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: 1773432
Sex: M
Age:
State: FL

Vax Date: 05/19/2021
Onset Date:
Rec V Date: 10/09/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: It has been more than 36 days and the patient did not receive the second dose...He did not know that there was a limited amount of time to receive the second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION IN ERROR (It has been more than 36 days and the patient did not receive the second dose...He did not know that there was a limited amount of time to receive the second dose) in a 50-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination. No Medical History information was reported. On 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION IN ERROR (It has been more than 36 days and the patient did not receive the second dose...He did not know that there was a limited amount of time to receive the second dose). At the time of the report, PRODUCT DOSE OMISSION IN ERROR (It has been more than 36 days and the patient did not receive the second dose..He did not know that there was a limited amount of time to receive the second dose) had resolved. Patient date of birth given as 1971. Concomitant product information was not provided. Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 01-Oct-2021: Follow-up received, contains no new information. Corrected: event start date removed, event outcome updated to resolved and action taken updated to not applicable from initial.

Other Meds:

Current Illness:

ID: 1773433
Sex: M
Age:
State: MD

Vax Date: 05/27/2021
Onset Date: 06/24/2021
Rec V Date: 10/09/2021
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: Second dose outside the 30 day window, 4 days after 24-Jun-2021; Patients received doses from an expired vial; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (patients received doses from an expired vial) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose outside the 30 day window, 4 days after 24-Jun-2021) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054C21A and 054C21A) for COVID-19 vaccination. No Medical History information was reported. On 27-May-2021 at 3:20 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jun-2021 at 11:03 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Jun-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (patients received doses from an expired vial). On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose outside the 30 day window, 4 days after 24-Jun-2021). On 24-Jun-2021, EXPIRED PRODUCT ADMINISTERED (patients received doses from an expired vial) had resolved. At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose outside the 30 day window, 4 days after 24-Jun-2021) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided by reporter. Treatment medications were not provided by reporter. Most recent FOLLOW-UP information incorporated above includes: On 24-Aug-2021: Significant followup received included time of second dose vaccination details were updated and additional event of inappropriate schedule of vaccine administered

Other Meds:

Current Illness:

ID: 1773434
Sex: F
Age:
State: KY

Vax Date: 03/30/2021
Onset Date: 03/30/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data: Test Name: Body temperature; Result Unstructured Data: 99 something.

Allergies:

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

Symptoms: Ulcerative colitis; Swollen knee and leg; Severe cramping on the intestines; Pretty sick for 28 days; Swelling Left leg/Swelling of legs; Severe fatigue; abdominal cramp; loose stool; Sore arm; Very low grade fever (99. something); This spontaneous case was reported by a consumer and describes the occurrence of COLITIS ULCERATIVE (Ulcerative colitis), JOINT SWELLING (Swollen knee and leg), GASTROINTESTINAL PAIN (Severe cramping on the intestines), DIARRHOEA (loose stool) and ILLNESS (Pretty sick for 28 days) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Ulcerative colitis (Had been in remission for 4 years until Moderna shot) since 18-Jan-1999 and Drug allergy. Concomitant products included MESALAZINE (DELZICOL) from 20-Jan-1999 to an unknown date for Ulcerative colitis. On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Mar-2021, the patient experienced MYALGIA (Sore arm) and PYREXIA (Very low grade fever (99. something)). On 04-Apr-2021, the patient experienced DIARRHOEA (loose stool) and ABDOMINAL PAIN (abdominal cramp). On 06-Apr-2021, the patient experienced PERIPHERAL SWELLING (Swelling Left leg/Swelling of legs) and FATIGUE (Severe fatigue). On an unknown date, the patient experienced COLITIS ULCERATIVE (Ulcerative colitis), JOINT SWELLING (Swollen knee and leg), GASTROINTESTINAL PAIN (Severe cramping on the intestines) and ILLNESS (Pretty sick for 28 days). On 01-May-2021, DIARRHOEA (loose stool) and ABDOMINAL PAIN (abdominal cramp) had resolved. On 30-Jun-2021, PERIPHERAL SWELLING (Swelling Left leg/Swelling of legs) had resolved. On 05-Jul-2021, FATIGUE (Severe fatigue) had resolved. At the time of the report, COLITIS ULCERATIVE (Ulcerative colitis), JOINT SWELLING (Swollen knee and leg), GASTROINTESTINAL PAIN (Severe cramping on the intestines), ILLNESS (Pretty sick for 28 days), MYALGIA (Sore arm) and PYREXIA (Very low grade fever (99. something)) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: high (High) 99 something. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment medications were reported. The patient received first dose Moderna COVID-19 vaccine on 30-Mar2021 and on left, non-dominant arm and reported a swollen knee and leg was the same side vaccine was administered. It started with a sore arm, very low-grade fever (99. something), and then 4 to 5 days in the patient experienced severe cramping on the intestines and loose stool. Later the patient said the swelling on leg and knee started. The patient has an auto immune condition, ulcerative colitis. Was on remission until took the Moderna and it went back. Patient wanted to be fully vaccinated but was concerned as it was pretty sick for 28 days. It was reported that the patient experienced on first day of vaccine, mild fever and sore arm. Good after that. 4 to 5 days in severe abdominal cramping. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Most recent FOLLOW-UP information incorporated above includes: On 01-Oct-2021: follow up received on 01-OCT-2021 added Patient Information, Relevant medical history, Events and information (outcome, start date and stop) of evens updated.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: Delzicol

Current Illness: Drug allergy; Ulcerative colitis (Had been in remission for 4 years until Moderna shot).

ID: 1773435
Sex: U
Age: 37
State: CA

Vax Date: 06/17/2021
Onset Date: 07/16/2021
Rec V Date: 10/09/2021
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: Vaccine administered BUD (on day 32); This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine administered BUD (on day 32)) in a 37-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination. No Medical History information was reported. On 17-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jul-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine administered BUD (on day 32)). On 16-Jul-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine administered BUD (on day 32)) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant medication information was reported. No Treatment medications were provided. Patient has experienced no side effects with no unusual symptoms was reported. The 8 patients received a dose from a vial that was stored refrigerated for more than 30 days which was put in the fridge on 14Jun2021 and doses were administered on 16Jul2021 (on Day 32). No temperature excursion episodes occurred. Vial was kept between 36 and 45.9 degrees Fahrenheit, was reported. Most recent FOLLOW-UP information incorporated above includes: On 02-Oct-2021: Significant follow-up received on 04-OCT-2021 and included first dose information.

