VAERS 2021 Database www.vaers.hhs.gov

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

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

COVID19 Lot Number

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

Incidents per State

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

ID: 1790358
Sex: F
Age: 44
State: SD

Vax Date: 12/29/2020
Onset Date: 01/26/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Name: Covid test; Test Result: Negative ; Result Unstructured Data: Negative; Test Name: D-dimer; Result Unstructured Data: Elevated; Test Name: D-dimer; Result Unstructured Data: 974 below500 was normal; Test Name: Brain MRI; Result Unstructured Data: Normal; Test Name: Oxygen; Result Unstructured Data: 80-90; Test Name: Vitamin d; Result Unstructured Data: abnormal

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: Weird Symptoms after 2nd dose; facial paresthesia; tingling sensation around face. mouth, and nose; severe migraine headaches/it started it with aching and next day It was migraines; burning sensation that started in ear and morphed into cheeks and face for 15 minutes; inflamed pulmonary poura; whole face went completely numb for half hour; menthol feeling around face and lips; inflamed pulmonary poura and had atelectasis; blurry vision in left eye/focusing issues with left eye; left eye is not moving unison with right eye; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (burning sensation that started in ear and morphed into cheeks and face for 15 minutes), MIGRAINE (severe migraine headaches/it started it with aching and next day It was migraines), PARAESTHESIA (tingling sensation around face. mouth, and nose), VACCINATION COMPLICATION (Weird Symptoms after 2nd dose) and PNEUMONITIS (inflamed pulmonary poura) in a 45-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030L20A and 011J20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19. Concomitant products included VITAMIN D [VITAMIN D NOS] for an unknown indication. On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced MIGRAINE (severe migraine headaches/it started it with aching and next day It was migraines). In February 2021, the patient experienced PARAESTHESIA (tingling sensation around face. mouth, and nose). In 2021, the patient experienced BURNING SENSATION (burning sensation that started in ear and morphed into cheeks and face for 15 minutes), PNEUMONITIS (inflamed pulmonary poura), HYPOAESTHESIA (whole face went completely numb for half hour), FEELING ABNORMAL (menthol feeling around face and lips), ATELECTASIS (inflamed pulmonary poura and had atelectasis), VISION BLURRED (blurry vision in left eye/focusing issues with left eye) and BINOCULAR EYE MOVEMENT DISORDER (left eye is not moving unison with right eye). On an unknown date, the patient experienced VACCINATION COMPLICATION (Weird Symptoms after 2nd dose) and PARAESTHESIA (facial paresthesia). In 2021, HYPOAESTHESIA (whole face went completely numb for half hour) had resolved. At the time of the report, BURNING SENSATION (burning sensation that started in ear and morphed into cheeks and face for 15 minutes) had not resolved and MIGRAINE (severe migraine headaches/it started it with aching and next day It was migraines), PARAESTHESIA (tingling sensation around face. mouth, and nose), VACCINATION COMPLICATION (Weird Symptoms after 2nd dose), PNEUMONITIS (inflamed pulmonary poura), FEELING ABNORMAL (menthol feeling around face and lips), ATELECTASIS (inflamed pulmonary poura and had atelectasis), VISION BLURRED (blurry vision in left eye/focusing issues with left eye) and BINOCULAR EYE MOVEMENT DISORDER (left eye is not moving unison with right eye) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Covid test: negative (Negative) Negative. On an unknown date, Fibrin D dimer: elevated (High) Elevated and 974 (High) 974 below500 was normal. On an unknown date, Magnetic resonance imaging head: normal (normal) Normal. On an unknown date, Oxygen saturation: 80-90 80-90. On an unknown date, Vitamin D: abnormal (abnormal) abnormal. The patient stated she had immediate reactions after both doses of the vaccine, but long-term issues after 2nd dose. She stated after her 2nd dose of the vaccine, that night, she had severe migraine headaches. She states she started having them daily and never had headaches in life. It differed in severity, it started with aching and next day it was migraines. She added that 10-12 days after 2nd dose, she started getting tingling sensation around face. mouth, and nose. It would happen and it would go away in 2 minutes. She felt like Novocain wearing off. Couple weeks later same things happened, but more severe, lasted longer, and covered more in face. It was more uncomfortable. She stated that 3rd time it happened, which was 3 weeks after 2nd time, it was burning sensation that started in ear and morphed into cheeks and face for 15 minutes. It felt like pricking sensation. Then a month and half later, the whole face went completely numb for half hour. She made an appointment in end of May or June to see a PCP. She made an appointment because of facial paresthesia. Her MD ran some lab work. Week after seeing MD, she started seeing new symptoms. She describes the symptoms as menthol feeling around face and lips. It was continuous for 3 weeks and lasted 10 minutes. Her MD could not come up with a diagnosis. She was referred for Brain MRI. Then she started getting inflamed pulmonary poura and had atelectasis. There were chest x-ray and other tests done. Her blood oxygen level was at 80-90 %. She had 3 tests total, all came back negative. MD could not find anything wrong with her. Then she stated having problems with blurry vision in left eye. Now she is having focusing issues. She added her D-dimer kept on elevating, but no signs of pulmonary embolism. Her brain MRI came back normal, but D-dimer had doubled after her 1st D-dimer test. She said when her eye test was done, left was not moving unison with right eye. This case was linked to MOD-2021-342990 (Patient Link).

Other Meds: VITAMIN D [VITAMIN D NOS]

Current Illness:

ID: 1790359
Sex: M
Age:
State: TN

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

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: This spontaneous case was reported by a pharmacist and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (Patient received a mixed series) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product TOZINAMERAN (PFIZER BIONTECH 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 and TOZINAMERAN (PFIZER BIONTECH COVID-19 VACCINE) (unknown route) 1 dosage form. On an unknown date, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (Patient received a mixed series). At the time of the report, INTERCHANGE OF VACCINE PRODUCTS (Patient received a mixed series) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported by reporter. No treatment medication was reported by reporter.

Other Meds:

Current Illness:

ID: 1790360
Sex: F
Age: 52
State: MI

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

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

Lab Data:

Allergies:

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

Symptoms: little bit of arm pain; stiff neck pain; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (little bit of arm pain) and MUSCULOSKELETAL STIFFNESS (stiff neck pain) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030A21A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included HYDROCHLOROTHIAZIDE and THYROID (ARMOUR THYROID) for an unknown indication. On 09-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 (little bit of arm pain) and MUSCULOSKELETAL STIFFNESS (stiff neck pain). At the time of the report, PAIN IN EXTREMITY (little bit of arm pain) and MUSCULOSKELETAL STIFFNESS (stiff neck pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Treatment medications are Reported.

Other Meds: HYDROCHLOROTHIAZIDE; ARMOUR THYROID

Current Illness:

ID: 1790361
Sex: U
Age:
State: IL

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

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

Lab Data:

Allergies:

Symptom List: Dizziness, Fatigue, Mobility decreased

Symptoms: issues with heart rate; issues with blood pressure; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of HEART RATE ABNORMAL (issues with heart rate) and BLOOD PRESSURE ABNORMAL (issues with blood pressure) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) 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 HEART RATE ABNORMAL (issues with heart rate) and BLOOD PRESSURE ABNORMAL (issues with blood pressure). At the time of the report, HEART RATE ABNORMAL (issues with heart rate) and BLOOD PRESSURE ABNORMAL (issues with blood pressure) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant products were reported. No Treatment medication were reported.

Other Meds:

Current Illness:

ID: 1790362
Sex: M
Age: 58
State: CA

Vax Date: 07/01/2021
Onset Date: 10/04/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Bells Palsy/ facial paralysis affecting the left side/can not eat/can not drink/can not smile/can not close their left eye; can not sleep; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Bells Palsy/ facial paralysis affecting the left side/can not eat/can not drink/can not smile/can not close their left eye) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hypertension (High blood pressure) and Diabetes. Concomitant products included METFORMIN for an unknown indication. In July 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 04-Oct-2021, the patient experienced BELL'S PALSY (Bells Palsy/ facial paralysis affecting the left side/can not eat/can not drink/can not smile/can not close their left eye) (seriousness criterion medically significant) and INSOMNIA (can not sleep). The patient was treated with PREDNISONE on 04-Oct-2021 for Adverse event, at an unspecified dose and frequency and VALACICLOVIR on 04-Oct-2021 for Adverse event, at an unspecified dose and frequency. At the time of the report, BELL'S PALSY (Bells Palsy/ facial paralysis affecting the left side/can not eat/can not drink/can not smile/can not close their left eye) and INSOMNIA (can not sleep) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications also included statins, high blood pressure medication and another diabetes oral medication. Treatment medications also included some eye ointment, an eye patch at night to keep the eye shut, and some eye drops for daytime. Patient reported that he went to the ER yesterday as he wanted to rule out a stroke. There he was diagnosed with Bell's Palsy. He reported that he could not eat, could not drink, could not smile and could not close his left eye. Company comment: This case concerns a 58 year-old male patient with history of diabetes, who experienced the unexpected serious event and AESI of Bell's palsy. The event occurred approximately 2 months after the second dose of mRNA-1273 vaccine. Because diabetes is a risk factor for the event, the patient's medical history remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 58 year-old male patient with history of diabetes, who experienced the unexpected serious event and AESI of Bell's palsy. The event occurred approximately 2 months after the second dose of mRNA-1273 vaccine. Because diabetes is a risk factor for the event, the patient's medical history remains a confounder. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.

Other Meds: METFORMIN

Current Illness: Diabetes; Hypertension (High blood pressure).

