheumatoid arthritis. Concomitant products included METHOTREXATE, ETHINYLESTRADIOL, NORETHISTERONE ACETATE (JUNEL) and ETANERCEPT (ENBREL) for Rheumatoid arthritis, UPADACITINIB (RINVOQ) for an unknown indication. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Sep-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced CHILLS (Chills after the 3rd dose). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Pain, at an unspecified dose and frequency; NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. On 22-Sep-2021, CHILLS (Chills after the 3rd dose) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Oct-2021, Alanine aminotransferase (0-32): 22 (normal) 22 IU/L -normal. On 15-Oct-2021, Albumin globulin ratio (1.2-2.2): 1.6 (normal) 1.6 - normal. On 15-Oct-2021, Aspartate aminotransferase (0-40): 22 (normal) 22 IU/L - Normal. On 15-Oct-2021, Basophil count: 0.1?10e3/ul (normal) 0.1?10E3/uL - normal Normal range- 0 to 0?10E3/uL. On 15-Oct-2021, Blood albumin (3.8-4.8): 4.5 (normal) 4.5 g/dL -normal. On 15-Oct-2021, Blood alkaline phosphatase (44-121): 81 (normal) 81 IU/L - Normal. On 15-Oct-2021, Blood bilirubin (0.0-1.2): 0.3 (normal) 0.3 mg/dL -Normal. On 15-Oct-2021, Blood calcium (8.7-10.3): 10.2 (normal) 10.2 mg/dL -Normal. On 15-Oct-2021, Blood chloride (96-106): 103 (normal) 103 mmol/L -normal. On 15-Oct-2021, Blood creatinine (0.57-1.00): 0.83 (normal) 0.83 mg/dL. On 15-Oct-2021, Blood glucose (65-99): 92 mg/dl (normal) 92 mg/dL-Normal. On 15-Oct-2021, Blood potassium (3.5-5.2): 5.5 (High) 5.5 mmol/L -High. On 15-Oct-2021, Blood urea (8-27): 9 mg/dl (normal) 9 mg/dL-Normal. On 15-Oct-2021, Blood urea nitrogen/creatinine ratio (12-28): 11 (Low) Decreased. On 15-Oct-2021, C-reactive protein (0.0-10.0): 9 mg/l (normal) 9mg/L - Normal. On 15-Oct-2021, Carbon dioxide (8.7-10.3): 10.2 (normal) 10.2 mg/dL -Normal. On 15-Oct-2021, Eosinophil count: 0.3?10e3/ul (normal) 0.3?10E3/uL- normal Normal range is 0?10E3/uL. On 15-Oct-2021, Globulin (1.5-4.5): 2.9 (normal) 2.9 g/dL -Normal. On 15-Oct-2021, Glomerular filtration rate: 72 (High) 72 mL/min/1.73 Normal range is > 59mL/min/1.73. On 15-Oct-2021, Haematocrit (34-46): 38.4 (normal) 38.4%- Normal. On 15-Oct-2021, Haemoglobin (11.1-15.9): 12.6 (normal) 12.6 g/dL -Normal. On 15-Oct-2021, Hepatitis B surface antibody: non reactive (Negative) Non reactive - inconsistent with immunity, less than 10mlU/ml.. On 15-Oct-2021, Hepatitis B surface antigen: negative (Negative) negative. On 15-Oct-2021, Hepatitis C antibody (0.0-0.9): <0.1 (normal) <0.1 s/co ratio. On 15-Oct-2021, Hepatitis C virus test: negative (Negative) Negative. On 15-Oct-2021, Immature granulocyte count (0.0-0.1): 0.0?10e3/ul (normal) 0.0?10E3/uL- normal. On 15-Oct-2021, Lymphocyte count: 1.5?10e3/ul (normal) 1.5?10E3/uL -Normal Normal range is 0-3?10E3/uL. On 15-Oct-2021, Mean cell haemoglobin (26.6-33.0): 31.7 (normal) 31.7 pg- normal. On 15-Oct-2021, Mean cell haemoglobin concentration (31-35): 32.8 (normal) 32.8 g/dL- normal. On 15-Oct-2021, Mean cell volume (79.0-97.0): 97 (normal) 97 fL - normal. On 15-Oct-2021, Monocyte count: 0.7?10e3/ul (normal) 0.7?10E3/uL- normal Normal range is 0-0?10E3/uL. On 15-Oct-2021, Neutrophil count: 3.5?10e3/ul (normal) 3.5?10E3/uL Normal range is 1-7?10E3/uL. On 15-Oct-2021, Platelet count: 373?10e3/ul (normal) 373?10E3/uL Normal range is 150-450?10E3/uL. On 15-Oct-2021, Protein total (6.0-8.5): 7.4 (normal) 7.4 g/dL - normal. On 15-Oct-2021, Red blood cell count: 3.98?10 (normal) 3.98?10E6/uL -Normal Normal range is 3.77-5.28?10E3/uL. On 15-Oct-2021, Red blood cell sedimentation rate normal (0-40): 8 (normal) 8 mm/hr - Normal. On 15-Oct-2021, SARS-CoV-2 antibody test: positive (Positive) >25000.0 U/mL, Positive. On 15-Oct-2021, Tuberculosis: negative (Negative) Negative. On 15-Oct-2021, White blood cell count: 6.0?10 e3/ul (normal) 6.0?10 E3/uL -normal Normal range is 3.4-10.8?10E3/uL. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Reported in a F/U , patient stated that she had positive effect of Moderna COVID-19 vaccination on RHEUMATOID ARTHRITIS as she have been able to discontinue weekly injection of 100cc of methotrexate and a daily Rinvoc tablet and controlling her pain level with Advil and/or Aleve with an occasional Tylenol. Other lab data includes on 15-Oct-2021 Quantiferon Tb Ag 0.12IU/mL, Quantiferon Tb2 Ag value is 0.07IU/mL, Quantiferon Nil value 0.06 IU/mL, Quantiferon mitogen value 7.77 IU/mL, Quantieron TB gold was negative. GFRMDRD Non Af Amer (> 59 mL/min/1.73) : 72ml/min/1.73: (normal) GFRMDRD Af Amer (> 59 mL/min/1.73) : 83 ml/min/1.73: (normal) neutrophils relative 58% lymphocytes relative 25% monocytes relative 12% eosinophils relative 4% basophils relative 1% immature granulocytes 0% This case was linked to MOD-2021-232463 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 21-Oct-2021: Source document contains no new information. On 21-Oct-2021: Captured all the lab details into lab data as well as I-narrative supplement.