Other Meds:

Current Illness:

ID: 1773436
Sex: M
Age: 30
State: NY

Vax Date: 07/30/2021
Onset Date: 08/27/2021
Rec V Date: 10/09/2021
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: aches; fatigue; Administered 7 doses past 30 days in the fridge; This spontaneous case was reported by a physician and describes the occurrence of PAIN (aches), FATIGUE (fatigue) and EXPIRED PRODUCT ADMINISTERED (Administered 7 doses past 30 days in the fridge) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination. No Medical History information was reported. On 30-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Aug-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Administered 7 doses past 30 days in the fridge). On an unknown date, the patient experienced PAIN (aches) and FATIGUE (fatigue). On 27-Aug-2021, EXPIRED PRODUCT ADMINISTERED (Administered 7 doses past 30 days in the fridge) had resolved. At the time of the report, PAIN (aches) and FATIGUE (fatigue) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided. No treatment medication were provided. The vials were stored in the refrigerator on 03 May2021 and administered to the patient on 27 Aug 2021. Vials were placed in the refrigerator on 03 May2021 and were administered as recent as September 2021, some were vaccinated in August 2021 and 1 patient in September2021. Most recent FOLLOW-UP information incorporated above includes: On 29-Sep-2021: Follow up was received and the patient demographics was updated, second dose information was updated. On 01-Oct-2021: Follow up was received and the first dose information was updated. On 05-Oct-2021: Follow-up was received and new events aches and fatigue were updated.

Other Meds:

Current Illness:

ID: 1773437
Sex: M
Age: 61
State: CA

Vax Date: 03/28/2021
Onset Date: 08/20/2021
Rec V Date: 10/09/2021
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: tingling in the same arm; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (tingling in the same arm) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045A21A and 045A21A) for COVID-19 vaccination. Concurrent medical conditions included HIV disease. Concomitant products included BICTEGRAVIR SODIUM, EMTRICITABINE, TENOFOVIR ALAFENAMIDE FUMARATE (BIKTARVY) and ATORVASTATIN for an unknown indication. On 28-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 20-Aug-2021, the patient experienced PARAESTHESIA (tingling in the same arm). At the time of the report, PARAESTHESIA (tingling in the same arm) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Treatment information was not provided. This case was linked to MOD-2021-335482 (Patient Link).

Other Meds: BIKTARVY; ATORVASTATIN

Current Illness: HIV disease

ID: 1773438
Sex: F
Age: 53
State: TX

Vax Date: 08/28/2021
Onset Date: 08/28/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data: Test Date: 20210828; Test Name: Body temperature; Result Unstructured Data: fever not above 100?F

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: third dose had an impact on her hormones; sick with all three doses; had the period start and it is still coming; breasts were terribly sore (one week ago)/breasts hurt so bad/hurt to put on a bra; fever not above a 100?F after dose 3; extremely lethargic after dose 3; Too much sleep after dose 3; This spontaneous case was reported by a consumer and describes the occurrence of MENSTRUAL DISORDER (had the period start and it is still coming), VACCINATION COMPLICATION (third dose had an impact on her hormones), ILLNESS (sick with all three doses), LETHARGY (extremely lethargic after dose 3) and SOMNOLENCE (Too much sleep after dose 3) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 28-Aug-2021, the patient received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Aug-2021, the patient experienced LETHARGY (extremely lethargic after dose 3), SOMNOLENCE (Too much sleep after dose 3) and PYREXIA (fever not above a 100?F after dose 3). On 22-Sep-2021, the patient experienced BREAST PAIN (breasts were terribly sore (one week ago)/breasts hurt so bad/hurt to put on a bra). On 28-Sep-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced MENSTRUAL DISORDER (had the period start and it is still coming). On an unknown date, the patient experienced VACCINATION COMPLICATION (third dose had an impact on her hormones) and ILLNESS (sick with all three doses). The patient was treated with IBUPROFEN on 29-Aug-2021 for Adverse event, at an unspecified dose and frequency. On 29-Aug-2021, LETHARGY (extremely lethargic after dose 3), SOMNOLENCE (Too much sleep after dose 3) and PYREXIA (fever not above a 100?F after dose 3) had resolved. At the time of the report, MENSTRUAL DISORDER (had the period start and it is still coming) had not resolved, VACCINATION COMPLICATION (third dose had an impact on her hormones) and ILLNESS (sick with all three doses) outcome was unknown and BREAST PAIN (breasts were terribly sore (one week ago)/breasts hurt so bad/hurt to put on a bra) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 28-Aug-2021, Body temperature: 100 (High) fever not above 100?F. No relevant concomitant medications were reported. PAPs smear was completely normal. This case was linked to MOD-2021-335764, MOD-2021-335745 (Patient Link).

Other Meds:

Current Illness:

ID: 1773439
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/09/2021
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: sick; mouth is numb; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (sick) and HYPOAESTHESIA ORAL (mouth is numb) in a 51-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received 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 ILLNESS (sick) and HYPOAESTHESIA ORAL (mouth is numb). At the time of the report, ILLNESS (sick) and HYPOAESTHESIA ORAL (mouth is numb) outcome was unknown. Concomitant medication was not provided. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1773440
Sex: F
Age: 52
State: MD

Vax Date: 08/27/2021
Onset Date:
Rec V Date: 10/09/2021
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: sweating; couldn't sleep one night; headaches; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (sweating), INSOMNIA (couldn't sleep one night) and HEADACHE (headaches) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination. The patient's past medical history included Heart murmur, Skin cancer, Brain neoplasm benign and Depression. Concomitant products included ALPRAZOLAM (XANAX) and ZOLPIDEM for an unknown indication. On 27-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPERHIDROSIS (sweating), INSOMNIA (couldn't sleep one night) and HEADACHE (headaches). At the time of the report, HYPERHIDROSIS (sweating), INSOMNIA (couldn't sleep one night) and HEADACHE (headaches) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No treatment was reported by the reporter.

Other Meds: XANAX; ZOLPIDEM

Current Illness:

ID: 1773441
Sex: F
Age: 64
State: FL

Vax Date: 12/30/2020
Onset Date: 09/26/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data: Test Name: BODY TEMPERATURE; Result Unstructured Data: fever of 99.2.

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: has a sore arm with some itching as of today 29Sep2021only her arm is still affected; The following day everything hurt but her hair, she could stay up a half hour then; fever of 99.2; joint pain; bad headache; Her 3rd injection was on 26Sep2021 at 11:30AM that day she had a sore arm; she started feeling bad; she hardly ate or drank all day; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (she started feeling bad), DECREASED APPETITE (she hardly ate or drank all day), VACCINATION SITE PRURITUS (has a sore arm with some itching as of today 29Sep2021only her arm is still affected), MYALGIA (The following day everything hurt but her hair, she could stay up a half hour then) and PYREXIA (fever of 99.2) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 30-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-Sep-2021 at 11:30 AM, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 26-Sep-2021, the patient experienced FEELING ABNORMAL (she started feeling bad), DECREASED APPETITE (she hardly ate or drank all day), MYALGIA (The following day everything hurt but her hair, she could stay up a half hour then), PYREXIA (fever of 99.2), ARTHRALGIA (joint pain), HEADACHE (bad headache) and VACCINATION SITE PAIN (Her 3rd injection was on 26Sep2021 at 11:30AM that day she had a sore arm). On 29-Sep-2021, the patient experienced VACCINATION SITE PRURITUS (has a sore arm with some itching as of today 29Sep2021only her arm is still affected). On 28-Sep-2021, FEELING ABNORMAL (she started feeling bad), DECREASED APPETITE (she hardly ate or drank all day), MYALGIA (The following day everything hurt but her hair, she could stay up a half hour then), PYREXIA (fever of 99.2), ARTHRALGIA (joint pain), HEADACHE (bad headache) and VACCINATION SITE PAIN (Her 3rd injection was on 26Sep2021 at 11:30AM that day she had a sore arm) had resolved. At the time of the report, VACCINATION SITE PRURITUS (has a sore arm with some itching as of today 29Sep2021only her arm is still affected) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.2 (High) fever of 99.2.. No concomitant medication reported. No treatment information was provided. This case was linked to MOD-2021-335962, MOD-2021-335979, MOD-2021-335962 (Patient Link).