ID: 1790363
Sex: U
Age:
State:

Vax Date:
Onset Date: 10/05/2021
Rec V Date: 10/16/2021
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: 3rd dose administered to non-immunocompromised individual; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of OFF LABEL USE (3rd dose administered to non-immunocompromised individual) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Oct-2021, the patient experienced OFF LABEL USE (3rd dose administered to non-immunocompromised individual). On 05-Oct-2021, OFF LABEL USE (3rd dose administered to non-immunocompromised individual) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Caller was not willing to report adverse event. Caller stated a 3rd dose was administered to an non-eligible consumer. Concomitant medication use was unknown Treatment information was unknown

Other Meds:

Current Illness:

ID: 1790364
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: Hot right arm injection site; Right arm injection site hard lump that has got softer the last few days - injection site feels like a big knot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot right arm injection site) and VACCINATION SITE MASS (Right arm injection site hard lump that has got softer the last few days - injection site feels like a big knot) 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 01-Oct-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE WARMTH (Hot right arm injection site) and VACCINATION SITE MASS (Right arm injection site hard lump that has got softer the last few days - injection site feels like a big knot). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE WARMTH (Hot right arm injection site) and VACCINATION SITE MASS (Right arm injection site hard lump that has got softer the last few days - injection site feels like a big knot) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication was not provided. Patient stated that after first vaccine she said that the injection site at the right arm felt like there was a hard lump that has got softer the last fewdays and felt like a big knot and it is hot.. It was reported that Manufacturer date of suspect drug was Apr2021, Lot number and expiration date of suspect drug was unknown.

Other Meds:

Current Illness:

ID: 1790365
Sex: M
Age:
State: NY

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

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Vaccination adverse reaction; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Vaccination adverse reaction) 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 VACCINATION COMPLICATION (Vaccination adverse reaction). At the time of the report, VACCINATION COMPLICATION (Vaccination adverse reaction) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment medication was reported. No Concomitant medication was reported. No lab data was provided.

Other Meds:

Current Illness:

ID: 1790366
Sex: M
Age:
State: NY

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

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: left abdominal pain/symptom; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (left abdominal pain/symptom) 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 (left abdominal pain/symptom). At the time of the report, ABDOMINAL PAIN (left abdominal pain/symptom) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported No treatment information was provided

Other Meds:

Current Illness:

ID: 1790367
Sex: M
Age:
State: CA

Vax Date: 07/01/2021
Onset Date: 10/04/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: can not sleep; Bells Palsy; This spontaneous case was reported by a consumer and describes the occurrence of BELL'S PALSY (Bells Palsy) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. In July 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 04-Oct-2021, the patient experienced BELL'S PALSY (Bells Palsy) (seriousness criterion medically significant). On an unknown date, the patient experienced INSOMNIA (can not sleep). The patient was treated with PREDNISONE for Adverse event, at an unspecified dose and frequency and VALACICLOVIR for Adverse event, at an unspecified dose and frequency. At the time of the report, BELL'S PALSY (Bells Palsy) and INSOMNIA (can not sleep) outcome was unknown. No concomitant medications were reported. Patient was also treated with eye ointment, an eye patch at night to keep the eye shut, and some eye drops for daytime. Reported that Patient went to the ER because they developed facial paralysis affecting the left side and wanted to rule out a stroke. Reported that There patient were diagnosed with Bell's Palsy and can not eat and can not drink, can not smile, can not sleep, can not close their left eye. Company comment: This case concerns a male patient of unknown age with no reported medical history, who experienced the unexpected serious event and AESI of Bell's palsy. The event occurred approximately 2 months after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Sender's Comments: This case concerns a male patient of unknown age with no reported medical history, who experienced the unexpected serious event and AESI of Bell's palsy. The event occurred approximately 2 months after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.

Other Meds:

Current Illness:

ID: 1790368
Sex: F
Age: 33
State: GA

Vax Date: 09/02/2021
Onset Date: 09/03/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: still having arm pain/not as bad for first few days/still hurts on occasion/down the arm/vaccination it was severe, then it eased up, but still hurts; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (still having arm pain/not as bad for first few days/still hurts on occasion/down the arm/vaccination it was severe, then it eased up, but still hurts) in a 33-year-old female patient who received mRNA-1273 (COVID-19 Vaccine Moderna) (batch no. 022C21A) for COVID-19 vaccination. Concurrent medical conditions included Shellfish allergy. On 02-Sep-2021, the patient received first dose of mRNA-1273 (COVID-19 Vaccine Moderna) (unknown route) 1 dosage form. On 03-Sep-2021, the patient experienced PAIN IN EXTREMITY (still having arm pain/not as bad for first few days/still hurts on occasion/down the arm/vaccination it was severe, then it eased up, but still hurts). The patient was treated with IBUPROFEN for Pain in arm, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (still having arm pain/not as bad for first few days/still hurts on occasion/down the arm/vaccination it was severe, then it eased up, but still hurts) had not resolved. The action taken with mRNA-1273 (COVID-19 Vaccine Moderna) (Unknown) was unknown. No concomitant medication details was provided. Patient was trying applying ice, heat pad. The medication and remedies was not subsiding the pain.

Other Meds:

Current Illness: Shellfish allergy

ID: 1790369
Sex: F
Age: 51
State: FL

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

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: Airport security monitor showed human figure on vaccination site twice at different airports; Missed second dose intentionally; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE DISCOLORATION (Airport security monitor showed human figure on vaccination site twice at different airports) and PRODUCT DOSE OMISSION ISSUE (Missed second dose intentionally) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In August 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In September 2021, the patient experienced VACCINATION SITE DISCOLORATION (Airport security monitor showed human figure on vaccination site twice at different airports) and PRODUCT DOSE OMISSION ISSUE (Missed second dose intentionally). In September 2021, PRODUCT DOSE OMISSION ISSUE (Missed second dose intentionally) had resolved. At the time of the report, VACCINATION SITE DISCOLORATION (Airport security monitor showed human figure on vaccination site twice at different airports) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1790370
Sex: M
Age: 46
State: AZ

Vax Date: 07/23/2021
Onset Date: 07/23/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: he was in a lot of pain for at least a week/It was just like all over body pain/pain was a little worse on his left side/pain throughout his whole body/soreness; tired a lot for several days/he was aching all over/He had fatigue/mainly tiredness/lot of fatigue/stronger reaction than her; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (he was in a lot of pain for at least a week/It was just like all over body pain/pain was a little worse on his left side/pain throughout his whole body/soreness) and FATIGUE (tired a lot for several days/he was aching all over/He had fatigue/mainly tiredness/lot of fatigue/stronger reaction than her) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 408D21A) for COVID-19 vaccination. No Medical History information was reported. On 23-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jul-2021, the patient experienced MYALGIA (he was in a lot of pain for at least a week/It was just like all over body pain/pain was a little worse on his left side/pain throughout his whole body/soreness) and FATIGUE (tired a lot for several days/he was aching all over/He had fatigue/mainly tiredness/lot of fatigue/stronger reaction than her). At the time of the report, MYALGIA (he was in a lot of pain for at least a week/It was just like all over body pain/pain was a little worse on his left side/pain throughout his whole body/soreness) and FATIGUE (tired a lot for several days/he was aching all over/He had fatigue/mainly tiredness/lot of fatigue/stronger reaction than her) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Concomitant medications were provided by the reporter No Treatment information was provided by the reporter This case was linked to MOD-2021-342936 (Patient Link).

Other Meds:

Current Illness:

ID: 1790371
Sex: F
Age: 40
State: KY

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

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

Lab Data:

Allergies:

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

Symptoms: Received expired dose of the vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received expired dose of the vaccine) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037B21A) for COVID-19 vaccination. No Medical History information was reported. On 05-Oct-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Received expired dose of the vaccine). On 05-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Received expired dose of the vaccine) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant medications were reported. Patient didn't experienced Adverse Events Date the vial was initially stored in the refrigerator: 27-SEP-2021. No Treatment information was reported.

Other Meds:

Current Illness:

ID: 1790372
Sex: M
Age: 32
State: NJ

Vax Date: 09/03/2021
Onset Date: 03/25/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Heart rate decreased, Heart rate increased, Hypertension, Injection site pain, Musculoskeletal chest pain

Symptoms: 2nd dose received more than 5 months after the second; different COVID-19 vaccine for 1st and 2nd dose; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 05-Oct-2021 and was forwarded to Moderna on 05-Oct-2021. This spontaneous case was reported by an other health care professional and describes the occurrence of INTERCHANGE OF VACCINE PRODUCTS (different COVID-19 vaccine for 1st and 2nd dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received more than 5 months after the second) in a 32-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. Previously administered products included for an unreported indication: COVID-19 VACCINE NRVV AD on 25-Mar-2021. On 03-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Mar-2021, the patient experienced INTERCHANGE OF VACCINE PRODUCTS (different COVID-19 vaccine for 1st and 2nd dose). On 03-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received more than 5 months after the second). On 03-Sep-2021, INTERCHANGE OF VACCINE PRODUCTS (different COVID-19 vaccine for 1st and 2nd dose) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (2nd dose received more than 5 months after the second) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant treatment was provided. No treatment medication was provided. First dose lot number includes 1805031 and expiration date includes 31-DEC-2069 Patient had stated that No adverse events are experienced.

