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: 1643792
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: 8 weeks since first dose; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (8 weeks since first 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (8 weeks since first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (8 weeks since first dose) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided by the reporter. No treatment details were provided by the reporter.

Other Meds:

Current Illness:

ID: 1643793
Sex: U
Age:
State:

Vax Date: 02/26/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Anxiety, Dyspnoea

Symptoms: pain in arm/pain in left arm; I can hardly lift; left shoulder and under arm and shoulder blade have been in pain/ left shoulder the wing where arm goes up and down in back; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (pain in arm/pain in left arm), MYALGIA (I can hardly lift) and ARTHRALGIA (left shoulder and under arm and shoulder blade have been in pain/ left shoulder the wing where arm goes up and down in back) 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 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (pain in arm/pain in left arm), MYALGIA (I can hardly lift) and ARTHRALGIA (left shoulder and under arm and shoulder blade have been in pain/ left shoulder the wing where arm goes up and down in back). At the time of the report, PAIN IN EXTREMITY (pain in arm/pain in left arm) and MYALGIA (I can hardly lift) had not resolved and ARTHRALGIA (left shoulder and under arm and shoulder blade have been in pain/ left shoulder the wing where arm goes up and down in back) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported. No treatment information was provided. The patient gone to urgent care, still had not got the events resolved. Most recent FOLLOW-UP information incorporated above includes: On 26-Jul-2021: New event Muscular weakness added, outcome of an event pain in arm and narrative updated. On 28-Jul-2021: Follow up was received does not contains any new information

Other Meds:

Current Illness:

ID: 1643794
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: This spontaneous case reported by an other healthcare professional, describes the occurrence of lymphadenopathy (lymph node swelling) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient experienced lymphadenopathy (lymph node swelling). At the time of the report, lymphadenopathy (lymph node swelling) outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine), intramuscular: unknown. No concomitant medication or treatment information provided.

Other Meds:

Current Illness:

ID: 1643795
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/28/2021
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: Incorrect route of administration; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Incorrect route of administration) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Incorrect route of administration). At the time of the report, PRODUCT ADMINISTERED AT INAPPROPRIATE SITE (Incorrect route of administration) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant or treatment medications were reported.

Other Meds:

Current Illness:

ID: 1643796
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: missed their second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (missed their second 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (missed their second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (missed their second dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant drug was not reported. Treatment medication was not reported. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1643797
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: sore throat; This spontaneous case was reported by a patient and describes the occurrence of OROPHARYNGEAL PAIN (sore throat) 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 OROPHARYNGEAL PAIN (sore throat). At the time of the report, OROPHARYNGEAL PAIN (sore throat) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medication was reported. No treatment medication was reported.

Other Meds:

Current Illness:

ID: 1643798
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: runny nose; sore throat; This spontaneous case was reported by a consumer and describes the occurrence of RHINORRHOEA (runny nose) and OROPHARYNGEAL PAIN (sore throat) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RHINORRHOEA (runny nose) and OROPHARYNGEAL PAIN (sore throat). At the time of the report, RHINORRHOEA (runny nose) and OROPHARYNGEAL PAIN (sore throat) outcome was unknown. No concomitant medications were reported. No treatment details were reported.

Other Meds:

Current Illness:

ID: 1643799
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: experienced a blood clot behind my left eye; 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 OCULAR HYPERAEMIA (experienced a blood clot behind my left eye) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced OCULAR HYPERAEMIA (experienced a blood clot behind my left eye). At the time of the report, OCULAR HYPERAEMIA (experienced a blood clot behind my left eye) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Crosslinked with case MOD21-116551. AE submitted via social media. Consent for follow up declined. I experienced a blood clot behind my left eye after my first shot in February...since then I have found 4 more people with same thing....any correlation? Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1643800
Sex: F
Age:
State:

Vax Date: 01/24/2021
Onset Date: 01/30/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: Missed her second dose/More than 35 days have passed; tested positive for COVID; was sick; This spontaneous case was reported by a pharmacist and describes the occurrence of ILLNESS (was sick), PRODUCT DOSE OMISSION ISSUE (Missed her second dose/More than 35 days have passed) and COVID-19 (tested positive for COVID) 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 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Jan-2021, the patient experienced ILLNESS (was sick) and COVID-19 (tested positive for COVID). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed her second dose/More than 35 days have passed). At the time of the report, ILLNESS (was sick) and COVID-19 (tested positive for COVID) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Missed her second dose/More than 35 days have passed) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1643801
Sex: F
Age: 69
State: GA

Vax Date: 01/13/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: becoming allergic to Tylenol and ibuprofen & Sensitive to food that contained salicylate; any new supplement or drug she tries he has a reaction dermatologically; arms burn like sunburn; rash under the skin; This spontaneous case was reported by a consumer and describes the occurrence of HYPERSENSITIVITY (becoming allergic to Tylenol and ibuprofen & Sensitive to food that contained salicylate), SKIN REACTION (any new supplement or drug she tries he has a reaction dermatologically), BURNING SENSATION (arms burn like sunburn) and RASH (rash under the skin) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026L20A and 012M20A) for COVID-19 vaccination. Concurrent medical conditions included Drug allergy (Tylenol), Drug allergy and Food allergy (Sensitive to food that contained salicylate). On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-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 HYPERSENSITIVITY (becoming allergic to Tylenol and ibuprofen & Sensitive to food that contained salicylate), SKIN REACTION (any new supplement or drug she tries he has a reaction dermatologically), BURNING SENSATION (arms burn like sunburn) and RASH (rash under the skin). At the time of the report, HYPERSENSITIVITY (becoming allergic to Tylenol and ibuprofen & Sensitive to food that contained salicylate), SKIN REACTION (any new supplement or drug she tries he has a reaction dermatologically), BURNING SENSATION (arms burn like sunburn) and RASH (rash under the skin) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. The action taken with mRNA-1273 with the events was considered as not applicable. No concomitant medication reported by reporter. No treatment medication reported by reporter. This case was linked to MOD-2021-239094 (Patient Link).