Other Meds: METHOTREXATE; JUNEL; ENBREL; RINVOQ

Current Illness: Rheumatoid arthritis

ID: 1827201
Sex: F
Age:
State: FL

Vax Date: 01/01/2021
Onset Date:
Rec V Date: 10/29/2021
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: Eye infection; This spontaneous case was reported by a consumer and describes the occurrence of EYE INFECTION (Eye infection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EYE INFECTION (Eye infection). The patient was treated with DEXAMETHASONE, TOBRAMYCIN (TOBRAMYCIN + DEXAMETHASONE) for Eye infection, at an unspecified dose and frequency. At the time of the report, EYE INFECTION (Eye infection) outcome was unknown. Not Provided No concomitant medication information was provided. Most recent FOLLOW-UP information incorporated above includes: On 22-Oct-2021: Follow up received included non significant information.

Other Meds:

Current Illness:

ID: 1827202
Sex: M
Age:
State: GA

Vax Date: 10/20/2021
Onset Date: 10/20/2021
Rec V Date: 10/29/2021
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: The patient received a 4 day expired vaccine.; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (The patient received a 4 day expired vaccine.) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination. No Medical History information was reported. On 20-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (The patient received a 4 day expired vaccine.). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (The patient received a 4 day expired vaccine.) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant and treatment information were reported by the reporter

Other Meds:

Current Illness:

ID: 1827203
Sex: F
Age:
State: FL

Vax Date: 08/26/2021
Onset Date: 08/28/2021
Rec V Date: 10/29/2021
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: Strokes; Blood clots; Myocarditis were diagnosed; Pericarditis were diagnosed; Heart blocks; Started with arrithmias 5 days after; Felt sick like flu 2 days after; This spontaneous case was reported by a consumer and describes the occurrence of ARRHYTHMIA (Started with arrithmias 5 days after), CEREBROVASCULAR ACCIDENT (Strokes), THROMBOSIS (Blood clots), MYOCARDITIS (Myocarditis were diagnosed) and PERICARDITIS (Pericarditis were diagnosed) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 26-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Aug-2021, the patient experienced INFLUENZA LIKE ILLNESS (Felt sick like flu 2 days after). On 31-Aug-2021, the patient experienced ARRHYTHMIA (Started with arrithmias 5 days after) (seriousness criterion medically significant). On an unknown date, the patient experienced CEREBROVASCULAR ACCIDENT (Strokes) (seriousness criterion medically significant), THROMBOSIS (Blood clots) (seriousness criterion medically significant), MYOCARDITIS (Myocarditis were diagnosed) (seriousness criterion medically significant), PERICARDITIS (Pericarditis were diagnosed) (seriousness criterion medically significant) and ATRIOVENTRICULAR BLOCK (Heart blocks). At the time of the report, ARRHYTHMIA (Started with arrithmias 5 days after), CEREBROVASCULAR ACCIDENT (Strokes), THROMBOSIS (Blood clots), MYOCARDITIS (Myocarditis were diagnosed), PERICARDITIS (Pericarditis were diagnosed), ATRIOVENTRICULAR BLOCK (Heart blocks) and INFLUENZA LIKE ILLNESS (Felt sick like flu 2 days after) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication were reported. Treatment medication included Beta-blockers. The patient used a heart monitor for 3 weeks. Company comment: This case concerns a 43 year-old female patient with no reported medical history, who experienced the expected serious events of Myocarditis (AESI) and Pericarditis (AESI) and the unexpected serious events of Cerebrovascular accident (AESI), Arrhythmia (AESI), and Thrombosis. The event of Arrhythmia occurred 5 days after the first dose of mRNA-1273 vaccine and the other events occurred an unknown number of days after the first dose. Details of clinical presentation, diagnostic criteria, and clinical course for the events were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 43 year-old female patient with no reported medical history, who experienced the expected serious events of Myocarditis (AESI) and Pericarditis (AESI) and the unexpected serious events of Cerebrovascular accident (AESI), Arrhythmia (AESI), and Thrombosis. The event of Arrhythmia occurred 5 days after the first dose of mRNA-1273 vaccine and the other events occurred an unknown number of days after the first dose. Details of clinical presentation, diagnostic criteria, and clinical course for the events were not provided. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.

Other Meds:

Current Illness:

ID: 1827204
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/29/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: Problem, Large reaction; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Problem, Large reaction) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Problem, Large reaction). At the time of the report, VACCINATION COMPLICATION (Problem, Large reaction) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication was not reported. Treatment information was not reported.

Other Meds:

Current Illness:

