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**
PLEASE CHECK BACK SOON
Download the files above while you wait.







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: 1644344
Sex: F
Age: 39
State: NC

Vax Date: 03/06/2021
Onset Date: 03/06/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: have not received second dose; Swollen lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Swollen lymph nodes) and PRODUCT DOSE OMISSION ISSUE (have not received second dose) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. No Medical History information was reported. On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Mar-2021, the patient experienced LYMPHADENOPATHY (Swollen lymph nodes). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (have not received second dose). On 06-Mar-2021, LYMPHADENOPATHY (Swollen lymph nodes) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (have not received second dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not reported. Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 13-Aug-2021: Non-significant follow up, patient demographic was updated.

Other Meds:

Current Illness:

ID: 1644345
Sex: F
Age:
State: GA

Vax Date: 05/07/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: Blood clot in her left leg; Has been sick ever since; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clot in her left leg) and ILLNESS (Has been sick ever since) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A and 005C21A) for COVID-19 vaccination. No Medical History information was reported. On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Blood clot in her left leg) (seriousness criteria hospitalization, medically significant and life threatening) and ILLNESS (Has been sick ever since) (seriousness criteria hospitalization and life threatening). The patient was hospitalized on 27-Jun-2021 due to ILLNESS and THROMBOSIS. The patient was treated with RIVAROXABAN (XARELTO VASCULAR) for Thrombosis, at a dose of 15 milligram twice a day and RIVAROXABAN (XARELTO VASCULAR) for Thrombosis, at a dose of 20 milligram once a day. At the time of the report, THROMBOSIS (Blood clot in her left leg) and ILLNESS (Has been sick ever since) outcome was unknown. On 27-JUN-2021 patient went to the emergency room and was hospitalized overnight due to the blood clot in her left leg currently patient is on blood thinner treatment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1644346
Sex: M
Age: 74
State: NV

Vax Date: 06/24/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: heterotopic ossification; hunch back; This spontaneous case was reported by a consumer and describes the occurrence of PERI-SPINAL HETEROTOPIC OSSIFICATION (heterotopic ossification) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Shoulder operation NOS (shoulder) in March 2021. On 24-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PERI-SPINAL HETEROTOPIC OSSIFICATION (heterotopic ossification) (seriousness criterion medically significant) and KYPHOSIS (hunch back). At the time of the report, PERI-SPINAL HETEROTOPIC OSSIFICATION (heterotopic ossification) and KYPHOSIS (hunch back) outcome was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided. Company comment: Although a temporal; association exist, based on the information provided, it is unlikely that the reported event is associated with the administration of mRNA-1273 . subject is of an advanced age and event usually occur after spinal cord injury.; Sender's Comments: Although a temporal; association exist, based on the information provided, it is unlikely that the reported event is associated with the administration of mRNA-1273 . subject is of an advanced age and event usually occur after spinal cord injury

Other Meds:

Current Illness:

ID: 1644347
Sex: F
Age: 12
State: NE

Vax Date: 07/31/2021
Onset Date: 07/31/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Patient vaccinated with expired Moderna Covid-19 vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient vaccinated with expired Moderna Covid-19 vaccine) in a 13-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. No Medical History information was reported. On 31-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Jul-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient vaccinated with expired Moderna Covid-19 vaccine). On 31-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Patient vaccinated with expired Moderna Covid-19 vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomittant medications and treatment was reported by the patient. Most recent FOLLOW-UP information incorporated above includes: On 12-Aug-2021: Follow up received contains new information included updated demographic information of patient.

Other Meds:

Current Illness:

ID: 1644348
Sex: M
Age: 38
State: GA

Vax Date: 07/30/2021
Onset Date: 07/30/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210730; Test Name: Body temperature; Result Unstructured Data: Fever ranges from 101 to 103 degrees F

Allergies:

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

Symptoms: Had a little cough; Fever ranges from 101 to 103 degrees F; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (Had a little cough) and PYREXIA (Fever ranges from 101 to 103 degrees F) in a 38-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included TRAZODONE for an unknown indication. On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021, the patient experienced COUGH (Had a little cough) and PYREXIA (Fever ranges from 101 to 103 degrees F). At the time of the report, COUGH (Had a little cough) and PYREXIA (Fever ranges from 101 to 103 degrees F) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jul-2021, Body temperature: 101 to 103 degrees f (High) Fever ranges from 101 to 103 degrees F. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment medication was reported. Most recent FOLLOW-UP information incorporated above includes: On 17-Aug-2021: Follow-up information contain correction of spelling in patient first name.

Other Meds: TRAZODONE

Current Illness:

ID: 1644349
Sex: F
Age: 88
State: GA

Vax Date: 03/29/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: left elbow becomes paralyzed; on and off sharp left elbow pain; This spontaneous case was reported by a consumer and describes the occurrence of PARALYSIS (left elbow becomes paralyzed) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037B21A and 038A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Mastectomy in 2007. Concurrent medical conditions included Drug allergy (Has a lot of medication allergies, but did not list them.). Concomitant products included LEVOTHYROXINE, AMLODIPINE, METOPROLOL, LISINOPRIL, GABAPENTIN, FORMOTEROL FUMARATE (PERFOROMIST), ASCORBIC ACID, BETACAROTENE, CUPRIC OXIDE, TOCOPHERYL ACETATE, ZINC OXIDE (PRESERVISION) and MULTIVITAMIN [VITAMINS NOS] for an unknown indication. On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PARALYSIS (left elbow becomes paralyzed) (seriousness criterion medically significant) and ARTHRALGIA (on and off sharp left elbow pain). At the time of the report, PARALYSIS (left elbow becomes paralyzed) and ARTHRALGIA (on and off sharp left elbow pain) outcome was unknown. Additional concomitant medications include vitamin B12 and Timolol Maleate 5% Eye Drops. This patient received the second dose in the series and she had a little reaction. She started experiencing on and off sharp left elbow pain. She stated her left elbow becomes paralyzed where she can't move it for 1/2 to 1 second and then it resolves. She stated these events come and go. She did not report these events to her healthcare provider. She has not treated her elbow pain with any medications. Very limited information regarding this events has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Very limited information regarding this events has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: LEVOTHYROXINE; AMLODIPINE; METOPROLOL; LISINOPRIL; GABAPENTIN; PERFOROMIST; PRESERVISION; MULTIVITAMIN [VITAMINS NOS]

Current Illness: Drug allergy (Has a lot of medication allergies, but did not list them.)

ID: 1644350
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
Hospital: Y

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: had a reaction; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (had a reaction) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (had a reaction) (seriousness criterion hospitalization). At the time of the report, ADVERSE EVENT (had a reaction) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product was not provided. Treatment medication was not reported.; Sender's Comments: Very limited information regarding the events has been provided at this time.

Other Meds:

Current Illness:

ID: 1644351
Sex: F
Age: 72
State: MA

Vax Date: 03/02/2021
Onset Date: 04/06/2021
Rec V Date: 08/28/2021
Hospital: Y

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

Lab Data: Test Name: X-ray; Result Unstructured Data: gallstones

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: stomach pain; gallstones; Shuffle but can't walk without a walker; painful from knee to the ankle; bothers me so bad I can hardly walk; physical problem; stomach pain; whole body was really numb, still has the numbness and the pain; still really painful, especially in the evening; feet started feeling funny, legs started getting heavy; legs started getting heavy, gradually moved from her legs and feet all the way up; stomach issues; pain in middle of chest; pain under both breasts; pain under both arms; pain up my back; pain up my neck; numbness on bottom lip; headache; pain in shoulders; can't go up and down stairs or anything; Myalgia; This spontaneous case was reported by a consumer and describes the occurrence of the second episode of ABDOMINAL PAIN UPPER (stomach pain) and CHOLELITHIASIS (gallstones) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 010A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure and Heartburn. Concomitant products included POTASSIUM and PROCATEROL HYDROCHLORIDE (PRO-AIR) for an unknown indication. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced MOBILITY DECREASED (can't go up and down stairs or anything) and MYALGIA (Myalgia). On 13-Apr-2021, the patient experienced LIMB DISCOMFORT (feet started feeling funny, legs started getting heavy), CONDITION AGGRAVATED (legs started getting heavy, gradually moved from her legs and feet all the way up), ABDOMINAL DISCOMFORT (stomach issues), CHEST PAIN (pain in middle of chest), BREAST PAIN (pain under both breasts), PAIN IN EXTREMITY (pain under both arms), BACK PAIN (pain up my back), NECK PAIN (pain up my neck), HYPOAESTHESIA ORAL (numbness on bottom lip), HYPOAESTHESIA (whole body was really numb, still has the numbness and the pain), PAIN (still really painful, especially in the evening), GAIT DISTURBANCE (bothers me so bad I can hardly walk), MALAISE (physical problem), the first episode of ABDOMINAL PAIN UPPER (stomach pain), HEADACHE (headache) and ARTHRALGIA (pain in shoulders). On 01-Jun-2021, the patient experienced the second episode of ABDOMINAL PAIN UPPER (stomach pain) (seriousness criterion hospitalization prolonged) and CHOLELITHIASIS (gallstones) (seriousness criterion hospitalization). On 13-Jun-2021, the patient experienced PAIN IN EXTREMITY (painful from knee to the ankle). On 21-Jul-2021, the patient experienced GAIT INABILITY (Shuffle but can't walk without a walker). The patient was hospitalized on 01-Jun-2021 due to ABDOMINAL PAIN UPPER and CHOLELITHIASIS. At the time of the report, last episode of ABDOMINAL PAIN UPPER (stomach pain), CHOLELITHIASIS (gallstones), MOBILITY DECREASED (can't go up and down stairs or anything), LIMB DISCOMFORT (feet started feeling funny, legs started getting heavy), CONDITION AGGRAVATED (legs started getting heavy, gradually moved from her legs and feet all the way up), ABDOMINAL DISCOMFORT (stomach issues), CHEST PAIN (pain in middle of chest), BREAST PAIN (pain under both breasts), PAIN IN EXTREMITY (pain under both arms), BACK PAIN (pain up my back), NECK PAIN (pain up my neck), HYPOAESTHESIA ORAL (numbness on bottom lip), GAIT INABILITY (Shuffle but can't walk without a walker), PAIN (still really painful, especially in the evening), PAIN IN EXTREMITY (painful from knee to the ankle), GAIT DISTURBANCE (bothers me so bad I can hardly walk), MALAISE (physical problem), MYALGIA (Myalgia), HEADACHE (headache) and ARTHRALGIA (pain in shoulders) outcome was unknown and HYPOAESTHESIA (whole body was really numb, still has the numbness and the pain) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, X-ray: gallstones (abnormal) gallstones. Treatment medication was not reported. Concomitant products blood pressure medication, nasal spray, vitamins and heartburn medication was reported. After several x-rays and other test patient was diagnosed with gallstones reported. The patient underwent an operation to have her gallbladder removed. Based on the 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. However, the medical history of 3moths and gender factor could be a contributory factor.; Sender's Comments: Based on the 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. However, the medical history of 3moths and gender factor could be a contributory factor.

