VAERS 2021 Database www.vaers.hhs.gov

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

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

COVID19 Lot Number

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

Incidents per State

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

ID: 1706852
Sex: M
Age:
State: AR

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: More than 35 days passed since the first dose and the patient did not receive the second dose; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (More than 35 days passed since the first dose and the patient did not receive the second dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. 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 PRODUCT DOSE OMISSION ISSUE (More than 35 days passed since the first dose and the patient did not receive the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (More than 35 days passed since the first dose and the patient did not receive the second 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 medications were reported.

Other Meds:

Current Illness:

ID: 1706853
Sex: M
Age: 72
State: CT

Vax Date: 03/03/2021
Onset Date:
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: Fell down; This spontaneous case was reported by a consumer and describes the occurrence of FALL (Fell down) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Prostate cancer. On 03-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced FALL (Fell down). At the time of the report, FALL (Fell down) outcome was unknown. No relevant concomitant medications were reported. Treatment information was unknown.

Other Meds:

Current Illness: Prostate cancer

ID: 1706854
Sex: M
Age:
State: LA

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: slept all the time; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (slept all the time) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Parkinson's disease. 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 SOMNOLENCE (slept all the time). At the time of the report, SOMNOLENCE (slept all the time) outcome was unknown. No relevant concomitant medications were reported. No treatment information was provided. This case was linked to MOD-2021-304900 (Patient Link).

Other Meds:

Current Illness: Parkinson's disease

ID: 1706855
Sex: F
Age: 43
State: GA

Vax Date: 07/21/2021
Onset Date:
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: Pain all over her body; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Pain all over her body) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination. The patient's past medical history included Knee injury (15 years ago). On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN (Pain all over her body). At the time of the report, PAIN (Pain all over her body) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant information was not reported. Treatment information was not reported. Patient stated that she injured her right kneel 15 years ago but now both of her knees ache really bad. Patient used Tylenol to alleviate the pain, but the relief is not long lasting. patient plans to see her healthcare provider about her knees. Her knees still ache. This case was linked to MOD-2021-304929 (Patient Link).

Other Meds:

Current Illness:

ID: 1706856
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: Side effects; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Sep-2021 and was forwarded to Moderna on 01-Sep-2021. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Side effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Side effects). At the time of the report, VACCINATION COMPLICATION (Side effects) outcome was unknown. No concomitant product use was provided by the reporter. No treatment medication was provided. A question was asked that have any side effects been reported 4 months after receiving both shots of moderna.

Other Meds:

Current Illness:

ID: 1706857
Sex: F
Age: 67
State: AL

Vax Date: 01/12/2021
Onset Date: 01/12/2021
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: A sore arm for a week; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (A sore arm for a week) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011J00A) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure high, Skin disorder NOS and Hair disorder NOS. Concomitant products included DOXYCYCLINE and ALBUTEROL [SALBUTAMOL] for an unknown indication. On 12-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Jan-2021, the patient experienced VACCINATION SITE PAIN (A sore arm for a week). On 19-Jan-2021, VACCINATION SITE PAIN (A sore arm for a week) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications also included medications for blood pressure and skin and hair condition. Treatment details were not provided. This case was linked to MOD-2021-304953, MOD-2021-301915 (Patient Link).

Other Meds: DOXYCYCLINE; ALBUTEROL [SALBUTAMOL]

Current Illness: Blood pressure high; Hair disorder NOS; Skin disorder NOS

ID: 1706858
Sex: F
Age: 27
State: SD

Vax Date: 04/14/2021
Onset Date:
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: greater than 35 days between Moderna Covid-19 vaccines; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (greater than 35 days between Moderna Covid-19 vaccines) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination. No Medical History information was reported. On 14-Apr-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 DOSE OMISSION ISSUE (greater than 35 days between Moderna Covid-19 vaccines). At the time of the report, PRODUCT DOSE OMISSION ISSUE (greater than 35 days between Moderna Covid-19 vaccines) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications were not provided. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1706859
Sex: M
Age:
State: GA

Vax Date: 07/01/2021
Onset Date: 07/01/2021
Rec V Date: 09/17/2021
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: hives/hives; welts/welts; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (hives/hives) and URTICARIA (welts/welts) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Allergy. Concomitant products included EPINEPHRINE (EPIPEN) for Allergy. In July 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, the patient experienced URTICARIA (hives/hives) and URTICARIA (welts/welts). At the time of the report, URTICARIA (hives/hives) and URTICARIA (welts/welts) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient got hives, then welts that went away. No treatment information were provided. Rechallenge was positive on august 2021. This case was linked to MOD-2021-304977 (Patient Link).

Other Meds: EPIPEN

Current Illness: Allergy

ID: 1706860
Sex: M
Age: 52
State: CA

Vax Date: 08/21/2021
Onset Date: 08/29/2021
Rec V Date: 09/17/2021
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: swelling in legs and feet on both sides; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swelling in legs and feet on both sides) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 21-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 29-Aug-2021, the patient experienced PERIPHERAL SWELLING (swelling in legs and feet on both sides). At the time of the report, PERIPHERAL SWELLING (swelling in legs and feet on both sides) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided. It was reported that patient not taking any medications and did not receive any treatments

Other Meds:

Current Illness:

ID: 1706861
Sex: M
Age:
State: GA

Vax Date: 07/01/2021
Onset Date: 07/01/2021
Rec V Date: 09/17/2021
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: Hives/Welts; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives/Welts) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history information was reported. . Concomitant products included EPINEPHRINE (EPIPEN) for an unknown indication. In July 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In August 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In July 2021, the patient experienced URTICARIA (Hives/Welts). At the time of the report, URTICARIA (Hives/Welts) outcome was unknown. Treatment information was not provided. This case was linked to MOD-2021-304952 (Patient Link).

Other Meds: EPIPEN

Current Illness:

ID: 1706862
Sex: M
Age: 52
State:

Vax Date: 03/29/2021
Onset Date:
Rec V Date: 09/17/2021
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: fistula was bleeding for a couple of weeks; extreme lower back pain; lower back muscle spasms; This spontaneous case was reported by a consumer and describes the occurrence of ARTERIOVENOUS FISTULA SITE HAEMORRHAGE (fistula was bleeding for a couple of weeks), BACK PAIN (extreme lower back pain) and MUSCLE SPASMS (lower back muscle spasms) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053E21A and 006B21A) for COVID-19 vaccination. The patient's past medical history included Dialysis. Concurrent medical conditions included Immunocompromised and End stage renal disease. On 29-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ARTERIOVENOUS FISTULA SITE HAEMORRHAGE (fistula was bleeding for a couple of weeks) (seriousness criterion medically significant), BACK PAIN (extreme lower back pain) (seriousness criterion medically significant) and MUSCLE SPASMS (lower back muscle spasms) (seriousness criterion medically significant). At the time of the report, ARTERIOVENOUS FISTULA SITE HAEMORRHAGE (fistula was bleeding for a couple of weeks), BACK PAIN (extreme lower back pain) and MUSCLE SPASMS (lower back muscle spasms) had not resolved. The patient experienced slight fever after the second dose of Moderna. After the third dose (for/due to being immunocompromised) the patient experienced extreme lower back pain and muscle spasms. Narcotics did nothing, however, muscle relaxers and pain relievers did help but was still very bad. The patient was an end stage renal patient who does his dialysis treatments at home via a fistula. That fistula was bleeding for a couple of weeks and he had to have surgery on it today. The pain was so bad he had difficulty even going to the surgery. Although very limited information has been provided at this time, based on the current available information and temporal association between the use of the product and the onset date of the events (likely exacerbation of fistula site bleeding post-vaccination with symptoms of excruciating low back pain and muscle spasms), a causal relationship cannot be excluded. This case was linked to MOD-2021-304969. Reporter did not allow further contact; Sender's Comments: Although very limited information has been provided at this time, based on the current available information and temporal association between the use of the product and the onset date of the events (likely exacerbation of fistula site bleeding post-vaccination with symptoms of excruciating low back pain and muscle spasms), a causal relationship cannot be excluded.

