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: 1627086
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/24/2021
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: This spontaneous case reported by a patient, describes the occurrence of oral herpes (woke up with cold scores) 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), intramuscular; 1 dosage form. 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 had oral herpes (woke up with cold scores). At the time of the report, oral herpes (woke up with cold scores) outcome: unknown. No concomitant medication or treatment information provided.

Other Meds:

Current Illness:

ID: 1627087
Sex: F
Age: 78
State: AL

Vax Date: 04/28/2021
Onset Date: 04/28/2021
Rec V Date: 08/24/2021
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: her symptoms have gotten worse after the second dose; Bruises all over her/her blood vessels broke in her arms stomach and legs; Pain; Arm swollen and hot; feet and ankle swollen; Bladder hurts; Goes to the bathroom every 30 minutes,; Every joint and ligament is so tight; connote walk, cannot get up and down the stairs, couldn't get out of the bed; Cannot squeeze her hands together; joint pain; her whole body is hurting, her lower back hurts, her whole body hurts, her ankle hurts, her feet hurts, muscle pain; This spontaneous case was reported by a consumer and describes the occurrence of CONDITION AGGRAVATED (her symptoms have gotten worse after the second dose), CONTUSION (Bruises all over her/her blood vessels broke in her arms stomach and legs), PAIN (Pain), PERIPHERAL SWELLING (Arm swollen and hot) and PERIPHERAL SWELLING (feet and ankle swollen) in a 78-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Diabetic and Kidney failure (Compromise kidney). On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced CONTUSION (Bruises all over her/her blood vessels broke in her arms stomach and legs), PAIN (Pain), PERIPHERAL SWELLING (Arm swollen and hot), PERIPHERAL SWELLING (feet and ankle swollen), BLADDER PAIN (Bladder hurts), ABDOMINAL DISCOMFORT (Goes to the bathroom every 30 minutes,), JOINT STIFFNESS (Every joint and ligament is so tight), MOBILITY DECREASED (connote walk, cannot get up and down the stairs, couldn't get out of the bed), MUSCULAR WEAKNESS (Cannot squeeze her hands together), ARTHRALGIA (joint pain) and MYALGIA (her whole body is hurting, her lower back hurts, her whole body hurts, her ankle hurts, her feet hurts, muscle pain). On an unknown date, the patient experienced CONDITION AGGRAVATED (her symptoms have gotten worse after the second dose). The patient was treated with PARACETAMOL (TYLENOL) for Adverse event, at an unspecified dose and frequency. At the time of the report, CONDITION AGGRAVATED (her symptoms have gotten worse after the second dose), CONTUSION (Bruises all over her/her blood vessels broke in her arms stomach and legs), PAIN (Pain), PERIPHERAL SWELLING (Arm swollen and hot), PERIPHERAL SWELLING (feet and ankle swollen), BLADDER PAIN (Bladder hurts), ABDOMINAL DISCOMFORT (Goes to the bathroom every 30 minutes,), JOINT STIFFNESS (Every joint and ligament is so tight), MOBILITY DECREASED (connote walk, cannot get up and down the stairs, couldn't get out of the bed), MUSCULAR WEAKNESS (Cannot squeeze her hands together), ARTHRALGIA (joint pain) and MYALGIA (her whole body is hurting, her lower back hurts, her whole body hurts, her ankle hurts, her feet hurts, muscle pain) had not resolved. Concomitant medication were not provided. Action taken with the mRNA-1273 in response to the event is not applicable. This case was linked to MOD-2021-216148 (Patient Link).

Other Meds:

Current Illness: Diabetic; Kidney failure (Compromise kidney)

ID: 1627088
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/24/2021
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: Racing heart; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PALPITATIONS (Racing heart) in a 61-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 PALPITATIONS (Racing heart). At the time of the report, PALPITATIONS (Racing heart) outcome was unknown. The patient was taking no concomitant medication. Patient went to the emergency room 3.5 weeks after second shot with a racing heart. Treatment information was not provided. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1627090
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/24/2021
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: second dose in 6 weeks; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose in 6 weeks) 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 INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose in 6 weeks). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose in 6 weeks) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication were reported. No treatment information was reported Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1627091
Sex: M
Age:
State:

Vax Date: 01/16/2021
Onset Date: 01/18/2021
Rec V Date: 08/24/2021
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: Swetted down; Fever; vomiting; Diarrhoea; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Swetted down), DIARRHOEA (Diarrhoea), PYREXIA (Fever) and VOMITING (vomiting) 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 16-Jan-2021 at 11:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 18-Jan-2021 at 9:30 AM, the patient experienced DIARRHOEA (Diarrhoea). On 18-Jan-2021 at 10:30 AM, the patient experienced VOMITING (vomiting). On an unknown date, the patient experienced HYPERHIDROSIS (Swetted down) and PYREXIA (Fever). On 19-Jan-2021, DIARRHOEA (Diarrhoea) and VOMITING (vomiting) had resolved. At the time of the report, HYPERHIDROSIS (Swetted down) and PYREXIA (Fever) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No information regarding concomitant medication was provided. No information regarding treatment medication was provided.