Other Meds:

Current Illness:

ID: 1773442
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 10/09/2021
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: has been felling sick since the night of his second dose of the Moderna covid19 vaccine; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (has been felling sick since the night of his second dose of the Moderna covid19 vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (has been felling sick since the night of his second dose of the Moderna covid19 vaccine). At the time of the report, MALAISE (has been felling sick since the night of his second dose of the Moderna covid19 vaccine) outcome was unknown. No concomitant medication details was reported. No treatment medication details was reported.

Other Meds:

Current Illness:

ID: 1773443
Sex: F
Age: 48
State:

Vax Date: 09/22/2021
Onset Date: 09/25/2021
Rec V Date: 10/09/2021
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: a little numbness ( Right eye); My vision has been wonky (Right eye)/right eye twitching (like a tremor); my vision has been wonky (Right eye); This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (a little numbness ( Right eye)), OCULAR DISCOMFORT (My vision has been wonky (Right eye)/right eye twitching (like a tremor)) and VISUAL IMPAIRMENT (my vision has been wonky (Right eye)) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination. Concurrent medical conditions included Diabetes and Hypertension. On 22-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Sep-2021, the patient experienced HYPOAESTHESIA (a little numbness ( Right eye)), OCULAR DISCOMFORT (My vision has been wonky (Right eye)/right eye twitching (like a tremor)) and VISUAL IMPAIRMENT (my vision has been wonky (Right eye)). At the time of the report, HYPOAESTHESIA (a little numbness ( Right eye)), OCULAR DISCOMFORT (My vision has been wonky (Right eye)/right eye twitching (like a tremor)) and VISUAL IMPAIRMENT (my vision has been wonky (Right eye)) 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. Concomitant medications were not reported. treatment medications were not reported.

Other Meds:

Current Illness: Diabetes; Hypertension

ID: 1773444
Sex: F
Age: 40
State: WI

Vax Date: 07/27/2021
Onset Date:
Rec V Date: 10/09/2021
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: diagnosed with covid after first dose of the vaccine; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Sep-2021 and was forwarded to Moderna on 29-Sep-2021. This spontaneous case was reported by a nurse and describes the occurrence of COVID-19 (diagnosed with covid after first dose of the vaccine) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. No medical history was provided. On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (diagnosed with covid after first dose of the vaccine). At the time of the report, COVID-19 (diagnosed with covid after first dose of the vaccine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medications was not provided by the reporter Treatment information was not provided; Sender's Comments: This case concerns a 40-year-old female with a non-serious unexpected event of COVID-19. Event onset with unknown latency after first dose mRNA-1273. Event outcome unknown. No information reported on second dose and rechallenge. Reporter causality not provided. Causality possible based on temporal association. Events consistent with known profile of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.

Other Meds:

Current Illness:

ID: 1773445
Sex: F
Age: 53
State: GA

Vax Date: 06/01/2021
Onset Date:
Rec V Date: 10/09/2021
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: Test Name: pyrexia; Result Unstructured Data: fever of 102.7

Allergies:

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

Symptoms: experiencing pain in the arm they got the shot in; nearly got dizzy/experiencing whoozy; nearly got nauseated; was feeling bad; sweating; pain in her arm was getting severe/begin to feel pain throughout the body; could not walk; legs felt heavy/ felt like legs were paralysis/legs were extremely heavy; the fever was there but not too hot; experiencing tingling in leg/hands were feeling tingling for 1st-2 days; rubber gun feeling in leg, ankle, and ribs; feet were feeling numbness for the 1st-2 days; Patient was told that she maybe experience some of the expected reaction from vaccine; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (experiencing pain in the arm they got the shot in), DIZZINESS (nearly got dizzy/experiencing whoozy), NAUSEA (nearly got nauseated), FEELING ABNORMAL (was feeling bad) and HYPERHIDROSIS (sweating) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. In June 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 PAIN (experiencing pain in the arm they got the shot in), DIZZINESS (nearly got dizzy/experiencing whoozy), NAUSEA (nearly got nauseated), FEELING ABNORMAL (was feeling bad), HYPERHIDROSIS (sweating), PAIN (pain in her arm was getting severe/begin to feel pain throughout the body), GAIT INABILITY (could not walk), LIMB DISCOMFORT (legs felt heavy/ felt like legs were paralysis/legs were extremely heavy), PYREXIA (the fever was there but not too hot), PARAESTHESIA (experiencing tingling in leg/hands were feeling tingling for 1st-2 days), PAIN (rubber gun feeling in leg, ankle, and ribs), HYPOAESTHESIA (feet were feeling numbness for the 1st-2 days) and INFLUENZA LIKE ILLNESS (Patient was told that she maybe experience some of the expected reaction from vaccine). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at an unspecified dose and frequency and IBUPROFEN for Pain, at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (experiencing pain in the arm they got the shot in), DIZZINESS (nearly got dizzy/experiencing whoozy), NAUSEA (nearly got nauseated), FEELING ABNORMAL (was feeling bad), HYPERHIDROSIS (sweating), PAIN (pain in her arm was getting severe/begin to feel pain throughout the body), GAIT INABILITY (could not walk), LIMB DISCOMFORT (legs felt heavy/ felt like legs were paralysis/legs were extremely heavy), PYREXIA (the fever was there but not too hot), PARAESTHESIA (experiencing tingling in leg/hands were feeling tingling for 1st-2 days), PAIN (rubber gun feeling in leg, ankle, and ribs), HYPOAESTHESIA (feet were feeling numbness for the 1st-2 days) and INFLUENZA LIKE ILLNESS (Patient was told that she maybe experience some of the expected reaction from vaccine) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Pyrexia: 102.7 (High) fever of 102.7. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. HCP recommended that to bedrest and plenty of fluid to washout whatever was in the body.