Other Meds:

Current Illness:

Date Died:

ID: 1790373
Sex: F
Age:
State: MD

Vax Date:
Onset Date:
Rec V Date: 10/16/2021
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: alanine aminotransferase; Result Unstructured Data: 600 U/L (on the Day of Admission); Test Name: alanine aminotransferase; Result Unstructured Data: 1746 U/L (on the Last Day of Hospitalization); Test Name: aldolase level; Result Unstructured Data: 353 U/L on further investigation, but it was falsely elevated due to hemoglobin contamination secondary to hemolysis.; Test Name: Anion gap; Result Unstructured Data: 19 mEQ/L (on the Day of Admission); Test Name: Anion gap; Result Unstructured Data: 20 mEQ/L (on the Last Day of Hospitalization); Test Name: aspartate aminotransferase; Result Unstructured Data: 1422 U/L (on the Day of Admission); Test Name: aspartate aminotransferase; Result Unstructured Data: 2066 U/L (on the Last Day of Hospitalization); Test Name: Blood alkaline phosphatase; Result Unstructured Data: 600 U/L; Test Name: Blood bicarbonate; Result Unstructured Data: 13 mmol/L (on the Day of Admission); Test Name: Blood bicarbonate; Result Unstructured Data: 39 mmol/L (on the Last Day of Hospitalization); Test Name: Blood bilirubin; Result Unstructured Data: 0.3 mg/dL (on the Day of Admission); Test Name: Blood bilirubin; Result Unstructured Data: 0.6 mg/dL (on the Last Day of Hospitalization); Test Name: Calcium; Result Unstructured Data: 8.4 mg/dL (on the Day of Admission); Test Name: Calcium; Result Unstructured Data: 5.3 mg/dL (on the Last Day of Hospitalization); Test Name: creatine phosphokinase; Result Unstructured Data: more than 14,000 U/L (on the Day of Admission); Test Name: creatine phosphokinase; Result Unstructured Data: more than14,000 U/L (on the Last Day of Hospitalization); Test Name: Serum creatinine; Result Unstructured Data: 6 mg/dL (on the Day of Admission); Test Name: Serum creatinine; Result Unstructured Data: 2.7 mg/dL (on the Last Day of Hospitalization); Test Name: Blood glucose; Result Unstructured Data: 73 mg/dl; Test Name: Lactic acid; Result Unstructured Data: 1.3 mmol/L (on the Day of Admission); Test Name: Lactic acid; Result Unstructured Data: 19.3 mmol/L (on the Last Day of Hospitalization); Test Name: Phosphorus; Result Unstructured Data: 7.2 mg/dL (on the Day of Admission); Test Name: Phosphorus; Result Unstructured Data: 10.4 mg/dL (on the Last Day of Hospitalization); Test Name: Potassium; Result Unstructured Data: 4.6 mmol/L (on the Day of Admission); Test Name: Potassium; Result Unstructured Data: 6 mmol/L (on the Last Day of Hospitalization); Test Name: Sodium; Result Unstructured Data: 134 mmol/L(on the Day of Admission); Test Name: Sodium; Result Unstructured Data: 153 mmol/L (on the Last Day of Hospitalization); Test Name: blood urea nitrogen; Result Unstructured Data: 21 mg/dL (on the Day of Admission); Test Name: blood urea nitrogen; Result Unstructured Data: 61 mg/dL (on the Last Day of Hospitalization); Test Name: Brain natriuretic peptide; Result Unstructured Data: 1388 pg/mL (on the Day of Admission); Test Name: Brain natriuretic peptide; Result Unstructured Data: 5391 pg/mL (on the Last Day of Hospitalization); Test Name: chest scan; Res

Allergies:

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

Symptoms: Rhabdomyolysis; Cardiac arrest; generalized weakness; muscle cramps; loss of appetite; urine color changing dark brown to black; confused or experiencing hallucinations; mentation started to decline; pitting edema over the bilateral upper and lower extremities; Diastolic heart failure; Ascites; Acute renal failure; Pleural effusion; experienced nausea, without any vomiting/diarrhea; This literature-non-study case was reported in a literature article and describes the occurrence of RHABDOMYOLYSIS (Rhabdomyolysis), CARDIAC ARREST (Cardiac arrest), ASTHENIA (generalized weakness), MUSCLE SPASMS (muscle cramps), DECREASED APPETITE (loss of appetite), CHROMATURIA (urine color changing dark brown to black), HALLUCINATION (confused or experiencing hallucinations), MENTAL IMPAIRMENT (mentation started to decline), OEDEMA (pitting edema over the bilateral upper and lower extremities), LEFT VENTRICULAR FAILURE (Diastolic heart failure), ASCITES (Ascites), ACUTE KIDNEY INJURY (Acute renal failure) and PLEURAL EFFUSION (Pleural effusion) in an 85-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Cerebrovascular accident (2 months prior) and Physiotherapy (For the past 2 months, the patient was undergoing professional physiotherapy once a week as advised by the therapist.) since an unknown date. Family history included Autoimmune disorder (Family history was positive for autoimmune disease in maternal grandmother.). Concurrent medical conditions included Rheumatoid arthritis, Hyperlipidemia and Asthma. Concomitant products included CLOPIDOGREL and TRAZODONE for Stroke, METOPROLOL, NIFEDIPINE, ROSUVASTATIN, TELMISARTAN and TOFACITINIB for an unknown indication. 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 RHABDOMYOLYSIS (Rhabdomyolysis) (seriousness criteria death, hospitalization and medically significant), CARDIAC ARREST (Cardiac arrest) (seriousness criteria death, hospitalization and medically significant), ASTHENIA (generalized weakness) (seriousness criterion hospitalization), MUSCLE SPASMS (muscle cramps) (seriousness criterion hospitalization), DECREASED APPETITE (loss of appetite) (seriousness criterion hospitalization), CHROMATURIA (urine color changing dark brown to black) (seriousness criterion hospitalization), HALLUCINATION (confused or experiencing hallucinations) (seriousness criteria hospitalization and medically significant), MENTAL IMPAIRMENT (mentation started to decline) (seriousness criteria hospitalization and medically significant), OEDEMA (pitting edema over the bilateral upper and lower extremities) (seriousness criterion hospitalization), LEFT VENTRICULAR FAILURE (Diastolic heart failure) (seriousness criteria hospitalization prolonged and medically significant), ASCITES (Ascites) (seriousness criteria hospitalization prolonged and medically significant), ACUTE KIDNEY INJURY (Acute renal failure) (seriousness criteria hospitalization prolonged and medically significant), PLEURAL EFFUSION (Pleural effusion) (seriousness criterion hospitalization prolonged) and NAUSEA (experienced nausea, without any vomiting/diarrhea). The patient died on an unknown date. The reported cause of death was Rhabdomyolysis and Cardiac arrest. It is unknown if an autopsy was performed. At the time of death, ASTHENIA (generalized weakness), MUSCLE SPASMS (muscle cramps), DECREASED APPETITE (loss of appetite), CHROMATURIA (urine color changing dark brown to black), HALLUCINATION (confused or experiencing hallucinations), MENTAL IMPAIRMENT (mentation started to decline), OEDEMA (pitting edema over the bilateral upper and lower extremities), LEFT VENTRICULAR FAILURE (Diastolic heart failure), ASCITES (Ascites), ACUTE KIDNEY INJURY (Acute renal failure), PLEURAL EFFUSION (Pleural effusion) and NAUSEA (experienced nausea, without any vomiting/diarrhea) outcome was unknown. Possible DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Alanine aminotransferase (12-78): 600 u/l 600 U/L (on the Day of Admission) and 1746 u/l 1746 U/L (on the Last Day of Hospitalization). On an unknown date, Aldolase: 353 u/l 353 U/L on further investigation, but it was falsely elevated due to hemoglobin contamination secondary to hemolysis.. On an unknown date, Anion gap (8-16): 19 meq/l 19 mEQ/L (on the Day of Admission) and 20 meq/l 20 mEQ/L (on the Last Day of Hospitalization). On an unknown date, Aspartate aminotransferase (15-37): 1422 u/l 1422 U/L (on the Day of Admission) and 2066 u/l 2066 U/L (on the Last Day of Hospitalization). On an unknown date, Blood alkaline phosphatase (45-117): 600 u/l 600 U/L. On an unknown date, Blood bicarbonate (21-32): 13 mmol/l 13 mmol/L (on the Day of Admission) and 39 mmol/l 39 mmol/L (on the Last Day of Hospitalization). On an unknown date, Blood bilirubin (0.2-1): 0.3 mg/dl 0.3 mg/dL (on the Day of Admission) and 0.6 mg/dl 0.6 mg/dL (on the Last Day of Hospitalization). On an unknown date, Blood calcium (8.5-10.1): 8.4 mg/dl 8.4 mg/dL (on the Day of Admission) and 5.3 mg/dl 5.3 mg/dL (on the Last Day of Hospitalization). On an unknown date, Blood creatine phosphokinase (26-192): more than 14,000 u/l more than 14,000 U/L (on the Day of Admission) and more than 14,000 u/l more than14,000 U/L (on the Last Day of Hospitalization). On an unknown date, Blood creatinine (0.6-1.3): 6 mg/dl 6 mg/dL (on the Day of Admission) and 2.7 mg/dl 2.7 mg/dL (on the Last Day of Hospitalization). On an unknown date, Blood glucose (40-70): 73 mg/dl 73 mg/dl. On an unknown date, Blood lactic acid (0.4-2): 1.3 mmol/l 1.3 mmol/L (on the Day of Admission) and 19.3 mmol/l 19.3 mmol/L (on the Last Day of Hospitalization). On an unknown date, Blood phosphorus (2.5-4.9): 7.2 mg/dl 7.2 mg/dL (on the Day of Admission) and 10.4 mg/dl 10.4 mg/dL (on the Last Day of Hospitalization). On an unknown date, Blood potassium (3.5-5.1): 4.6 mmol/l 4.6 mmol/L (on the Day of Admission) and 6 mmol/l 6 mmol/L (on the Last Day of Hospitalization). On an unknown date, Blood sodium (136-145): 134 mmol/l 134 mmol/L(on the Day of Admission) and 153 mmol/l 153 mmol/L (on the Last Day of Hospitalization). On an unknown date, Blood urea (7-18): 21 mg/dl 21 mg/dL (on the Day of Admission) and 61 mg/dl 61 mg/dL (on the Last Day of Hospitalization). On an unknown date, Brain natriuretic peptide (5-450): 1388 pg/ml 1388 pg/mL (on the Day of Admission) and 5391 pg/ml 5391 pg/mL (on the Last Day of Hospitalization). On an unknown date, C-reactive protein: 74 mg/l 74 mg/L (on the Day of Admission) and 17.8 mg/l 17.8 mg/L (on the Last Day of Hospitalization). On an unknown date, CSF myelin basic protein: 8.7 ng/dl 8.7 ng/dl. On an unknown date, CSF protein (15-60): 31.6 mg/dl 31.6 mg/dl. On an unknown date, CSF red blood cell count: 2/cu mm 2/cu mm. On an unknown date, CSF test: clear appearance Cerebrospinal fluid (CSF) analysis revealed a clear appearance, with cultures remaining negative. On an unknown date, CSF white blood cell count: 2/cu mm 2/cu mm Range(0-5cu mm). On an unknown date, Chest scan: complete consolidation chest CT showed complete consolidation and volume loss of the right lower lobe, partial consolidation and volume loss of the left lower lobe, mild ascites, and moderate anasarca.. On an unknown date, Computerised tomogram: no acute finding computed tomography (CT) of the abdomen and head revealed no acute finding.. On an unknown date, Echocardiogram: elevated (High) showed an ejection fraction of 55? 60% with diastolic dysfunction. On an unknown date, Glomerular filtration rate: 6 ml/min 6 mL/min (on the Day of Admission) and 16 ml/min 16 mL/min (on the Last Day of Hospitalization). On an unknown date, Haemoglobin (11-16): 12.4 g/dl 12.4 g/dL(on the Day of Admission) and 4.4 g/dl 4.4 g/dL (on the La