Other Meds:

Current Illness: Drug allergy (Tylenol); Drug allergy

ID: 1643802
Sex: F
Age: 50
State: GA

Vax Date: 06/21/2021
Onset Date: 06/21/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Name: Body temperature; Result Unstructured Data: Increased 100.3F

Allergies:

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

Symptoms: Worried about the second vaccine side effects; Chills; Fever 100.3 F; Body Aches; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), PYREXIA (Fever 100.3 F), MYALGIA (Body Aches) and ANXIETY (Worried about the second vaccine side effects) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. Medical history was not provided. On 21-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jun-2021, the patient experienced CHILLS (Chills), PYREXIA (Fever 100.3 F) and MYALGIA (Body Aches). On 28-Jun-2021, the patient experienced ANXIETY (Worried about the second vaccine side effects). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 1 dosage form. On 23-Jun-2021, CHILLS (Chills), PYREXIA (Fever 100.3 F) and MYALGIA (Body Aches) had resolved. At the time of the report, ANXIETY (Worried about the second vaccine side effects) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 100.3f (High) Increased 100.3F. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication information was not provided.

Other Meds:

Current Illness:

ID: 1643803
Sex: M
Age:
State: CA

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

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

Lab Data:

Allergies:

Symptom List: Rash, Urticaria

Symptoms: Second dose 37 days after the first dose; This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose 37 days after the first dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose 37 days after the first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Second dose 37 days after the first dose) had resolved. No concomitant medication were reported. No treatment information was reported.

Other Meds:

Current Illness:

ID: 1643804
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: This spontaneous case reported by a consumer, describes the occurrence of vaccination site bruising (bruise at the injection site) in a patient, of an unknown age and gender, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced vaccination site bruising (bruise at the injection site). At the time of the report, vaccination site bruising (bruise at the injection site) outcome: unknown. Action taken with mRNA-1273 in response to the event: not applicable. No concomitant medications or treatment details reported.

Other Meds:

Current Illness:

ID: 1643805
Sex: F
Age: 53
State: NJ

Vax Date: 03/10/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: difficulty breathing / winded / can't catch breath/waking up in the middle of the night feeling winded; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (difficulty breathing / winded / can't catch breath/waking up in the middle of the night feeling winded) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 032B21A and 030A21A) for COVID-19 vaccination. Concurrent medical conditions included Blood pressure abnormal. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 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 an unknown date, the patient experienced DYSPNOEA (difficulty breathing / winded / can't catch breath/waking up in the middle of the night feeling winded). At the time of the report, DYSPNOEA (difficulty breathing / winded / can't catch breath/waking up in the middle of the night feeling winded) had not resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. Action taken with mRNA-1273 vaccine due to the event was not applicable. This case was linked to MOD-2021-239099 (Patient Link).

Other Meds:

Current Illness: Blood pressure abnormal

ID: 1643806
Sex: M
Age:
State: FL

Vax Date: 05/01/2021
Onset Date: 05/28/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: 13 year old received the first dose of the Moderna Covid-19 Vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 year old received the first dose of the Moderna Covid-19 Vaccine) in a 13-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In May 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 year old received the first dose of the Moderna Covid-19 Vaccine). On 28-May-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (13 year old received the first dose of the Moderna Covid-19 Vaccine) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1643807
Sex: F
Age: 68
State: NC

Vax Date: 03/02/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: still have numbness on two fingers; still have a radiating tingling sensation goin up their arm, not constant, for almost 4 month now; uncomfortable feeling; soreness of the arm after both shots; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HYPOAESTHESIA (still have numbness on two fingers), PARAESTHESIA (still have a radiating tingling sensation goin up their arm, not constant, for almost 4 month now), FEELING ABNORMAL (uncomfortable feeling) and PAIN IN EXTREMITY (soreness of the arm after both shots) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014M20A) for COVID-19 vaccination. No Medical History information was reported. On 02-Mar-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. 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 HYPOAESTHESIA (still have numbness on two fingers), PARAESTHESIA (still have a radiating tingling sensation goin up their arm, not constant, for almost 4 month now), FEELING ABNORMAL (uncomfortable feeling) and PAIN IN EXTREMITY (soreness of the arm after both shots). The patient was treated with VITAMIN B12 [VITAMIN B12 NOS] at an unspecified dose and frequency. At the time of the report, HYPOAESTHESIA (still have numbness on two fingers), PARAESTHESIA (still have a radiating tingling sensation goin up their arm, not constant, for almost 4 month now) and FEELING ABNORMAL (uncomfortable feeling) had not resolved and PAIN IN EXTREMITY (soreness of the arm after both shots) outcome was unknown. No Concomitant medications were reported. HCP recommended to ice the area.

