VAERS 2021 Database www.vaers.hhs.gov

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

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

COVID19 Lot Number

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

Incidents per State

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

ID: 1800216
Sex: F
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 10/20/2021
Hospital:

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

Lab Data: Test Name: Anticardiolipin antibodies; Result Unstructured Data: Negative; Test Name: Beta-2 glycoprotein antibody; Result Unstructured Data: Negative; Test Name: Lupus anticoagulant; Result Unstructured Data: Positive; Comments: Prior APS panel for lupus anticoagulant antibody (Ab) on initial and repeat testing was positive.; Test Name: Complete blood count; Result Unstructured Data: 172 10*9/L; Test Name: Venous Doppler; Result Unstructured Data: DVT in both legs; Comments: Acute femoral-to-peroneal DVT in the right leg and a chronic femoral DVT in the left leg.; Test Name: Prothrombin time; Result Unstructured Data: 33 sec; Test Name: SARS-CoV-2 IgG antibody test; Result Unstructured Data: 8.08; Comments: 8.08 index (S/C); Test Name: Heparin-induced thrombocytopenia test; Result Unstructured Data: Negative; Test Name: International normalized ratio; Result Unstructured Data: 3.03

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: ACUTE FEMORAL-TO-PERONEAL DVT IN THE RIGHT LEG AND A CHRONIC FEMORAL DVT IN THE LEFT LEG; This spontaneous report was received from literature: THE CLOT THICKENS: DOES THE JOHNSON & JOHNSON COVID-19 VACCINE INCREASE THE RISK OF THROMBUS IN A HYPERCOAGULABLE STATE?. CHEST 2021. 2021 Oct 11; 160/4. This report concerned a 54-year-old female of an unspecified ethnic origin. The patient's height, and weight were not reported. The patient's past medical history included: severe covid-19 infection, and concurrent conditions included: antiphospholipid syndrome (APS). Prior APS panel for lupus anticoagulant antibody (Ab) on initial and repeat testing was positive. Anticardiolipin and beta-2 glycoprotein Ab were negative. Her complication from APS included chronic left lower extremity deep vein thrombosis (DVT) since 2018. She was compliant with warfarin. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration, batch number; unknown, and expiry date: unknown) dose was not reported, frequency time was 01 total, start therapy date was not reported (twenty days prior to present visit) for prophylactic vaccination. The batch number was not reported and has been requested. Concomitant medications included warfarin for chronic left lower extremity DVT. On an unspecified date, fifteen days after receiving the vaccine, she developed bilateral lower extremity swelling and calf pain, left worse than right. On exam, vital signs were within normal limits. She had 1 plus non-pitting edema and tenderness in her left calf, worse compared to the right. Complete blood count showed platelets 172 10 rest to 9/L (reference range: 167-378 10 rest to 9/L). international normalized ratio (INR) 3.03, prothrombin time 33 seconds (reference range: 9.8-12.9). COVID-19 Immunoglobulin G (IgG) titer 8.08 index (S/C) (reference range: 0 - 1.39). Heparin-induced thrombocytopenia (HIT) screen was negative. Venous Doppler ultrasound showed an acute femoral-to-peroneal DVT in the right leg and a chronic femoral DVT in the left leg. Due to recent joint statement by the Centers for Disease Control and Prevention (CDC) and Food and Drug Administration (FDA) advising against heparin in patients with new thrombi after receiving the J&J vaccine due to HIT-like behavior of these thrombi, the patient was treated with rivaroxaban and was currently doing well. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient was recovering from acute femoral-to-peroneal DVT in the right leg and a chronic femoral DVT in the left leg. Author emphasized on the correlation, that had been shown between severity of COVID-19 and degree of inflammation. Severe illness leads to generation of excessive inflammatory cytokines and chemokines, endothelial dysfunction, and a host of other pathways to increase risk of thrombosis. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211023622-COVID-19 VACCINE AD26.COV2.S-acute femoral-to-peroneal DVT in the right leg and a chronic femoral DVT in the left leg.. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: UNDERLYING DISEASE

Other Meds: WARFARIN

Current Illness: Antiphospholipid syndrome (This complication included chronic left lower extremity DVT. She was compliant with warfarin.)

ID: 1800217
Sex: F
Age:
State: NY

Vax Date:
Onset Date: 10/07/2021
Rec V Date: 10/20/2021
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: INCORRECT PRODUCT STORAGE; OUT OF SPECIFICATION PRODUCT USE; This spontaneous report received from a health care professional concerned a 94 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: chronic kidney disease, anemia, high cholesterol, hypertension, latex allergy, and penicillin allergy. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, intramuscular, batch number: 212A21A, and expiry: 21-DEC-2021) dose was not reported, administered on 07-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 07-OCT-2021, the patient experienced incorrect product storage. On 07-OCT-2021, the patient experienced out of specification product use. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the incorrect product storage and out of specification product use was not reported. This report was non-serious.

Other Meds:

Current Illness: Anemia; Cholesterol high; Chronic kidney disease; Hypertension; Latex allergy; Penicillin allergy

ID: 1800218
Sex: M
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 10/20/2021
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: Test Name: Pain scale; Result Unstructured Data: goes from 4-5, at night 6-7

Allergies:

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

Symptoms: NEUROPATHY IN FEET; IMPAIRED QUALITY OF LIFE; ISSUES THINKING/ GO BLANK ON THOUGHTS WHILE HAVING A CONVERSATION; This spontaneous report received from a patient concerned a male of unspecified age, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805029 and expiry: 08-JUN-2021) dose was not reported, 1 total administered on 13-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On an unspecified date, soon after the vaccination he was diagnosed with neuropathy in his feet and also had issues thinking and would get blank on his thoughts while a conversation with his staff. The patient visited to his primary care physician (PCP) and Orthopedic. Then he scheduled to see a neurologist. He was in constant pain and his feet both hurted 24/7. His pain level went from a 4-5, and at night to 6-7. He rubbed his feet several times a day with recommended creamer just to get a little relief. He also stated that he need assistance, this was affecting his work and mobility and quality of life. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from neuropathy in feet, and impaired quality of life, and the outcome of issues thinking/ go blank on thoughts while having a conversation was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211028677-Covid-19 vaccine ad26.cov2.s -Neuropathy in feet. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds:

Current Illness:

ID: 1800219
Sex: F
Age:
State: NY

Vax Date:
Onset Date: 06/28/2021
Rec V Date: 10/20/2021
Hospital: Y

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

Lab Data: Test Date: 20210705; Test Name: Magnetic resonance imaging spinal; Result Unstructured Data: abnormal

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: SPONTANEOUS CEREBROSPINAL FLUID LEAKAGE; This spontaneous report received from a patient via other company (Pfizer) concerned a 33 year old female of unspecified race and ethic origin. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient was not ill at the time of vaccination and had no known medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Z03AZIA, expiry: UNKNOWN) dose was not reported, 1 total administered on 12-APR-2021 to right arm for prophylactic vaccination. Concomitant medications included ethinylestradiol/norgestimate for birth control. On 28-JUN-2021, the patient diagnosed with a spontaneous cerebrospinal fluid leakage (CSF leak), and was hospitalized (date unspecified). Duration of hospitalization was not reported. On 05-JUL-2021, Laboratory data included: Magnetic resonance imaging spinal (NR: not provided) abnormal. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from spontaneous cerebrospinal fluid leakage. This report was serious (Hospitalization Caused / Prolonged).; Sender's Comments: V0: 20211029187-Covid-19 vaccine ad26.cov2.s - spontaneous cerebrospinal fluid leakage. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds: ESTARYLLA

Current Illness:

Date Died:

ID: 1800220
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/20/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: DIED; SUPERIOR SAGITTAL SINUS THROMBOSIS; LEFT LEG PAIN; MYALGIA; FEVER; This spontaneous report received from a patient via a company representative concerned a 37 year old female of unspecified race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, Expiry: Unknown) 1 total dose administered, 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, after 7 days of vaccination the patient experienced headache, myalgia and fever. 3 days later, patient experienced persistent headaches and onset of left leg pain (unspecified date). 2 days later, patient experienced vomiting episodes, Superior sagittal sinus thrombosis (unspecified date) and she was died. It was unspecified if an autopsy was performed. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient died on an unspecified date, and the outcome of myalgia, fever, left leg pain and superior sagittal sinus thrombosis was not reported. This report was serious (Death, and Other Medically Important Condition).; Sender's Comments: V0: 20211031470-Covid-19 vaccine ad26.cov2.s-Died, Superior sagittal sinus thrombosis. 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: 1800221
Sex: F
Age:
State: TN