Other Meds:

Current Illness:

ID: 1627092
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/24/2021
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: Four patients received vaccine that was left out room temperature for over 12 hours after being punctured; This spontaneous case was reported by a consumer and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Four patients received vaccine that was left out room temperature for over 12 hours after being punctured) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Four patients received vaccine that was left out room temperature for over 12 hours after being punctured). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Four patients received vaccine that was left out room temperature for over 12 hours after being punctured) 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. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1627093
Sex: F
Age: 17
State: MO

Vax Date: 06/09/2021
Onset Date: 06/09/2021
Rec V Date: 08/24/2021
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: vaccine administered to a sixteen year old; Off label use in unapproved age group; This spontaneous case was reported by a nurse and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine administered to a sixteen year old) and OFF LABEL USE (Off label use in unapproved age group) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031b21a) for COVID-19 vaccination. Concurrent medical conditions included Hearing reduced since 23-Jun-2021, Obesity since 23-Jun-2021 and Penicillin allergy. Concomitant products included MEDROXYPROGESTERONE ACETATE (DEPO-PROVERA) from 23-Jun-2021 to an unknown date for Contraception. On 09-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine administered to a sixteen year old) and OFF LABEL USE (Off label use in unapproved age group). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (vaccine administered to a sixteen year old) and OFF LABEL USE (Off label use in unapproved age group) 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. Patient received a Moderna vaccine that was not age-indicated. Patient did not experience any adverse event at any time. No treatment information was provided. Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: added reporter details. added current conditions. added concomitants. added no adrs after receiving vaccine.

Other Meds: DEPO-PROVERA

Current Illness: Hearing reduced; Obesity

ID: 1627094
Sex: M
Age:
State: PA

Vax Date: 04/26/2021
Onset Date: 05/12/2021
Rec V Date: 08/24/2021
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: Received first dose on 26Apr2021 and second dose on 12May2021; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received first dose on 26Apr2021 and second dose on 12May2021) 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 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 12-May-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received first dose on 26Apr2021 and second dose on 12May2021). On 12-May-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received first dose on 26Apr2021 and second dose on 12May2021) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant and treatment information not provided

Other Meds:

Current Illness:

ID: 1627095
Sex: F
Age:
State: GA

Vax Date: 03/03/2021
Onset Date:
Rec V Date: 08/24/2021
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: walking difficulty; Widespread Pain; Had muscle pain every day since then.; Had fatigue every day since then.; Knee pain; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (walking difficulty), PAIN (Widespread Pain), MYALGIA (Had muscle pain every day since then.), FATIGUE (Had fatigue every day since then.) and ARTHRALGIA (Knee pain) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A21A and 013A21A) for COVID-19 vaccination. The patient's past medical history included Breast cancer on 18-Nov-2013. Concurrent medical conditions included Plastic sensitivity (Plastic Tape), Drug allergy (Betadyne), Fibromyalgia (Widespread pain and fatigue) since 05-Jan-2011 and Osteoarthritis (Joint inflammation and pain) since 12-Mar-2021. Concomitant products included ANASTROZOLE from 15-Jan-2018 to an unknown date for Breast cancer, BUPROPIONE from 01-Jan-2016 to an unknown date for Depression, VALSARTAN from 18-Nov-2019 to an unknown date and HYDROCHLOROTHIAZIDE from 06-Aug-2020 to an unknown date for Hypertension. On 03-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-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 GAIT DISTURBANCE (walking difficulty), PAIN (Widespread Pain), MYALGIA (Had muscle pain every day since then.), FATIGUE (Had fatigue every day since then.) and ARTHRALGIA (Knee pain). The patient was treated with GABAPENTIN (NEURONTIN) for Pain and Muscle pain, at an unspecified dose and frequency. At the time of the report, GAIT DISTURBANCE (walking difficulty), PAIN (Widespread Pain), MYALGIA (Had muscle pain every day since then.), FATIGUE (Had fatigue every day since then.) and ARTHRALGIA (Knee pain) outcome was unknown. She decide she will begin physical therapy on 28-Jul-2021 she will follow up with orthopedic surgeon and pain specialist on 28-Jul-2021. Most recent FOLLOW-UP information incorporated above includes: On 22-Jul-2021: Follow-up received on 22-Jul-2021 and contain significant information. Reporter phone number, state, patient demographic, concomitant medication, treatment medications and event has been updated.

Other Meds: VALSARTAN; ANASTROZOLE; BUPROPIONE; HYDROCHLOROTHIAZIDE

Current Illness: Drug allergy (Betadyne); Fibromyalgia (Widespread pain and fatigue); Osteoarthritis (Joint inflammation and pain); Plastic sensitivity (Plastic Tape)

ID: 1627096
Sex: M
Age: 80
State:

Vax Date: 05/07/2021
Onset Date: 06/08/2021
Rec V Date: 08/24/2021
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: Could not get out of bed; Muscle weakness; Fever; Sore arm; Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULAR WEAKNESS (Muscle weakness), PYREXIA (Fever), PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache) and FATIGUE (Fatigue) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concomitant products included LISINOPRIL, APIXABAN (ELIQUIS), AMLODIPINE and HYDROCODONE BITARTRATE, PARACETAMOL (NORCO) for an unknown indication. On 07-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 08-Jun-2021, the patient experienced MUSCULAR WEAKNESS (Muscle weakness), PYREXIA (Fever), PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache) and FATIGUE (Fatigue). On 10-Jun-2021, the patient experienced LETHARGY (Could not get out of bed). On 10-Jun-2021, PYREXIA (Fever), PAIN IN EXTREMITY (Sore arm), HEADACHE (Headache) and FATIGUE (Fatigue) had resolved. At the time of the report, MUSCULAR WEAKNESS (Muscle weakness) and LETHARGY (Could not get out of bed) outcome was unknown. Case crosslinked with Patient's wife's case - MOD21-109695 Action taken with mRNA-1273 in response to the event was not applicable. Treatment information was not provided.