ID: 1827205
Sex: M
Age: 49
State: CO

Vax Date: 09/18/2021
Onset Date: 10/01/2021
Rec V Date: 10/29/2021
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: Tinnitus,Ringing in the ears Severe enough, ringingin ears just gotten worsen, its driving me insane; Typical Flu like symptoms; Cold sweats; Body aches; Cannot sleep at night Keeps him awake,Can't sleepwithout pills even then its very little; it had an drastic effect on him as he can't run his business and function as business man and has an effect on him with his family and life in general; Can't rest; I can't hardly function; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Cannot sleep at night Keeps him awake,Can't sleepwithout pills even then its very little), TINNITUS (Tinnitus,Ringing in the ears Severe enough, ringingin ears just gotten worsen, its driving me insane), IMPAIRED WORK ABILITY (it had an drastic effect on him as he can't run his business and function as business man and has an effect on him with his family and life in general), RESTLESSNESS (Can't rest) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I can't hardly function) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A and 035C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 18-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In October 2021, the patient experienced IMPAIRED WORK ABILITY (it had an drastic effect on him as he can't run his business and function as business man and has an effect on him with his family and life in general), RESTLESSNESS (Can't rest) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I can't hardly function). On 16-Oct-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INSOMNIA (Cannot sleep at night Keeps him awake,Can't sleepwithout pills even then its very little). On 17-Oct-2021, the patient experienced TINNITUS (Tinnitus,Ringing in the ears Severe enough, ringingin ears just gotten worsen, its driving me insane), INFLUENZA LIKE ILLNESS (Typical Flu like symptoms), COLD SWEAT (Cold sweats) and MYALGIA (Body aches). The patient was treated with ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL, SALICYLAMIDE (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL;SALICYLAMIDE]) at a dose of 1 dosage form; IBUPROFEN at a dose of 1 dosage form and ACETAMINOPHEN at a dose of 1 dosage form. At the time of the report, INSOMNIA (Cannot sleep at night Keeps him awake,Can't sleepwithout pills even then its very little), TINNITUS (Tinnitus,Ringing in the ears Severe enough, ringingin ears just gotten worsen, its driving me insane), IMPAIRED WORK ABILITY (it had an drastic effect on him as he can't run his business and function as business man and has an effect on him with his family and life in general), RESTLESSNESS (Can't rest) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (I can't hardly function) had not resolved and INFLUENZA LIKE ILLNESS (Typical Flu like symptoms), COLD SWEAT (Cold sweats) and MYALGIA (Body aches) was resolving. No concomitant medication was reported. Patient reported ringing in ears has just gotten worse ha s driving him insane. The patient also stated that he is starting to feel better but stated that he can't sleep, can't rest and is sleep deprived for days. Most recent FOLLOW-UP information incorporated above includes: On 25-Oct-2021: Follow up received on 25-oct-2021 contains significant information events were added. Description to be coded is changed to MedDRA terms

Other Meds:

Current Illness:

ID: 1827206
Sex: F
Age: 55
State: NM

Vax Date: 03/25/2021
Onset Date: 10/01/2021
Rec V Date: 10/29/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: Body temperature; Result Unstructured Data: Normal; Comments: Normal

Allergies:

Symptom List: Nausea

Symptoms: She feels very hot, but does not have temperature; wrist of her left arm was swollen; wrist of her left arm was red,right hand's knuckles were red; veins in both hands were protruding; sore throat on the right side; feels as if the head were heavy; neck is achy; wrist of her left arm was sore; Saturday she slept all day; headache (coming and going every 6 hours); left arm was swollen (the size of a base ball around the injection area); sore to the touch it was of the size of a base ball around the injection area; lymph nodes they were sore to the touch; got third dose and is not immunocompromised; the lymph nodes under her arm swelled up to the size of a marble,lymph nodes in her neck swelled up,lymph nodes between her legs (crotch area) swelled up; severe flu like symptoms after third dose; left arm was hard; before 17oct21 her voice started to sound different; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (Saturday she slept all day), HEAD DISCOMFORT (feels as if the head were heavy), NECK PAIN (neck is achy), FEELING HOT (She feels very hot, but does not have temperature) and JOINT SWELLING (wrist of her left arm was swollen) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A, 044B21A and 045A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 in December 2020. Previously administered products included for an unreported indication: FLU VACCINE VII on 04-Oct-2021. On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Oct-2021, the patient experienced LYMPHADENOPATHY (the lymph nodes under her arm swelled up to the size of a marble,lymph nodes in her neck swelled up,lymph nodes between her legs (crotch area) swelled up), INFLUENZA LIKE ILLNESS (severe flu like symptoms after third dose), MASS (left arm was hard), VACCINATION SITE SWELLING (left arm was swollen (the size of a base ball around the injection area)), VACCINATION SITE PAIN (sore to the touch it was of the size of a base ball around the injection area), LYMPH NODE PAIN (lymph nodes they were sore to the touch) and EXTRA DOSE ADMINISTERED (got third dose and is not immunocompromised). In October 2021, the patient experienced DYSPHONIA (before 17oct21 her voice started to sound different). On 16-Oct-2021, the patient experienced SOMNOLENCE (Saturday she slept all day) and HEADACHE (headache (coming and going every 6 hours)). On 17-Oct-2021, the patient experienced HEAD DISCOMFORT (feels as if the head were heavy), NECK PAIN (neck is achy), JOINT SWELLING (wrist of her left arm was swollen), ERYTHEMA (wrist of her left arm was red,right hand's knuckles were red), VEIN DISORDER (veins in both hands were protruding), OROPHARYNGEAL PAIN (sore throat on the right side) and ARTHRALGIA (wrist of her left arm was sore). On 21-Oct-2021, the patient experienced FEELING HOT (She feels very hot, but does not have temperature). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Headache, at an unspecified dose and frequency. On 15-Oct-2021, EXTRA DOSE ADMINISTERED (got third dose and is not immunocompromised) had resolved. On 19-Oct-2021, INFLUENZA LIKE ILLNESS (severe flu like symptoms after third dose) and LYMPH NODE PAIN (lymph nodes they were sore to the touch) had resolved. On 20-Oct-2021, LYMPHADENOPATHY (the lymph nodes under her arm swelled up to the size of a marble,lymph nodes in her neck swelled up,lymph nodes between her legs (crotch area) swelled up) outcome was unknown, MASS (left arm was hard), VACCINATION SITE SWELLING (left arm was swollen (the size of a base ball around the injection area)) and VACCINATION SITE PAIN (sore to the touch it was of the size of a base ball around the injection area) had resolved. At the time of the report, SOMNOLENCE (Saturday she slept all day), HEAD DISCOMFORT (feels as if the head were heavy), NECK PAIN (neck is achy), FEELING HOT (She feels very hot, but does not have temperature), JOINT SWELLING (wrist of her left arm was swollen), ERYTHEMA (wrist of her left arm was red,right hand's knuckles were red), VEIN DISORDER (veins in both hands were protruding), OROPHARYNGEAL PAIN (sore throat on the right side), DYSPHONIA (before 17oct21 her voice started to sound different), HEADACHE (headache (coming and going every 6 hours)) and ARTHRALGIA (wrist of her left arm was sore) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature (97.6-99.6): 98.4 (normal) Normal. No concomitant medications were reported. This case was linked to MOD-2021-358827 (Patient Link).