Vax Date:
Onset Date: 04/08/2021
Rec V Date: 10/20/2021
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: Test Date: 20210408; Test Name: Body temperature; Result Unstructured Data: Low grade; Test Date: 20211013; Test Name: Antibody test; Result Unstructured Data: levels were greater than 2500

Allergies:

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

Symptoms: TINGLING IN RIGHT HAND; TIREDNESS AND FATIGUE; TWO VACCINE DOSES GIVEN IN ERROR; ACHES AND PAINS ESPECIALLY IN KNEES; COLD CHILLS; LOW GRADE FEVER; MILD HEADACHE; This spontaneous report received from a patient concerned a 58 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: alcohol user, non-smoker, high hemoglobin, and ragweed allergy, and other pre-existing medical conditions included: Patient did not have any history of drug abuse or illicit drug use. The patient never had the covid-19 virus. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 041A21A expiry: UNKNOWN, and batch number: 211A21A expiry: UNKNOWN) dose was not reported, administered on 08-APR-2021, and dose was not reported, administered on 24-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 08-APR-2021, the patient experienced aches and pains especially in knees. On 08-APR-2021, the patient experienced cold chills. On 08-APR-2021, the patient experienced low grade fever. On 08-APR-2021, the patient experienced mild headache. Laboratory data included: Body temperature (NR: not provided) Low grade. On 24-SEP-2021, the patient experienced two vaccine doses given in error. On 13-OCT-2021, Laboratory data included: Antibody test (NR: not provided) levels were greater than 2500. On an unspecified date, the patient experienced tingling in right hand, and tiredness and fatigue. Treatment medications (dates unspecified) included: ibuprofen, mecobalamin, and magnesium. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from aches and pains especially in knees, cold chills, low grade fever, and mild headache on 08-APR-2021, and tiredness and fatigue, had not recovered from tingling in right hand, and the outcome of two vaccine doses given in error was not reported. This report was non-serious. This case, from the same reporter is linked to 20211031574.

Other Meds:

Current Illness: Alcohol use (less than 10 beer per week.); Hemoglobin high; Non-smoker; Ragweed allergy

ID: 1800222
Sex: U
Age:
State: NJ

Vax Date:
Onset Date:
Rec V Date: 10/20/2021
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: HORRIBLE SIDE EFFECTS; OFF LABEL USE; VACCINE ADMINISTERED TO CHILD; This spontaneous report received from a consumer via a company representative concerned a child of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown, expiry: Unknown) dose was not reported, 1 total, 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 horrible side effects that had to be corrected by surgery, off label use, and vaccine administered to child. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the horrible side effects, off label use and vaccine administered to child was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0;20211031658-covid-19 vaccine ad26.cov2.s- Horrible side effects that had to be corrected by surgery. This event is considered unassessable. The event has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event.

Other Meds:

Current Illness:

ID: 1800223
Sex: F
Age:
State: PA

Vax Date:
Onset Date: 09/22/2021
Rec V Date: 10/20/2021
Hospital:

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

Lab Data: Test Date: 20210922; Test Name: COVID-19 virus test; Result Unstructured Data: Positive; Test Name: Body temperature; Result Unstructured Data: 101 F

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: CONFIRMED CLINICAL VACCINATION FAILURE; CONFIRMED COVID-19 INFECTION; This spontaneous report received from a patient concerned a 37 year old female. The patient's weight was 130 pounds, and height was 67 inches. The patient's pre-existing medical conditions included: The patient was not pregnant at the time of vaccination, had no known allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 202A21A expiry: 21-SEP-2021), 1 total, dose was not reported, administered on 17-AUG-2021 for prophylactic vaccination on left arm. No concomitant medications were reported. On SEP-2021 about a month after vaccination, the patient started experiencing achy, exhausted (flu-like symptoms) for about 2 days along with fever of 101 F. On 22-SEP-2021, the patient was tested positive for covid (confirmed clinical vaccination failure) along with loss of taste and smell (confirmed covid-19 infection). The patient did not seek medical treatment and stayed home. Laboratory data included: COVID-19 virus test (NR: not provided) Positive and Body temperature (NR: not provided) 101 F. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from confirmed clinical vaccination failure, and confirmed covid-19 infection. This report was serious (Other Medically Important Condition). This case was associated with product quality complaint 90000197714.; Sender's Comments: V0: 20211031819-covid-19 vaccine ad26.cov2.s-Confirmed clinical vaccination failure. This event(s) is considered not related. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There are other factors more likely to be associated with the event(s) than the drug. Specifically: SPECIAL SITUATIONS

Other Meds:

Current Illness:

ID: 1800224
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/20/2021
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: NEARLY KILLED ME AT NIGHT; CHILLS; HEADACHES; This spontaneous report received from a patient via a company representative through social media concerned a patient of unspecified age, sex, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received Covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: unknown, expiry: unknown) dose was not reported, start therapy date were not reported, 1 total, administered 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 reported "the vaccine nearly killed me at night". Had chills and headaches. The action taken with Covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the nearly killed me at night, chills and headaches was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0 20211031849-COVID-19 VACCINE AD26.COV2.S-Nearly killed me at night. This event(s) is considered unassessable. The event(s) has an unknown/unclear temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds:

Current Illness:

ID: 1800225
Sex: F
Age:
State:

Vax Date:
Onset Date: 08/01/2021
Rec V Date: 10/20/2021
Hospital:

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

Lab Data: Test Date: 202108; Test Name: Investigation; Result Unstructured Data: negative

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: MENSES; RASH ALL OVER BODY; PASSED OUT; VOMITING; ASTHMA ATTACK; MIGRAINE HEADACHE; FATIGUE; NUMBNESS AND TINGLING IN LOWER EXTREMITIES AND HANDS; PETEHIAE ALL OVER BODY; WAKE UP I ALL HOURS OF NIGHT; BRUISE EASILY; BURNING SENSATION IN LOWER EXTREMITIES & HANDS; MUSCLE SPASMS IN LOWER EXTREMITIES; This spontaneous report received from a patient concerned a patient of unspecified age, race and ethnicity. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient have not had menses in plus 2 years and was fine until received vaccine. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: unknown) dose was not reported, 1 total administered on 14-AUG-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 14-AUG-2021, 15-20 minutes after receiving the vaccination, had an asthma attack with a migraine headache, on 15-AUG-2021, had vomiting and passed out. On 17-AUG-2021, had rash all over body & menses, Haven't had menses in 2 plus years and had seen gynecologist and all tests came negative. Petechiae all over the body. Numbness and tingling in lower extremities and hands with burning sensation and Wake up all hours of night with muscle spasms in lower extremities and bruise easily, Fatigue easily. This all occurred within days of receiving the vaccine. And patient was fine until getting the vaccine. The patient reported that, ultimately have untoward life long side effects from the product that is horrific. Laboratory data (dates unspecified) included: Investigation (NR: not provided) negative. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the asthma attack, migraine headache, vomiting, passed out, rash all over body, menses, petechiae all over body, numbness and tingling in lower extremities and hands, muscle spasms in lower extremities, bruise easily, fatigue and burning sensation in lower extremities & hands was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211031961-Covid-19 vaccine ad26.cov2.s ?Passed out. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds:

Current Illness:

ID: 1800226
Sex: F
Age:
State: IL

Vax Date:
Onset Date: 04/28/2021
Rec V Date: 10/20/2021
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: VERTIGO; RACING HEART; ANXIETY; NOT FEELING QUITE LIKE SELF; TROUBLE SLEEPING AT NIGHT; NAUSEA; FELT TIRED; TINNITUS; NO ENERGY; This spontaneous report received from a patient concerned a 61 year old female. The patient's height, and weight were not reported. The patient's concurrent conditions included: glaucoma, and other pre-existing medical conditions included: Patient had no pertinent medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805025 expiry: 23-AUG-2021) dose was not reported, administered on 24-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 28-APR-2021, the patient experienced vertigo. On 28-APR-2021, the patient experienced racing heart. On 28-APR-2021, the patient experienced anxiety. On 28-APR-2021, the patient experienced not feeling quite like self. On 28-APR-2021, the patient experienced trouble sleeping at night. On 28-APR-2021, the patient experienced nausea. On 28-APR-2021, the patient experienced felt tired. On 28-APR-2021, the patient experienced tinnitus. On 28-APR-2021, the patient experienced no energy. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from vertigo, racing heart, anxiety, not feeling quite like self, nausea, felt tired, and no energy on 23-JUN-2021, and trouble sleeping at night on 11-OCT-2021, and had not recovered from tinnitus. This report was non-serious.