Other Meds: LISINOPRIL; ELIQUIS; AMLODIPINE; NORCO

Current Illness:

ID: 1627097
Sex: F
Age: 68
State: VA

Vax Date: 03/03/2021
Onset Date:
Rec V Date: 08/24/2021
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: Cold sores/blisters in roof of mouth cleared up; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Cold sores/blisters in roof of mouth cleared up) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 03621A and 031B21A) for COVID-19 vaccination. No Medical History information was reported. On 03-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 THERAPEUTIC RESPONSE UNEXPECTED (Cold sores/blisters in roof of mouth cleared up). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Cold sores/blisters in roof of mouth cleared up) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Concomitant medications were provided No Treatment information provided

Other Meds:

Current Illness:

ID: 1627098
Sex: M
Age:
State:

Vax Date: 05/01/2021
Onset Date:
Rec V Date: 08/24/2021
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 discoloration of the skin; This spontaneous case was reported by a consumer and describes the occurrence of SKIN DISCOLOURATION (a little discoloration of the skin ) 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. In 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 SKIN DISCOLOURATION (a little discoloration of the skin ). At the time of the report, SKIN DISCOLOURATION (a little discoloration of the skin ) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. The patient stated that the discoloration was not located where the vaccine was given. The patient described the discoloration as chalk white circular skin blotches the size of a pencil eraser head and did not match his body skin color. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1627099
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/24/2021
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: Can joint aches resurface 2 weeks post 2nd shot?; Can muscle aches resurface 2 weeks post 2nd shot?; 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 ARTHRALGIA (Can joint aches resurface 2 weeks post 2nd shot?) and MYALGIA (Can muscle aches resurface 2 weeks post 2nd shot?) 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, the patient experienced ARTHRALGIA (Can joint aches resurface 2 weeks post 2nd shot?) and MYALGIA (Can muscle aches resurface 2 weeks post 2nd shot?). At the time of the report, ARTHRALGIA (Can joint aches resurface 2 weeks post 2nd shot?) and MYALGIA (Can muscle aches resurface 2 weeks post 2nd shot?) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was not applicabe No Relevant concomitant medications was reported. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1627100
Sex: U
Age:
State:

Vax Date: 03/23/2021
Onset Date:
Rec V Date: 08/24/2021
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: starting to lose range of motion; I still have soreness in my arm; This spontaneous case was reported by a patient and describes the occurrence of MOBILITY DECREASED (starting to lose range of motion) and MYALGIA (I still have soreness in my arm) 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 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MOBILITY DECREASED (starting to lose range of motion) and MYALGIA (I still have soreness in my arm). At the time of the report, MOBILITY DECREASED (starting to lose range of motion) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant information were not reported. Treatment information were not reported.

Other Meds:

Current Illness:

ID: 1627101
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/24/2021
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 Name: body temperature; Result Unstructured Data: Fever

Allergies:

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

Symptoms: fever of 102; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever of 102) 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, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PYREXIA (fever of 102). At the time of the report, PYREXIA (fever of 102) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 102 (High) Fever. No concomitant medication information given. No treatment information provided.

Other Meds:

Current Illness:

ID: 1627102
Sex: M
Age: 72
State: NC

Vax Date: 05/29/2021
Onset Date: 06/05/2021
Rec V Date: 08/24/2021
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: Burning skin; Red splotches; Red splotches; This spontaneous case was reported by a nurse and describes the occurrence of SKIN BURNING SENSATION (Burning skin), RASH (Red splotches) and ERYTHEMA (Red splotches) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 29-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jun-2021, the patient experienced SKIN BURNING SENSATION (Burning skin), RASH (Red splotches) and ERYTHEMA (Red splotches). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL A) for Burning skin and Patchy rash, at a dose of UNK dosage form. On 05-Jun-2021, SKIN BURNING SENSATION (Burning skin), RASH (Red splotches) and ERYTHEMA (Red splotches) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided. This case was linked to MOD-2021-216184 (Patient Link).

Other Meds:

Current Illness:

ID: 1627103
Sex: U
Age:
State:

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

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

Lab Data:

Allergies:

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

Symptoms: Swollen at the vaccination site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (Swollen at the vaccination site) 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, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE SWELLING (Swollen at the vaccination site). At the time of the report, VACCINATION SITE SWELLING (Swollen at the vaccination site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication was not provided. Treatment information was not provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) in response to the event was not applicable.

Other Meds:

Current Illness:

ID: 1627104
Sex: F
Age: 41
State: CA

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

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: Some pressure on head; Left arm was extremely swollen; Could not even stretch out arm; Uncomfortable to sleep; Very sore arm/ Pain in left arm pit; This spontaneous case was reported by a consumer and describes the occurrence of HEAD DISCOMFORT (Some pressure on head), MYALGIA (Very sore arm/ Pain in left arm pit), PERIPHERAL SWELLING (Left arm was extremely swollen), LIMB DISCOMFORT (Could not even stretch out arm) and INSOMNIA (Uncomfortable to sleep) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination. No Medical History information was reported. On 28-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 HEAD DISCOMFORT (Some pressure on head), MYALGIA (Very sore arm/ Pain in left arm pit), PERIPHERAL SWELLING (Left arm was extremely swollen), LIMB DISCOMFORT (Could not even stretch out arm) and INSOMNIA (Uncomfortable to sleep). At the time of the report, HEAD DISCOMFORT (Some pressure on head), PERIPHERAL SWELLING (Left arm was extremely swollen), LIMB DISCOMFORT (Could not even stretch out arm) and INSOMNIA (Uncomfortable to sleep) 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.

Other Meds:

Current Illness:

ID: 1627105
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/24/2021
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: Very fatigued; Insomnia; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Very fatigued) and INSOMNIA (Insomnia) 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 FATIGUE (Very fatigued) and INSOMNIA (Insomnia). At the time of the report, FATIGUE (Very fatigued) and INSOMNIA (Insomnia) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication were provided. No treatment details were provided.

