VAERS 2021 Database www.vaers.hhs.gov

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

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

COVID19 Lot Number

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

Incidents per State

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

ID: 1790106
Sex: M
Age:
State: MD

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
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: 2021; Test Name: cardiac troponin levels; Result Unstructured Data: significantly elevated

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: This literature-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (myocarditis) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. LITERATURE REFERENCE: Myocarditis following immunization with mRNA COVID-19 vaccines. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced MYOCARDITIS (myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (myocarditis) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Troponin: high (High) significantly elevated. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MYOCARDITIS (myocarditis) to be possibly related. No concomitant medication was reported. Patient received supportive care. Patient presented with acute onset of marked chest pain within 4 days after receipt of an mRNA COVID-19 vaccine. Infectious, ischemic, or autoimmune etiologies was not identified for myocarditis. Patient was physically fit by military standards and lacking any known history of cardiac disease, significant cardiac risk factors, or exposure to cardiotoxic agents. No structural abnormalities were noted on echocardiograms. Company Comment: This is a literature report of myocarditis in an adult male. Based on the current available information and temporal association between the use of the product, and the start date of the event, a causal relationship cannot be excluded. Further information has been requested to the author. This case was linked to MOD-2021-284001, MOD-2021-284002, MOD-2021-284003, MOD-2021-284004, MOD-2021-284005, MOD-2021-284006, MOD-2021-284007, MOD-2021-245527, MOD-2021-284009, MOD-2021-284010, MOD-2021-284011, MOD-2021-284012, MOD-2021-284013, MOD-2021-284014, MOD-2021-284015 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Upon internal review on 06-Sep-2021 E2B Company Number was updated from US-MODERNATX, INC.-MOD-2021-245527 to US-MODERNATX, INC.- MOD-2021-284008 On 05-Jul-2021: Follow up received by safety 07-Jul-2021 included a report type updated to literature-study based on the initial additional document received. On 07-Jul-2021: Follow up received by safety 08-Jul-2021 included a full text article added with no new information.; Sender's Comments: This is a literature report of myocarditis in an adult male. Based on the current available information and temporal association between the use of the product, and the start date of the event, a causal relationship cannot be excluded. Further information has been requested to the author.

Other Meds:

Current Illness:

ID: 1790107
Sex: M
Age:
State: MD

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
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: 2021; Test Name: cardiac troponin levels; Result Unstructured Data: Significantly elevated.

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: This literature-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (myocarditis) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. LITERATURE REFERENCE: Myocarditis following immunization with mRNA COVID-19 vaccines in members of the military. 2021:e212833 No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced MYOCARDITIS (myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (myocarditis) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Troponin: high (High) significantly elevated. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MYOCARDITIS (myocarditis) to be possibly related. No concomitant medication was reported. Patient received supportive care. Patient presented with acute onset of marked chest pain within 4 days after receipt of an mRNA COVID-19 vaccine. Infectious, ischemic, or autoimmune etiologies was not identified for myocarditis. Patient was physically fit by military standards and lacking any known history of cardiac disease, significant cardiac risk factors, or exposure to cardiotoxic agents. No structural abnormalities were noted on echocardiograms. Company Comment: This is a literature report of Myocarditis in an adult male. Based on the current available information and temporal association between the use of the product, and the start date of the event, a causal relationship cannot be excluded. Further information has been requested to the author. This case was linked to MOD-2021-284001, MOD-2021-284002, MOD-2021-284003, MOD-2021-284004, MOD-2021-284005, MOD-2021-284006, MOD-2021-284007, MOD-2021-284008, MOD-2021-284009, MOD-2021-245527, MOD-2021-284011, MOD-2021-284012, MOD-2021-284013, MOD-2021-284014, MOD-2021-284015 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Upon internal review on 06-Sep-2021 E2B Company Number was updated from US-MODERNATX, INC.-MOD-2021-245527 to US-MODERNATX, INC.- MOD-2021-284010 On 05-Jul-2021: Follow up received by safety 07-Jul-2021 included a report type updated to literature-study based on the initial additional document received. On 07-Jul-2021: Follow up received by safety 08-Jul-2021 included a full text article added with no new information.; Sender's Comments: This is a literature report of Myocarditis in an adult male. Based on the current available information and temporal association between the use of the product, and the start date of the event, a causal relationship cannot be excluded. Further information has been requested to the author.

Other Meds:

Current Illness:

ID: 1790108
Sex: M
Age:
State: MD

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
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 Date: 2021; Test Name: cardiac troponin levels; Result Unstructured Data: Significantly elevated.

Allergies:

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

Symptoms: This literature-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (myocarditis) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. LITERATURE REFERENCE: Myocarditis following immunization with mRNA COVID-19 vaccines in members of the military. 2021:e212833 No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced MYOCARDITIS (myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (myocarditis) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Troponin: high (High) significantly elevated. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MYOCARDITIS (myocarditis) to be possibly related. No concomitant medication was reported. Patient received supportive care. Patient presented with acute onset of marked chest pain within 4 days after receipt of an mRNA COVID-19 vaccine. Infectious, ischemic, or autoimmune etiologies was not identified for myocarditis. Patient was physically fit by military standards and lacking any known history of cardiac disease, significant cardiac risk factors, or exposure to cardiotoxic agents. No structural abnormalities were noted on echocardiograms. Company Comment: This is a literature report of myocarditis in an adult male after receiving the product. Based on the current available information and temporal association between the use of the product, and the start date of the event, a causal relationship cannot be excluded. Further information has been requested. This case was linked to MOD-2021-284001, MOD-2021-284002, MOD-2021-284003, MOD-2021-284004, MOD-2021-284005, MOD-2021-284006, MOD-2021-284007, MOD-2021-284008, MOD-2021-284009, MOD-2021-284010, MOD-2021-284011, MOD-2021-245527, MOD-2021-284013, MOD-2021-284014, MOD-2021-284015 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Upon internal review on 08-Sep-2021 it was found that Incorrect reports were generated for so Incorrect E2B Company Number was removed. Hence new reports generated. On 05-Jul-2021: Follow up received by safety 07-Jul-2021 included a report type updated to literature-study based on the initial additional document received. On 07-Jul-2021: Follow up received by safety 08-Jul-2021 included a full text article added with no new information.; Sender's Comments: This is a literature report of myocarditis in an adult male after receiving the product. Based on the current available information and temporal association between the use of the product, and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.

Other Meds:

Current Illness:

ID: 1790109
Sex: M
Age:
State: MD

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

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

Lab Data: Test Date: 2021; Test Name: cardiac troponin levels; Result Unstructured Data: Significantly elevated.

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: This literature-study case was reported in a literature article and describes the occurrence of MYOCARDITIS (myocarditis) in an adult male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. LITERATURE REFERENCE: Myocarditis following immunization with mRNA COVID-19 vaccines in members of the military. 2021:e212833 No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In 2021, the patient experienced MYOCARDITIS (myocarditis) (seriousness criterion medically significant). At the time of the report, MYOCARDITIS (myocarditis) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Troponin: high (High) significantly elevated. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered MYOCARDITIS (myocarditis) to be possibly related. No concomitant medication was reported. Patient received supportive care. Patient presented with acute onset of marked chest pain within 4 days after receipt of an mRNA COVID-19 vaccine. Infectious, ischemic, or autoimmune etiologies was not identified for myocarditis. Patient was physically fit by military standards and lacking any known history of cardiac disease, significant cardiac risk factors, or exposure to cardiotoxic agents. No structural abnormalities were noted on echocardiograms. Company Comment: This is a literature report of myocarditis in an adult male. Based on the current available information and temporal association between the use of the product, and the start date of the event, a causal relationship cannot be excluded. This case was linked to MOD-2021-284001, MOD-2021-284002, MOD-2021-284003, MOD-2021-284004, MOD-2021-284005, MOD-2021-284006, MOD-2021-284007, MOD-2021-284008, MOD-2021-284009, MOD-2021-284010, MOD-2021-284011, MOD-2021-284012, MOD-2021-284013, MOD-2021-245527, MOD-2021-284015 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Upon internal review on 08-Sep-2021 it was found that Incorrect reports were generated so Incorrect E2B Company Number was removed. Hence new reports generated. On 05-Jul-2021: Follow up received by safety 07-Jul-2021 included a report type updated to literature-study based on the initial additional document received. On 07-Jul-2021: Follow up received by safety 08-Jul-2021 included a full text article added with no new information.; Sender's Comments: This is a literature report of myocarditis in an adult male. Based on the current available information and temporal association between the use of the product, and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1790110
Sex: F
Age: 75
State: IN

Vax Date: 02/04/2021
Onset Date: 08/23/2021
Rec V Date: 10/16/2021
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: itching and being irritating; itching and being irritating; Intentional administration of >2doses, Intentional dose administration < or > 1 month; Broke out in hives on my face,neck, shoulder and arms,I have the shadows of the hives; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Broke out in hives on my face,neck, shoulder and arms,I have the shadows of the hives), PRURITUS (itching and being irritating), SKIN IRRITATION (itching and being irritating) and OFF LABEL USE (Intentional administration of >2doses, Intentional dose administration < or > 1 month) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A, 013M20A and 030A21A) for COVID-19 vaccination. Concurrent medical conditions included Cardiac disorder NOS and Chronic kidney disease stage 3. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Aug-2021, the patient experienced URTICARIA (Broke out in hives on my face,neck, shoulder and arms,I have the shadows of the hives) and OFF LABEL USE (Intentional administration of >2doses, Intentional dose administration < or > 1 month). On 27-Aug-2021, the patient experienced PRURITUS (itching and being irritating) and SKIN IRRITATION (itching and being irritating). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (topical) for Hives, at an unspecified dose and frequency. On 27-Aug-2021, URTICARIA (Broke out in hives on my face,neck, shoulder and arms,I have the shadows of the hives) had resolved. At the time of the report, PRURITUS (itching and being irritating) and SKIN IRRITATION (itching and being irritating) had not resolved and OFF LABEL USE (Intentional administration of >2doses, Intentional dose administration < or > 1 month) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication was not provided Patient received Benadryl and cortisone cream as treatment.

Other Meds:

Current Illness: Cardiac disorder NOS; Chronic kidney disease stage 3

ID: 1790111
Sex: U
Age:
State: NY

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

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

Lab Data: Test Name: NP CPR; Test Result: Positive; Result Unstructured Data: Positive.

Allergies:

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

Symptoms: Covid-19 infection post vaccination; This literature-study case was reported in a literature article and describes the occurrence of COVID-19 (Covid-19 infection post vaccination) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. LITERATURE REFERENCE: Development of COVID-19 infection in transplant recipients after SARS-CoV-2 vaccination. Transplantation. 2021;105(9):e104-6 The patient's past medical history included Kidney transplant (16 months). Concurrent medical conditions included Immunosuppression. Concomitant products included TACROLIMUS, MYCOPHENOLATE MOFETIL and PREDNISONE for Immunosuppression. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced COVID-19 (Covid-19 infection post vaccination) (seriousness criterion hospitalization). At the time of the report, COVID-19 (Covid-19 infection post vaccination) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered COVID-19 (Covid-19 infection post vaccination) to be possibly related. This case related to patient 2 as per article and initial symptoms included were Cough, fatigue. No treatment was reported for the patient. Outcome of the event was reported as alive Company Comment: This is a literature report of mild COVID-19 in a kidney immunosuppressed patient of 68 years old, 4 days after receiving the second dose of the product. Doses dates are not provided, thus appropriateness of product administration schedule is not assessable. Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. This case was linked to MOD-2021-303225, MOD-2021-303228, MOD-2021-303227, MOD-2021-303226 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 02-Sep-2021: Follow up received by safety 2-Sep-2021 included an Email with FTA received from Regulatory Authority team and does not contain any new information.; Sender's Comments: This is a literature report of mild COVID-19 in a kidney immunosuppressed patient of 68 years old, 4 days after receiving the second dose of the product. Doses dates are not provided, thus appropriateness of product administration schedule is not assessable. Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable.