Other Meds: CLOPIDOGREL; METOPROLOL; NIFEDIPINE; ROSUVASTATIN; TELMISARTAN; TOFACITINIB; TRAZODONE

Current Illness: Asthma; Hyperlipidemia; Physiotherapy (For the past 2 months, the patient was undergoing professional physiotherapy once a week as advised by the therapist.); Rheumatoid arthritis

ID: 1790374
Sex: F
Age: 46
State: NC

Vax Date: 09/23/2021
Onset Date:
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: migraine; got cold; muscles started jerking\kind of like a seizure jerk; sore arm for 3 days; slept the whole day; small headache; was so tired; This spontaneous case was reported by a patient and describes the occurrence of MIGRAINE (migraine), FEELING COLD (got cold), MYOCLONUS (muscles started jerking\kind of like a seizure jerk), PAIN IN EXTREMITY (sore arm for 3 days) and HYPERSOMNIA (slept the whole day) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included METFORMIN and SEMAGLUTIDE (OZEMPIC) for an unknown indication. On 23-Sep-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 MIGRAINE (migraine), FEELING COLD (got cold), MYOCLONUS (muscles started jerking\kind of like a seizure jerk), PAIN IN EXTREMITY (sore arm for 3 days), HYPERSOMNIA (slept the whole day), HEADACHE (small headache) and FATIGUE (was so tired). The patient was treated with PARACETAMOL (TYLENOL) for Migraine, at an unspecified dose and frequency. At the time of the report, MIGRAINE (migraine), FEELING COLD (got cold), MYOCLONUS (muscles started jerking\kind of like a seizure jerk), PAIN IN EXTREMITY (sore arm for 3 days), HYPERSOMNIA (slept the whole day), HEADACHE (small headache) and FATIGUE (was so tired) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.; Sender's Comments: This case concerns a 46-year-old, female patient with no relevant medical history, who experienced the unexpected events of Migraine, feeling cold, myoclonus, pain in extremity and hypersomnia, and listed events of headache and fatigue. The events occurred approximately 1 day after the first dose of Spikevax. The rechallenge was unknown since no information about the second dose was disclosed. The benefit-risk relationship of Spikevax is not affected by this report.

Other Meds: METFORMIN; OZEMPIC

Current Illness:

ID: 1790375
Sex: M
Age: 46
State: AZ

Vax Date: 07/23/2021
Onset Date: 08/20/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: he had difficulty eating much; tremendous amount of pain on his left side of his body; For a month after, he was extremely nauseous; This spontaneous case was reported by a consumer and describes the occurrence of EATING DISORDER (he had difficulty eating much), MYALGIA (tremendous amount of pain on his left side of his body) and NAUSEA (For a month after, he was extremely nauseous) in a 46-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 408D21A) for COVID-19 vaccination. Concomitant products included GABAPENTIN, IBUPROFEN (IBUPROFEN 2CARE4) and PARACETAMOL (TYLENOL) for Pain. On 23-Jul-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Aug-2021, the patient experienced EATING DISORDER (he had difficulty eating much), MYALGIA (tremendous amount of pain on his left side of his body) and NAUSEA (For a month after, he was extremely nauseous). At the time of the report, EATING DISORDER (he had difficulty eating much), MYALGIA (tremendous amount of pain on his left side of his body) and NAUSEA (For a month after, he was extremely nauseous) outcome was unknown. This case was linked to MOD-2021-342936 (Patient Link).

Other Meds: GABAPENTIN; IBUPROFEN 2CARE4; TYLENOL

Current Illness:

ID: 1790376
Sex: U
Age:
State: NJ

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

Vax Type: PNC13
Manufacturer: PFIZER\WYETH
Vax Name: PNEUMO (PREVNAR13)
Lot:
Dose Series: UNK
Vax Route:
Vax Site: LG

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: few of the tenants received the booster shot and have been throwing up / this patient stated that there were others; 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 VOMITING (few of the tenants received the booster shot and have been throwing up / this patient stated that there were others) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VOMITING (few of the tenants received the booster shot and have been throwing up / this patient stated that there were others). At the time of the report, VOMITING (few of the tenants received the booster shot and have been throwing up / this patient stated that there were others) outcome was unknown. Not Provided No concomitant treatment was provided. No treatment medication was provided. Reporter believes that the patients are immunocompromised since she knows Moderna has not approved a booster dose, but not sure patients are immunocompromised or not.

Other Meds:

Current Illness:

Date Died: 09/24/2021

ID: 1790377
Sex: F
Age: 65
State: FL

Vax Date: 08/05/2021
Onset Date: 09/01/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Name: Blood sugar; Result Unstructured Data: Had blood sugar levels up for 6 months

Allergies:

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

Symptoms: she found her mother dead on her bed; More than 36 days after the first dose without receiving the second dose; shortness of breath/ it was the worst ever; the patient had burning in her chest; stayed in bed for a few days; not feeling well/ did not feel great; This spontaneous case was reported by a consumer and describes the occurrence of DEATH (she found her mother dead on her bed) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037C21A and 027C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood sugar increased (took Insulin because she had her blood sugar levels up for 6 months). Concomitant products included INSULIN for Blood sugar increased, GABAPENTIN, CEFIXIME (FLEXERIL [CEFIXIME]) and RISPERIDONE for an unknown indication. On 05-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 15-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days after the first dose without receiving the second dose). In September 2021, the patient experienced DYSPNOEA (shortness of breath/ it was the worst ever), CHEST PAIN (the patient had burning in her chest), BED REST (stayed in bed for a few days) and VACCINATION COMPLICATION (not feeling well/ did not feel great). The patient died on 24-Sep-2021. The cause of death was not reported. It is unknown if an autopsy was performed. At the time of death, DYSPNOEA (shortness of breath/ it was the worst ever), CHEST PAIN (the patient had burning in her chest), BED REST (stayed in bed for a few days) and VACCINATION COMPLICATION (not feeling well/ did not feel great) was resolving and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days after the first dose without receiving the second dose) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood glucose: up (High) Had blood sugar levels up for 6 months. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered BED REST (stayed in bed for a few days) to be possibly related. No further causality assessments were provided for DEATH (she found her mother dead on her bed), DYSPNOEA (shortness of breath/ it was the worst ever), CHEST PAIN (the patient had burning in her chest), VACCINATION COMPLICATION (not feeling well/ did not feel great) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (More than 36 days after the first dose without receiving the second dose). It was reported that treatment was not taken by the patient. Caller states that she took her mother to take her second vaccination with the Moderna Covid19 vaccine on 15September2021.After the vaccine, she had some side effects: At first she stayed in bed for a few days, not feeling well, she had some side effects and didn't feel great. It took her 3 days to get out of bed, she had shortness of breath but was feeling good. Caller also stated that the patient had burning in her chest: The patient stated she never felt anything like the burning in her chest that she felt those 3 days, and also felt shortness of breath. Stated "it was the worst ever". After those 3 days she got up and started moving around for a couple of days. And caller states that 9 days after, on 24September2021, she found her mother dead on her bed. Patient did not see any doctor for months, she was fine, and there was no diagnose made by a doctor on the cause. Patient did not receive any treatment, she had side effects and didn't feel well, but started feeling better and thought everything was better. She did not have a prior diagnose of Covid or Myocarditis or Pericarditis, and did not experience symptoms like this before. Company Comment: This case concerns a 65 year-old female patient with no relevant medical history, who experienced the unexpected fatal event of Death (unknown cause). The event occurred approximately one week after the second dose of mRNA-1273 vaccine. the cause of death is unknown, however the non-serious events of shortness of breath and chest pain may have contributed to the event and fatal outcome. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Sender's Comments: This case concerns a 65 year-old female patient with no relevant medical history, who experienced the unexpected fatal event of Death (unknown cause). The event occurred approximately one week after the second dose of mRNA-1273 vaccine. the cause of death is unknown, however the non-serious events of shortness of breath and chest pain may have contributed to the event and fatal outcome. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report.; Reported Cause(s) of Death: unknown cause of death