Other Meds:

Current Illness:

ID: 1627106
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/24/2021
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: heart problems; This spontaneous case was reported by a patient and describes the occurrence of CARDIAC DISORDER (heart problems) 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 CARDIAC DISORDER (heart problems). At the time of the report, CARDIAC DISORDER (heart problems) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Concomitant medications were provided No Treatment information provided

Other Meds:

Current Illness:

ID: 1627107
Sex: F
Age: 33
State: NY

Vax Date: 04/06/2021
Onset Date: 04/06/2021
Rec V Date: 08/24/2021
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: menstrual spotting on 06May2021 and still happening; like heavy menstrual cramps; only site pain like soreness; This spontaneous case was reported by a consumer and describes the occurrence of INTERMENSTRUAL BLEEDING (menstrual spotting on 06May2021 and still happening), DYSMENORRHOEA (like heavy menstrual cramps) and VACCINATION SITE PAIN (only site pain like soreness) in a 33-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 036B21A and 031B21A) for COVID-19 vaccination. Concurrent medical conditions included Pollen allergy, Seasonal allergy and Penicillin allergy. Concomitant products included ESCITALOPRAM for Antidepressant drug level. On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 06-Apr-2021, the patient experienced VACCINATION SITE PAIN (only site pain like soreness). On 05-May-2021, the patient experienced INTERMENSTRUAL BLEEDING (menstrual spotting on 06May2021 and still happening) and DYSMENORRHOEA (like heavy menstrual cramps). The patient was treated with IBUPROFEN at an unspecified dose and frequency. At the time of the report, INTERMENSTRUAL BLEEDING (menstrual spotting on 06May2021 and still happening), DYSMENORRHOEA (like heavy menstrual cramps) and VACCINATION SITE PAIN (only site pain like soreness) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication with birth control pill was reported by the patient . Treatment with Ibuprofen was reported by the reporter.

Other Meds: ESCITALOPRAM

Current Illness: Penicillin allergy; Pollen allergy; Seasonal allergy

ID: 1627108
Sex: F
Age: 76
State: NY

Vax Date: 04/16/2021
Onset Date: 05/21/2021
Rec V Date: 08/24/2021
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: fever; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (fever) and FATIGUE (fatigue) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 042B21A) for COVID-19 vaccination. No Medical History information was reported. On 16-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 21-May-2021, the patient experienced PYREXIA (fever) and FATIGUE (fatigue). On 21-May-2021, PYREXIA (fever) and FATIGUE (fatigue) had resolved. No concomitant medication use was provided by the reporter. No treatment of events was reported. Action taken with mRNA-1273 in response to the drug was not applicable.

Other Meds:

Current Illness:

ID: 1627109
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/24/2021
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: Chills; Body hurts; Running fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of CHILLS (Chills), MYALGIA (Body hurts) and PYREXIA (Running fever) 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 CHILLS (Chills), MYALGIA (Body hurts) and PYREXIA (Running fever). At the time of the report, CHILLS (Chills), MYALGIA (Body hurts) and PYREXIA (Running fever) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported. Treatment medication was not provided.

Other Meds:

Current Illness:

ID: 1627110
Sex: M
Age:
State:

Vax Date: 05/03/2021
Onset Date:
Rec V Date: 08/24/2021
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: He has been sick for a week; Bad cold; lost his sense of smell; lost his sense of taste; had trouble breathing one night; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (He has been sick for a week), NASOPHARYNGITIS (Bad cold), ANOSMIA (lost his sense of smell), AGEUSIA (lost his sense of taste) and DYSPNOEA (had trouble breathing one night) 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 03-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (He has been sick for a week), NASOPHARYNGITIS (Bad cold), ANOSMIA (lost his sense of smell), AGEUSIA (lost his sense of taste) and DYSPNOEA (had trouble breathing one night). At the time of the report, VACCINATION COMPLICATION (He has been sick for a week), NASOPHARYNGITIS (Bad cold), ANOSMIA (lost his sense of smell), AGEUSIA (lost his sense of taste) and DYSPNOEA (had trouble breathing one night) outcome was unknown. Action taken with mRNA-1273 in response to the event was not applicable. Treatment information was not provided. Concomitant product use was not provided.

Other Meds:

Current Illness:

ID: 1627111
Sex: F
Age: 65
State: TX

Vax Date: 04/28/2021
Onset Date:
Rec V Date: 08/24/2021
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: Sore right arm briefly; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE PAIN (Sore right arm briefly) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Hyperlipidaemia and GERD. Concomitant products included PANTOPRAZOLE for GERD, ATORVASTATIN for Hyperlipidemia, GABAPENTIN, AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL), LAMOTRIGINE, CITALOPRAM and LUBIPROSTONE for an unknown indication. On 28-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 VACCINATION SITE PAIN (Sore right arm briefly). At the time of the report, VACCINATION SITE PAIN (Sore right arm briefly) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information was not provided by the reporter. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: GABAPENTIN; ATORVASTATIN; ADDERALL; LAMOTRIGINE; CITALOPRAM; PANTOPRAZOLE; LUBIPROSTONE

Current Illness: GERD; Hyperlipidaemia

ID: 1627112
Sex: F
Age: 25
State: VA

Vax Date: 05/17/2021
Onset Date: 05/17/2021
Rec V Date: 08/24/2021
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: abdominal cramps that doubled after every 10 mins , the abdominal pain lasted for two days; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL PAIN (abdominal cramps that doubled after every 10 mins , the abdominal pain lasted for two days) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included Advil for an unknown indication. On 17-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-May-2021, the patient experienced ABDOMINAL PAIN (abdominal cramps that doubled after every 10 mins , the abdominal pain lasted for two days). The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds: Advil

Current Illness:

ID: 1627113
Sex: M
Age: 23
State: NC

Vax Date: 06/09/2021
Onset Date: 06/10/2021
Rec V Date: 08/24/2021
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: Feeling Heavy; Feeling very drowsy; Experiencing tiredness; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (Feeling Heavy), SOMNOLENCE (Feeling very drowsy) and FATIGUE (Experiencing tiredness) in a 23-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 09-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-Jun-2021, the patient experienced FEELING ABNORMAL (Feeling Heavy), SOMNOLENCE (Feeling very drowsy) and FATIGUE (Experiencing tiredness). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FEELING ABNORMAL (Feeling Heavy), SOMNOLENCE (Feeling very drowsy) and FATIGUE (Experiencing tiredness) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1627114
Sex: F
Age: 65
State: TX