Other Meds:

Current Illness:

ID: 1643808
Sex: F
Age: 55
State: TX

Vax Date: 03/09/2021
Onset Date: 03/16/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210309; Test Name: Electrocardiogram; Result Unstructured Data: Normal

Allergies:

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

Symptoms: She was afraid to take her second injection Will not take second dose; heaviness in chest; burning in chest; This spontaneous case was reported by a consumer and describes the occurrence of CHEST DISCOMFORT (heaviness in chest), CHEST PAIN (burning in chest) and INTENTIONAL PRODUCT USE ISSUE (She was afraid to take her second injection Will not take second dose) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. No Medical History information was reported. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Mar-2021, the patient experienced CHEST DISCOMFORT (heaviness in chest) and CHEST PAIN (burning in chest). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (She was afraid to take her second injection Will not take second dose). At the time of the report, CHEST DISCOMFORT (heaviness in chest), CHEST PAIN (burning in chest) and INTENTIONAL PRODUCT USE ISSUE (She was afraid to take her second injection Will not take second dose) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 09-Mar-2021, Electrocardiogram: normal Normal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications was reported. No treatment drug details was reported.

Other Meds:

Current Illness:

ID: 1643809
Sex: M
Age: 86
State: UT

Vax Date: 01/27/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Name: Clostridium difficile; Test Result: Negative ; Result Unstructured Data: Negative

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Diarrhea; Vaccination adverse reaction; Tenderness; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (Diarrhea), VACCINATION COMPLICATION (Vaccination adverse reaction) and TENDERNESS (Tenderness) in an 87-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 010A21A and 010M20A) for COVID-19 vaccination. No medical history was provided by the reporter. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIARRHOEA (Diarrhea), VACCINATION COMPLICATION (Vaccination adverse reaction) and TENDERNESS (Tenderness). At the time of the report, DIARRHOEA (Diarrhea), VACCINATION COMPLICATION (Vaccination adverse reaction) and TENDERNESS (Tenderness) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Clostridium test: negative (Negative) Negative. This case was linked to MOD-2021-239141 (Patient Link).

Other Meds:

Current Illness:

ID: 1643810
Sex: F
Age: 55
State: NC

Vax Date: 03/02/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Abdominal pain upper, Dizziness, Dysgeusia

Symptoms: chills; could not bend her right leg /could not bend her leg; pain in left hip/ after couple of days started in her left knee and left hip; Patient got severe pain behind her left leg and could not bend her leg; left knee very painful/could only bend her left knee a little bit; some general side effects; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (chills), HYPOKINESIA (could not bend her right leg /could not bend her leg), ARTHRALGIA (pain in left hip/ after couple of days started in her left knee and left hip), PAIN IN EXTREMITY (Patient got severe pain behind her left leg and could not bend her leg) and ARTHRALGIA (left knee very painful/could only bend her left knee a little bit) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028A21A and 8077Z27399) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Medical history was not provided. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-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 CHILLS (chills), HYPOKINESIA (could not bend her right leg /could not bend her leg), ARTHRALGIA (pain in left hip/ after couple of days started in her left knee and left hip), PAIN IN EXTREMITY (Patient got severe pain behind her left leg and could not bend her leg), ARTHRALGIA (left knee very painful/could only bend her left knee a little bit) and GENERAL SYMPTOM (some general side effects). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Chills, Knee pain and Pain in hip, at a dose of 1 dosage form. At the time of the report, CHILLS (chills), HYPOKINESIA (could not bend her right leg /could not bend her leg), ARTHRALGIA (pain in left hip/ after couple of days started in her left knee and left hip), PAIN IN EXTREMITY (Patient got severe pain behind her left leg and could not bend her leg), ARTHRALGIA (left knee very painful/could only bend her left knee a little bit) and GENERAL SYMPTOM (some general side effects) outcome was unknown. Patient stated that she was not on any concomitant medications. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.

Other Meds:

Current Illness:

ID: 1643811
Sex: M
Age: 86
State: UT

Vax Date: 01/27/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: very little local reactions; Tenderness; headache; This case was initially received via an unknown source (no reference has been entered for a health authority or license partner) on 28-Jun-2021. The most recent information was received on 02-Aug-2021 and was forwarded to Moderna on 02-Aug-2021. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (very little local reactions), TENDERNESS (Tenderness) and HEADACHE (headache) in an 86-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. No medical history was provided by the reporter. Concurrent medical conditions included Trigeminal neuralgia since 18-Mar-2020, Penicillin allergy, Fruit allergy, Latex allergy, Hay fever and Cholesterol. Concomitant products included CALCIUM for Calcium supplementation, PRAVASTATIN for Cholesterol, CYANOCOBALAMIN (VIT B12) for Elderly, ASCORBIC ACID (VITAMINS C) for Immunization, MULTIVITAMINS [VITAMINS NOS] for Vitamin supplementation. On 27-Jan-2021 at 3:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (very little local reactions), TENDERNESS (Tenderness) and HEADACHE (headache). The patient was treated with IBUPROFEN for Headache, at an unspecified dose and frequency. At the time of the report, VACCINATION COMPLICATION (very little local reactions), TENDERNESS (Tenderness) and HEADACHE (headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. This case was linked to MOD-2021-239138 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 02-Aug-2021: Significant follow-up received. Updated reporter name, patient current condition/allergy, and concomitant drugs.