Other Meds:

Current Illness:

ID: 1773446
Sex: F
Age: 75
State: NY

Vax Date: 03/04/2021
Onset Date: 09/02/2021
Rec V Date: 10/09/2021
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: administration of vaccine past 30 days in the fridge; This spontaneous case was reported by a physician and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (administration of vaccine past 30 days in the fridge) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 035C21A) for COVID-19 vaccination. Concurrent medical conditions included Cancer. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 02-Sep-2021, received third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Sep-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (administration of vaccine past 30 days in the fridge). At the time of the report, EXPIRED PRODUCT ADMINISTERED (administration of vaccine past 30 days in the fridge) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. HCP vaccinated patients with vials that were past 30 days in the fridge. No concomitant drug details were reported. No treatment details were reported. Most recent FOLLOW-UP information incorporated above includes: On 01-Oct-2021: Updated dose 1 and dose 2 details.

Other Meds:

Current Illness: Cancer

ID: 1773450
Sex: F
Age: 68
State: WI

Vax Date: 02/20/2021
Onset Date: 09/30/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: I just felt real tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (I just felt real tired) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023H20A) for COVID-19 vaccination. No Medical History information was reported. On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Sep-2021, the patient experienced FATIGUE (I just felt real tired). At the time of the report, FATIGUE (I just felt real tired) outcome was unknown. No concomitant medications were reported. No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1773453
Sex: F
Age: 74
State: LA

Vax Date: 09/09/2021
Onset Date: 09/22/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data: elevated CRP

Allergies: amoxiicillin,plaquenil, clindamycin, thorazine ,Fluzone quadrivalent HD

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

Symptoms: Acute exacerbation of amyopatis dermatomyositis. Prominen heliotrope rash and swelling of eyelids, "shawl" sign eruption, scalp dermatomyositis flare

Other Meds: methotrexate, dutasteride, klonopin, amyltryptiline RHEUMate

Current Illness: Amyopathic dermatomyositis in remission

ID: 1773454
Sex: F
Age: 28
State: CA

Vax Date: 09/24/2021
Onset Date: 09/25/2021
Rec V Date: 10/09/2021
Hospital: Y

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

Lab Data: So much blood work. Inflammation markers were high but seems normal that late in pregnancy. Liver enzymes with 100+ (AST/ALT) and that seems to concern doctors the most of all the blood work.

Allergies: Moxifloxacin

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Woke up the morning of 9/25 with trouble breathing. This was ~19 hours after 2nd dose. Held off for a day and checked myself into ER. Cardiologist at ER diagnosed me with acute pericarditis and sent me home without meds since the meds typically used to treat acute pericarditis are not used for pregnant women. On Monday 9/27 I had a 34 week OB-GYN checkup. Doctor saw me and urged me to go to the hospital where she delivers as soon as possible. My husband and I drove to Hospital. Was checked into ER and sent to the Telemetry department. Dr's there did blood work and an echocardiogram and confirm that I have acute pericarditis. Was advised to deliver baby ASAP so that the appropriate meds can be used to help my symptoms. Was induced and gave birth on 10/1 to a baby 34 weeks and 5 days old.

Other Meds: None

Current Illness: No

ID: 1773455
Sex: F
Age: 19
State: GA

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

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

Lab Data: MRI- Reactive Lymphadenopathy

Allergies: none

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: Reactive lymphadenopathy/diagnosed 10/5/2021 10/1/2021-Swelling in neck/ Underarm wasn't notice until doctors visit on 10/5/2021 10/4/2021- swelling of feet that went away the next day 10/8/2021-nipples hurting9Not diagnose or treated

Other Meds: none

Current Illness: none

ID: 1773456
Sex: M
Age: 28
State: CA

Vax Date: 09/25/2021
Onset Date: 09/29/2021
Rec V Date: 10/09/2021
Hospital: Y

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

Lab Data: Coombs (+), elevated LDH, elevated direct bilirubin, slightly elevated ferritin, leukocytosis 13, anemia 8.4, reticulocyte elevation 7.4

Allergies: None

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

Symptoms: Warm autoimmune hemolytic anemia

Other Meds: No prescribed medications Occasional acetaminophen

Current Illness: None

ID: 1773457
Sex: F
Age: 44
State: WA

Vax Date: 10/07/2021
Onset Date: 10/07/2021
Rec V Date: 10/09/2021
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: None

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

Symptoms: Swelling and pain in right eye occurred within 10 minutes of getting shot. Eye swelled nearly shut overnight and over 24 hours later is still swollen with a burning pain.

Other Meds: Birth control, iron

Current Illness: None

ID: 1773459
Sex: F
Age: 35
State: CA

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

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

Lab Data:

Allergies: Kiwi

Symptom List: Unevaluable event

Symptoms: Hives developed over entire body at 6 hours post vaccine and lasted for 12 days. Treated with prednisone.

Other Meds: None

Current Illness: None

ID: 1773460
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: Pain in the injection site/Pain is severe; Patient received 3rd dose; 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 SITE PAIN (Pain in the injection site/Pain is severe) and EXTRA DOSE ADMINISTERED (Patient received 3rd dose) 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 VACCINATION SITE PAIN (Pain in the injection site/Pain is severe) and EXTRA DOSE ADMINISTERED (Patient received 3rd dose). At the time of the report, VACCINATION SITE PAIN (Pain in the injection site/Pain is severe) outcome was unknown and EXTRA DOSE ADMINISTERED (Patient received 3rd dose) had resolved. No concomitant medications were provided. No treatment medications were reported. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1773461
Sex: F
Age: 26
State: NC

Vax Date: 10/05/2021
Onset Date: 10/08/2021
Rec V Date: 10/09/2021
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: Peanuts

Symptom List: Injection site pain, Pain

Symptoms: On Friday October 8th, 2021, three days after receiving my first dose My left side of my face began to swell and form a rash. As a couple of hours went by the rash spread to the right side of the face. Jaw line and neck as well as hands and arms. I contacted the local clinic to inform them of my symptoms and they suggested to go to the hospital. I went to the hospital and received medication to help the swelling and slow down the spread of the rash.

Other Meds: N/A

Current Illness: N/A

ID: 1773462
Sex: M
Age: 20
State:

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

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

Lab Data: Patient believes he had a blood test while in the ER but was feeling really bad so he is not sure. He does not know the results.

Allergies: N/A

Symptom List: Injection site pain, Menorrhagia

Symptoms: At approximately 2 PM which was four hours after vaccination patient began to become ill. He developed headache, fever, chills, nausea and vomiting. He continued to have persistent vomiting throughout the night. He was seen in ER. He reports that he was given 2, IV's of Ondansetron (4 mg each) at which time it brought his non stop vomiting under control. He was also given a shot of Toradol for his headache. He was given a prescription of Ondansetron and told to take Tylenol or Advil for his headache. His symptoms required that he take these medications for 3 days. Patient was home sick for 24 hours after ER visit and then was able to go to work again in the ER using his medications.

Other Meds: N/A

Current Illness: N/A

ID: 1773463
Sex: F
Age: 60
State: AZ

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

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

Lab Data: BP check at PCP's office next door to pharmacy. Clonidine given to reduce blood pressure as quickly as possible. Given approximately 20 minutes after shot on 10-23-21.