Other Meds: POTASSIUM; PRO-AIR

Current Illness: Blood pressure; Heartburn

ID: 1644352
Sex: U
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: We found other cases of HLH post-COVID vaccination, including patients that received the Moderna vaccine./11 VAERS reports of the HLH condition after the Moderna vaccine.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of HAEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS (We found other cases of HLH post-COVID vaccination, including patients that received the Moderna vaccine./11 VAERS reports of the HLH condition after the Moderna vaccine.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced HAEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS (We found other cases of HLH post-COVID vaccination, including patients that received the Moderna vaccine./11 VAERS reports of the HLH condition after the Moderna vaccine.) (seriousness criterion medically significant). At the time of the report, HAEMOPHAGOCYTIC LYMPHOHISTIOCYTOSIS (We found other cases of HLH post-COVID vaccination, including patients that received the Moderna vaccine./11 VAERS reports of the HLH condition after the Moderna vaccine.) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The reporter stated that they found in Vaers 11 reports of the HLH condition after the Moderna vaccine. No concomitant product information was provided by the reporter. No treatment information was provided by the reporter. Company comment: Very scant information is given and follow-up is requested. Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Follow-up information included no new information.; Sender's Comments: Very scant information is given and follow-up is requested. Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1644353
Sex: F
Age: 51
State: AZ

Vax Date: 06/03/2021
Onset Date: 06/04/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: feel only a little numbness on their feet/still have the numbness they always have had in their feet, toes, and fingers; I had an adverse reaction to vaccine, it was not compatible with my psychotropics, Geodon?since the reaction I've meltdowns with people giving me poor customer; suicidal thoughts and strong urges to hurt myself ie death; has not gotten the second dose yet/I keep forgetting to go back to get the second dose; feet hurt only on occasion like when cleaning, walked 2 mile; could walk again,neropathy is gone,pain is gone,feel fine, able to walk to bathroom, dance, able to walk the dog on a 5min walk/ the patient has not had to take as much medication that they usually do when they have migraines; still feel tired on their feet "like you have to kick back and relax; This spontaneous case was reported by a consumer and describes the occurrence of SUICIDAL IDEATION (suicidal thoughts and strong urges to hurt myself ie death) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Neuropathy (diagnosed with neuropathy about 4 years ago. The patient stated it was debilitating, they couldn't walk, they crawled, they were in a lot of pain, and nothing they tried helped.), Migraine, Debility, Chronic pain, Crawling sensation and Walking disability. Concomitant products included CYCLOBENZAPRINE HYDROCHLORIDE (FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE]), PREGABALIN (LYRICA), BUTALBITAL, CAFFEINE, PARACETAMOL (FIORICET), LORATADINE (LARITOL), LUMATEPERONE TOSYLATE (CAPLYTA) and ZIPRASIDONE HYDROCHLORIDE (GEODON [ZIPRASIDONE HYDROCHLORIDE]) for an unknown indication. On 03-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Jun-2021, the patient experienced PAIN IN EXTREMITY (feet hurt only on occasion like when cleaning, walked 2 mile), THERAPEUTIC RESPONSE UNEXPECTED (could walk again,neropathy is gone,pain is gone,feel fine, able to walk to bathroom, dance, able to walk the dog on a 5min walk/ the patient has not had to take as much medication that they usually do when they have migraines) and FATIGUE (still feel tired on their feet "like you have to kick back and relax). On an unknown date, the patient experienced SUICIDAL IDEATION (suicidal thoughts and strong urges to hurt myself ie death) (seriousness criterion medically significant), HYPOAESTHESIA (feel only a little numbness on their feet/still have the numbness they always have had in their feet, toes, and fingers), ADVERSE REACTION (I had an adverse reaction to vaccine, it was not compatible with my psychotropics, Geodon?since the reaction I've meltdowns with people giving me poor customer) and PRODUCT DOSE OMISSION ISSUE (has not gotten the second dose yet/I keep forgetting to go back to get the second dose). At the time of the report, SUICIDAL IDEATION (suicidal thoughts and strong urges to hurt myself ie death), PAIN IN EXTREMITY (feet hurt only on occasion like when cleaning, walked 2 mile), HYPOAESTHESIA (feel only a little numbness on their feet/still have the numbness they always have had in their feet, toes, and fingers), ADVERSE REACTION (I had an adverse reaction to vaccine, it was not compatible with my psychotropics, Geodon?since the reaction I've meltdowns with people giving me poor customer), THERAPEUTIC RESPONSE UNEXPECTED (could walk again,neropathy is gone,pain is gone,feel fine, able to walk to bathroom, dance, able to walk the dog on a 5min walk/ the patient has not had to take as much medication that they usually do when they have migraines) and FATIGUE (still feel tired on their feet "like you have to kick back and relax) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (has not gotten the second dose yet/I keep forgetting to go back to get the second dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient was advised by her psychiatrist not to take the second injection. No treatment information was provided. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Concomitant medical conditions/medications could be potentially confounders/co-suspects for the events. Further information has been requested. Most recent FOLLOW-UP information incorporated above includes: On 10-Aug-2021: Updated information about past medical history, start date of 1st dose of vaccine, additional concomitant medications were added and update the onset date for events and additional events were added On 18-Aug-2021: Significant follow-up received and added new events suicidal intention and adverse event; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Concomitant medical conditions/medications could be potentially confounders/co-suspects for the events. Further information has been requested.

Other Meds: FLEXERIL [CYCLOBENZAPRINE HYDROCHLORIDE]; LYRICA; FIORICET; LARITOL; CAPLYTA; GEODON [ZIPRASIDONE HYDROCHLORIDE]

Current Illness: Chronic pain; Debility; Migraine; Neuropathy (diagnosed with neuropathy about 4 years ago. The patient stated it was debilitating, they couldn't walk, they crawled, they were in a lot of pain, and nothing they tried helped.)

ID: 1644354
Sex: F
Age: 48
State:

Vax Date: 05/11/2021
Onset Date: 07/01/2021
Rec V Date: 08/28/2021
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: muscles tigthened up; joints tightened up; could barely walk and get up from bed; bumps/welts under her skin where the veins are; in serious pain; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TIGHTNESS (muscles tigthened up), JOINT STIFFNESS (joints tightened up), BEDRIDDEN (could barely walk and get up from bed), URTICARIA (bumps/welts under her skin where the veins are) and PAIN (in serious pain) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination. No Medical History information was reported. On 11-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2021, the patient experienced MUSCLE TIGHTNESS (muscles tigthened up), JOINT STIFFNESS (joints tightened up), BEDRIDDEN (could barely walk and get up from bed), URTICARIA (bumps/welts under her skin where the veins are) and PAIN (in serious pain). At the time of the report, MUSCLE TIGHTNESS (muscles tigthened up), JOINT STIFFNESS (joints tightened up), BEDRIDDEN (could barely walk and get up from bed), URTICARIA (bumps/welts under her skin where the veins are) and PAIN (in serious pain) had not resolved. No relevant concomitant medications were reported. No treatment information was provided. This case was linked to MOD-2021-273412 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1644355
Sex: M
Age: 65
State: AL

Vax Date: 07/07/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: body temperature; Result Unstructured Data: 94.5?F; Test Date: 2021; Test Name: body temperature; Result Unstructured Data: 104?F; Test Date: 2021; Test Name: White blood cell count; Result Unstructured Data: elevated

Allergies:

Symptom List: Rash, Urticaria

Symptoms: Cellulitis - A staph infection,mainly around the ankle; Staph infection,staph infection at right lower leg and upper part of the leg, around the ankle and then up and down on the right leg; Adverse reaction; Sore arm; Ran fevers from 94.5 degrees (low) to under 104 degrees (high); This spontaneous case was reported by a consumer and describes the occurrence of CELLULITIS STAPHYLOCOCCAL (Cellulitis - A staph infection,mainly around the ankle) and STAPHYLOCOCCAL INFECTION (Staph infection,staph infection at right lower leg and upper part of the leg, around the ankle and then up and down on the right leg) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 07-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced CELLULITIS STAPHYLOCOCCAL (Cellulitis - A staph infection,mainly around the ankle) (seriousness criterion medically significant), STAPHYLOCOCCAL INFECTION (Staph infection,staph infection at right lower leg and upper part of the leg, around the ankle and then up and down on the right leg) (seriousness criterion medically significant), ADVERSE REACTION (Adverse reaction), MYALGIA (Sore arm) and PYREXIA (Ran fevers from 94.5 degrees (low) to under 104 degrees (high)). The patient was treated with SULFAMETHOXAZOLE, TRIMETHOPRIM (BACTRIM) at a dose of 500 milligram; CEFALEXIN MONOHYDRATE (KEFLEX [CEFALEXIN MONOHYDRATE]) at a dose of 500 milligram and DOXYCYCLINE for Cellulitis, at a dose of 2 days. At the time of the report, CELLULITIS STAPHYLOCOCCAL (Cellulitis - A staph infection,mainly around the ankle) and STAPHYLOCOCCAL INFECTION (Staph infection,staph infection at right lower leg and upper part of the leg, around the ankle and then up and down on the right leg) had resolved and ADVERSE REACTION (Adverse reaction), MYALGIA (Sore arm) and PYREXIA (Ran fevers from 94.5 degrees (low) to under 104 degrees (high)) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Body temperature: 94.5 (Low) 94.5?F and 104 (High) 104?F. In 2021, White blood cell count: elevated (High) elevated. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. Patient stated that blood work was done, and everything was normal except for the white blood cell count which was elevated. Very limited information regarding this event/s has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Very limited information regarding this event/s has been provided at this time. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1644356
Sex: F
Age: 58
State: OH

Vax Date: 04/26/2021
Onset Date: 04/26/2021
Rec V Date: 08/28/2021
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: MRI; Result Unstructured Data: showed nothing wrong

Allergies:

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

Symptoms: sore throat; headache/headaches are debilitating 2 to 3 times per week/headaches each day; ringing in both of her ears/ringing more pronounced in her right ear; fever; mild muscle pain in her left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (sore throat), HEADACHE (headache/headaches are debilitating 2 to 3 times per week/headaches each day) and TINNITUS (ringing in both of her ears/ringing more pronounced in her right ear) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Apr-2021, the patient experienced VACCINATION SITE PAIN (mild muscle pain in her left injection site arm). On 24-May-2021, the patient experienced HEADACHE (headache/headaches are debilitating 2 to 3 times per week/headaches each day) (seriousness criterion medically significant), TINNITUS (ringing in both of her ears/ringing more pronounced in her right ear) (seriousness criterion medically significant) and PYREXIA (fever). On an unknown date, the patient experienced OROPHARYNGEAL PAIN (sore throat) (seriousness criterion medically significant). At the time of the report, OROPHARYNGEAL PAIN (sore throat), HEADACHE (headache/headaches are debilitating 2 to 3 times per week/headaches each day), TINNITUS (ringing in both of her ears/ringing more pronounced in her right ear), PYREXIA (fever) and VACCINATION SITE PAIN (mild muscle pain in her left injection site arm) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: showed nothing wrong (normal) showed nothing wrong. Steroids , antibiotics used as treatment medications. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-273428 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

Date Died: 05/29/2021

ID: 1644357
Sex: M
Age: 64
State:

Vax Date: 04/24/2021
Onset Date: 05/15/2021
Rec V Date: 08/28/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: Chest pain/Heart attack symptoms; Patient did not seem himself; Fatal heart attack; Shortness of breath; Pressure in his jaw; Stabbing pain in his back; Headache; This spontaneous case was reported by a patient family member or friend and describes the occurrence of MYOCARDIAL INFARCTION (Fatal heart attack), CHEST PAIN (Chest pain/Heart attack symptoms), DYSPNOEA (Shortness of breath), JOINT STIFFNESS (Pressure in his jaw), BACK PAIN (Stabbing pain in his back) and HEADACHE (Headache) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A and 001C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], AMLODIPINE and LOSARTAN for an unknown indication. On 24-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 15-May-2021, the patient experienced CHEST PAIN (Chest pain/Heart attack symptoms) (seriousness criterion hospitalization). On 24-May-2021, the patient experienced DYSPNOEA (Shortness of breath) (seriousness criterion hospitalization), JOINT STIFFNESS (Pressure in his jaw) (seriousness criterion hospitalization), BACK PAIN (Stabbing pain in his back) (seriousness criterion hospitalization) and HEADACHE (Headache) (seriousness criterion hospitalization). On 29-May-2021, the patient experienced MYOCARDIAL INFARCTION (Fatal heart attack) (seriousness criteria death and medically significant). On an unknown date, the patient experienced FEELING ABNORMAL (Patient did not seem himself). The patient was hospitalized from 24-May-2021 to 26-May-2021 due to CHEST PAIN. The patient died on 29-May-2021. The reported cause of death was fatal heart attack. It is unknown if an autopsy was performed. At the time of death, CHEST PAIN (Chest pain/Heart attack symptoms), DYSPNOEA (Shortness of breath), JOINT STIFFNESS (Pressure in his jaw), BACK PAIN (Stabbing pain in his back), HEADACHE (Headache) and FEELING ABNORMAL (Patient did not seem himself) outcome was unknown. Treatment information was not provided. This is a case of a 64 yo Male who died of a Myocardial Infarction 7 days after receiving the second dose. Very limited information regarding these events have been provided at this time. Patient's symptoms of jaw pain, pressure I his head and chest pain prior to vaccination may be a confounding factor to the events. No further information is expected. This case was linked to MOD-2021-287620 (Patient Link).; Sender's Comments: This is a case of a 64 yo Male who died of a Myocardial Infarction 7 days after receiving the second dose. Very limited information regarding these events have been provided at this time. Patient's symptoms of jaw pain, pressure I his head and chest pain prior to vaccination may be a confounding factor to the events. No further information is expected.; Reported Cause(s) of Death: Fatal Heart attack

