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: 1627036
Sex: F
Age: 86
State: NY

Vax Date: 04/01/2021
Onset Date: 04/01/2021
Rec V Date: 08/24/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: Patient contracted COVID-19; This spontaneous case was reported by a pharmacist and describes the occurrence of COVID-19 (Patient contracted COVID-19) in an 87-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. In April 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, the patient experienced COVID-19 (Patient contracted COVID-19). At the time of the report, COVID-19 (Patient contracted COVID-19) 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 relevant concomitant medications was reported. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1627037
Sex: F
Age: 56
State:

Vax Date: 01/16/2021
Onset Date: 01/16/2021
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: yet to receive the second dose; Bursitis In The Arm; Sore Back; Positive COVID-19 Test; Sore Arm/ Achy; A Little Tired; This spontaneous case was reported by a consumer and describes the occurrence of BURSITIS (Bursitis In The Arm), BACK PAIN (Sore Back), COVID-19 (Positive COVID-19 Test), MYALGIA (Sore Arm/ Achy) and FATIGUE (A Little Tired) in a 56-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 16-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Jan-2021, the patient experienced MYALGIA (Sore Arm/ Achy) and FATIGUE (A Little Tired). On 08-Feb-2021, the patient experienced COVID-19 (Positive COVID-19 Test). On 10-Feb-2021, the patient experienced BURSITIS (Bursitis In The Arm) and BACK PAIN (Sore Back). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (yet to receive the second dose). At the time of the report, BURSITIS (Bursitis In The Arm), BACK PAIN (Sore Back), COVID-19 (Positive COVID-19 Test), MYALGIA (Sore Arm/ Achy), FATIGUE (A Little Tired) and PRODUCT DOSE OMISSION ISSUE (yet to receive the second dose) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment included Ibuprofen every 5-6 hours to treat the initial symptoms related to the first dose

Other Meds:

Current Illness:

ID: 1627038
Sex: M
Age: 16
State: MO

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: EL1284
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: she administered Moderna COVID19 Vaccine to sixteen years old individuals on 09June2021. Doctor provided lot 031b21a.; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (she administered Moderna COVID19 Vaccine to sixteen years old individuals on 09June2021. Doctor provided lot 031b21a.) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031b21a) for COVID-19 vaccination. Concurrent medical conditions included Sulfonamide allergy. On 09-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (she administered Moderna COVID19 Vaccine to sixteen years old individuals on 09June2021. Doctor provided lot 031b21a.). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (she administered Moderna COVID19 Vaccine to sixteen years old individuals on 09June2021. Doctor provided lot 031b21a.) 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 treatment information was provided by the reporter. No concomitant product was provided by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Follow up received on 29-July-2021 contains Significant information new reporter details added, updated patient details and medical history.

Other Meds:

Current Illness: Sulfonamide allergy

ID: 1627039
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: This spontaneous case reported by a consumer, describes the occurrence of chills, pyrexia (fever) and myalgia (body aches) 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 chills, pyrexia (fever) and myalgia (body aches). At the time of the report, chills, pyrexia (fever) and myalgia (body aches) outcome: unknown. Concomitant product use and treatment information not provided.

Other Meds:

Current Illness:

ID: 1627040
Sex: F
Age: 25
State: TX

Vax Date: 04/24/2021
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: 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: greater than 35 days between doses of the Moderna Covid-19 vaccine; Migraine Headache; Fever; chills; muscle aches; joint aches; This case was received via an unknown source (no reference has been entered for a health authority or license partner) on 10-Jun-2021 and was forwarded to Moderna on 10-Jun-2021. This spontaneous case was reported by a consumer and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (greater than 35 days between doses of the Moderna Covid-19 vaccine), MIGRAINE (Migraine Headache), PYREXIA (Fever), CHILLS (chills) and MYALGIA (muscle aches) in a 25-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 008C21A and 022B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 24-Apr-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 09-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (greater than 35 days between doses of the Moderna Covid-19 vaccine), MIGRAINE (Migraine Headache), PYREXIA (Fever), CHILLS (chills), MYALGIA (muscle aches) and ARTHRALGIA (joint aches). On 09-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (greater than 35 days between doses of the Moderna Covid-19 vaccine) had resolved. At the time of the report, MIGRAINE (Migraine Headache), PYREXIA (Fever), CHILLS (chills), MYALGIA (muscle aches) and ARTHRALGIA (joint aches) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were provided. No treatments were provided.

Other Meds:

Current Illness:

ID: 1627041
Sex: F
Age: 71
State: NC

Vax Date: 05/13/2021
Onset Date: 05/13/2021
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: sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination. No Medical History information was reported. On 13-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-May-2021, the patient experienced PAIN IN EXTREMITY (sore arm). The patient was treated with PARACETAMOL (TYLENOL) at a dose of UNK dosage form. At the time of the report, PAIN IN EXTREMITY (sore arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds:

Current Illness:

ID: 1627042
Sex: M
Age:
State: CA

Vax Date: 03/10/2021
Onset Date: 06/10/2021
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: Patient missed his 2nd dose, more than 42 days; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Patient missed his 2nd dose, more than 42 days) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 10-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient missed his 2nd dose, more than 42 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Patient missed his 2nd dose, more than 42 days) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.