Other Meds: PRAVASTATIN; MULTIVITAMINS [VITAMINS NOS]; VITAMINS C; VIT B12; CALCIUM

Current Illness: Trigeminal neuralgia

ID: 1643812
Sex: F
Age:
State: KY

Vax Date: 06/26/2021
Onset Date: 06/26/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: punctured 18 hours before vaccination; This spontaneous case was reported by a pharmacist and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (punctured 18 hours before vaccination) 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 26-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (punctured 18 hours before vaccination). At the time of the report, EXPIRED PRODUCT ADMINISTERED (punctured 18 hours before vaccination) 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 Relevant concomitant medications was reported. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1643813
Sex: M
Age: 29
State: TX

Vax Date: 05/26/2021
Onset Date: 06/26/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Unevaluable event

Symptoms: Tingle sensation in the index finger all up to the middle finger; This spontaneous case was reported by a pharmacist and describes the occurrence of PARAESTHESIA (Tingle sensation in the index finger all up to the middle finger) in a 29-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 033B21A) for COVID-19 vaccination. No Medical History information was reported. On 26-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jun-2021, the patient experienced PARAESTHESIA (Tingle sensation in the index finger all up to the middle finger). At the time of the report, PARAESTHESIA (Tingle sensation in the index finger all up to the middle finger) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was provided by the reporter. No concomitant medication information was provided by the reporter.

Other Meds:

Current Illness:

ID: 1643814
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: glands in throat to swell/It feels like i have a golf ball in my throat; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (glands in throat to swell/It feels like i have a golf ball in my throat) 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 LYMPHADENOPATHY (glands in throat to swell/It feels like i have a golf ball in my throat). At the time of the report, LYMPHADENOPATHY (glands in throat to swell/It feels like i have a golf ball in my throat) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were mentioned. No treatment details were reported. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1643815
Sex: F
Age:
State:

Vax Date:
Onset Date: 05/28/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: Sore injection site pain; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (Sore injection site pain) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concomitant products included AMLODIPINE BESILATE (AMLODIPINE BESYLATE), PROGESTERONE and ESTRADIOL 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 28-May-2021, the patient experienced VACCINATION SITE PAIN (Sore injection site pain). At the time of the report, VACCINATION SITE PAIN (Sore injection site 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 medication provided by reporter. This case was linked to MOD-2021-239156.

Other Meds: AMLODIPINE BESYLATE; PROGESTERONE; ESTRADIOL

Current Illness:

ID: 1643816
Sex: F
Age: 33
State: CA

Vax Date: 05/24/2021
Onset Date: 06/21/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: Patient received her second dose of the Moderna Covid-19 vaccine as an expired vaccine.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received her second dose of the Moderna Covid-19 vaccine as an expired vaccine.) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048C21A) for COVID-19 vaccination. No Medical History information was reported. On 24-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received her second dose of the Moderna Covid-19 vaccine as an expired vaccine.). On 21-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Patient received her second dose of the Moderna Covid-19 vaccine as an expired vaccine.) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications was reported. No treatment drug details was reported. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1643817
Sex: F
Age:
State:

Vax Date: 04/07/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: swollen arm; sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (swollen arm) and PAIN IN EXTREMITY (sore arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Medical history was not provided. On 07-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (swollen arm) and PAIN IN EXTREMITY (sore arm). At the time of the report, PERIPHERAL SWELLING (swollen arm) and PAIN IN EXTREMITY (sore arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported by the reporter. Treatment medication was not provided by the reporter.

Other Meds:

Current Illness:

ID: 1643818
Sex: U
Age:
State:

Vax Date: 04/22/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: I took the 1st Moderna shot on 04/22/21. Less than 2 weeks later started feeling bad went to a walk in; have not taken shot since 4/22/2021; and they said I had the Flu; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (I took the 1st Moderna shot on 04/22/21. Less than 2 weeks later started feeling bad went to a walk in), PRODUCT DOSE OMISSION ISSUE (have not taken shot since 4/22/2021) and INFLUENZA (and they said I had the Flu) 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 22-Apr-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 FEELING ABNORMAL (I took the 1st Moderna shot on 04/22/21. Less than 2 weeks later started feeling bad went to a walk in), PRODUCT DOSE OMISSION ISSUE (have not taken shot since 4/22/2021) and INFLUENZA (and they said I had the Flu). At the time of the report, FEELING ABNORMAL (I took the 1st Moderna shot on 04/22/21. Less than 2 weeks later started feeling bad went to a walk in), PRODUCT DOSE OMISSION ISSUE (have not taken shot since 4/22/2021) and INFLUENZA (and they said I had the Flu) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds:

Current Illness:

ID: 1643819
Sex: F
Age: 52
State: UT

Vax Date: 05/28/2021
Onset Date: 06/26/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: stomach ache; excessive urination; Body Chills; Debilitating Headache/headache was sensitive to light; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN UPPER (stomach ache), POLLAKIURIA (excessive urination), CHILLS (Body Chills) and HEADACHE (Debilitating Headache/headache was sensitive to light) in a 52-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21 and 038C21A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included AMLODIPINE BESILATE (AMLODIPINE BESYLATE), PROGESTERONE and ESTRADIOL for an unknown indication. On 28-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Jun-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach ache), POLLAKIURIA (excessive urination), CHILLS (Body Chills) and HEADACHE (Debilitating Headache/headache was sensitive to light). On 27-Jun-2021, ABDOMINAL PAIN UPPER (stomach ache), POLLAKIURIA (excessive urination), CHILLS (Body Chills) and HEADACHE (Debilitating Headache/headache was sensitive to light) had resolved. No treatment information was provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable. This case was linked to MOD-2021-239147 (Patient Link).