Other Meds: Tacrolimus; Mycophenolate Mofetil; Prednisone

Current Illness: Immunosuppression

ID: 1790112
Sex: U
Age:
State: NY

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

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

Lab Data: Test Name: Oxygen saturation; Test Result: Inconclusive ; Result Unstructured Data: less than 94% on ambient air; Test Name: Respiratory rate; Test Result: Inconclusive ; Result Unstructured Data: more than or equal to 24 breaths per minute; Test Name: NP PCR test; Test Result: Positive ; Result Unstructured Data: Positive

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: COVID-19 infections post vaccination; Lack of drug effect; This literature-study case was reported in a literature article and describes the occurrence of COVID-19 (COVID-19 infections post vaccination) in a 71-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. LITERATURE REFERENCE: Development of COVID-19 infection in transplant recipients after SARS-CoV-2 vaccination. Transplantation. 2021;105(9):e104-6 The patient's past medical history included Kidney transplant (24 months). Concurrent medical conditions included Immunosuppression. Concomitant products included TACROLIMUS, MYCOPHENOLATE MOFETIL and PREDNISONE for Immunosuppression. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID-19 infections post vaccination) (seriousness criterion hospitalization). an unknown date, the patient experienced DRUG INEFFECTIVE (Lack of drug effect). The patient was treated with REMDESIVIR for COVID-19, at an unspecified dose and frequency; DEXAMETHASONE for COVID-19, at an unspecified dose and frequency and CONVALESCENT PLASMA COVID-19 for COVID-19, at an unspecified dose and frequency. At the time of the report, COVID-19 (COVID-19 infections post vaccination) and DRUG INEFFECTIVE (Lack of drug effect) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Oxygen saturation: less than 94% on ambient air (Inconclusive) less than 94% on ambient air. On an unknown date, Respiratory rate: more than or equal to 24 breaths per minute) (Inconclusive) more than or equal to 24 breaths per minute. On an unknown date, SARS-CoV-2 test: positive (Positive) Positive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered COVID-19 (COVID-19 infections post vaccination) and DRUG INEFFECTIVE (Lack of drug effect) to be possibly related. This case related to patient 9 as per article and patient initial symptoms included were fever, diarrhea, and vomiting. Vaccine to sx onset was 15 days. The patient may also needed mechanical ventilation and supplemental oxygen. Treatment also included Monoclonal antibody which was done outside of hospital. Company Comment: This is a literature report of a severe COVID-19 more than 15 days after the second dose of the product in a renal transplant immunosuppressed patient of 71 years old. Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. For the event Drug ineffective a causal relationship cannot be excluded. This case was linked to MOD-2021-303163, MOD-2021-303228, MOD-2021-303227, MOD-2021-303226 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 02-Sep-2021: Follow up received by safety on 02-Sep-2021 included an Email with FTA received from team and does not contain any new information.; Sender's Comments: This is a literature report of a severe COVID-19 more than 15 days after the second dose of the product in a renal transplant immunosuppressed patient of 71 years old. Based on the mechanism of action of mRNA-1273 causal association between the event of COVID-19 infection and mRNA-1273 is assessed as not applicable. For the event Drug ineffective a causal relationship cannot be excluded.

Other Meds: TACROLIMUS; MYCOPHENOLATE MOFETIL; PREDNISONE

Current Illness: Immunosuppression

ID: 1790113
Sex: F
Age: 62
State: NY

Vax Date: 05/12/2021
Onset Date: 05/12/2021
Rec V Date: 10/16/2021
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: surrounding area pain had persisted, especially with movement and daily activities, such as showering, dressing, brushing/blow-drying hair, reaching, applying vehicle seatbelt, etc; frozen shoulder/adhesive capsulitis; arm soreness/ My arm is still sore; Pain in the shoulder/right shoulder pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm soreness/ My arm is still sore), PERIARTHRITIS (frozen shoulder/adhesive capsulitis), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (surrounding area pain had persisted, especially with movement and daily activities, such as showering, dressing, brushing/blow-drying hair, reaching, applying vehicle seatbelt, etc) and ARTHRALGIA (Pain in the shoulder/right shoulder pain) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027C21A) for COVID-19 vaccination. Previously administered products included for Product used for unknown indication: pneumonia (Route: IM, body site: deltoid, Dose number in series: 1of1) on 24-Mar-2021, tetanus (Route: IM, body site: deltoid and Dose number in series: 1of1) on 24-Mar-2021. Past adverse reactions to the above products included No adverse event with pneumonia and tetanus. Concurrent medical conditions included Muscle cramps and Ache. Concomitant products included POTASSIUM GLUCONATE from 07-Apr-2021 to an unknown date and MAGNESIUM OXIDE from 07-Apr-2021 to an unknown date for Muscle cramps and Ache. On 12-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-May-2021, the patient experienced ARTHRALGIA (Pain in the shoulder/right shoulder pain). On 13-May-2021, the patient experienced PAIN IN EXTREMITY (arm soreness/ My arm is still sore). On 29-Sep-2021, the patient experienced PERIARTHRITIS (frozen shoulder/adhesive capsulitis). On an unknown date, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (surrounding area pain had persisted, especially with movement and daily activities, such as showering, dressing, brushing/blow-drying hair, reaching, applying vehicle seatbelt, etc). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency and DICLOFENAC SODIUM (VOLTAREN [DICLOFENAC SODIUM]) (topical) for Frozen shoulder, at a dose of 2g to right shoulder up to 4 times daily as needed. At the time of the report, PAIN IN EXTREMITY (arm soreness/ My arm is still sore) and ARTHRALGIA (Pain in the shoulder/right shoulder pain) had not resolved and PERIARTHRITIS (frozen shoulder/adhesive capsulitis) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (surrounding area pain had persisted, especially with movement and daily activities, such as showering, dressing, brushing/blow-drying hair, reaching, applying vehicle seatbelt, etc) outcome was unknown. The patient had typical upper arm discomfort after first dose that resolved with massage and movement of arm within a few days. The patient kept the arm active and massaged the area, but the pain persisted. The patient used massage, heat and ibuprofen, with minor degree of temporary relief. On 29-Sep-2021, the patient was evaluated by my primary medical doctor for this condition. No imaging was performed. Her PMD (primary medical doctor) suspected adhesive capsulitis/"frozen shoulder" and prescribed diclofenac sodium (Voltaren) 1% gel 2g to right shoulder up to 4 times daily as needed and physical therapy. The patient was using the topical gel as prescribed, without relief of right shoulder and surrounding area pain. Physical therapy had been scheduled and was pending. Her arm was still sore even after months. The pain in the shoulder never went away. This case was linked to MOD-2021-304599 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 06-Oct-2021: Follow-up information included historical vaccine, concomitant, treatment medication and new events.; Sender's Comments: This case concerns a 62-year-old female patient with no relevant medical history, who experienced the unexpected event of Periarthritis and expected event of Arthralgia. The event Arthralgia occurred on the same day after the second dose of mRNA-1273 (Moderna COVID-19 Vaccine) while the event Periarthritis occurred 140 days after the second dose. The rechallenge was unknown since it was not disclosed if the event resolved after the first dose. The benefit-risk relationship of mRNA-1273 (Moderna COVID-19 Vaccine) is not affected by this report.

Other Meds: POTASSIUM GLUCONATE; MAGNESIUM OXIDE

Current Illness: Ache; Muscle cramps

ID: 1790114
Sex: M
Age: 33
State: UT

Vax Date: 08/09/2021
Onset Date: 09/01/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: interchange of vaccine; Moderna first dose and Pfizer second dose; Second dose given on day 23; This spontaneous case was reported by a nurse and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine), OFF LABEL USE (Moderna first dose and Pfizer second dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose given on day 23) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No Medical History information was reported. On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose given on day 23). On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine) and OFF LABEL USE (Moderna first dose and Pfizer second dose). On 01-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose given on day 23) had resolved. At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (interchange of vaccine) and OFF LABEL USE (Moderna first dose and Pfizer second dose) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. A patient had received the first COVID-19 vaccination from Moderna on 09Aug2021 on unknown deltoid muscle Concomitant product use was not provided by the reporter. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1790115
Sex: M
Age:
State: OR

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
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: administered 1 ml of the Moderna COVID-19 vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of ACCIDENTAL OVERDOSE (administered 1 ml of the Moderna COVID-19 vaccine) in a 29-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 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 ACCIDENTAL OVERDOSE (administered 1 ml of the Moderna COVID-19 vaccine). At the time of the report, ACCIDENTAL OVERDOSE (administered 1 ml of the Moderna COVID-19 vaccine) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product was not provided by the reporter Treatment information was not provided

Other Meds:

Current Illness:

ID: 1790116
Sex: U
Age:
State: TX

Vax Date: 08/24/2021
Onset Date: 08/24/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: administered past the 30 day refrigeration time; storage medication error; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) and PRODUCT STORAGE ERROR (storage medication error) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 008C21A) for COVID-19 vaccination. No Medical History information was reported. On 24-Aug-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Aug-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) and PRODUCT STORAGE ERROR (storage medication error). On 24-Aug-2021, EXPIRED PRODUCT ADMINISTERED (administered past the 30 day refrigeration time) and PRODUCT STORAGE ERROR (storage medication error) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication information not provided. Treatment information not provided.

Other Meds:

Current Illness:

ID: 1790117
Sex: F
Age: 38
State: MS

Vax Date: 09/09/2021
Onset Date: 09/10/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: Purple band around my arm; Covid hands; Skin began to peel/down to the 3rd or 4th layer of skin; Weird bumps on my hands; low grade fever; really bad reaction on my arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE REACTION (really bad reaction on my arm), SKIN DISCOLOURATION (Purple band around my arm), VACCINATION COMPLICATION (Covid hands), RASH (Skin began to peel/down to the 3rd or 4th layer of skin) and VACCINATION SITE RASH (Weird bumps on my hands) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Eczema. Concomitant products included CORTISONE for Rash. On 09-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Sep-2021, the patient experienced VACCINATION SITE REACTION (really bad reaction on my arm) and PYREXIA (low grade fever). On 12-Sep-2021, the patient experienced RASH (Skin began to peel/down to the 3rd or 4th layer of skin) and VACCINATION SITE RASH (Weird bumps on my hands). On an unknown date, the patient experienced SKIN DISCOLOURATION (Purple band around my arm) and VACCINATION COMPLICATION (Covid hands). At the time of the report, VACCINATION SITE REACTION (really bad reaction on my arm) and PYREXIA (low grade fever) outcome was unknown and SKIN DISCOLOURATION (Purple band around my arm), VACCINATION COMPLICATION (Covid hands), RASH (Skin began to peel/down to the 3rd or 4th layer of skin) and VACCINATION SITE RASH (Weird bumps on my hands) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Treatment information was provided by reporter. She has tried multiple different lotions and creams for her hands including cortisone, eczema medication and psoriasis medication. She has an appointment to see a dermatologist on Thursday. Most recent FOLLOW-UP information incorporated above includes: On 05-Oct-2021: Significant followup appended-Start date, medical history, new events added.

Other Meds: CORTISONE

Current Illness:

ID: 1790118
Sex: M
Age: 60
State: IL

Vax Date: 02/02/2021
Onset Date: 03/09/2021
Rec V Date: 10/16/2021
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 left injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left injection site arm) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036A21A and 030L20A) for COVID-19 vaccination. Concurrent medical conditions included Penicillin allergy. Concomitant products included ALPRAZOLAM from 01-Jan-2015 to an unknown date for Anxiety, AMLODIPINE from 01-Jan-2020 to an unknown date, HYDROCHLOROTHIAZIDE from 01-Jan-2017 to an unknown date and LOSARTAN POTASSIUM from 01-Jan-2015 to an unknown date for Blood pressure, ROSUVASTATIN from 01-Jan-2013 to an unknown date for Cholesterol, LEVOTHYROXINE from 01-Jan-2013 to an unknown date for an unknown indication. On 02-Feb-2021 at 5:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Mar-2021 at 5:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Mar-2021 at 5:00 PM, the patient experienced VACCINATION SITE PAIN (sore left injection site arm). On 12-Mar-2021, VACCINATION SITE PAIN (sore left injection site arm) had resolved. Patient treatment include Ice packs on shoulder. Most recent FOLLOW-UP information incorporated above includes: On 22-Sep-2021: Follow-up information on 22-SEP-2021 included reporter mail id, vaccine facility information, patient demographics and concomitant medications were added. Event stop date and outcome updated.