Other Meds:

Current Illness:

ID: 1627043
Sex: F
Age: 37
State: NY

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: UNK
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Cant hear very well/hears a muffled voice/ unless the person is standing next to her, cant make out what others are saying/ can feel the vibrations of the noise; dizzy; Headache; This spontaneous case was reported by a consumer and describes the occurrence of HYPOACUSIS (Cant hear very well/hears a muffled voice/ unless the person is standing next to her, cant make out what others are saying/ can feel the vibrations of the noise), DIZZINESS (dizzy) and HEADACHE (Headache) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 054C21A and 003C21A) 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) (Intramuscular) 1 dosage form. On 02-Jun-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 HYPOACUSIS (Cant hear very well/hears a muffled voice/ unless the person is standing next to her, cant make out what others are saying/ can feel the vibrations of the noise), DIZZINESS (dizzy) and HEADACHE (Headache). At the time of the report, HYPOACUSIS (Cant hear very well/hears a muffled voice/ unless the person is standing next to her, cant make out what others are saying/ can feel the vibrations of the noise), DIZZINESS (dizzy) and HEADACHE (Headache) outcome was unknown. No concomitant medications reported. No treatment information was provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.

Other Meds:

Current Illness:

ID: 1627044
Sex: M
Age: 45
State: IL

Vax Date: 05/10/2021
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: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Abdominal pain, Chills, Sleep disorder

Symptoms: Fever; Fatigue, laid down entire day; Stomach pain; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever), FATIGUE (Fatigue, laid down entire day) and ABDOMINAL PAIN UPPER (Stomach pain) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038C21A and 005C21A) for COVID-19 vaccination. No Medical History information was reported. On 10-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Jun-2021, the patient experienced PYREXIA (Fever), FATIGUE (Fatigue, laid down entire day) and ABDOMINAL PAIN UPPER (Stomach pain). At the time of the report, PYREXIA (Fever), FATIGUE (Fatigue, laid down entire day) and ABDOMINAL PAIN UPPER (Stomach pain) outcome was unknown. No concomitant medications reported. The patient had a lot of stomach pain. He had to go to bathroom couple of times. He also had fever and fatigue. He laid down entire day. No treatment information was provided. Action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was not applicable.

Other Meds:

Current Illness:

ID: 1627045
Sex: M
Age: 54
State: NY

Vax Date: 05/18/2021
Onset Date: 06/03/2021
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: Test Date: 20210604; Test Name: PCR test; Test Result: Positive ; Result Unstructured Data: diagnosed with Covid after 1st shot

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Diagnosed with Covid After 1st shot; Weakness; dizziness; bodyache; headache; This spontaneous case was reported by a consumer and describes the occurrence of COVID-19 (Diagnosed with Covid After 1st shot), ASTHENIA (Weakness), DIZZINESS (dizziness), MYALGIA (bodyache) and HEADACHE (headache) in a 54-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination. No Medical History information was reported. On 18-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Jun-2021, the patient experienced ASTHENIA (Weakness), DIZZINESS (dizziness), MYALGIA (bodyache) and HEADACHE (headache). On 04-Jun-2021, the patient experienced COVID-19 (Diagnosed with Covid After 1st shot). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, EPHEDRINE SULFATE, ETHANOL, PARACETAMOL (NYQUIL) at a dose of 1 dosage form. At the time of the report, COVID-19 (Diagnosed with Covid After 1st shot), ASTHENIA (Weakness), DIZZINESS (dizziness), MYALGIA (bodyache) and HEADACHE (headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 04-Jun-2021, SARS-CoV-2 test: positive (Positive) diagnosed with Covid after 1st shot. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication information was provided. Most recent FOLLOW-UP information incorporated above includes: On 17-Jun-2021: Added lab data, treatment medication and patient anatomical section.

Other Meds:

Current Illness:

ID: 1627046
Sex: M
Age:
State: FL

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: SYR
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: Received 3 doses of Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of EXTRA DOSE ADMINISTERED (Received 3 doses of Moderna vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (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 and third dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced EXTRA DOSE ADMINISTERED (Received 3 doses of Moderna vaccine). At the time of the report, EXTRA DOSE ADMINISTERED (Received 3 doses of Moderna vaccine) had resolved. No Concomitant medications were provided No Treatment information provided

Other Meds:

Current Illness:

ID: 1627047
Sex: F
Age: 40
State: IL

Vax Date: 05/10/2021
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: Hives on lips, face, chest, head, arms, throat; Pain in arm so much that if arm moves; Rash on stomach, back, chest; Feels like throwing up.; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (Hives on lips, face, chest, head, arms, throat), PAIN IN EXTREMITY (Pain in arm so much that if arm moves), RASH (Rash on stomach, back, chest) and NAUSEA (Feels like throwing up.) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 005C21A and 038C21A) for COVID-19 vaccination. No Medical History information was reported. On 10-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 an unknown date, the patient experienced URTICARIA (Hives on lips, face, chest, head, arms, throat), PAIN IN EXTREMITY (Pain in arm so much that if arm moves), RASH (Rash on stomach, back, chest) and NAUSEA (Feels like throwing up.). At the time of the report, URTICARIA (Hives on lips, face, chest, head, arms, throat), PAIN IN EXTREMITY (Pain in arm so much that if arm moves), RASH (Rash on stomach, back, chest) and NAUSEA (Feels like throwing up.) outcome was unknown. Relevant concomitant medications were not provided. Treatment medication was not provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments

Other Meds:

Current Illness:

ID: 1627048
Sex: M
Age: 48
State: NY

Vax Date: 05/03/2021
Onset Date: 05/05/2021
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: LA

Lab Data: Test Date: 20210517; Test Name: Temperature; Result Unstructured Data: fever of 101; Test Date: 20210609; Test Name: Temperature; Result Unstructured Data: temperature went up to 101.8.

Allergies:

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

Symptoms: conjunctivitis/ eye infection; aches; right forearm started to feel like it was almost paralyzed or numb; run down feeling; fever of 101/ temperature went up to 101.8. I was worried I was going to have to call the ambulance. I took lots of fluids and packed myself with ice; flu like feeling; sinuses were congestion; started feeling crappy; cold; shaking; aches; headache; chills/ hot/cold chills; This spontaneous case was reported by a consumer and describes the occurrence of NASOPHARYNGITIS (cold), FEELING ABNORMAL (started feeling crappy), CONJUNCTIVITIS (conjunctivitis/ eye infection), TREMOR (shaking) and INFLUENZA (flu like feeling) in a 48-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 014C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Pituitary disorder on 01-Jan-2012, Anemia on 01-Jan-2017 and Mental disorder on 01-Jan-2011. Concomitant products included MIRTAZAPINE (REMERON) from 01-Jan-2016 to 05-Jan-2021 for Insomnia, MULTIVITAMINS [VITAMINS NOS] for an unknown indication. On 03-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced NASOPHARYNGITIS (cold), TREMOR (shaking), the first episode of PAIN (aches), HEADACHE (headache) and CHILLS (chills/ hot/cold chills). On 16-May-2021, the patient experienced FEELING ABNORMAL (started feeling crappy). On 17-May-2021, the patient experienced INFLUENZA (flu like feeling), SINUS CONGESTION (sinuses were congestion) and PYREXIA (fever of 101/ temperature went up to 101.8. I was worried I was going to have to call the ambulance. I took lots of fluids and packed myself with ice). On 06-Jun-2021, the patient experienced FATIGUE (run down feeling). On 09-Jun-2021, the patient experienced the second episode of PAIN (aches) and HYPOAESTHESIA (right forearm started to feel like it was almost paralyzed or numb). On an unknown date, the patient experienced CONJUNCTIVITIS (conjunctivitis/ eye infection). The patient was treated with CLOMIFENE CITRATE (CLOMID) at an unspecified dose and frequency and SERTRALINE HYDROCHLORIDE (ZOLOFT) on 15-Jun-2021 at an unspecified dose and frequency. On 06-May-2021, NASOPHARYNGITIS (cold), TREMOR (shaking) and HEADACHE (headache) had resolved. On 18-May-2021, FEELING ABNORMAL (started feeling crappy), INFLUENZA (flu like feeling), SINUS CONGESTION (sinuses were congestion) and PYREXIA (fever of 101/ temperature went up to 101.8. I was worried I was going to have to call the ambulance. I took lots of fluids and packed myself with ice) had resolved. At the time of the report, CONJUNCTIVITIS (conjunctivitis/ eye infection) had resolved, last episode of PAIN (aches), HYPOAESTHESIA (right forearm started to feel like it was almost paralyzed or numb) and FATIGUE (run down feeling) had not resolved and CHILLS (chills/ hot/cold chills) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 17-May-2021, Body temperature: 101 (High) fever of 101. On 09-Jun-2021, Body temperature: 101.8 (High) temperature went up to 101.8.. The patient took lots of fluid and packed himself with ice to help alleviate the fever and also used medications like iron and antibiotic eye ointment. Most recent FOLLOW-UP information incorporated above includes: On 16-Jul-2021: Follow up received 16-Jul-2021, and patient demographics, medical history, concomitant medications, treatment details and new events were added.

Other Meds: REMERON; MULTIVITAMINS [VITAMINS NOS]

Current Illness:

ID: 1627049
Sex: M
Age: 60
State: WA

Vax Date: 04/21/2021
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: Develop an inflammatory lung disease; This spontaneous case was reported by a physician and describes the occurrence of PNEUMONITIS (Develop an inflammatory lung disease) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 008C21A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included ATORVASTATIN and SILDENAFIL CITRATE (VIAGRA) for an unknown indication. On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-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 PNEUMONITIS (Develop an inflammatory lung disease). At the time of the report, PNEUMONITIS (Develop an inflammatory lung disease) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient had a costophrenic chest x-ray on 19-May-2021, he has multiple 5 cm cavities, he only have inflammatory labs, no malignancy or infections. Treatment information was not provided. This case was linked to MOD-2021-215987 (Patient Link).