Allergies: Penicillin and all related antibiotics Cats Fabreze

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

Symptoms: Blood pressure to 185/109 within 10 minutes. Potassium level (serum) drop. Pulse at 51 bpm. Typical BP is 110 / 75. Followed over course of 48 hours with extreme muscle weakness and near flaccid paralysis, irregular heartbeat and gripping headache (not a common occurrence for me) with "brain fog"; slept approximately 16 hours over the next 36. Second reaction better than first dose because we prepared better based on first reaction.

Other Meds: Potassium as Ultima Replenisher (electrolyte powder formula); B-12 (vegan); Vit D (Vegan); Artichoke leaf

Current Illness:

ID: 1773464
Sex: M
Age: 25
State:

Vax Date: 09/08/2021
Onset Date: 09/08/2021
Rec V Date: 10/09/2021
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: vision screening: 20/20 OD, 20/16 OS, 20/16 b/l IOP's: 12 b/l

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: reported blurry vision, intermittent x 1 month starting day of vaccination. Currently monitoring, awaiting further workup

Other Meds:

Current Illness: none reported

ID: 1773465
Sex: F
Age: 15
State:

Vax Date: 09/30/2021
Onset Date: 10/01/2021
Rec V Date: 10/09/2021
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: I was unable to eat or drink because everything smelled and tasted rotten. The sight and smell of food or drink besides water made me gag or vomit. It took me more than three days to transition to liquids besides water, and five for solid foods. I still cannot eat or drink foods with strong smell without feeling nauseous, is had been at least eight days.

Other Meds:

Current Illness:

ID: 1773466
Sex: F
Age: 50
State: MD

Vax Date: 09/15/2021
Onset Date: 09/15/2021
Rec V Date: 10/09/2021
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: None

Allergies: Iron infusions Fentanyl Potassium iodide

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

Symptoms: My first 2 doses were Moderna 8 months prior. About 6 or so hours later I smelled burnt chemicals when apple pies were cooking. I had diminished taste with peppermint candy. It went away with in about 3 hours

Other Meds: Exforge HCT Synthroid Zyrtec

Current Illness:

ID: 1773467
Sex: F
Age: 34
State: CA

Vax Date: 04/27/2021
Onset Date: 05/01/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data: I?ve taken iron tests which showed that I was becoming iron deficient from the blood loss. I am now on iron pills ? I?d never experienced iron deficiency previous to these incidents.

Allergies: Cigarettes

Symptom List: Nausea

Symptoms: My periods have been very irregular since I?ve received my vaccination. Not only do they last significantly longer (10+ days when they would originally go 5 or 6 days), I?ve had heavy mensural bleeding and blood clots. I?ve been filling one super+ tampon every 2 hours for at least 5 days of my period. I wear pads every day because I have continuous bleeding throughout the month. This has impacted my quality of life.

Other Meds: N/a

Current Illness: N/a

ID: 1773468
Sex: F
Age: 41
State: UT

Vax Date: 09/25/2021
Onset Date: 10/06/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data:

Allergies: Peanut allergy

Symptom List: Injection site pain

Symptoms: ?Covid arm.? Large, red, swollen, rash at injection site, 5.5 inches in diameter. Joint pain, weakness, tiredness.

Other Meds: Levothyroxine Liothyronine Lisinopril Estradiol

Current Illness: None

ID: 1773469
Sex: F
Age: 65
State: CA

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

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

Lab Data:

Allergies: Penicillin, Phenergan, Latex

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

Symptoms: Stomach cramps, achy joints, mild fever and chills, very sore arm that received the injection. Symptoms lasted approx. 1 day. Note: This was the third dose (booster). Dose one produced no symptoms. Dose two produced moderate joint pain.

Other Meds: Multi-vitamin

Current Illness: None

ID: 1773470
Sex: F
Age: 43
State: CA

Vax Date: 10/08/2021
Onset Date: 10/08/2021
Rec V Date: 10/09/2021
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: Lightheadedness within 15 minutes that remained intermittent and low. Nausea within 15 minutes that was transient. 9 hours after injection body aches hear through pelvis. Excessive yawning and stretching. Headaches. Right side worse than left. Jaw pain especially right side

Other Meds: Vitamin d3, calcium, melatonin

Current Illness:

ID: 1773471
Sex: U
Age: 55
State: TX

Vax Date: 09/23/2021
Onset Date: 09/27/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data: N/A

Allergies: Latex, PCN.

Symptom List: Tremor

Symptoms: Shingles on R forehead, w painful tingling, erythematous patch w papular lesions. Seen in Urgent Care 28 Sep, ER 10/4/21.

Other Meds: Gabapentin Oral. Iron Oral. TraZODone HCl Oral. Vitamin B-12 Oral.

Current Illness: Anemia

ID: 1773472
Sex: F
Age: 65
State: WA

Vax Date: 10/04/2021
Onset Date: 10/05/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data: none

Allergies: None Known

Symptom List: Erythema, Pruritus

Symptoms: 24 hours after COVID booster shot felt itchy, and tired.

Other Meds: Metformin 500 mgAtorvastatin 20 mg Losartan/HCTZ Meloxicam 15 mg Vitamin D 3 125mg Iron 65mg

Current Illness: None known

ID: 1773473
Sex: F
Age: 65
State: NY

Vax Date: 08/03/2021
Onset Date: 08/03/2021
Rec V Date: 10/09/2021
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: Itches; more patient scratches it, the more it sores; Irritation; rash in the injection site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itches), PAIN (more patient scratches it, the more it sores), SKIN IRRITATION (Irritation) and VACCINATION SITE RASH (rash in the injection site) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination. No Medical History information was reported. On 03-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Aug-2021, the patient experienced PRURITUS (Itches), PAIN (more patient scratches it, the more it sores), SKIN IRRITATION (Irritation) and VACCINATION SITE RASH (rash in the injection site). At the time of the report, PRURITUS (Itches), PAIN (more patient scratches it, the more it sores), SKIN IRRITATION (Irritation) and VACCINATION SITE RASH (rash in the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was reported. The patient applied creams and ointments give by dermatologist to treat symptoms.

Other Meds:

Current Illness:

ID: 1773474
Sex: F
Age: 54
State:

Vax Date: 04/01/2021
Onset Date: 05/08/2021
Rec V Date: 10/09/2021
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: Blood clot

Other Meds:

Current Illness:

ID: 1773475
Sex: F
Age: 37
State: UT

Vax Date: 11/05/2020
Onset Date: 11/05/2020
Rec V Date: 10/09/2021
Hospital:

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

Lab Data: Dec. 14, 2020, I was finally able to get in to see a PA, at the Medical Center. She referred me to a gastroenterologist at Medical. I believe that appointment was on Jan. 4, 2021. Dr. performed an endoscopy on me on Jan. 13, 2021 at the Medical Center. They took some biopsies and told me it looked like I had some irritation and gasteritist. On Jan. 19, 2021, I received a call from Dr. office asking me to go get a blood draw because the biopsies looked like I had Celiac Disease. I had never experienced any issues with gluten so I thought this to be odd. I went that day down to our lab and got a blood draw. The results came back that I indeed, now have Celiac Disease. A brand new diagnosis.