Other Meds: AMLODIPINE BESYLATE; PROGESTERONE; ESTRADIOL

Current Illness:

ID: 1643820
Sex: M
Age: 71
State: NJ

Vax Date: 02/22/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: "Horrendous case of vertigo",; Cerebellar vertigo; Vomiting; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO ("Horrendous case of vertigo",), VERTIGO CNS ORIGIN (Cerebellar vertigo) and VOMITING (Vomiting) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. No Medical History information was reported. On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced VERTIGO ("Horrendous case of vertigo",), VERTIGO CNS ORIGIN (Cerebellar vertigo) and VOMITING (Vomiting). The patient was treated with SALINE [SODIUM CHLORIDE] for Vomiting, at a dose of UNK dosage form and MECLIZINE HCL for Vomiting, at a dose of UNK dosage form. At the time of the report, VERTIGO ("Horrendous case of vertigo",), VERTIGO CNS ORIGIN (Cerebellar vertigo) and VOMITING (Vomiting) outcome was unknown. No relevant concomitant medications were reported.

Other Meds:

Current Illness:

ID: 1643821
Sex: F
Age: 21
State: CA

Vax Date: 06/21/2021
Onset Date: 06/21/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: Patient received his first dose of the Moderna Covid-19 vaccine as an expired vaccine.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received his first dose of the Moderna Covid-19 vaccine as an expired vaccine.) in a 21-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination. The patient's past medical history included No adverse reaction. On 21-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received his first dose of the Moderna Covid-19 vaccine as an expired vaccine.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received his first dose of the Moderna Covid-19 vaccine as an expired 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. no concomitant medications were reported. no treatment drugs were reported.

Other Meds:

Current Illness:

ID: 1643822
Sex: M
Age: 54
State:

Vax Date: 06/01/2021
Onset Date: 06/01/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain

Symptoms: sore injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (sore injection site arm) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included IBUPROFEN, PARACETAMOL (ACETAMINOPHEN) and CAFFEINE, PARACETAMOL (EXCEDRIN [CAFFEINE;PARACETAMOL]) for an unknown indication. On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jun-2021, the patient experienced VACCINATION SITE PAIN (sore injection site arm). At the time of the report, VACCINATION SITE PAIN (sore injection site arm) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. Treatment information was not provided. This case was linked to MOD-2021-239201 (Patient Link).

Other Meds: IBUPROFEN; ACETAMINOPHEN; EXCEDRIN [CAFFEINE;PARACETAMOL]

Current Illness:

ID: 1643823
Sex: U
Age:
State:

Vax Date:
Onset Date: 05/03/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: rapid heartbeat; This spontaneous case was reported by a consumer and describes the occurrence of HEART RATE INCREASED (rapid heartbeat) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 03-May-2021, the patient experienced HEART RATE INCREASED (rapid heartbeat). At the time of the report, HEART RATE INCREASED (rapid heartbeat) outcome was unknown. the patient received the first dose of vaccination on January 2021 and the second dose was received on February 2021. No concomitant medications and treatment information were reported.

Other Meds:

Current Illness:

ID: 1643824
Sex: F
Age: 62
State: MA

Vax Date: 03/01/2021
Onset Date: 03/30/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210412; Test Name: Blood sugar; Result Unstructured Data: increased.

Allergies:

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

Symptoms: throwing up twice the next day; Nausea; after being vaccinated had an issue when was monitoring the daily values, but didn't clarified anything; Sickness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Sickness), VOMITING (throwing up twice the next day), NAUSEA (Nausea) and VACCINATION SITE REACTION (after being vaccinated had an issue when was monitoring the daily values, but didn't clarified anything) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001AZ1A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included INSULIN GLARGINE (LANTUS XR), METFORMIN, ATORVASTATIN, OMEPRAZOLE SODIUM (OMEPRAZOLE [OMEPRAZOLE SODIUM]) and VITAMIN D3 for an unknown indication. On 01-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 VACCINATION COMPLICATION (Sickness). On an unknown date, the patient experienced VOMITING (throwing up twice the next day), NAUSEA (Nausea) and VACCINATION SITE REACTION (after being vaccinated had an issue when was monitoring the daily values, but didn't clarified anything). On 30-Mar-2021, VACCINATION COMPLICATION (Sickness) had resolved. At the time of the report, VOMITING (throwing up twice the next day), NAUSEA (Nausea) and VACCINATION SITE REACTION (after being vaccinated had an issue when was monitoring the daily values, but didn't clarified anything) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 12-Apr-2021, Blood glucose increased: increased (High) increased.. 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. N0 treatment medication provided by reporter. This case was linked to MOD-2021-239097 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Significant follow up appended

Other Meds: LANTUS XR; METFORMIN; ATORVASTATIN; OMEPRAZOLE [OMEPRAZOLE SODIUM]; VITAMIN D3

Current Illness:

ID: 1643825
Sex: F
Age:
State: FL

Vax Date: 03/19/2021
Onset Date: 04/16/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Tremor