Other Meds: ATORVASTATIN; VIAGRA

Current Illness:

ID: 1627050
Sex: F
Age: 66
State: AL

Vax Date: 03/24/2021
Onset Date: 04/07/2021
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: LA

Lab Data:

Allergies:

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

Symptoms: weird smell that would come and go/ thought it was propane gas/ weird gross smell, stinky; This spontaneous case was reported by a consumer and describes the occurrence of PAROSMIA (weird smell that would come and go/ thought it was propane gas/ weird gross smell, stinky) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 003A21A) for COVID-19 vaccination. The patient's past medical history included Joint reconstruction (shoulder reconstruction). Concurrent medical conditions included Breast cancer. Concomitant products included ANASTROZOLE for Breast cancer, LEVOTHYROXINE, CLONAZEPAM (CLONOPIN), AMFETAMINE ASPARTATE, AMFETAMINE SULFATE, DEXAMFETAMINE SACCHARATE, DEXAMFETAMINE SULFATE (ADDERALL), ARIPIPRAZOLE (ABILIFY), METOPROLOL, VITAMIN D3, CALCIUM and MONASCUS PURPUREUS (RED YEAST RICE) for an unknown indication. On 24-Mar-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 07-Apr-2021, the patient experienced PAROSMIA (weird smell that would come and go/ thought it was propane gas/ weird gross smell, stinky). At the time of the report, PAROSMIA (weird smell that would come and go/ thought it was propane gas/ weird gross smell, stinky) had resolved. It was reported that, the smell did not last very long when it came. It went away sometime between 15-May-2021 to 02-Jun-2021. Treatment information not provided.

Other Meds: LEVOTHYROXINE; CLONOPIN; ADDERALL; ABILIFY; METOPROLOL; VITAMIN D3; CALCIUM; RED YEAST RICE; ANASTROZOLE

Current Illness: Breast cancer

ID: 1627051
Sex: F
Age: 58
State: FL

Vax Date: 05/04/2021
Onset Date: 05/07/2021
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: Got sick 5 days after the 1st dose; Coughing after the 1st dose; Sneezing after the 1st dose; Congestion after the 1st dose; Secondary sinus infection after the 1st dose; Fatigue after the 1st dose/very tired fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Got sick 5 days after the 1st dose), COUGH (Coughing after the 1st dose), SNEEZING (Sneezing after the 1st dose), NASAL CONGESTION (Congestion after the 1st dose) and SINUSITIS (Secondary sinus infection after the 1st dose) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Sinus infection. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), PROGESTERONE and ESTRADIOL (DIVIGEL) for an unknown indication. On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 07-May-2021, the patient experienced ILLNESS (Got sick 5 days after the 1st dose), COUGH (Coughing after the 1st dose), SNEEZING (Sneezing after the 1st dose), NASAL CONGESTION (Congestion after the 1st dose), SINUSITIS (Secondary sinus infection after the 1st dose) and FATIGUE (Fatigue after the 1st dose/very tired fatigue). The patient was treated with FLUTICASONE PROPIONATE (FLONASE [FLUTICASONE PROPIONATE]) for Nasal congestion, at a dose of UNK nasal spray; AZELASTINE HYDROCHLORIDE (ASTELIN [AZELASTINE HYDROCHLORIDE]) for Nasal congestion, at a dose of UNK nasal spray; CEPHALEXIN [CEFALEXIN] at an unspecified dose and frequency and CIPROFLOXACIN for Infection, at a dose of 500 mg twice a day. At the time of the report, ILLNESS (Got sick 5 days after the 1st dose), COUGH (Coughing after the 1st dose), SNEEZING (Sneezing after the 1st dose), NASAL CONGESTION (Congestion after the 1st dose), SINUSITIS (Secondary sinus infection after the 1st dose) and FATIGUE (Fatigue after the 1st dose/very tired fatigue) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. On an unknown date, the patient visited an ENT as her symptoms were worsening. The ENT diagnosed the patient with a secondary sinus infection which they state was not related to COVID-19. On an unknown date, it was reported that the patient discontinued cephalexin after 4 days due to culture insensitivity. Most recent FOLLOW-UP information incorporated above includes: On 11-Jun-2021: Follow-up received and reporter information and patient demographics updated, vaccine information, and concomitant/treatment medication information updated, event terms and onset updated and outcome updated to recovered/resolved.

Other Meds: SYNTHROID; PROGESTERONE; DIVIGEL

Current Illness: Sinus infection

ID: 1627052
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: got my second shot 3 weeks after the first dose; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got my second shot 3 weeks after the 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got my second shot 3 weeks after the first dose). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (got my second shot 3 weeks after the first dose) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided. No treatment details were provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1627053
Sex: U
Age:
State:

Vax Date:
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: This spontaneous case reported by a consumer, describes the occurrence of dizziness (dizzy/lightheaded) 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), unknown route; 1 dosage form. On an unknown date, patient experienced dizziness (dizzy/lightheaded). The action taken with mRNA-1273 (Moderna COVID-19 vaccine): unknown.