Other Meds: GABAPENTIN; FLEXERIL [CEFIXIME]; RISPERIDONE; INSULIN

Current Illness: Blood sugar increased (took Insulin because she had her blood sugar levels up for 6 months)

ID: 1790378
Sex: F
Age: 28
State: MI

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

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

Lab Data:

Allergies:

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

Symptoms: sore left injection site arm; fever; fatigue; joint pain; Swollen lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore left injection site arm), PYREXIA (fever), FATIGUE (fatigue), ARTHRALGIA (joint pain) and LYMPHADENOPATHY (Swollen lymph nodes) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 03-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Sep-2021, the patient experienced PAIN IN EXTREMITY (sore left injection site arm), PYREXIA (fever), FATIGUE (fatigue), ARTHRALGIA (joint pain) and LYMPHADENOPATHY (Swollen lymph nodes). On 04-Sep-2021, PAIN IN EXTREMITY (sore left injection site arm), PYREXIA (fever), FATIGUE (fatigue), ARTHRALGIA (joint pain) and LYMPHADENOPATHY (Swollen lymph nodes) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication included Birth Control. No treatment information provided. This case was linked to MOD-2021-343341 (Patient Link).

Other Meds:

Current Illness:

ID: 1790379
Sex: F
Age: 58
State: CA

Vax Date: 10/04/2021
Onset Date: 10/04/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: Patient received a dose of Moderna vaccine from a vial that had been punctured for more than 12 hours.; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received a dose of Moderna vaccine from a vial that had been punctured for more than 12 hours.) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037F21A) for COVID-19 vaccination. No Medical History information was reported. On 04-Oct-2021, 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 04-Oct-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received a dose of Moderna vaccine from a vial that had been punctured for more than 12 hours.). On 04-Oct-2021, EXPIRED PRODUCT ADMINISTERED (Patient received a dose of Moderna vaccine from a vial that had been punctured for more than 12 hours.) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The pharmacist stated that the patient claimed to be immuno-comprormised.

Other Meds:

Current Illness:

ID: 1790380
Sex: F
Age: 28
State: MI

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

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

Lab Data: Test Date: 20211004; Test Name: body temperature; Result Unstructured Data: 99 to 101.1 degrees Farenheight

Allergies:

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

Symptoms: extreme vomiting; Fever of 99 to 101.1 degrees Farenheight; joint pain in both legs/joint pain in both knees; headache; chills; nausea; sore right injection site arm; swollen lymph node in her right arm; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (extreme vomiting), PYREXIA (Fever of 99 to 101.1 degrees Farenheight), ARTHRALGIA (joint pain in both legs/joint pain in both knees), HEADACHE (headache) and CHILLS (chills) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 03-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Oct-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Oct-2021, the patient experienced VOMITING (extreme vomiting), PYREXIA (Fever of 99 to 101.1 degrees Farenheight), ARTHRALGIA (joint pain in both legs/joint pain in both knees), HEADACHE (headache), CHILLS (chills), NAUSEA (nausea), MYALGIA (sore right injection site arm) and LYMPHADENOPATHY (swollen lymph node in her right arm). At the time of the report, VOMITING (extreme vomiting), PYREXIA (Fever of 99 to 101.1 degrees Farenheight), ARTHRALGIA (joint pain in both legs/joint pain in both knees), HEADACHE (headache), CHILLS (chills), NAUSEA (nausea), MYALGIA (sore right injection site arm) and LYMPHADENOPATHY (swollen lymph node in her right arm) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Oct-2021, Body temperature: 99 to 101.1 (High) 99 to 101.1 degrees Farenheight. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications include Birth control pills. Treatment medications were not reported. This case was linked to MOD-2021-343259 (Patient Link).

Other Meds:

Current Illness:

ID: 1790381
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: Swollen lips; her eyelids and lips were swollen; allergic reaction to the first dose; This spontaneous case was reported by an other health care professional and describes the occurrence of LIP SWELLING (Swollen lips), EYE SWELLING (her eyelids and lips were swollen) and ALLERGY TO VACCINE (allergic reaction to the first dose) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Histamine intolerance, Multiple sclerosis and Immunocompromised. On 05-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 LIP SWELLING (Swollen lips), EYE SWELLING (her eyelids and lips were swollen) and ALLERGY TO VACCINE (allergic reaction to the first dose). At the time of the report, LIP SWELLING (Swollen lips), EYE SWELLING (her eyelids and lips were swollen) and ALLERGY TO VACCINE (allergic reaction to the first dose) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Patient had anaphylactic reaction to tetanus toxoid and the shingles vaccine. The patient have pre serious allergic reactions so, to manage the allergic reaction she received five injections in a step wise manner three in one arm and two in another in 15-minute intervals. After the third injection, she did feelsome tingling in her arm, but it resolved on its own. No concomitants were reported. No treatment drugs were reported.

Other Meds:

Current Illness: Histamine intolerance; Immunocompromised; Multiple sclerosis

ID: 1790382
Sex: F
Age: 59
State: FL

Vax Date: 02/12/2021
Onset Date: 02/01/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: itchy rash at the injection site; itchy rash at the injection site/itchy rash at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PRURITUS (itchy rash at the injection site) and VACCINATION SITE RASH (itchy rash at the injection site/itchy rash at the injection site) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The patient's past medical history included Immunoglobulins increased. Concurrent medical conditions included Bug bite (bug bite allergy). On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced VACCINATION SITE PRURITUS (itchy rash at the injection site) and VACCINATION SITE RASH (itchy rash at the injection site/itchy rash at the injection site). In March 2021, VACCINATION SITE PRURITUS (itchy rash at the injection site) and VACCINATION SITE RASH (itchy rash at the injection site/itchy rash at the injection site) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. No concomitant medications provided. No treatment medication was reported for the events happened for first dose. This case was linked to MOD-2021-343352 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 05-Oct-2021: Non Significant Follow Up received contains picture.

Other Meds:

Current Illness: Bug bite (bug bite allergy)

ID: 1790383
Sex: F
Age: 59
State: FL

Vax Date: 02/12/2021
Onset Date: 03/12/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Date: 20210324; Test Name: Biopsy; Test Result: Negative; Result Unstructured Data: negative for shingles.

Allergies:

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

Symptoms: itchy rash at the injection site/itchy rash at the injection site; itchy rash (looked like prickly heat) on her lower back/itchy rash on her shoulder blades; red rash (looked like prickly heat) on her lower back; lower back pain/sharp pain in her lower back; itchy rash at the injection site; rash on lower back that itched and burned; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (rash on lower back that itched and burned), RASH PRURITIC (itchy rash (looked like prickly heat) on her lower back/itchy rash on her shoulder blades), RASH ERYTHEMATOUS (red rash (looked like prickly heat) on her lower back), BACK PAIN (lower back pain/sharp pain in her lower back) and VACCINATION SITE PRURITUS (itchy rash at the injection site) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 031L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Hives. Concurrent medical conditions included Shellfish allergy (patient experienced diarrhea for shellfish allergy). On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced BURNING SENSATION (rash on lower back that itched and burned). On 13-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (itchy rash at the injection site). On 14-Mar-2021, the patient experienced RASH PRURITIC (itchy rash (looked like prickly heat) on her lower back/itchy rash on her shoulder blades), RASH ERYTHEMATOUS (red rash (looked like prickly heat) on her lower back) and BACK PAIN (lower back pain/sharp pain in her lower back). On an unknown date, the patient experienced VACCINATION SITE RASH (itchy rash at the injection site/itchy rash at the injection site). The patient was treated with LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL) for Itching, at a dose of 5 milligram; BETAMETHASONE DIPROPIONATE (topical) for Rash, at an unspecified dose and frequency; CLOBETASOL PROPIONATE ongoing from 24-Mar-2021 for Rash, at an unspecified dose and frequency; MONOLAURIN [GLYCERINE MONOLAURATE] for Shingles, at an unspecified dose and frequency; L-LYSINE [LYSINE] for Shingles, at an unspecified dose and frequency; PREDNISONE (oral) for Adverse event, at a dose of methyl prednisone and Physical therapy for Back pain. At the time of the report, BURNING SENSATION (rash on lower back that itched and burned), RASH PRURITIC (itchy rash (looked like prickly heat) on her lower back/itchy rash on her shoulder blades), RASH ERYTHEMATOUS (red rash (looked like prickly heat) on her lower back), VACCINATION SITE PRURITUS (itchy rash at the injection site) and VACCINATION SITE RASH (itchy rash at the injection site/itchy rash at the injection site) was resolving and BACK PAIN (lower back pain/sharp pain in her lower back) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Mar-2021, Biopsy: negative for shingles (Negative) negative for shingles. Patient concomitant medication included natrol biotin at a dose of 5000 microgram from 2019 On 05/Oct/2021, a consumer reported that she had a severe reaction to bug bites and had a high immunoglobulin level. She took no medications On 15-Mar-2021, the patient went to chiropractor, who did an adjustment which worked, but did not help. On an unknown date, the patient went to orthopedic and they did not find anything wrong. The patient was given steroid shot (methyl prednisone) and physical therapy three times a week. The patient was not pregnant. This case was linked to MOD-2021-343345 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 05-Oct-2021: Follow up received contains no new clinically significant information. On 08-Oct-2021: significant follow up received.patient demography updated. patient allergy added. patient medical history added. lab data updated. concomitant product received.treatment information updated. event burning sensation added. event assessment updated. outcome of event back pain changed from unknown to not recovered. outcome of remaining events changed from unknown to recovering

Other Meds:

Current Illness: Shellfish allergy (patient experienced diarrhea for shellfish allergy).

