VAERS 2021 Database www.vaers.hhs.gov

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VAERS Updated: 11/12/2021
** VAERS DATABASE Last updated: November 12, 2021**
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Manufacturers

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

COVID19 Lot Number

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

Incidents per State

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

ID: 1823434
Sex: F
Age:
State:

Vax Date: 01/01/2021
Onset Date:
Rec V Date: 10/28/2021
Hospital:

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

Lab Data: Test Date: 202107; Test Name: Blood test; Result Unstructured Data: Done bloodwork after second dose, in July. Level of antibodies was 1200 .; Test Date: 202108; Test Name: Blood test; Result Unstructured Data: After 3rd dose, patient did another blood work and level of antibodies was 2500.

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: loss of taste and smell; loss of taste and smell; This spontaneous case was reported by a consumer and describes the occurrence of AGEUSIA (loss of taste and smell) and ANOSMIA (loss of taste and smell) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Immunocompromised and Crohn's disease. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced AGEUSIA (loss of taste and smell) and ANOSMIA (loss of taste and smell). At the time of the report, AGEUSIA (loss of taste and smell) and ANOSMIA (loss of taste and smell) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2021, Antibody test: 1200 (High) Done bloodwork after second dose, in July. Level of antibodies was 1200 .. In August 2021, Antibody test: 2500 (High) After 3rd dose, patient did another blood work and level of antibodies was 2500.. Concomitant medication includes Opioids. No treatment medication was provided. Patient said to be immunocompromised and has Chron's disease. After third dose patient experienced loss of taste and smell. This case concerns a patient of unknown age and gender, with no relevant medical history, who experienced the non-serious unexpected AESI's of AGEUSIA and ANOSMIA. The events occurred on an unknown date after receiving the third dose of Spikevax. The rechallenge is not applicable since the events have not resolved and no further dose is expected. The benefit-risk relation of Spikevax is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 21-Oct-2021: Significant followup appended, Email address and outcome of events updated.; Sender's Comments: This case concerns a patient of unknown age and gender, with no relevant medical history, who experienced the non-serious unexpected AESI's of AGEUSIA and ANOSMIA. The events occurred on an unknown date after receiving the third dose of Spikevax. The rechallenge is not applicable since the events have not resolved and no further dose is expected. The benefit-risk relation of Spikevax is not affected by this report.

Other Meds:

Current Illness:

ID: 1823435
Sex: M
Age: 69
State: OR

Vax Date: 02/08/2021
Onset Date: 10/07/2021
Rec V Date: 10/28/2021
Hospital:

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

Lab Data: Test Date: 20211007; Test Name: oxygen level; Result Unstructured Data: abnormal

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: so breathless he cannot take off his coat.; feels very fatigue.; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (so breathless he cannot take off his coat.) and FATIGUE (feels very fatigue.) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A, 002A21A and 007M20A) for COVID-19 vaccination. Concurrent medical conditions included Immunocompromised. Concomitant products included RUXOLITINIB for Cancer, PHENYTOIN (DILANTIN [PHENYTOIN]), PHENOBARBITAL SODIUM (PHENOBARBITAL [PHENOBARBITAL SODIUM]), LEVOTHYROXINE SODIUM (SYNTHROID), SPIRONOLACTONE and TORSEMIDE for an unknown indication. On 08-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 07-Oct-2021, the patient experienced DYSPNOEA (so breathless he cannot take off his coat.) and FATIGUE (feels very fatigue.). At the time of the report, DYSPNOEA (so breathless he cannot take off his coat.) and FATIGUE (feels very fatigue.) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 07-Oct-2021, Oxygen saturation: 93-96 (abnormal) abnormal. weight was reported as 200. No treatment medications were reported.

Other Meds: RUXOLITINIB; DILANTIN [PHENYTOIN]; PHENOBARBITAL [PHENOBARBITAL SODIUM]; SYNTHROID; SPIRONOLACTONE; TORSEMIDE

Current Illness: Immunocompromised

ID: 1823436
Sex: M
Age: 46
State: AL

Vax Date: 09/03/2021
Onset Date:
Rec V Date: 10/28/2021
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: Test Name: COVID-19 test; Test Result: Positive ; Result Unstructured Data: Positive

Allergies:

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

Symptoms: Tested positive for COVID-19; Tested positive for COVID-19.missed their second dose due to quarantine and are nowgoing to get vaccinated past the 42 day window; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Tested positive for COVID-19) and PRODUCT DOSE OMISSION ISSUE (Tested positive for COVID-19.missed their second dose due to quarantine and are nowgoing to get vaccinated past the 42 day window) in a 47-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination. No medical history was provided by the reporter. On 03-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (Tested positive for COVID-19) and PRODUCT DOSE OMISSION ISSUE (Tested positive for COVID-19.missed their second dose due to quarantine and are nowgoing to get vaccinated past the 42 day window). At the time of the report, COVID-19 (Tested positive for COVID-19) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Tested positive for COVID-19.missed their second dose due to quarantine and are nowgoing to get vaccinated past the 42 day window) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant products were reported. No Treatment information was provided. The reporter stated that the patient got the first Moderna COVID-19 vaccination and then tested positive for COVID-19. The patient missed their second dose due to quarantine and were now going to get vaccinated past the 42 day window. The reporter did not want to provide the patients concomitant medication list and was unsure of when the patient tested positive for COVID-19. This case concerns a 47 year old male with no reported medical history, who experienced the non-serious, unexpected event of Covid 19 and Product dose omission issue , which occurred on an unknown time after vaccination with the 1st dose of mRNA - 1273 (Moderna). The re-challenge for this case is not applicable. The benefit - risk relationship of mRNA-1273 (Moderna ) is not affected by this report.; Sender's Comments: This case concerns a 47 year old male with no reported medical history, who experienced the non-serious, unexpected event of Covid 19 and Product dose omission issue , which occurred on an unknown time after vaccination with the 1st dose of mRNA - 1273 (Moderna). The re-challenge for this case is not applicable. The benefit - risk relationship of mRNA-1273 (Moderna ) is not affected by this report.

Other Meds:

Current Illness:

ID: 1823437
Sex: F
Age:
State: CA

Vax Date: 02/16/2021
Onset Date: 03/16/2021
Rec V Date: 10/28/2021
Hospital:

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

Lab Data: Test Name: Heart beat; Result Unstructured Data: very fast

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: realized it must be from the COVID19 vaccine.; Heart problems; chest pain for 6 minutes; Shortness of breath; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (Heart problems), CHEST PAIN (chest pain for 6 minutes), DYSPNOEA (Shortness of breath) and VACCINATION COMPLICATION (realized it must be from the COVID19 vaccine.) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044A21A and 016M20A) for COVID-19 vaccination. The patient's past medical history included Heartbeats increased (faster heartbeat, but that it only happens every one or two months and lasts at its longest one minute). On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced CARDIAC DISORDER (Heart problems), CHEST PAIN (chest pain for 6 minutes) and DYSPNOEA (Shortness of breath). On an unknown date, the patient experienced VACCINATION COMPLICATION (realized it must be from the COVID19 vaccine.). At the time of the report, CARDIAC DISORDER (Heart problems), DYSPNOEA (Shortness of breath) and VACCINATION COMPLICATION (realized it must be from the COVID19 vaccine.) outcome was unknown and CHEST PAIN (chest pain for 6 minutes) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Heart rate: fast (High) very fast. No concomitant medication details provided. No treatment medication details provided. Patient reported that since the patient got the second dose of the vaccine, she has had "very fast heartbeat" and "heart problems". For months, this happened everyday and lasted almost 40 minutes at times. Patient stated she went to the ER and the doctor thought she had a heart attack because she had chest pain for 6 minutes, shortness of breath and a fast heartbeat. This lasted several months, until September 2021. Patient stated events seems like it happens once or twice a week, it has slowed down. Patient attributes this to acupuncture. Patient stated that at first, she didn't know why this was happening and then realized it must be from the COVID19 vaccine. Company comment include This case concerns a 70-year-old, female patient with medical history of heartbeats increased, who experienced the unexpected non serious events of cardiac disorder, heart rate increased, dyspnoea and chest pain. The events occurred following the second dose of Moderna COVID-19 Vaccine. Ever since the patient got the second dose of the vaccine, she has had "very fast heartbeat" and "heart problems". For months, this happened everyday and lasted almost 40 minutes at times, as reported. The patient stated she went to the ER and the doctor thought she had a heart attack because she had chest pain for 6 minutes, shortness of breath and a fast heartbeat. This lasted several months. Patient stated events no happen once or twice a week, as it has slowed down. Patient attributes this to acupuncture. The rechallenge was not applicable. The reporter assessed the events as related to the product. The medical history of increased heartbeat remains a confounder. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.; Sender's Comments: This case concerns a 70-year-old, female patient with medical history of heartbeats increased, who experienced the unexpected non serious events of cardiac disorder, heart rate increased, dyspnoea and chest pain. The events occurred following the second dose of Moderna COVID-19 Vaccine. Ever since the patient got the second dose of the vaccine, she has had "very fast heartbeat" and "heart problems". For months, this happened everyday and lasted almost 40 minutes at times, as reported. The patient stated she went to the ER and the doctor thought she had a heart attack because she had chest pain for 6 minutes, shortness of breath and a fast heartbeat. This lasted several months. Patient stated events no happen once or twice a week, as it has slowed down. Patient attributes this to acupuncture. The rechallenge was not applicable. The reporter assessed the events as related to the product. The medical history of increased heartbeat remains a confounder. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.