Other Meds:

Current Illness:

ID: 1627054
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: diarrhea; a little soreness on my arm; This spontaneous case was reported by a consumer and describes the occurrence of DIARRHOEA (diarrhea) and MYALGIA (a little soreness on 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 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 DIARRHOEA (diarrhea) and MYALGIA (a little soreness on my arm). At the time of the report, DIARRHOEA (diarrhea) and MYALGIA (a little soreness on my arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication information given. No treatment information provided. Most recent FOLLOW-UP information incorporated above includes: On 14-Jul-2021: Follow up received contains no new information.

Other Meds:

Current Illness:

ID: 1627055
Sex: M
Age:
State: FL

Vax Date: 04/26/2021
Onset Date: 06/10/2021
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: It has been 45 days since the patient's first dose; This spontaneous case was reported by a pharmacist and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (It has been 45 days since the patient's first dose) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 074A21A) 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) (Intramuscular) 1 dosage form. On 10-Jun-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (It has been 45 days since the patient's first dose). On 10-Jun-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (It has been 45 days since the patient's first dose) 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 were provided. No treatment information provided. Most recent FOLLOW-UP information incorporated above includes: On 10-Jun-2021: No newinformation.

Other Meds:

Current Illness:

ID: 1627056
Sex: U
Age:
State: FL

Vax Date: 03/26/2021
Onset Date:
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: Missed second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed 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 26-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 PRODUCT DOSE OMISSION ISSUE (Missed second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed second dose) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was reported. Treatment medication was not provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable.

Other Meds:

Current Illness:

ID: 1627057
Sex: F
Age: 78
State: TX

Vax Date: 05/19/2021
Onset Date: 05/23/2021
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: Tingling in the Left Arm and Left Shoulder (Injected Arm); This spontaneous case was reported by a consumer and describes the occurrence of PARAESTHESIA (Tingling in the Left Arm and Left Shoulder (Injected Arm)) in a 78-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 19-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-May-2021, the patient experienced PARAESTHESIA (Tingling in the Left Arm and Left Shoulder (Injected Arm)). At the time of the report, PARAESTHESIA (Tingling in the Left Arm and Left Shoulder (Injected Arm)) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. No treatment information was provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments

Other Meds:

Current Illness:

ID: 1627058
Sex: M
Age: 55
State: MD

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:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: Vaccine dose was administered from the vial punctured for > 12 hours; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine dose was administered from the vial punctured for > 12 hours) in a 55-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) 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) (unknown route) 1 dosage form. On 09-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine dose was administered from the vial punctured for > 12 hours). On 09-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine dose was administered from the vial punctured for > 12 hours) 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 treatment information was provided.

Other Meds:

Current Illness:

ID: 1627059
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: 011L20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain, Pain

Symptoms: pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (pain at the injection 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) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE PAIN (pain at the injection site). At the time of the report, VACCINATION SITE PAIN (pain at the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. treatment information not provided. Concomitant medications were not provided.

Other Meds:

Current Illness:

ID: 1627060
Sex: M
Age: 46
State: AL

Vax Date: 05/24/2021
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: Numbness in little finger of arm of injection after 2nd dose; Tingling in little finger of arm of injection after 2nd dose; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Numbness in little finger of arm of injection after 2nd dose) and PARAESTHESIA (Tingling in little finger of arm of injection after 2nd 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 24-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA (Numbness in little finger of arm of injection after 2nd dose) and PARAESTHESIA (Tingling in little finger of arm of injection after 2nd dose). At the time of the report, HYPOAESTHESIA (Numbness in little finger of arm of injection after 2nd dose) had not resolved and PARAESTHESIA (Tingling in little finger of arm of injection after 2nd dose) outcome was unknown. No concomitant medications reported. Treatment information not provided.

Other Meds:

Current Illness:

ID: 1627061
Sex: M
Age:
State: FL

Vax Date:
Onset Date:
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: Full body aches; Pain in opposite shoulder of injection; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Full body aches) and ARTHRALGIA (Pain in opposite shoulder of injection) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Thyroid disorder. 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) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced PAIN (Full body aches) and ARTHRALGIA (Pain in opposite shoulder of injection). At the time of the report, PAIN (Full body aches) and ARTHRALGIA (Pain in opposite shoulder of injection) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant products included thyroid medication daily. Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 30-Jul-2021: Follow-up received on 31-jul-2021 contains updated event outcome of both the events from Unknown to Resolved.

Other Meds:

Current Illness: Thyroid disorder

ID: 1627062
Sex: M
Age: 24
State: MD

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:
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Nausea, Pain in extremity, Pyrexia

Symptoms: Vaccine dose was administered from the vial punctured for > 12 hours; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine dose was administered from the vial punctured for > 12 hours) in a 24-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041C21A) 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 09-Jun-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine dose was administered from the vial punctured for > 12 hours). On 09-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Vaccine dose was administered from the vial punctured for > 12 hours) 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 were reported. No treatment medications were provided by the reporter.