Other Meds:

Current Illness:

ID: 1827207
Sex: F
Age: 30
State: WI

Vax Date: 03/11/2021
Onset Date: 10/01/2021
Rec V Date: 10/29/2021
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: short term memory; don't remember anything it; hit her head; syncope, it shuts down her organ; vasovagal response; blacked out; Fell to the floor; leg pain; This spontaneous case was reported by a consumer and describes the occurrence of LOSS OF CONSCIOUSNESS (blacked out) and SYNCOPE (syncope, it shuts down her organ) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In October 2021, the patient experienced FALL (Fell to the floor). October 2021, the patient experienced PAIN IN EXTREMITY (leg pain). On 18-Oct-2021, the patient experienced LOSS OF CONSCIOUSNESS (blacked out) (seriousness criterion medically significant). On an unknown date, the patient experienced SYNCOPE (syncope, it shuts down her organ) (seriousness criterion medically significant), PRESYNCOPE (vasovagal response), AMNESIA (short term memory), MEMORY IMPAIRMENT (don't remember anything it) and HEAD INJURY (hit her head). At the time of the report, LOSS OF CONSCIOUSNESS (blacked out), SYNCOPE (syncope, it shuts down her organ), PRESYNCOPE (vasovagal response), FALL (Fell to the floor), AMNESIA (short term memory), MEMORY IMPAIRMENT (don't remember anything it), HEAD INJURY (hit her head) and PAIN IN EXTREMITY (leg pain) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment medications included were, patient was taking Antibiotic, Blood thinners and Steroids. Patient states that same events happened after the first dose and again after the second dose. Company comment: This case concerns a 31-year-old female patient with no reported medical history who experienced the expected event of loss of consciousness and syncope. The event occurred following an unspecified date after the third dose of the mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was unknown as details pertaining to first and second doses were not disclosed. Causality assessment with product use was not provided by the reporter. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Loss of consciousness and syncope are both medically important events. This case was linked to MOD-2021-043122, MOD-2021-074920 (Patient Link).; Sender's Comments: This case concerns a 31-year-old female patient with no reported medical history who experienced the expected event of loss of consciousness and syncope. The event occurred following an unspecified date after the third dose of the mRNA-1273 (Moderna COVID-19 Vaccine). The rechallenge was unknown as details pertaining to first and second doses were not disclosed. Causality assessment with product use was not provided by the reporter. The benefit-risk relationship of mRNA-1273 Vaccine is not affected by this report. Loss of consciousness and syncope are both medically important events.

Other Meds:

Current Illness:

ID: 1827208
Sex: M
Age: 90
State: MI

Vax Date: 10/01/2021
Onset Date: 10/01/2021
Rec V Date: 10/29/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: received third dose from vial refrigerated for more than 30 days; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received third dose from vial refrigerated for more than 30 days) in a 90-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 01-Oct-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received third dose from vial refrigerated for more than 30 days). On 01-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received third dose from vial refrigerated for more than 30 days) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Reporter reported that the vaccine was defrosted in 30-Aug-2021. Date the vial was initially stored in the refrigerator was 30-Aug-2021. The reporter stated that it is unknown if patient is immunocompromised. This case was linked to MOD-2021-358921, MOD-2021-358773 (Patient Link).

Other Meds:

Current Illness:

ID: 1827209
Sex: F
Age: 65
State: PA

Vax Date: 01/29/2021
Onset Date: 07/01/2021
Rec V Date: 10/29/2021
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: they mention the texture of their hair is different, it feels thinner and dryer; extreme fatigue; Around July2021 they noticed a lot of hair loss, their hair was falling out more than normal/ hair loss (diverse); This spontaneous case was reported by a consumer and describes the occurrence of ALOPECIA (Around July2021 they noticed a lot of hair loss, their hair was falling out more than normal/ hair loss (diverse)), HAIR TEXTURE ABNORMAL (they mention the texture of their hair is different, it feels thinner and dryer) and FATIGUE (extreme fatigue) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 012M20A) for COVID-19 vaccination. No medical history was provided by the reporter. The patient's past medical history included AFib (no afib in more than a year) in June 2019. Previously administered products included for Product used for unknown indication: Shingrix from 10-Nov-2020 to 03-May-2021; for Pneumonia: Previnar (2nd shot) on 09-Dec-2020. Past adverse reactions to the above products included No adverse event with Previnar and Shingrix. Concurrent medical conditions included Penicillin allergy, Sulfonamide allergy, Allergy to antibiotic (Azithromycin), Drug allergy (Prednisone), Allergy to animal (Cat), Dust allergy, Sjoegren's syndrome (extreme fatigue) since November 2011, Brugada syndrome (extreme fatigue) since November 2009, Osteoarthritis since November 2011, Hypertension since January 2008, Hypothyroidism and High cholesterol. Concomitant products included ROSUVASTATIN CALCIUM (CRESTOR) from 01-May-2021 to an unknown date for High cholesterol, OLMESARTAN MEDOXOMIL (BENICAR) from 2017 to an unknown date for Hypertension, LEVOTHYROXINE SODIUM (SYNTHROID) from 1990 to an unknown date for Hypothyroidism, HYDROXYCHLOROQUINE SULFATE (PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]) from 2011 to an unknown date for Sjoegren's syndrome, FLUCONAZOLE (FLUCONAL), CICLOSPORIN (RESTASIS) and ALUMINIUM HYDROXIDE GEL, DRIED, MAGNESIUM CARBONATE (PEPCID [ALUMINIUM HYDROXIDE GEL, DRIED;MAGNESIUM CARBONATE]) for an unknown indication. On 29-Jan-2021 at 1:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021 at 2:40 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Jul-2021, the patient experienced ALOPECIA (Around July2021 they noticed a lot of hair loss, their hair was falling out more than normal/ hair loss (diverse)) and FATIGUE (extreme fatigue). On an unknown date, the patient experienced HAIR TEXTURE ABNORMAL (they mention the texture of their hair is different, it feels thinner and dryer). At the time of the report, ALOPECIA (Around July2021 they noticed a lot of hair loss, their hair was falling out more than normal/ hair loss (diverse)), HAIR TEXTURE ABNORMAL (they mention the texture of their hair is different, it feels thinner and dryer) and FATIGUE (extreme fatigue) had not resolved. Acute illnesses at the time of vaccination and up to one month before was reported as none. About 5 months later after vaccination, the patient noticed that she was losing more hair than normal. When she washed her hair, lots of hair was on her hands. The hair loss was diverse (no bald spots). The only time that ever happened was 30plus years ago, when she was diagnosed with hypothyroidism. She mentioned the hair loss to her PCP in mid-July along with extreme fatigue, and was seeing for a cosmetic treatment. The dermatologist examined and said that the hair loss should subside in about 3 months that would be by the end of September. She noticed slowing of the hair loss but her usual full head of healthy hair was thin, limp and very dry. The PCP ran a battery of tests, and did not had an explanation. In the past the patient had these condition years ago, low thyroid and after surgery/anesthesia and sjogrens, hypothyroid. The patient had flu shot on 29-Sep-2021. The also had supplements as other concomitant medication. This case was linked to MOD-2021-358708 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 21-Oct-2021: Follow up received on 21-OCT-2021 Updated Patient (added medical history, race, ethnic origin), Products (added indication, start date of concomitant medication), Event (updated outcome of the events, onset date) and narrative.