Symptoms: Could not drive; Immobilized for 3 days in bed; Fever; Nausea; Arm was tender; Lethargy; Generalized burning pain; This spontaneous case was reported by a patient and describes the occurrence of TENDERNESS (Arm was tender), LETHARGY (Lethargy), PAIN (Generalized burning pain), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Could not drive) and MOBILITY DECREASED (Immobilized for 3 days in bed) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 021B21A and 030A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Hysterectomy in 1994. Concurrent medical conditions included Drug allergy (Allergy to Narcotics), Allergy to edible fungus (Allergy to Yeast), Allergy to nuts (Allergy to Peanuts), Allergy to vaccine (Tetanus), Fibromyalgia since 2009, Hypoglycemia since 1980, Hypothyroidism since 2015 and Irritable bowel syndrome since 1980. Concomitant products included LEVOTHYROXINE and ESTRADIOL for an unknown indication. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced TENDERNESS (Arm was tender), LETHARGY (Lethargy), PAIN (Generalized burning pain), MOBILITY DECREASED (Immobilized for 3 days in bed), PYREXIA (Fever) and NAUSEA (Nausea). On 19-Apr-2021, the patient experienced LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Could not drive). The patient was treated with PARACETAMOL (TYLENOL) for Pain, Fever, Nausea and Lethargy, at a dose of UNK dosage form; IBUPROFEN ongoing since an unknown date for Fever, Pain, Nausea and Lethargy, at a dose of UNK dosage form; GABAPENTIN ongoing since an unknown date for Pain, Fever, Nausea and Lethargy, at a dose of UNK dosage form and MELOXICAM ongoing since an unknown date for Fever, Nausea, Pain and Lethargy, at a dose of UNK dosage form. On 23-Apr-2021, TENDERNESS (Arm was tender), LETHARGY (Lethargy), PAIN (Generalized burning pain), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (Could not drive), MOBILITY DECREASED (Immobilized for 3 days in bed), PYREXIA (Fever) and NAUSEA (Nausea) had resolved. The patient received both scheduled doses of mRNA-1273 prior to the events; therefore, action taken with the drug in response to the events is not applicable. This case was linked to MOD-2021-073340 (Patient Link).

Other Meds: LEVOTHYROXINE; ESTRADIOL

Current Illness: Allergy to edible fungus (Allergy to Yeast); Allergy to nuts (Allergy to Peanuts); Allergy to vaccine (Tetanus); Drug allergy (Allergy to Narcotics); Fibromyalgia; Hypoglycemia; Hypothyroidism; Irritable bowel syndrome

ID: 1643826
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

Symptom List: Erythema, Pruritus

Symptoms: Chest pain; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced CHEST PAIN (Chest pain). At the time of the report, CHEST PAIN (Chest pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1643827
Sex: F
Age: 56
State: CA

Vax Date: 04/02/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: shortness of breath; soft stool; diarrhea; runny nose; constant sneezing; gastro-intestinal issues; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (shortness of breath), FAECES SOFT (soft stool), DIARRHOEA (diarrhea), RHINORRHOEA (runny nose) and SNEEZING (constant sneezing) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. #045B21A and 039A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Diverticulosis, Thyroid disorder and Diabetes. On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (shortness of breath), FAECES SOFT (soft stool), DIARRHOEA (diarrhea), RHINORRHOEA (runny nose), SNEEZING (constant sneezing) and ABDOMINAL DISCOMFORT (gastro-intestinal issues). The patient was treated with PARACETAMOL (TYLENOL) for Pain, at a dose of 1 dosage form once a day. At the time of the report, DYSPNOEA (shortness of breath), FAECES SOFT (soft stool), DIARRHOEA (diarrhea), RHINORRHOEA (runny nose), SNEEZING (constant sneezing) and ABDOMINAL DISCOMFORT (gastro-intestinal issues) outcome was unknown. The patient's concomitant medication included thyroid medication and diabetes medication. Treatment medication included medication for diarrhea Action taken with mRNA-1273 in response to the event was not applicable. This case was linked to MOD-2021-116349, MOD-2021-116401 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Medical history - Diverticulitis, New events added.

Other Meds:

Current Illness: Diabetes; Diverticulosis; Thyroid disorder

ID: 1643828
Sex: M
Age: 44
State: CA

Vax Date: 05/21/2021
Onset Date: 06/21/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Patient received his second dose of the Moderna Covid-19 vaccine as an expired vaccine.; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Patient received his second dose of the Moderna Covid-19 vaccine as an expired vaccine.) in a 44-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048C21A and 026C21A) for COVID-19 vaccination. Medical history was not provided. On 21-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 21-Jun-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced EXPIRED PRODUCT ADMINISTERED (Patient received his second dose of the Moderna Covid-19 vaccine as an expired vaccine.). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Patient received his second dose of the Moderna Covid-19 vaccine as an expired vaccine.) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Action taken with mRNA-1273 in response to the events was not applicable. No Treatment medications were reported. No Concomitant medications were reported. Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Non significant follow up appended

Other Meds:

Current Illness:

ID: 1643829
Sex: M
Age:
State: CA

Vax Date: 03/19/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: still feeling very sluggish; no energy during the day\ I've lost so much energy; night sweats/, gets up and is soaked; it is a little strange/has been bugging him; no appetite; at night feverish; This spontaneous case was reported by a patient and describes the occurrence of SLUGGISHNESS (still feeling very sluggish), ASTHENIA (no energy during the day\ I've lost so much energy), NIGHT SWEATS (night sweats/, gets up and is soaked), FEELING ABNORMAL (it is a little strange/has been bugging him) and DECREASED APPETITE (no appetite) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included LORAZEPAM. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced SLUGGISHNESS (still feeling very sluggish), ASTHENIA (no energy during the day\ I've lost so much energy), NIGHT SWEATS (night sweats/, gets up and is soaked), FEELING ABNORMAL (it is a little strange/has been bugging him), DECREASED APPETITE (no appetite) and PYREXIA (at night feverish). The patient was treated with VITAMIN B COMPLEX (B-COMPLEX [VITAMIN B COMPLEX]) at an unspecified dose and frequency. At the time of the report, SLUGGISHNESS (still feeling very sluggish), ASTHENIA (no energy during the day\ I've lost so much energy), NIGHT SWEATS (night sweats/, gets up and is soaked), FEELING ABNORMAL (it is a little strange/has been bugging him), DECREASED APPETITE (no appetite) and PYREXIA (at night feverish) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. This case was linked to MOD-2021-239185 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 28-Jun-2021: Follow up received to safety on 29-Jun-2021 as Consent denied to follow up and no other information was added.