Other Meds:

Current Illness: Glaucoma (Glaucoma drops in eyes every day.)

ID: 1800227
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/20/2021
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 Name: Antibody test; Result Unstructured Data: Antibodies increase; Comments: Antibodies currently through the roof

Allergies:

Symptom List: Rash, Urticaria

Symptoms: EXTREMELY SICK; This spontaneous report received from a consumer via a company representative concerned a patient of unspecified age and sex. The patient's height, and weight were not reported. The patient's past medical history included: covid-19. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin, and batch number were not reported) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced extremely sick. Laboratory data (dates unspecified) included: Antibody test (NR: not provided) Antibodies increase. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of extremely sick was not reported. This report was non-serious. This case, from the same reporter is linked to 20211032028.

Other Meds:

Current Illness:

ID: 1800228
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/20/2021
Hospital:

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

Lab Data: Test Name: Body temperature; Result Unstructured Data: 102

Allergies:

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

Symptoms: VERY SICK FOR 12 HOURS STRAIGHT; FEVER WAS AT 102 FOR A FEW HOURS; 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On an unspecified date, the patient experienced very sick for 12 hours straight, and fever was at 102 for a few hours. Laboratory data (dates unspecified) included: Body temperature (NR: not provided) 102. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from very sick for 12 hours straight, and fever was at 102 for a few hours. This report was non-serious. This case, from the same reporter is linked to 20211031768.

Other Meds:

Current Illness:

ID: 1800230
Sex: M
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 10/20/2021
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: Test Name: Antibody test; Result Unstructured Data: Low

Allergies:

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

Symptoms: LACK OF EFFECT/VACCINE DID NOT WORK; LOW ANTIBODIES WHEN TESTED; This spontaneous report received from a patient concerned a male of unspecified age, race and ethnicity. Initial information was processed along with the additional information received on 15-OCT-2021. The patient's height, and weight were not reported. The patient's past medical history included: cancer, and the patient is not being treated for cancer and the patient is not using immunosuppressive therapy at the time of reporting. 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, 1 total administered for prophylactic vaccination. The batch number was not reported. Per procedure, no follow up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient had performed antibody test and the results came back as low (low antibody count). The patient reports that the Janssen Covid-19 vaccine did not work (lack of effect) and the patient also states that he cannot travel due to antibody testing requirements in other countries due to his low antibodies. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the lack of effect/vaccine did not work and low antibodies when tested was not reported. This report was serious (Other Medically Important Condition). This case was associated with Product quality complaint number: 90000197727.; Sender's Comments: V0; 20211032610-COVID-19 VACCINE AD26.COV2.S-Lack of effect. This event is considered not related. The event(s) has an unknown/unclear 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: 1800231
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/20/2021
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: MYOCARDITIS; This spontaneous report received from a consumer via social media via a company representative concerned a female of unspecified age, race and ethnicity. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: Unknown, expiry: Unknown) dose, 1 total, 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, as per reporter "Your shot gave my wife myocarditis" The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of myocarditis was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211033613-covid-19 vaccine ad26.cov2.s-myocarditis. This event(s) is considered unassessable. The event(s) has a compatible/suggestive temporal relationship, is unlabeled, and has unknown scientific plausibility. There is no information on any other factors potentially associated with the event(s).

Other Meds:

Current Illness:

Date Died:

ID: 1800232
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/20/2021
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: DEATH; This spontaneous report received from a consumer via a company representative concerned a 35 year old male. The patient's weight, height, and medical history were not 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, 1 total, 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 consumer's lawyer's husband got the johnson and johnson shot and died days later. On 2021, the patient died from unknown cause of death. It was unknown if an 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: 20211033764- Covid-19 vaccine ad26.cov2.s-Death. This event is considered unassessable. The event 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.; Reported Cause(s) of Death: UNKNOWN CAUSE OF DEATH

Other Meds:

Current Illness:

ID: 1800233
Sex: M
Age:
State: NY

Vax Date:
Onset Date: 03/25/2021
Rec V Date: 10/20/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: VERY DRY HANDS WITH OPEN AREAS; BODY RASH; ITCHING BODY; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1805022, and expiry: UNKNOWN) dose was not reported, administered on 11-MAR-2021 for prophylactic vaccination. No concomitant medications were reported. On 25-MAR-2021, the patient experienced itching body. On 25-MAR-2021, the patient experienced body rash. On 01-SEP-2021, the patient experienced very dry hands with open areas. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from itching body, and body rash on 29-APR-2021, and had not recovered from very dry hands with open areas. This report was non-serious.

Other Meds:

Current Illness:

ID: 1800234
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/20/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: HAIR FALLING OUT; 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, Expiry: 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 hair falling out. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of hair falling out was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1800235
Sex: F
Age:
State: OK

Vax Date:
Onset Date:
Rec V Date: 10/20/2021
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: EXHAUSTION; This spontaneous report received from a consumer 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, 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 exhaustion. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of exhaustion was not reported. This report was non-serious. This case, from the same reporter is linked to 20211016208.

Other Meds:

Current Illness:

ID: 1800236
Sex: M
Age:
State: PA

Vax Date:
Onset Date: 04/18/2021
Rec V Date: 10/20/2021
Hospital:

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

Lab Data: Test Name: Blood test; Result Unstructured Data: Everything good; Test Name: Physical examination; Result Unstructured Data: not reported

Allergies:

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

Symptoms: BRAIN FOG; MAJOR FATIGUE; ENERGY LEVEL NOT AT THE SAME LEVEL IT USED TO BE; This spontaneous report received from a patient concerned a 63 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: penicillin allergy, alcohol user, and non smoker, and other pre-existing medical conditions included: The patient did not have any history of drug abuse or illicit drug use. The patient experienced severe chills and shakes when treated with influenza vaccine for prophylactic vaccination. 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 17-APR-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On 18-APR-2021, the patient experienced brain fog. On 18-APR-2021, the patient experienced major fatigue. On 18-APR-2021, the patient experienced energy level not at the same level it used to be. Laboratory data (dates unspecified) included: Blood test (NR: not provided) Everything good, and Physical examination (NR: not provided) Not reported. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient recovered from brain fog on JUN-2021, was recovering from major fatigue, and had not recovered from energy level not at the same level it used to be. This report was non-serious.

Other Meds:

Current Illness: Alcohol use (Socially (one drink per month)); Non-smoker; Penicillin allergy ((does not remember nature of reaction because he was young).)

ID: 1800237
Sex: U
Age:
State:

Vax Date:
Onset Date: 10/17/2021
Rec V Date: 10/20/2021
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: SOMETHING POPPED IN HEAD; SICK AS DOG; 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: Unk) dose, start therapy date were not reported for prophylactic vaccination. The batch number was not reported. The Company is unable to perform follow-up to request batch/lot numbers. No concomitant medications were reported. On 17-OCT-2021, the patient experienced something popped in head. On 17-OCT-2021, the patient experienced sick as dog. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of the something popped in head and sick as dog was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1800238
Sex: M
Age:
State: SC

Vax Date:
Onset Date: 10/06/2021
Rec V Date: 10/20/2021
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: RIGHT AND LEFT THIGH AND CALF PAIN, THE DISCOMFORT SUBSIDES AFTER MOVING AND WALKING A BIT, PAIN WAS TOWARDS THE FRONT AND WORSE ON THE LEFT; This spontaneous report received from a patient concerned a 70 year old male. The patient's height, and weight were not reported. The patient's concurrent conditions included: non-alcohol user, and non-smoker, and other pre-existing medical conditions included: The patient had no known allergies. The patient did not have any drug abuse/illicit drug use. Patient has no medical history. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, and batch number: 1822809 expiry: 07-MAR-2022) dose was not reported, administered on 22-SEP-2021 for prophylactic vaccination. Concomitant medications included influenza vaccine for prophylactic vaccination. On 06-OCT-2021, the patient experienced right and left thigh and calf pain, the discomfort subsides after moving and walking a bit, pain was towards the front and worse on the left. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from right and left thigh and calf pain, the discomfort subsides after moving and walking a bit, pain was towards the front and worse on the left. This report was non-serious.