Other Meds: BENICAR; SYNTHROID; FLUCONAL; RESTASIS; PEPCID [ALUMINIUM HYDROXIDE GEL, DRIED;MAGNESIUM CARBONATE]; CRESTOR; PLAQUENIL [HYDROXYCHLOROQUINE SULFATE]

Current Illness: Allergy to animal (Cat); Allergy to antibiotic (Azithromycin); Brugada syndrome (extreme fatigue); Drug allergy (Prednisone); Dust allergy; High cholesterol; Hypertension; Hypothyroidism; Osteoarthritis; Penicillin allergy; Sjoegren's syndrome (extreme fatigue); Sulfonamide allergy

ID: 1827210
Sex: M
Age: 57
State: CA

Vax Date: 10/17/2021
Onset Date: 10/17/2021
Rec V Date: 10/29/2021
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: Pharmacist called in to report patients received an expired dose of the Moderna vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Pharmacist called in to report patients received an expired dose of the Moderna vaccine) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination. No Medical History information was reported. On 17-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Pharmacist called in to report patients received an expired dose of the Moderna vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Pharmacist called in to report patients received an expired dose of the Moderna vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not reported.

Other Meds:

Current Illness:

ID: 1827211
Sex: U
Age:
State: IA

Vax Date: 10/19/2021
Onset Date: 10/19/2021
Rec V Date: 10/29/2021
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: 2 doses that expired 13Oct2021 were administered; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (2 doses that expired 13Oct2021 were administered) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination. No Medical History information was reported. On 19-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (2 doses that expired 13Oct2021 were administered). On 19-Oct-2021, EXPIRED PRODUCT ADMINISTERED (2 doses that expired 13Oct2021 were administered) 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 use was reported.

Other Meds:

Current Illness:

ID: 1827212
Sex: M
Age: 47
State: NY

Vax Date: 07/31/2021
Onset Date: 07/31/2021
Rec V Date: 10/29/2021
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: left arm started to tingle/tingling in his lower leg and foot/ felt pins and needles; The next day, his left hand was shaking; shooting pain every time he took a step; burning sensation over part of his chest/his ribs were burning/his left leg was burning; This spontaneous case was reported by a physician and describes the occurrence of PARAESTHESIA (left arm started to tingle/tingling in his lower leg and foot/ felt pins and needles), BURNING SENSATION (burning sensation over part of his chest/his ribs were burning/his left leg was burning), TREMOR (The next day, his left hand was shaking) and PAIN (shooting pain every time he took a step) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Cervical disc disease. On 31-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jul-2021, the patient experienced BURNING SENSATION (burning sensation over part of his chest/his ribs were burning/his left leg was burning). On 01-Aug-2021, the patient experienced PARAESTHESIA (left arm started to tingle/tingling in his lower leg and foot/ felt pins and needles), TREMOR (The next day, his left hand was shaking) and PAIN (shooting pain every time he took a step). At the time of the report, PARAESTHESIA (left arm started to tingle/tingling in his lower leg and foot/ felt pins and needles), BURNING SENSATION (burning sensation over part of his chest/his ribs were burning/his left leg was burning), TREMOR (The next day, his left hand was shaking) and PAIN (shooting pain every time he took a step) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were reported. Lab data included CT scan of the brain, ultrasound of his leg, and bloodwork were normal. It was reported that his complete neurological exam on 20-Oct-2021 was normal. The physician reported that the patient went to the emergency room on 02-Aug-2021 but was not hospitalized. Neurological exam was normal including light touch, pin prick, vibratory sense, simultaneous stimulation and temperature . Most recent FOLLOW-UP information incorporated above includes: On 21-Oct-2021: Significant follow up received contain Patient demographic details added, Medical history added, events outcome updated, event verbatim added, lab data added.

Other Meds:

Current Illness:

ID: 1827213
Sex: F
Age: 37
State: CA

Vax Date: 10/20/2021
Onset Date: 10/20/2021
Rec V Date: 10/29/2021
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: receiving a dose of an expired vaccine; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (receiving a dose of an expired vaccine) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016c21a) for COVID-19 vaccination. No Medical History information was reported. On 20-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (receiving a dose of an expired vaccine). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (receiving a dose of an expired vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was mentioned. No treatment medication was mentioned.

Other Meds:

Current Illness:

ID: 1827214
Sex: M
Age:
State: NJ

Vax Date: 10/16/2021
Onset Date: 10/16/2021
Rec V Date: 10/29/2021
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: Patient administered an expired vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient administered an expired vaccine) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination. No Medical History information was reported. On 16-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient administered an expired vaccine). On 16-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient administered an expired vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not provided. Treatment information was not provided. Reporter reported that Vaccine moved to refrigeration on 15Oct2021 and Used by13Oct2021 This case was linked to MOD-2021-013872 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 21-Oct-2021: Follow up document included no new information.