Other Meds: LORAZEPAM

Current Illness:

ID: 1643830
Sex: F
Age: 79
State: CA

Vax Date: 06/21/2021
Onset Date: 06/21/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 20210621; Test Name: Blood pressure

Allergies:

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

Symptoms: Nervous; Blood Pressure fluctuated ( Maximum 142/90 mmHg); Could not sleep; Decreased Urination; This spontaneous case was reported by a consumer and describes the occurrence of NERVOUSNESS (Nervous), BLOOD PRESSURE FLUCTUATION (Blood Pressure fluctuated ( Maximum 142/90 mmHg)), INSOMNIA (Could not sleep) and MICTURITION DISORDER (Decreased Urination) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029C21A) for COVID-19 vaccination. The patient's past medical history included Kidney cancer and Cancer surgery. Concurrent medical conditions included Allergy to chemicals (Blood Pressure After Colonoscopy because sensitive to PEG). On 21-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jun-2021, the patient experienced NERVOUSNESS (Nervous), BLOOD PRESSURE FLUCTUATION (Blood Pressure fluctuated ( Maximum 142/90 mmHg)), INSOMNIA (Could not sleep) and MICTURITION DISORDER (Decreased Urination). At the time of the report, NERVOUSNESS (Nervous), BLOOD PRESSURE FLUCTUATION (Blood Pressure fluctuated ( Maximum 142/90 mmHg)), INSOMNIA (Could not sleep) and MICTURITION DISORDER (Decreased Urination) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Jun-2021, Blood pressure measurement: 142/90 High. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication was not provided. Treatment information was not provided.

Other Meds:

Current Illness: Allergy to chemicals (Blood Pressure After Colonoscopy because sensitive to PEG)

ID: 1643831
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: bad headache; body hurts; been in bed; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (bad headache), MYALGIA (body hurts) and MOBILITY DECREASED (been in bed) 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (bad headache), MYALGIA (body hurts) and MOBILITY DECREASED (been in bed). At the time of the report, HEADACHE (bad headache), MYALGIA (body hurts) and MOBILITY DECREASED (been in bed) outcome was unknown. No concomitant medications were reported. No treatment medications were reported.

Other Meds:

Current Illness:

ID: 1643832
Sex: M
Age:
State: NJ

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

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

Lab Data:

Allergies:

Symptom List: Pain in extremity

Symptoms: vertigo; This spontaneous case was reported by a consumer and describes the occurrence of VERTIGO (vertigo) in a 40-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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VERTIGO (vertigo). At the time of the report, VERTIGO (vertigo) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1643833
Sex: M
Age:
State: CA

Vax Date: 03/19/2021
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Sluggish; No energy; Sore arm; No appetite; In bed for 3 days; Fever; This spontaneous case was reported by a consumer and describes the occurrence of SLUGGISHNESS (Sluggish), ASTHENIA (No energy), PAIN IN EXTREMITY (Sore arm), DECREASED APPETITE (No appetite) and VACCINATION COMPLICATION (In bed for 3 days) in a 37-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001A21A) 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 LORAZEPAM for Sleep disorder NOS. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SLUGGISHNESS (Sluggish), ASTHENIA (No energy), PAIN IN EXTREMITY (Sore arm), DECREASED APPETITE (No appetite), VACCINATION COMPLICATION (In bed for 3 days) and PYREXIA (Fever). At the time of the report, SLUGGISHNESS (Sluggish), ASTHENIA (No energy), PAIN IN EXTREMITY (Sore arm), DECREASED APPETITE (No appetite), VACCINATION COMPLICATION (In bed for 3 days) and PYREXIA (Fever) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information was not provided by reporter. This case was linked to MOD-2021-239170 (Patient Link).

Other Meds: LORAZEPAM

Current Illness:

ID: 1643834
Sex: M
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: Brother had PII(32):AQDN9h82R6H0p0NWk/naI8pzv0KHJsvY and PII(32):AQDN9h82R6H0p0NWk/naI8pzv0KHJsvY vaccine, got Covid; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Brother had PII(32):AQDN9h82R6H0p0NWk/naI8pzv0KHJsvY and PII(32):AQDN9h82R6H0p0NWk/naI8pzv0KHJsvY vaccine, got Covid) 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 COVID-19 (Brother had PII(32):AQDN9h82R6H0p0NWk/naI8pzv0KHJsvY and PII(32):AQDN9h82R6H0p0NWk/naI8pzv0KHJsvY vaccine, got Covid). At the time of the report, COVID-19 (Brother had PII(32):AQDN9h82R6H0p0NWk/naI8pzv0KHJsvY and PII(32):AQDN9h82R6H0p0NWk/naI8pzv0KHJsvY vaccine, got Covid) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications was reported. No treatment drug details was reported.