Other Meds: AMLODIPINE; ALPRAZOLAM; LEVOTHYROXINE; HYDROCHLOROTHIAZIDE; ROSUVASTATIN; LOSARTAN POTASSIUM

Current Illness: Penicillin allergy

ID: 1790119
Sex: U
Age:
State: NV

Vax Date: 03/01/2021
Onset Date: 03/23/2021
Rec V Date: 10/16/2021
Hospital: Y

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

Lab Data:

Allergies:

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

Symptoms: Pericarditis and changes in sense of smell; Pericarditis and changes in sense of smell/ myocardial pericarditis; Inappropriate schedule of vaccine administered; This spontaneous case was reported by a consumer and describes the occurrence of PAROSMIA (Pericarditis and changes in sense of smell) and PERICARDITIS (Pericarditis and changes in sense of smell/ myocardial pericarditis) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 01-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On an unknown date, the patient experienced PAROSMIA (Pericarditis and changes in sense of smell) (seriousness criterion hospitalization) and PERICARDITIS (Pericarditis and changes in sense of smell/ myocardial pericarditis) (seriousness criteria hospitalization and medically significant). On 23-Mar-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) had resolved. At the time of the report, PAROSMIA (Pericarditis and changes in sense of smell) and PERICARDITIS (Pericarditis and changes in sense of smell/ myocardial pericarditis) had not resolved. Concomitant medications were not provided. Treatment information was not provided. Patient height was 185.42 cm Action taken was not applicable. Company Comment: This case concerns a 68-year-old patient, of an unknown gender with no relevant medical history reported, who experienced the unexpected event of parosmia and expected event of pericarditis. The event occurred on an unknown date and it is not clear if it was before or after the vaccination with the Moderna Covid-19 vaccine. Additional unexpected event of Inappropriate Schedule of Product Administration was added. The rechallenge was not applicable, as the event occurred on an unknown date. The reporter's assessment is not provided in this case. The benefit-risk relationship of the vaccine is not affected by this report. Most recent FOLLOW-UP information incorporated above includes: On 17-Sep-2021: Added start date and stop date of the event 'inappropriate schedule of vaccine administered', event verbatim to the event 'pericarditis'. Updated patient initials.; Sender's Comments: This case concerns a 68-year-old patient, of an unknown gender with no relevant medical history reported, who experienced the unexpected event of parosmia and expected AESI event of pericarditis. The events occurred on an unknown date and it is not clear if it was before or after the vaccination with the Moderna Covid-19 vaccine. Additional unexpected event of Inappropriate Schedule of Product Administration was added. The rechallenge was not applicable, as the events occurred on unknown dates. The benefit-risk relationship of the vaccine is not affected by this report.

Other Meds:

Current Illness:

ID: 1790120
Sex: F
Age: 30
State: AR

Vax Date: 07/27/2021
Onset Date: 09/16/2021
Rec V Date: 10/16/2021
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: Receiving Moderna COVID-19 vaccine as a second dose but already received Pfizer COVID-19 vaccine as a 1st dose; This spontaneous case was reported by a nurse and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Receiving Moderna COVID-19 vaccine as a second dose but already received Pfizer COVID-19 vaccine as a 1st dose) in a 30-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014F21A) for COVID-19 vaccination. Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) for an unknown indication. Concurrent medical conditions included Anxiety. Concomitant products included TRAZODONE, PAROXETINE and BUSPIRONE for an unknown indication. On 27-Jul-2021, the patient started TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On 16-Sep-2021 at 3:45 PM, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Sep-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Receiving Moderna COVID-19 vaccine as a second dose but already received Pfizer COVID-19 vaccine as a 1st dose). On 16-Sep-2021, INTERCHANGE OF VACCINE PRODUCTS (Receiving Moderna COVID-19 vaccine as a second dose but already received Pfizer COVID-19 vaccine as a 1st dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 20-Sep-2021: Follow-up was received on 20-SEP-2021 and Patient's demographics added, race and ethnicity added, medical history added, concomitant medication dosage details and frequency added

Other Meds: TRAZODONE; PAROXETINE; BUSPIRONE

Current Illness: Anxiety

ID: 1790121
Sex: M
Age:
State: AZ

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
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: swollen testicles for a few days (blueballs); could not walk right for a few days; second vaccination gave me only slight feeling of body imbalance; 10 or so hours after receiving it my testcles ached; Just an ache, making me uncomfortable; This case was received via Regulatory Authority(Reference number: US-irms-MOD21-145833) on 21-Sep-2021 and was forwarded to Moderna on 21-Sep-2021. This spontaneous case was reported by a consumer and describes the occurrence of TESTICULAR SWELLING (swollen testicles for a few days (blueballs)), GAIT DISTURBANCE (could not walk right for a few days), BALANCE DISORDER (second vaccination gave me only slight feeling of body imbalance), TESTICULAR PAIN (10 or so hours after receiving it my testcles ached) and DISCOMFORT (Just an ache, making me uncomfortable) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Testicular swelling (40 years ago), Blood pressure high since 2008 and Non-consummation. Concomitant products included METOPROLOL from 2008 to an unknown date and AMLODIPINE from 2008 to an unknown date for Blood pressure. In 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced TESTICULAR SWELLING (swollen testicles for a few days (blueballs)), GAIT DISTURBANCE (could not walk right for a few days), BALANCE DISORDER (second vaccination gave me only slight feeling of body imbalance), TESTICULAR PAIN (10 or so hours after receiving it my testcles ached) and DISCOMFORT (Just an ache, making me uncomfortable). In 2021, TESTICULAR SWELLING (swollen testicles for a few days (blueballs)) and GAIT DISTURBANCE (could not walk right for a few days) had resolved. At the time of the report, BALANCE DISORDER (second vaccination gave me only slight feeling of body imbalance), TESTICULAR PAIN (10 or so hours after receiving it my testcles ached) and DISCOMFORT (Just an ache, making me uncomfortable) outcome was unknown. Treatment medications was not reported. The patient received the first dose of Moderna COVID-19 vaccine 2-3 months ago. He also received the second shot of Moderna COVID-19 vaccine about 2 months ago. The patient was not sexually active now. The patient did not have any history of prostate problems. Most recent FOLLOW-UP information incorporated above includes: On 24-Sep-2021: Follow up contains significant information of patient history, concomitants, new events and patient demographics.

Other Meds: METOPROLOL; AMLODIPINE

Current Illness: Blood pressure high; Non-consummation; Testicular swelling (40 years ago)

ID: 1790122
Sex: M
Age:
State: IL

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
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: Fever; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever) and CHILLS (Chills) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Malignant neoplasm of kidney, except pelvis (Malignant neoplasm of left kidney). Concomitant products included LENVATINIB MESILATE (LENVIMA) for Malignant neoplasm of kidney, except pelvis. 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, the patient experienced PYREXIA (Fever) and CHILLS (Chills). At the time of the report, PYREXIA (Fever) and CHILLS (Chills) outcome was unknown. Not Provided Concomitant products were not provided. Treatment medication were not reported. This case was linked to MOD-2021-331510 (Patient Link). Reporter did not allow further contact

Other Meds: LENVIMA

Current Illness: Malignant neoplasm of kidney, except pelvis (Malignant neoplasm of left kidney)

ID: 1790123
Sex: M
Age: 43
State: PA

Vax Date: 01/31/2021
Onset Date: 02/28/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: headache; Chills; Fever; vomiting; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache), CHILLS (Chills), PYREXIA (Fever) and VOMITING (vomiting) in a 43-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002A21A and 028L20A) for COVID-19 vaccination. Previously administered products included for Product used for unknown indication: Flu shot. Past adverse reactions to the above products included Headache with Flu shot. On 31-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 28-Feb-2021, the patient experienced HEADACHE (headache), CHILLS (Chills), PYREXIA (Fever) and VOMITING (vomiting). On 01-Mar-2021, HEADACHE (headache), CHILLS (Chills), PYREXIA (Fever) and VOMITING (vomiting) had resolved. Concomitant medication was not reported. Treatment information was not reported. Reporter stated that headache and vomiting are the same symptoms patient experienced when they get a flu shot. This case was linked to MOD-2021-333400 (Patient Link). Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 08-Oct-2021: Historical vaccine and events associated with it were updated.

Other Meds:

Current Illness:

ID: 1790124
Sex: F
Age: 33
State: MI

Vax Date: 09/01/2021
Onset Date: 09/01/2021
Rec V Date: 10/16/2021
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: Moderna COVID-19 vaccine administered after temperature excursion; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (Moderna COVID-19 vaccine administered after temperature excursion) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. No Medical History information was reported. On 01-Sep-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Sep-2021, the patient experienced PRODUCT STORAGE ERROR (Moderna COVID-19 vaccine administered after temperature excursion). On 01-Sep-2021, PRODUCT STORAGE ERROR (Moderna COVID-19 vaccine administered after temperature excursion) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. The reporter stated that the vaccine was administered intramuscularly in the upper deltoid and the patients did not experience any adverse reactions following administration. The reporter stated that the vial was moved from freezer to fridge on 31Aug2021, and was only in fridge for a day prior to administration. No concomitant medication details were provided. No treatment medication details were reported. Most recent FOLLOW-UP information incorporated above includes: On 30-Sep-2021: Follow up received on 30-SEP-2021 contains non significant information. On 01-Oct-2021: Additional information received on 04-OCT-2021: Vaccination anatomical site added and Patient demographics added.

Other Meds:

Current Illness:

ID: 1790125
Sex: M
Age:
State: KY

Vax Date: 09/24/2021
Onset Date:
Rec V Date: 10/16/2021
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: dose administered from a carton of vials some of which did not thaw as expected; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT STORAGE ERROR (dose administered from a carton of vials some of which did not thaw as expected) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019F21A) for COVID-19 vaccination. Concurrent medical conditions included COPD since 14-Feb-2014, Chronic pain since 11-Oct-2019, Anxiety on 09-Dec-2013, Hypertension, Allergy (Bee) and Pollen allergy. Concomitant products included FERROUS GLUCONATE (FERGON) from 11-Mar-2016 to an unknown date for Anemia, ALPRAZOLAM (XANAX) from 09-Dec-2013 to an unknown date for Anxiety, OXYCODONE from 28-Nov-2010 to an unknown date for Chronic pain, METOPROLOL from 18-Jul-2014 to an unknown date for Hypertension, ERGOCALCIFEROL (DRISDOL) from 11-Mar-2016 to an unknown date for Vitamin D deficiency. On 24-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 PRODUCT STORAGE ERROR (dose administered from a carton of vials some of which did not thaw as expected). At the time of the report, PRODUCT STORAGE ERROR (dose administered from a carton of vials some of which did not thaw as expected) had resolved. 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 30-Sep-2021: Follow up received on 30-Sep-2021. Patient's information (age, race, demographics), medical history and concomitant medications were updated. New reporter added.