Other Meds: ASPIRIN [ACETYLSALICYLIC ACID]; AMLODIPINE; LOSARTAN

Current Illness:

ID: 1644358
Sex: M
Age:
State: AL

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: Long hauler, Long haul symptoms and about killed him; This spontaneous case was reported by a consumer and describes the occurrence of POST-ACUTE COVID-19 SYNDROME (Long hauler, Long haul symptoms and about killed him) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced POST-ACUTE COVID-19 SYNDROME (Long hauler, Long haul symptoms and about killed him). At the time of the report, POST-ACUTE COVID-19 SYNDROME (Long hauler, Long haul symptoms and about killed him) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1644359
Sex: F
Age: 56
State: CA

Vax Date: 03/18/2021
Onset Date: 05/01/2021
Rec V Date: 08/28/2021
Hospital: Y

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

Lab Data: Test Name: Blood potassium; Result Unstructured Data: Low; Test Name: blood sodium; Result Unstructured Data: Low; Test Date: 20210502; Test Name: platelet count; Result Unstructured Data: had a complete platelet crash; her platelet had gone from 314 to 14

Allergies:

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

Symptoms: Blood clot; Aggravated diverticulitis; Chills; Massive headache; cant raise hand over head; covid arm; she did not feel good; Urinary infection; Platelet crash; her platelet had gone from 314 to 14; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of THROMBOSIS (Blood clot), DIVERTICULITIS (Aggravated diverticulitis), CHILLS (Chills), HEADACHE (Massive headache), VACCINATION SITE MOVEMENT IMPAIRMENT (cant raise hand over head), VACCINATION SITE REACTION (covid arm), FEELING ABNORMAL (she did not feel good), URINARY TRACT INFECTION (Urinary infection) and THROMBOCYTOPENIA (Platelet crash; her platelet had gone from 314 to 14) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003B21A and 027B21A) for COVID-19 vaccination. Concomitant products included LISINOPRIL and LEVOTHYROXINE for an unknown indication. On 18-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-May-2021, the patient experienced URINARY TRACT INFECTION (Urinary infection) (seriousness criterion hospitalization). On 02-May-2021, the patient experienced THROMBOCYTOPENIA (Platelet crash; her platelet had gone from 314 to 14) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced THROMBOSIS (Blood clot) (seriousness criteria hospitalization and medically significant), DIVERTICULITIS (Aggravated diverticulitis) (seriousness criteria hospitalization and medically significant), CHILLS (Chills) (seriousness criterion hospitalization), HEADACHE (Massive headache) (seriousness criterion hospitalization), VACCINATION SITE MOVEMENT IMPAIRMENT (cant raise hand over head) (seriousness criterion hospitalization), VACCINATION SITE REACTION (covid arm) (seriousness criterion hospitalization) and FEELING ABNORMAL (she did not feel good) (seriousness criterion hospitalization). The patient was hospitalized for 9 days due to THROMBOCYTOPENIA. At the time of the report, THROMBOSIS (Blood clot), DIVERTICULITIS (Aggravated diverticulitis), CHILLS (Chills), HEADACHE (Massive headache), VACCINATION SITE MOVEMENT IMPAIRMENT (cant raise hand over head), VACCINATION SITE REACTION (covid arm), FEELING ABNORMAL (she did not feel good), URINARY TRACT INFECTION (Urinary infection) and THROMBOCYTOPENIA (Platelet crash; her platelet had gone from 314 to 14) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-May-2021, Platelet count: low (Low) had a complete platelet crash; her platelet had gone from 314 to 14. On an unknown date, Blood potassium: low (Low) Low. On an unknown date, Blood sodium: low (Low) Low. Antibiotics used as a treatment medication. Treatment: Blood transfusion. It was reported that patient went to the emergency room and had a complete platelet crash.her platelet had gone from 314 to 14. She was hospitalized for 9 days getting blood transfusion. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-273541 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: LISINOPRIL; LEVOTHYROXINE

Current Illness:

ID: 1644360
Sex: F
Age: 29
State: FL

Vax Date: 01/04/2021
Onset Date: 02/01/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210730; Test Name: PCR; Test Result: Positive ; Result Unstructured Data: The PCR test results came back positive for COVID-19; Test Date: 20210806; Test Name: PCR; Test Result: Negative ; Result Unstructured Data: Negative-not detected; Test Date: 20210730; Test Name: SARS-CoV-2 test; Test Result: Positive ; Result Unstructured Data: subsequently tested positive after exposure to partner, who also tested positive for COVID-19 by PCR

Allergies:

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

Symptoms: Drug ineffective; Completely asymptomatic; Exposed to unvaccinated patient with COVID-19; Received second dose of Moderna vaccine while pregnant; Headache; Sneezing; Back ache; This spontaneous prospective pregnancy case was reported by a nurse and describes the occurrence of SNEEZING (Sneezing), BACK PAIN (Back ache), DRUG INEFFECTIVE (Drug ineffective), ASYMPTOMATIC COVID-19 (Completely asymptomatic) and OCCUPATIONAL EXPOSURE TO SARS-COV-2 (Exposed to unvaccinated patient with COVID-19) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Pregnant. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) for an unknown indication. 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) (Intramuscular) dosage was changed to 1 dosage form. The patient's last menstrual period was on 22-Dec-2020 and the estimated date of delivery was 26-Sep-2021. On 01-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Received second dose of Moderna vaccine while pregnant). On 30-Jul-2021, the patient experienced ASYMPTOMATIC COVID-19 (Completely asymptomatic) and OCCUPATIONAL EXPOSURE TO SARS-COV-2 (Exposed to unvaccinated patient with COVID-19). On an unknown date, the patient experienced SNEEZING (Sneezing), BACK PAIN (Back ache), DRUG INEFFECTIVE (Drug ineffective) and HEADACHE (Headache). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the fifth week of the pregnancy. At the time of the report, SNEEZING (Sneezing), BACK PAIN (Back ache), ASYMPTOMATIC COVID-19 (Completely asymptomatic) and HEADACHE (Headache) outcome was unknown and DRUG INEFFECTIVE (Drug ineffective), OCCUPATIONAL EXPOSURE TO SARS-COV-2 (Exposed to unvaccinated patient with COVID-19) and EXPOSURE DURING PREGNANCY (Received second dose of Moderna vaccine while pregnant) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jul-2021, Polymerase chain reaction: positive (Positive) The PCR test results came back positive for COVID-19. On 30-Jul-2021, SARS-CoV-2 test: positive (Positive) subsequently tested positive after exposure to partner, who also tested positive for COVID-19 by PCR. On 06-Aug-2021, Polymerase chain reaction: negative (Negative) Negative-not detected. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided. The patient was in her third trimester. The patient was indirectly exposed to a patient who had not been vaccinated on Friday, 30-Jul-2021, at her place of employment and was swabbed the same day. The patient was currently in isolation. The patient was 32 weeks pregnant when she tested positive. This is a case of lack of effect in the patient diagnosed with COVID-19 approximately 6 months after 2 doses of Moderna vaccine. there were other events reported. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-273725 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 17-Aug-2021: Added lab data, added new events of headache, back ache and sneezing and updated gestation period; Sender's Comments: This is a case of lack of effect in the patient diagnosed with COVID-19 approximately 6 months after 2 doses of Moderna vaccine. there were other events reported. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]

Current Illness: Pregnant

ID: 1644361
Sex: F
Age: 63
State: NM

Vax Date: 07/29/2021
Onset Date: 07/30/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210801; Test Name: COVID-19; Test Result: Negative ; Result Unstructured Data: Negative

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: became nervous and went to the emergency room on Sunday in which they sent her home; Has blisters in back of throat; Neck is "so sore and swollen"; Neck is swollen; Throat is so sore it hurts to swallow; Throat is so sore it hurts to swallow; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL BLISTERING (Has blisters in back of throat) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 29-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jul-2021, the patient experienced OROPHARYNGEAL BLISTERING (Has blisters in back of throat) (seriousness criterion medically significant), NECK PAIN (Neck is "so sore and swollen"), SWELLING (Neck is swollen), OROPHARYNGEAL PAIN (Throat is so sore it hurts to swallow) and ODYNOPHAGIA (Throat is so sore it hurts to swallow). On 01-Aug-2021, the patient experienced NERVOUSNESS (became nervous and went to the emergency room on Sunday in which they sent her home). The patient was treated with PARACETAMOL (TYLENOL) for Adverse reaction, at an unspecified dose and frequency and IBUPROFEN for Adverse reaction, at an unspecified dose and frequency. At the time of the report, OROPHARYNGEAL BLISTERING (Has blisters in back of throat), NECK PAIN (Neck is "so sore and swollen"), SWELLING (Neck is swollen), OROPHARYNGEAL PAIN (Throat is so sore it hurts to swallow), ODYNOPHAGIA (Throat is so sore it hurts to swallow) and NERVOUSNESS (became nervous and went to the emergency room on Sunday in which they sent her home) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Aug-2021, COVID-19: negative (Negative) Negative. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Additional treatment included a salt water gargle. Concomitant medication use included prescribed medications and supplements for which details were not provided. On 01-Aug-2021, the patient went to the emergency room and took a Strep throat test which came negative and patient was sent home. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-273688 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1644362
Sex: F
Age: 25
State: NV

Vax Date: 08/01/2021
Onset Date: 08/01/2021
Rec V Date: 08/28/2021
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: Expired Vaccine administered to patient; Product storage error; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered to patient) and PRODUCT STORAGE ERROR (Product storage error) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 939902) for COVID-19 vaccination. No Medical History information was reported. On 01-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered to patient) and PRODUCT STORAGE ERROR (Product storage error). On 01-Aug-2021, PRODUCT STORAGE ERROR (Product storage error) had resolved. On 03-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Expired Vaccine administered to patient) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was reported No treatment medication was reported. Vial of Moderna COVID-19 vaccine was taken out of the refrigerator, punctured and kept at room temperature (67.2 degree Fahrenheit) beyond 12 hours. The vial was first punctured at 01:01 PM on 31-Jul-2021 and that was when it was first moved to the room temperature. Most recent FOLLOW-UP information incorporated above includes: On 12-Aug-2021: significant follow up received on 12-Aug-2021 included updated patient's race information.

Other Meds:

Current Illness:

ID: 1644363
Sex: M
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: Bacterial culture from a pustule; Test Result: Negative ; Result Unstructured Data: Bacterial culture from a pustule did not reveal a causative organism; Test Name: Histopathology; Result Unstructured Data: Interstitial and intrafollicular infiltrate composed mostly of neutrophils with some admixed lymphocytes and plasma cells that are present in the superficial and deep dermis. Also showed follicular dilatation, plugging and neutrophils with prominent involvement of hair follicles.; Test Name: neutrophilic predominance; Result Unstructured Data: High

Allergies:

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

Symptoms: acute localized exanthematous pustulosis; patient noticed swelling, predominantly of the central face and eye lids; patient noticed swelling, predominantly of the central face and eye lids; weakness; malaise; subjective fevers; Tachycardia; leukocytosis with neutrophil dominance; pain in face and eyelids; facial erythema; erythematous, edematous plaques spanning the eyelids, cheeks, and nasal dorsum; monomorphic submillimeter follicularly based pustule; crust emerged within the erythema; facial eruption; This literature-non-study case was reported in a literature article and describes the occurrence of ACUTE GENERALISED EXANTHEMATOUS PUSTULOSIS (acute localized exanthematous pustulosis) in an elderly male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ACUTE GENERALISED EXANTHEMATOUS PUSTULOSIS (acute localized exanthematous pustulosis) (seriousness criterion medically significant), SWELLING OF EYELID (patient noticed swelling, predominantly of the central face and eye lids) and SWELLING FACE (patient noticed swelling, predominantly of the central face and eye lids). an unknown date, the patient experienced ASTHENIA (weakness), MALAISE (malaise), PYREXIA (subjective fevers), TACHYCARDIA (Tachycardia), LEUKOCYTOSIS (leukocytosis with neutrophil dominance), FACIAL PAIN (pain in face and eyelids) and RASH (facial eruption). an unknown date, the patient experienced ERYTHEMA (facial erythema), SKIN PLAQUE (erythematous, edematous plaques spanning the eyelids, cheeks, and nasal dorsum), PUSTULE (monomorphic submillimeter follicularly based pustule) and SCAB (crust emerged within the erythema). The patient was treated with VANCOMYCIN for Adverse event, at an unspecified dose and frequency; PIPERACILLIN SODIUM, TAZOBACTAM SODIUM (PIPERACILLIN/TAZOBACTAM) for Adverse event, at an unspecified dose and frequency; TACROLIMUS for Adverse event, at a dose of 0.1 percent and DOXYCYCLINE for Adverse event, at an unspecified dose and frequency. At the time of the report, ACUTE GENERALISED EXANTHEMATOUS PUSTULOSIS (acute localized exanthematous pustulosis), SWELLING OF EYELID (patient noticed swelling, predominantly of the central face and eye lids), SWELLING FACE (patient noticed swelling, predominantly of the central face and eye lids), ASTHENIA (weakness), MALAISE (malaise), PYREXIA (subjective fevers), TACHYCARDIA (Tachycardia), LEUKOCYTOSIS (leukocytosis with neutrophil dominance), FACIAL PAIN (pain in face and eyelids), ERYTHEMA (facial erythema), SKIN PLAQUE (erythematous, edematous plaques spanning the eyelids, cheeks, and nasal dorsum), PUSTULE (monomorphic submillimeter follicularly based pustule), SCAB (crust emerged within the erythema) and RASH (facial eruption) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Bacterial test: negative (Negative) Bacterial culture from a pustule did not reveal a causative organism. On an unknown date, Histology: interstitial and intrafollicular infiltrate (abnormal) Interstitial and intrafollicular infiltrate composed mostly of neutrophils with some admixed lymphocytes and plasma cells that are present in the superficial and deep dermis. Also showed follicular dilatation, plugging and neutrophils with prominent involvement of hair follicles.. On an unknown date, Neutrophil count: high (High) High. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered ACUTE GENERALISED EXANTHEMATOUS PUSTULOSIS (acute localized exanthematous pustulosis), SWELLING OF EYELID (patient noticed swelling, predominantly of the central face and eye lids), SWELLING FACE (patient noticed swelling, predominantly of the central face and eye lids), ASTHENIA (weakness), MALAISE (malaise), PYREXIA (subjective fevers), TACHYCARDIA (Tachycardia), LEUKOCYTOSIS (leukocytosis with neutrophil dominance), FACIAL PAIN (pain in face and eyelids), ERYTHEMA (facial erythema), SKIN PLAQUE (erythematous, edematous plaques spanning the eyelids, cheeks, and nasal dorsum), PUSTULE (monomorphic submillimeter follicularly based pustule), SCAB (crust emerged within the erythema) and RASH (facial eruption) to be possibly related. Concomitant product use was not provided by the reporter. The abrupt onset of facial erythema, edema, and pustules may be consistent with rosacea fulminans, although the lack of nodules, papules, and cysts and occurrence in 2 older men go against that diagnosis. It was unclear if that facial eruption in the setting of the mRNA-1273 vaccine represents a distinct entity or an unmasking of a dermatologic condition in a predisposed individual. It was also notable that for patient 2, the eruption occurred after the second dose only, which had been reported elsewhere. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case is from a literature review. This case was linked to MOD-2021-273868 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case is from a literature review.

Other Meds:

Current Illness:

ID: 1644364
Sex: M
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: bacterial culture; Test Result: Negative ; Result Unstructured Data: bacterial culture from a pustule did not reveal a causative organism; Test Date: 2021; Test Name: Histopathology results; Result Unstructured Data: Interstitial and intrafollicular infiltrate composed mostly of neutrophils with some admixed lymphocytes and plasma cells that are present in the superficial and deep dermis, showing negative infectious stains. There is follicular dilatation and plugging. Neutrophils with prominent involvement of hair follicles.; Test Date: 2021; Test Name: neutrophil predominance; Result Unstructured Data: leukocytosis with neutrophil predominance

Allergies:

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

Symptoms: acute localized exanthematous pustulosis; facial swelling; nonpruritic erythema/ bilateral edematous, erythematous; leukocytosis with neutrophil predominance; Demodex folliculitis; skin and soft tissue infection; neutrophilic dermatosis; rosacea fulminans; chills; facial rash; This literature-non-study case was reported in a literature article and describes the occurrence of ACUTE GENERALISED EXANTHEMATOUS PUSTULOSIS (acute localized exanthematous pustulosis) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. LITERATURE REFERENCE: No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ACUTE GENERALISED EXANTHEMATOUS PUSTULOSIS (acute localized exanthematous pustulosis) (seriousness criterion medically significant), LEUKOCYTOSIS (leukocytosis with neutrophil predominance), FOLLICULITIS (Demodex folliculitis), SKIN BACTERIAL INFECTION (skin and soft tissue infection), NEUTROPHILIC DERMATOSIS (neutrophilic dermatosis), ROSACEA (rosacea fulminans) and RASH (facial rash). an unknown date, the patient experienced SWELLING FACE (facial swelling), ERYTHEMA (nonpruritic erythema/ bilateral edematous, erythematous) and CHILLS (chills). The patient was treated with CEPHALEXIN [CEFALEXIN] for Adverse event, at an unspecified dose and frequency and HALOBETASOL for Adverse event, at a dose of 0.05 percent. At the time of the report, ACUTE GENERALISED EXANTHEMATOUS PUSTULOSIS (acute localized exanthematous pustulosis), SWELLING FACE (facial swelling), ERYTHEMA (nonpruritic erythema/ bilateral edematous, erythematous), LEUKOCYTOSIS (leukocytosis with neutrophil predominance), FOLLICULITIS (Demodex folliculitis), SKIN BACTERIAL INFECTION (skin and soft tissue infection), NEUTROPHILIC DERMATOSIS (neutrophilic dermatosis), ROSACEA (rosacea fulminans) and CHILLS (chills) outcome was unknown and RASH (facial rash) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Bacterial test: negative (Negative) bacterial culture from a pustule did not reveal a causative organism. In 2021, Histology: infiltrate of neutrophils interstitially (abnormal) Interstitial and intrafollicular infiltrate composed mostly of neutrophils with some admixed lymphocytes and plasma cells that are present in the superficial and deep dermis, showing negative infectious stains. There is follicular dilatation and plugging. Neutrophils with prominent involvement of hair follicles.. In 2021, Neutrophil count: high (High) leukocytosis with neutrophil predominance. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered ACUTE GENERALISED EXANTHEMATOUS PUSTULOSIS (acute localized exanthematous pustulosis), SWELLING FACE (facial swelling), ERYTHEMA (nonpruritic erythema/ bilateral edematous, erythematous), LEUKOCYTOSIS (leukocytosis with neutrophil predominance), FOLLICULITIS (Demodex folliculitis), SKIN BACTERIAL INFECTION (skin and soft tissue infection), NEUTROPHILIC DERMATOSIS (neutrophilic dermatosis), ROSACEA (rosacea fulminans), RASH (facial rash) and CHILLS (chills) to be possibly related. Concomitant product use was not provided by the reporter. It was reported that the patient involved was presented to their department 4 days after receiving initial dose of the mRNA-1273 vaccine. On examination, a well-demarcated plaque with overlying punctate monomorphic pustules and crusting on the central face and eyelids at 4 days after administration of an mRNA-1273 vaccine in patient 1 was observed. The abrupt onset of facial erythema, edema, and pustules may be consistent with rosacea fulminans, although the lack of nodules, papules, and cysts and occurrence in 2 older men go against that diagnosis. It was unclear if that facial eruption in the setting of the mRNA-1273 vaccine represents a distinct entity or an unmasking of a dermatologic condition in a predisposed individual. The patient received the second vaccine dose as scheduled without recurrence. Company Comment: Based on the current available information which includes a temporal association between the use of the product and onset of the event and excluding bother etiologies, a causal relationship cannot be excluded. Rash and chills are consistent with the product known safety profile This case was linked to MOD-2021-273838 (Patient Link).; Sender's Comments: Based on the current available information which includes a temporal association between the use of the product and onset of the event and excluding bother etiologies, a causal relationship cannot be excluded. Rash and chills are consistent with the product known safety profile

Other Meds:

Current Illness:

ID: 1644365
Sex: M
Age: 81
State: MI

Vax Date: 02/11/2021
Onset Date: 04/11/2021
Rec V Date: 08/28/2021
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: He became deaf a month after receiving 2nd dose.; She saw him shivering and he couldn't hear anything.; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 02-Aug-2021 and was forwarded to Moderna on 02-Aug-2021. This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (He became deaf a month after receiving 2nd dose.) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Dementia. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 11-Apr-2021, the patient experienced DEAFNESS (He became deaf a month after receiving 2nd dose.) (seriousness criterion medically significant) and CHILLS (She saw him shivering and he couldn't hear anything.). At the time of the report, DEAFNESS (He became deaf a month after receiving 2nd dose.) and CHILLS (She saw him shivering and he couldn't hear anything.) outcome was unknown. One of the patient's concomitant medications is a dementia medication. No treatment was given for symptoms. Company comment: Based on the 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. However, elderly age and underlying condition of dementia could be risk factors for the event of deafness. This case was linked to MOD-2021-273358 (Patient Link).; Sender's Comments: Based on the 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. However, elderly age and underlying condition of dementia could be risk factors for the event of deafness.

Other Meds:

Current Illness:

ID: 1644366
Sex: M
Age:
State: MI

Vax Date: 03/31/2021
Onset Date: 07/15/2021
Rec V Date: 08/28/2021
Hospital: Y

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

Lab Data: Test Date: 20210715; Test Name: SARS-CoV-2 test; Test Result: Positive ; Result Unstructured Data: positive

Allergies:

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

Symptoms: COVID-19; Dyspnoea; Hypoxia; This case was received via regulatory Authority (Reference number: 1490338) on 03-Aug-2021 and was forwarded to the company on 03-Aug-2021. This regulatory authority case was reported by an other health care professional and describes the occurrence of COVID-19 (COVID-19), DYSPNOEA (Dyspnoea) and HYPOXIA (Hypoxia) in an 84-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. No Medical History information was reported. On 31-Mar-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 15-Jul-2021, the patient experienced COVID-19 (COVID-19) (seriousness criterion hospitalization), DYSPNOEA (Dyspnoea) (seriousness criterion hospitalization) and HYPOXIA (Hypoxia) (seriousness criteria hospitalization and medically significant). The patient was hospitalized on 19-Jul-2021 due to DYSPNOEA and HYPOXIA. At the time of the report, COVID-19 (COVID-19), DYSPNOEA (Dyspnoea) and HYPOXIA (Hypoxia) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 15-Jul-2021, SARS-CoV-2 test: positive (Positive) positive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication information was not provided. The patient tested positive for COVID on 15-07-2021 after being exposed to family member(s) that were also positive. Patient went to the hospital on 19-07-2021 with symptoms of shortness of breath, hypoxia, and dyspnea. Treatment information was not provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (unknown) was not applicable Company Comment Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. Based on the current available information and temporal association between the use of the product and the start date of the events dyspnoea and hypoxia, a causal relationship cannot be excluded. However, COVID-19 could be a contributory factor these events.; Sender's Comments: Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. Based on the current available information and temporal association between the use of the product and the start date of the events dyspnoea and hypoxia, a causal relationship cannot be excluded. However, COVID-19 could be a contributory factor these events.