Other Meds:

Current Illness:

ID: 1823438
Sex: F
Age: 28
State: CA

Vax Date: 09/14/2021
Onset Date: 10/19/2021
Rec V Date: 10/28/2021
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 erythema, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: Received expired second dose; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired second dose) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 006C21A and 008C21A) for COVID-19 vaccination. No Medical History information was reported. On 14-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Oct-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired second dose). On 19-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received expired second dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. No treatment information was provided. This case was linked to MOD-2021-357255 (Patient Link).

Other Meds:

Current Illness:

ID: 1823439
Sex: U
Age: 82
State: PA

Vax Date: 09/20/2021
Onset Date: 10/18/2021
Rec V Date: 10/28/2021
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: Administered vaccine after 33 days in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) in an 82-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination. No Medical History information was reported. On 20-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No symptoms reported. No concomitant medication were provided. No treatment information were provided.

Other Meds:

Current Illness:

ID: 1823440
Sex: F
Age:
State:

Vax Date: 02/04/2021
Onset Date: 08/01/2021
Rec V Date: 10/28/2021
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: Pyrexia, White blood cell count decreased

Symptoms: In August she was diagnosed with a blood clot on her leg; This spontaneous case was reported by a consumer and describes the occurrence of THROMBOSIS (In August she was diagnosed with a blood clot on her leg) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 04-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. In August 2021, the patient experienced THROMBOSIS (In August she was diagnosed with a blood clot on her leg) (seriousness criterion medically significant). At the time of the report, THROMBOSIS (In August she was diagnosed with a blood clot on her leg) outcome was unknown. No concomitant medications were reported. No treatment medications were reported. Company Comment: This case concerns an unknown age female patient with no relevant medical history, who experienced serious unexpected event of thrombosis. The event occurred approximately 25 days after the second dose of mRNA-1273 vaccine. Rechallenge was not applicable since the event occurred after the second dose and no additional dosing is expected. The benefit-risk relationship of vaccine is not affected by this report.; Sender's Comments: This case concerns an unknown age female patient with no relevant medical history, who experienced serious unexpected event of thrombosis. The event occurred approximately 25 days after the second dose of mRNA-1273 vaccine. Rechallenge was not applicable since the event occurred after the second dose and no additional dosing is expected. The benefit-risk relationship of vaccine is not affected by this report.

Other Meds:

Current Illness:

ID: 1823441
Sex: F
Age: 52
State: CT

Vax Date: 09/01/2021
Onset Date: 10/01/2021
Rec V Date: 10/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: no longer wanted cigarettes, quit smoking; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (no longer wanted cigarettes, quit smoking) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059E21A and 061E21A) for COVID-19 vaccination. The patient's past medical history included Smoker (smoking for 40 years). On 01-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Oct-2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (no longer wanted cigarettes, quit smoking). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (no longer wanted cigarettes, quit smoking) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No Treatment informations were reported.

Other Meds:

Current Illness:

ID: 1823442
Sex: F
Age: 70
State: FL

Vax Date: 09/11/2021
Onset Date: 10/17/2021
Rec V Date: 10/28/2021
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: 20211018; Test Name: body temperature; Result Unstructured Data: 100.6 degrees Fahrenheit

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: Feeling better, but weak; Arm has a slightly reddened area and is warm to the touch; Foggy brain; warm to touch; Unable to concentrate; Chills; Temperature started going up fast, Highest temperature 100.6 degrees Fahrenheit; Received 2nd dose 36 days after first dose; Right arm was sore\aches and pains; Poor Sleep; This spontaneous case was reported by a nurse and describes the occurrence of PAIN IN EXTREMITY (Right arm was sore\aches and pains), ASTHENIA (Feeling better, but weak), ERYTHEMA (Arm has a slightly reddened area and is warm to the touch), FEELING ABNORMAL (Foggy brain) and FEELING HOT (warm to touch) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 939906 and 939906) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 11-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Oct-2021, the patient experienced PAIN IN EXTREMITY (Right arm was sore\aches and pains), POOR QUALITY SLEEP (Poor Sleep) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose 36 days after first dose). On 18-Oct-2021, the patient experienced ASTHENIA (Feeling better, but weak), ERYTHEMA (Arm has a slightly reddened area and is warm to the touch), FEELING ABNORMAL (Foggy brain), FEELING HOT (warm to touch), DISTURBANCE IN ATTENTION (Unable to concentrate), CHILLS (Chills) and PYREXIA (Temperature started going up fast, Highest temperature 100.6 degrees Fahrenheit). On 17-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose 36 days after first dose) had resolved. On 18-Oct-2021, POOR QUALITY SLEEP (Poor Sleep) and PYREXIA (Temperature started going up fast, Highest temperature 100.6 degrees Fahrenheit) had resolved. At the time of the report, PAIN IN EXTREMITY (Right arm was sore\aches and pains), ASTHENIA (Feeling better, but weak), ERYTHEMA (Arm has a slightly reddened area and is warm to the touch), FEELING ABNORMAL (Foggy brain), FEELING HOT (warm to touch), DISTURBANCE IN ATTENTION (Unable to concentrate) and CHILLS (Chills) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Oct-2021, Body temperature: 100.6 (High) 100.6 degrees Fahrenheit. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No Treatment informations were reported. This case was linked to -MODERNATX, INC.-MOD-2021-357651 (E2B Linked Report). This case was linked to MOD21-144365 (Patient Link).; Sender's Comments: -MODERNATX, INC.-MOD-2021-357651:daughter case

Other Meds:

Current Illness:

ID: 1823443
Sex: F
Age: 41
State: AZ

Vax Date: 07/30/2021
Onset Date: 10/18/2021
Rec V Date: 10/28/2021
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: Patient was administered an injection from a vial that had expired a week ago; 1st dose was administered on 30Jul21 and 2nd dose on 18Oct2021; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient was administered an injection from a vial that had expired a week ago) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose was administered on 30Jul21 and 2nd dose on 18Oct2021) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 049E21A and 040C21A) for COVID-19 vaccination. No Medical History information was reported. On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient was administered an injection from a vial that had expired a week ago) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose was administered on 30Jul21 and 2nd dose on 18Oct2021). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient was administered an injection from a vial that had expired a week ago) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (1st dose was administered on 30Jul21 and 2nd dose on 18Oct2021) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Treatment informations were reported. Concomitant product use was not provided.