Vax Date: 06/09/2021
Onset Date: 06/09/2021
Rec V Date: 08/24/2021
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: right arm swollen; hard knot; red; second dose on Day 43; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE SWELLING (right arm swollen), VACCINATION SITE MASS (hard knot), VACCINATION SITE ERYTHEMA (red) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose on Day 43) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) for COVID-19 vaccination. Concomitant products included PANTOPRAZOLE for GERD, ATORVASTATIN for Hyperlipidemia, GABAPENTIN, AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL), LAMOTRIGINE, CITALOPRAM and LUBIPROSTONE for an unknown indication. On 09-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose on Day 43). On 10-Jun-2021, the patient experienced VACCINATION SITE SWELLING (right arm swollen), VACCINATION SITE MASS (hard knot) and VACCINATION SITE ERYTHEMA (red). At the time of the report, VACCINATION SITE SWELLING (right arm swollen), VACCINATION SITE MASS (hard knot), VACCINATION SITE ERYTHEMA (red) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (second dose on Day 43) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. She stated that there is no pain unless it is pressed upon. It looks like a mosquito bite. Her daughter has put a circle around the knot so that they can watch if the knot changes shape or color. Action taken with mRNA-1273 in response to the event was not applicable. No treatment medication information were reported

Other Meds: GABAPENTIN; ATORVASTATIN; ADDERALL; LAMOTRIGINE; CITALOPRAM; PANTOPRAZOLE; LUBIPROSTONE

Current Illness:

ID: 1627115
Sex: F
Age:
State: OR

Vax Date:
Onset Date:
Rec V Date: 08/24/2021
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: 10 people received a dose from an expired vaccine; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (10 people received a dose from an expired vaccine) in a 38-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 021C21A) 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 EXPIRED PRODUCT ADMINISTERED (10 people received a dose from an expired vaccine). At the time of the report, EXPIRED PRODUCT ADMINISTERED (10 people received a dose from an expired vaccine) 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 (Moderna COVID-19 Vaccine) was not applicable.

Other Meds:

Current Illness:

ID: 1627116
Sex: M
Age:
State: CA

Vax Date: 02/17/2021
Onset Date:
Rec V Date: 08/24/2021
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: Physician stated that the patient did not get the second dose/second dose not scheduled >42 days; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Physician stated that the patient did not get the second dose/second dose not scheduled >42 days) in a 61-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 17-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 PRODUCT DOSE OMISSION ISSUE (Physician stated that the patient did not get the second dose/second dose not scheduled >42 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Physician stated that the patient did not get the second dose/second dose not scheduled >42 days) 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. Treatment information was not provided. Concomitant product use was not provided.

Other Meds:

Current Illness:

ID: 1627117
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/24/2021
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: side effects; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (side effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (side effects). At the time of the report, VACCINATION COMPLICATION (side effects) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds:

Current Illness:

ID: 1627118
Sex: F
Age: 46
State: CA

Vax Date: 05/15/2021
Onset Date:
Rec V Date: 08/24/2021
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: patient past 42 days for second shot; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient past 42 days for second shot) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 15-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient past 42 days for second shot). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (patient past 42 days for second shot) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication was not provided. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1627119
Sex: F
Age: 36
State: MD

Vax Date: 06/07/2021
Onset Date: 06/07/2021
Rec V Date: 08/24/2021
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: the pain with the feet; arm started hurting badly after 3 hours/Consistent stabbing arm pain; Cant lift arm; This spontaneous case was reported by a patient and describes the occurrence of MOBILITY DECREASED (Cant lift arm), PAIN IN EXTREMITY (the pain with the feet) and MYALGIA (arm started hurting badly after 3 hours/Consistent stabbing arm pain) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 054C21A) for COVID-19 vaccination. No Medical History information was reported. On 07-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 07-Jun-2021, the patient experienced MOBILITY DECREASED (Cant lift arm) and MYALGIA (arm started hurting badly after 3 hours/Consistent stabbing arm pain). On an unknown date, the patient experienced PAIN IN EXTREMITY (the pain with the feet). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Pain, at a dose of 1 dosage form. At the time of the report, MOBILITY DECREASED (Cant lift arm), PAIN IN EXTREMITY (the pain with the feet) and MYALGIA (arm started hurting badly after 3 hours/Consistent stabbing arm pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: No New Information

Other Meds:

Current Illness:

ID: 1627120
Sex: F
Age: 77
State: AZ

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

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

Lab Data: Test Date: 20210606; Test Name: Body Temperature; Result Unstructured Data: Had fever of "101 point something

Allergies:

Symptom List: Tremor

Symptoms: feeling a little off in my stomach; hiccups; burping; vomiting; nausea; muscle aches and pains/ pain all over; pins and needles; tired; fever of 101 point something; brain was messed up; lethargic / couldn't get out of bed; soreness in her arm; This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (pins and needles), ABDOMINAL DISCOMFORT (feeling a little off in my stomach), HICCUPS (hiccups), ERUCTATION (burping) and FEELING ABNORMAL (brain was messed up) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Gastritis (Gastrointestinal issues) and Diverticulitis (Gastrointestinal issues). On 05-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-Jun-2021, the patient experienced VACCINATION SITE PAIN (soreness in her arm). On 06-Jun-2021, the patient experienced FEELING ABNORMAL (brain was messed up), LETHARGY (lethargic / couldn't get out of bed), PYREXIA (fever of 101 point something) and FATIGUE (tired). On 07-Jun-2021, the patient experienced PARAESTHESIA (pins and needles) and MYALGIA (muscle aches and pains/ pain all over). On 10-Jun-2021, the patient experienced HICCUPS (hiccups), ERUCTATION (burping), VOMITING (vomiting) and NAUSEA (nausea). On an unknown date, the patient experienced ABDOMINAL DISCOMFORT (feeling a little off in my stomach). The patient was treated with PARACETAMOL (TYLENOL EXTRA STRENGTH) at an unspecified dose and frequency; CEFIXIME (FLEXERIL [CEFIXIME]) at an unspecified dose and frequency; ASPIRIN [ACETYLSALICYLIC ACID] at a dose of 1 dosage form and NAPROXEN at a dose of 1 dosage form. On 05-Jun-2021, VACCINATION SITE PAIN (soreness in her arm) had resolved. On 06-Jun-2021, FEELING ABNORMAL (brain was messed up), LETHARGY (lethargic / couldn't get out of bed), PYREXIA (fever of 101 point something) and FATIGUE (tired) had resolved. At the time of the report, PARAESTHESIA (pins and needles), ABDOMINAL DISCOMFORT (feeling a little off in my stomach), HICCUPS (hiccups), ERUCTATION (burping), VOMITING (vomiting) and NAUSEA (nausea) outcome was unknown and MYALGIA (muscle aches and pains/ pain all over) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jun-2021, Body temperature: 101 (High) Had fever of "101 point something. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient also experienced "up chucking" and a pins and by needles feeling patient deemed the "movie theater experience." No concomitant medications were reported. The patient reported she saw her HCP for her symptoms.

Other Meds:

Current Illness:

ID: 1627121
Sex: F
Age: 67
State: IL

Vax Date: 06/08/2021
Onset Date: 06/08/2021
Rec V Date: 08/24/2021
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: Fever; Sore arm; fatigue; Headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), MYALGIA (Sore arm), FATIGUE (fatigue) and HEADACHE (Headache) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included High cholesterol medication, High blood pressure medication, Medication for digestion and PAROXETINE for an unknown indication. On 08-Jun-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jun-2021, the patient experienced PYREXIA (Fever), MYALGIA (Sore arm), FATIGUE (fatigue) and HEADACHE (Headache). On 10-Jun-2021, PYREXIA (Fever), MYALGIA (Sore arm), FATIGUE (fatigue) and HEADACHE (Headache) had resolved.

Other Meds: High cholesterol medication; High blood pressure medication; Medication for digestion; PAROXETINE

Current Illness:

ID: 1627122
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/24/2021
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: This spontaneous case reported by a consumer, describes the occurrence of cough 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 a dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced cough. At the time of the report, cough outcome: unknown. The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown. No concomitant medication or treatment information provided.

Other Meds:

Current Illness:

ID: 1627123
Sex: F
Age: 62
State: CA

Vax Date: 03/01/2021
Onset Date:
Rec V Date: 08/24/2021
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: Unexpected beneficial therapeutic response; flu like symtoms; frequent thirst; dry mouth from Lupus; Headache; felt feverish; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (Unexpected beneficial therapeutic response), INFLUENZA LIKE ILLNESS (flu like symtoms), THIRST (frequent thirst), DRY MOUTH (dry mouth from Lupus) and HEADACHE (Headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Lupus erythematosus and Fibromyalgia. In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (Unexpected beneficial therapeutic response), INFLUENZA LIKE ILLNESS (flu like symtoms), THIRST (frequent thirst), DRY MOUTH (dry mouth from Lupus), HEADACHE (Headache) and PYREXIA (felt feverish). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (Unexpected beneficial therapeutic response), INFLUENZA LIKE ILLNESS (flu like symtoms), THIRST (frequent thirst), DRY MOUTH (dry mouth from Lupus), HEADACHE (Headache) and PYREXIA (felt feverish) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient experienced her skin is soft and soaky after receiving the vaccine. She also reported that her skin cleared up from the goosebumps No concomitant medication reported. Ice packs used as treatment This case was linked to MOD-2021-216514 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Additional information added include medical history and new events.

Other Meds:

Current Illness: Fibromyalgia; Lupus erythematosus

ID: 1627124
Sex: U
Age:
State:

Vax Date: 04/23/2021
Onset Date:
Rec V Date: 08/24/2021
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: Second dose not received for >35days; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Second dose not received for >35days) 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 23-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 PRODUCT DOSE OMISSION ISSUE (Second dose not received for >35days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Second dose not received for >35days) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant and treatment information were not provided for mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not any causality assessment.

Other Meds:

Current Illness:

ID: 1627125
Sex: F
Age: 46
State: MI

Vax Date: 04/29/2021
Onset Date: 05/28/2021
Rec V Date: 08/24/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: nervous about rash; "heart beat rate because of panic"; "foggy brain"; "real dizzy"; rash on the face; headache; swollen lymph node left side; This spontaneous case was reported by a consumer and describes the occurrence of NERVOUSNESS (nervous about rash), PALPITATIONS ("heart beat rate because of panic"), FEELING ABNORMAL ("foggy brain"), DIZZINESS ("real dizzy") and RASH (rash on the face) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 044B21A and 022B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Allergy. Concomitant products included LORATADINE, PSEUDOEPHEDRINE SULFATE (CLARITIN D 12 HOUR) for Allergy. On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-May-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LYMPHADENOPATHY (swollen lymph node left side). On 07-Jun-2021, the patient experienced NERVOUSNESS (nervous about rash), PALPITATIONS ("heart beat rate because of panic"), FEELING ABNORMAL ("foggy brain"), DIZZINESS ("real dizzy"), RASH (rash on the face) and HEADACHE (headache). The patient was treated with HYDROCORTISONE ACETATE (CORTISONE [HYDROCORTISONE ACETATE]) (topical) for Rash, at an unspecified dose and frequency. On 30-May-2021, LYMPHADENOPATHY (swollen lymph node left side) had resolved. At the time of the report, NERVOUSNESS (nervous about rash), PALPITATIONS ("heart beat rate because of panic"), FEELING ABNORMAL ("foggy brain"), DIZZINESS ("real dizzy"), RASH (rash on the face) and HEADACHE (headache) outcome was unknown.