Other Meds:

Current Illness: End stage renal disease; Immunocompromised

ID: 1706863
Sex: F
Age: 77
State: LA

Vax Date: 01/21/2021
Onset Date:
Rec V Date: 09/17/2021
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: Right arm pain from her shoulder around to her neck; Can hardly sleep; She can hardly get up from the pain. It hurts so bad it seems like paralysis is taking over her body.; Muscle pain all over her body all the time; Joint pain all over her body all the time; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Right arm pain from her shoulder around to her neck), INSOMNIA (Can hardly sleep), PAIN (She can hardly get up from the pain. It hurts so bad it seems like paralysis is taking over her body.), MYALGIA (Muscle pain all over her body all the time) and ARTHRALGIA (Joint pain all over her body all the time) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012M20A and 032L20A) for COVID-19 vaccination. Concurrent medical conditions included Knee pain. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Right arm pain from her shoulder around to her neck), INSOMNIA (Can hardly sleep), PAIN (She can hardly get up from the pain. It hurts so bad it seems like paralysis is taking over her body.), MYALGIA (Muscle pain all over her body all the time) and ARTHRALGIA (Joint pain all over her body all the time). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (Right arm pain from her shoulder around to her neck), INSOMNIA (Can hardly sleep), PAIN (She can hardly get up from the pain. It hurts so bad it seems like paralysis is taking over her body.), MYALGIA (Muscle pain all over her body all the time) and ARTHRALGIA (Joint pain all over her body all the time) outcome was unknown. No concomitant medications were reported. This case was linked to MOD-2021-030007 (Patient Link).

Other Meds:

Current Illness: Knee pain

ID: 1706864
Sex: F
Age: 47
State: NY

Vax Date: 01/28/2021
Onset Date:
Rec V Date: 09/17/2021
Hospital:

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

Lab Data: Test Date: 20210128; Test Name: Blood test; Result Unstructured Data: The only weird thing in her blood is that she has high nucleotide inflammatory marker,like she has a current autoimmune issues going on.

Allergies:

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

Symptoms: Like she has a current autoimmune issues going on; It feels like she's getting the flu but nothing really advances from there; Her neck is uncomfortable and it feels like her neck has lymph pain; When she walks up the stairs and tries to do something that needs more power, its like a weight over her head; There is a lot of neck pain; Has a lot of lymph soreness/lymph discomfort/lymph pain/Her neck is uncomfortable and it feels like her neck has lymph pain; Lymph swelling; generalized inflammation; The lymph discomfort presents like myalgia, like when she walks up the stairs and tries to do something that needs more power, its like a weight over her head/She thinks its either muscle pain; There is a lot of hip pain/There is a lot of proximal shoulder pain; This spontaneous case was reported by an other health care professional and describes the occurrence of AUTOIMMUNE DISORDER (Like she has a current autoimmune issues going on) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced AUTOIMMUNE DISORDER (Like she has a current autoimmune issues going on) (seriousness criterion medically significant), INFLUENZA LIKE ILLNESS (It feels like she's getting the flu but nothing really advances from there), MUSCULOSKELETAL DISCOMFORT (Her neck is uncomfortable and it feels like her neck has lymph pain), GAIT DISTURBANCE (When she walks up the stairs and tries to do something that needs more power, its like a weight over her head), NECK PAIN (There is a lot of neck pain), LYMPH NODE PAIN (Has a lot of lymph soreness/lymph discomfort/lymph pain/Her neck is uncomfortable and it feels like her neck has lymph pain), LYMPHADENOPATHY (Lymph swelling), INFLAMMATION (generalized inflammation), MYALGIA (The lymph discomfort presents like myalgia, like when she walks up the stairs and tries to do something that needs more power, its like a weight over her head/She thinks its either muscle pain) and ARTHRALGIA (There is a lot of hip pain/There is a lot of proximal shoulder pain). On 01-Sep-2021, MYALGIA (The lymph discomfort presents like myalgia, like when she walks up the stairs and tries to do something that needs more power, its like a weight over her head/She thinks its either muscle pain) and ARTHRALGIA (There is a lot of hip pain/There is a lot of proximal shoulder pain) had resolved. At the time of the report, AUTOIMMUNE DISORDER (Like she has a current autoimmune issues going on), INFLUENZA LIKE ILLNESS (It feels like she's getting the flu but nothing really advances from there), MUSCULOSKELETAL DISCOMFORT (Her neck is uncomfortable and it feels like her neck has lymph pain), GAIT DISTURBANCE (When she walks up the stairs and tries to do something that needs more power, its like a weight over her head), NECK PAIN (There is a lot of neck pain), LYMPH NODE PAIN (Has a lot of lymph soreness/lymph discomfort/lymph pain/Her neck is uncomfortable and it feels like her neck has lymph pain), LYMPHADENOPATHY (Lymph swelling) and INFLAMMATION (generalized inflammation) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Jan-2021, Blood test: abnormal (abnormal) The only weird thing in her blood is that she has high nucleotide inflammatory marker,like she has a current autoimmune issues going on.. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment information was provided. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. More information has been requested. The patient received her first dose on 28Jan2021 and second dose 28 days later in her right non dominant deltoid. It is now September and she still has side effects. She has a lot of generalized inflammation, a lot of soreness 12 hours after getting the first dose, she has not felt the same since. She has a lot of lymph soreness. It feels like she's getting the flu but nothing really advances from there. There is generalized aching and lymph swelling. The lymph discomfort presents like myalgia, like when she walks up the stairs and tries to do something that needs more power, its like a weight over her head. There is a lot of proximal shoulder, hip, and neck pain. She thinks its either muscle pain or lymph pain. Her neck is uncomfortable and it feels like her neck has lymph pain. She has had blood testing and seen a rheumatologist and a NP. The only weird thing in her blood is that she has high nucleotide inflammatory marker, like she has a current autoimmune issues going on. This case was linked to MOD-2021-286805 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. More information has been requested.