Other Meds:

Current Illness:

ID: 1823444
Sex: F
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 10/28/2021
Hospital:

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

Lab Data: Test Name: Magnetic resonance imaging; Result Unstructured Data: diagnosed with a Torn rotator Cuff muscle; Test Name: X-ray; Result Unstructured Data: diagnosed with a Torn rotator Cuff muscle

Allergies:

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

Symptoms: little bit of discomfort; Torn rotator Cuff muscle; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (little bit of discomfort) and ROTATOR CUFF SYNDROME (Torn rotator Cuff muscle) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Shoulder discomfort. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DISCOMFORT (little bit of discomfort) and ROTATOR CUFF SYNDROME (Torn rotator Cuff muscle). The patient was treated with Physical therapy (Exercises) for Rotator cuff syndrome. At the time of the report, DISCOMFORT (little bit of discomfort) and ROTATOR CUFF SYNDROME (Torn rotator Cuff muscle) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Magnetic resonance imaging: abnormal (abnormal) diagnosed with a Torn rotator Cuff muscle. On an unknown date, X-ray: abnormal (abnormal) diagnosed with a Torn rotator Cuff muscle. Concomitant medications was not provided by the reporter. Treatment information was not provided. Patient said that after the shots , she developed a LOT of shoulder pain ( 8 to 9 out of 10 ) in a 10 scale range . Most recent FOLLOW-UP information incorporated above includes: On 20-Oct-2021: Follow up received. Updated the Medical history, Lab data, Vaccine information (Dose 1 and 2), Action taken (from unknown to not applicable) and Events (Hypokinesia and Arthralgia).

Other Meds:

Current Illness:

ID: 1823445
Sex: M
Age: 60
State: NY

Vax Date: 09/27/2021
Onset Date: 10/18/2021
Rec V Date: 10/28/2021
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: 20211019; Test Name: Blood pressure measurement; Result Unstructured Data: 119/93; Test Date: 20211019; Test Name: Blood pressure measurement; Result Unstructured Data: 160/100; Test Date: 20211019; Test Name: Heart rate; Result Unstructured Data: 98; Test Date: 20211019; Test Name: Heart rate; Result Unstructured Data: 100; Test Date: 20211019; Test Name: Heart rate; Result Unstructured Data: 96; Test Date: 20211019; Test Name: Oxygen saturation; Result Unstructured Data: 89; Test Date: 20211019; Test Name: Oxygen saturation; Result Unstructured Data: 96

Allergies:

Symptom List: Rash, Urticaria

Symptoms: started feeling sick; started to feel nauseous; said he was cold to the bone,blankets on him but that did not work; he was shaking; had anxiety; it was not a good experience; but he is a mess; doesn't have that much dizziness; definitely experiencing weakness.; his heart was so effected,; second shot did not go well.; morning at 6am, he was shivering; Last night he was very tired; Received 2nd dose 21 days after 1st dose; woke up at 10:30,couldn't go back to sleep; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose 21 days after 1st dose), ILLNESS (started feeling sick), SLEEP DISORDER (woke up at 10:30,couldn't go back to sleep), FEELING COLD (said he was cold to the bone,blankets on him but that did not work) and TREMOR (he was shaking) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048F21A and 048B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hypertension. On 27-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Oct-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose 21 days after 1st dose). 18-Oct-2021, the patient experienced SLEEP DISORDER (woke up at 10:30,couldn't go back to sleep) and FATIGUE (Last night he was very tired). On 19-Oct-2021, the patient experienced FEELING COLD (said he was cold to the bone,blankets on him but that did not work), TREMOR (he was shaking), ANXIETY (had anxiety), FEELING ABNORMAL (it was not a good experience), MALAISE (but he is a mess), DIZZINESS (doesn't have that much dizziness), ASTHENIA (definitely experiencing weakness.), HEART RATE INCREASED (his heart was so effected,), VACCINATION COMPLICATION (second shot did not go well.), CHILLS (morning at 6am, he was shivering) and NAUSEA (started to feel nauseous). On an unknown date, the patient experienced ILLNESS (started feeling sick). On 18-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received 2nd dose 21 days after 1st dose) had resolved. At the time of the report, ILLNESS (started feeling sick), SLEEP DISORDER (woke up at 10:30,couldn't go back to sleep), FEELING COLD (said he was cold to the bone, blankets on him but that did not work), TREMOR (he was shaking), ANXIETY (had anxiety), FEELING ABNORMAL (it was not a good experience), MALAISE (but he is a mess), DIZZINESS (doesn't have that much dizziness), ASTHENIA (definitely experiencing weakness.), HEART RATE INCREASED (his heart was so effected,), VACCINATION COMPLICATION (second shot did not go well.), CHILLS (morning at 6am, he was shivering), FATIGUE (Last night he was very tired) and NAUSEA (started to feel nauseous) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Oct-2021, Blood pressure measurement: 119/93 (High) 119/93 and high (High) 160/100. On 19-Oct-2021, Heart rate: high (High) 98, high (High) 100 and high (High) 96. On 19-Oct-2021, Oxygen saturation: normal (normal) 89 and normal (normal) 96. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment information was provided by reporter. Patient had a history of hypertension and takes a dietary supplement called Cardiotone for it. This case was linked to MOD-2021-357603 (Patient Link).

Other Meds:

Current Illness: Hypertension

ID: 1823446
Sex: F
Age: 66
State: MA

Vax Date: 02/26/2021
Onset Date: 02/01/2021
Rec V Date: 10/28/2021
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: Blood pressure decreased, Chest pain, Chills, Confusional state, Decreased appetite

Symptoms: Sore arm; Headache; Diagnosed with lymphoma / cancer this year (February); This spontaneous case was reported by a consumer and describes the occurrence of LYMPHOMA (Diagnosed with lymphoma / cancer this year (February)) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001A21A and 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In February 2021, the patient experienced LYMPHOMA (Diagnosed with lymphoma / cancer this year (February)) (seriousness criterion medically significant). On an unknown date, the patient experienced PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache). The patient was treated with ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL]) on 27-Feb-2021 at an unspecified dose and frequency. At the time of the report, LYMPHOMA (Diagnosed with lymphoma / cancer this year (February)), PAIN IN EXTREMITY (Sore arm) and HEADACHE (Headache) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. Concomitant product use was not provided by the reporter. Patient was diagnosed with lymphoma in perhaps in February 2021/ March 2021. patient was not sure of exact date. Company Comment : This spontaneous report concerns a 67 year old female patient with no relevant medical history who experienced a serious unexpected event of lymphoma. The event occurred unknown duration after the first or second dose of mRNA-1273. The patient additionally experienced non-serious events of pain in extremity and headache after both the doses. However, the outcome of the events after each dose is not reported. The benefit risk relationship of mRNA-1273 is not affected by this report. The event lymphoma was reported as non-serious, but was automatically upgraded as serious as per IME list. Based on the available information and as per medical judgement(considering the nature of the event), it was retained as serious. This case was linked to MOD-2021-357784 (Patient Link).; Sender's Comments: This spontaneous report concerns a 67 year old female patient with no relevant medical history who experienced a serious unexpected event of lymphoma. The event occurred unknown duration after the first or second dose of mRNA-1273. The patient additionally experienced non-serious events of pain in extremity and headache after both the doses. However, the outcome of the events after each dose is not reported. The benefit risk relationship of mRNA-1273 is not affected by this report. The event lymphoma was reported as non-serious, but was automatically upgraded as serious as per IME list. Based on the available information and as per medical judgement(considering the nature of the event), it was retained as serious.

Other Meds:

Current Illness:

ID: 1823447
Sex: M
Age:
State: PA

Vax Date:
Onset Date: 10/01/2021
Rec V Date: 10/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Ache/Pain; Fatigue/tired; Nurse accidentally administered 2 vials after 10 days after expiry to 18 patients; This spontaneous case was reported by a physician and describes the occurrence of PAIN (Ache/Pain), FATIGUE (Fatigue/tired) and EXPIRED PRODUCT ADMINISTERED (Nurse accidentally administered 2 vials after 10 days after expiry to 18 patients) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) 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. In October 2021, the patient experienced PAIN (Ache/Pain), FATIGUE (Fatigue/tired) and EXPIRED PRODUCT ADMINISTERED (Nurse accidentally administered 2 vials after 10 days after expiry to 18 patients). In October 2021, EXPIRED PRODUCT ADMINISTERED (Nurse accidentally administered 2 vials after 10 days after expiry to 18 patients) had resolved. At the time of the report, PAIN (Ache/Pain) and FATIGUE (Fatigue/tired) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment information was provided. Patient either received first dose, second dose or the booster shot.He stated the department of Pennsylvania thought Moderna will extended the lot 045B21A for 9months. When the reporter checked the online tools, it showed the vaccine expired 10 days. The vials were removed from the freezer. The first vial was removed on 15 Oct 2021 and the second vial on 18 Oct 2021. The vials were defrosted for one hour at room temperature and administer in a period of four hours. The vials were initially stored in the freezer and used within six hours. The dates of administration were 15 Oct 2021 to eight or nine patients and 18 Oct 2021 to eight or nine patient. The vials have never undergone any temperature excursions. This case was linked to MOD-2021-357469, MOD-2021-357755 (Patient Link).