Other Meds:

Current Illness:

ID: 1644367
Sex: M
Age: 46
State: PA

Vax Date: 03/26/2021
Onset Date: 04/24/2021
Rec V Date: 08/28/2021
Hospital: Y

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

Lab Data: Test Name: Blood test; Result Unstructured Data: Normal; Test Date: 20210507; Test Name: Blood test; Result Unstructured Data: Diagnosed with hyperthyroidism and EPSTEIN-BARR VIRUS aggravation.; Test Date: 20210516; Test Name: Blood test; Result Unstructured Data: Normal; Test Date: 20210517; Test Name: Blood test; Result Unstructured Data: Normal; Test Date: 20210506; Test Name: Endoscopy; Result Unstructured Data: Normal with having a minor gastritis; another observation was thyroid glands were swollen

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: Gastritis; This symptom made the patient lose 22 pounds/Heavy weight loss up to 20 pounds/ Weight loss; Hyper acidity; Epstein-Barr virus aggravation; Thyroid gland was attacked/Thyroid glands were swollen; Swollen throat; Cough; Decreased appetite; Fever for a couple of days/ Mild fever; Hyperthyroidism; Pain did not allow the patient to eat/Not able to eat anything because it attack the thyroid gland/ Big time difficulty swallowing the food; Sore throat; Lots of weakness/Heavy weakness; Tachycardia; Severe pain in the mouth joint; Severe pain in jaws; This spontaneous case was reported by a consumer and describes the occurrence of WEIGHT DECREASED (This symptom made the patient lose 22 pounds/Heavy weight loss up to 20 pounds/ Weight loss), HYPERCHLORHYDRIA (Hyper acidity) and GASTRITIS (Gastritis) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043B21A and 018B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Epstein-Barr virus infection. Concurrent medical conditions included Hypercholesterolemia. Concomitant products included ATORVASTATIN for Hypercholesterolemia, MINERALS NOS, VITAMINS NOS (VITAL [MINERALS NOS;VITAMINS NOS]) from 13-Sep-2019 to an unknown date and CYANOCOBALAMIN (VITAMIN B-12) from 13-Sep-2019 to an unknown date for Vitamin supplementation. On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced ORAL PAIN (Severe pain in the mouth joint) and PAIN IN JAW (Severe pain in jaws). On 25-Apr-2021, the patient experienced WEIGHT DECREASED (This symptom made the patient lose 22 pounds/Heavy weight loss up to 20 pounds/ Weight loss) (seriousness criterion hospitalization), HYPERCHLORHYDRIA (Hyper acidity) (seriousness criterion hospitalization), HYPERTHYROIDISM (Hyperthyroidism), FEEDING DISORDER (Pain did not allow the patient to eat/Not able to eat anything because it attack the thyroid gland/ Big time difficulty swallowing the food), ASTHENIA (Lots of weakness/Heavy weakness), TACHYCARDIA (Tachycardia), COUGH (Cough) and DECREASED APPETITE (Decreased appetite). 25-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat). 25-Apr-2021, the patient experienced PYREXIA (Fever for a couple of days/ Mild fever). On 26-Apr-2021, the patient experienced PHARYNGEAL SWELLING (Swollen throat). On 06-May-2021, the patient experienced GOITRE (Thyroid gland was attacked/Thyroid glands were swollen). On 11-May-2021, the patient experienced EPSTEIN-BARR VIRUS INFECTION (Epstein-Barr virus aggravation). On an unknown date, the patient experienced GASTRITIS (Gastritis) (seriousness criterion hospitalization). The patient was hospitalized from 06-May-2021 to 16-May-2021 due to HYPERCHLORHYDRIA and WEIGHT DECREASED. The patient was treated with METHIMAZOLE on 14-May-2021 at a dose of 10 mg twice a day; OMEPRAZOLE on 14-May-2021 at a dose of 20 mg once a day and BENZONATATE on 14-May-2021 at a dose of 100 mg three times a day. On 06-May-2021, WEIGHT DECREASED (This symptom made the patient lose 22 pounds/Heavy weight loss up to 20 pounds/ Weight loss), PAIN IN JAW (Severe pain in jaws), OROPHARYNGEAL PAIN (Sore throat), PHARYNGEAL SWELLING (Swollen throat), COUGH (Cough) and PYREXIA (Fever for a couple of days/ Mild fever) had resolved. At the time of the report, HYPERCHLORHYDRIA (Hyper acidity), HYPERTHYROIDISM (Hyperthyroidism) and ORAL PAIN (Severe pain in the mouth joint) had resolved, GASTRITIS (Gastritis), TACHYCARDIA (Tachycardia) and EPSTEIN-BARR VIRUS INFECTION (Epstein-Barr virus aggravation) outcome was unknown and FEEDING DISORDER (Pain did not allow the patient to eat/Not able to eat anything because it attack the thyroid gland/ Big time difficulty swallowing the food), ASTHENIA (Lots of weakness/Heavy weakness), DECREASED APPETITE (Decreased appetite) and GOITRE (Thyroid gland was attacked/Thyroid glands were swollen) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-May-2021, Endoscopy: abnormal (abnormal) Normal with having a minor gastritis; another observation was thyroid glands were swollen. On 07-May-2021, Blood test: abnormal (abnormal) Diagnosed with hyperthyroidism and EPSTEIN-BARR VIRUS aggravation.. On 16-May-2021, Blood test: normal (normal) Normal. On 17-May-2021, Blood test: normal (normal) Normal. On an unknown date, Blood test: normal (normal) Normal. As per the physicians observations Epsein Barr virus aggravation which might have affected the thyroid glands and that E-B virus might have aggravated because of the hormonal or other changes which might have happened due to the COVID-19 / mRNA-1273 vaccination. Company comment: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 19-Aug-2021: Added relevant history, concomitant medication details, laboratory, added adverse event details, added seriousness criteria, investigation details, treatment medication details and additional information's.; Sender's Comments: Based on current available information and the temporal association between product use and the start date of the events a causal relationship cannot be excluded.

Other Meds: VITAL [MINERALS NOS;VITAMINS NOS]; VITAMIN B-12; ATORVASTATIN

Current Illness: Hypercholesterolemia

ID: 1644368
Sex: M
Age: 59
State: NJ

Vax Date: 01/29/2021
Onset Date: 07/01/2021
Rec V Date: 08/28/2021
Hospital: Y

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: Guillain-Barre syndrome; Two blood clots; Pain was bad in legs and feet; This spontaneous case was reported by a consumer and describes the occurrence of GUILLAIN-BARRE SYNDROME (Guillain-Barre syndrome), THROMBOSIS (Two blood clots) and PAIN IN EXTREMITY (Pain was bad in legs and feet) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 007M20A) for COVID-19 vaccination. No medical history was reported by the reporter. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR), RIVAROXABAN (XARELTO) and EZETIMIBE (ZETIA) for an unknown indication. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In July 2021, the patient experienced PAIN IN EXTREMITY (Pain was bad in legs and feet) (seriousness criterion hospitalization). On 23-Jul-2021, the patient experienced THROMBOSIS (Two blood clots) (seriousness criterion hospitalization). On 27-Jul-2021, the patient experienced GUILLAIN-BARRE SYNDROME (Guillain-Barre syndrome) (seriousness criteria hospitalization and medically significant). At the time of the report, GUILLAIN-BARRE SYNDROME (Guillain-Barre syndrome), THROMBOSIS (Two blood clots) and PAIN IN EXTREMITY (Pain was bad in legs and feet) outcome was unknown. The patient was treated with IV immunoglobulin. The patient has been in the hospital for a week now. Company comment: Very limited information regarding these events has been provided at this time. Further information has been requested. Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Follow up received with no new information; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.

Other Meds: LIPITOR; XARELTO; ZETIA

Current Illness:

ID: 1644369
Sex: F
Age: 79
State: PA

Vax Date: 03/06/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: Stress Test; Result Unstructured Data: Heart was pumping only 29% of blood. Heart was beating erratically.

Allergies:

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

Symptoms: heart was fluttering/heart problems; heart was only pumping 29% of the blood/heart wasn't pumping enough blood; short of breath; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (heart was fluttering/heart problems), CARDIAC FAILURE (heart was only pumping 29% of the blood/heart wasn't pumping enough blood) and DYSPNOEA (short of breath) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 013M20A) for COVID-19 vaccination. No medical history information was provided by the reporter. Concomitant products included AMLODIPINE and ATORVASTATIN for an unknown indication. On 06-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CARDIAC FLUTTER (heart was fluttering/heart problems) (seriousness criteria medically significant and life threatening), CARDIAC FAILURE (heart was only pumping 29% of the blood/heart wasn't pumping enough blood) (seriousness criteria medically significant and life threatening) and DYSPNOEA (short of breath) (seriousness criterion life threatening). At the time of the report, CARDIAC FLUTTER (heart was fluttering/heart problems), CARDIAC FAILURE (heart was only pumping 29% of the blood/heart wasn't pumping enough blood) and DYSPNOEA (short of breath) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Cardiac stress test: abnormal (abnormal) Heart was pumping only 29% of blood. Heart was beating erratically.. Treatment information was not reported. Patient was not aware whether she experienced the symptoms after first dose of vaccine or second dose of vaccine. Patient was on Life Vest to keep herself from sudden death. Based on the current available information and temporal association between the use of the product, a causal relationship cannot be excluded. Further information has been requested regarding event dates. Company comment: Based on the current available information and temporal association between the use of the product, a causal relationship cannot be excluded. Further information has been requested regarding event dates.; Sender's Comments: Based on the current available information and temporal association between the use of the product, a causal relationship cannot be excluded. Further information has been requested regarding event dates.

Other Meds: AMLODIPINE; ATORVASTATIN

Current Illness:

ID: 1644370
Sex: F
Age:
State: NJ

Vax Date:
Onset Date: 07/15/2021
Rec V Date: 08/28/2021
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: Patient thought she was having a stroke and was diagnosed with Bell's Palsy on the left side of her face; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of BELL'S PALSY (Patient thought she was having a stroke and was diagnosed with Bell's Palsy on the left side of her face) in a 41-year-old 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 15-Jul-2021, the patient experienced BELL'S PALSY (Patient thought she was having a stroke and was diagnosed with Bell's Palsy on the left side of her face) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (Patient thought she was having a stroke and was diagnosed with Bell's Palsy on the left side of her face) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment medications included steroids and an eye cream. Concomitant medications were not provided. Patient thought she got first vaccine on 30-JUN-2021 or during the 1st week of July 2021. On 15-JUL-2021, she thought she was having a stroke, went to the emergency room and was diagnosed with Bell's Palsy on the left side of her face. Her left eye was not closing all the way and would not blink at same pace as the right eye. She told that it had gotten better but it was not back to 100 percent. Company comment: Based on the 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.; Sender's Comments: Based on the 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: 1644371
Sex: M
Age: 71
State: NJ

Vax Date: 02/15/2021
Onset Date: 07/28/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210728; Test Name: annual echocardiogram; Result Unstructured Data: 29Jul2021, husband received a call from his cardiologist, who said that a blood clot at the top/tip of his heart

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: blood clot at the top/tip of his heart; This spontaneous case was reported by a consumer and describes the occurrence of INTRACARDIAC THROMBUS (blood clot at the top/tip of his heart) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002B21A and 011M20A) for COVID-19 vaccination. The patient's past medical history included Heart attack (patient had heart attack at age 40.), Bypass surgery in 1993 and Defibrillator/pacemaker insertion in 2006. Concurrent medical conditions included Heart disease aggravated. Concomitant products included METOPROLOL TARTRATE (METOPROLOL CT), HYDROCHLOROTHIAZIDE, PANTOPRAZOLE, ESCITALOPRAM, RANOLAZINE (RANEXA), ACETYLSALICYLIC ACID (ASPIRIN (E.C.)), CLOPIDOGREL, SIMVASTATIN (SIMVASTATIN AL), TAMSULOSIN HYDROCHLORIDE, TOLTERODINE L-TARTRATE (TAMSULIN T), TRAZODONE HYDROCHLORIDE (TRAZODONE FOCUS), FINASTERIDE and LOSARTAN POTASSIUM (LOSARTAN "AGP") for an unknown indication, ISOSORBIDE MONONITRATE (ISOSORBIDE AN). On 15-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jul-2021, the patient experienced INTRACARDIAC THROMBUS (blood clot at the top/tip of his heart) (seriousness criterion medically significant). The patient was treated with WARFARIN ongoing from 30-Jul-2021 for Adverse event, at a dose of 5 mg once a day. At the time of the report, INTRACARDIAC THROMBUS (blood clot at the top/tip of his heart) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jul-2021, Echocardiogram: abnormal (abnormal) 29Jul2021, husband received a call from his cardiologist, who said that a blood clot at the top/tip of his heart. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, the medical history/ occurrence of Heart attack , Bypass surgery and Defibrillator/pacemaker insertion, Heart disease aggravated could be a contributory factor. This case was linked to MOD-2021-280866 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, the medical history/ occurrence of Heart attack , Bypass surgery and Defibrillator/pacemaker insertion, Heart disease aggravated could be a contributory factor.