ID: 1790384
Sex: U
Age:
State: FL

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

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: itchy rash; 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 RASH PRURITIC (itchy rash) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (itchy rash). At the time of the report, RASH PRURITIC (itchy rash) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were reported. No treatment medications were reported. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1790385
Sex: F
Age:
State: FL

Vax Date: 04/23/2021
Onset Date:
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: She has had outbreaks on her skin, then it appears on her back; It feels like a burning sensation It is spreading to part of her leg; it caused her depression; Her leg is becoming sensitive; had a horrible rash under her breast, in between her chest, which spread all over her back, and her forehead; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISORDER (She has had outbreaks on her skin, then it appears on her back), BURNING SENSATION (It feels like a burning sensation It is spreading to part of her leg), DEPRESSION (it caused her depression), SENSITIVE SKIN (Her leg is becoming sensitive) and RASH (had a horrible rash under her breast, in between her chest, which spread all over her back, and her forehead) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination. No Medical History information was reported. On 23-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced SKIN DISORDER (She has had outbreaks on her skin, then it appears on her back), BURNING SENSATION (It feels like a burning sensation It is spreading to part of her leg), DEPRESSION (it caused her depression), SENSITIVE SKIN (Her leg is becoming sensitive) and RASH (had a horrible rash under her breast, in between her chest, which spread all over her back, and her forehead). At the time of the report, SKIN DISORDER (She has had outbreaks on her skin, then it appears on her back), BURNING SENSATION (It feels like a burning sensation It is spreading to part of her leg), DEPRESSION (it caused her depression), SENSITIVE SKIN (Her leg is becoming sensitive) and RASH (had a horrible rash under her breast, in between her chest, which spread all over her back, and her forehead) outcome was unknown. Patient went to a dermatologist and she was given some medications. No treatment and concomitant medications were provided. Action taken with mRNA-1273 in response to the event was not applicable. This case was linked to MOD-2021-060501, MOD-2021-060501.

Other Meds:

Current Illness:

ID: 1790386
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Headache, Heart rate increased, Injection site erythema, Injection site pain, Injection site swelling

Symptoms: she suffered a stroke; blood clots after the 2nd shot; she lost her speech for a while; This spontaneous case was reported by a consumer and describes the occurrence of CEREBROVASCULAR ACCIDENT (she suffered a stroke) and THROMBOSIS (blood clots after the 2nd shot) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 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 CEREBROVASCULAR ACCIDENT (she suffered a stroke) (seriousness criterion medically significant), THROMBOSIS (blood clots after the 2nd shot) (seriousness criterion medically significant) and APHASIA (she lost her speech for a while). At the time of the report, CEREBROVASCULAR ACCIDENT (she suffered a stroke), THROMBOSIS (blood clots after the 2nd shot) and APHASIA (she lost her speech for a while) outcome was unknown. Concomitant medications was not provided by the reporter Treatment information was not provided Company Comment : This case concerns a female patient of unknown age with no reported medical history, who experienced the unexpected serious events of stroke and blood clots. The events occurred an unknown number of days after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Details are limited for the events and additional information is not expected.; Sender's Comments: This case concerns a female patient of unknown age with no reported medical history, who experienced the unexpected serious events of stroke and blood clots. The events occurred an unknown number of days after the second dose of mRNA-1273 vaccine. The benefit-risk relationship of mRNA-1273 vaccine is not affected by this report. Details are limited for the events and additional information is not expected.

Other Meds:

Current Illness:

ID: 1790387
Sex: M
Age: 72
State: NJ

Vax Date: 08/19/2021
Onset Date: 08/19/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Name: antibody reactive result of 012; Result Unstructured Data: antibody reactive result of 012

Allergies:

Symptom List: Nausea

Symptoms: a little soreness at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (a little soreness at the injection site) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 19-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Aug-2021, the patient experienced VACCINATION SITE PAIN (a little soreness at the injection site). In August 2021, VACCINATION SITE PAIN (a little soreness at the injection site) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Antibody test: 012 (abnormal) antibody reactive result of 012. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication were reported. No treatment information was provided by the reporter. It was reported that the patient had just a little soreness at the injection site, started immediately and went away after a week.

Other Meds:

Current Illness:

ID: 1790388
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: Adverse reaction to Moderna vaccine; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Adverse reaction to Moderna vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (Adverse reaction to Moderna vaccine). At the time of the report, VACCINATION COMPLICATION (Adverse reaction to Moderna vaccine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Most recent FOLLOW-UP information incorporated above includes: On 05-Oct-2021: Follow up received contains no new information. On 06-Oct-2021: Follow up received contains no new information.

Other Meds:

Current Illness:

ID: 1790389
Sex: U
Age:
State: TN

Vax Date:
Onset Date: 10/06/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: few people in my church started getting Covid; 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 COVID-19 (few people in my church started getting Covid) 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. In 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Oct-2021, the patient experienced COVID-19 (few people in my church started getting Covid). At the time of the report, COVID-19 (few people in my church started getting Covid) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Reporter stated that even though vaccinated few people in his church got COVID-19 and none of them had to be in Hospital. No relevant concomitant medications were reported. No treatment information was provided.; Sender's Comments: This spontaneous report concerns patients of unknown age and gender with no relevant medical history who experienced non-serious AESI event of COVID-19. The event occurred after an unknown duration following vaccination with mRNA-1273. The reporter stated that the patients were vaccinated, however still contracted COVID-19 infection. Re-challenge is unknown as there is no information on the vaccine doses. The benefit-risk relationship of mRNA-1273 is not affected by this report. Based on the available information, the case has been classified as invalid.

Other Meds:

Current Illness:

ID: 1790390
Sex: F
Age: 77
State:

Vax Date: 09/03/2021
Onset Date: 09/12/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: rash/rash in stomach; rash in injected arm; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 06-Oct-2021 and was forwarded to Moderna on 06-Oct-2021. This spontaneous case was reported by a consumer and describes the occurrence of RASH (rash/rash in stomach) and VACCINATION SITE RASH (rash in injected arm) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 03-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Sep-2021, the patient experienced RASH (rash/rash in stomach) and VACCINATION SITE RASH (rash in injected arm). At the time of the report, RASH (rash/rash in stomach) and VACCINATION SITE RASH (rash in injected arm) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment medications were reported. Patient's symptoms subsided after a coupe of weeks.

Other Meds:

Current Illness:

ID: 1790391
Sex: M
Age: 58
State: OH

Vax Date: 03/24/2021
Onset Date: 10/01/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data: Test Date: 20211001; Test Name: COVID-19 virus test; Test Result: Positive ; Result Unstructured Data: Positive

Allergies:

Symptom List: Tremor

Symptoms: Chest discomfort; Pyrexia; Headache; Tested positive for COVID after vaccination; Lack of efficacy; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Tested positive for COVID after vaccination), DRUG INEFFECTIVE (Lack of efficacy), CHEST DISCOMFORT (Chest discomfort), PYREXIA (Pyrexia) and HEADACHE (Headache) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 037A21B) for COVID-19 vaccination. Concurrent medical conditions included Asthma and Hepatitis C. On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 01-Oct-2021, the patient experienced COVID-19 (Tested positive for COVID after vaccination) and DRUG INEFFECTIVE (Lack of efficacy). On an unknown date, the patient experienced CHEST DISCOMFORT (Chest discomfort), PYREXIA (Pyrexia) and HEADACHE (Headache). At the time of the report, COVID-19 (Tested positive for COVID after vaccination), DRUG INEFFECTIVE (Lack of efficacy), CHEST DISCOMFORT (Chest discomfort), PYREXIA (Pyrexia) and HEADACHE (Headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Oct-2021, SARS-CoV-2 test positive: positive (Positive) Positive. No concomitant medication was reported by the reporter. No treatment was reported by the reporter.; Sender's Comments: This case concerns a 58-year-old male patient with medical history of Asthma and Hepatitis C, who experienced the unexpected events of SARS-CoV test positive and chest discomfort, and the expected events of pyrexia and headache. Latency 6 months and 8 days after the first dose of mRNA-1273. Drug ineffective was considered as an additional event. The rechallenge was not applicable, as no additional dosing will be given. The medical history of Asthma could be potentially confounder for the event of chest discomfort. The benefit-risk relationship of vaccine in not affected by this report. The case was assessed as non-serious based on reported seriousness and medical judgement.

Other Meds:

Current Illness: Asthma; Hepatitis C

ID: 1790392
Sex: U
Age:
State: VA

Vax Date: 01/30/2021
Onset Date: 09/07/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: The doses are greater than 42 days apart; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The doses are greater than 42 days apart) 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 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Sep-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The doses are greater than 42 days apart). On 07-Sep-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (The doses are greater than 42 days apart) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication was reported. No treatment information was reported. Most recent FOLLOW-UP information incorporated above includes: On 06-Oct-2021: Follow up document received contain no new information.