Other Meds:

Current Illness:

ID: 1823448
Sex: F
Age: 71
State: CO

Vax Date: 01/13/2021
Onset Date: 01/13/2021
Rec V Date: 10/28/2021
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: Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore arm) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027L20A) for COVID-19 vaccination. No Medical History information was reported. On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 13-Jan-2021, the patient experienced PAIN IN EXTREMITY (Sore arm). On 16-Jan-2021, PAIN IN EXTREMITY (Sore arm) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. No concomitant medications was reported. No treatment drug details was reported. This case was linked to MOD-2021-357792 (Patient Link).

Other Meds:

Current Illness:

ID: 1823449
Sex: F
Age: 18
State: CA

Vax Date: 10/19/2021
Onset Date: 10/19/2021
Rec V Date: 10/28/2021
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: Nausea, Pain, Pain in extremity, Paraesthesia oral, Pyrexia

Symptoms: Received expired first dose.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired first dose.) in an 18-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. No Medical History information was reported. On 19-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired first dose.). On 19-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received expired first dose.) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant information was not reported. Treatment information was not reported.

Other Meds:

Current Illness:

ID: 1823450
Sex: U
Age: 34
State: PA

Vax Date: 10/18/2021
Onset Date: 10/18/2021
Rec V Date: 10/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Administered vaccine after 33 days in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) in a 34-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination. No Medical History information was reported. On 18-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient have reported symptoms. Concomitant product information was not provided. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1823451
Sex: M
Age: 47
State: FL

Vax Date: 01/08/2021
Onset Date: 07/22/2021
Rec V Date: 10/28/2021
Hospital: Y

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

Lab Data: Test Name: CT angiogram; Result Unstructured Data: ruled out coronary artery embolism, showed left pleural effusion and pericarditis with hemoohagic effusion fluid; Test Name: Fever; Result Unstructured Data: 101.5; Test Date: 20210812; Test Name: EKG; Result Unstructured Data: Showed atrial fibrillation and bundle branch block; Test Name: COVID-19 Test; Test Result: Negative ; Result Unstructured Data: Negative; Test Name: Troponin; Result Unstructured Data: Normal; Test Name: X-ray; Result Unstructured Data: ruled out coronary artery embolism, showed left pleural effusion and pericarditis with hemoohagic effusion fluid

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: pneumonia; Hemorrhagic effusion/ drained 1 liter of fluid; pre-cardiac tamponade; Pericarditis with hemorrhagic effusion fluid; left pleural effusion/ bilateral pleural effusions; Fever greater than 101.5; His EKG showed atrial fibrillation and a bundle branch block; His EKG showed atrial fibrillation and a bundle branch block; palpitations; chest pain/ sternal chest pain; chest discomfort; sternal chest pain; pain when lying on his left side at night; Pain with taking a deep breath; This spontaneous case was reported by a nurse and describes the occurrence of PALPITATIONS (palpitations), PLEURAL EFFUSION (left pleural effusion/ bilateral pleural effusions), PYREXIA (Fever greater than 101.5), BUNDLE BRANCH BLOCK (His EKG showed atrial fibrillation and a bundle branch block), ATRIAL FIBRILLATION (His EKG showed atrial fibrillation and a bundle branch block), PNEUMONIA (pneumonia), HAEMOTHORAX (Hemorrhagic effusion/ drained 1 liter of fluid), CARDIAC TAMPONADE (pre-cardiac tamponade) and PERICARDITIS (Pericarditis with hemorrhagic effusion fluid) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included IBUPROFEN and COLCHICINE for an unknown indication. On 08-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Jul-2021, the patient experienced CHEST PAIN (chest pain/ sternal chest pain), CHEST DISCOMFORT (chest discomfort), CHEST PAIN (sternal chest pain), PAIN (pain when lying on his left side at night) and DYSPNOEA (Pain with taking a deep breath). On 12-Aug-2021, the patient experienced PALPITATIONS (palpitations) (seriousness criteria hospitalization prolonged, medically significant and life threatening), BUNDLE BRANCH BLOCK (His EKG showed atrial fibrillation and a bundle branch block) (seriousness criteria hospitalization prolonged, medically significant and life threatening) and ATRIAL FIBRILLATION (His EKG showed atrial fibrillation and a bundle branch block) (seriousness criteria hospitalization prolonged, medically significant and life threatening). On an unknown date, the patient experienced PLEURAL EFFUSION (left pleural effusion/ bilateral pleural effusions) (seriousness criteria hospitalization prolonged, medically significant and life threatening), PYREXIA (Fever greater than 101.5) (seriousness criteria hospitalization prolonged, medically significant and life threatening), PNEUMONIA (pneumonia) (seriousness criteria hospitalization prolonged, medically significant and life threatening), HAEMOTHORAX (Hemorrhagic effusion/ drained 1 liter of fluid) (seriousness criteria hospitalization prolonged, medically significant and life threatening), CARDIAC TAMPONADE (pre-cardiac tamponade) (seriousness criteria hospitalization prolonged, medically significant and life threatening) and PERICARDITIS (Pericarditis with hemorrhagic effusion fluid) (seriousness criteria hospitalization prolonged, medically significant and life threatening). At the time of the report, PALPITATIONS (palpitations), PLEURAL EFFUSION (left pleural effusion/ bilateral pleural effusions), PYREXIA (Fever greater than 101.5), BUNDLE BRANCH BLOCK (His EKG showed atrial fibrillation and a bundle branch block), ATRIAL FIBRILLATION (His EKG showed atrial fibrillation and a bundle branch block), PNEUMONIA (pneumonia), HAEMOTHORAX (Hemorrhagic effusion/ drained 1 liter of fluid), CARDIAC TAMPONADE (pre-cardiac tamponade), PERICARDITIS (Pericarditis with hemorrhagic effusion fluid), CHEST PAIN (chest pain/ sternal chest pain), CHEST DISCOMFORT (chest discomfort), CHEST PAIN (sternal chest pain), PAIN (pain when lying on his left side at night) and DYSPNOEA (Pain with taking a deep breath) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Aug-2021, Electrocardiogram: atrial fibrillation and bundle branch block (abnormal) Showed atrial fibrillation and bundle branch block. On an unknown date, Angiogram: pleural effusion and pericarditis (abnormal) ruled out coronary artery embolism, showed left pleural effusion and pericarditis with hemoohagic effusion fluid. On an unknown date, Body temperature: 101.5 (High) 101.5. On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. On an unknown date, Troponin: normal (normal) Normal. On an unknown date, X-ray: pleural effusion and pericarditis (abnormal) ruled out coronary artery embolism, showed left pleural effusion and pericarditis with hemoohagic effusion fluid. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered PALPITATIONS (palpitations), PLEURAL EFFUSION (left pleural effusion/ bilateral pleural effusions), PYREXIA (Fever greater than 101.5), BUNDLE BRANCH BLOCK (His EKG showed atrial fibrillation and a bundle branch block), ATRIAL FIBRILLATION (His EKG showed atrial fibrillation and a bundle branch block), PNEUMONIA (pneumonia), HAEMOTHORAX (Hemorrhagic effusion/ drained 1 liter of fluid), CARDIAC TAMPONADE (pre-cardiac tamponade), PERICARDITIS (Pericarditis with hemorrhagic effusion fluid), CHEST PAIN (chest pain/ sternal chest pain), CHEST DISCOMFORT (chest discomfort), CHEST PAIN (sternal chest pain), PAIN (pain when lying on his left side at night) and DYSPNOEA (Pain with taking a deep breath) to be possibly related. EKG showed atrial fibrillation and a bundle branch block. Also received a chest Xray and CT angiogram of chest which ruled out pulmonary embolism, but showed a left pleural effusion, and pericarditis with hemorrhagic effusion fluid. So much fluid like precardiac tamponade. The pericarditis was idiopathic. Admitted to hospital for pericarditis where they surgically removed 1L of fluid and cut out a piece of the back of heart. Intubated during this procedure and discharged from the hospital and since returned to hospital 2 additional time for having a fever more than 101.5F. The first was attributed to pericarditis and second was due to pericarditis and pneumonia. At the most recent hospital visit, they found bilateral pleural effusions on his chest x-ray, but the fluid had not come back around heart. The pneumonia was projected to be a postsurgical complication of his procedure. Tested for COVID-19 at all hospitalizations, but all tests were negative. was experiencing fever >101.5 again. Company Comment: This case concerns a 48-year-old male patient with no relevant medical history, who experienced the unexpected events of Palpitations, Atrial Fibrillation, Bundle Branch Block, Pyrexia, Pneumonia, Pleural Effusion, Haemothorax, Cardiac Tamponade and the expected event of Pericarditis. The events Palpitations, Atrial Fibrillation, and Bundle Branch Block, occurred at 7 months 5 days after receiving the second dose of mRNA-1273 (Moderna COVID-19 Vaccine) while the events of Pyrexia, Pneumonia, Pleural Effusion, Haemothorax, Cardiac Tamponade, and Pericarditis occurred on an unknown date with outcome of hospitalization. The rechallenge was unknown as there's no information available about the first dose. The The event of pericarditis is consistent with the current understanding of the mechanism of action of the vaccine. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.; Sender's Comments: This case concerns a 48-year-old male patient with no relevant medical history, who experienced the unexpected events of Palpitations, Atrial Fibrillation, Bundle Branch Block, Pyrexia, Pneumonia, Pleural Effusion, Haemothorax, Cardiac Tamponade and the expected event of Pericarditis. The events Palpitations, Atrial Fibrillation, and Bundle Branch Block, occurred at 7 months 5 days after receiving the second dose of mRNA-1273 (Moderna COVID-19 Vaccine) while the events of Pyrexia, Pneumonia, Pleural Effusion, Haemothorax, Cardiac Tamponade, and Pericarditis occurred on an unknown dat