Other Meds:

Current Illness:

ID: 1627063
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:
Dose Series: UNK
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Chills, Fatigue, Headache, Myalgia

Symptoms: bruises all over her; blood vessels broke in her arms stomach and legs; pain; Cannot squeeze her hands together; 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/culdn't get out of the bed; couldn't get out of the bed; her lower back hurts; Joint pain; muscle pain/whole body is hurting/whole body hurts/ankle hurts/feet hurts; This spontaneous case was reported by a consumer and describes the occurrence of CONTUSION (bruises all over her), VASCULAR INJURY (blood vessels broke in her arms stomach and legs), PAIN (pain), MUSCULAR WEAKNESS (Cannot squeeze her hands together) and PERIPHERAL SWELLING (arm swollen and hot) 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. On 28-Apr-2021, the patient received first 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), VASCULAR INJURY (blood vessels broke in her arms stomach and legs), PAIN (pain), MUSCULAR WEAKNESS (Cannot squeeze her hands together), 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/culdn't get out of the bed), BEDRIDDEN (couldn't get out of the bed), BACK PAIN (her lower back hurts), ARTHRALGIA (Joint pain) and MYALGIA (muscle pain/whole body is hurting/whole body hurts/ankle hurts/feet hurts). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency; Physical therapy for Contusion; Physical therapy for Vascular injury; Physical therapy for Pain; Physical therapy for Muscular weakness; Physical therapy for Peripheral swelling; Physical therapy for Peripheral swelling; Physical therapy for Joint stiffness; Physical therapy for Mobility decreased; Physical therapy for Back pain; Physical therapy for Arthralgia and Physical therapy for Myalgia. At the time of the report, CONTUSION (bruises all over her), VASCULAR INJURY (blood vessels broke in her arms stomach and legs), PAIN (pain), MUSCULAR WEAKNESS (Cannot squeeze her hands together), 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/culdn't get out of the bed), BEDRIDDEN (couldn't get out of the bed), BACK PAIN (her lower back hurts), ARTHRALGIA (Joint pain) and MYALGIA (muscle pain/whole body is hurting/whole body hurts/ankle hurts/feet hurts) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient had a Compromised kidney. No concomitant medication was provided. This case was linked to MOD-2021-216265 (Patient Link).

Other Meds:

Current Illness: Diabetic

ID: 1627064
Sex: F
Age: 81
State: MD

Vax Date: 04/30/2021
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: RA

Lab Data:

Allergies:

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

Symptoms: Reddish,itching rash on legs; Itching rash on legs; This spontaneous case was reported by a consumer and describes the occurrence of RASH ERYTHEMATOUS (Reddish,itching rash on legs) and RASH PRURITIC (Itching rash on legs) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037 and 040B21A) for COVID-19 vaccination. No medical history was reported. Concomitant products included AMLODIPINE, FOLIC ACID and MONTELUKAST for an unknown indication. On 30-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Jun-2021, the patient experienced RASH ERYTHEMATOUS (Reddish,itching rash on legs) and RASH PRURITIC (Itching rash on legs). The patient was treated with CORTISONE on 10-Jun-2021 for Itchy rash, at a dose of UNK dosage form. At the time of the report, RASH ERYTHEMATOUS (Reddish,itching rash on legs) and RASH PRURITIC (Itching rash on legs) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.

Other Meds: AMLODIPINE; FOLIC ACID; MONTELUKAST

Current Illness:

ID: 1627065
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: RA

Lab Data:

Allergies:

Symptom List: Nausea

Symptoms: side effect; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (side effect) 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 effect). At the time of the report, VACCINATION COMPLICATION (side effect) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Relevant concomitant medications was reported. Treatment information was not provided

Other Meds:

Current Illness:

ID: 1627066
Sex: U
Age:
State:

Vax Date:
Onset Date: 06/10/2021
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: Injection site pain

Symptoms: alump appeared in the injection site; This spontaneous case was reported by a patient and describes the occurrence of VACCINATION SITE MASS (alump appeared in the injection 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 10-Jun-2021, the patient experienced VACCINATION SITE MASS (alump appeared in the injection site). At the time of the report, VACCINATION SITE MASS (alump appeared in the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No Concomitant medication were reported. No Treatment information was reported.

Other Meds:

Current Illness:

ID: 1627067
Sex: M
Age: 58
State: NC

Vax Date: 05/06/2021
Onset Date: 05/06/2021
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 induration, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: difficult to eat; had a reaction to the second dose; sore throat; roof of mouth sore; roof of mouth swollen; roof of mouth red; night sweats; didn't feel good; headache; feverish; sore left upper arm / sore arm; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (sore left upper arm / sore arm), NIGHT SWEATS (night sweats), FEELING ABNORMAL (didn't feel good), OROPHARYNGEAL PAIN (sore throat) and ORAL PAIN (roof of mouth sore) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 06-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-May-2021, the patient experienced MYALGIA (sore left upper arm / sore arm). On 03-Jun-2021, the patient experienced NIGHT SWEATS (night sweats), FEELING ABNORMAL (didn't feel good), HEADACHE (headache) and PYREXIA (feverish). On 05-Jun-2021, the patient experienced OROPHARYNGEAL PAIN (sore throat), ORAL PAIN (roof of mouth sore), MOUTH SWELLING (roof of mouth swollen) and ORAL MUCOSAL ERYTHEMA (roof of mouth red). On an unknown date, the patient experienced EATING DISORDER (difficult to eat) and VACCINATION COMPLICATION (had a reaction to the second dose). On 09-May-2021, MYALGIA (sore left upper arm / sore arm) had resolved. On 04-Jun-2021, NIGHT SWEATS (night sweats) had resolved. At the time of the report, FEELING ABNORMAL (didn't feel good), OROPHARYNGEAL PAIN (sore throat), ORAL PAIN (roof of mouth sore), MOUTH SWELLING (roof of mouth swollen), HEADACHE (headache), PYREXIA (feverish), ORAL MUCOSAL ERYTHEMA (roof of mouth red), EATING DISORDER (difficult to eat) and VACCINATION COMPLICATION (had a reaction to the second dose) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant products reported No treatment products reported