Other Meds:

Current Illness:

ID: 1706865
Sex: F
Age: 39
State: TX

Vax Date: 12/31/2020
Onset Date:
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: when I come into contact with something metal, my heart will flutter; Can't wear certain jewelry,highly allergic to my cellphone; eyeball swelled up; body and skin reacted to certain things; can't hold [phone] because I start getting hives and nervous,when I touch the gas pedal, my feet break out into hives; can't use my laptop anymore,it's affected her job; throat felt like it was about to close; She gets really bad migraines now; scared; Developed an allergy to anything metal; Can't eat fish or any kind of seafood; Allergy iodine-containing anything; when I put bobby pins in my hair, I get a headache,when I take the pins out, my head stops hurting; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (when I come into contact with something metal, my heart will flutter) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032L20A and 037K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 31-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In 2021, the patient experienced CARDIAC FLUTTER (when I come into contact with something metal, my heart will flutter) (seriousness criterion medically significant), HYPERSENSITIVITY (Can't wear certain jewelry,highly allergic to my cellphone), EYE SWELLING (eyeball swelled up), SENSITIVE SKIN (body and skin reacted to certain things), URTICARIA (can't hold [phone] because I start getting hives and nervous,when I touch the gas pedal, my feet break out into hives), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (can't use my laptop anymore,it's affected her job), THROAT TIGHTNESS (throat felt like it was about to close), MIGRAINE (She gets really bad migraines now), FEAR (scared), ALLERGY TO METALS (Developed an allergy to anything metal), FOOD ALLERGY (Can't eat fish or any kind of seafood), IODINE ALLERGY (Allergy iodine-containing anything) and HEADACHE (when I put bobby pins in my hair, I get a headache,when I take the pins out, my head stops hurting). At the time of the report, CARDIAC FLUTTER (when I come into contact with something metal, my heart will flutter), HYPERSENSITIVITY (Can't wear certain jewelry,highly allergic to my cellphone), EYE SWELLING (eyeball swelled up), SENSITIVE SKIN (body and skin reacted to certain things), URTICARIA (can't hold [phone] because I start getting hives and nervous,when I touch the gas pedal, my feet break out into hives), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (can't use my laptop anymore,it's affected her job), THROAT TIGHTNESS (throat felt like it was about to close), MIGRAINE (She gets really bad migraines now), FEAR (scared), ALLERGY TO METALS (Developed an allergy to anything metal), FOOD ALLERGY (Can't eat fish or any kind of seafood), IODINE ALLERGY (Allergy iodine-containing anything) and HEADACHE (when I put bobby pins in my hair, I get a headache,when I take the pins out, my head stops hurting) outcome was unknown. Concomitant medications were not reported. Treatment medications were not reported. Company Comment : Very limited information regarding this event has been provided at this time. Further information regarding temporal association is necessary. Further information has been requested.; Sender's Comments: Very limited information regarding this event has been provided at this time. Further information regarding temporal association is necessary. Further information has been requested.

Other Meds:

Current Illness:

ID: 1706866
Sex: M
Age:
State: GA

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: swelling under his groin; swelling under the arm of injection; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (swelling under his groin) and AXILLARY MASS (swelling under the arm of injection) in a 47-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 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 SWELLING (swelling under his groin) and AXILLARY MASS (swelling under the arm of injection). At the time of the report, SWELLING (swelling under his groin) and AXILLARY MASS (swelling under the arm of injection) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported. No treatment medication use was reported.

Other Meds:

Current Illness:

ID: 1706867
Sex: U
Age: 58
State: GA

Vax Date: 01/29/2021
Onset Date:
Rec V Date: 09/17/2021
Hospital: Y

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

Lab Data: Test Name: MRI; Result Unstructured Data: vestibular neuritis; Test Name: hearing test; Result Unstructured Data: vestibular neuritis

Allergies:

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

Symptoms: Could not perform her minimal daily work and activities; Different kind of dizziness ( Jell-O head, tipsy feeling without head spinning); Tinnitus; Vestibular neuritis; Stiff neck; Migraine type of headache; Pressure in her brain; Headache; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED ACTIVITY (Could not perform her minimal daily work and activities), FEELING DRUNK (Different kind of dizziness ( Jell-O head, tipsy feeling without head spinning)), TINNITUS (Tinnitus), VESTIBULAR NEURONITIS (Vestibular neuritis), MUSCULOSKELETAL STIFFNESS (Stiff neck), MIGRAINE (Migraine type of headache), HEAD DISCOMFORT (Pressure in her brain) and HEADACHE (Headache) in a 58-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013A21A and 0316204) for COVID-19 vaccination. No Medical History information was reported. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DECREASED ACTIVITY (Could not perform her minimal daily work and activities) (seriousness criterion hospitalization), FEELING DRUNK (Different kind of dizziness ( Jell-O head, tipsy feeling without head spinning)) (seriousness criterion hospitalization), TINNITUS (Tinnitus) (seriousness criterion hospitalization), VESTIBULAR NEURONITIS (Vestibular neuritis) (seriousness criterion hospitalization), MUSCULOSKELETAL STIFFNESS (Stiff neck) (seriousness criterion hospitalization), MIGRAINE (Migraine type of headache) (seriousness criterion hospitalization), HEAD DISCOMFORT (Pressure in her brain) (seriousness criterion hospitalization) and HEADACHE (Headache) (seriousness criterion hospitalization). At the time of the report, DECREASED ACTIVITY (Could not perform her minimal daily work and activities), FEELING DRUNK (Different kind of dizziness ( Jell-O head, tipsy feeling without head spinning)), TINNITUS (Tinnitus) and VESTIBULAR NEURONITIS (Vestibular neuritis) outcome was unknown and MUSCULOSKELETAL STIFFNESS (Stiff neck), MIGRAINE (Migraine type of headache), HEAD DISCOMFORT (Pressure in her brain) and HEADACHE (Headache) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Acoustic stimulation tests: vestibular neuritis (abnormal) vestibular neuritis. On an unknown date, Magnetic resonance imaging: vestibular neuritis (abnormal) vestibular neuritis. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported. No treatment medication was reported. Company comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-304573 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1706868
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: blood pressure from the 11 patients increased right after the vaccine to dangerous levels; 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 BLOOD PRESSURE INCREASED (blood pressure from the 11 patients increased right after the vaccine to dangerous levels) 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 BLOOD PRESSURE INCREASED (blood pressure from the 11 patients increased right after the vaccine to dangerous levels). At the time of the report, BLOOD PRESSURE INCREASED (blood pressure from the 11 patients increased right after the vaccine to dangerous levels) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant and treatment medications were reported.