Other Meds: IBUPROFEN; COLCHICINE

Current Illness:

ID: 1823452
Sex: U
Age: 63
State: PA

Vax Date: 03/02/2021
Onset Date: 10/18/2021
Rec V Date: 10/28/2021
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: Administered vaccine after 33 days in the refrigerator; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 19-Oct-2021 and was forwarded to Moderna on 19-Oct-2021. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) in a 64-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 02-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was reported. The treatment information was unknown.

Other Meds:

Current Illness:

ID: 1823453
Sex: F
Age:
State: GA

Vax Date: 01/01/2021
Onset Date:
Rec V Date: 10/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Patient is calling to update her own adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Patient is calling to update her own adverse reaction) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Patient is calling to update her own adverse reaction). At the time of the report, VACCINATION COMPLICATION (Patient is calling to update her own adverse reaction) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant and medication information provided. No treatment information provided

Other Meds:

Current Illness:

ID: 1823454
Sex: M
Age: 64
State: FL

Vax Date: 03/17/2021
Onset Date:
Rec V Date: 10/28/2021
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:

Allergies:

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

Symptoms: COVID arm/hurting/it is a reaction/COVID shoulder; little pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (COVID arm/hurting/it is a reaction/COVID shoulder) and VACCINATION SITE PAIN (little pain) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. No Medical history was reported. Concomitant products included METFORMIN, HCTZ, ICOSAPENT ETHYL and FLUTICASONE for an unknown indication. On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE REACTION (COVID arm/hurting/it is a reaction/COVID shoulder) and VACCINATION SITE PAIN (little pain). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE REACTION (COVID arm/hurting/it is a reaction/COVID shoulder) and VACCINATION SITE PAIN (little pain) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. concomitant product included spectrum and is used as Multivitamin Men's Health It was reported that there was a little pain prior to the second shot that was a level 1 out of 10 usually when patient was doing things like mowing the grass or putting up lights. He would take ibuprofen to help. This case was linked to MOD-2021-357899.

Other Meds: METFORMIN; HCTZ; ICOSAPENT ETHYL; FLUTICASONE

Current Illness:

ID: 1823455
Sex: U
Age: 73
State: PA

Vax Date: 02/03/2021
Onset Date: 10/18/2021
Rec V Date: 10/28/2021
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: This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) in a 74-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination. Concurrent medical conditions included Immunocompromised. 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) (unknown route) dosage was changed to 1 dosage form. On 18-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Oct-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. Patient did not received treatment.

Other Meds:

Current Illness: Immunocompromised

ID: 1823456
Sex: M
Age: 64
State: FL

Vax Date: 03/17/2021
Onset Date:
Rec V Date: 10/28/2021
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: Test Date: 202107; Test Name: MRI; Result Unstructured Data: They did an MRI and it was verified that he had a torn rotator cuff described as a small full tear

Allergies:

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

Symptoms: he had a torn rotator cuff described as a small full tear/ It is painful/His pain level now is a 9 out of 10; He mentioned a second time having COVID shoulder; he has continuous pain in his left shoulder; This spontaneous case was reported by a patient and describes the occurrence of ROTATOR CUFF SYNDROME (he had a torn rotator cuff described as a small full tear/ It is painful/His pain level now is a 9 out of 10), VACCINATION SITE REACTION (He mentioned a second time having COVID shoulder) and ARTHRALGIA (he has continuous pain in his left shoulder) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 023M20A and 027A21A) for COVID-19 vaccination. The patient's past medical history included Shoulder pain. Concomitant products included IBUPROFEN for Shoulder pain, METFORMIN, HCTZ, ICOSAPENT ETHYL and FLUTICASONE for an unknown indication. On 17-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ROTATOR CUFF SYNDROME (he had a torn rotator cuff described as a small full tear/ It is painful/His pain level now is a 9 out of 10), VACCINATION SITE REACTION (He mentioned a second time having COVID shoulder) and ARTHRALGIA (he has continuous pain in his left shoulder). The patient was treated with DICLOFENAC (oral) for Rotator cuff tear, at a dose of UNK, bid; DICLOFENAC (VOLTAREN [DICLOFENAC]) (topical) for Rotator cuff tear, at a dose of UNK, qid and Physical therapy (he started physical therapy and is still doing it at home) for Rotator cuff syndrome. At the time of the report, ROTATOR CUFF SYNDROME (he had a torn rotator cuff described as a small full tear/ It is painful/His pain level now is a 9 out of 10) and ARTHRALGIA (he has continuous pain in his left shoulder) had not resolved and VACCINATION SITE REACTION (He mentioned a second time having COVID shoulder) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In July 2021, Magnetic resonance imaging: abnormal (abnormal) They did an MRI and it was verified that he had a torn rotator cuff described as a small full tear. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. In concomitant medications, spectrum multivitamin men's health was also reported. Patient reported that he thought he had arthritis so he went to the doctor on 09-Jul-2021. The patient was diagnosed with torn rotator cuff. The doctor did not think it happened from the Moderna COVID-19 vaccination but he was unsure if the vaccine brought the pain to the forefront. The patient went to the orthopedic place. The patient stated that he does not know if he got the shot too high up but it did not bother him until after the COVID-19 vaccination. The doctor told the patient that Surgery might be an option. There was a little pain prior to the second shot that was a level 1 out of 10 usually when he was doing things like mowing the grass or putting up lights This case was linked to MOD-2021-357880 (Patient Link).