Other Meds:

Current Illness:

ID: 1827215
Sex: M
Age: 67
State: FL

Vax Date: 03/16/2021
Onset Date: 03/01/2021
Rec V Date: 10/29/2021
Hospital: Y

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

Lab Data: Test Name: Blood pressure; Result Unstructured Data: blood pressure was lowered to the point where he almost died

Allergies:

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

Symptoms: dizzy; shortness of breath; slurred speech; medication they gave him to counter the low blood pressure burned his toes and fingers; Blood pressure low; first dose > 25 days ago; couldn't go to work/obviously can't work; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (dizzy), DYSPNOEA (shortness of breath), DYSARTHRIA (slurred speech), ADVERSE DRUG REACTION (medication they gave him to counter the low blood pressure burned his toes and fingers) and HYPOTENSION (Blood pressure low) in a 67-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced DYSPNOEA (shortness of breath) (seriousness criteria hospitalization prolonged and disability), DYSARTHRIA (slurred speech) (seriousness criteria hospitalization prolonged and disability) and IMPAIRED WORK ABILITY (couldn't go to work/obviously can't work). On 16-Mar-2021, the patient experienced DIZZINESS (dizzy) (seriousness criteria hospitalization prolonged and disability). In 2021, the patient experienced ADVERSE DRUG REACTION (medication they gave him to counter the low blood pressure burned his toes and fingers) (seriousness criteria hospitalization prolonged and disability). On an unknown date, the patient experienced HYPOTENSION (Blood pressure low) (seriousness criterion medically significant) and PRODUCT DOSE OMISSION ISSUE (first dose > 25 days ago). At the time of the report, DIZZINESS (dizzy), DYSPNOEA (shortness of breath), DYSARTHRIA (slurred speech), ADVERSE DRUG REACTION (medication they gave him to counter the low blood pressure burned his toes and fingers), HYPOTENSION (Blood pressure low) and IMPAIRED WORK ABILITY (couldn't go to work/obviously can't work) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (first dose > 25 days ago) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: low (Low) blood pressure was lowered to the point where he almost died. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The patient states he is trying to deal with the injury compensation program.he remained in hospital for 5 months. His blood pressure was lowered to the point where he almost died. They amputated both of his feet and the all fingers on his right hand because the medication they gave him to counter the low blood pressure burned his toes and fingers. He states there was a similar case from a lady. She had both hands and feet amputated. He states he was fully healthy before he got the shot. Obviously now he can't work. No concomitant medications were reported. No treatment information was provided. Company comment: This case concerns Product dose omission issue in a 67 year-old male patient with no reported medical history, who experienced the unexpected serious events of Dizziness, Dyspnoea, Dysarthria, Hypotension, and Adverse drug reaction. The event of Dizziness occurred on the same day as the first dose of mRNA-1273 vaccine, and the other events occurred an unknown number of days after the first dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns Product dose omission issue in a 67 year-old male patient with no reported medical history, who experienced the unexpected serious events of Dizziness, Dyspnoea, Dysarthria, Hypotension, and Adverse drug reaction. The event of Dizziness occurred on the same day as the first dose of mRNA-1273 vaccine, and the other events occurred an unknown number of days after the first dose. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.

Other Meds:

Current Illness:

ID: 1827216
Sex: F
Age: 63
State: OH

Vax Date: 03/11/2021
Onset Date:
Rec V Date: 10/29/2021
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: band-aid mark on the injection site (right arm); This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (band-aid mark on the injection site (right arm)) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. No Medical History information was reported. On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (band-aid mark on the injection site (right arm)). At the time of the report, VACCINATION SITE REACTION (band-aid mark on the injection site (right arm)) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was mentioned. No treatment medication was mentioned. This case was linked to MOD-2021-358960 (Patient Link).

Other Meds:

Current Illness:

ID: 1827217
Sex: M
Age: 60
State: MI

Vax Date: 04/05/2021
Onset Date: 04/01/2021
Rec V Date: 10/29/2021
Hospital:

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

Lab Data: Test Date: 202105; Test Name: blood pressure; Result Unstructured Data: increased; Test Date: 202106; Test Name: blood pressure; Result Unstructured Data: increased; Test Date: 202105; Test Name: heart rate; Result Unstructured Data: increased; Test Date: 202106; Test Name: heart rate; Result Unstructured Data: increased

Allergies:

Symptom List: Pain in extremity

Symptoms: had some kidney stones removed; heart rate increased significantly; body pain; joint pain; sore arm; blood pressure increased significantly; This spontaneous case was reported by a consumer and describes the occurrence of NEPHROLITHIASIS (had some kidney stones removed) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 05-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced PAIN IN EXTREMITY (sore arm), MYALGIA (body pain) and ARTHRALGIA (joint pain). In May 2021, the patient experienced HEART RATE INCREASED (heart rate increased significantly). In 2021, the patient experienced HYPERTENSION (blood pressure increased significantly). On an unknown date, the patient experienced NEPHROLITHIASIS (had some kidney stones removed) (seriousness criterion medically significant). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency and PARACETAMOL (MINAMOL) at an unspecified dose and frequency. At the time of the report, NEPHROLITHIASIS (had some kidney stones removed), HYPERTENSION (blood pressure increased significantly), PAIN IN EXTREMITY (sore arm), HEART RATE INCREASED (heart rate increased significantly), MYALGIA (body pain) and ARTHRALGIA (joint pain) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In May 2021, Blood pressure measurement: increased (High) increased. In May 2021, Heart rate: increased (High) increased. In June 2021, Blood pressure measurement: increased (High) increased. In June 2021, Heart rate: increased (High) increased. The patient reported that, they are a high risk patient.. The Patient 1 stated that on 01Nov2021 they will be going to the hospital for a procedure on their kidneys. No concomitant medications were provided by the reporter. Company Comment: This case concerns a 61-year-old, male patient with no relevant medical history, who experienced the serious unexpected event of Nephrolithiasis. The event occurred after unspecified time after the second dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as the event occurred after the second dose. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report. This case was linked to MOD-2021-055014 (Patient Link).; Sender's Comments: This case concerns a 61-year-old, male patient with no relevant medical history, who experienced the serious unexpected event of Nephrolithiasis. The event occurred after unspecified time after the second dose of Moderna COVID-19 Vaccine. The rechallenge was not applicable as the event occurred after the second dose. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.