Other Meds: XANAX; DRISDOL; FERGON; METOPROLOL; OXYCODONE

Current Illness: Chronic pain; COPD

ID: 1790126
Sex: M
Age:
State: MN

Vax Date: 09/29/2021
Onset Date: 09/29/2021
Rec V Date: 10/16/2021
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: Administered covid vaccine outside 12-hour range of puncture; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered covid vaccine outside 12-hour range of puncture) in an 81-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047C21A) for COVID-19 vaccination. Concurrent medical conditions included Immunocompromised (patient is immunocompromised so got the 3rd dose). On 29-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. 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 29-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered covid vaccine outside 12-hour range of puncture). On 29-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Administered covid vaccine outside 12-hour range of puncture) 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. Initially, vial was stored in the refrigerator, on 21Sept2021 and was first punctured: on 28Sept2021 @ 4PM and vial stored post puncture in room temperature (RT), not undergone any temperature excursions. and totally vial exposed to 21 hours of room temperature. Patient has reported that he has no allergies to any medications, food, and other products. Also reported that he has never been diagnosed with COVID-19, positive. In addition, said that he didn't report any adverse effects and as per manufacture, he took third dose on opposite arm (i.e., right arm). Most recent FOLLOW-UP information incorporated above includes: On 04-Oct-2021: Follow up received on 04-Oct-2021 and included reporter's contact information (Address). On 06-Oct-2021: Follow up received on 06-OCT-2021 and included race and ethnicity.

Other Meds:

Current Illness: Immunocompromised (patient is immunocompromised so got the 3rd dose)

ID: 1790127
Sex: M
Age: 61
State: LA

Vax Date: 03/21/2021
Onset Date: 04/20/2021
Rec V Date: 10/16/2021
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: Felt like he had a mild case of the flu; Felt achy and gross; Didn't feel good; Felt like he had a bad case of the flu; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Felt achy and gross), FEELING ABNORMAL (Didn't feel good), INFLUENZA (Felt like he had a bad case of the flu) and INFLUENZA (Felt like he had a mild case of the flu) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026B21A and 016B21A) for COVID-19 vaccination. No Medical History information was reported. On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Apr-2021, the patient experienced PAIN (Felt achy and gross), FEELING ABNORMAL (Didn't feel good) and INFLUENZA (Felt like he had a bad case of the flu). On 21-Apr-2021, the patient experienced INFLUENZA (Felt like he had a mild case of the flu). At the time of the report, PAIN (Felt achy and gross), FEELING ABNORMAL (Didn't feel good), INFLUENZA (Felt like he had a bad case of the flu) and INFLUENZA (Felt like he had a mild case of the flu) had resolved. No concomitant medication were provided. No treatment information were provided. This case was linked to MOD-2021-336800 (Patient Link).

Other Meds:

Current Illness:

ID: 1790128
Sex: F
Age: 31
State: MI

Vax Date: 09/01/2021
Onset Date: 09/01/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Sore left injection site arm; Patient is pregnant; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Sore left injection site arm) and MATERNAL EXPOSURE DURING PREGNANCY (Patient is pregnant) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination. No Medical History information was reported. On 01-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 01-Sep-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Patient is pregnant). On an unknown date, the patient experienced INJECTION SITE PAIN (Sore left injection site arm). On 01-Sep-2021, MATERNAL EXPOSURE DURING PREGNANCY (Patient is pregnant) had resolved. At the time of the report, INJECTION SITE PAIN (Sore left injection site arm) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. No Concomitant medications were reported. The patient reported a sore left injection site arm. The due date was reported as Nov-2021. This case concerns a 32-year-old pregnant female patient with no reported medical history, who experienced the non-serious unexpected events Injection site pain and maternal exposure during pregnancy. The events occurred after the first dose of mRNA-1273 Moderna vaccine. Last menstrual period and estimated date of delivery were not provided. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report. This case was linked to MOD-2021-336953 (Patient Link).; Sender's Comments: This case concerns a 32-year-old pregnant female patient with no reported medical history, who experienced the non-serious unexpected events Injection site pain and maternal exposure during pregnancy. The events occurred after the first dose of mRNA-1273 Moderna vaccine. Last menstrual period and estimated date of delivery were not provided. The benefit-risk relationship of mRNA-1273 Moderna vaccine is not affected by this report.

Other Meds:

Current Illness:

ID: 1790129
Sex: F
Age: 31
State: MI

Vax Date: 09/01/2021
Onset Date: 09/29/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: sore left arm; Patient received expired vaccine; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore left arm) and EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) in a 32-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination. No Medical History information was reported. On 01-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 29-Sep-2021, the patient experienced VACCINATION SITE PAIN (sore left arm) and EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine). On 29-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Patient received expired vaccine) had resolved. At the time of the report, VACCINATION SITE PAIN (sore left arm) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient was pregnant and pregnancy due date was Nov 2021. No concomitant medication information were provided. No treatment medication information was given. This case involves a 32-year-old female subject with n information on medical history who experienced the unlisted non-serious adverse event of expired product administered and the listed adverse event of vaccination site pain at her second vaccination. The patient was pregnant at the time of both vaccinations. The due date of the pregnancy has been reported for November 2021. The pregnancy has not been impacted by the vaccinations The re-challenge is positive for vaccination site pain. The benefit-risk relationship of mRNA-1273 is no affected by this report. This case was linked to MOD-2021-336915 (Patient Link).; Sender's Comments: This case involves a 32-year-old female subject with n information on medical history who experienced the unlisted non-serious adverse event of expired product administered and the listed adverse event of vaccination site pain at her second vaccination. The patient was pregnant at the time of both vaccinations. The due date of the pregnancy has been reported for November 2021. The pregnancy has not been impacted by the vaccinations The re-challenge is positive for vaccination site pain. The benefit-risk relationship of mRNA-1273 is no affected by this report.

Other Meds:

Current Illness:

ID: 1790130
Sex: F
Age: 35
State: MA

Vax Date: 12/28/2020
Onset Date:
Rec V Date: 10/16/2021
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: 20210730; Test Name: Pregnancy test; Test Result: Positive ; Result Unstructured Data: Positive

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: special situation of pregnancy applies to me; minor soreness at the injection site; This spontaneous prospective pregnancy case was reported by an other health care professional and describes the occurrence of MATERNAL EXPOSURE BEFORE PREGNANCY (special situation of pregnancy applies to me) and VACCINATION SITE PAIN (minor soreness at the injection site) in a 36-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 011J20A) for COVID-19 vaccination. The patient's past medical history included Alcohol use (1 drink/week) on 04-Jul-2021. Concurrent medical conditions included Drug hypersensitivity (Allergy to sulfa drugs) and Migraine with aura (occasional frequency (1 every few months) has not changed.) since 01-Jan-1998. Concomitant products included MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) from 01-Jan-2019 to an unknown date for an unknown indication. On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on 30-Jun-2021 and the estimated date of delivery was 08-Apr-2022. On an unknown date, the patient experienced MATERNAL EXPOSURE BEFORE PREGNANCY (special situation of pregnancy applies to me) and VACCINATION SITE PAIN (minor soreness at the injection site). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) during pregnancy. At the time of the report, MATERNAL EXPOSURE BEFORE PREGNANCY (special situation of pregnancy applies to me) and VACCINATION SITE PAIN (minor soreness at the injection site) had resolved. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Jul-2021, Pregnancy test: positive (Positive) Positive. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment medication reported. This case involves a 36-year-old female with a medical history of alcohol use once per week and concurrent medical conditions of drug hypersensitivity and migraine with aura who experienced the non-serious listed adverse events of minor soreness at the injection site after receiving her first vaccination and of fever, fatigue and headache after her second vaccination. 6 months after her second vaccination, the subject received a positive pregnancy test result on 30 July 2021. This is a case of maternal exposure before pregnancy. No adverse events concerning the pregnancy have occurred, yet. No positive re-challenge has occurred. The benefit-risk relationship of mRNA-1273 has not been affected by this report. This case was linked to MOD-2021-345917 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 07-Oct-2021: Significant: HCP contact details added, patient demographic details added, patient pregnancy details added (LMP date, pregnancy test, estimated due date), medical history added, past drug history added. Covid vaccines details for both the doses updated. Concomitant drug was added. On 07-Oct-2021: minor soreness at the injection site, event was provided.; Sender's Comments: This case involves a 36-year-old female with a medical history of alcohol use once per week and concurrent medical conditions of drug hypersensitivity and migraine with aura who experienced the non-serious listed adverse events of minor soreness at the injection site after receiving her first vaccination and of fever, fatigue and headache after her second vaccination. 6 months after her second vaccination, the subject received a positive pregnancy test result on 30 July 2021. This is a case of maternal exposure before pregnancy. No adverse events concerning the pregnancy have occurred, yet. No positive re-challenge has occurred. The benefit-risk relationship of mRNA-1273 has not been affected by this report.

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

Current Illness: Alcohol use (1 drink/week); Drug hypersensitivity (Allergy to sulfa drugs); Migraine with aura (occasional frequency (1 every few months) has not changed.)

ID: 1790131
Sex: F
Age: 75
State: PA

Vax Date: 09/14/2021
Onset Date: 09/14/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Name: allergy; Test Result: Negative ; Result Unstructured Data: negative

Allergies:

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

Symptoms: \itching in different body parts\head itched; Second dose Pfizer 26Feb2021 and Third dose Moderna 14Sep2021; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (\itching in different body parts\head itched) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose Pfizer 26Feb2021 and Third dose Moderna 14Sep2021) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043B21A) for COVID-19 vaccination. Concurrent medical conditions included Sjogren's syndrome (Causes dry mouth and dry eyes suffering for more than 20 years), Fibromyalgia (for more than 20 years along with Sjogren Syndrome), Diabetes, Thyroid disorder and Asthma. On 14-Sep-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose Pfizer 26Feb2021 and Third dose Moderna 14Sep2021). On 21-Sep-2021, the patient experienced PRURITUS (\itching in different body parts\head itched). On 14-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose Pfizer 26Feb2021 and Third dose Moderna 14Sep2021) had resolved. At the time of the report, PRURITUS (\itching in different body parts\head itched) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Hypersensitivity: negativen (Negative) negative. Concomitant medications include medicines for thyroid, diabetes, asthma and head. Treatment information includes intake of steroids for hives.

Other Meds:

Current Illness: Asthma; Diabetes; Fibromyalgia (for more than 20 years along with Sjogren Syndrome); Sjogren's syndrome (Causes dry mouth and dry eyes suffering for more than 20 years); Thyroid disorder

ID: 1790132
Sex: F
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
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: autoimmune inner ear disease; hearing loss; dizziness; This literature-study case was reported in a literature article and describes the occurrence of AUTOIMMUNE INNER EAR DISEASE (autoimmune inner ear disease) and DEAFNESS (hearing loss) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Autoimmune inner ear disease (5 plus years of duration). 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 AUTOIMMUNE INNER EAR DISEASE (autoimmune inner ear disease) (seriousness criterion medically significant), DEAFNESS (hearing loss) (seriousness criterion medically significant) and DIZZINESS (dizziness). At the time of the report, AUTOIMMUNE INNER EAR DISEASE (autoimmune inner ear disease), DEAFNESS (hearing loss) and DIZZINESS (dizziness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered AUTOIMMUNE INNER EAR DISEASE (autoimmune inner ear disease), DEAFNESS (hearing loss) and DIZZINESS (dizziness) to be possibly related. Concomitant product use was not provided by the reporter. Treatment information was not provided. Patient had Hearing loss and Dizziness as symptoms. Company Comment: A 74-year-old female, with concurrent autoimmune inner ear disease, presented with serious unexpected events of autoimmune inner ear disease with hearing loss and dizziness. Event latency 7 days after first dose. Event outcome not reported. Rechallenge unknown. Reporter causality assessed as possibly related. Causality possible from temporal association. Event consistent with known immunomodulation effect of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report. This case was linked to MOD-2021-337994, MOD-2021-337995, MOD-2021-337996, MOD-2021-337997, MOD-2021-337998, MOD-2021-337999, MOD-2021-338000, MOD-2021-338001, MOD-2021-338002, MOD-2021-338003, MOD-2021-338004, MOD-2021-338005, MOD-2021-338006, MOD-2021-338007, MOD-2021-338008, MOD-2021-338009, MOD-2021-338010.; Sender's Comments: A 74-year-old female, with concurrent autoimmune inner ear disease, presented with serious unexpected events of autoimmune inner ear disease with hearing loss and dizziness. Event latency 7 days after first dose. Event outcome not reported. Rechallenge unknown. Reporter causality assessed as possibly related. Causality possible from temporal association. Event consistent with known immunomodulation effect of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.