Other Meds: METFORMIN; HCTZ; ICOSAPENT ETHYL; FLUTICASONE; IBUPROFEN

Current Illness:

ID: 1823457
Sex: F
Age: 53
State: NY

Vax Date: 08/16/2021
Onset Date:
Rec V Date: 10/28/2021
Hospital:

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

Lab Data: Test Date: 20211004; Test Name: mammogram; Result Unstructured Data: some abnormalities on their left breast; Test Date: 20211004; Test Name: SONOGRAM; Result Unstructured Data: some abnormalities on their left breast

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: pain under the left arm; swelling under the left arm; pain on their left breast; a knot around the injection site; abnormalities on their left breast; lymph nodes under their left arm were swollen; Patient did not get the second dose still; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain under the left arm), PERIPHERAL SWELLING (swelling under the left arm), BREAST PAIN (pain on their left breast), VACCINATION SITE MASS (a knot around the injection site) and BREAST DISCOMFORT (abnormalities on their left breast) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 16-Aug-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 PAIN IN EXTREMITY (pain under the left arm), PERIPHERAL SWELLING (swelling under the left arm), BREAST PAIN (pain on their left breast), VACCINATION SITE MASS (a knot around the injection site), BREAST DISCOMFORT (abnormalities on their left breast), LYMPHADENOPATHY (lymph nodes under their left arm were swollen) and PRODUCT DOSE OMISSION ISSUE (Patient did not get the second dose still). The patient was treated with ACETAMINOPHEN for Pain, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (pain under the left arm), PERIPHERAL SWELLING (swelling under the left arm), BREAST PAIN (pain on their left breast), VACCINATION SITE MASS (a knot around the injection site), BREAST DISCOMFORT (abnormalities on their left breast) and LYMPHADENOPATHY (lymph nodes under their left arm were swollen) had not resolved and PRODUCT DOSE OMISSION ISSUE (Patient did not get the second dose still) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Oct-2021, Mammogram: abnormal (abnormal) some abnormalities on their left breast. On 04-Oct-2021, Ultrasound scan: abnormal (abnormal) some abnormalities on their left breast. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication reported.

Other Meds:

Current Illness:

ID: 1823458
Sex: F
Age:
State: TN

Vax Date: 10/18/2021
Onset Date: 10/18/2021
Rec V Date: 10/28/2021
Hospital:

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

Lab Data: Test Date: 20211019; Test Name: Body temperature; Result Unstructured Data: Fever 100.0 F

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: Can not calm down; Can not Lift the left Arm; Heart racing this morning but it is better now; Chills; Fever 100.0 F; Sore Left Arm; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Can not calm down), VACCINATION SITE MOVEMENT IMPAIRMENT (Can not Lift the left Arm), PAIN IN EXTREMITY (Sore Left Arm), PALPITATIONS (Heart racing this morning but it is better now) and CHILLS (Chills) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039D21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 18-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced PAIN IN EXTREMITY (Sore Left Arm). On 19-Oct-2021, the patient experienced FEELING ABNORMAL (Can not calm down), VACCINATION SITE MOVEMENT IMPAIRMENT (Can not Lift the left Arm), PALPITATIONS (Heart racing this morning but it is better now), CHILLS (Chills) and PYREXIA (Fever 100.0 F). The patient was treated with IBUPROFEN on 19-Oct-2021 for Fever, at a dose of 1 dosage form. At the time of the report, FEELING ABNORMAL (Can not calm down), VACCINATION SITE MOVEMENT IMPAIRMENT (Can not Lift the left Arm), PAIN IN EXTREMITY (Sore Left Arm), CHILLS (Chills) and PYREXIA (Fever 100.0 F) outcome was unknown and PALPITATIONS (Heart racing this morning but it is better now) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 19-Oct-2021, Body temperature: 100 (High) Fever 100.0 F. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication were reported.

Other Meds:

Current Illness:

ID: 1823459
Sex: M
Age:
State: GA

Vax Date: 10/19/2021
Onset Date: 10/19/2021
Rec V Date: 10/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: A patient received an expired 1st dose; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A patient received an expired 1st dose) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination. No Medical History information was reported. On 19-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (A patient received an expired 1st dose). On 19-Oct-2021, EXPIRED PRODUCT ADMINISTERED (A patient received an expired 1st dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. It was also reported that the vial did not undergo any temperature excursions Concomitant medication information was not reported Treatment information was not reported

Other Meds:

Current Illness:

ID: 1823460
Sex: M
Age: 50
State: FL

Vax Date: 10/18/2021
Onset Date: 10/18/2021
Rec V Date: 10/28/2021
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: Extra Bowel Movement then before; Swelling only present during the 15 minutes after vaccination.; Tenderness only present during the 15 minutes after vaccination.; I experienced tingling in my arm during that 15 minutes; But my arm,where I was injected, I was feeling it and it is feeling a little numb; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PARAESTHESIA (I experienced tingling in my arm during that 15 minutes), INJECTION SITE HYPOAESTHESIA (But my arm,where I was injected, I was feeling it and it is feeling a little numb), FREQUENT BOWEL MOVEMENTS (Extra Bowel Movement then before), VACCINATION SITE SWELLING (Swelling only present during the 15 minutes after vaccination.) and VACCINATION SITE PAIN (Tenderness only present during the 15 minutes after vaccination.) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026021A) for COVID-19 vaccination. Concurrent medical conditions included Immune system disorder (NOS) (Overactive immune system) and Headache. On 18-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Oct-2021, the patient experienced INJECTION SITE PARAESTHESIA (I experienced tingling in my arm during that 15 minutes), INJECTION SITE HYPOAESTHESIA (But my arm,where I was injected, I was feeling it and it is feeling a little numb), VACCINATION SITE SWELLING (Swelling only present during the 15 minutes after vaccination.) and VACCINATION SITE PAIN (Tenderness only present during the 15 minutes after vaccination.). On an unknown date, the patient experienced FREQUENT BOWEL MOVEMENTS (Extra Bowel Movement then before). On 18-Oct-2021, INJECTION SITE PARAESTHESIA (I experienced tingling in my arm during that 15 minutes), INJECTION SITE HYPOAESTHESIA (But my arm,where I was injected, I was feeling it and it is feeling a little numb), VACCINATION SITE SWELLING (Swelling only present during the 15 minutes after vaccination.) and VACCINATION SITE PAIN (Tenderness only present during the 15 minutes after vaccination.) had resolved. At the time of the report, FREQUENT BOWEL MOVEMENTS (Extra Bowel Movement then before) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant information was not provided. Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 22-Oct-2021: Follow up added contact information and new event.

Other Meds:

Current Illness: Headache; Immune system disorder (NOS) (Overactive immune system)

ID: 1823461
Sex: M
Age: 48
State: CA

Vax Date: 10/19/2021
Onset Date: 10/19/2021
Rec V Date: 10/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: Received expired first dose.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired first dose.) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. No Medical History information was reported. On 19-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired first dose.). On 19-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received expired first dose.) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant medications were reported. No Treatment information was reported.

Other Meds:

Current Illness:

ID: 1823462
Sex: F
Age: 75
State: TN

Vax Date: 10/18/2021
Onset Date: 10/18/2021
Rec V Date: 10/28/2021
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: Expired dose given to patients; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired dose given to patients) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination. No Medical History information was reported. On 18-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired dose given to patients). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Expired dose given to patients) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided. Date moved to refrigeration on 13-Oct-2021 and Use by date on 13-Oct-2021. This case was linked to MOD-2021-357519 (Patient Link).

Other Meds:

Current Illness:

ID: 1823463
Sex: F
Age: 20
State: FL

Vax Date: 10/18/2021
Onset Date: 10/18/2021
Rec V Date: 10/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: vaginal bleeding which was light but now it is heavy The patient stated that she did have her period 2 weeks ago; vaginal bleeding which was light but now it is heavy. The patient stated that she did have her period 2 weeks ago; shivering; fever of 100?F; arm hurting; tingling of her lips; swelling of her lips; rash with light pink with dots on her chest; redness on both her cheeks.; She had a sore arm.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm hurting), PARAESTHESIA ORAL (tingling of her lips), LIP SWELLING (swelling of her lips), RASH ERYTHEMATOUS (rash with light pink with dots on her chest) and ERYTHEMA (redness on both her cheeks.) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was reported. Concomitant products included ETHINYLESTRADIOL, NORGESTREL (CRYSELLE) for Birth control. On 18-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Oct-2021, the patient experienced MYALGIA (She had a sore arm.). On 19-Oct-2021, the patient experienced PAIN IN EXTREMITY (arm hurting), PARAESTHESIA ORAL (tingling of her lips), LIP SWELLING (swelling of her lips), RASH ERYTHEMATOUS (rash with light pink with dots on her chest), ERYTHEMA (redness on both her cheeks.), CHILLS (shivering) and PYREXIA (fever of 100?F). On an unknown date, the patient experienced HEAVY MENSTRUAL BLEEDING (vaginal bleeding which was light but now it is heavy The patient stated that she did have her period 2 weeks ago) and POLYMENORRHOEA (vaginal bleeding which was light but now it is heavy. The patient stated that she did have her period 2 weeks ago). At the time of the report, PAIN IN EXTREMITY (arm hurting), PARAESTHESIA ORAL (tingling of her lips), LIP SWELLING (swelling of her lips), RASH ERYTHEMATOUS (rash with light pink with dots on her chest), ERYTHEMA (redness on both her cheeks.), POLYMENORRHOEA (vaginal bleeding which was light but now it is heavy. The patient stated that she did have her period 2 weeks ago), CHILLS (shivering), PYREXIA (fever of 100?F) and MYALGIA (She had a sore arm.) outcome was unknown and HEAVY MENSTRUAL BLEEDING (vaginal bleeding which was light but now it is heavy The patient stated that she did have her period 2 weeks ago) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment medications were reported. Most recent FOLLOW-UP information incorporated above includes: On 21-Oct-2021: significant follow up appended : Event Updated , Patient details updated