Allergies: Gentamicin, penacillin, Ciprofloxacin, Nickel, Cinnamon, Acrylate, 2-hydroxyethylmethacrylate, Hydroperoxides of limonene

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: The reactions I have to the Flu vaccine are always the same but the adverse reaction time was become more rapid. This one was instantaneous. On Nov. 5, 2020, I went to Employee Heath to receive my free vaccine, this is the first time I had received this free vaccine. The moment that the fluid hit my muscle, I immediately experience vertigo with the entire room spinning, I went cold and clammy, and experience immediate nausea. I was told the color drained from my face with the gentleman coming out of the room next door because he saw my reaction and the monitor. I always have someone drive me to and from my vaccinations due to my previous adverse reactions. Before I even made it to the car, I went down in the parking lot because the lot started to spin and I became quite light headed. I live about 6 minutes from the hospital and before I even got home I was throwing up. I then experienced extreme nausea, vomiting, and diarrhea for the next three months. Following the vaccination, I missed meetings for work and even had to call off of a few shifts because I was unable to due my job.

Other Meds: VitB12 complex, VitD, Mg+, Ca+,

Current Illness: NA

ID: 1773476
Sex: M
Age: 29
State: IL

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

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

Lab Data: None

Allergies: Shellfish

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

Symptoms: My ears are ringing. Like a high frequency test tone. It?s constant in both ears. I have never experienced tinnitus before nor diagnosed with it. What I?m experiencing is not of an orthostatic nature. It?s constant laying down or standing/walking.

Other Meds: Atenolol25mg, Amphetamine/dextroamphepamine 30mg IR, amlodipine 10mg, hydrochlorothiazide 25mg, abilify 5mg.

Current Illness: None

ID: 1773477
Sex: M
Age: 34
State: CA

Vax Date: 03/10/2021
Onset Date: 03/26/2021
Rec V Date: 10/09/2021
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: No tests, but doctors have diagnosed symptoms as hives.

Allergies: None

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

Symptoms: Hives developed two weeks after vaccination. Hives are daily and have not dissipated.

Other Meds: Trileptol

Current Illness: None

ID: 1773478
Sex: F
Age: 41
State: AL

Vax Date: 09/17/2021
Onset Date: 09/29/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data: CT of the head due to severe ear pain prior to the rash showing up. Will also be seeing a general surgeon in a couple of weeks to have a lipoma removed.

Allergies: Codeine

Symptom List: Pain in extremity

Symptoms: I got shingles within 2 weeks after my 2nd shot. No hx health problems. I believe it to be a severe case on my face. I spent time in the ER due to this and despite treatment, still in severe pain 1.5 weeks after the initial onset of sxs. I am unable to work due to the pain. This was 2 weeks after my 2nd Moderna shot. I also had a lipoma grow on my forearm within 2 weeks after my first shot. No hx of lipomas, and no family hx of them either. I now have to have it removed by a general surgeon.

Other Meds: None

Current Illness: None

ID: 1773479
Sex: F
Age: 39
State: MD

Vax Date: 04/01/2021
Onset Date: 04/22/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data:

Allergies: No

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

Symptoms: Since getting the vaccine I have had a rash and itching that I have been seen twice for and none of the prescribed medications have cured it. Additionally my mental cycle is sometimes twice monthly and the clotting is large and abnormal for my usual period. I experience heavy bleeding that last for several days.

Other Meds: No

Current Illness: No

ID: 1773480
Sex: M
Age: 52
State: CA

Vax Date: 01/01/2021
Onset Date: 02/21/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data: D-Dimer (2,749). CT Angiogram confirmed PE's

Allergies: None

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

Symptoms: I was diagnosed to two "unprovoked" Pulmonary Embolisms in my right lung.

Other Meds: Zinc, Vitamin D3, Vitamin K2, Vitamin C

Current Illness: None

ID: 1773482
Sex: F
Age: 44
State: CA

Vax Date: 09/10/2021
Onset Date: 09/13/2021
Rec V Date: 10/09/2021
Hospital:

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

Lab Data: None

Allergies: None

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

Symptoms: Almost had to be admitted into Emergency room, but I left the hospital because they wouldn't let my husband inside. I had severe heart issue! Not sure exactly what was wrong but I came close to having heart attack! This lasted for a few days. I had the worst dizziness that lasted more than 23 minutes! Chest pain, restricted breathing, and static sound in my head between the ears. The vaccine also left a taste in my throat even though I got the shot in my arm. My heart has not felt right since the vaccine! I felt wonderful just prior to getting the injection!

Other Meds: None

Current Illness: None

ID: 1773483
Sex: M
Age: 31
State: FL

Vax Date: 08/09/2021
Onset Date: 07/10/2021
Rec V Date: 10/09/2021
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: second dose made it worse; Redness; very inflamed; not been able to sleep; massive sweats; intense dreams; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (not been able to sleep), HYPERHIDROSIS (massive sweats), ABNORMAL DREAMS (intense dreams), CONDITION AGGRAVATED (second dose made it worse) and ERYTHEMA (Redness) in a 31-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046C21A and 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. The patient's past medical history included COVID-19 in June 2020, Neurological symptoms NOS (amplified neurological effects) on 04-Jul-2020, Bug bite and Rash (had sever rashes all over leg and arm left marks due to bug). Concurrent medical conditions included Type 1 diabetes mellitus (type 1 diabetic with major neuropathic reaction). Concomitant products included INSULIN for an unknown indication. On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Sep-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Jul-2021, the patient experienced INSOMNIA (not been able to sleep), HYPERHIDROSIS (massive sweats), ABNORMAL DREAMS (intense dreams), ERYTHEMA (Redness) and INFLAMMATION (very inflamed). On an unknown date, the patient experienced CONDITION AGGRAVATED (second dose made it worse). At the time of the report, INSOMNIA (not been able to sleep), HYPERHIDROSIS (massive sweats), ABNORMAL DREAMS (intense dreams), CONDITION AGGRAVATED (second dose made it worse), ERYTHEMA (Redness) and INFLAMMATION (very inflamed) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment information was provided by the reporter. This case was linked to MOD-2021-337495 (Patient Link).