Other Meds:

Current Illness: Autoimmune inner ear disease (5 plus years of duration)

ID: 1790133
Sex: M
Age:
State: MO

Vax Date: 09/28/2021
Onset Date: 09/28/2021
Rec V Date: 10/16/2021
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: vaccine that had experienced a temperature excursion was given as 1st dose; vaccine that had experienced a temperature excursion was given as 1st dose; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (vaccine that had experienced a temperature excursion was given as 1st dose) and EXPIRED PRODUCT ADMINISTERED (vaccine that had experienced a temperature excursion was given as 1st dose) in a 22-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 28-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Sep-2021, the patient experienced PRODUCT STORAGE ERROR (vaccine that had experienced a temperature excursion was given as 1st dose). On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (vaccine that had experienced a temperature excursion was given as 1st dose). At the time of the report, PRODUCT STORAGE ERROR (vaccine that had experienced a temperature excursion was given as 1st dose) and EXPIRED PRODUCT ADMINISTERED (vaccine that had experienced a temperature excursion was given as 1st dose) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was provided. No treatment medication was provided.

Other Meds:

Current Illness:

ID: 1790134
Sex: M
Age:
State: MO

Vax Date: 09/29/2021
Onset Date: 09/29/2021
Rec V Date: 10/16/2021
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: vaccine that had experienced a temperature excursion was given as 1st dose; poor quality product administered; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (vaccine that had experienced a temperature excursion was given as 1st dose) and POOR QUALITY PRODUCT ADMINISTERED (poor quality product administered) in a 33-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 29-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Sep-2021, the patient experienced PRODUCT STORAGE ERROR (vaccine that had experienced a temperature excursion was given as 1st dose) and POOR QUALITY PRODUCT ADMINISTERED (poor quality product administered). At the time of the report, PRODUCT STORAGE ERROR (vaccine that had experienced a temperature excursion was given as 1st dose) and POOR QUALITY PRODUCT ADMINISTERED (poor quality product administered) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was provided. No treatment medication was provided. The refrigerator was cooled a little bit more than normal. Six vials stored in the refrigerator were exposed to temperatures below 36?F. Minimum temperature was 34.7?F. There were 145 incidents in total and each one lasted less than 15 minutes: 142 times fridge temperatures were between 35?F and 36?F; while three times temperatures were under 35?F, reaching 34.7?F (minimum). Five patients received doses from four of the 6 vials.

Other Meds:

Current Illness:

ID: 1790135
Sex: F
Age: 33
State: TN

Vax Date: 09/29/2021
Onset Date: 09/30/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Date: 20210930; Test Name: Body temperature; Result Unstructured Data: fever reached 103.9?F

Allergies:

Symptom List: Nausea

Symptoms: It's like never pain but also "extreme muscle pain that radiates up my neck and shoulder and down my arm/aches/aches; got me in tears; extreme arm pain in the left arm - "got me in tears; arm is sore now; fever/cannot keep the fever down and has reached 103.9?F; feel really sick; full blown flu; severe arm pain, non stop for hours; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (It's like never pain but also "extreme muscle pain that radiates up my neck and shoulder and down my arm/aches/aches), ILLNESS (feel really sick), INFLUENZA (full blown flu), PAIN IN EXTREMITY (severe arm pain, non stop for hours) and TEARFULNESS (got me in tears) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. no medical history was reported. On 29-Sep-2021 at 2:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Sep-2021, the patient experienced ILLNESS (feel really sick) and INFLUENZA (full blown flu). 30-Sep-2021, the patient experienced PAIN IN EXTREMITY (severe arm pain, non stop for hours) and PYREXIA (fever/cannot keep the fever down and has reached 103.9?F). On 01-Oct-2021, the patient experienced MYALGIA (arm is sore now). On an unknown date, the patient experienced PAIN (It's like never pain but also "extreme muscle pain that radiates up my neck and shoulder and down my arm/aches/aches), TEARFULNESS (got me in tears) and VACCINATION SITE PAIN (extreme arm pain in the left arm - "got me in tears). The patient was treated with IBUPROFEN for Adverse reaction, at a dose of 600 mg and PARACETAMOL (TYLENOL) for Adverse reaction, at an unspecified dose and frequency. At the time of the report, PAIN (It's like never pain but also "extreme muscle pain that radiates up my neck and shoulder and down my arm/aches/aches), INFLUENZA (full blown flu), TEARFULNESS (got me in tears), VACCINATION SITE PAIN (extreme arm pain in the left arm - "got me in tears) and MYALGIA (arm is sore now) outcome was unknown and ILLNESS (feel really sick), PAIN IN EXTREMITY (severe arm pain, non stop for hours) and PYREXIA (fever/cannot keep the fever down and has reached 103.9?F) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 30-Sep-2021, Body temperature: 103.9 (High) fever reached 103.9?F. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. no concomitant medication was provided This case was linked to MOD-2021-338403 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 01-Oct-2021: follow-Up received contains patient's city updated , new events added , new treatment medication added

Other Meds:

Current Illness:

ID: 1790136
Sex: F
Age:
State:

Vax Date: 08/13/2021
Onset Date:
Rec V Date: 10/16/2021
Hospital: Y

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

Lab Data: Test Name: COVID-19 Test; Test Result: Positive ; Result Unstructured Data: COVID-19 positive

Allergies:

Symptom List: Injection site pain

Symptoms: does not remember a thing; tested positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of MEMORY IMPAIRMENT (does not remember a thing) and COVID-19 (tested positive for COVID-19) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 13-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 MEMORY IMPAIRMENT (does not remember a thing) (seriousness criterion hospitalization) and COVID-19 (tested positive for COVID-19) (seriousness criterion hospitalization). At the time of the report, MEMORY IMPAIRMENT (does not remember a thing) and COVID-19 (tested positive for COVID-19) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) COVID-19 positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. NO Concomitant medication was reported NO treatment Drug was reported On 27Aug2021 the patient was in hospital until recently (about a month ) and tested positive for COVID-19 company comment: This case concerns a female patient of unknown age with no relevant medical history, who experienced the unexpected event of COVID-19 and Memory impairment. The events occurred after the first dose of Moderna Covid-19 vaccine. Hospitalization was on 27-AUG-2021 for a month and the patient tested positive for Covid-19. The events were considered related to the product per the reporter's assessment. The rechallenge was unknown since the events occurred only after the first dose. The benefit-risk relationship of Moderna Covid-19 vaccine in not affected by this report.; Sender's Comments: This case concerns a female patient of unknown age with no relevant medical history, who experienced the unexpected event of COVID-19 and Memory impairment. The events occurred after the first dose of Moderna Covid-19 vaccine. Hospitalization was on 27-AUG-2021 for a month and the patient tested positive for Covid-19. The events were considered related to the product per the reporter's assessment. The rechallenge was unknown since the events occurred only after the first dose. The benefit-risk relationship of Moderna Covid-19 vaccine in not affected by this report.

Other Meds:

Current Illness:

ID: 1790137
Sex: F
Age: 38
State: CA

Vax Date: 01/20/2021
Onset Date: 01/20/2021
Rec V Date: 10/16/2021
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: had a fever; Stayed in bed; Pregnancy; Inappropriate schedule of vaccine administered; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of PYREXIA (had a fever), BEDRIDDEN (Stayed in bed), INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Thyroid disorder. Concomitant products included METHYLPREDNISOLONE (MEDROL [METHYLPREDNISOLONE]) for Drug therapy. On 20-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. The patient's last menstrual period was on an unknown date and the estimated date of delivery was 19-Nov-2021. On 20-Jan-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered). On 28-Feb-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy). On an unknown date, the patient experienced PYREXIA (had a fever) and BEDRIDDEN (Stayed in bed). On 28-Feb-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Inappropriate schedule of vaccine administered) and MATERNAL EXPOSURE DURING PREGNANCY (Pregnancy) had resolved. At the time of the report, PYREXIA (had a fever) and BEDRIDDEN (Stayed in bed) outcome was unknown. Concomitant medication includes-Thyroid medication No treatment medication was provided This case of inappropriate schedule of vaccine administration and maternal exposure during pregnancy, first trimester, concerns a 38-year-old female patient with relevant medical history of thyroid disorder and concurrent use of methylprednisolone for fertility therapy, who experienced associated non serious expected events of bedridden and expected event of pyrexia. The events occurred after the second dose of Spikevax however, the exact time to onset and onset date were not provided. Rechallenge was not applicable since the events occurred after the second dose. Patient's thyroid disorder and concurrent use of methylprednisolone are possible confounders. The benefit-risk relationship of drug is not affected by this report; Sender's Comments: This case of inappropriate schedule of vaccine administration and maternal exposure during pregnancy, first trimester, concerns a 38-year-old female patient with relevant medical history of thyroid disorder and concurrent use of methylprednisolone for fertility therapy, who experienced associated non serious expected events of bedridden and expected event of pyrexia. The events occurred after the second dose of Spikevax however, the exact time to onset and onset date were not provided. Rechallenge was not applicable since the events occurred after the second dose. Patient's thyroid disorder and concurrent use of methylprednisolone are possible confounders. The benefit-risk relationship of drug is not affected by this report

Other Meds: MEDROL [METHYLPREDNISOLONE]

Current Illness: Thyroid disorder

ID: 1790138
Sex: F
Age: 32
State: AL

Vax Date: 03/29/2021
Onset Date: 09/04/2021
Rec V Date: 10/16/2021
Hospital: Y

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

Lab Data: Test Date: 2021; Test Name: CK; Result Unstructured Data: Isoenzymes, liver functions, lactate, and D-Dimer were normal; Test Date: 20210907; Test Name: CK; Result Unstructured Data: 55-60% abnormal; Test Date: 2021; Test Name: blood culture; Test Result: Negative ; Result Unstructured Data: Negative; Test Date: 2021; Test Name: igG; Test Result: Positive ; Result Unstructured Data: Positive; Test Date: 2021; Test Name: IgM; Test Result: Positive ; Result Unstructured Data: Positive; Test Date: 2021; Test Name: Blood pressure; Result Unstructured Data: abnormal; Test Date: 20210907; Test Name: Blood pressure; Result Unstructured Data: abnormal; Test Date: 20210908; Test Name: Blood pressure; Result Unstructured Data: abnormal (normally has about 130/80 blood pressures while on prednisone); Test Date: 20210904; Test Name: Body temperature; Result Unstructured Data: abnormal; Test Date: 20210908; Test Name: chest X-ray; Result Unstructured Data: normal; Test Date: 2021; Test Name: abdominal/pelvic CT scan; Result Unstructured Data: Normal; Test Date: 2021; Test Name: CRP; Result Unstructured Data: normal; Test Date: 2021; Test Name: urine culture; Test Result: Negative ; Result Unstructured Data: Negative; Test Date: 20210908; Test Name: ECG; Result Unstructured Data: normal; Test Date: 20210909; Test Name: ECG; Result Unstructured Data: showed mild left ventricle enlargement; Test Date: 20210909; Test Name: Ejection fraction; Result Unstructured Data: 50-60% abnormal; Test Date: 2021; Test Name: ECG; Result Unstructured Data: normal; Test Date: 2021; Test Name: CBC; Result Unstructured Data: normal; Test Date: 2021; Test Name: ESR; Result Unstructured Data: normal; Test Date: 2021; Test Name: SARs- Cov 2; Test Result: Negative ; Result Unstructured Data: Negative; Test Date: 2021; Test Name: Ferritin; Result Unstructured Data: normal; Test Date: 20210909; Test Name: troponin T; Result Unstructured Data: ng at 2:23; Test Date: 20210909; Test Name: Troponin T; Result Unstructured Data: (ng/L) In morning; Test Date: 20210909; Test Name: Troponin T; Result Unstructured Data: In afternoon; Test Date: 20210909; Test Name: Troponin T; Result Unstructured Data: ng at 15:21; Test Date: 20210909; Test Name: Troponin T; Result Unstructured Data: ng at 18:10; Test Date: 2021; Test Name: White blood cells in urine; Result Unstructured Data: 36 WBC/hpf