Other Meds: INFLUENZA VACCINE

Current Illness: Abstains from alcohol; Non-smoker

ID: 1800239
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/20/2021
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: SIDE EFFECTS; This spontaneous report received from a patient via a company representative concerned a patient of unspecified age and sex. The patient's weight, height, and medical history were not 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. Per procedure, no follow-up will be requested for this case. No concomitant medications were reported. On an unspecified date, the patient experienced side effects. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of side effects was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1800240
Sex: F
Age:
State: OR

Vax Date:
Onset Date: 10/01/2021
Rec V Date: 10/20/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: STARTED PERIOD A WEEK EARLY; 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 08-OCT-2021 for prophylactic vaccination. The batch number was not reported and has been requested. No concomitant medications were reported. On OCT-2021, the patient experienced started period a week early. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of started period a week early was not reported. This report was non-serious.

Other Meds:

Current Illness:

ID: 1800241
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/20/2021
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: BELLS PALSY; This spontaneous report received from a consumer via a company representative through social media concerned a patient of unspecified age, sex, race and ethnic origin. The patient's height, and weight were not reported. No past medical history or concurrent conditions were reported. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of administration not reported, batch number: Unknown expiry: Unknown) dose, start therapy date were not reported, 01 total administered 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. It was reported that, "the patient got bells palsy exactly 1 month after the J and J jab." The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of bells palsy was not reported. This report was serious (Other Medically Important Condition).; Sender's Comments: V0: 20211034768-COVID-19 VACCINE AD26.COV2.S-Bells palsy. This event is considered unassessable. The event 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.

Other Meds:

Current Illness:

ID: 1800242
Sex: M
Age:
State: FL

Vax Date:
Onset Date: 10/17/2021
Rec V Date: 10/20/2021
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: FELT LIKE HAVING THE FLU; This spontaneous report received from a patient concerned a male of unspecified age. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no new changes in lifestyle within the last two weeks. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1822811, and expiry: 20-MAR-2022) dose was not reported, administered on 17-OCT-2021 for prophylactic vaccination. No concomitant medications were reported. On 17-OCT-2021, the patient experienced felt like having the flu. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from felt like having the flu. This report was non-serious.

Other Meds:

Current Illness:

ID: 1800243
Sex: U
Age: 76
State: CA

Vax Date: 01/23/2021
Onset Date: 01/23/2021
Rec V Date: 10/20/2021
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: Cheek Redness; Cheek Swelling; A spontaneous report was received from a consumer concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events cheek swelling, cheek redness and redness. ? The patient's medical history included dermatological fillers on an unknown date in 2014. No relevant concomitant medications were reported.??? ? On an unknown date, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 042L20A ) intramuscularly in the right arm for prophylaxis of COVID-19 infection.? ? On an unknown date,?the?patient experienced the swelling on both cheeks but predominantly on the left side (cheek) immediately following the vaccination on her right arm.? Laboratory details was not provided.? ? No treatment information was provided.?? ? Action taken with mRNA-1273 in response to the events was not reported.?? ? The outcome of the events were resolved.; Reporter's Comments: This case concerns a patient of unknown age and gender, with a medical history of dermatological fillers, who had NS unexpected events of erythema, swelling face, and circumoral swelling. Event onset with unknown latency after first dose of mRNA-1273. Treatment known. The "reaction went away about 30 minutes." Events resolved. Based on current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1800244
Sex: F
Age: 77
State: AR

Vax Date: 08/12/2021
Onset Date: 08/12/2021
Rec V Date: 10/20/2021
Hospital:

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

Lab Data: Test Name: Body temperature; Result Unstructured Data: 101.7

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: Didn't sleep hardly any; Neck hurt; Chills in the night; Arm was sore; Fever of 101.7; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Didn't sleep hardly any), NECK PAIN (Neck hurt), CHILLS (Chills in the night), MYALGIA (Arm was sore) and PYREXIA (Fever of 101.7) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002F21A) for COVID-19 vaccination. No Medical History information was reported. On 12-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Aug-2021, the patient experienced INSOMNIA (Didn't sleep hardly any), NECK PAIN (Neck hurt), CHILLS (Chills in the night), MYALGIA (Arm was sore) and PYREXIA (Fever of 101.7). At the time of the report, INSOMNIA (Didn't sleep hardly any), NECK PAIN (Neck hurt), CHILLS (Chills in the night), MYALGIA (Arm was sore) and PYREXIA (Fever of 101.7) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101.7 (High) 101.7. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided by the reporter. No treatment information was provided by the reporter.

Other Meds:

Current Illness:

ID: 1800245
Sex: F
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 10/20/2021
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: Received 3rd dose being not eligible; This spontaneous case was reported by a physician and describes the occurrence of INCORRECT DOSE ADMINISTERED (Received 3rd dose being not eligible) in an elderly female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INCORRECT DOSE ADMINISTERED (Received 3rd dose being not eligible). At the time of the report, INCORRECT DOSE ADMINISTERED (Received 3rd dose being not eligible) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Lab test data included Patient did antibody test PCR test but results are not provided. No Concomitant medication was reported. No treatment medication use was reported. Pharmacist used 100 ul instead of the 50 original two part series. This case was linked to MOD-2021-329821 (Patient Link).

Other Meds:

Current Illness:

ID: 1800246
Sex: U
Age: 58
State: FL

Vax Date: 09/03/2021
Onset Date: 10/03/2021
Rec V Date: 10/20/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: Received expired second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired second dose) in a 58-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037f21a and 014F21A) for COVID-19 vaccination. No Medical History information was reported. On 03-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired second dose). On 03-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received expired second dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. Treatment medication was not provided by the reporter. This case was linked to MOD-2021-347607, MOD-2021-347368 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 14-Oct-2021: Non-Significant follow up appended-Email ID updated

Other Meds:

Current Illness:

ID: 1800247
Sex: U
Age: 74
State: FL

Vax Date: 09/03/2021
Onset Date: 10/01/2021
Rec V Date: 10/20/2021
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: Received expired second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired second dose) in a 74-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037f21a and 014F21A) for COVID-19 vaccination. No Medical History information was reported. On 03-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Oct-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired second dose). On 01-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received expired second dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medications was reported. Treatment information was not provided. This case was linked to MOD-2021-347607, MOD-2021-347368 (Patient Link).

Other Meds:

Current Illness:

ID: 1800248
Sex: U
Age: 55
State: FL

Vax Date: 09/03/2021
Onset Date: 10/01/2021
Rec V Date: 10/20/2021
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 expired second dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired second dose) in a 55-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 014F21A and 037f21a) for COVID-19 vaccination. No Medical History information was reported. On 03-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired second dose). On 01-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received expired second dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant product use was reported. No treatment information was provided. The patient received expired second dose. This case was linked to MOD-2021-347607, MOD-2021-346406, MOD-2021-346347, MOD-2021-346608, MOD-2021-346268, MOD-2021-347607, MOD-2021-346421, MOD-2021-347067, MOD-2021-347112, MOD-2021-346981 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 14-Oct-2021: Follow-up information includes reporter email id.