Other Meds: INSULIN

Current Illness: Type 1 diabetes mellitus (type 1 diabetic with major neuropathic reaction)

ID: 1773484
Sex: F
Age: 68
State: PA

Vax Date: 03/10/2021
Onset Date: 04/07/2021
Rec V Date: 10/09/2021
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: last 6 months a lot of brain fog/ She is now 6 months past the 2nd dose and she still has a lot of brain fog; my memory issues got worse/ just feels like my memory is going; This spontaneous case was reported by a patient and describes the occurrence of FEELING ABNORMAL (last 6 months a lot of brain fog/ She is now 6 months past the 2nd dose and she still has a lot of brain fog) and MEMORY IMPAIRMENT (my memory issues got worse/ just feels like my memory is going) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 002B21A) for COVID-19 vaccination. The patient's past medical history included Back surgery. Concurrent medical conditions included Cold sores, Urinary tract disorder, Fibromyalgia, Arthritis, Muscle pain, Sleep apnea and Lipoma. Concomitant products included AMOXICILLIN for Back surgery, VALACICLOVIR HYDROCHLORIDE (VALTREX) for Cold sores, PREGABALIN (LYRICA) for Fibromyalgia and Arthritis, ARNICA MONTANA for Muscle pain, OXYGEN for Sleep apnea, TROSPIUM CHLORIDE for Urinary tract disorder, CETIRIZINE HYDROCHLORIDE (ZYRTEC ALLERGY), CALCIUM, COLECALCIFEROL (VITAMIN D3), ASCORBIC ACID (VITAMIN C PLUS [ASCORBIC ACID]), LISINOPRIL, LORAZEPAM (ATIVAN), DONEPEZIL HYDROCHLORIDE (ARICEPT), ESCITALOPRAM OXALATE (LEXAPRO), QUETIAPINE FUMARATE (SEROQUEL), ATORVASTATIN, FISH OIL and TIOTROPIUM BROMIDE MONOHYDRATE (SPIRIVA) for an unknown indication. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 07-Apr-2021, the patient experienced FEELING ABNORMAL (last 6 months a lot of brain fog/ She is now 6 months past the 2nd dose and she still has a lot of brain fog) and MEMORY IMPAIRMENT (my memory issues got worse/ just feels like my memory is going). The patient was treated with DONEPEZIL HYDROCHLORIDE (ARICEPT) for Adverse event, at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (last 6 months a lot of brain fog/ She is now 6 months past the 2nd dose and she still has a lot of brain fog) had not resolved and MEMORY IMPAIRMENT (my memory issues got worse/ just feels like my memory is going) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication details also included centrum silver, breo and albuterol for unknown indication. Patient reported that she got her EKG and bloodwork done for the surgery. The patient took 20-30 seconds to remember where she got her EKG and bloodwork done.

Other Meds: ZYRTEC ALLERGY; AMOXICILLIN; CALCIUM; VALTREX; VITAMIN D3; VITAMIN C PLUS [ASCORBIC ACID]; TROSPIUM CHLORIDE; LISINOPRIL; ATIVAN; ARICEPT; LEXAPRO; LYRICA; SEROQUEL; ATORVASTATIN; FISH OIL; ARNICA MONTANA; SPIRIVA; OXYGEN

Current Illness: Arthritis; Cold sores; Fibromyalgia; Lipoma; Muscle pain; Sleep apnea; Urinary tract disorder

ID: 1773485
Sex: M
Age: 63
State: FL

Vax Date: 09/16/2021
Onset Date: 09/18/2021
Rec V Date: 10/09/2021
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: Test Date: 20210920; Test Name: CAT scan; Result Unstructured Data: the sciatic; Test Date: 20210920; Test Name: X-ray; Result Unstructured Data: the sciatic

Allergies:

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

Symptoms: Cannot walk properly ongoing for more than 10 days now; Cannot sleep ongoing for more than 10 days now; Losing work ongoing for more than 10 days now; The pain feels now is like ten times the pain felt with previous "sciatic"; Vomited twice due to steroid medication; Diagnosed with "the sciatic"; Pain in left leg; Pain went up to groin; Pain in the knee joint / pain went up to hip; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Pain in left leg), GROIN PAIN (Pain went up to groin), SCIATICA (Diagnosed with "the sciatic"), GAIT DISTURBANCE (Cannot walk properly ongoing for more than 10 days now) and INSOMNIA (Cannot sleep ongoing for more than 10 days now) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020F21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Sciatica and Spondylitis. Concurrent medical conditions included Diabetes and Arthritis. Concomitant products included SEMAGLUTIDE (RYBELSUS) for Diabetes. On 16-Sep-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Sep-2021, the patient experienced PAIN IN EXTREMITY (Pain in left leg), GROIN PAIN (Pain went up to groin) and ARTHRALGIA (Pain in the knee joint / pain went up to hip). On 20-Sep-2021, the patient experienced SCIATICA (Diagnosed with "the sciatic"). On an unknown date, the patient experienced GAIT DISTURBANCE (Cannot walk properly ongoing for more than 10 days now), INSOMNIA (Cannot sleep ongoing for more than 10 days now), IMPAIRED WORK ABILITY (Losing work ongoing for more than 10 days now), PAIN (The pain feels now is like ten times the pain felt with previous "sciatic") and VOMITING (Vomited twice due to steroid medication). The patient was treated with HYDROCODONE for Sciatica, at an unspecified dose and frequency; ACETAMINOPHEN for Sciatica, at an unspecified dose and frequency; PREDNISONE for Sciatica, at an unspecified dose and frequency; MELOXICAM for Sciatica, at a dose of 7.5 mg; TRAMADOL for Sciatica, at a dose of 50 mg and DICLOFENAC for Pain, at a dose of 50 mg three times a day. At the time of the report, PAIN IN EXTREMITY (Pain in left leg), GROIN PAIN (Pain went up to groin), SCIATICA (Diagnosed with "the sciatic"), GAIT DISTURBANCE (Cannot walk properly ongoing for more than 10 days now), INSOMNIA (Cannot sleep ongoing for more than 10 days now), IMPAIRED WORK ABILITY (Losing work ongoing for more than 10 days now), PAIN (The pain feels now is like ten times the pain felt with previous "sciatic"), ARTHRALGIA (Pain in the knee joint / pain went up to hip) and VOMITING (Vomited twice due to steroid medication) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 20-Sep-2021, Computerised tomogram: 20-sep-2021 (abnormal) the sciatic. On 20-Sep-2021, X-ray: abnormal (abnormal) the sciatic. 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. When patient had took third hydrocodone dose he had vomited twice and after that he had discontinue the medications. patient state that he was not able to walk properly, he was not able to sleep, he had losing his work these. The patient had ongoing from 10 days. He states that in the past he had "the sciatic" but the pain subsided taking 3xdiclofenac 50mg o putting some patches on. The pain he feels now is like ten times the pain he used to feel.