Other Meds:

Current Illness:

ID: 1790393
Sex: F
Age: 35
State: FL

Vax Date: 09/26/2021
Onset Date:
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: face became red/arms became red all over/legs turned red up to below their knees/all their body joints including, fingers, ankles and elbows were dark red/face and ears turned red, starting in their forehead/arms turned red again, reaching the elbows; face became swollen; between the index fingers and their thumbs, became swollen; between the index fingers and their thumbs hurts/hurts to separate those fingers/buttocks and the back of their legs hurt; between the index fingers and their thumbsthey have a tingling sensation/right hand has the tingling sensation again; between the index fingers and their thumbs feels like cramping; area between those fingers is dark, with red parts and bluish parts/the index finger is dark in the knuckle section/buttocks, had hot dark areas/soles of their feet were colored from pink to purple/bottom and top eyelids pur/cheeks and nose got purp; itchiness in their belly/itchiness in their knees; knees were dark and swollen; the back of their head and neck felt weird like something was squeezing their head; face turned hot; bottom and top eyelids swelled up; felt like having sinusitis; buttocks and the back of their legs, till the knees, hurt and were hot; Head felt tight, feeling compression in their head/then the back of their head and neck felt weird like something was squeezing their head; knees, hurt; body aches; tired; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (face became red/arms became red all over/legs turned red up to below their knees/all their body joints including, fingers, ankles and elbows were dark red/face and ears turned red, starting in their forehead/arms turned red again, reaching the elbows), SWELLING FACE (face became swollen), PERIPHERAL SWELLING (between the index fingers and their thumbs, became swollen), PAIN IN EXTREMITY (between the index fingers and their thumbs hurts/hurts to separate those fingers/buttocks and the back of their legs hurt) and PARAESTHESIA (between the index fingers and their thumbsthey have a tingling sensation/right hand has the tingling sensation again) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050F21A) 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 vitamin C, ZINC, omega 3 and Vitamin D3&K2 for an unknown indication. On 26-Sep-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 ERYTHEMA (face became red/arms became red all over/legs turned red up to below their knees/all their body joints including, fingers, ankles and elbows were dark red/face and ears turned red, starting in their forehead/arms turned red again, reaching the elbows), SWELLING FACE (face became swollen), PERIPHERAL SWELLING (between the index fingers and their thumbs, became swollen), PAIN IN EXTREMITY (between the index fingers and their thumbs hurts/hurts to separate those fingers/buttocks and the back of their legs hurt), PARAESTHESIA (between the index fingers and their thumbsthey have a tingling sensation/right hand has the tingling sensation again), MUSCLE SPASMS (between the index fingers and their thumbs feels like cramping), SKIN DISCOLOURATION (area between those fingers is dark, with red parts and bluish parts/the index finger is dark in the knuckle section/buttocks, had hot dark areas/soles of their feet were colored from pink to purple/bottom and top eyelids pur/cheeks and nose got purp), PRURITUS (itchiness in their belly/itchiness in their knees), JOINT SWELLING (knees were dark and swollen), MUSCULOSKELETAL DISCOMFORT (the back of their head and neck felt weird like something was squeezing their head), FEELING HOT (face turned hot), SWELLING OF EYELID (bottom and top eyelids swelled up), FEELING ABNORMAL (felt like having sinusitis), MUSCULOSKELETAL PAIN (buttocks and the back of their legs, till the knees, hurt and were hot), HEAD DISCOMFORT (Head felt tight, feeling compression in their head/then the back of their head and neck felt weird like something was squeezing their head), ARTHRALGIA (knees, hurt), MYALGIA (body aches) and FATIGUE (tired). At the time of the report, ERYTHEMA (face became red/arms became red all over/legs turned red up to below their knees/all their body joints including, fingers, ankles and elbows were dark red/face and ears turned red, starting in their forehead/arms turned red again, reaching the elbows), SWELLING FACE (face became swollen), PERIPHERAL SWELLING (between the index fingers and their thumbs, became swollen), PAIN IN EXTREMITY (between the index fingers and their thumbs hurts/hurts to separate those fingers/buttocks and the back of their legs hurt), PARAESTHESIA (between the index fingers and their thumbsthey have a tingling sensation/right hand has the tingling sensation again), MUSCLE SPASMS (between the index fingers and their thumbs feels like cramping), SKIN DISCOLOURATION (area between those fingers is dark, with red parts and bluish parts/the index finger is dark in the knuckle section/buttocks, had hot dark areas/soles of their feet were colored from pink to purple/bottom and top eyelids pur/cheeks and nose got purp), PRURITUS (itchiness in their belly/itchiness in their knees), JOINT SWELLING (knees were dark and swollen), MUSCULOSKELETAL DISCOMFORT (the back of their head and neck felt weird like something was squeezing their head), FEELING HOT (face turned hot), SWELLING OF EYELID (bottom and top eyelids swelled up), FEELING ABNORMAL (felt like having sinusitis), MUSCULOSKELETAL PAIN (buttocks and the back of their legs, till the knees, hurt and were hot), HEAD DISCOMFORT (Head felt tight, feeling compression in their head/then the back of their head and neck felt weird like something was squeezing their head), ARTHRALGIA (knees, hurt), MYALGIA (body aches) and FATIGUE (tired) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. NO treatment medication was reported

Other Meds: vitamin C; ZINC; omega 3; Vitamin D3&K2

Current Illness:

ID: 1790394
Sex: F
Age: 17
State: AL

Vax Date: 09/06/2021
Onset Date:
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Cough, Limb discomfort, Pain, SARS-CoV-2 test positive

Symptoms: has not administered the second dose/ to give the second dose but it is considered off-label; This spontaneous case was reported by a pharmacist and describes the occurrence of OFF LABEL USE (has not administered the second dose/ to give the second dose but it is considered off-label) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039B21A) for COVID-19 vaccination. No Medical History information was reported. On 06-Sep-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 OFF LABEL USE (has not administered the second dose/ to give the second dose but it is considered off-label). At the time of the report, OFF LABEL USE (has not administered the second dose/ to give the second dose but it is considered off-label) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Reporter stated that the Pharmacy staff did not notice the deviation until the patient came back to get her second dose on 03-OCT-2021. Pharmacist has not administered the second dose to the patient. No relevant concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1790395
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: his upper lip swollen, most of his whole upper lip and right side of his jaw; jaw are swollen, most of his whole upper lip and right side of his jaw.; He states he doesn't feel good; thinks it could be an allergic reaction; This spontaneous case was reported by a consumer and describes the occurrence of LIP SWELLING (his upper lip swollen, most of his whole upper lip and right side of his jaw), SWELLING FACE (jaw are swollen, most of his whole upper lip and right side of his jaw.), FEELING ABNORMAL (He states he doesn't feel good) and HYPERSENSITIVITY (thinks it could be an allergic reaction) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The medical history was not provided by the reporter. On 05-Oct-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 LIP SWELLING (his upper lip swollen, most of his whole upper lip and right side of his jaw), SWELLING FACE (jaw are swollen, most of his whole upper lip and right side of his jaw.), FEELING ABNORMAL (He states he doesn't feel good) and HYPERSENSITIVITY (thinks it could be an allergic reaction). At the time of the report, LIP SWELLING (his upper lip swollen, most of his whole upper lip and right side of his jaw), SWELLING FACE (jaw are swollen, most of his whole upper lip and right side of his jaw.), FEELING ABNORMAL (He states he doesn't feel good) and HYPERSENSITIVITY (thinks it could be an allergic reaction) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant information was provided by the reporter. No treatment information was provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1790396
Sex: F
Age:
State: CA

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

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

Lab Data:

Allergies:

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

Symptoms: Improper steps prior to administration/vial was turned up and down a couple times; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT PREPARATION ERROR (Improper steps prior to administration/vial was turned up and down a couple times) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT PREPARATION ERROR (Improper steps prior to administration/vial was turned up and down a couple times). At the time of the report, PRODUCT PREPARATION ERROR (Improper steps prior to administration/vial was turned up and down a couple times) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were mentioned. No treatment details were reported. Caller reported that the patient stated, when the vaccine was brought out of the refrigerator, it was not left at room temperature for 15 minutes before it was administered. Also that she felt the bottle was still cold and frosty and that the vaccine provider did not gently swirl the bottle, but they turned the bottle up and down a couple times like they do for the Pfizer Covid-19 vaccine.

Other Meds:

Current Illness:

ID: 1790397
Sex: F
Age:
State: VA

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

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

Lab Data:

Allergies:

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

Symptoms: Tingling; Numbness; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling) and HYPOAESTHESIA (Numbness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PARAESTHESIA (Tingling) and HYPOAESTHESIA (Numbness). At the time of the report, PARAESTHESIA (Tingling) and HYPOAESTHESIA (Numbness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant product use was provided by the reporter. No treatment medication was provided.