Other Meds:

Current Illness:

ID: 1706869
Sex: F
Age:
State: CA

Vax Date: 08/31/2021
Onset Date: 08/31/2021
Rec V Date: 09/17/2021
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: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (this is all symptoms of the vaccine booster), DRY MOUTH (mouth started getting dry) and MYALGIA (left arm sore) all the body is sore (chest, shoulder, and back)) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 058E) for COVID-19 vaccination. The patient's past medical history included Breast implant user. On 31-Aug-2021 at 11:00 AM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient 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 31-Aug-2021, the patient experienced DRY MOUTH (mouth started getting dry) and MYALGIA (left arm sore / all the body is sore (chest, shoulder, and back)). On an unknown date, the patient experienced VACCINATION COMPLICATION (this is all symptoms of the vaccine booster). At the time of the report, VACCINATION COMPLICATION (this is all symptoms of the vaccine booster), DRY MOUTH (mouth started getting dry) and MYALGIA (left arm sore / all the body is sore (chest, shoulder, and back)) was resolving. No concomitant medications were reported. No treatment information was reported. This case was linked to MOD-2021-308700. Most recent FOLLOW-UP information incorporated above includes: On 02-Sep-2021: Follow up received included Additional event and events outcome updated. On 03-Sep-2021: Non significant follow up received on 03-Sep-2021.

Other Meds:

Current Illness:

ID: 1706870
Sex: F
Age: 53
State: GA

Vax Date: 07/01/2021
Onset Date: 07/01/2021
Rec V Date: 09/17/2021
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: Swollen arm; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Swollen arm) and PAIN IN EXTREMITY (Sore arm) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In July 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In July 2021, the patient experienced PERIPHERAL SWELLING (Swollen arm) and PAIN IN EXTREMITY (Sore arm). At the time of the report, PERIPHERAL SWELLING (Swollen arm) and PAIN IN EXTREMITY (Sore arm) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. Concomitant medication was not provided by the reporter. Treatment information was not reported. Reporter states that Patient had her second shot on Aug 2021.

Other Meds:

Current Illness:

ID: 1706871
Sex: M
Age: 88
State: VA

Vax Date: 01/16/2021
Onset Date: 08/01/2021
Rec V Date: 09/17/2021
Hospital: Y

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: trouble with Benadryl and had to go to the Hospital; Hives all over his body except the trunk; lumps all over his body except the trunk; started itching terribly; rash on thighs, legs, and arms/covered with a rash all over his body except the trunk; This spontaneous case was reported by a patient family member or friend and describes the occurrence of ADVERSE REACTION (trouble with Benadryl and had to go to the Hospital) and URTICARIA (Hives all over his body except the trunk) in an 88-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 017E21A, 013L20A and 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 16-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 20-Aug-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In August 2021, the patient experienced ADVERSE REACTION (trouble with Benadryl and had to go to the Hospital) (seriousness criterion hospitalization). On 23-Aug-2021, the patient experienced RASH (rash on thighs, legs, and arms/covered with a rash all over his body except the trunk). On 24-Aug-2021, the patient experienced URTICARIA (Hives all over his body except the trunk) (seriousness criterion medically significant), SKIN MASS (lumps all over his body except the trunk) and PRURITUS (started itching terribly). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) on 25-Aug-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, ADVERSE REACTION (trouble with Benadryl and had to go to the Hospital) outcome was unknown and URTICARIA (Hives all over his body except the trunk), SKIN MASS (lumps all over his body except the trunk), PRURITUS (started itching terribly) and RASH (rash on thighs, legs, and arms/covered with a rash all over his body except the trunk) was resolving. Concomitant medications were not reported. The patient did not have any adverse events following the first two doses of the vaccine. On 25-Aug-2021, the doctor started the patient on steroid injections. The patient had trouble with Benadryl and had to go to the hospital and was released (had nothing to do with the vaccine). His reaction was 90% cleared, however, it was reported that he still had some red bumps. The wife of the patient stated that she also received the 3 shots at the same time as her husband and with the same lot number. She denied having had any adverse reactions. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, more information is required for further assessment. For the event adverse reaction: Reporter's causality assessment considered the event unlikely related to the vaccine. Treatment drug Benadryl is a confounding factor. However, very limited information is available to assess causality. This case refers to a case of third dose of Moderna. Clarification regarding patient?s history of immunodeficiency has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. However, more information is required for further assessment. For the event adverse reaction: Reporter's causality assessment considered the event unlikely related to the vaccine. Treatment drug Benadryl is a confounding factor. However, very limited information is available to assess causality. This case refers to a case of third dose of Moderna. Clarification regarding patient?s history of immunodeficiency has been requested.

Other Meds:

Current Illness:

ID: 1706872
Sex: F
Age: 24
State: LA

Vax Date: 08/03/2021
Onset Date: 08/14/2021
Rec V Date: 09/17/2021
Hospital:

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

Lab Data: Test Date: 20210816; Test Name: COVID-19; Test Result: Positive ; Result Unstructured Data: positive for COVID-19

Allergies:

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

Symptoms: Scheduled for second dose on 31Aug2021 (but couldn't get it, as they had to evacuate due to a stage 4 hurricane).; positive for COVID-19; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (positive for COVID-19) and PRODUCT DOSE OMISSION ISSUE (Scheduled for second dose on 31Aug2021 (but couldn't get it, as they had to evacuate due to a stage 4 hurricane).) in a 24-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007D21A) for COVID-19 vaccination. No medical history was provided. Concomitant products included ESOMEPRAZOLE SODIUM (NEXIUM [ESOMEPRAZOLE SODIUM]) for an unknown indication. On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Aug-2021, the patient experienced COVID-19 (positive for COVID-19). On 31-Aug-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Scheduled for second dose on 31Aug2021 (but couldn't get it, as they had to evacuate due to a stage 4 hurricane).). At the time of the report, COVID-19 (positive for COVID-19) and PRODUCT DOSE OMISSION ISSUE (Scheduled for second dose on 31Aug2021 (but couldn't get it, as they had to evacuate due to a stage 4 hurricane).) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Aug-2021, SARS-CoV-2 test: positive (Positive) positive for COVID-19. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Other Concomitant medication includes birth control medication. Treatment information was not provided On 14-Aug-2021, Patient started with COVID-19 symptoms (water eye, couldn't breath, no sense of smell). A pharmacist said that she should wait 14 days for 2nd vaccine but other pharmacist (they were evacuees due to a stage 4 hurricane) said that patient had to wait 90 days.