Allergies:

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

Symptoms: Ventricle enlargement; Hypotension; MIS-A; Nauseous; Near syncope; Substernal chest pain; Sweating/diaphoretic; Very pale; Felt very bad; Scarletina rash; Her face and ears became very red; Tiny bullae; Face and ears becomes edematous; Fever; Throat then had a red spotty appearance; Sharp abdominal pain; This spontaneous case was reported by a physician and describes the occurrence of RASH SCARLATINIFORM (Scarletina rash), PRESYNCOPE (Near syncope), CHEST PAIN (Substernal chest pain), PYREXIA (Fever), HYPERHIDROSIS (Sweating/diaphoretic), ERYTHEMA (Her face and ears became very red), BLISTER (Tiny bullae), PALLOR (Very pale), FEELING ABNORMAL (Felt very bad), VENTRICULAR ENLARGEMENT (Ventricle enlargement), HYPOTENSION (Hypotension), MULTISYSTEM INFLAMMATORY SYNDROME IN CHILDREN (MIS-A), NAUSEA (Nauseous) and EAR SWELLING (Face and ears becomes edematous) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A, 019B21A and 019B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Splenomegaly. Concomitant products included PREDNISONE for Myasthenia gravis. On 29-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Sep-2021, the patient experienced PYREXIA (Fever) (seriousness criterion hospitalization) and ABDOMINAL PAIN (Sharp abdominal pain). On 06-Sep-2021, the patient experienced RASH SCARLATINIFORM (Scarletina rash) (seriousness criterion hospitalization), ERYTHEMA (Her face and ears became very red) (seriousness criterion hospitalization), BLISTER (Tiny bullae) (seriousness criterion hospitalization), EAR SWELLING (Face and ears becomes edematous) (seriousness criterion hospitalization) and PHARYNGEAL ERYTHEMA (Throat then had a red spotty appearance). On 08-Sep-2021, the patient experienced PRESYNCOPE (Near syncope) (seriousness criteria hospitalization and medically significant), CHEST PAIN (Substernal chest pain) (seriousness criterion hospitalization), HYPERHIDROSIS (Sweating/diaphoretic) (seriousness criterion hospitalization), PALLOR (Very pale) (seriousness criterion hospitalization), FEELING ABNORMAL (Felt very bad) (seriousness criterion hospitalization) and NAUSEA (Nauseous) (seriousness criterion hospitalization). On an unknown date, the patient experienced VENTRICULAR ENLARGEMENT (Ventricle enlargement) (seriousness criterion hospitalization), HYPOTENSION (Hypotension) (seriousness criterion hospitalization) and MULTISYSTEM INFLAMMATORY SYNDROME IN CHILDREN (MIS-A) (seriousness criterion hospitalization). The patient was treated with ONDANSETRON ongoing since an unknown date at an unspecified dose and frequency. On 04-Sep-2021, ABDOMINAL PAIN (Sharp abdominal pain) had resolved. On 07-Sep-2021, PHARYNGEAL ERYTHEMA (Throat then had a red spotty appearance) had resolved. At the time of the report, RASH SCARLATINIFORM (Scarletina rash), PYREXIA (Fever) and HYPERHIDROSIS (Sweating/diaphoretic) had resolved, PRESYNCOPE (Near syncope), ERYTHEMA (Her face and ears became very red), BLISTER (Tiny bullae), PALLOR (Very pale), FEELING ABNORMAL (Felt very bad), VENTRICULAR ENLARGEMENT (Ventricle enlargement), HYPOTENSION (Hypotension), MULTISYSTEM INFLAMMATORY SYNDROME IN CHILDREN (MIS-A), NAUSEA (Nauseous) and EAR SWELLING (Face and ears becomes edematous) outcome was unknown and CHEST PAIN (Substernal chest pain) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Blood creatine phosphokinase: normal (normal) Isoenzymes, liver functions, lactate, and D-Dimer were normal. In 2021, Blood culture: negative (Negative) Negative. In 2021, Blood immunoglobulin G: postive (Positive) Positive. In 2021, Blood immunoglobulin M: positive (Positive) Positive. In 2021, Blood pressure measurement: 108/66 (abnormal) abnormal. In 2021, C-reactive protein: 2.1 (normal) normal. In 2021, Computerised tomogram: normal (normal) Normal. In 2021, Culture urine: negative (Negative) Negative. In 2021, Electrocardiogram: normal (normal) normal. In 2021, Full blood count: normal (normal) normal. In 2021, Red blood cell sedimentation rate normal: 28 (normal) normal. In 2021, SARS-CoV-2 test: negative (Negative) Negative. In 2021, Serum ferritin: 155 (normal) normal. In 2021, White blood cells urine: abnormal (abnormal) 36 WBC/hpf. On 04-Sep-2021, Body temperature: 39.5 (abnormal) abnormal. On 07-Sep-2021, Blood creatine phosphokinase: 55-60 (abnormal) 55-60% abnormal. On 07-Sep-2021, Blood pressure measurement: 149/92 (abnormal) abnormal. On 08-Sep-2021, Blood pressure measurement: 94/74 (abnormal) abnormal (normally has about 130/80 blood pressures while on prednisone). On 08-Sep-2021, Chest X-ray: normal (normal) normal. On 08-Sep-2021, Echocardiogram: normal (normal) normal. On 09-Sep-2021, Echocardiogram: abnormal (abnormal) showed mild left ventricle enlargement. On 09-Sep-2021, Ejection fraction: 50-60 (abnormal) 50-60% abnormal. On 09-Sep-2021, Troponin T: 52 (normal) ng at 2:23, 57 (normal) (ng/L) In morning, 64 (normal) In afternoon, 66 (normal) ng at 15:21 and 53 (normal) ng at 18:10. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment medication includes IV fluids. EBV serology was negative for IgM, and positive for IgG VCA and NA. A large nasopharyngeal molecular panel for respiratory pathogens was negative, as were serologies for B. burgdorferi, Babesia, Ehrlichia, and Anaplasma. The rash started improving and the fever and diaphoresis resolved over the next 12 hours after hospital admission. An infectious etiology was suspected, but the patient had been largely sheltered from potential sources of infection. Per reporter the current case meets diagnostic criteria for MIS-A (fever for 4 days, scarletina rash, elevated inflammatory markers, abdominal pain, chest pain with hypotension, diaphoresis, and elevated troponin T) other than not having evidence of COVID-19. Company comment: This case concerns a 33-year-old, female patient with relevant medical history of myasthenia gravis, who experienced the unexpected events of rash This case concerns a 33-year-old, female patient with relevant medical history of myasthenia gravis, who experienced the unexpected events of rash scarlatiniform, blister, presyncope, pallor, feeling abormal, chest pain, pyrexia, abdominal pain, hyperhydrosis, erythema, swelling face, ear swelling, pharyngeal erythema, ventricular enlargement, hypotension, nausea and multisystem inflammatory syndrome in adults. The events occurred approximately 11 to 15 days after the third dose of Moderna COVID-19 Vaccine. The patient first experienced abdominal pain and pyrexia followed by nausea on the next day and occurrence of scarlatiniform rash, erythema, blister, sweeling face and ears and pharyngeal erythema. The patient also experienced substernal chest pain and was taken to ER. The patient had elevated troponine and left ventricle enlargement. Infectious workup was negative. The reported stated that the patient met criteria for Multisystem Inflammatory Syndrome in adults. The rechallenge was not applicable as events occurred after third dose and no further dosing was reported or planned, based on information provided. The medical history of myastenia gravis and use of prednisone remain a confounder. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report. This case was linked to MOD-2021-343729 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 05-Oct-2021: Follow-up received on 05-OCT-2021 with Event, Lab. data, Patient details, Concomitant and treatment medication updated.; Sender's Comments: This case concerns a 33-year-old, female patient with relevant medical

Other Meds: PREDNISONE

Current Illness:

ID: 1790139
Sex: U
Age:
State: NY

Vax Date: 07/01/2021
Onset Date: 07/01/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: 31 Patients were administered a dose after the 30 day beyond use date.; 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 (31 Patients were administered a dose after the 30 day beyond use date.) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination. No Medical History information was reported. In July 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (31 Patients were administered a dose after the 30 day beyond use date.). In July 2021, EXPIRED PRODUCT ADMINISTERED (31 Patients were administered a dose after the 30 day beyond use date.) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported. No treatment medications were reported. Dose Count is 31 Refrigeration Date is 5/21/2021 Vaccination Dates 2021 , 01-July and 02-july. Refrigerated Storage Temperature 35?F to 38?F, It was reported that Moderna cannot guarantee patients received full protection against the COVID-19 Virus. This case was linked to MOD-2021-323906 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 05-Oct-2021: Dose details were captured On 06-Oct-2021: Follow-up received on 06-OCT-2021 contains no newsignificant information found.

Other Meds:

Current Illness:

ID: 1790140
Sex: F
Age: 69
State: VA

Vax Date: 09/29/2021
Onset Date: 09/29/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Name: blood pressure; Result Unstructured Data: blood pressure and was up 190/100 and it stayed that way for a good twelve hours; Test Date: 20210929; Test Name: blood pressure; Result Unstructured Data: 190/110 mmHg at 5:30; Test Date: 20210929; Test Name: blood pressure; Result Unstructured Data: 178/98 at 9:00 pm; Test Date: 20210930; Test Name: blood pressure; Result Unstructured Data: at 9 am; Test Date: 20210930; Test Name: blood pressure; Result Unstructured Data: at 11:00; Test Name: Systolic blood pressure; Result Unstructured Data: less than 90 mmHg; Test Date: 20210929; Test Name: Body temperature; Result Unstructured Data: at 5:30 (degree F); Test Date: 20210930; Test Name: Body temperature; Result Unstructured Data: at 9 am; Test Date: 20210930; Test Name: Body temperature; Result Unstructured Data: at 11:00; Test Date: 20210929; Test Name: Heart rate; Result Unstructured Data: at 5:30 (beats per minute); Test Date: 20210929; Test Name: Heart rate; Result Unstructured Data: at 9:00 pm; Test Date: 20210930; Test Name: Heart rate; Result Unstructured Data: at 9 am; Test Date: 20210930; Test Name: Heart rate; Result Unstructured Data: at 11:00