Other Meds:

Current Illness:

ID: 1800249
Sex: F
Age: 75
State: NY

Vax Date: 01/14/2021
Onset Date: 02/10/2021
Rec V Date: 10/20/2021
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: urinated on herself; everything went black; broke out in sweats; felt her heart "go down to her feet"/petrified; petrified/felt like she was dying; getting nauseated; This spontaneous case was reported by a consumer and describes the occurrence of DYSURIA (urinated on herself), DIZZINESS (everything went black), HYPERHIDROSIS (broke out in sweats), FEELING ABNORMAL (felt her heart "go down to her feet"/petrified) and FEAR (petrified/felt like she was dying) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K10-2A and 012C20A or 012C70A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included GERD, Blood pressure, High cholesterol and Hypothyroidism. Concomitant products included DENOSUMAB (XGEVA) for Osteoporosis, NEBIVOLOL HYDROCHLORIDE (BYSTOLIC), OLMESARTAN, LEVOTHYROXINE SODIUM (SYNTHROID), ROSUVASTATIN CALCIUM (CRESTOR), AMLODIPINE and FAMOTIDINE for an unknown indication. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced DYSURIA (urinated on herself), DIZZINESS (everything went black), HYPERHIDROSIS (broke out in sweats), FEELING ABNORMAL (felt her heart "go down to her feet"/petrified), FEAR (petrified/felt like she was dying) and NAUSEA (getting nauseated). At the time of the report, DYSURIA (urinated on herself), DIZZINESS (everything went black), HYPERHIDROSIS (broke out in sweats), FEELING ABNORMAL (felt her heart "go down to her feet"/petrified), FEAR (petrified/felt like she was dying) and NAUSEA (getting nauseated) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The caller reported no known drug or food allergies. She did report she switched from Prolia to Xgeva to treat osteoporosis because her doctor suspected she may have an allergy to latex, but it is unknown. This case was linked to MOD-2021-346435 (Patient Link).

Other Meds: BYSTOLIC; XGEVA; OLMESARTAN; SYNTHROID; CRESTOR; AMLODIPINE; FAMOTIDINE

Current Illness:

ID: 1800250
Sex: U
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 10/20/2021
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: Headache like flu; Headache like flu; Body ache; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Headache like flu), HEADACHE (Headache like flu) and MYALGIA (Body ache) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced INFLUENZA LIKE ILLNESS (Headache like flu), HEADACHE (Headache like flu) and MYALGIA (Body ache). At the time of the report, INFLUENZA LIKE ILLNESS (Headache like flu), HEADACHE (Headache like flu) and MYALGIA (Body ache) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitants were reported. No treatments were reported. This case was linked to MOD-2021-286293, MOD-2021-024366, MOD-2021-024366, MOD-2021-329115, MOD-2021-329194, MOD-2021-329313 (Patient Link).

Other Meds:

Current Illness:

ID: 1800251
Sex: F
Age:
State: FL

Vax Date:
Onset Date: 08/25/2021
Rec V Date: 10/20/2021
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: Covid positive after complete vaccination schedule/complete exhaustion for one month/Fever for a day/Could hardly move her body/awful taste in the mouth/Felt so tired; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Covid positive after complete vaccination schedule/complete exhaustion for one month/Fever for a day/Could hardly move her body/awful taste in the mouth/Felt so tired) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Type 2 diabetes mellitus. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 25-Aug-2021, the patient experienced COVID-19 (Covid positive after complete vaccination schedule/complete exhaustion for one month/Fever for a day/Could hardly move her body/awful taste in the mouth/Felt so tired). On 25-Sep-2021, COVID-19 (Covid positive after complete vaccination schedule/complete exhaustion for one month/Fever for a day/Could hardly move her body/awful taste in the mouth/Felt so tired) had resolved. Concomitant medication information was not provided by the reporter. Treatment information was not provided by the reporter. The patient suffered from covid19 after vaccination, the symptoms were exhaustion for a month as well as feeling tired, fever for a day when she first discovered she had COVID-19, could hardly move her body and had an awful taste in her mouth. Company Comment: This case concerns a 73-year-old female patient, with no relevant medical history, who experienced the non-serious unexpected AESI of COVID-19. The event occurred after receiving the second dose of Spikevax, which administration date is unknown. The rechallenge is not applicable since no additional dose will be administered. The benefit-risk relation of Spikevax is not affected by this report.; Sender's Comments: This case concerns a 73-year-old female patient, with no relevant medical history, who experienced the non-serious unexpected AESI of COVID-19. The event occurred after receiving the second dose of Spikevax, which administration date is unknown. The rechallenge is not applicable since no additional dose will be administered. The benefit-risk relation of Spikevax is not affected by this report.

Other Meds:

Current Illness: Type 2 diabetes mellitus

ID: 1800252
Sex: M
Age: 83
State: FL

Vax Date: 01/04/2021
Onset Date: 02/01/2021
Rec V Date: 10/20/2021
Hospital: Y

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

Lab Data: Test Name: Blood pressure measurement; Result Unstructured Data: His blood pressure is usually 130/70; Test Name: ECG; Result Unstructured Data: They measured a 12 second pause 1 time and some other pauses throughout his hospitalization

Allergies:

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

Symptoms: Arrhythmia /They measured a 12 second pause 1 time and some other pauses throughout his hospitalization.; fell/smashing his nose and face; He was diagnosed with atrial fibrillation and given a pacemaker on 9AUG2021; Shaking; Sweating; felt cold even with a coat on/stayed in bed for the next 3 days/ couldn't get warm; vision went to nothing; fainting spells/fainting episodes; felt weak like he was going to faint; This spontaneous case was reported by a nurse and describes the occurrence of ARRHYTHMIA (Arrhythmia /They measured a 12 second pause 1 time and some other pauses throughout his hospitalization.), SYNCOPE (fainting spells/fainting episodes) and ATRIAL FIBRILLATION (He was diagnosed with atrial fibrillation and given a pacemaker on 9AUG2021) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031L20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Macular degeneration. Concomitant products included LISINOPRIL for Low blood pressure. On 04-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Feb-2021, the patient experienced TREMOR (Shaking), HYPERHIDROSIS (Sweating), FEELING COLD (felt cold even with a coat on/stayed in bed for the next 3 days/ couldn't get warm) and VISUAL IMPAIRMENT (vision went to nothing). In February 2021, the patient experienced SYNCOPE (fainting spells/fainting episodes) (seriousness criteria medically significant and life threatening) and DIZZINESS (felt weak like he was going to faint). In 2021, the patient experienced ARRHYTHMIA (Arrhythmia /They measured a 12 second pause 1 time and some other pauses throughout his hospitalization.) (seriousness criteria hospitalization, medically significant and life threatening). On 04-Aug-2021, the patient experienced FALL (fell/smashing his nose and face). In August 2021, the patient experienced ATRIAL FIBRILLATION (He was diagnosed with atrial fibrillation and given a pacemaker on 9AUG2021) (seriousness criteria medically significant and life threatening). The patient was treated with LORATADINE (CLARITIN [LORATADINE]) for Adverse event, at an unspecified dose and frequency and Surgery (Given a pacemaker on 09 Aug 2021) for Atrial fibrillation. In February 2021, FEELING COLD (felt cold even with a coat on/stayed in bed for the next 3 days/ couldn't get warm) was resolving. At the time of the report, ARRHYTHMIA (Arrhythmia /They measured a 12 second pause 1 time and some other pauses throughout his hospitalization.), SYNCOPE (fainting spells/fainting episodes), ATRIAL FIBRILLATION (He was diagnosed with atrial fibrillation and given a pacemaker on 9AUG2021), TREMOR (Shaking), HYPERHIDROSIS (Sweating), DIZZINESS (felt weak like he was going to faint), VISUAL IMPAIRMENT (vision went to nothing) and FALL (fell/smashing his nose and face) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure measurement: 130/70 (abnormal) His blood pressure is usually 130/70. On an unknown date, Electrocardiogram: abnormal (abnormal) They measured a 12 second pause 1 time and some other pauses throughout his hospitalization. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Lab test data included ECG, echocardiogram, and imaging but specific results not provided. He was hospitalized for 1 week with a significant work up of ECG, echocardiogram, and imaging. They measured a 12 second pause 1 time and some other pauses throughout his hospitalization.He was diagnosed with atrial fibrillation and given a pacemaker on 9AUG2021. He has not had any episodes of atrial fibrillation since receiving the pace maker. Company comment: This case concerns a 84-year-old, male patient with previous relevant medical history of hypertension and use of concomitant medication, who experienced the unexpected events of arrhythmia, syncope and atrial fibrillation. The events occurred approximately 6 months after the second dose of mRNA-1273. The rechallenge was not applicable since the events happened after the second dose. The medical history of hypertension and use of concomitant medication remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.; Sender's Comments: This case concerns a 84-year-old, male patient with previous relevant medical history of hypertension and use of concomitant medication, who experienced the unexpected events of arrhythmia, syncope and atrial fibrillation. The events occurred approximately 6 months after the second dose of mRNA-1273. The rechallenge was not applicable since the events happened after the second dose. The medical history of hypertension and use of concomitant medication remains a confounder. The benefit-risk relationship of mRNA-1273 is not affected by this report.