Other Meds:

Current Illness:

ID: 1627068
Sex: F
Age:
State:

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: 011j20a
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

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

Symptoms: Her face started to feel sore/her face, is very sore, tender, and swollen; Her face, is very sore, tender, and swollen; Face is tender; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PAIN (Her face started to feel sore/her face, is very sore, tender, and swollen), SWELLING FACE (Her face, is very sore, tender, and swollen) and TENDERNESS (Face is tender) in a 40-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 ESCITALOPRAM OXALATE (LEXAPRO), SPIRONOLACTONE, MINOXIDIL and ETHINYLESTRADIOL, LEVONORGESTREL (LEVORA [ETHINYLESTRADIOL;LEVONORGESTREL]) for an unknown indication. On 08-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) (unknown route) 1 dosage form. On 08-Jun-2021, the patient experienced FACIAL PAIN (Her face started to feel sore/her face, is very sore, tender, and swollen), SWELLING FACE (Her face, is very sore, tender, and swollen) and TENDERNESS (Face is tender). The patient was treated with PREDNISONE at an unspecified dose and frequency. At the time of the report, FACIAL PAIN (Her face started to feel sore/her face, is very sore, tender, and swollen), SWELLING FACE (Her face, is very sore, tender, and swollen) and TENDERNESS (Face is tender) outcome was unknown. The patient symptom included the patient had symptom where a filler in the face, also had face tender.

Other Meds: LEXAPRO; SPIRONOLACTONE; MINOXIDIL; LEVORA [ETHINYLESTRADIOL;LEVONORGESTREL]

Current Illness:

ID: 1627069
Sex: F
Age: 62
State: NY

Vax Date: 02/22/2021
Onset Date: 03/23/2021
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:

Allergies:

Symptom List: Tremor

Symptoms: Hives all over the body; Sun burns/couldn't stay under sun for 5 min; Allergic reaction to any of the ingredients of Moderna COVID-19 vaccine; Bad skin rash all over the body; Itchy; Red spot around the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (Hives all over the body), SUNBURN (Sun burns/couldn't stay under sun for 5 min), ALLERGY TO VACCINE (Allergic reaction to any of the ingredients of Moderna COVID-19 vaccine), RASH (Bad skin rash all over the body) and VACCINATION SITE PRURITUS (Itchy) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. P38A21A and 0LYM20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included LEVOTHYROXINE SODIUM (THYROXINE) for Hypothyroidism, CITALOPRAM HYDROBROMIDE (CELEXA [CITALOPRAM HYDROBROMIDE]) for Panic attacks, VITAMIN D [VITAMIN D NOS] for an unknown indication. On 22-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Mar-2021, the patient experienced VACCINATION SITE PRURITUS (Itchy). In April 2021, the patient experienced URTICARIA (Hives all over the body), SUNBURN (Sun burns/couldn't stay under sun for 5 min), ALLERGY TO VACCINE (Allergic reaction to any of the ingredients of Moderna COVID-19 vaccine) and RASH (Bad skin rash all over the body). On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (Red spot around the injection site). On 03-Apr-2021, VACCINATION SITE PRURITUS (Itchy) had resolved. At the time of the report, URTICARIA (Hives all over the body), SUNBURN (Sun burns/couldn't stay under sun for 5 min), ALLERGY TO VACCINE (Allergic reaction to any of the ingredients of Moderna COVID-19 vaccine) and RASH (Bad skin rash all over the body) outcome was unknown and VACCINATION SITE ERYTHEMA (Red spot around the injection site) had resolved. No treatment products were reported.

Other Meds: CELEXA [CITALOPRAM HYDROBROMIDE]; THYROXINE; VITAMIN D [VITAMIN D NOS]

Current Illness:

ID: 1627070
Sex: F
Age: 57
State: TX

Vax Date: 12/28/2020
Onset Date: 12/28/2020
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: developed gastro problems; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of ABDOMINAL DISCOMFORT (developed gastro problems) and DIARRHOEA (Diarrhea) in a 57-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. No Medical History information was reported. On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Dec-2020, the patient experienced ABDOMINAL DISCOMFORT (developed gastro problems) and DIARRHOEA (Diarrhea). At the time of the report, ABDOMINAL DISCOMFORT (developed gastro problems) and DIARRHOEA (Diarrhea) 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 not provided. Concomitant medications were not provided. This case was linked to MOD-2021-215957 (Patient Link).