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: Did not sleep all night; Thought I was going to die; Had trouble breathing and was not able to walk very far because of shortness of breath; Heart rate increased; Blood pressure was very high; whole body turned red/From then on the face was red/cheeks were fiery red; I was like on fire, I couldn't cool it down; You could feel the heat in the body/I just kept drinking, I was too hot; Nausea; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Did not sleep all night), FEELING ABNORMAL (Thought I was going to die), DYSPNOEA (Had trouble breathing and was not able to walk very far because of shortness of breath), HEART RATE INCREASED (Heart rate increased) and BLOOD PRESSURE INCREASED (Blood pressure was very high) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Hypersensitivity NOS (history of hypersensitivity reactions). On 29-Sep-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Sep-2021, the patient experienced DYSPNOEA (Had trouble breathing and was not able to walk very far because of shortness of breath), HEART RATE INCREASED (Heart rate increased), BLOOD PRESSURE INCREASED (Blood pressure was very high), ERYTHEMA (whole body turned red/From then on the face was red/cheeks were fiery red), BURNING SENSATION (I was like on fire, I couldn't cool it down), FEELING HOT (You could feel the heat in the body/I just kept drinking, I was too hot) and NAUSEA (Nausea). On an unknown date, the patient experienced INSOMNIA (Did not sleep all night) and FEELING ABNORMAL (Thought I was going to die). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) from 29-Sep-2021 to 01-Oct-2021 at a dose of 2 tablets 50 mg. On 01-Oct-2021, BURNING SENSATION (I was like on fire, I couldn't cool it down) and FEELING HOT (You could feel the heat in the body/I just kept drinking, I was too hot) had resolved. At the time of the report, INSOMNIA (Did not sleep all night), FEELING ABNORMAL (Thought I was going to die), DYSPNOEA (Had trouble breathing and was not able to walk very far because of shortness of breath), HEART RATE INCREASED (Heart rate increased) and NAUSEA (Nausea) outcome was unknown and BLOOD PRESSURE INCREASED (Blood pressure was very high) and ERYTHEMA (whole body turned red/From then on the face was red/cheeks were fiery red) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Sep-2021, Blood pressure measurement: 190/110 (High) 190/110 mmHg at 5:30 and 178/98 (High) 178/98 at 9:00 pm. On 29-Sep-2021, Body temperature: 98.8 (normal) at 5:30 (degree F). On 29-Sep-2021, Heart rate: 120 (High) at 5:30 (beats per minute) and 100 (High) at 9:00 pm. On 30-Sep-2021, Blood pressure measurement: 169/98 (High) at 9 am and 117/74 (normal) at 11:00. On 30-Sep-2021, Body temperature: 97.6 (normal) at 9 am and 98.2 (normal) at 11:00. On 30-Sep-2021, Heart rate: 98 (High) at 9 am and 82 (normal) at 11:00. On an unknown date, Blood pressure measurement: 190/100 (High) blood pressure and was up 190/100 and it stayed that way for a good twelve hours. On an unknown date, Blood pressure systolic: abnormal (abnormal) less than 90 mmHg. 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. The patient did not take any treatment medications. She only drank water. Reaction start date was reported as 29-Sep-2021 at 5:00 pm (reactions not specified). Most recent FOLLOW-UP information incorporated above includes: On 07-Oct-2021: Non significant follow up appended. On 09-Oct-2021: Added medical history, lab data(body temperature, heart rate, blood pressure systolic and additional data on blood pressure); events were added (dyspnoea, heart rate increased, blood pressure increased, nausea).

Other Meds:

Current Illness:

ID: 1790141
Sex: F
Age: 67
State: FL

Vax Date: 05/01/2021
Onset Date:
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Experiencing like something in her throat / like a sore throat; inflammation on her throat; she had normal reaction; Allergic reaction; is in a lot of pain; rash in her throat; body aches; fever; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Experiencing like something in her throat / like a sore throat), INFLAMMATION (inflammation on her throat), VACCINATION COMPLICATION (she had normal reaction), ALLERGY TO VACCINE (Allergic reaction) and PAIN (is in a lot of pain) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. In May 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 OROPHARYNGEAL PAIN (Experiencing like something in her throat / like a sore throat), INFLAMMATION (inflammation on her throat), VACCINATION COMPLICATION (she had normal reaction), ALLERGY TO VACCINE (Allergic reaction), PAIN (is in a lot of pain), RASH (rash in her throat), MYALGIA (body aches) and PYREXIA (fever). At the time of the report, OROPHARYNGEAL PAIN (Experiencing like something in her throat / like a sore throat), INFLAMMATION (inflammation on her throat) and ALLERGY TO VACCINE (Allergic reaction) outcome was unknown, VACCINATION COMPLICATION (she had normal reaction), MYALGIA (body aches) and PYREXIA (fever) had resolved and PAIN (is in a lot of pain) and RASH (rash in her throat) had not resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. Patient was treated with antibiotics and steroids. This case was linked to MOD-2021-339220 (Patient Link).

Other Meds:

Current Illness:

ID: 1790142
Sex: F
Age: 90
State: CA

Vax Date: 02/04/2021
Onset Date: 03/06/2021
Rec V Date: 10/16/2021
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: My arm was sore at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (My arm was sore at the injection site) in a 90-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 020A21A and 013M20A) for COVID-19 vaccination. No Medical History information was reported. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (My arm was sore at the injection site). At the time of the report, VACCINATION SITE PAIN (My arm was sore at the injection site) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported by reporter. No treatment medication was reported by reporter. Most recent FOLLOW-UP information incorporated above includes: On 06-Oct-2021: Translation received on 06-oct-2021 Event outcome updated.

Other Meds:

Current Illness:

ID: 1790143
Sex: F
Age:
State: MI

Vax Date: 04/13/2021
Onset Date: 06/06/2021
Rec V Date: 10/16/2021
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: I started developing hives on my forearms.; the swelling came back full force; redness on swollen skin areas; progressing inflammation everyday different; swollen lips; muscle under my thumb, palm side swollen; hands swollen/ forearms swollen, swelling on finger tips, feet; itching on the swollen skin; Throat swelling; further swelling on face; swollen eye lids at night; welts on both forearms; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (redness on swollen skin areas), INFLAMMATION (progressing inflammation everyday different), LIP SWELLING (swollen lips), MUSCLE SWELLING (muscle under my thumb, palm side swollen) and PERIPHERAL SWELLING (hands swollen/ forearms swollen, swelling on finger tips, feet) in a 41-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A and 040B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Allergy to chemicals (Shampoo: Burning of the scalp/ear Polycrylic : swelling around the eyes/face), Blood pressure high and Anxiety. Concomitant products included SERTRALINE HCL for Anxiety, BISOPROLOL for Blood pressure. On 13-Apr-2021 at 6:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-May-2021 at 6:00 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jun-2021, the patient experienced ERYTHEMA (redness on swollen skin areas), MUSCLE SWELLING (muscle under my thumb, palm side swollen), PRURITUS (itching on the swollen skin), PHARYNGEAL SWELLING (Throat swelling) and SWELLING OF EYELID (swollen eye lids at night). 06-Jun-2021, the patient experienced INFLAMMATION (progressing inflammation everyday different), LIP SWELLING (swollen lips), PERIPHERAL SWELLING (hands swollen/ forearms swollen, swelling on finger tips, feet) and SWELLING FACE (further swelling on face). 06-Jun-2021, the patient experienced URTICARIA (welts on both forearms). On 01-Oct-2021, the patient experienced SWELLING (the swelling came back full force). On an unknown date, the patient experienced URTICARIA (I started developing hives on my forearms.). The patient was treated with PREDNISONE ACETATE (PREDNISONE [PREDNISONE ACETATE]) from 14-Sep-2021 to 28-Sep-2021 at a dose of 10/50 mg,Daily for two weeks until weaned off; LORATADINE (CLARITIN [LORATADINE]) from 05-Aug-2021 to 01-Sep-2021 at a dose of daily for few weeks; CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) from 05-Aug-2021 to 01-Sep-2021 at a dose of Daily for weeks and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) from 05-Aug-2021 to 01-Sep-2021 at a dose of Daily for few weeks. At the time of the report, ERYTHEMA (redness on swollen skin areas), INFLAMMATION (progressing inflammation everyday different), LIP SWELLING (swollen lips), MUSCLE SWELLING (muscle under my thumb, palm side swollen), PERIPHERAL SWELLING (hands swollen/ forearms swollen, swelling on finger tips, feet), PRURITUS (itching on the swollen skin), PHARYNGEAL SWELLING (Throat swelling), SWELLING FACE (further swelling on face), SWELLING OF EYELID (swollen eye lids at night), URTICARIA (welts on both forearms), URTICARIA (I started developing hives on my forearms.) and SWELLING (the swelling came back full force) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient reported that Labwork was done but unsure of what testing was done, One test shows inflammation within patient's body, unsure of name of test. Treatment medication included Benadryl. Type of facility was Fairgrounds Most recent FOLLOW-UP information incorporated above includes: On 05-Oct-2021: Significant follow up received. Updated patient's demographics, patients relevant history. Added concomitant and treatment medications. Updated 1st dose details and added new events.

Other Meds: BISOPROLOL; SERTRALINE HCL

Current Illness: Allergy to chemicals (Shampoo: Burning of the scalp/ear Polycrylic : swelling around the eyes/face); Anxiety; Blood pressure high

ID: 1790144
Sex: M
Age: 84
State: NY

Vax Date: 02/11/2021
Onset Date: 03/11/2021
Rec V Date: 10/16/2021
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: sore injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore injection site arm) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012A21A and 010M20A) for COVID-19 vaccination. No Medical History information was reported. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 11-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PAIN (sore injection site arm). At the time of the report, VACCINATION SITE PAIN (sore injection site arm) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant drug details were reported. No treatment details were reported. This case was linked to MOD-2021-339291 (Patient Link).

Other Meds:

Current Illness:

ID: 1790145
Sex: F
Age: 70
State:

Vax Date: 01/14/2021
Onset Date: 10/02/2021
Rec V Date: 10/16/2021
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: Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019F21A, M012M20A and M-13L20A) for COVID-19 vaccination. No medical history was provided by the reporter. Previously administered products included for an unreported indication: FLU on 08-Feb-2021. Concomitant products included ATORVASTATIN for Cholesterol, METFORMIN for Diabetes, LISINOPRIL for Hypertension, MULTIVITAMINS [VITAMINS NOS] for Supplementation therapy, AMLODIPINE from 23-Aug-2021 to an unknown date for an unknown indication. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Oct-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness). At the time of the report, PAIN IN EXTREMITY (Arm soreness) outcome was unknown. No treatment medications were not provided. Most recent FOLLOW-UP information incorporated above includes: On 05-Oct-2021: Significant Follow-Up received on 5-Oct-2021.Updated concomitant medication, event start date and stop date, Updated event ADR term to Pain in Arm.

Other Meds: METFORMIN; LISINOPRIL; ATORVASTATIN; MULTIVITAMINS [VITAMINS NOS]; AMLODIPINE

Current Illness:

ID: 1790146
Sex: F
Age:
State: MN

Vax Date:
Onset Date: 08/21/2021
Rec V Date: 10/16/2021
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: Vaccine exposure during breastfeeding; Tingling in hands and feet after first shot/ Pins and needles in hands and feet after first shot; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling in hands and feet after first shot/ Pins and needles in hands and feet after first shot) and MATERNAL EXPOSURE DURING BREAST FEEDING (Vaccine exposure during breastfeeding) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Breast feeding and Gestational diabetes. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Aug-2021, the patient experienced PARAESTHESIA (Tingling in hands and feet after first shot/ Pins and needles in hands and feet after first shot). On an unknown date, the patient experienced MATERNAL EXPOSURE DURING BREAST FEEDING (Vaccine exposure during breastfeeding). On 28-Aug-2021, PARAESTHESIA (Tingling in hands and feet after first shot/ Pins and needles in hands and feet after first shot) had resolved. At the time of the report, MATERNAL EXPOSURE DURING BREAST FEEDING (Vaccine exposure during breastfeeding) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant and treatment medication were provided. Patient received the second dose at around 21-AUG-2021. Company Comment: This is a case of Maternal Exposure during breastfeeding for this 24-year-old female patient with no relevant medical history who experienced the non serious unexpected event of Paraesthesia. This event occurred after the first dose of Moderna COVID-19 Vaccine and was described as tingling in hands and feet and sensation of pins and needles in hands and feet. The exact start date was not provided, however it was reported that the event lasted for one week. Rechallenge is considered negative as the it was reported that the patient received the second vaccination, however, this event did not reoccur. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report. Patient will continue to be contacted for further monitoring. This case was linked to MOD-2021-339358 (Patient Link).; Sender's Comments: This is a case of Maternal Exposure during breastfeeding for this 24-year-old female patient with no relevant medical history who experienced the non serious unexpected event of Paraesthesia. This event occurred after the first dose of Moderna COVID-19 Vaccine and was described as tingling in hands and feet and sensation of pins and needles in hands and feet. The exact start date was not provided, however it was reported that the event lasted for one week. Rechallenge is considered negative as the it was reported that the patient received the second vaccination, however, this event did not reoccur. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report. Patient will continue to be contacted for further monitoring.