Other Meds: CRYSELLE

Current Illness:

ID: 1823464
Sex: F
Age: 25
State: TX

Vax Date: 12/30/2020
Onset Date: 04/24/2021
Rec V Date: 10/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: got first dose on 30Dec2020 and another "first" dose on 24Apr2021; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got first dose on 30Dec2020 and another "first" dose on 24Apr2021) in a 26-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included COVID-19 in November 2020. On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Apr-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got first dose on 30Dec2020 and another "first" dose on 24Apr2021). On 24-Apr-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got first dose on 30Dec2020 and another "first" dose on 24Apr2021) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient got another "first" dose of the Moderna vaccine (at second dose provider contact) on 24Apr2021, also on the left arm. No concomitant medication was reported. No treatment medication use was reported.

Other Meds:

Current Illness:

ID: 1823465
Sex: U
Age: 70
State: PA

Vax Date: 02/05/2021
Onset Date: 10/18/2021
Rec V Date: 10/28/2021
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: Administered vaccine after 33 days in the refrigerator; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) in a 70-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 005C21A) for COVID-19 vaccination. Concurrent medical conditions included Immunocompromised. On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 18-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 18-Oct-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator). On 18-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered vaccine after 33 days in the refrigerator) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication information provided. No treatment information were provided. Patient had not reported any events.

Other Meds:

Current Illness: Immunocompromised

ID: 1823466
Sex: U
Age: 78
State: FL

Vax Date: 02/16/2021
Onset Date: 10/17/2021
Rec V Date: 10/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: completely weak,; everything started to spin; vomiting; headache; nausea; third dose was administered on 17Oct2021; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (completely weak,), VERTIGO (everything started to spin), VOMITING (vomiting), HEADACHE (headache) and NAUSEA (nausea) in a 79-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 025021A, 030A21A and 023M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Cancer (Patient did not had chemotherapy). Concurrent medical conditions included Arthritis and Vasculitis. On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 17-Oct-2021, the patient experienced ASTHENIA (completely weak,), VERTIGO (everything started to spin), VOMITING (vomiting), HEADACHE (headache), NAUSEA (nausea) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (third dose was administered on 17Oct2021). On 17-Oct-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (third dose was administered on 17Oct2021) had resolved. At the time of the report, ASTHENIA (completely weak,), VERTIGO (everything started to spin), VOMITING (vomiting), HEADACHE (headache) and NAUSEA (nausea) outcome was unknown. No concomitant medications were provided. No treatment medications were provided. Patient had no effects after first and second dose.

Other Meds:

Current Illness: Arthritis; Vasculitis

ID: 1823467
Sex: M
Age: 59
State: FL

Vax Date: 05/17/2021
Onset Date: 06/01/2021
Rec V Date: 10/28/2021
Hospital:

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

Lab Data: Test Date: 2021; Test Name: EKG; Result Unstructured Data: normal; Test Date: 202106; Test Name: PULSE; Result Unstructured Data: 32 beats per minute; Test Date: 202109; Test Name: PULSE; Result Unstructured Data: 34 beats per minute

Allergies:

Symptom List: Tremor

Symptoms: Little nervous; infection from the red tide; cardiac problems/ pulse is running really low/ problem with a lower pulse/ pulse dips down to 32, 34 beats per minute/ pulse was 34; He doesn't want to go to sleep and not wake up; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (cardiac problems/ pulse is running really low/ problem with a lower pulse/ pulse dips down to 32, 34 beats per minute/ pulse was 34), NERVOUSNESS (Little nervous), FEELING ABNORMAL (He doesn't want to go to sleep and not wake up) and INFECTION (infection from the red tide) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 050C21A and 022B21A) for COVID-19 vaccination. The patient's past medical history included Block heart and Stent placement. On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In June 2021, the patient experienced CARDIAC DISORDER (cardiac problems/ pulse is running really low/ problem with a lower pulse/ pulse dips down to 32, 34 beats per minute/ pulse was 34) and FEELING ABNORMAL (He doesn't want to go to sleep and not wake up). On 05-Sep-2021, the patient experienced INFECTION (infection from the red tide). On an unknown date, the patient experienced NERVOUSNESS (Little nervous). At the time of the report, CARDIAC DISORDER (cardiac problems/ pulse is running really low/ problem with a lower pulse/ pulse dips down to 32, 34 beats per minute/ pulse was 34), NERVOUSNESS (Little nervous), FEELING ABNORMAL (He doesn't want to go to sleep and not wake up) and INFECTION (infection from the red tide) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Electrocardiogram: normal (normal) normal. In June 2021, Heart rate: 32 (Low) 32 beats per minute. In September 2021, Heart rate: 34 (Low) 34 beats per minute. Concomitant information was not provided. The patient was treated with IV antibiotic for about 6 weeks for the infection. Patient reports no other treatment taken in addition to this. It was reported that the patient was instructed to insert the pacemaker as a part of correction procedure and patient confirms that patient doesn't have atrial fibrillation.

Other Meds:

Current Illness:

ID: 1823468
Sex: F
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 10/28/2021
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: sore arm after both of her doses of the Moderna Covid-19 Vaccine.; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore arm after both of her doses of the Moderna Covid-19 Vaccine.) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (sore arm after both of her doses of the Moderna Covid-19 Vaccine.). At the time of the report, VACCINATION SITE PAIN (sore arm after both of her doses of the Moderna Covid-19 Vaccine.) outcome was unknown. No relevant concomitant medications were reported. No treatment information was provided. This case was linked to MOD-2021-358258, MOD-2021-358220 (Patient Link).

Other Meds:

Current Illness:

ID: 1823469
Sex: F
Age: 69
State: NJ

Vax Date: 02/15/2021
Onset Date:
Rec V Date: 10/28/2021
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: Test Name: SARS COVID-2 IgG IgM; Test Result: Negative ; Result Unstructured Data: Negative

Allergies:

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

Symptoms: hallucination which lasted for 2 1/2 weeks; fever; This spontaneous case was reported by a consumer and describes the occurrence of HALLUCINATION (hallucination which lasted for 2 1/2 weeks) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 14M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 15-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HALLUCINATION (hallucination which lasted for 2 1/2 weeks) (seriousness criterion medically significant) and PYREXIA (fever). At the time of the report, HALLUCINATION (hallucination which lasted for 2 1/2 weeks) and PYREXIA (fever) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: negative (Negative) Negative. Concomitant medications was not provided by the reporter Treatment information was not provided This case concerns a 69-year-old, female patient with no relevant medical history, who experienced the unexpected event of Hallucination. The event on an unspecified date after the second dose of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was as event occurred after the second dose. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report. This case was linked to MOD-2021-358365 (Patient Link).; Sender's Comments: This case concerns a 69-year-old, female patient with no relevant medical history, who experienced the unexpected event of Hallucination. The event on an unspecified date after the second dose of mRNA-1273 (Moderna Covid-19 vaccine). The rechallenge was as event occurred after the second dose. The benefit-risk relationship of mRNA-1273 (Moderna Covid-19 vaccine) is not affected by this report.