Other Meds: CLARITIN D 12 HOUR

Current Illness: Allergy

ID: 1627126
Sex: F
Age: 54
State: NY

Vax Date: 06/09/2021
Onset Date: 06/09/2021
Rec V Date: 08/24/2021
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: pain in arm of injection; dizzy; nausea; headache; tingling down arm into fingers; back pain; fever; pressure on chest; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain in arm of injection), DIZZINESS (dizzy), NAUSEA (nausea ), HEADACHE (headache ) and PARAESTHESIA (tingling down arm into fingers) in a 55-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. On 09-Jun-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 09-Jun-2021, the patient experienced DIZZINESS (dizzy), NAUSEA (nausea ), HEADACHE (headache ), BACK PAIN (back pain ), PYREXIA (fever ) and CHEST DISCOMFORT (pressure on chest). On an unknown date, the patient experienced VACCINATION SITE PAIN (pain in arm of injection) and PARAESTHESIA (tingling down arm into fingers). At the time of the report, VACCINATION SITE PAIN (pain in arm of injection), DIZZINESS (dizzy), NAUSEA (nausea ), HEADACHE (headache ), PARAESTHESIA (tingling down arm into fingers), BACK PAIN (back pain ), PYREXIA (fever ) and CHEST DISCOMFORT (pressure on chest) outcome was unknown. No relevant concomitant medications were reported. No treatment information was provided. This case was linked to MOD-2021-216505, MOD-2021-216360 (Patient Link).

Other Meds:

Current Illness:

ID: 1627127
Sex: M
Age:
State:

Vax Date: 05/05/2021
Onset Date:
Rec V Date: 08/24/2021
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: sick; sweating profusely; throwing up this thick mucus; vomiting/holding no food down/throwing up this thick mucus; This spontaneous case was reported by a patient and describes the occurrence of ILLNESS (sick), HYPERHIDROSIS (sweating profusely), SECRETION DISCHARGE (throwing up this thick mucus) and VOMITING (vomiting/holding no food down/throwing up this thick mucus) 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 05-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ILLNESS (sick), HYPERHIDROSIS (sweating profusely), SECRETION DISCHARGE (throwing up this thick mucus) and VOMITING (vomiting/holding no food down/throwing up this thick mucus). At the time of the report, ILLNESS (sick), HYPERHIDROSIS (sweating profusely), SECRETION DISCHARGE (throwing up this thick mucus) and VOMITING (vomiting/holding no food down/throwing up this thick mucus) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported. Treatment medication was not provided.

Other Meds:

Current Illness:

ID: 1627128
Sex: M
Age:
State: LA

Vax Date: 03/15/2021
Onset Date: 04/30/2021
Rec V Date: 08/24/2021
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: Received the 2nd dose on day 46 ?; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the 2nd dose on day 46 ?) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044A21A) for COVID-19 vaccination. No Medical History information was reported. On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the 2nd dose on day 46 ?). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Received the 2nd dose on day 46 ?) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment information was not provided. Lab details were not provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.

Other Meds:

Current Illness:

ID: 1627129
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/24/2021
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: Sweating more; Odor on my skin; dont have sensitive teeth and I am not getting those headaches anymore; This spontaneous case was reported by a consumer and describes the occurrence of HYPERHIDROSIS (Sweating more), SKIN ODOUR ABNORMAL (Odor on my skin) and THERAPEUTIC RESPONSE UNEXPECTED (dont have sensitive teeth and I am not getting those headaches anymore) 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 HYPERHIDROSIS (Sweating more), SKIN ODOUR ABNORMAL (Odor on my skin) and THERAPEUTIC RESPONSE UNEXPECTED (dont have sensitive teeth and I am not getting those headaches anymore). At the time of the report, HYPERHIDROSIS (Sweating more), SKIN ODOUR ABNORMAL (Odor on my skin) and THERAPEUTIC RESPONSE UNEXPECTED (dont have sensitive teeth and I am not getting those headaches anymore) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant medications were reported No treatment medications were reported

Other Meds:

Current Illness:

ID: 1627130
Sex: F
Age:
State: NY

Vax Date: 06/09/2021
Onset Date: 06/09/2021
Rec V Date: 08/24/2021
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: Dizzy; tingling down arm into fingers; Back pain; pressure on chest; pain in arm of injection; Headache; nausea; fever; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Dizzy), PARAESTHESIA (tingling down arm into fingers), BACK PAIN (Back pain), CHEST DISCOMFORT (pressure on chest) and VACCINATION SITE PAIN (pain in arm of injection) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 09-Jun-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 09-Jun-2021, the patient experienced DIZZINESS (Dizzy), PARAESTHESIA (tingling down arm into fingers), BACK PAIN (Back pain), CHEST DISCOMFORT (pressure on chest), VACCINATION SITE PAIN (pain in arm of injection), HEADACHE (Headache), NAUSEA (nausea) and PYREXIA (fever). At the time of the report, DIZZINESS (Dizzy), PARAESTHESIA (tingling down arm into fingers), BACK PAIN (Back pain), CHEST DISCOMFORT (pressure on chest), VACCINATION SITE PAIN (pain in arm of injection), HEADACHE (Headache), NAUSEA (nausea) and PYREXIA (fever) outcome was unknown. No relevant concomitant medications were reported. No treatment information was provided. This case was linked to MOD-2021-216479 (Patient Link).