Other Meds: NEXIUM [ESOMEPRAZOLE SODIUM]

Current Illness:

ID: 1706873
Sex: F
Age:
State: AK

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: She got the second dose two weeks apart; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She got the second dose two weeks apart) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She got the second dose two weeks apart). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (She got the second dose two weeks apart) 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: 1706874
Sex: F
Age: 71
State: MD

Vax Date: 03/28/2021
Onset Date: 03/28/2021
Rec V Date: 09/17/2021
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: Like if someone was "twisting the muscle" / Can't do anything /Stop everything she's doing; Pain isalso getting sooner than later, more often than before, almost everyday; Pain in the middle of her upper arm, in the inside muscle; Second injection wasn't as painful as the first dose, but pain's still there; This spontaneous case was reported by a consumer and describes the occurrence of MOBILITY DECREASED (Like if someone was "twisting the muscle" / Can't do anything /Stop everything she's doing), CONDITION AGGRAVATED (Pain isalso getting sooner than later, more often than before, almost everyday), VACCINATION SITE PAIN (Second injection wasn't as painful as the first dose, but pain's still there) and MYALGIA (Pain in the middle of her upper arm, in the inside muscle) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 206A21A) for COVID-19 vaccination. No Medical History information was reported. On 28-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Mar-2021, the patient experienced VACCINATION SITE PAIN (Second injection wasn't as painful as the first dose, but pain's still there). On an unknown date, the patient experienced MOBILITY DECREASED (Like if someone was "twisting the muscle" / Can't do anything /Stop everything she's doing) and MYALGIA (Pain in the middle of her upper arm, in the inside muscle). an unknown date, the patient experienced CONDITION AGGRAVATED (Pain isalso getting sooner than later, more often than before, almost everyday). At the time of the report, MOBILITY DECREASED (Like if someone was "twisting the muscle" / Can't do anything /Stop everything she's doing), CONDITION AGGRAVATED (Pain isalso getting sooner than later, more often than before, almost everyday) and MYALGIA (Pain in the middle of her upper arm, in the inside muscle) outcome was unknown and VACCINATION SITE PAIN (Second injection wasn't as painful as the first dose, but pain's still there) had not resolved. The Patient stated that she has not taken any medication for the pain as it comes in short episodes and last a few seconds. The patient stated that she consulted her Physician on 31 August 2021. No concomitant product use was provided by the reporter. This case was linked to MOD-2021-305083 (Patient Link).

Other Meds:

Current Illness:

ID: 1706875
Sex: U
Age:
State:

Vax Date: 08/31/2021
Onset Date: 08/31/2021
Rec V Date: 09/17/2021
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: Itching badly on upper torso/still itchy; Lips were tingly; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching badly on upper torso/still itchy) and PARAESTHESIA ORAL (Lips were tingly) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Allergy to plants (Allergic reaction to nettle) and Allergy to animal (Allergic reaction to scorpions). On 31-Aug-2021 at 1:30 PM, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Aug-2021, the patient experienced PARAESTHESIA ORAL (Lips were tingly). On 31-Aug-2021 at 4:00 PM, the patient experienced PRURITUS (Itching badly on upper torso/still itchy). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) in 2021 for Itching, at an unspecified dose and frequency. At the time of the report, PRURITUS (Itching badly on upper torso/still itchy) had not resolved and PARAESTHESIA ORAL (Lips were tingly) outcome was unknown. No concomitant medications were provided. Patient was taking Benadryl every 3-4 hours and it helped a lot.

Other Meds:

Current Illness: Allergy to animal (Allergic reaction to scorpions); Allergy to plants (Allergic reaction to nettle)

ID: 1706876
Sex: M
Age: 81
State: TX

Vax Date: 03/28/2021
Onset Date: 06/07/2021
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: had a stroke; got real dizzy; he had headache; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (had a stroke) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 002C21A and 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 07-Jun-2021, the patient experienced DIZZINESS (got real dizzy) and HEADACHE (he had headache). On 17-Jun-2021, the patient experienced CEREBROVASCULAR ACCIDENT (had a stroke) (seriousness criterion medically significant). The patient was treated with PARACETAMOL (TYLENOL) on 17-Jun-2021 for Adverse event, at an unspecified dose and frequency and AMLODIPINE on 17-Jun-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, CEREBROVASCULAR ACCIDENT (had a stroke), DIZZINESS (got real dizzy) and HEADACHE (he had headache) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. On 17-Jun-2021, patient visited emergency room and got discharged the same night. Although very limited information has been provided at this time, based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded.; Sender's Comments: Although very limited information has been provided at this time, based on the current available information and temporal association between the use of the product and the onset of the events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1706877
Sex: M
Age: 45
State: TX

Vax Date: 08/17/2021
Onset Date: 08/21/2021
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: another ache in the same arm on a different site/ on his inside bicep area/it's not real severe/it hasn't gone away yet; it feels like a tenderness/like when you work the muscle too much; he had a sore arm from the next day which lasted for a couple of days; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (another ache in the same arm on a different site/ on his inside bicep area/it's not real severe/it hasn't gone away yet), TENDERNESS (it feels like a tenderness/like when you work the muscle too much) and MYALGIA (he had a sore arm from the next day which lasted for a couple of days) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 053E21A) for COVID-19 vaccination. No Medical History information was reported. On 17-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Aug-2021, the patient experienced PAIN IN EXTREMITY (another ache in the same arm on a different site/ on his inside bicep area/it's not real severe/it hasn't gone away yet), TENDERNESS (it feels like a tenderness/like when you work the muscle too much) and MYALGIA (he had a sore arm from the next day which lasted for a couple of days). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (another ache in the same arm on a different site/ on his inside bicep area/it's not real severe/it hasn't gone away yet) had not resolved, TENDERNESS (it feels like a tenderness/like when you work the muscle too much) outcome was unknown and MYALGIA (he had a sore arm from the next day which lasted for a couple of days) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication were not reported

Other Meds:

Current Illness:

ID: 1706878
Sex: F
Age: 43
State: SC

Vax Date: 03/31/2021
Onset Date:
Rec V Date: 09/17/2021
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: a sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (a sore arm) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for an unknown indication. On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (a sore arm) (seriousness criterion disability). At the time of the report, PAIN IN EXTREMITY (a sore arm) outcome was unknown. Treatment information was unknown Caller received the 1st dose of the Moderna vaccine on 31Mar2021 (no expiration date) on her right arm and had a sore arm. She received the 2nd dose on 28Apr2021 (lot #010M20A, no expiration date) on her left arm and a week later she had a bad headache on the frontal lobe like if she had an aneurism, ringing on her ears, she went to a neurologist, got a MRI done, has had migraines everyday ever since, lost hearing of her right ear, tinnitus, brain fog, vision problems. Caller says she was healthy before the vaccine. She says she's part of a 300,000 people group who has had issues with vaccines Company comment: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. This case was linked to MOD-2021-305146 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds: SYMBICORT

Current Illness:

ID: 1706879
Sex: F
Age: 43
State: SC

Vax Date: 03/31/2021
Onset Date: 05/01/2021
Rec V Date: 09/17/2021
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: lost hearing of her right ear; ringing on her ears / tinnitus; has had migraines everyday ever since; brain fog; vision problems; a bad headache on the frontal lobe like if she had an aneurism; This spontaneous case was reported by a consumer and describes the occurrence of DEAFNESS (lost hearing of her right ear) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included BUDESONIDE, FORMOTEROL FUMARATE (SYMBICORT) for an unknown indication. On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In May 2021, the patient experienced DEAFNESS (lost hearing of her right ear) (seriousness criterion medically significant), TINNITUS (ringing on her ears / tinnitus), MIGRAINE (has had migraines everyday ever since), FEELING ABNORMAL (brain fog), VISUAL IMPAIRMENT (vision problems) and HEADACHE (a bad headache on the frontal lobe like if she had an aneurism). At the time of the report, DEAFNESS (lost hearing of her right ear), TINNITUS (ringing on her ears / tinnitus), MIGRAINE (has had migraines everyday ever since), FEELING ABNORMAL (brain fog), VISUAL IMPAIRMENT (vision problems) and HEADACHE (a bad headache on the frontal lobe like if she had an aneurism) outcome was unknown. The patient went to MRI and the results were unknown. She went to a neurologist. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. More information has been requested. This case was linked to MOD-2021-305139 (Patient Link).; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. More information has been requested.