Other Meds:

Current Illness:

ID: 1827218
Sex: M
Age: 64
State: WA

Vax Date: 10/18/2021
Onset Date: 10/18/2021
Rec V Date: 10/29/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: One patient developed the regular mild flu-like symptoms; Patient received vaccine that may not have an extended expiration date; This spontaneous case was reported by a physician and describes the occurrence of INFLUENZA LIKE ILLNESS (One patient developed the regular mild flu-like symptoms) and EXPIRED PRODUCT ADMINISTERED (Patient received vaccine that may not have an extended expiration date) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) 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) (Intramuscular) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received vaccine that may not have an extended expiration date). On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (One patient developed the regular mild flu-like symptoms). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient received vaccine that may not have an extended expiration date) had resolved. At the time of the report, INFLUENZA LIKE ILLNESS (One patient developed the regular mild flu-like symptoms) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant and Treatment was not specified. vial was removed from the freezer 40 minutes before administration. Most recent FOLLOW-UP information incorporated above includes: On 25-Oct-2021: The follow up received on 25Oct2021 contains new event of flu-like symptoms

Other Meds:

Current Illness:

ID: 1827219
Sex: M
Age: 59
State: CO

Vax Date: 09/24/2021
Onset Date:
Rec V Date: 10/29/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Dose administered after a temperature excursion; Poor quality product administered; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 034C21A and 035C21A) for COVID-19 vaccination. No Medical History information was reported. On 24-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered). At the time of the report, PRODUCT TEMPERATURE EXCURSION ISSUE (Dose administered after a temperature excursion) and POOR QUALITY PRODUCT ADMINISTERED (Poor quality product administered) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. It was reported that the reporter had a temperature excursion of about 20 doses of Moderna, it got down to 32?F, then went up to 34?F, then up to 36?F, then up to 37?F over the course of an hour. The doses were put in a portable transport unit and left at 32? and the transport unit was not prepared for enough time to maintain the temperature. Expiration date of the dose administered was on 30-Oct-2021. No concomitant medication was reported. No treatment information was reported.

Other Meds:

Current Illness:

ID: 1827220
Sex: U
Age:
State: TX

Vax Date: 10/20/2021
Onset Date: 10/20/2021
Rec V Date: 10/29/2021
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: Expired doses were administered on 20Oct2021; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired doses were administered on 20Oct2021) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination. No Medical History information was reported. On 20-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired doses were administered on 20Oct2021). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired doses were administered on 20Oct2021) 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. 3 doses were administered after manufacturer date of expiry. On 19-Oct-2021, the vial was initially stored in the refrigerator. The vial did not undergo any temperature excursions. HCP declined to report AE. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1827221
Sex: F
Age:
State: OH

Vax Date: 07/07/2021
Onset Date: 07/07/2021
Rec V Date: 10/29/2021
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: Fatigue day 3 till now; Breast tenderness 2 days from shot date; Dizziness and nausea day 2 after injection/ feeling light headed day 2 till now; Dizziness and nausea day 2 after injection; Eye pain; Headaches come and go from day 2 till today; Severe arm pain in left arm around injection/ 2 hrs after injection lasting 3 days; This is a spontaneous report from a non-contactable consumer, the patient. A 36-year-old non-pregnant female patient received first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0198) via an unspecified route of administration in the left arm on 07Jul2021 at 12:00 (at the age of 36-years-old) as a single dose for COVID-19 immunisation. Medical history was not reported. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included colecalciferol (VIT D3), cyanocobalamin (B12), meclozine hydrochloride (BONINE), cetirizine hydrochloride (ZYRTEC), birth control and sambucus nigra (ELDERBERRY) for an unknown indication from an unknown date and unknown if ongoing. The patient did not receive any other vaccine within four weeks prior to the COVID-19 vaccine. On 07Jul2021 at 14:00, the patient experienced severe arm pain in left arm around injection/2 hrs after injection lasting 3 days. On 09Jul2021, the patient experienced breast tenderness 2 days from shot date, dizziness and nausea day 2 after injection and continued till the time of reporting 18Jul2021, feeling light headed day 2 till the time of reporting, eye pain and headaches come and go from day 2 till the time of reporting. On 10Jul2021, the patient experienced fatigue day 3 till the time of reporting. The events did not result in doctor or other healthcare professional office/clinic visit, and emergency room/department or urgent care. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event severe arm pain in left arm around injection/ 2 hrs after injection lasting 3 days was resolved on 10Jul2021, after the duration of 3 days whereas breast tenderness, dizziness and nausea/feeling light headed, eye pain, headaches and fatigue was not resolved at the time of this report. No follow-up attempts are possible. No further information is expected.

Other Meds: VIT D3; VITAMIN B 12 [CYANOCOBALAMIN]; BONINE; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; ELDERBERRY [SAMBUCUS NIGRA]

Current Illness:

ID: 1827222
Sex: M
Age:
State: AL

Vax Date: 06/01/2021
Onset Date: 06/22/2021
Rec V Date: 10/29/2021
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: Shoulder pain; Hand pain; Arm pain; Knee pain; Foot pain; Stiffness; This is a spontaneous report from a contactable consumer, the patient. A 68-year-old male patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the right arm on 01Jun2021 at 00:00 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. Medical history included osteoarthritis which is ongoing and also asthma, high cholesterol, osteoarthritis, high blood pressure (BPH), COVID-19 and known allergy of shellfish. Prior to the vaccination, the patient was diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. Concomitant medications included fluticasone furoate, vilanterol trifenatate (BREO ELLIPTA), morniflumate (FLOMAX) and acetylsalicylic acid (ASPIRIN); from an unknown start date for an unknown indication and unknown if ongoing. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8737) via an unspecified route of administration in the right arm on 10May2021 at 00:00 (at the age of 68-years-old) as a single dose for COVID-19 immunisation. On 22Jun2021 the patient experienced shoulder pain, hand pain, arm pain, knee pain, foot pain and stiffness. It was far more significant than any arthritis pain prior to that. The patient's osteoarthritis was in remission with no pain. The events did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of the events. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events shoulder pain, hand pain, arm pain, knee pain, foot pain and stiffness were not recovered at the time of this report.