Other Meds:

Current Illness:

ID: 1627131
Sex: F
Age: 62
State: CA

Vax Date: 03/01/2021
Onset Date:
Rec V Date: 08/24/2021
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: skin is soft and soaky, skin cleared up from the goosebumps she had since birth; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (skin is soft and soaky, skin cleared up from the goosebumps she had since birth) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In April 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 THERAPEUTIC RESPONSE UNEXPECTED (skin is soft and soaky, skin cleared up from the goosebumps she had since birth). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (skin is soft and soaky, skin cleared up from the goosebumps she had since birth) outcome was unknown. Not Provided No concomitant medications were reported. This case was linked to MOD-2021-216460 (Patient Link).

Other Meds:

Current Illness:

ID: 1627132
Sex: U
Age:
State: CA

Vax Date:
Onset Date: 06/04/2021
Rec V Date: 08/24/2021
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: Moderna Covid-19 vaccine that has stayed 6 days beyond use date was administered to 23 patients; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that has stayed 6 days beyond use date was administered to 23 patients) 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 04-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that has stayed 6 days beyond use date was administered to 23 patients). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Moderna Covid-19 vaccine that has stayed 6 days beyond use date was administered to 23 patients) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1627133
Sex: U
Age:
State: WA

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

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

Lab Data:

Allergies:

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

Symptoms: stated there were 112 reported incidents of both the Pfizer and Moderna COVID19 vaccine bringing about shingles; 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 HERPES ZOSTER (stated there were 112 reported incidents of both the Pfizer and Moderna COVID19 vaccine bringing about shingles) 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 HERPES ZOSTER (stated there were 112 reported incidents of both the Pfizer and Moderna COVID19 vaccine bringing about shingles). At the time of the report, HERPES ZOSTER (stated there were 112 reported incidents of both the Pfizer and Moderna COVID19 vaccine bringing about shingles) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided. Treatment details were not provided.

Other Meds:

Current Illness:

ID: 1627134
Sex: F
Age: 55
State: MD

Vax Date: 04/28/2021
Onset Date: 06/02/2021
Rec V Date: 08/24/2021
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: Test Date: 20210521; Test Name: MRI; Test Result: Inconclusive ; Result Unstructured Data: Inconclusive

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: facial swelling; puffy eyes; Swollen lymph nodes; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (facial swelling), PERIORBITAL SWELLING (puffy eyes) and LYMPHADENOPATHY (Swollen lymph nodes) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 016c21a) for COVID-19 vaccination. No Medical History information was reported. On 28-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 25-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Jun-2021, the patient experienced SWELLING FACE (facial swelling), PERIORBITAL SWELLING (puffy eyes) and LYMPHADENOPATHY (Swollen lymph nodes). At the time of the report, SWELLING FACE (facial swelling), PERIORBITAL SWELLING (puffy eyes) and LYMPHADENOPATHY (Swollen lymph nodes) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-May-2021, Magnetic resonance imaging: inconclusive (Inconclusive) Inconclusive. Concomitant medications were not provided. Treatment information was not reported.

Other Meds:

Current Illness:

ID: 1627135
Sex: F
Age: 75
State: PA

Vax Date: 06/05/2021
Onset Date: 06/05/2021
Rec V Date: 08/24/2021
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: "a blotch of red bumps"; "not too comfortable"; frustrated; "I'm not feeling better"; "I don't know my body now"/a lot of strange things are happening"; "a blotch of red bumps"; a little itchy; been itching like crazy; feel like a junky because I am scratching on one side and scratching on the other side; felt tired; "felt a little weak"; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA ("felt a little weak"), RASH MACULAR ("a blotch of red bumps"), DISCOMFORT ("not too comfortable"), FRUSTRATION TOLERANCE DECREASED (frustrated) and MALAISE ("I'm not feeling better") in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 050C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Glaucoma. Concomitant products included BIMATOPROST (LUMIGAN) for Glaucoma, VITAMIN C [ASCORBIC ACID] and CURCUMA LONGA (TURMERIC [CURCUMA LONGA]) for an unknown indication. On 05-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jun-2021, the patient experienced ASTHENIA ("felt a little weak"), PRURITUS (a little itchy; been itching like crazy; feel like a junky because I am scratching on one side and scratching on the other side) and FATIGUE (felt tired). On 07-Jun-2021, the patient experienced RASH MACULAR ("a blotch of red bumps"), DISCOMFORT ("not too comfortable"), FRUSTRATION TOLERANCE DECREASED (frustrated), MALAISE ("I'm not feeling better"), FEELING ABNORMAL ("I don't know my body now"/a lot of strange things are happening") and RASH ERYTHEMATOUS ("a blotch of red bumps"). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Adverse event, at a dose of 1 dosage form. At the time of the report, ASTHENIA ("felt a little weak"), RASH MACULAR ("a blotch of red bumps"), DISCOMFORT ("not too comfortable"), FRUSTRATION TOLERANCE DECREASED (frustrated), MALAISE ("I'm not feeling better"), RASH ERYTHEMATOUS ("a blotch of red bumps"), PRURITUS (a little itchy; been itching like crazy; feel like a junky because I am scratching on one side and scratching on the other side) and FATIGUE (felt tired) outcome was unknown and FEELING ABNORMAL ("I don't know my body now"/a lot of strange things are happening") had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Patient took Blood Builder supplement as concomitant product. patient took Benadryl to treat her symptoms.

Other Meds: LUMIGAN; VITAMIN C [ASCORBIC ACID]; TURMERIC [CURCUMA LONGA]

Current Illness: Glaucoma

ID: 1627136
Sex: U
Age:
State: OH

Vax Date:
Onset Date:
Rec V Date: 08/24/2021
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: Paralysis; 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 PARALYSIS (Paralysis) 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) Unknown. On an unknown date, the patient experienced PARALYSIS (Paralysis). At the time of the report, PARALYSIS (Paralysis) 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 medication and treatment information not reported. Company Comment: Based on the current case data, this case has been classified as invalid.; Sender's Comments: Based on the current case data, this case has been classified as invalid.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am