Other Meds: METOPROLOL CT; ISOSORBIDE AN; HYDROCHLOROTHIAZIDE; PANTOPRAZOLE; ESCITALOPRAM; RANEXA; ASPIRIN (E.C.); CLOPIDOGREL; SIMVASTATIN AL; TAMSULIN T; TRAZODONE FOCUS; FINASTERIDE; LOSARTAN "AGP"

Current Illness: Heart disease aggravated

ID: 1644372
Sex: F
Age: 50
State: GA

Vax Date: 07/27/2021
Onset Date: 07/27/2021
Rec V Date: 08/28/2021
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: Itchy at injection site; Developed a hard red knot at the injection site; Left arm was really sore at the injection site; Did not have any energy (Felt drained); Developed a hard red knot at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Did not have any energy (Felt drained)), VACCINATION SITE MASS (Developed a hard red knot at the injection site), VACCINATION SITE PRURITUS (Itchy at injection site), VACCINATION SITE ERYTHEMA (Developed a hard red knot at the injection site) and VACCINATION SITE PAIN (Left arm was really sore at the injection site) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C212A) for COVID-19 vaccination. No Medical History information was reported. On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jul-2021, the patient experienced ASTHENIA (Did not have any energy (Felt drained)), VACCINATION SITE MASS (Developed a hard red knot at the injection site), VACCINATION SITE ERYTHEMA (Developed a hard red knot at the injection site) and VACCINATION SITE PAIN (Left arm was really sore at the injection site). On 02-Aug-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy at injection site). At the time of the report, ASTHENIA (Did not have any energy (Felt drained)), VACCINATION SITE MASS (Developed a hard red knot at the injection site), VACCINATION SITE ERYTHEMA (Developed a hard red knot at the injection site) and VACCINATION SITE PAIN (Left arm was really sore at the injection site) had not resolved and VACCINATION SITE PRURITUS (Itchy at injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported No treatment medications were reported Most recent FOLLOW-UP information incorporated above includes: On 13-Aug-2021: Non-significant follow-up received.

Other Meds:

Current Illness:

Date Died:

ID: 1644373
Sex: F
Age: 85
State: AZ

Vax Date: 01/28/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital: Y

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: liver failure; developed a clot in her portal vein; This spontaneous case was reported by a consumer and describes the occurrence of PORTAL VEIN THROMBOSIS (developed a clot in her portal vein) and HEPATIC FAILURE (liver failure) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 041L20A) for COVID-19 vaccination. Concurrent medical conditions included Hypertension and Diabetes. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PORTAL VEIN THROMBOSIS (developed a clot in her portal vein) (seriousness criteria death, hospitalization and medically significant) and HEPATIC FAILURE (liver failure) (seriousness criteria death, hospitalization and medically significant). The reported cause of death was Liver failure. It is unknown if an autopsy was performed. It was reported that the reporter believed that her mother passed away as a result of a complication with the vaccine. Patient's mother received first dose on 28-JAN-2021. Patient received second dose one 26-FEB-2021. The patient was 85-year-old with hypertension and diabetes and developed a clot in her portal vein. Patient was hospitalized. The clot made her go into liver failure which was the cause of death. The date of the reported events remained unknown at the time of the report. Treatment information were not provided by the reporter. Concomitant medications were not reported by reporter. Company Comment: This is the case of an 85-year-old female subject with a history of hypetension and diabetes who died due to hepatic falure. Reportedly, the patient initially developed thrombosis in portal vein (a clot in her portal vein), however a temporal association between the use of the product and the start date of the event was not reported. The patient subsequently developed liver failure and died due to liver failure, as reported, however, the date of death was not provided. It is unknown if an autopsy was performed. Very limited information regarding these events has been provided at this time. Causality is confounded with the patient's advanced age, hypertension and diabetes.; Sender's Comments: This is the case of an 85-year-old female subject with a history of hypetension and diabetes who died due to hepatic falure. Reportedly, the patient initially developed thrombosis in portal vein (a clot in her portal vein), however a temporal association between the use of the product and the start date of the event was not reported. The patient subsequently developed liver failure and died due to liver failure, as reported, however, the date of death was not provided. It is unknown if an autopsy was performed. Very limited information regarding these events has been provided at this time. Causality is confounded with the patient's advanced age, hypertension and diabetes.; Reported Cause(s) of Death: Liver failure

Other Meds:

Current Illness: Diabetes; Hypertension

ID: 1644374
Sex: M
Age: 74
State: CA

Vax Date: 02/03/2021
Onset Date: 03/01/2021
Rec V Date: 08/28/2021
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: 20210618; Test Name: Blood glucose; Result Unstructured Data: 158 mg/dL; Test Date: 20210618; Test Name: Magnesium; Result Unstructured Data: normal; Test Date: 20210618; Test Name: Blood pressure; Result Unstructured Data: 130/70; Test Date: 20210618; Test Name: TSH; Result Unstructured Data: Normal; Test Date: 20210618; Test Name: Chest X-ray; Result Unstructured Data: No acute cardiopulmonary process.; Test Date: 20210618; Test Name: CT of the brain; Result Unstructured Data: no acute intracranial abnormality; Test Date: 20210618; Test Name: Cervical CT; Result Unstructured Data: no spine fracture; Test Date: 20210618; Test Name: CBC; Result Unstructured Data: unremarkable; Test Date: 20210618; Test Name: Liver enzymes; Result Unstructured Data: normal; Test Date: 20171020; Test Name: MRI Lumbar Spine; Result Unstructured Data: Some epidural fat narrowing at canal L3-L4, no central canal narrowing at L4-L5. L5-S1 there was a focal posterior osteophyte paracentral to the right, which contacted the descending right S1 nerve root and serve left and mild right foraminal narrowing.; Test Date: 20210618; Test Name: Ultrasound; Result Unstructured Data: some fluids in the lower quadrant concerning ascites

Allergies:

Symptom List: Injection site pain

Symptoms: difficult to walk; hard to pick up things; neurologist diagnosed as having Carpal Tunnel Syndrome, more svere on left than right; fluid in the lower quadrant; diabetes; Axonal neuropathy with stocking hypoethesia to pin and absent vibration in his feet.; Felt generally weak; Pain in neck; paresthesia in his lower extrimities; left hand went numb/ right hand went numb/ his legs and feet up to his knees went numb, bilateral ullnar neuropathy; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of ASCITES (fluid in the lower quadrant) and DIABETES MELLITUS (diabetes) in a 75-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025A21A and 015M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Carpal tunnel syndrome (diagnosed with Carpal Tunnel Syndrome in the past), Atrial fibrillation (status post modified maze procedure 2008, not anticoagulated.), Surgery, Shoulder operation (left shoulder surgery) in 2020 and Cox-Maze procedure (status post modified maze procedure, not anticoagulated) in 2008. Concurrent medical conditions included Drug allergy (Lipitor (atorvastatin) - 25 years ago, the patient experienced a similar numbness after taking Lipitor and once stopped the Lipitor, the numbness resolved) since 1996, Allergy to antibiotic (Flagyl (metronidazole)) and Chronic back pain (He has seen pain management physician for some time). Concomitant products included ALLOPURINOL, CELECOXIB (CELEBREX), LEVOTHYROXINE SODIUM (SYNTHROID), POTASSIUM, TESTOSTERONE, CARVEDILOL, SACUBITRIL VALSARTAN SODIUM HYDRATE (ENTRESTO) and FUROSEMIDE (LASIX [FUROSEMIDE]) for an unknown indication. On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In March 2021, the patient experienced HYPOAESTHESIA (left hand went numb/ right hand went numb/ his legs and feet up to his knees went numb, bilateral ullnar neuropathy). On 18-Jun-2021, the patient experienced PARAESTHESIA (paresthesia in his lower extrimities) and NECK PAIN (Pain in neck). On an unknown date, the patient experienced ASCITES (fluid in the lower quadrant) (seriousness criterion medically significant), DIABETES MELLITUS (diabetes) (seriousness criterion medically significant), GAIT DISTURBANCE (difficult to walk), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (hard to pick up things), CARPAL TUNNEL SYNDROME (neurologist diagnosed as having Carpal Tunnel Syndrome, more svere on left than right), AXONAL NEUROPATHY (Axonal neuropathy with stocking hypoethesia to pin and absent vibration in his feet.) and ASTHENIA (Felt generally weak). The patient was treated with GABAPENTIN ongoing since an unknown date for Adverse event, at a dose of 300 milligram twice a day and PREDNISONE ongoing since an unknown date for Adverse event, at an unspecified dose and frequency. At the time of the report, ASCITES (fluid in the lower quadrant), DIABETES MELLITUS (diabetes), HYPOAESTHESIA (left hand went numb/ right hand went numb/ his legs and feet up to his knees went numb, bilateral ullnar neuropathy), GAIT DISTURBANCE (difficult to walk), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (hard to pick up things), CARPAL TUNNEL SYNDROME (neurologist diagnosed as having Carpal Tunnel Syndrome, more svere on left than right), PARAESTHESIA (paresthesia in his lower extrimities), AXONAL NEUROPATHY (Axonal neuropathy with stocking hypoethesia to pin and absent vibration in his feet.), ASTHENIA (Felt generally weak) and NECK PAIN (Pain in neck) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Oct-2017, Magnetic resonance imaging: epidural fat narrowing at canal l3-l4 (abnormal) Some epidural fat narrowing at canal L3-L4, no central canal narrowing at L4-L5. L5-S1 there was a focal posterior osteophyte paracentral to the right, which contacted the descending right S1 nerve root and serve left and mild right foraminal narrowing.. On 18-Jun-2021, Blood glucose: 158 (High) 158 mg/dL. On 18-Jun-2021, Blood magnesium: normal (normal) normal. On 18-Jun-2021, Blood pressure measurement: 130/70 (normal) 130/70. On 18-Jun-2021, Blood thyroid stimulating hormone: normal (normal) Normal. On 18-Jun-2021, Chest X-ray: normal (normal) No acute cardiopulmonary process.. On 18-Jun-2021, Computerised tomogram: no acute intracranial abnormality (normal) no acute intracranial abnormality. On 18-Jun-2021, Computerised tomogram spine: no spine fracture (normal) no spine fracture. On 18-Jun-2021, Full blood count: unremarkable (normal) unremarkable. On 18-Jun-2021, Hepatic enzyme: normal (normal) normal. On 18-Jun-2021, Ultrasound abdomen: revealed some fluids (abnormal) some fluids in the lower quadrant concerning ascites. It was reported that the patient presented to the emergency room one month prior to the report because of the events and consulted a neurologist and two other physicians. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded Most recent FOLLOW-UP information incorporated above includes: On 18-Aug-2021: Follow-up received by safety 18-Aug-2021 added medical history, added laboratory data, added events and narrative was updated accordingly.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded

Other Meds: ALLOPURINOL; CELEBREX; SYNTHROID; POTASSIUM; TESTOSTERONE; CARVEDILOL; ENTRESTO; LASIX [FUROSEMIDE]

Current Illness: Allergy to antibiotic (Flagyl (metronidazole)); Chronic back pain (He has seen pain management physician for some time); Drug allergy (Lipitor (atorvastatin) - 25 years ago, the patient experienced a similar numbness after taking Lipitor and once stopped the Lipitor, the numbness resolved)

ID: 1644375
Sex: U
Age:
State: NJ

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: After getting vaccine the cancer got reactivated.; This spontaneous case was reported by a consumer and describes the occurrence of RECURRENT CANCER (After getting vaccine the cancer got reactivated) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Cancer. 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 RECURRENT CANCER (After getting vaccine the cancer got reactivated.) (seriousness criterion medically significant). At the time of the report, RECURRENT CANCER (After getting vaccine the cancer got reactivated.) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product was not provided by the reporter The was provided updated contact information since his wife passed away and also stated that a friend of his next-door neighbor's who had cancer and was considered as cured few years ago, after getting vaccine the cancer got reactivated. Lab data was not provided Treatment product was not provided by the reporter Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1644376
Sex: F
Age: 31
State: KY