Other Meds:

Current Illness:

ID: 1823470
Sex: M
Age: 52
State: CA

Vax Date: 10/19/2021
Onset Date: 10/19/2021
Rec V Date: 10/28/2021
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: Cough, Limb discomfort, Pain, SARS-CoV-2 test positive

Symptoms: Received expired first dose.; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired first dose.) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006C21A) for COVID-19 vaccination. No Medical History information was reported. On 19-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired first dose.). On 19-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received expired first dose.) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications reported. No treatment information was provided. This case was linked to MOD-2021-357255 (Patient Link).

Other Meds:

Current Illness:

ID: 1823471
Sex: M
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 10/28/2021
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: heart problem after the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC DISORDER (heart problem after the vaccine) in a 69-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) (unknown route) 1 dosage form. On an unknown date, the patient experienced CARDIAC DISORDER (heart problem after the vaccine). At the time of the report, CARDIAC DISORDER (heart problem after the vaccine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant medications were provided by the reporter. No Treatment information was reported.

Other Meds:

Current Illness:

ID: 1823472
Sex: F
Age: 43
State: FL

Vax Date: 10/12/2021
Onset Date: 10/12/2021
Rec V Date: 10/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Patient received a dose more than 12 hours after vial puncture.; wouldn't take it to room temperature, just take it out of the refrigerator, drag a dose, and back; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a dose more than 12 hours after vial puncture.) and PRODUCT STORAGE ERROR (wouldn't take it to room temperature, just take it out of the refrigerator, drag a dose, and back) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination. No Medical History information was reported. On 12-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a dose more than 12 hours after vial puncture.) and PRODUCT STORAGE ERROR (wouldn't take it to room temperature, just take it out of the refrigerator, drag a dose, and back). On 12-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient received a dose more than 12 hours after vial puncture.) and PRODUCT STORAGE ERROR (wouldn't take it to room temperature, just take it out of the refrigerator, drag a dose, and back) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication were reported. No treatment information was provided by the reporter.

Other Meds:

Current Illness:

ID: 1823473
Sex: F
Age:
State: MI

Vax Date:
Onset Date:
Rec V Date: 10/28/2021
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:

Allergies:

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

Symptoms: Had headaches after both doses of the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Had headaches after both doses of the vaccine) in a 47-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 an unknown date, the patient experienced HEADACHE (Had headaches after both doses of the vaccine). At the time of the report, HEADACHE (Had headaches after both doses of the vaccine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant products were reported. No treatment information was reported by the reporter. This case was linked to MOD-2021-358541 (Patient Link).

Other Meds:

Current Illness:

ID: 1823474
Sex: F
Age:
State: MI

Vax Date:
Onset Date:
Rec V Date: 10/28/2021
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: headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headaches) in a 47-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 an unknown date, 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 HEADACHE (headaches). At the time of the report, HEADACHE (headaches) outcome was unknown. No concomitant medications were reported. No treatment medications were reported. This case was linked to MOD-2021-358529 (Patient Link).

Other Meds:

Current Illness:

ID: 1823475
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: joint pain; 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 ARTHRALGIA (joint pain) 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 ARTHRALGIA (joint pain). At the time of the report, ARTHRALGIA (joint pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1823476
Sex: M
Age: 26
State: CA

Vax Date: 10/17/2021
Onset Date: 10/17/2021
Rec V Date: 10/28/2021
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: administered an expired dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered an expired dose) in a 26-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination. No Medical History information was reported. On 17-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered an expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administered an expired dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant and treatment information were reported by the reporter

Other Meds:

Current Illness:

ID: 1823477
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/28/2021
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: received dose from vial expired 5 days before; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received dose from vial expired 5 days before) 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 EXPIRED PRODUCT ADMINISTERED (received dose from vial expired 5 days before). At the time of the report, EXPIRED PRODUCT ADMINISTERED (received dose from vial expired 5 days before) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1823478
Sex: M
Age:
State: WI

Vax Date: 09/22/2021
Onset Date:
Rec V Date: 10/28/2021
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: gout/symptoms started a week ago; This spontaneous case was reported by a consumer and describes the occurrence of GOUT (gout/symptoms started a week ago) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011F21A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included VITAMIN D NOS for an unknown indication. On 22-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Oct-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 GOUT (gout/symptoms started a week ago). At the time of the report, GOUT (gout/symptoms started a week ago) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable Other Concomitant medications included blood pressure medicine, high sugar medications. No treatment medications were reported.

Other Meds: VITAMIN D NOS

Current Illness:

ID: 1823479
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/28/2021
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: adverse event with our temperature data logger; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (adverse event with our temperature data logger) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (adverse event with our temperature data logger). At the time of the report, VACCINATION COMPLICATION (adverse event with our temperature data logger) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was provided Treatment medication was not provided by the reporter Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1823480
Sex: M
Age: 50
State: MD

Vax Date: 03/01/2021
Onset Date:
Rec V Date: 10/28/2021
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: Back pain, Cold sweat, Headache, Nausea, Vomiting

Symptoms: Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Fatigue) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 019B21A) for COVID-19 vaccination. No Medical History information was reported. On 01-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Apr-2021, 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 FATIGUE (Fatigue). At the time of the report, FATIGUE (Fatigue) outcome was unknown. No concomitant medication was provided. No treatment medication was provided. This case was linked to MOD-2021-359055 (Patient Link).

Other Meds:

Current Illness:

ID: 1823481
Sex: F
Age: 76
State: AL

Vax Date: 04/01/2021
Onset Date: 05/29/2021
Rec V Date: 10/28/2021
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: sick to her stomach; Feeling rotten; pain in leg; pain in knee/pain in joint/very painful from hip down to knee; tired all the time/still feels the same way; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (sick to her stomach), FEELING ABNORMAL (Feeling rotten), PAIN IN EXTREMITY (pain in leg), ARTHRALGIA (pain in knee/pain in joint/very painful from hip down to knee) and FATIGUE (tired all the time/still feels the same way) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 043BZ1A and 028A21A) for COVID-19 vaccination. No medical history information was reported. Concomitant products included AMLODIPINE, ATORVASTATIN, DICYCLOMINE [DICYCLOVERINE], METOPROLOL TARTRATE, OMEPRAZOLE and TRAMADOL for an unknown indication. On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 29-May-2021, the patient experienced ABDOMINAL DISCOMFORT (sick to her stomach), FEELING ABNORMAL (Feeling rotten), PAIN IN EXTREMITY (pain in leg), ARTHRALGIA (pain in knee/pain in joint/very painful from hip down to knee) and FATIGUE (tired all the time/still feels the same way). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO BISMOL [BISMUTH SUBSALICYLATE]) for Adverse event, at an unspecified dose and frequency and VITAMINS NOS for Adverse event, at an unspecified dose and frequency. At the time of the report, ABDOMINAL DISCOMFORT (sick to her stomach) and FATIGUE (tired all the time/still feels the same way) had not resolved and FEELING ABNORMAL (Feeling rotten), PAIN IN EXTREMITY (pain in leg) and ARTHRALGIA (pain in knee/pain in joint/very painful from hip down to knee) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient had contacted her doctor about it and received 2 shots of steroids in her hip 4 weeks. Patient had also taken Tramadol as treatment drug.

Other Meds: AMLODIPINE; ATORVASTATIN; DICYCLOMINE [DICYCLOVERINE]; METOPROLOL TARTRATE; OMEPRAZOLE; TRAMADOL

Current Illness:

ID: 1823482
Sex: F
Age:
State: GA

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

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

Lab Data:

Allergies:

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

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

Other Meds:

Current Illness:

ID: 1823483
Sex: M
Age:
State: AK

Vax Date: 10/20/2021
Onset Date: 10/20/2021
Rec V Date: 10/28/2021
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: received a dose of the Moderna COVID19 vaccine beyond 12hours after first punctured; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (received a dose of the Moderna COVID19 vaccine beyond 12hours after first punctured) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E21A) for COVID-19 vaccination. No Medical History information was reported. On 20-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 20-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (received a dose of the Moderna COVID19 vaccine beyond 12hours after first punctured). On 20-Oct-2021, EXPIRED PRODUCT ADMINISTERED (received a dose of the Moderna COVID19 vaccine beyond 12hours after first punctured) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication were provided. No treatment information were provided.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am