Other Meds: SYMBICORT

Current Illness:

ID: 1706880
Sex: F
Age: 20
State: TX

Vax Date: 09/01/2021
Onset Date: 09/01/2021
Rec V Date: 09/17/2021
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: A dose past 26 hours punctured today; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (A dose past 26 hours punctured today) in a 20-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 047B21A) for COVID-19 vaccination. No Medical History information was reported. On 01-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (A dose past 26 hours punctured today). At the time of the report, EXPIRED PRODUCT ADMINISTERED (A dose past 26 hours punctured today) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1706881
Sex: F
Age: 56
State: PA

Vax Date: 02/23/2021
Onset Date: 02/23/2021
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: it's been over 4 months since receiving the 1st dose; It was 2nd worst migraine I've ever had; severe vomiting; started to get migraine-like symptoms headache/severe pain in the head; This spontaneous case was reported by a consumer and describes the occurrence of MIGRAINE (It was 2nd worst migraine I've ever had), VOMITING (severe vomiting), HEADACHE (started to get migraine-like symptoms headache/severe pain in the head) and PRODUCT DOSE OMISSION ISSUE (it's been over 4 months since receiving the 1st dose) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031M20A) for COVID-19 vaccination. Concurrent medical conditions included Allergy (preservatives) and Migraine (pretty bad). On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced MIGRAINE (It was 2nd worst migraine I've ever had), VOMITING (severe vomiting) and HEADACHE (started to get migraine-like symptoms headache/severe pain in the head). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (it's been over 4 months since receiving the 1st dose). At the time of the report, MIGRAINE (It was 2nd worst migraine I've ever had), VOMITING (severe vomiting) and HEADACHE (started to get migraine-like symptoms headache/severe pain in the head) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (it's been over 4 months since receiving the 1st dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication information was not provided by the reporter. Treatment information was not provided by the reporter.

Other Meds:

Current Illness: Allergy (preservatives); Migraine (pretty bad)

ID: 1706882
Sex: F
Age: 61
State: FL

Vax Date: 07/01/2021
Onset Date:
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: sore injection site arm; This spontaneous case was reported by a nurse and describes the occurrence of VACCINATION SITE PAIN (sore injection site arm) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In July 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In August 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced 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 medication were reported. The treatment information were unknown.

Other Meds:

Current Illness:

ID: 1706883
Sex: F
Age:
State:

Vax Date: 08/30/2021
Onset Date:
Rec V Date: 09/17/2021
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: is like feeling the need to cough, it's like there's air bellow her throat and it will come out in sort of a half cough; throat is also, like the inside of her throat is a; This spontaneous case was reported by a consumer and describes the occurrence of COUGH (is like feeling the need to cough, it's like there's air bellow her throat and it will come out in sort of a half cough) and OROPHARYNGEAL DISCOMFORT (throat is also, like the inside of her throat is a) 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 30-Aug-2021 at 9:04 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced COUGH (is like feeling the need to cough, it's like there's air bellow her throat and it will come out in sort of a half cough) and OROPHARYNGEAL DISCOMFORT (throat is also, like the inside of her throat is a). At the time of the report, COUGH (is like feeling the need to cough, it's like there's air bellow her throat and it will come out in sort of a half cough) and OROPHARYNGEAL DISCOMFORT (throat is also, like the inside of her throat is a) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient stated something regarding the inside of the throat which is unclear. Concomitant medications were not provided. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1706884
Sex: M
Age: 68
State: FL

Vax Date: 08/20/2021
Onset Date: 08/20/2021
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: post bleeding in the shoulder; Really sore; no energy, felt drained; Feeling jittery; hives; itched; Fluttering/ heart fluttering; nervous; COVID shoulder; slight rash on shoulder, neck, chest and slightly on belly; Dizzy/lightheaded; vertigo; tingling throughout the body like arms; tightness around the chest; couldn't move my shoulder; This spontaneous case was reported by a consumer and describes the occurrence of CARDIAC FLUTTER (Fluttering/ heart fluttering) and HAEMORRHAGE (post bleeding in the shoulder) in a 68-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 051C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Drug allergy (Sensitivity to epinephrine.) and Vascular disorder (Patient does have Bleeding disorder). Concomitant products included COLECALCIFEROL (VITAMIN D3), PROBIOTICS NOS, PYRIDOXINE HYDROCHLORIDE (VITAMIN B6), MAGNESIUM and ARGININE for an unknown indication. On 20-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Aug-2021, the patient experienced CARDIAC FLUTTER (Fluttering/ heart fluttering) (seriousness criterion medically significant), DIZZINESS (Dizzy/lightheaded), VERTIGO (vertigo), PARAESTHESIA (tingling throughout the body like arms), CHEST DISCOMFORT (tightness around the chest), MOBILITY DECREASED (couldn't move my shoulder), NERVOUSNESS (nervous), INJECTION SITE PAIN (COVID shoulder) and RASH (slight rash on shoulder, neck, chest and slightly on belly). On 21-Aug-2021, the patient experienced URTICARIA (hives) and PRURITUS (itched). On 22-Aug-2021, the patient experienced ASTHENIA (no energy, felt drained) and FEELING JITTERY (Feeling jittery). On an unknown date, the patient experienced HAEMORRHAGE (post bleeding in the shoulder) (seriousness criterion medically significant) and MYALGIA (Really sore). At the time of the report, CARDIAC FLUTTER (Fluttering/ heart fluttering), HAEMORRHAGE (post bleeding in the shoulder), DIZZINESS (Dizzy/lightheaded), VERTIGO (vertigo), PARAESTHESIA (tingling throughout the body like arms), URTICARIA (hives), PRURITUS (itched), NERVOUSNESS (nervous), INJECTION SITE PAIN (COVID shoulder) and RASH (slight rash on shoulder, neck, chest and slightly on belly) had resolved and CHEST DISCOMFORT (tightness around the chest), MOBILITY DECREASED (couldn't move my shoulder), ASTHENIA (no energy, felt drained), FEELING JITTERY (Feeling jittery) and MYALGIA (Really sore) 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. No treatment information was provided Company comment Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: VITAMIN D3; PROBIOTICS NOS; VITAMIN B6; MAGNESIUM; ARGININE

Current Illness: Drug allergy (Sensitivity to epinephrine.); Vascular disorder (Patient does have Bleeding disorder)

ID: 1706885
Sex: F
Age: 82
State: TX

Vax Date: 08/23/2021
Onset Date: 08/23/2021
Rec V Date: 09/17/2021
Hospital:

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

Lab Data: Test Date: 20210823; Test Name: Blood pressure; Result Unstructured Data: Blood pressure increased

Allergies:

Symptom List: Tremor

Symptoms: She drops things; Kind of a headache; Felt tired for the first couple of days; Got tinnitus, can only hear whistles and noise; Shaking, hands are shaking / hand shaking; This spontaneous case was reported by a consumer and describes the occurrence of TINNITUS (Got tinnitus, can only hear whistles and noise), TREMOR (Shaking, hands are shaking / hand shaking), GRIP STRENGTH DECREASED (She drops things), HEADACHE (Kind of a headache) and FATIGUE (Felt tired for the first couple of days) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 049E21A) for COVID-19 vaccination. Concurrent medical conditions included Allergy to antibiotic. On 23-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Aug-2021, the patient experienced TREMOR (Shaking, hands are shaking / hand shaking). On 27-Aug-2021, the patient experienced TINNITUS (Got tinnitus, can only hear whistles and noise). On an unknown date, the patient experienced GRIP STRENGTH DECREASED (She drops things), HEADACHE (Kind of a headache) and FATIGUE (Felt tired for the first couple of days). At the time of the report, TINNITUS (Got tinnitus, can only hear whistles and noise), TREMOR (Shaking, hands are shaking / hand shaking), GRIP STRENGTH DECREASED (She drops things), HEADACHE (Kind of a headache) and FATIGUE (Felt tired for the first couple of days) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Aug-2021, Blood pressure measurement: increased (High) Blood pressure increased. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient did not take any medication for the adverse events and does not take any concomitant medications. Most recent FOLLOW-UP information incorporated above includes: On 05-Sep-2021: Patient medical history and lab data were added. Event verbatim was changed and hand shaking event date was added.

Other Meds:

Current Illness: Allergy to antibiotic

ID: 1706886
Sex: M
Age: 74
State:

Vax Date: 03/01/2021
Onset Date:
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: Patient confirmed that the tingling stared after the first dose and was able to do things; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Patient confirmed that the tingling stared after the first dose and was able to do things) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Diabetic. In March 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 PARAESTHESIA (Patient confirmed that the tingling stared after the first dose and was able to do things). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Tingling, at an unspecified dose and frequency. At the time of the report, PARAESTHESIA (Patient confirmed that the tingling stared after the first dose and was able to do things) outcome was unknown. 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. This case was linked to MOD-2021-305223.

Other Meds:

Current Illness: Diabetic

ID: 1706887
Sex: F
Age: 61
State: OK

Vax Date: 01/24/2021
Onset Date:
Rec V Date: 09/17/2021
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: I spent 3 days in bed, I slept 14 hours at a time; pain in my right injection site arm; feverish; This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE (I spent 3 days in bed, I slept 14 hours at a time), VACCINATION SITE PAIN (pain in my right injection site arm) and PYREXIA (feverish) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SOMNOLENCE (I spent 3 days in bed, I slept 14 hours at a time), VACCINATION SITE PAIN (pain in my right injection site arm) and PYREXIA (feverish). At the time of the report, SOMNOLENCE (I spent 3 days in bed, I slept 14 hours at a time), VACCINATION SITE PAIN (pain in my right injection site arm) and PYREXIA (feverish) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. No concomitant medications were provided by reporter. No treatment details were provided by reporter.

Other Meds:

Current Illness:

ID: 1706888
Sex: F
Age: 65
State: IN

Vax Date: 02/05/2021
Onset Date:
Rec V Date: 09/17/2021
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: This spontaneous case was reported by a consumer and describes the occurrence of DIARRHEA (Diarrhea came back and never went away), FLATULENCE (Flatus), ABDOMINAL DISTENSION (Bloating) and DYSPEPSIA (Heartburn) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 013M20A) for COVID-19 vaccination. Concomitant products included PRIMIDONE, MELATONIN, DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), COLECALCIFEROL (VITAMIN D3), ACETYLSALICYLIC ACID (BABY ASPIRIN), DICLOFENAC SODIUM, LEVOTHYROXINE, ROSUVASTATIN CALCIUM (CRESTOR), SERTRALINE, QUETIAPINE FUMARATE (SEROQUEL) and UBIDECARENONE (COQ10 [UBIDECARENONE]) for an unknown indication. On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced DIARRHEA (Diarrhea came back and never went away). On an unknown date, the patient experienced FLATULENCE (Flatus), ABDOMINAL DISTENSION (Bloating) and DYSPEPSIA (Heartburn). The patient was treated with ALUMINIUM HYDROXIDE GEL, DRIED, MAGNESIUM CARBONATE (PEPCID [ALUMINIUM HYDROXIDE GEL, DRIED;MAGNESIUM CARBONATE]) for Heartburn, at an unspecified dose and frequency and DICYCLOVERINE HYDROCHLORIDE (BENTYL) for Adverse event, at an unspecified dose and frequency. At the time of the report, DIARRHEA (Diarrhea came back and never went away) had not resolved and FLATULENCE (Flatus), ABDOMINAL DISTENSION (Bloating) and DYSPEPSIA (Heartburn) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. This case was linked to MOD-2021-305229.

Other Meds: PRIMIDONE; MELATONIN; BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]; VITAMIN D3; BABY ASPIRIN; DICLOFENAC SODIUM; LEVOTHYROXINE; CRESTOR; SERTRALINE; SEROQUEL; COQ10 [UBIDECARENONE]

Current Illness:

ID: 1706889
Sex: M
Age: 72
State: NJ

Vax Date: 01/19/2021
Onset Date:
Rec V Date: 09/17/2021
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: cut his finger; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 01-Sep-2021 and was forwarded to Moderna on 01-Sep-2021. This spontaneous case was reported by a consumer and describes the occurrence of SKIN LACERATION (cut his finger) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013l20a and 015m20a) for COVID-19 vaccination. No Medical History information was reported. On 19-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On an unknown date, the patient experienced SKIN LACERATION (cut his finger). The patient was treated with DOXYCYCLINE for Laceration of finger, at an unspecified dose and frequency. At the time of the report, SKIN LACERATION (cut his finger) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient takes blood pressure medicines as concomitant drug. Patient had to receive a tetanus shot as a week ago he cut his finger.

Other Meds:

Current Illness:

ID: 1706890
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: I received the vaccine now my arm is red and warm to touch; I received the vaccine now my arm is red and warm to touch; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (I received the vaccine now my arm is red and warm to touch) and VACCINATION SITE ERYTHEMA (I received the vaccine now my arm is red and warm to touch) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (I received the vaccine now my arm is red and warm to touch) and VACCINATION SITE ERYTHEMA (I received the vaccine now my arm is red and warm to touch). At the time of the report, VACCINATION SITE WARMTH (I received the vaccine now my arm is red and warm to touch) and VACCINATION SITE ERYTHEMA (I received the vaccine now my arm is red and warm to touch) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The Concomitant medication was not reported. The Treatment history was not reported.