Vax Date: 07/28/2021
Onset Date: 08/01/2021
Rec V Date: 08/28/2021
Hospital: Y

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: pain had spread into the back of my skull and very tender; extreme pain and swelling in left lymph node; Swelling in her lymph node on the same side where she got the shot/has gotten bigger/ knot growing out of my left lymph node; Sinus issues like colds; extreme pain in neck; unable to turn neck; sick at my stomach; double ear ache; lots of drainage in ears, nose and throat; no energy; out of breath; lots of drainage in ears; dizziness; sore in chest when breathing; severe cold symptoms; soft ball size knot grow at the injection site; extreme fatigue; body aches; Arm where she got the shot is very sore; feverish; This spontaneous case was reported by a consumer and describes the occurrence of LYMPH NODE PAIN (extreme pain and swelling in left lymph node), HEADACHE (pain had spread into the back of my skull and very tender) and LYMPHADENOPATHY (Swelling in her lymph node on the same side where she got the shot/has gotten bigger/ knot growing out of my left lymph node) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Endometrial disorder NOS (Endometriosis) and Hysterotomy in July 2018. Concurrent medical conditions included Depression and Bipolar disorder. Concomitant products included LAMOTRIGINE from 10-Jul-2021 to an unknown date for Bipolar affective disorder, PAROXETINE HYDROCHLORIDE (PAXIL [PAROXETINE HYDROCHLORIDE]) from 15-Feb-2018 to an unknown date for Depression. On 28-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Aug-2021, the patient experienced LYMPHADENOPATHY (Swelling in her lymph node on the same side where she got the shot/has gotten bigger/ knot growing out of my left lymph node) (seriousness criterion hospitalization). On 02-Aug-2021, the patient experienced LYMPH NODE PAIN (extreme pain and swelling in left lymph node) (seriousness criterion hospitalization). On 03-Aug-2021, the patient experienced HEADACHE (pain had spread into the back of my skull and very tender) (seriousness criterion hospitalization). On an unknown date, the patient experienced NASOPHARYNGITIS (Sinus issues like colds), NECK PAIN (extreme pain in neck), MOBILITY DECREASED (unable to turn neck), ABDOMINAL DISCOMFORT (sick at my stomach), EAR PAIN (double ear ache), RHINORRHOEA (lots of drainage in ears, nose and throat), ASTHENIA (no energy), DYSPNOEA (out of breath), OTORRHOEA (lots of drainage in ears), DIZZINESS (dizziness), CHEST PAIN (sore in chest when breathing), NASOPHARYNGITIS (severe cold symptoms), VACCINATION SITE INDURATION (soft ball size knot grow at the injection site), FATIGUE (extreme fatigue), MYALGIA (body aches), VACCINATION SITE PAIN (Arm where she got the shot is very sore) and PYREXIA (feverish). The patient was hospitalized on 02-Aug-2021 due to LYMPH NODE PAIN and LYMPHADENOPATHY. At the time of the report, LYMPH NODE PAIN (extreme pain and swelling in left lymph node), HEADACHE (pain had spread into the back of my skull and very tender), LYMPHADENOPATHY (Swelling in her lymph node on the same side where she got the shot/has gotten bigger/ knot growing out of my left lymph node) and VACCINATION SITE INDURATION (soft ball size knot grow at the injection site) had not resolved and NASOPHARYNGITIS (Sinus issues like colds), NECK PAIN (extreme pain in neck), MOBILITY DECREASED (unable to turn neck), ABDOMINAL DISCOMFORT (sick at my stomach), EAR PAIN (double ear ache), RHINORRHOEA (lots of drainage in ears, nose and throat), ASTHENIA (no energy), DYSPNOEA (out of breath), OTORRHOEA (lots of drainage in ears), DIZZINESS (dizziness), CHEST PAIN (sore in chest when breathing), NASOPHARYNGITIS (severe cold symptoms), FATIGUE (extreme fatigue), MYALGIA (body aches), VACCINATION SITE PAIN (Arm where she got the shot is very sore) and PYREXIA (feverish) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication included anti-depressants and over the counter medication. Treatment information was not provided. The patient applied heating pad for her symptoms. The patient reported that she the swelling on her left side has gotten bigger from the bottom of her neck and now up to her back. Physician (friend) advised to use compresses and massage was noted. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow up received included additional Information received included patient demographics, historical conditions, concomitants, new events, case upgraded to serious and start date of event were added and event oucomes were updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: PAXIL [PAROXETINE HYDROCHLORIDE]; LAMOTRIGINE

Current Illness: Bipolar disorder; Depression.

ID: 1644377
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: Possible heart inflammation; This spontaneous case was reported by a consumer and describes the occurrence of MYOCARDITIS (Possible heart inflammation) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYOCARDITIS (Possible heart inflammation) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (Possible heart inflammation) outcome was unknown. Relevant concomitant product usage were not reported by the reporter. No treatment details were added. Company comment: Very limited information regarding the events has been provided at this time.; Sender's Comments: Very limited information regarding the events has been provided at this time.

Other Meds:

Current Illness:

ID: 1644378
Sex: U
Age:
State: OK

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: Pharmacist said she has patients who have not received their second dose and it has been more tan 37 days.; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Pharmacist said she has patients who have not received their second dose and it has been more tan 37 days.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Pharmacist said she has patients who have not received their second dose and it has been more tan 37 days.). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Pharmacist said she has patients who have not received their second dose and it has been more tan 37 days.) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 18-Aug-2021: Follow- up received : contains No new information

Other Meds:

Current Illness:

ID: 1644379
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Had complications not related to the vaccine; First COVID vaccine in March, wasn't able to get the second dose until now; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 03-Aug-2021 and was forwarded to Moderna on 03-Aug-2021. This spontaneous case was reported by an other health care professional and describes the occurrence of ADVERSE EVENT (Had complications not related to the vaccine) and PRODUCT DOSE OMISSION ISSUE (First COVID vaccine in March, wasn't able to get the second dose until now) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Had complications not related to the vaccine) and PRODUCT DOSE OMISSION ISSUE (First COVID vaccine in March, wasn't able to get the second dose until now). The patient was treated with Surgery for Adverse event. At the time of the report, ADVERSE EVENT (Had complications not related to the vaccine) and PRODUCT DOSE OMISSION ISSUE (First COVID vaccine in March, wasn't able to get the second dose until now) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered ADVERSE EVENT (Had complications not related to the vaccine) to be not related. No further causality assessment was provided for PRODUCT DOSE OMISSION ISSUE (First COVID vaccine in March, wasn't able to get the second dose until now). No concomitant medications were provided. Treatment for the events were not provided. Patient got first COVID vaccine in March and had surgery later and had complications not related to the vaccine and wasn't able to get the second dose until now. Company comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information is not expected. Reporter did not allow further contact; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information is not expected.

Other Meds:

Current Illness:

ID: 1644380
Sex: M
Age:
State: TN

Vax Date: 01/08/2021
Onset Date: 04/01/2021
Rec V Date: 08/28/2021
Hospital: Y

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: took ill and was in hospitalized; had their first dose of the Moderna vaccine on 08Jan2021 and has not gotten the second dose yet.; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (took ill and was in hospitalized) 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 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 2021, the patient experienced ILLNESS (took ill and was in hospitalized) (seriousness criterion hospitalization). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (had their first dose of the Moderna vaccine on 08Jan2021 and has not gotten the second dose yet.). At the time of the report, ILLNESS (took ill and was in hospitalized) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (had their first dose of the Moderna vaccine on 08Jan2021 and has not gotten the second dose yet.) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications reported by investigator. No treatment medications provided by the reporter. Patient has not received the second dose yet. Company comment: Causality for the event Product dose omission issue is not applicable. The event illness appears temporally dissociated with the product use; however, a causal relationship cannot be excluded.; Sender's Comments: Causality for the event Product dose omission issue is not applicable. The event illness appears temporally dissociated with the product use; however, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1644381
Sex: U
Age:
State: OK

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Wheezing; Coughing; Mass in her lungs; This spontaneous case was reported by a consumer and describes the occurrence of WHEEZING (Wheezing), COUGH (Coughing) and PULMONARY MASS (Mass in her lungs) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced WHEEZING (Wheezing), COUGH (Coughing) and PULMONARY MASS (Mass in her lungs). At the time of the report, WHEEZING (Wheezing), COUGH (Coughing) and PULMONARY MASS (Mass in her lungs) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was provided by reporter. No treatment information was provided by reporter. Most recent FOLLOW-UP information incorporated above includes: On 17-Aug-2021: Follow-up included no new information.

Other Meds:

Current Illness:

ID: 1644382
Sex: U
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: had an allergic reaction to the first dose of the Moderna vaccine; anaphylaxis; This spontaneous case was reported by a consumer and describes the occurrence of ALLERGY TO VACCINE (had an allergic reaction to the first dose of the Moderna vaccine) and ANAPHYLACTIC REACTION (anaphylaxis) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ALLERGY TO VACCINE (had an allergic reaction to the first dose of the Moderna vaccine) (seriousness criterion hospitalization) and ANAPHYLACTIC REACTION (anaphylaxis) (seriousness criteria hospitalization and medically significant). At the time of the report, ALLERGY TO VACCINE (had an allergic reaction to the first dose of the Moderna vaccine) and ANAPHYLACTIC REACTION (anaphylaxis) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication details were reported. It was reported that, because of this anaphylaxis, the patient has been disqualified from taking the second dose of the vaccine. The patient's HCP recommended that patient receive the Pfizer vaccine for a second dose. The patient went to a vaccination clinic where they refused to give a dose of the Pfizer vaccine. The patient is concerned because she needs documentation showing 2 doses of vaccine to participate in school. The patient does not want this reaction to prevent her from attending school. The patient has also followed up with her HCP after being declined by the vaccination provider who was steadfast in their recommendation to receive the second dose of the vaccine. Company Comment: Based on the 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. Most recent FOLLOW-UP information incorporated above includes: On 03-Aug-2021: Follow-up information received which included updated narrative, seriousness criteria and treatment information.; Sender's Comments: Based on the 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: 1644383
Sex: F
Age: 57
State: NC

Vax Date: 05/19/2021
Onset Date: 06/20/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Name: Weight; Result Unstructured Data: gained 30 pounds.

Allergies:

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

Symptoms: her kidney is in the limit of a kidney failure; cannot sleep; it's itching like crazy; anxiety; panic attacks; depression; condition worsened; started breaking out on a rash in different parts of the body; scratched and started having bruises; itched so much; scratched and started having bruises; it was like boils on her body; This spontaneous case was reported by a consumer and describes the occurrence of RENAL FAILURE (her kidney is in the limit of a kidney failure) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 035C21A and 027CZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was reported. Concomitant products included ESTRADIOL, LIOTHYRONINE, AMITRIPTYLINE, FLUOXETINE, GABAPENTIN, PROGESTERONE, SPIRONOLACTONE, DIPHENHYDRAMINE HYDROCHLORIDE (ANTIHISTAMINE ALLERGY RELIEF), DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A), MONTELUKAST, LEVOTHYROXINE, FLUTICASONE, ZINC, CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) and ESSENTIAL OILS NOS for an unknown indication. On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Jun-2021, the patient experienced RASH PRURITIC (itched so much), CONTUSION (scratched and started having bruises), FURUNCLE (it was like boils on her body), SKIN ABRASION (scratched and started having bruises) and RASH (started breaking out on a rash in different parts of the body). On an unknown date, the patient experienced RENAL FAILURE (her kidney is in the limit of a kidney failure) (seriousness criterion medically significant), INSOMNIA (cannot sleep), PRURITUS (it's itching like crazy), ANXIETY (anxiety), PANIC ATTACK (panic attacks), DEPRESSION (depression) and CONDITION AGGRAVATED (condition worsened). At the time of the report, RENAL FAILURE (her kidney is in the limit of a kidney failure), RASH PRURITIC (itched so much), CONTUSION (scratched and started having bruises), FURUNCLE (it was like boils on her body), INSOMNIA (cannot sleep), PRURITUS (it's itching like crazy), ANXIETY (anxiety), PANIC ATTACK (panic attacks), DEPRESSION (depression), SKIN ABRASION (scratched and started having bruises), CONDITION AGGRAVATED (condition worsened) and RASH (started breaking out on a rash in different parts of the body) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Weight: 30 (High) gained 30 pounds. Patient had been to her doctor, to a dermatologist and to the ER.. Patient was 5 rounds of prednisone and had prednisone shots (that's when she got better but as soon as she stops it, the itching came back and worsened). Said it was freaking miserable. Patient gained 30 pounds because of being in prednisone and patient in the border of dialysis. patient was never had any of this before the vaccine. Patient stopped the prednisone because her kidney is in the limit of a kidney failure. Patient was been in every antihistamine and they were not helping. It was pretty bad. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information is not expected. This case was linked to MOD-2021-275213 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information is not expected.