Other Meds: RYBELSUS

Current Illness: Arthritis; Diabetes

ID: 1773486
Sex: F
Age: 61
State: OH

Vax Date: 12/30/2020
Onset Date: 03/01/2021
Rec V Date: 10/09/2021
Hospital: Y

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: Admitted to hospital for three weeks; Memory issue/ it effects your memory; Diagnosed with autoimmune encephalitis; This spontaneous case was reported by a consumer and describes the occurrence of ENCEPHALITIS AUTOIMMUNE (Diagnosed with autoimmune encephalitis), HOSPITALISATION (Admitted to hospital for three weeks) and MEMORY IMPAIRMENT (Memory issue/ it effects your memory) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 025J20A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included ATORVASTATIN CALCIUM (LIPITOR) for an unknown indication. On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced ENCEPHALITIS AUTOIMMUNE (Diagnosed with autoimmune encephalitis) (seriousness criteria hospitalization and medically significant). On an unknown date, the patient experienced HOSPITALISATION (Admitted to hospital for three weeks) (seriousness criterion hospitalization) and MEMORY IMPAIRMENT (Memory issue/ it effects your memory) (seriousness criterion hospitalization). The patient was hospitalized on sometime in March 2021 due to ENCEPHALITIS AUTOIMMUNE. At the time of the report, ENCEPHALITIS AUTOIMMUNE (Diagnosed with autoimmune encephalitis), HOSPITALISATION (Admitted to hospital for three weeks) and MEMORY IMPAIRMENT (Memory issue/ it effects your memory) outcome was unknown. After Moderna vaccine patient ended up with auto immune disease. The patient was admitted to hospital in March for three weeks and was diagnosed with autoimmune encephalitis. The patient was diagnosed by a neurologist and reported it affected memory. Treatment information was not provided. Company comment: This case concerns a 61-year-old female patient with no relevant medical history, who experienced the unexpected serious events of hospitalization, autoimmune encephalitis and memory impairment. The events occurred unknown number of days after the second dose of mRNA- 1273 vaccine / Moderna COVID-19 Vaccine. The rechallenge was not applicable, as the event was reported after the second dose and no additional dosing will be given. The benefit-risk relationship of vaccine is not affected by this report.; Sender's Comments: This case concerns a 61-year-old female patient with no relevant medical history, who experienced the unexpected serious events of hospitalization, autoimmune encephalitis and memory impairment. The events occurred unknown number of days after the second dose of mRNA- 1273 vaccine / Moderna COVID-19 Vaccine. The rechallenge was not applicable, as the event was reported after the second dose and no additional dosing will be given. The benefit-risk relationship of vaccine is not affected by this report.

Other Meds: LIPITOR

Current Illness:

ID: 1773487
Sex: M
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 10/09/2021
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: Hearing loss in left ear; This literature-study case was reported in a literature article and describes the occurrence of DEAFNESS UNILATERAL (Hearing loss in left ear) in an 83-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Meniere's disease (Duration: 12 years and status was stable) and Autoimmune inner ear disease (Duration: 12 years and status was stable). 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, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DEAFNESS UNILATERAL (Hearing loss in left ear) (seriousness criterion medically significant). At the time of the report, DEAFNESS UNILATERAL (Hearing loss in left ear) outcome was unknown. Possible For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered DEAFNESS UNILATERAL (Hearing loss in left ear) to be possibly related. Concomitant medications were not provided. This study includes 30 patients with post-vaccination otologic symptoms. Most of the patients were still undergoing treatment, which may include oral, IT steroids, and/or antivirals. In all cases magnetic resonance imaging of the internal auditory canals was also ordered. The extent of hearing recovery and/or symptom resolution is currently unknown. Their pre-treatment audiograms, with the PTA and WRS recorded, have given them a good baseline with which to document any treatment effect, as well as review outcome versus specific treatment given, to be reported in the future. The extent of hearing recovery and/or symptom resolution is currently unknown. Author discusses that although an increased incidence does not by itself prove causation, the trend here does bring up concern that in some patients, there may be a post-vaccination change in hearing. Author concluded that currently, there are no known definite correlations between sudden hearing loss or other otologic manifestations with COVID-19 vaccination and that the clinic has noticed a two-fold increase in diagnosis of idiopathic SNHL in a 30-day period in 2021 compared with the same interval 2 years ago, but cannot say if this specifically correlates to the pandemic or may represent an uncommon, but real AE not reported before this. Company Comment: This case concerns an 83 year-old male patient with history of Meniere's disease and autoimmune inner ear disease, who experienced the unexpected serious event of Hearing loss in left ear. The event 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. The patient's advanced age and history of Meniere's disease and autoimmune inner ear disease may have contributed to the event. This case was linked to MOD-2021-337903, MOD-2021-337994, MOD-2021-337996, MOD-2021-337997, MOD-2021-337998, MOD-2021-337999, MOD-2021-338000, MOD-2021-338001, MOD-2021-338002, MOD-2021-338003, MOD-2021-338004, MOD-2021-338005, MOD-2021-338006, MOD-2021-338007, MOD-2021-338008, MOD-2021-338009, MOD-2021-338010 (Patient Link).; Sender's Comments: This case concerns an 83 year-old male patient with history of Meniere's disease and autoimmune inner ear disease, who experienced the unexpected serious event of Hearing loss in left ear. The event 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. The patient's advanced age and history of Meniere's disease and autoimmune inner ear disease may have contributed to the event.

Other Meds:

Current Illness: Autoimmune inner ear disease (Duration: 12 years and status was stable); Meniere's disease (Duration: 12 years and status was stable)

ID: 1773488
Sex: F
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 10/09/2021
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: sensorineural hearing loss left ear; This literature-study case was reported in a literature article and describes the occurrence of DEAFNESS NEUROSENSORY (sensorineural hearing loss left ear) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Inner ear disorder (Prior oto history was stable). 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, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced DEAFNESS NEUROSENSORY (sensorineural hearing loss left ear) (seriousness criterion medically significant). At the time of the report, DEAFNESS NEUROSENSORY (sensorineural hearing loss left ear) outcome was unknown. Possible For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter considered DEAFNESS NEUROSENSORY (sensorineural hearing loss left ear) to be possibly related. No concomitant medication was reported. Treatment information was not reported. This study includes 18 patients with post-vaccination otologic symptoms. Most of our patients are still undergoing treatment, which may include oral, IT steroids, and/or antivirals. In all cases magnetic resonance imaging of the internal auditory canals was also ordered. Our pre-treatment audiograms, with the PTA and WRS recorded, have given us a good baseline with which to document any treatment effect, as well as review outcome versus specific treatment given, to be reported in the future. The extent of hearing recovery and/or symptom resolution was currently unknown. Company Comment: A 77-year-old female, with concurrent inner ear disorder, presented with a serious unexpected event of sensorineural hearing loss. Event latency 30 days after second dose. Event outcome not reported. Rechallenge not applicable. Reporter causality assessed as possibly related. Causality possible from temporal association. Event consistent with current knowledge of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report. This case was linked to MOD-2021-337903, MOD-2021-337994, MOD-2021-337995, MOD-2021-337997, MOD-2021-337998, MOD-2021-337999, MOD-2021-338000, MOD-2021-338001, MOD-2021-338002, MOD-2021-338003, MOD-2021-338004, MOD-2021-338005, MOD-2021-338006, MOD-2021-338007, MOD-2021-338008, MOD-2021-338009, MOD-2021-338010 (Patient Link).; Sender's Comments: A 77-year-old female, with concurrent inner ear disorder, presented with a serious unexpected event of sensorineural hearing loss. Event latency 30 days after second dose. Event outcome not reported. Rechallenge not applicable. Reporter causality assessed as possibly related. Causality possible from temporal association. Event consistent with current knowledge of mRNA-1273. The benefit-risk relationship of mRNA-1273 is not affected by this report.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am