Other Meds: LISINOPRIL

Current Illness:

ID: 1800253
Sex: F
Age: 73
State: UT

Vax Date: 02/06/2021
Onset Date:
Rec V Date: 10/20/2021
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: neuropathy in her feet; could hardly walk for 2 & 1/2 months because they were so painful; Arthritis in her knees; could hardly walk for 2 & 1/2 months because they were so painful; This spontaneous case was reported by a consumer and describes the occurrence of NEUROPATHY PERIPHERAL (neuropathy in her feet), GAIT DISTURBANCE (could hardly walk for 2 & 1/2 months because they were so painful), ARTHRITIS (Arthritis in her knees) and PAIN (could hardly walk for 2 & 1/2 months because they were so painful) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027A21A and 007M20A) for COVID-19 vaccination. No Medical History information was reported. On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-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 NEUROPATHY PERIPHERAL (neuropathy in her feet) (seriousness criterion medically significant), GAIT DISTURBANCE (could hardly walk for 2 & 1/2 months because they were so painful) (seriousness criterion medically significant), ARTHRITIS (Arthritis in her knees) (seriousness criterion medically significant) and PAIN (could hardly walk for 2 & 1/2 months because they were so painful) (seriousness criterion medically significant). At the time of the report, NEUROPATHY PERIPHERAL (neuropathy in her feet), GAIT DISTURBANCE (could hardly walk for 2 & 1/2 months because they were so painful), ARTHRITIS (Arthritis in her knees) and PAIN (could hardly walk for 2 & 1/2 months because they were so painful) outcome was unknown. No concomitant and treatment information were reported by the reporter Company Comment: This case concerns a 74-year-old, female patient with no reported relevant medical history, who experienced the serious (medically significant) unexpected events of neuropathy peripheral, gait disturbance, arthritis and pain. The events occurred within 4 to 5 days after the second dose of the mRNA-1273 (Moderna CoviD-19 Vaccine). The re-challenge was unknown since no information about the first another dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna CoviD-19 Vaccine) is not affected by this report.; Sender's Comments: This case concerns a 74-year-old, female patient with no reported relevant medical history, who experienced the serious (medically significant) unexpected events of neuropathy peripheral, gait disturbance, arthritis and pain. The events occurred within 4 to 5 days after the second dose of the mRNA-1273 (Moderna CoviD-19 Vaccine). The re-challenge was unknown since no information about the first another dose was disclosed. The benefit-risk relationship of mRNA-1273 (Moderna CoviD-19 Vaccine) is not affected by this report.

Other Meds:

Current Illness:

ID: 1800254
Sex: F
Age: 54
State: TN

Vax Date: 02/25/2021
Onset Date: 02/25/2021
Rec V Date: 10/20/2021
Hospital:

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

Lab Data: Test Date: 20201124; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Rapid Test Positive

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Mild headache and then went away; This spontaneous case was reported by a nurse and describes the occurrence of HEADACHE (Mild headache and then went away) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The patient's past medical history included COVID-19 on 24-Nov-2020. Concurrent medical conditions included Bipolar disorder since 23-Oct-2015, Restless legs syndrome since 20-Jun-2021 and Insomnia since 23-Oct-2015. Concomitant products included LAMOTRIGINE (LAMICTAL) from 23-Oct-2015 to an unknown date for Bipolar disorder, GABAPENTIN from 20-Jun-2021 to an unknown date for Insomnia and Restless legs syndrome, ESTRADIOL (ESTROGEN), ESCITALOPRAM OXALATE (LEXAPRO), ROSUVASTATIN CALCIUM (CRESTOR), VITAMIN D NOS and CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) for an unknown indication. On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Feb-2021, the patient experienced HEADACHE (Mild headache and then went away). At the time of the report, HEADACHE (Mild headache and then went away) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Nov-2020, SARS-CoV-2 test: positive (Positive) Rapid Test Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment medications were not provided. This case was linked to MOD-2021-348417, MOD-2021-348434 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 13-Oct-2021: Follow up received contains added patient demographic and details, medical history, concomitants medications.

Other Meds: ESTROGEN; LEXAPRO; CRESTOR; VITAMIN D NOS; VITAMIN B12 [CYANOCOBALAMIN]; GABAPENTIN; LAMICTAL

Current Illness: Bipolar disorder; Insomnia; Restless legs syndrome

ID: 1800255
Sex: U
Age:
State: WA

Vax Date:
Onset Date:
Rec V Date: 10/20/2021
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:

Allergies:

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

Symptoms: Myocarditis; Pericarditis; Based on the current case data, this case has been classified as invalid. This literature-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (Myocarditis) and PERICARDITIS (Pericarditis) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Myocarditis) (seriousness criteria hospitalization and medically significant) and PERICARDITIS (Pericarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Myocarditis) and PERICARDITIS (Pericarditis) outcome was unknown. Possible The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered MYOCARDITIS (Myocarditis) and PERICARDITIS (Pericarditis) to be possibly related. No relevant concomitant medications were reported. Two patients received a second vaccination after onset of myocarditis; neither had worsening of symptoms. All patients were discharged after a median of 2 days (IQR, 2-3 days). There were no readmissions or deaths. At last available follow-up (median, 23.5 days [IQR, 4.8-41.3 days] after symptom onset), 13 patients (65%; 95% CI, 43%- 82%) had symptom resolution and 7 (35%; 95% CI, 18%-57%) were improving. Pericarditis developed after the first immunization in 15 cases (40.5%; 95% CI, 26%-57%) and after the second immunization in 22 cases (59.5%; 95% CI, 44%-74%) (mRNA-1273 vaccine, 12 cases (32%). No treatment information was provided. Very limited information provided since in the report information of the case is only given as percentage without individual patient data. Medical query raised to author Company Comment: This case concerns a patient of unknown age and gender with no medical history disclosed, who experienced the expected serious adverse events of special interest of myocarditis and pericarditis. The events occurred on unknown date after the first dose of Spikevax (Moderna COVID-19 vaccine). The rechallenge was unknown since the events occurred after the first dose and there is no information about the second. The event was considered related to the vaccine per the reporter's assessment. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report. Very limited information is available in this case, so relevant data is requested. Most recent FOLLOW-UP information incorporated above includes: On 13-Oct-2021: Follow up received by safety on 13-Oct-2021 included an Email and does not contain any new information.; Sender's Comments: This case concerns a patient of unknown age and gender with no medical history disclosed, who experienced the expected serious adverse events of special interest of myocarditis and pericarditis. The events occurred on unknown date after the first dose of Spikevax (Moderna COVID-19 vaccine). The rechallenge was unknown since the events occurred after the first dose and there is no information about the second. The event was considered related to the vaccine per the reporter's assessment. The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report. Very limited information is available in this case, so relevant data is requested.