Other Meds: BREO ELLIPTA; FLOMAX [MORNIFLUMATE]; ASPIRIN [ACETYLSALICYLIC ACID]

Current Illness: Osteoarthritis

ID: 1827223
Sex: F
Age:
State:

Vax Date: 07/19/2021
Onset Date: 07/20/2021
Rec V Date: 10/29/2021
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: The day after vaccination, I have horrible body aches,; Chills; Low fever; Nausea; Diarrhea; This is a spontaneous report from a non-contactable consumer, the patient. A 24-year-old female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: FA6780) via an unspecified route of administration in the left arm on 19Jul2021 at 14:15 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. Medical history included asthma and known allergy to penicillin. Prior to the vaccination, the patient was not diagnosed with COVID-19. Concomitant medications included fluoxetine hydrochloride (PROZAC) for an unknown indication and combination birth control pill; both from an unknown date and unknown if ongoing. The patient did not receive any other vaccines within four weeks prior to the COVID vaccine. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: EW0191) via an unspecified route of administration in the left arm on 28Jun2021 at 14:15 (at the age of 24-years-old) as a single dose for COVID-19 immunisation. On 20Jul2021 at 03:00, the day after vaccination, the patient experienced horrible body aches, chills, low fever, nausea, and diarrhea. It came on very suddenly at 03:00. The event did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Therapeutic measures were taken as a result of the events and included treatment with over the counter (OTC) pain medicine. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the events horrible body aches, chills, low fever, nausea, and diarrhea were resolving at the time of this report. No follow-up attempts are possible. No further information is expected.

Other Meds: PROZAC

Current Illness:

ID: 1827224
Sex: F
Age:
State: VA

Vax Date:
Onset Date: 05/28/2021
Rec V Date: 10/29/2021
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: Test Date: 2021; Test Name: Nasal Swab; Test Result: Negative

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: After the shot, my periods have been out of wack.; I'm on day four, and it's just spotting; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the second dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: UNKNOWN) via an unspecified route of administration on an unknown date in 2021 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. Medical history included pregnancy in 2006 and 2012 and removal of tubes. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any medication within two weeks of vaccination. The patient previously received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot number: ER8731) via an unspecified route of administration in the left arm on 14Apr2021 (at the age of 31-years-old) as a single dose for COVID-19 immunisation. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patients period had been normal for the past 20 years except for when she was pregnant in 2006 and 2012. On 28May2021, after the shot, her periods had been out of wack. The patient was on her third period since her second dose, and her period was acting just like the last two, so she knew something was wrong. Usually, her second day of menstruation was her heaviest and had always been like that. The patient was on day four, and it was just spotting. Her last two periods were the same. She would spot for about four days, and then her period would arrive for just three days. Her regular periods were intense for the second to fourth day then would end on day five or six. The patient was reporting this because something was up with her cycle. She wouldn't get pregnant because she had removed her tubes, so it was not a pregnancy. The events did not result in doctor or other healthcare professional office/clinic visit, emergency room/department or urgent care. Since the vaccination, the patient had been tested for COVID-19. On an unknown date in 2021, the patient underwent COVID-19 test via nasal swab and the result was negative. Therapeutic measures were not taken as a result of the events. The clinical outcome of the events after the shot, periods had been out of wack, was on day four, and it was just spotting, last two periods were the same, she would spot for about four days, and then her period would arrive for just three days was not resolved at the time of this report. The lot number for BNT162b2 was not provided and will be requested during follow up.

Other Meds:

Current Illness:

ID: 1827225
Sex: F
Age:
State: MN

Vax Date: 04/14/2021
Onset Date: 04/28/2021
Rec V Date: 10/29/2021
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: I was expecting my period end of April and I missed having a period then and the next month. I had a period end of June. So I missed my period for two month; This is a spontaneous report from a contactable consumer, the patient. A 47-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8731) via an unspecified route of administration in the arm left on 14Apr2021 at 18:00 (at the age of 47-year-old) as a single dose for COVID-19 immunisation. The patient did not have any relevant medical history. The patient had no known allergies. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccines within four weeks prior to the vaccination. The patient did not receive any concomitant medications. On 28Apr2021, the patient expecting her period end of April and she missed having a period then and the next month. The patient had period at end of June. So, she missed her period for two month. It was also reported that highly unusual since she has been regular most of her life and does not suspect peri menopausal symptom. Therapeutic measures were not taken as a result of the event. The event did not result in doctor or other health care professional office/clinic visit, and emergency room/department or urgent care. Therapeutic measures were not taken as a result of event. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event 'I was expecting my period end of April and I missed having a period then and the next month. I had a period end of June. So I missed my period for two month' was unknown at the time of this report.

Other Meds:

Current Illness:

ID: 1827226
Sex: F
Age:
State: CA

Vax Date: 05/06/2021
Onset Date: 05/08/2021
Rec V Date: 10/29/2021
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: My menstrual cycle is all messed up. I am usually extremely regular and My periods have been coming late; My periods have been coming late, coming VERY heavy; Unusual ovarian pain; I am getting PMS symptoms like enlarged and painful breasts; I am getting PMS symptoms like enlarged and painful breasts; Bloating; Constipation; This is a spontaneous report from a contactable consumer, the patient. A 31-year-old non-pregnant female patient received the first dose of BNT162b2 (PFIZER-BIONTECH COVID-19 mRNA VACCINE; Lot Number: ER8736) via an unspecified route of administration on 06May2021 (at the age of 31-year-old), as a single dose for COVID-19 immunisation. Medical history was not reported. Prior to the vaccination, the patient was not diagnosed with COVID-19. The patient did not receive any other vaccine within four weeks prior to the COVID vaccine. Concomitant medications included fluticasone propionate (FLONASE) from an unknown date for an unknown indication. On 08May2021, the patient experienced menstrual cycle all messed up. The patient usually was extremely regular and periods had been coming late and very heavy, felt unusual ovarian pain, she was getting PMS symptoms like enlarged and painful breasts, bloating and constipation. Since the vaccination, the patient had not been tested for COVID-19. The clinical outcome of the event menstrual cycle late, very heavy periods, unusual ovarian pain, enlarged and painful breasts, bloating and constipation was unknown at the time of this report.

Other Meds: FLONASE [FLUTICASONE PROPIONATE]

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am