Other Meds: Estradiol; Liothyronine; Amitriptyline; Fluoxetine; Gabapentin; Progesterone; Spironolactone; Antihistamine Allergy Relief; Benadryl A; Montelukast; Levothyroxine; Fluticasone; Zinc; Vitamin D 2000; Essential Oils NOS

Current Illness:

ID: 1644384
Sex: F
Age:
State: MA

Vax Date: 03/16/2021
Onset Date: 04/24/2021
Rec V Date: 08/28/2021
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: This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning sensation inside her head and organs), TINNITUS (Tinnitus (second dose)), HYPOAESTHESIA (Numbness in the right side of the body (second dose)), SKIN DISCOLOURATION (Change in color of the skin) and AMENORRHOEA (Lost of menstruation cycle) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045B21A and 047A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included CLONAZEPAM for Anxiety, PARACETAMOL (TYLENOL) for an unknown indication. On 16-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced PYREXIA (Fever) and CHILLS (Chills). On an unknown date, the patient experienced BURNING SENSATION (Burning sensation inside her head and organs), TINNITUS (Tinnitus(second dose)), HYPOAESTHESIA (Numbness in the right side of the body (second dose)), SKIN DISCOLOURATION (Change in color of the skin), AMENORRHOEA (Lost of menstruation cycle), WEIGHT DECREASED (15lbs weight loss), INSOMNIA (insomnia) and ANXIETY (anxiety). On 26-Apr-2021, PYREXIA (Fever) and CHILLS (Chills) had resolved. At the time of the report, BURNING SENSATION (Burning sensation inside her head and organs), TINNITUS (Tinnitus(second dose)), HYPOAESTHESIA (Numbness in the right side of the body (second dose)), SKIN DISCOLOURATION (Change in color of the skin), AMENORRHOEA (Lost of menstruation cycle), WEIGHT DECREASED (15lbs weight loss), INSOMNIA (insomnia) and ANXIETY (anxiety) outcome was unknown. Treatment drugs included steroids for symptoms after second dose. Patient has an appointment scheduled on 04-AUG-2021. This case was linked to MOD-2021-275318 (Patient Link).

Other Meds: TYLENOL; CLONAZEPAM

Current Illness:

ID: 1644385
Sex: M
Age: 72
State: NV

Vax Date: 02/01/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital: Y

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

Lab Data: Test Date: 2021; Test Name: blood oxygen; Result Unstructured Data: blood oxygen dropped to 50%.; Test Date: 2021; Test Name: blood oxygen; Result Unstructured Data: oxygen levels are now at 70%.

Allergies:

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

Symptoms: blood oxygen dropped to 50% and oxygen levels are now at 70%; difficulty breathing/could not breathe right; fluid in their lungs; fluid around their heart; Congenital heart failure; feared/scared; got both doses of the Moderna vaccine on the left arm and also both doses of the Pfizer vaccine on the opposite arm; Moderna first dose was administered on 7 or 17 Jan2021, lot#025L20A (expiry date 25Jun2021), and the second on 25Feb2021; Congenital heart failure; This spontaneous case was reported by a consumer and describes the occurrence of HYPOXIA (blood oxygen dropped to 50% and oxygen levels are now at 70%), DYSPNOEA (difficulty breathing/could not breathe right), PULMONARY OEDEMA (fluid in their lungs), PERICARDIAL EFFUSION (fluid around their heart), HEART DISEASE CONGENITAL (Congenital heart failure) and CARDIAC FAILURE (Congenital heart failure) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for COVID-19 vaccination. Concomitant products included ATORVASTATIN, ACETYLSALICYLIC ACID (ASPIRIN 81), APIXABAN, AMLODIPINE BESYLATE, CARVEDILOL, LOSARTAN, FUROSEMIDE, POTASSIUM CHLORIDE and MAGNESIUM OXIDE for an unknown indication. On 01-Feb-2021, the patient received first dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 22-Feb-2021, received second dose of TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) dosage was changed to 1 dosage form. On 25-Feb-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 received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced HYPOXIA (blood oxygen dropped to 50% and oxygen levels are now at 70%) (seriousness criteria hospitalization and medically significant) and DYSPNOEA (difficulty breathing/could not breathe right) (seriousness criterion hospitalization). On an unknown date, the patient experienced PULMONARY OEDEMA (fluid in their lungs) (seriousness criterion medically significant), PERICARDIAL EFFUSION (fluid around their heart) (seriousness criterion medically significant), HEART DISEASE CONGENITAL (Congenital heart failure) (seriousness criterion medically significant), FEAR (feared/scared), COVID-19 IMMUNISATION (got both doses of the Moderna vaccine on the left arm and also both doses of the Pfizer vaccine on the opposite arm), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna first dose was administered on 7 or 17 Jan2021, lot#025L20A (expiry date 25Jun2021), and the second on 25Feb2021) and CARDIAC FAILURE (Congenital heart failure) (seriousness criterion medically significant). The patient was hospitalized for 5 days due to DYSPNOEA and HYPOXIA. At the time of the report, HYPOXIA (blood oxygen dropped to 50% and oxygen levels are now at 70%) and DYSPNOEA (difficulty breathing/could not breathe right) had not resolved, PULMONARY OEDEMA (fluid in their lungs), PERICARDIAL EFFUSION (fluid around their heart), HEART DISEASE CONGENITAL (Congenital heart failure), FEAR (feared/scared), COVID-19 IMMUNISATION (got both doses of the Moderna vaccine on the left arm and also both doses of the Pfizer vaccine on the opposite arm) and CARDIAC FAILURE (Congenital heart failure) outcome was unknown and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Moderna first dose was administered on 7 or 17 Jan2021, lot#025L20A (expiry date 25Jun2021), and the second on 25Feb2021) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Oxygen saturation: 50% (Low) blood oxygen dropped to 50%. and 70% (Low) oxygen levels are now at 70%. HCP told the patient they have too much antibodies on their system. Patient had labs done last Monday and was still waiting on the results. Patient was on oxygen . HCP was treating the Patient for Congenital heart failure. Company Comment: This is a case of inappropriate schedule of vaccine administered and covid 19 immunisation (revaccination with different covid 19 vaccine) with associated adverse events of hypoxia, dyspnoea, pulmonary oedema, pericardial effusion, heart disease congenital and cardiac failure. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information is expected.; Sender's Comments: This is a case of inappropriate schedule of vaccine administered and covid 19 immunisation (revaccination with different covid 19 vaccine) with associated adverse events of hypoxia, dyspnoea, pulmonary oedema, pericardial effusion, heart disease congenital and cardiac failure. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information is expected.

Other Meds: Atorvastatin; Aspirin 81; Apixaban; Amlodipine Besylate; Carvedilol; Losartan; Furosemide; Potassium Chloride; Magnesium Oxide

Current Illness:

ID: 1644386
Sex: F
Age:
State:

Vax Date: 01/01/2021
Onset Date: 01/19/2021
Rec V Date: 08/28/2021
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: diagnosed with covid 19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (diagnosed with covid 19) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced COVID-19 (diagnosed with covid 19). At the time of the report, COVID-19 (diagnosed with covid 19) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was reported. No treatment medication was provided. This case was linked to MOD-2021-013204 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 18-Aug-2021: Follow-up information received contains NNI.

Other Meds:

Current Illness:

Date Died:

ID: 1644387
Sex: M
Age: 78
State: TN

Vax Date: 02/26/2021
Onset Date: 03/10/2021
Rec V Date: 08/28/2021
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: Patients father passed away; sore arm; Hemorrhagic stroke; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Patients father passed away) and HAEMORRHAGIC STROKE (Hemorrhagic stroke) in a 78-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Diabetes and Heart disorder (Heart rhythm was not normal). On 26-Feb-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 10-Mar-2021, the patient experienced HAEMORRHAGIC STROKE (Hemorrhagic stroke) (seriousness criterion medically significant). On an unknown date, the patient experienced DEATH (Patients father passed away) (seriousness criteria death and medically significant) and MYALGIA (sore arm). The patient died on an unknown date. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, HAEMORRHAGIC STROKE (Hemorrhagic stroke) and MYALGIA (sore arm) outcome was unknown. Concomitant product was not provided by the reporter. Treatment product was not provided by the reporter. Company comment: Very limited information regarding these events has been provided at this time. Further information has been requested.; Sender's Comments: Very limited information regarding these events has been provided at this time. Further information has been requested.; Reported Cause(s) of Death: Unknown cause of death

Other Meds:

Current Illness:

ID: 1644388
Sex: M
Age:
State: CA

Vax Date: 04/01/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: Husband had his 1st dose of the Moderna Covid-19 Vaccine in April but has not gotten the 2nd dose; This spontaneous case was reported by a patient family member or friend and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Husband had his 1st dose of the Moderna Covid-19 Vaccine in April but has not gotten the 2nd dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In April 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 PRODUCT DOSE OMISSION ISSUE (Husband had his 1st dose of the Moderna Covid-19 Vaccine in April but has not gotten the 2nd dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Husband had his 1st dose of the Moderna Covid-19 Vaccine in April but has not gotten the 2nd dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant medication were reported. No treatment medication were reported.

Other Meds:

Current Illness:

ID: 1644389
Sex: U
Age:
State: AZ

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: bell's palsy after the vaccine; 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 BELL'S PALSY (bell's palsy after the vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced BELL'S PALSY (bell's palsy after the vaccine) (seriousness criterion medically significant). At the time of the report, BELL'S PALSY (bell's palsy after the vaccine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient's friend reported that patient experienced bell's palsy after the Moderna vaccine. No concomitant medications were provided by the reporter. No treatment information was provided by the reporter. Company Comment: Very limited information regarding this event/s has been provided at this time. Patient age and gender not reported. Further information has been requested.; Sender's Comments: Very limited information regarding this event/s has been provided at this time. Patient age and gender not reported. Further information has been requested.

Other Meds:

Current Illness:

Date Died:

ID: 1644390
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: Blood clots; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (Blood clots) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced THROMBOSIS (Blood clots) (seriousness criteria death, hospitalization and medically significant). The reported cause of death was blood clots. It is unknown if an autopsy was performed. The concomitant medication was not reported. A consumer called and stated that his uncle passed away 2 days after receiving Moderna Covis-19 Vaccine. Reporter stated that his uncle had to go to ICU due to blood clots and died from it. No treatment medication information was provided. This is a case of death of a Male subject who passed away two days after receiving the vaccine. Very limited information regarding the event has been provided at this time. No further information is expected.; Sender's Comments: This is a case of death of a Male subject who passed away two days after receiving the vaccine. Very limited information regarding the event has been provided at this time. No further information is expected.; Reported Cause(s) of Death: blood clots

Other Meds:

Current Illness:

Date Died:

ID: 1644391
Sex: U
Age:
State: UT

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: patient died after the second dose of the Moderna vaccine; 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 (patient died after the second dose of the Moderna vaccine) 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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided. Company Comment: Very limited information regarding the events has been provided at this time.; Sender's Comments: Very limited information regarding the events has been provided at this time.; Reported Cause(s) of Death: patient died after the second dose of the Moderna vaccine

Other Meds:

Current Illness:

ID: 1644392
Sex: F
Age: 25
State: MA

Vax Date: 05/01/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: admitted inpatient into a substance treatment facility; at least 13 weeks between the first and second doses; This spontaneous case was reported by a consumer and describes the occurrence of HOSPITALISATION (admitted inpatient into a substance treatment facility) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 01-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Aug-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 HOSPITALISATION (admitted inpatient into a substance treatment facility) (seriousness criterion hospitalization) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (at least 13 weeks between the first and second doses). The patient was hospitalized until 09-Jul-2021 due to HOSPITALISATION. On 09-Jul-2021, HOSPITALISATION (admitted inpatient into a substance treatment facility) outcome was unknown. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (at least 13 weeks between the first and second doses) had resolved. No concomitant medication were reported. No treatment history were reported. Patient denies any side effects or any changes after vaccination. Patient stated that there was no way of receiving the second dose vaccination as patient was admitted inpatient into a substance treatment facility until 09JUL2021. Patient is currently still in treatment living in a sober house. Company comment- This report refers to a case of Inappropriate schedule of product administration for mRNA-1273, lot # unknown with associated AE (Hospitalisation). Very limited information regarding this event has been provided at this time. Further information has been requested.; Sender's Comments: This report refers to a case of Inappropriate schedule of product administration for mRNA-1273, lot # unknown with associated AE (Hospitalisation). Very limited information regarding this event has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

Date Died:

ID: 1644393
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Death after vaccination; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (Death after vaccination) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. Death occurred on an unknown date The cause of death was not reported. It is unknown if an autopsy was performed. No concomitant medication details was provided. No treatment medication details was provided. Company comment: Very limited information regarding the events has been provided at this time. Further information is not expected.; Sender's Comments: Very limited information regarding the events has been provided at this time. Further information is not expected.; Reported Cause(s) of Death: unknown cause of death

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am