Other Meds:

Current Illness:

ID: 1790398
Sex: F
Age: 55
State: IL

Vax Date: 07/21/2021
Onset Date: 08/19/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: Now it is getting progressively worst.; her shoulder pops out of joint; If she puts in certain position, it freezes up and it feels like a TMJ./it's hard for her to hold both arms in the air after receiving 2 doses of vaccine/can't lay on her left side at all; complaints of muscle lock./can't lay on her left side at all.; It's hard for her to get her job done.; After receiving 2nd dose, next day, her muscle pain got worse from 1st dose.; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (After receiving 2nd dose, next day, her muscle pain got worse from 1st dose.), PAIN (Now it is getting progressively worst.), JOINT DISLOCATION (her shoulder pops out of joint), MOBILITY DECREASED (If she puts in certain position, it freezes up and it feels like a TMJ./it's hard for her to hold both arms in the air after receiving 2 doses of vaccine/can't lay on her left side at all) and MUSCLE SPASMS (complaints of muscle lock./can't lay on her left side at all.) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053E71A and 048C21A) 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 ATENOLOL, PROGESTERONE and ESTRADIOL for an unknown indication. On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 19-Aug-2021, the patient experienced PAIN IN EXTREMITY (After receiving 2nd dose, next day, her muscle pain got worse from 1st dose.). On an unknown date, the patient experienced PAIN (Now it is getting progressively worst.), JOINT DISLOCATION (her shoulder pops out of joint), MOBILITY DECREASED (If she puts in certain position, it freezes up and it feels like a TMJ./it's hard for her to hold both arms in the air after receiving 2 doses of vaccine/can't lay on her left side at all), MUSCLE SPASMS (complaints of muscle lock./can't lay on her left side at all.) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (It's hard for her to get her job done.). The patient was treated with NAPROXEN SODIUM (ALEVE) for Adverse event, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (After receiving 2nd dose, next day, her muscle pain got worse from 1st dose.), PAIN (Now it is getting progressively worst.), JOINT DISLOCATION (her shoulder pops out of joint), MOBILITY DECREASED (If she puts in certain position, it freezes up and it feels like a TMJ./it's hard for her to hold both arms in the air after receiving 2 doses of vaccine/can't lay on her left side at all), MUSCLE SPASMS (complaints of muscle lock./can't lay on her left side at all.) and LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (It's hard for her to get her job done.) outcome was unknown. This case was linked to MOD-2021-343734 (Patient Link).

Other Meds: ATENOLOL; PROGESTERONE; ESTRADIOL

Current Illness:

ID: 1790399
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: aches; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (aches) 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 third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MYALGIA (aches). At the time of the report, MYALGIA (aches) outcome was unknown. No concomitant medication provided. No treatment information given. The reporter wants to know that whether patient can take Advil or not. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1790400
Sex: F
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Consciousness fluctuating, Crying, Dry skin, Epistaxis, Headache

Symptoms: Fever; This spontaneous case was reported by a physician and describes the occurrence of PYREXIA (Fever) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Myasthenia gravis. Concomitant products included PREDNISONE for Myasthenia gravis. On 29-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 24-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 PYREXIA (Fever). At the time of the report, PYREXIA (Fever) outcome was unknown. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not provided. Treatment medications were not provided. This case was linked to MOD-2021-339089 (Patient Link).

Other Meds: PREDNISONE

Current Illness: Myasthenia gravis

ID: 1790401
Sex: F
Age: 55
State: IL

Vax Date: 07/21/2021
Onset Date: 07/21/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Hypotonia, Lethargy, Respiratory rate decreased, Screaming, Skin warm

Symptoms: This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm started hurting after 2-3 hours/ it's hard for her to hold both arms in the air after receiving 2 doses of vaccine) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048C21A and 053E71A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included ATENOLOL, PROGESTERONE and ESTRADIOL for an unknown indication. On 21-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 18-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-Jul-2021, the patient experienced PAIN IN EXTREMITY (arm started hurting after 2-3 hours/ it's hard for her to hold both arms in the air after receiving 2 doses of vaccine). The patient was treated with NAPROXEN SODIUM (ALEVE) for Adverse event, at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (arm started hurting after 2-3 hours/ it's hard for her to hold both arms in the air after receiving 2 doses of vaccine) outcome was unknown. This case was linked to MOD-2021-343679 (Patient Link).

Other Meds: ATENOLOL; PROGESTERONE; ESTRADIOL

Current Illness:

ID: 1790402
Sex: M
Age:
State: FL

Vax Date:
Onset Date: 10/06/2021
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: This spontaneous case reported by a consumer, describes the occurrence of memory impairment in a male patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On Oct 6, 2021, patient experienced memory impairment. At the time of the report, memory impairment outcome: unknown. No concomitant medications or treatment information reported.

Other Meds:

Current Illness:

ID: 1790403
Sex: F
Age:
State: SC

Vax Date: 02/05/2021
Onset Date:
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: congestive heart failure/fluid build up/could hardly breath; Anemic; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CARDIAC FAILURE CONGESTIVE (congestive heart failure/fluid build up/could hardly breath) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced CARDIAC FAILURE CONGESTIVE (congestive heart failure/fluid build up/could hardly breath) (seriousness criterion medically significant) and ANAEMIA (Anemic). The patient was treated with FUROSEMIDE (LASIX [FUROSEMIDE]) for Congestive heart failure, at an unspecified dose and frequency. At the time of the report, CARDIAC FAILURE CONGESTIVE (congestive heart failure/fluid build up/could hardly breath) and ANAEMIA (Anemic) outcome was unknown. No concomitant medication was reported. Patient had first shot in 05-Feb-2021 and second shot 05-Mar-2021. One month later patient was diagnosed with congestive heart failure. Patient went to hospital could not find anything wrong. Later found that she had fluid buildup that required two trips to the doctor to drain the fluid. She was given Lasix injections since it got so bad, she could hardly breath no other symptoms. She was also found to be anemic and given blood then sent to GI doctor. She thinks in second week in month of April, she was vaccinated in the right arm. Company Comment: This case refers to a female patient of unknown age with no relevant medical history who experienced the unexpected event of Cardiac Failure Congestive which occurred on an unknown date after exposure to Moderna COVID-19 Vaccine. Rechallenge was assessed as not applicable as there was only one episode reported. No causality assessment was provided by the reporter. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.; Sender's Comments: This case refers to a female patient of unknown age with no relevant medical history who experienced the unexpected event of Cardiac Failure Congestive which occurred on an unknown date after exposure to Moderna COVID-19 Vaccine. Rechallenge was assessed as not applicable as there was only one episode reported. No causality assessment was provided by the reporter. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.

Other Meds:

Current Illness:

ID: 1790404
Sex: U
Age:
State: MI

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

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

Lab Data:

Allergies:

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

Symptoms: Vials which undergone temperature excursion might have been administered to patients; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT STORAGE ERROR (Vials which undergone temperature excursion might have been administered to patients) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) 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 PRODUCT STORAGE ERROR (Vials which undergone temperature excursion might have been administered to patients). At the time of the report, PRODUCT STORAGE ERROR (Vials which undergone temperature excursion might have been administered to patients) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant product was provided by the reporter. No treatment medication was provided.

Other Meds:

Current Illness:

ID: 1790405
Sex: F
Age:
State: FL

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

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: bit foggy headed; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (bit foggy headed) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), ESCITALOPRAM OXALATE (LEXAPRO) and VITAMIN D NOS for an unknown indication. 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 FEELING ABNORMAL (bit foggy headed). At the time of the report, FEELING ABNORMAL (bit foggy headed) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment medication was provided for 1 st Dose This case was linked to MOD-2021-343986, MOD-2021-343987, MOD-2021-343986 (Patient Link).

Other Meds: SYNTHROID; LEXAPRO; VITAMIN D NOS

Current Illness:

Date Died:

ID: 1790406
Sex: M
Age:
State: PA

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

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

Lab Data:

Allergies:

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

Symptoms: he had COVID; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (he had COVID) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Fracture, Liver disorder and Dialysis (he was on a dialysis machine for his kidneys). Concurrent medical conditions included Congestive heart failure. 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 COVID-19 (he had COVID) (seriousness criterion death). The reported cause of death was he had Covid. It is unknown if an autopsy was performed. Concomitant medications was not provided by the reporter Treatment information was not provided He ended up contracting COVID which pushed all these pre-existing conditions to the max and led to his death. Company Comment: This case refers to a 61-year-old male patient with a medical history of liver disorder, congestive heart failure and on dialysis who experienced the unexpected event of COVID-19 at an unknown date after exposure to both doses of the Moderna COVID-19 Vaccine (dates of exposure for both doses not provided). Rechallenge was assessed as not applicable due to limited information. No causality assessment was provided by the reporter. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.; Sender's Comments: This case refers to a 61-year-old male patient with a medical history of liver disorder, congestive heart failure and on dialysis who experienced the unexpected event of COVID-19 at an unknown date after exposure to both doses of the Moderna COVID-19 Vaccine (dates of exposure for both doses not provided). Rechallenge was assessed as not applicable due to limited information. No causality assessment was provided by the reporter. The benefit-risk relationship of Moderna COVID-19 Vaccine is not affected by this report.; Reported Cause(s) of Death: he had COVID

Other Meds:

Current Illness: Congestive heart failure.

ID: 1790407
Sex: F
Age: 50
State: TX

Vax Date: 01/27/2021
Onset Date:
Rec V Date: 10/16/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Had a hard time lifting her arm/felt like a horse kicked her in the arm; Felt like had muscle failure in vaccinated arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE MOVEMENT IMPAIRMENT (Had a hard time lifting her arm/felt like a horse kicked her in the arm) and VACCINATION SITE REACTION (Felt like had muscle failure in vaccinated arm) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 012A21A) for COVID-19 vaccination. The patient's past medical history included Cancer. Concurrent medical conditions included Immunocompromised. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE MOVEMENT IMPAIRMENT (Had a hard time lifting her arm/felt like a horse kicked her in the arm) and VACCINATION SITE REACTION (Felt like had muscle failure in vaccinated arm). At the time of the report, VACCINATION SITE MOVEMENT IMPAIRMENT (Had a hard time lifting her arm/felt like a horse kicked her in the arm) and VACCINATION SITE REACTION (Felt like had muscle failure in vaccinated arm) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. No concomitant medication were reported. Treatment information were not provided. This case was linked to MOD-2021-343782 (Patient Link).

Other Meds:

Current Illness: Immunocompromised

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am