Other Meds:

Current Illness: Breast feeding; Gestational diabetes

ID: 1790147
Sex: M
Age: 34
State: TN

Vax Date: 05/06/2021
Onset Date:
Rec V Date: 10/16/2021
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: felt a little bit like "fluish"; stronger reaction; slight fever; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (felt a little bit like "fluish"), VACCINATION COMPLICATION (stronger reaction) and PYREXIA (slight fever) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. No Medical History information was reported. On 06-May-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 INFLUENZA LIKE ILLNESS (felt a little bit like "fluish"), VACCINATION COMPLICATION (stronger reaction) and PYREXIA (slight fever). At the time of the report, INFLUENZA LIKE ILLNESS (felt a little bit like "fluish") and PYREXIA (slight fever) outcome was unknown and VACCINATION COMPLICATION (stronger reaction) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant information was reported. No treatment information was reported. This case was linked to MOD-2021-339322 (Patient Link).

Other Meds:

Current Illness:

ID: 1790148
Sex: M
Age: 64
State: IN

Vax Date: 02/26/2021
Onset Date: 02/26/2021
Rec V Date: 10/16/2021
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: The pain is only on the left side the same side as covid shot.; STIFF NECK; injection site soreness that lasted for 2 days; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (STIFF NECK), PAIN (The pain is only on the left side the same side as covid shot.) and VACCINATION SITE PAIN (injection site soreness that lasted for 2 days) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 044A21A) for COVID-19 vaccination. Concurrent medical conditions included Hypertension and Diabetes. Concomitant products included APIXABAN (ELIQUIS) from 01-Jan-1998 to an unknown date for Anticoagulant therapy, SIMVASTATIN for Cholesterol, METFORMIN from 01-Jan-1998 to an unknown date for Diabetes, METOPROLOL from 01-Jan-1998 to an unknown date for Hypertension, LISINOPRIL from 1998 to an unknown date for Stroke, ACETYLSALICYLIC ACID (ASPIRIN 81) from 01-Jan-1998 to an unknown date for an unknown indication. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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. On 26-Feb-2021, the patient experienced VACCINATION SITE PAIN (injection site soreness that lasted for 2 days). On 28-Feb-2021 at 9:00 AM, the patient experienced MUSCULOSKELETAL STIFFNESS (STIFF NECK). On an unknown date, the patient experienced PAIN (The pain is only on the left side the same side as covid shot.). On 28-Feb-2021, VACCINATION SITE PAIN (injection site soreness that lasted for 2 days) had resolved. At the time of the report, MUSCULOSKELETAL STIFFNESS (STIFF NECK) had not resolved and PAIN (The pain is only on the left side the same side as covid shot.) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications included Vitafusion men's multi vitamins, Equate low dose aspirin 81mg No treatment medications were reported. patient consulted his family doctor about Stiff neck and pain at his regular appointment in June. Patient said it would probably go away in about 3 months. Most recent FOLLOW-UP information incorporated above includes: On 05-Oct-2021: Follow up received contains Reporter Information, , Patient Demographic details, Vaccine Facility Information, Concomitant medication and event information updated

Other Meds: METOPROLOL; METFORMIN; SIMVASTATIN; LISINOPRIL; ELIQUIS; ASPIRIN 81

Current Illness: Diabetes; Hypertension

ID: 1790149
Sex: F
Age: 40
State: AL

Vax Date: 10/02/2021
Onset Date: 10/02/2021
Rec V Date: 10/16/2021
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: administration of an expired dose; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of an expired dose) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048F21A) for COVID-19 vaccination. No Medical History information was reported. On 02-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of an expired dose). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administration of an expired dose) 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 information was provided This case was linked to MOD-2021-339498 (Patient Link).

Other Meds:

Current Illness:

ID: 1790150
Sex: M
Age: 70
State: FL

Vax Date: 01/14/2021
Onset Date: 10/02/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Date: 20211002; Test Name: Body temperature; Result Unstructured Data: 98.8 F

Allergies:

Symptom List: Vomiting

Symptoms: large lump in his armpit with a size of a golf ball; light headache; slight fever 98.8F; feeling tired; bad migraine; This spontaneous case was reported by a consumer and describes the occurrence of AXILLARY MASS (large lump in his armpit with a size of a golf ball), MIGRAINE (bad migraine), HEADACHE (light headache), PYREXIA (slight fever 98.8F) and FATIGUE (feeling tired) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019F21A, M012M20A and M-13L20A) for COVID-19 vaccination. Concurrent medical conditions included Hypertension and Drug allergy (Niscon allergy.). Concomitant products included LISINOPRIL and AMLODIPINE for Hypertension, MULTIVITAMINS [VITAMINS NOS] for Vitamin supplementation, FINASTERIDE and FENOFIBRATE for an unknown indication. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Oct-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Oct-2021, the patient experienced MIGRAINE (bad migraine), PYREXIA (slight fever 98.8F) and FATIGUE (feeling tired). On 03-Oct-2021, the patient experienced AXILLARY MASS (large lump in his armpit with a size of a golf ball) and HEADACHE (light headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at an unspecified dose and frequency and IBUPROFEN for Headache, at an unspecified dose and frequency. On 03-Oct-2021, MIGRAINE (bad migraine), PYREXIA (slight fever 98.8F) and FATIGUE (feeling tired) had resolved. At the time of the report, AXILLARY MASS (large lump in his armpit with a size of a golf ball) and HEADACHE (light headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Oct-2021, Body temperature: 98.8 f (High) 98.8 F. Indication for use of concomitant medication Finasteride was Prostate and for Fenofibrate was Cholesterol. Patient's historical vaccine includes Flu shot on 05AUG2021. Most recent FOLLOW-UP information incorporated above includes: On 05-Oct-2021: Follow-up received contains additional race, allergies and medical history and concomitant therapy dates information.

Other Meds: FINASTERIDE; FENOFIBRATE; LISINOPRIL; AMLODIPINE; MULTIVITAMINS [VITAMINS NOS]

Current Illness: Drug allergy (Niscon allergy.); Hypertension

ID: 1790151
Sex: U
Age:
State: AL

Vax Date: 10/02/2021
Onset Date: 10/02/2021
Rec V Date: 10/16/2021
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: Administered expired vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 02-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine). On 02-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Administered expired vaccine) 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.

Other Meds:

Current Illness:

ID: 1790152
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
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: Headache; Does not have any energy; Lot of pain; No appetite; Depressed; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), ASTHENIA (Does not have any energy), PAIN (Lot of pain), DECREASED APPETITE (No appetite) and DEPRESSED MOOD (Depressed) in a 65-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 second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache), ASTHENIA (Does not have any energy), PAIN (Lot of pain), DECREASED APPETITE (No appetite) and DEPRESSED MOOD (Depressed). The patient was treated with OXYCODONE for Pain, at a dose of 5 milligram. At the time of the report, HEADACHE (Headache), ASTHENIA (Does not have any energy), PAIN (Lot of pain), DECREASED APPETITE (No appetite) and DEPRESSED MOOD (Depressed) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Taking extra vitamins and an energy pack which didn't help Consumer advised she is on Oxycodone 5 mg 1 tab twice daily, but the vaccine intensified pain which is constant- 24/7. This case was linked to MOD-2021-328765 (Patient Link).

Other Meds:

Current Illness:

ID: 1790153
Sex: U
Age:
State: GA

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
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: 19 pulmonary embolisms; 20 cardiac arrests; 36 strokes; 15 DVTs; 10 heart attacks; 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 PULMONARY EMBOLISM, CARDIAC ARREST, CEREBROVASCULAR ACCIDENT, DEEP VEIN THROMBOSIS, and MYOCARDIAL INFARCTION 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 PULMONARY EMBOLISM (seriousness criterion medically significant), CARDIAC ARREST (seriousness criterion medically significant), CEREBROVASCULAR ACCIDENT (seriousness criterion medically significant), DEEP VEIN THROMBOSIS (seriousness criterion medically significant) and MYOCARDIAL INFARCTION (seriousness criterion medically significant). At the time of the report, PULMONARY EMBOLISM, CARDIAC ARREST, CEREBROVASCULAR ACCIDENT, DEEP VEIN THROMBOSIS, and MYOCARDIAL INFARCTION outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown. No relevant concomitant medications were reported. No treatment information was provided. The reporter reported that, she read that for some people, the vaccine did something to the inner core of the body, but her doctor had mentioned it was hard to prove. This case concerns a patient of unknown age and gender with no relevant medical history, who experienced the unexpected events of pulmonary embolism, cardiac arrest, cerebrovascular accident, deep vein thrombosis, and myocardial infarction. The events occurred on an unknown date after a dose of the Moderna COVID-19 vaccine. The rechallenge was unknown. The benefit-risk relationship of the Moderna COVID-19 vaccine is not affected by this report. This case was linked to US-MODERNATX, INC.-MOD-2021-339496 (E2B Linked Report). US-MODERNATX, INC.-MOD-2021-339496.

Other Meds:

Current Illness:

ID: 1790154
Sex: F
Age: 73
State: FL

Vax Date: 01/08/2021
Onset Date: 02/05/2021
Rec V Date: 10/16/2021
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: Nausea; shakes; chills; joint ache; This spontaneous case was reported by a consumer and describes the occurrence of TREMOR (shakes), CHILLS (chills), ARTHRALGIA (joint ache) and NAUSEA (Nausea) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010M20A, 012L20A and 939906) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included L-THYROXINE [LEVOTHYROXINE] and ALENDRONATE SODIUM (ALENDRONATE) 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) (unknown route) dosage was changed to 2 dosage form. On 16-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 05-Feb-2021 at 8:00 PM, the patient experienced TREMOR (shakes), CHILLS (chills) and ARTHRALGIA (joint ache). On 16-Sep-2021, the patient experienced NAUSEA (Nausea). On 08-Feb-2021, TREMOR (shakes), CHILLS (chills) and ARTHRALGIA (joint ache) had resolved. On 17-Sep-2021, NAUSEA (Nausea) had resolved. No treatment medications reported. Patient took Shingles vaccine in 8/20 and experienced same events. This case involves a 73-year-old female subject with unknown medical history who experienced the unlisted non-serious adverse event of tremor and the listed non-serious adverse events of chills, arthralgia and nausea over her three vaccination doses. No re-challenge information was provided or is applicable. The benefit-risk relationship of mRNA-1273 is not affected by this report. This case was linked to MOD-2021-339520, MOD-2021-322828 (Patient Link).; Sender's Comments: This case involves a 73-year-old female subject with unknown medical history who experienced the unlisted non-serious adverse event of tremor and the listed non-serious adverse events of chills, arthralgia and nausea over her three vaccination doses. No re-challenge information was provided or is applicable. The benefit-risk relationship of mRNA-1273 is not affected by this report.

Other Meds: L-THYROXINE [LEVOTHYROXINE]; ALENDRONATE

Current Illness:

ID: 1790155
Sex: U
Age:
State:

Vax Date: 03/01/2021
Onset Date: 03/01/2021
Rec V Date: 10/16/2021
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: This spontaneous case reported by a consumer, describes the occurrence of restlessness, feeling abnormal and pain in extremity (arm pain) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. In March 2021, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. In March 2021, patient experienced restlessness, feeling abnormal and pain in extremity (arm pain). At the time of the report, restlessness, feeling abnormal and pain in extremity (arm pain): resolved. Concomitant medication not reported. In the morning, of getting the first vaccine, patient did a prep: Sun gazing, gallons of water and an overdose of Vitamin D. On the evening of first dose, when the patient got back to home, he was so restless. He worked-out and felt like was a "mac truck driver on whites." By 9, patient took a shot of whiskey and needed to go to bed. The next day; no problems, no arm pain. No treatment information provided. This case linked to MOD-2021-339561 (patient link). Most recent follow-up information incorporated: On Oct 5, 2021: Follow-up information included no new information.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am