Other Meds:

Current Illness:

ID: 1706891
Sex: F
Age: 37
State: PR

Vax Date: 03/26/2021
Onset Date:
Rec V Date: 09/17/2021
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: tachycardia (fast heart beat); weakness; dizziness; hands were clammy; more than 35 days passed and she did not get the second dose; This spontaneous case was reported by a consumer and describes the occurrence of TACHYCARDIA (tachycardia (fast heart beat)), ASTHENIA (weakness), DIZZINESS (dizziness), COLD SWEAT (hands were clammy) and PRODUCT DOSE OMISSION ISSUE (more than 35 days passed and she did not get the second dose) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. No Medical History information was reported. On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced TACHYCARDIA (tachycardia (fast heart beat)), ASTHENIA (weakness), DIZZINESS (dizziness), COLD SWEAT (hands were clammy) and PRODUCT DOSE OMISSION ISSUE (more than 35 days passed and she did not get the second dose). At the time of the report, TACHYCARDIA (tachycardia (fast heart beat)), ASTHENIA (weakness), DIZZINESS (dizziness) and COLD SWEAT (hands were clammy) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (more than 35 days passed and she did not get the second dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication were provided. No treatment medication were provided. No lab data were provided. Reporter decided not to get the second dose as she did not knew if she was allergic or not. Now she was thinking of getting the second dose and she wonders if she should get it, given her reaction and if she were to get it should she start the series all over and Would it be the same to get a booster shot.

Other Meds:

Current Illness:

ID: 1706892
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
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: Severe abdominal pain; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (Severe abdominal pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ABDOMINAL PAIN (Severe abdominal pain). At the time of the report, ABDOMINAL PAIN (Severe abdominal pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications were not provided. Treatment medication was not provided.

Other Meds:

Current Illness:

ID: 1706893
Sex: U
Age:
State:

Vax Date: 09/01/2021
Onset Date: 09/02/2021
Rec V Date: 09/17/2021
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: Feeling very sick; Throwing up; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling very sick) and VOMITING (Throwing up) 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 01-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Sep-2021, the patient experienced MALAISE (Feeling very sick) and VOMITING (Throwing up). At the time of the report, MALAISE (Feeling very sick) and VOMITING (Throwing up) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant product information was provided. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1706894
Sex: F
Age:
State:

Vax Date: 09/01/2021
Onset Date: 09/01/2021
Rec V Date: 09/17/2021
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: constant sneezing; nose stuffy; This spontaneous case was reported by a consumer and describes the occurrence of SNEEZING (constant sneezing) and NASAL CONGESTION (nose stuffy) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Heart disease, unspecified (Heart issues), Lung disease (Lung issues), Diabetes, Blood pressure high and Nervous system disorder NOS (Nervous system problems). On 01-Sep-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Sep-2021, the patient experienced SNEEZING (constant sneezing) and NASAL CONGESTION (nose stuffy). At the time of the report, SNEEZING (constant sneezing) and NASAL CONGESTION (nose stuffy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided. No treatment medications were provided.

Other Meds:

Current Illness: Blood pressure high; Diabetes; Heart disease, unspecified (Heart issues); Lung disease (Lung issues); Nervous system disorder NOS (Nervous system problems)

ID: 1706895
Sex: F
Age:
State:

Vax Date: 08/30/2021
Onset Date: 08/30/2021
Rec V Date: 09/17/2021
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: third shot of Moderna, 2 Pfizer shots previously; This spontaneous case was reported by an other health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (third shot of Moderna, 2 Pfizer shots previously) in a 22-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 30-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Aug-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (third shot of Moderna, 2 Pfizer shots previously). On 30-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (third shot of Moderna, 2 Pfizer shots previously) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication were provided. No treatment medication were provided. Patient got their 2 shots of Pfizer previously, one of them got 2nd Pfizer shot on 25 Aug and took modern booster after 5 days.

Other Meds:

Current Illness:

ID: 1706896
Sex: M
Age:
State: CT

Vax Date:
Onset Date:
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: Had a some sort of blockage; This spontaneous case was reported by an other health care professional and describes the occurrence of VACCINATION COMPLICATION (Had a some sort of blockage) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Had a some sort of blockage). At the time of the report, VACCINATION COMPLICATION (Had a some sort of blockage) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1706897
Sex: M
Age: 54
State: TX

Vax Date: 09/01/2021
Onset Date: 09/01/2021
Rec V Date: 09/17/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Dose from expired vial administered; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Dose from expired vial administered) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. Concurrent medical conditions included Shellfish allergy (Shell fish allergy) and Iodine allergy (Iodine allergy). On 01-Sep-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Dose from expired vial administered). On 01-Sep-2021, EXPIRED PRODUCT ADMINISTERED (Dose from expired vial administered) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication was not provided. Patient did not experience any adverse events. Treatment information was not reported This case was linked to MOD-2021-306120, MOD-2021-306124 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 07-Sep-2021: Follow-up received: added ethnicity, allergy history, route of administration, dose number, site of administration.

Other Meds:

Current Illness: Iodine allergy (Iodine allergy); Shellfish allergy (Shell fish allergy)

ID: 1706898
Sex: F
Age: 31
State: CA

Vax Date: 08/10/2021
Onset Date: 08/10/2021
Rec V Date: 09/17/2021
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: Error: Booster Given Too Early-

Other Meds:

Current Illness:

ID: 1706899
Sex: F
Age: 60
State: VA

Vax Date: 08/23/2021
Onset Date: 08/27/2021
Rec V Date: 09/17/2021
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: Site: Pain at Injection Site-Medium, Site: Swelling at Injection Site-Medium, Systemic: Headache-Medium, Additional Details: PATIENT STATES HEADACHE ONSET 4 DAYS AFTER ADMIN OF VACCINE, HAS HAD HEADACHE EVER SINCE (STATES DOES NOT GET HEADACHES), ARM STILL SWOLLEN AFTER ADMIN

Other Meds:

Current Illness:

ID: 1706900
Sex: F
Age: 48
State: VA

Vax Date: 09/15/2021
Onset Date: 09/15/2021
Rec V Date: 09/17/2021
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: Error: Wrong Vaccine Formulation (ex. different manufact. initial and booster)-

Other Meds:

Current Illness:

ID: 1706901
Sex: M
Age: 23
State: CT

Vax Date: 09/15/2021
Onset Date: 09/15/2021
Rec V Date: 09/17/2021
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: Systemic: Fainting / Unresponsive-Severe, Systemic: Flushed / Sweating-Mild, Additional Details: Approximately 5 minutes after injection patient reported feeling faint. Pharmacist was at patient's side. Patient appeared pale, started sweating then fainted. Pharmacist kept patient safely in chair, patient was unconcious for approximately 2 minutes before regaining conciousness. EMS was called, they evaluated patient on site. Vitals were normal, blood sugar normal. Patient felt better and refused transportation to the hospital. Patient left pharmacy after approximately 30 minutes.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am