Other Meds:

Current Illness:

ID: 1643835
Sex: M
Age: 78
State: GA

Vax Date: 02/07/2020
Onset Date:
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: injured knee; pain significant enough that it makes it difficult to sleep some nights; injured knee starts to hurt; muscle pain in his shoulder; This spontaneous case was reported by a consumer and describes the occurrence of JOINT INJURY (injured knee), INSOMNIA (pain significant enough that it makes it difficult to sleep some nights), ARTHRALGIA (injured knee starts to hurt) and MYALGIA (muscle pain in his shoulder) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product DUPILUMAB (DUPIXENT) for Atopic dermatitis. No Medical History information was reported. On 07-Feb-2020, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) 300 milligram. In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In 2021, the patient experienced JOINT INJURY (injured knee), INSOMNIA (pain significant enough that it makes it difficult to sleep some nights), ARTHRALGIA (injured knee starts to hurt) and MYALGIA (muscle pain in his shoulder). At the time of the report, JOINT INJURY (injured knee) and ARTHRALGIA (injured knee starts to hurt) had not resolved and INSOMNIA (pain significant enough that it makes it difficult to sleep some nights) and MYALGIA (muscle pain in his shoulder) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter Reporter causality: related for joint injury and arthralgia; unassessable for rest of the events

Other Meds:

Current Illness:

ID: 1643836
Sex: M
Age: 49
State:

Vax Date: 04/20/2021
Onset Date: 04/22/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: vomiting; nausea; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 29-Jun-2021 and was forwarded to Moderna on 29-Jun-2021. This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (vomiting) and NAUSEA (nausea) in a 49-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 03621a and 047b21a) for COVID-19 immunisation. Concurrent medical conditions included Penicillin allergy, Drug allergy (acetaminophen), Diabetic and Hypertension. On 20-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form once. On 18-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced VOMITING (vomiting) and NAUSEA (nausea). On 20-May-2021, VOMITING (vomiting) had resolved. At the time of the report, NAUSEA (nausea) outcome was unknown. No treatment information was provided by the reporter. Action taken with mRNA-1273 in response to the event was not applicable. This case was linked to MOD-2021-162788 (Patient Link).

Other Meds:

Current Illness: Diabetic; Hypertension; Penicillin allergy

ID: 1643837
Sex: M
Age: 54
State:

Vax Date: 06/01/2021
Onset Date: 06/26/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: headache; body aches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (headache) and MYALGIA (body aches) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included IBUPROFEN, PARACETAMOL (ACETAMINOPHEN) and IBUPROFEN (EXCEDRIN IB) for an unknown indication. On 01-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Jun-2021, the patient experienced HEADACHE (headache) and MYALGIA (body aches). On 27-Jun-2021, HEADACHE (headache) and MYALGIA (body aches) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information were provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.

Other Meds: IBUPROFEN; ACETAMINOPHEN; EXCEDRIN IB

Current Illness:

ID: 1643838
Sex: F
Age: 50
State: IL

Vax Date: 07/01/2007
Onset Date: 06/01/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data: Test Date: 202012; Test Name: Blood Test; Result Unstructured Data: Normal

Allergies:

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

Symptoms: Vivid dreams; This spontaneous case was reported by an other health care professional and describes the occurrence of ABNORMAL DREAMS (Vivid dreams) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. en6199) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Psoriatic arthritis. The patient's past medical history included Psoriatic arthritis since July 2007, Thyroid neoplasm malignant since an unknown date, Vivid dreams and Psoriasis since an unknown date. Concurrent medical conditions included Allergy (Sulfonamide allergy). In July 2007, the patient started ADALIMUMAB (HUMIRA) (unknown route) 40 mg. On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1. On 09-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. In June 2021, the patient experienced ABNORMAL DREAMS (Vivid dreams). At the time of the report, ABNORMAL DREAMS (Vivid dreams) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In December 2020, Blood test: Normal. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. Concomitant Drugs Not Reported. Reporter did not allow further contact

Other Meds: HUMIRA

Current Illness: Psoriasis; Psoriatic arthritis; Thyroid neoplasm malignant

ID: 1643839
Sex: F
Age: 57
State: TX

Vax Date: 02/05/2021
Onset Date: 02/05/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 032L20A) for COVID-19 vaccination. No Medical History information was reported. On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (sore arm). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 UNK. On 08-Feb-2021, PAIN IN EXTREMITY (sore arm) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication information was provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments This case was linked to MOD-2021-036773 (Patient Link).

Other Meds:

Current Illness:

ID: 1643840
Sex: F
Age:
State:

Vax Date:
Onset Date: 06/24/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Pain in shoulder; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Pain in shoulder) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Jun-2021, the patient experienced ARTHRALGIA (Pain in shoulder). At the time of the report, ARTHRALGIA (Pain in shoulder) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No information about concomitants was provided. No information about treatment medication was provided by the reporter. This case was linked to MOD-2021-236539, MOD-2021-236555, MOD-2021-236569, MOD-2021-236580 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 16-Aug-2021: Follow-up information contains event onset date added.

Other Meds:

Current Illness:

ID: 1643841
Sex: F
Age: 35
State: DE

Vax Date: 01/14/2021
Onset Date: 01/19/2021
Rec V Date: 08/28/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Her neck swollen 5 days/ neck was swollen; She had pain/ pain; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 16-Feb-2021 and was forwarded to Moderna on 16-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (Her neck swollen 5 days/ neck was swollen) and PAIN (She had pain/ pain) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025J20A) for COVID-19 vaccination. No Medical History information was reported. On 14-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jan-2021, the patient experienced SWELLING (Her neck swollen 5 days/ neck was swollen) and PAIN (She had pain/ pain). At the time of the report, SWELLING (Her neck swollen 5 days/ neck was swollen) and PAIN (She had pain/ pain) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. Concomitant product use was not provided. Treatment information was not provided. This case was linked to MOD-2021-015272 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 01-Jul-2021: Follow up included NNI

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am