Other Meds:

Current Illness:

ID: 1800256
Sex: F
Age: 60
State: VA

Vax Date: 09/05/2021
Onset Date: 10/05/2021
Rec V Date: 10/20/2021
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: Feel weak; burning sensation in my chest; dizziness; neck felt really hot/neck got hotter; had red rash all over the front of me/ back of me; throat was numb; neck got redder; Vomiting; felt like I had the flu; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (felt like I had the flu), RASH ERYTHEMATOUS (had red rash all over the front of me/ back of me), PHARYNGEAL HYPOAESTHESIA (throat was numb), ERYTHEMA (neck got redder) and ASTHENIA (Feel weak) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A and 014C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Drug allergy (patient states that ?makes me sick to my stomach'). Concomitant products included METOPROLOL SUCCINATE (TOPROL), ASPIRIN [ACETYLSALICYLIC ACID] (Aspirin 325mg once a day) and OMEPRAZOLE MAGNESIUM (PRILOSEC [OMEPRAZOLE MAGNESIUM]) for an unknown indication. On 05-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Oct-2021, the patient experienced INFLUENZA LIKE ILLNESS (felt like I had the flu) and VOMITING (Vomiting). On 06-Oct-2021, the patient experienced RASH ERYTHEMATOUS (had red rash all over the front of me/ back of me), PHARYNGEAL HYPOAESTHESIA (throat was numb), ERYTHEMA (neck got redder) and FEELING HOT (neck felt really hot/neck got hotter). On 11-Oct-2021, the patient experienced ASTHENIA (Feel weak), CHEST PAIN (burning sensation in my chest) and DIZZINESS (dizziness). The patient was treated with DEXAMETHASONE ACETATE (DECADRON [DEXAMETHASONE ACETATE]) for Adverse event, at an unspecified dose and frequency; EPINEPHRINE for Adverse event, at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at an unspecified dose and frequency; KETOROLAC TROMETHAMINE (TORADOL) for Adverse event, at an unspecified dose and frequency and IVs for Adverse event, at an unspecified dose and frequency. At the time of the report, INFLUENZA LIKE ILLNESS (felt like I had the flu), RASH ERYTHEMATOUS (had red rash all over the front of me/ back of me), PHARYNGEAL HYPOAESTHESIA (throat was numb), ERYTHEMA (neck got redder), ASTHENIA (Feel weak), CHEST PAIN (burning sensation in my chest), FEELING HOT (neck felt really hot/neck got hotter), DIZZINESS (dizziness) and VOMITING (Vomiting) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.

Other Meds: TOPROL; Aspirin 325mg once a day; PRILOSEC [OMEPRAZOLE MAGNESIUM]

Current Illness: Drug allergy (patient states that ?makes me sick to my stomach')

ID: 1800257
Sex: F
Age: 50
State: CA

Vax Date: 09/22/2021
Onset Date: 09/22/2021
Rec V Date: 10/20/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: running nose; sneezing; allergy reaction; terrible diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (terrible diarrhea), RHINORRHOEA (running nose), SNEEZING (sneezing) and HYPERSENSITIVITY (allergy reaction) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination. No Medical History information was reported. On 22-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Sep-2021, the patient experienced DIARRHOEA (terrible diarrhea). On an unknown date, the patient experienced RHINORRHOEA (running nose), SNEEZING (sneezing) and HYPERSENSITIVITY (allergy reaction). At the time of the report, DIARRHOEA (terrible diarrhea) had not resolved and RHINORRHOEA (running nose), SNEEZING (sneezing) and HYPERSENSITIVITY (allergy reaction) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication details was reported. No treatment medication details was reported.

Other Meds:

Current Illness:

ID: 1800258
Sex: M
Age:
State: IA

Vax Date: 07/23/2021
Onset Date:
Rec V Date: 10/20/2021
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: MS; COPD; He couldn't feel his stomach. If he ate something, he could not tell if he ate it.; the shot almost killed me; Did not receive his second dose yet; Head felt it was as big as a Volkswagen/ had headaches/ really bad headache; This spontaneous case was reported by a consumer and describes the occurrence of MULTIPLE SCLEROSIS (MS) in a male patient of an unknown age 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 23-Jul-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 MULTIPLE SCLEROSIS (MS) (seriousness criterion medically significant), CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), ABDOMINAL DISCOMFORT (He couldn't feel his stomach. If he ate something, he could not tell if he ate it.), FEELING ABNORMAL (the shot almost killed me), PRODUCT DOSE OMISSION ISSUE (Did not receive his second dose yet) and HEADACHE (Head felt it was as big as a Volkswagen/ had headaches/ really bad headache). At the time of the report, MULTIPLE SCLEROSIS (MS), CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), ABDOMINAL DISCOMFORT (He couldn't feel his stomach. If he ate something, he could not tell if he ate it.), FEELING ABNORMAL (the shot almost killed me) and HEADACHE (Head felt it was as big as a Volkswagen/ had headaches/ really bad headache) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Did not receive his second dose yet) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. No treatment information was provided. Company comment This case refers to a male patient of unspecified age with no reported medical history who experienced the unexpected event of Multiple Sclerosis on an unknown date after the first dose of Spikevax. Rechallenge was assessed as not applicable. No causality assessment was provided by the reporter. The benefit-risk relationship of Spikevax is not affected by this report.; Sender's Comments: This case refers to a male patient of unspecified age with no reported medical history who experienced the unexpected event of Multiple Sclerosis on an unknown date after the first dose of Spikevax. Rechallenge was assessed as not applicable. No causality assessment was provided by the reporter. The benefit-risk relationship of Spikevax is not affected by this report.

Other Meds:

Current Illness:

ID: 1800259
Sex: F
Age:
State: TN

Vax Date:
Onset Date:
Rec V Date: 10/20/2021
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: Minor kidney problems; This spontaneous case was reported by a consumer and describes the occurrence of RENAL DISORDER (Minor kidney problems) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, 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 experienced RENAL DISORDER (Minor kidney problems). At the time of the report, RENAL DISORDER (Minor kidney problems) outcome was unknown. No concomitant medication details was reported. No treatment medication details was reported.

Other Meds:

Current Illness:

ID: 1800260
Sex: F
Age: 58
State: MS

Vax Date: 10/11/2021
Onset Date: 10/11/2021
Rec V Date: 10/20/2021
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: Dose administered >12 hours post puncture; stored at room temperature beyond 12 hours; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture) and PRODUCT STORAGE ERROR (stored at room temperature beyond 12 hours) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 061E21A) for COVID-19 vaccination. No Medical History information was reported. On 11-Oct-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture) and PRODUCT STORAGE ERROR (stored at room temperature beyond 12 hours). On 11-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Dose administered >12 hours post puncture) and PRODUCT STORAGE ERROR (stored at room temperature beyond 12 hours) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. patients received the second dose of Moderna COVID-19 vaccine from a vial that was punctured and stored at room temperature beyond 12 hours. no of vials is given as 1 , vial was initially stored in the refrigerator 2-oct-2021,first punctured on 10-oct-2021,administered on 11-oct-2021 at noon. Total amount of time the vial was exposed to room temperature range (8? to 25?C= 46? to 77?F): 30 hours. no concomitant and treatment medications are provided by the reporter. This case was linked to MOD-2021-348346 (Patient Link).

Other Meds:

Current Illness:

ID: 1800261
Sex: F
Age: 54
State: TN

Vax Date: 02/25/2021
Onset Date:
Rec V Date: 10/20/2021
Hospital:

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

Lab Data: Test Date: 20201124; Test Name: SARS-CoV-2 test; Test Result: Positive ; Result Unstructured Data: POSITIVE

Allergies:

Symptom List: Vomiting

Symptoms: mild headache and then went away; This spontaneous case was reported by a health care professional and describes the occurrence of HEADACHE (mild headache and then went away) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 040A21A and 031L20A) for COVID-19 vaccination. The patient's past medical history included Insomnia on 20-Oct-2015. Concurrent medical conditions included Bipolar disorder since 23-Oct-2015 and Restless leg syndrome since 20-Jun-2021. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) from 23-Oct-2015 to an unknown date and LAMOTRIGINE (LAMICTAL) from 23-Oct-2015 to an unknown date for Bipolar disorder, GABAPENTIN from 20-Jun-2021 to an unknown date for Restless leg syndrome, ESTRADIOL (ESTROGEN), ROSUVASTATIN CALCIUM (CRESTOR), VITAMIN D [VITAMIN D NOS] and CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) for an unknown indication. On 25-Feb-2021 at 1:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021 at 1:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced HEADACHE (mild headache and then went away). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Adverse event, at a dose of 1 dosage form and IBUPROFEN ongoing since an unknown date for Adverse event, at a dose of 1 dosage form. In 2021, HEADACHE (mild headache and then went away) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Nov-2020, SARS-CoV-2 test: positive (Positive) POSITIVE. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. This case was linked to MOD-2021-348352, MOD-2021-348434 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 13-Oct-2021: Follow up received on 13-oct-2021 Patient demographic details added, Medical history with start date added, Suspect anatomical location added,Concomitant medication with indication, Dose,Route added, Event start/stop date for third dose added, newverbatim added for event headache (PT) and intensity of event updated from mild to severe for 3rd dose event

Other Meds: ESTROGEN; LEXAPRO; CRESTOR; VITAMIN D [VITAMIN D NOS]; VITAMIN B12 [CYANOCOBALAMIN]; GABAPENTIN; LAMICTAL

Current Illness: Bipolar disorder; Restless leg syndrome

ID: 1800262
Sex: M
Age: 45
State: CA

Vax Date: 10/09/2021
Onset Date: 10/09/2021
Rec V Date: 10/20/2021
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: dose of the Moderna vaccine was administered that was expired by two days; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (dose of the Moderna vaccine was administered that was expired by two days) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. No Medical History information was reported. On 09-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 09-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (dose of the Moderna vaccine was administered that was expired by two days). On 09-Oct-2021, EXPIRED PRODUCT ADMINISTERED (dose of the Moderna vaccine was administered that was expired by two days) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were not reported. No treatment medications were not provided. Most recent FOLLOW-UP information incorporated above includes: On 14-Oct-2021: Significant follow up : Event start date added., anatomical location of vaccine updated, patient demographics added

Other Meds:

Current Illness:

ID: 1800263
Sex: F
Age: 54
State: TN

Vax Date: 02/25/2021
Onset Date: 09/30/2021
Rec V Date: 10/20/2021
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: Test Date: 20201124; Test Name: COVID-19 screening; Test Result: Positive

Allergies:

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

Symptoms: It is interfering with her work; took too much ibuprofen and now she has a stomach upset; daily headache she cannot get rid off; This spontaneous case was reported by an other health care professional and describes the occurrence of IMPAIRED WORK ABILITY (It is interfering with her work), ABDOMINAL DISCOMFORT (took too much ibuprofen and now she has a stomach upset) and HEADACHE (daily headache she cannot get rid off) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019F21A, 040A21A and 031L20A) for COVID-19 vaccination. No medical history was provided by the reporter. The patient's past medical history included COVID-19 on 24-Nov-2020. Concurrent medical conditions included Bipolar disorder since 23-Oct-2015, Insomnia since 23-Oct-2015 and Restless leg syndrome since 23-Jun-2021. Concomitant products included ESCITALOPRAM OXALATE (LEXAPRO) from 23-Oct-2015 to an unknown date for Bipolar disorder, GABAPENTIN from 20-Jun-2021 to an unknown date for Insomnia and Restless leg syndrome, ESTRADIOL (ESTROGEN), ROSUVASTATIN CALCIUM (CRESTOR), Vitamin D and Vitamin B12 for an unknown indication. On 25-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 30-Sep-2021, the patient experienced IMPAIRED WORK ABILITY (It is interfering with her work), ABDOMINAL DISCOMFORT (took too much ibuprofen and now she has a stomach upset) and HEADACHE (daily headache she cannot get rid off). The patient was treated with IBUPROFEN at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency. On 12-Oct-2021, HEADACHE (daily headache she cannot get rid off) had resolved. At the time of the report, IMPAIRED WORK ABILITY (It is interfering with her work) and ABDOMINAL DISCOMFORT (took too much ibuprofen and now she has a stomach upset) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Nov-2020, SARS-CoV-2 test: positive Positive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. It was reported that patient took too much ibuprofen and then she had a stomach upset. Patient reported that the headache is right above the ears and on top of the head, it was not like a sinus headache, it was not like the headaches she had before, it was like up in her head. Patient has been taking Lanietal 150 mg po for bipolar disorder from 23-OCT-2015 as concomitant medication. This case was linked to MOD-2021-348352, MOD-2021-348417 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 13-Oct-2021: Follow up received on 13-OCT-2021. Patient demographic details and medical history added. New conmeds added. Event outcome updated.

Other Meds: ESTROGEN; GABAPENTIN; LEXAPRO; CRESTOR; Vitamin D; Vitamin B12

Current Illness: Bipolar disorder; Insomnia; Restless leg syndrome

Date Died: 10/01/2021

ID: 1800264
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/20/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: Received the Moderna COVID-19 Vaccine and all had the same problems and that one of them died last week; All had the same problems; 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 DEATH (Received the Moderna COVID-19 Vaccine and all had the same problems and that one of them died last week) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. 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 DEATH (Received the Moderna COVID-19 Vaccine and all had the same problems and that one of them died last week) (seriousness criteria death and medically significant) and VACCINATION COMPLICATION (All had the same problems). The patient died in October 2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, VACCINATION COMPLICATION (All had the same problems) outcome was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided. Company comment: This case concerns a patient of unknown age and gender with no reported medical history, who experienced the unexpected serious event of Death (unknown cause). The event occurred an unknown number of days after tan unspecified dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a patient of unknown age and gender with no reported medical history, who experienced the unexpected serious event of Death (unknown cause). The event occurred an unknown number of days after tan unspecified dose of mRNA-1273 vaccine.The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: Unknown cause of death

Other Meds:

Current Illness:

ID: 1800265
Sex: F
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 10/20/2021
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: Warm to the touch Injection Site after 3rd shot; Itching from Head to toe after 3rd shot; Itchy Injection Site after 3rd shot; Swollen Injection Site after 3rd shot; Histamine reaction after 3rd shot; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE WARMTH (Warm to the touch Injection Site after 3rd shot), PRURITUS (Itching from Head to toe after 3rd shot), INJECTION SITE PRURITUS (Itchy Injection Site after 3rd shot), INJECTION SITE SWELLING (Swollen Injection Site after 3rd shot) and ALLERGY TO VACCINE (Histamine reaction after 3rd shot) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy (allergic to sulfa). On an unknown date, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE WARMTH (Warm to the touch Injection Site after 3rd shot), PRURITUS (Itching from Head to toe after 3rd shot), INJECTION SITE PRURITUS (Itchy Injection Site after 3rd shot), INJECTION SITE SWELLING (Swollen Injection Site after 3rd shot) and ALLERGY TO VACCINE (Histamine reaction after 3rd shot). At the time of the report, INJECTION SITE WARMTH (Warm to the touch Injection Site after 3rd shot), PRURITUS (Itching from Head to toe after 3rd shot), INJECTION SITE PRURITUS (Itchy Injection Site after 3rd shot), INJECTION SITE SWELLING (Swollen Injection Site after 3rd shot) and ALLERGY TO VACCINE (Histamine reaction after 3rd shot) outcome was unknown. No relevant concomitant medication was reported. Treatment information were not provided.

Other Meds:

Current Illness: Drug allergy (allergic to sulfa)

ID: 1800266
Sex: F
Age:
State: AZ

Vax Date:
Onset Date:
Rec V Date: 10/20/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: Mammogram; Result Unstructured Data: Mammogram done three months prior and was fine

Allergies:

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

Symptoms: After getting the COVID 19 vaccine the lady was diagnosed with cancer; This spontaneous case was reported by a consumer and describes the occurrence of NEOPLASM MALIGNANT (After getting the COVID 19 vaccine the lady was diagnosed with cancer) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced NEOPLASM MALIGNANT (After getting the COVID 19 vaccine the lady was diagnosed with cancer) (seriousness criterion medically significant). At the time of the report, NEOPLASM MALIGNANT (After getting the COVID 19 vaccine the lady was diagnosed with cancer) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Mammogram: normal (normal) Mammogram done three months prior and was fine. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were reported. No treatment information was provided. Patient had no history of breast cancer in her family as per the reporter. Assessment is limited due to very scarce information regarding the patient age, medical history, habits, familiar history, exact vaccination date, concomitant medications, type of malignant neoplasm and other risk factors. Company Comment - This case concerns a female patient of unknown age with no medical history reported, who experienced the unexpected serious event of neoplasm malignant of unknown type and location. The event occurred on unknown date after the first dose of Spikevax (Moderna COVID-19 vaccine). The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report. Very limited information is available in this case.; Sender's Comments: This case concerns a female patient of unknown age with no medical history reported, who experienced the unexpected serious event of neoplasm malignant of unknown type and location. The event occurred on unknown date after the first dose of Spikevax (Moderna COVID-19 vaccine). The benefit-risk relationship of Spikevax (Moderna COVID-19 vaccine) is not affected by this report. Very limited information is available in this case.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am