Other Meds:

Current Illness:

ID: 1627071
Sex: M
Age: 72
State: NC

Vax Date: 05/22/2021
Onset Date: 05/29/2021
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: Burning; Hard to breathe; Red splotches on the arms and torso; Terrible rash on the face/Terrible rash on neck; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (Burning), DYSPNOEA (Hard to breathe), RASH MACULAR (Red splotches on the arms and torso) and RASH (Terrible rash on the face/Terrible rash on neck) in a 72-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included High cholesterol and Hypertension. Concomitant products included PRAVASTATIN for High cholesterol, AMLODIPINE, LABETALOL, POTASSIUM and FUROSEMIDE for Hypertension. On 22-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-May-2021, the patient experienced BURNING SENSATION (Burning), DYSPNOEA (Hard to breathe), RASH MACULAR (Red splotches on the arms and torso) and RASH (Terrible rash on the face/Terrible rash on neck). At the time of the report, BURNING SENSATION (Burning), DYSPNOEA (Hard to breathe), RASH MACULAR (Red splotches on the arms and torso) and RASH (Terrible rash on the face/Terrible rash on neck) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment medication include Antihistamine and Aloe. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments This case was linked to MOD-2021-216334 (Patient Link). Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Additional information received on 02-JUL-2021 contained significant information.Outcome of event updated to Recovered

Other Meds: AMLODIPINE; LABETALOL; POTASSIUM; FUROSEMIDE; PRAVASTATIN

Current Illness: High cholesterol; Hypertension

ID: 1627072
Sex: M
Age:
State: AL

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:

Allergies:

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

Symptoms: Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of ARTHRALGIA (Joint pain) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ARTHRALGIA (Joint pain). At the time of the report, ARTHRALGIA (Joint pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications reported. Treatment information not provided.

Other Meds:

Current Illness:

ID: 1627073
Sex: F
Age:
State: FL

Vax Date: 01/02/2021
Onset Date: 01/14/2021
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: 202001; Test Name: blood count; Result Unstructured Data: Low; Test Date: 20210114; Test Name: blood count; Result Unstructured Data: chronic low WBC.

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: WBC decreased; This spontaneous case was reported by a consumer and describes the occurrence of WHITE BLOOD CELL COUNT DECREASED (WBC decreased) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011L02A and 012M20A) for COVID-19 vaccination. The patient's past medical history included WBC decreased since January 2020. Concomitant products included FLUOXETINE, ROSUVASTATIN, AMLODIPINE, CALCIUM, VITAMIN D NOS and VITAMIN B NOS for an unknown indication. On 02-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Jan-2021, the patient experienced WHITE BLOOD CELL COUNT DECREASED (WBC decreased). At the time of the report, WHITE BLOOD CELL COUNT DECREASED (WBC decreased) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In January 2020, Blood count (3.8-10.8): low (Low) Low. On 14-Jan-2021, Blood count (3.8-10.8): 3.7 (Low) chronic low WBC.. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment for the events not provided. Patient's WBC was low and 5 months later she has performed lab test again with low results. Her treating physician referred that her WBC low was normal for her. This case was linked to MOD-2021-018445 (Patient Link).

Other Meds: FLUOXETINE; ROSUVASTATIN; AMLODIPINE; CALCIUM; VITAMIN D NOS; VITAMIN B NOS

Current Illness: WBC decreased

ID: 1627074
Sex: F
Age: 67
State: NY

Vax Date: 04/23/2021
Onset Date: 06/10/2021
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: received her first dose on April 23, 2021; Expired dose was administered to 1 patient; This spontaneous case was reported by a health care professional and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (received her first dose on April 23, 2021) and EXPIRED PRODUCT ADMINISTERED (Expired dose was administered to 1 patient) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022C21A and 006C21A) 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) (Intramuscular) 1 dosage form. On 10-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 10-Jun-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (received her first dose on April 23, 2021) and EXPIRED PRODUCT ADMINISTERED (Expired dose was administered to 1 patient). On 10-Jun-2021, EXPIRED PRODUCT ADMINISTERED (Expired dose was administered to 1 patient) had resolved. At the time of the report, PRODUCT DOSE OMISSION ISSUE (received her first dose on April 23, 2021) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant and treatment medications were reported. Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Updated Contact number and an Event. On 03-Aug-2021: Non-significant follow up received.

Other Meds:

Current Illness:

ID: 1627075
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: EK9231
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: i had a severe reaction to my first dose; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (i had a severe reaction to my 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 dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (i had a severe reaction to my first dose). At the time of the report, VACCINATION COMPLICATION (i had a severe reaction to my first dose) 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: 1627076
Sex: M
Age:
State: PA

Vax Date: 02/12/2021
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: funny feeling or numbness (like novocaine) on the left side of his mouth; bad taste; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA ORAL (funny feeling or numbness (like novocaine) on the left side of his mouth) and TASTE DISORDER (bad taste) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. No Medical History information was reported. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Mar-2021, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HYPOAESTHESIA ORAL (funny feeling or numbness (like novocaine) on the left side of his mouth) and TASTE DISORDER (bad taste). At the time of the report, HYPOAESTHESIA ORAL (funny feeling or numbness (like novocaine) on the left side of his mouth) and TASTE DISORDER (bad taste) outcome was unknown. Action taken with mRNA-1273 in response to the events was not applicable No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1627077
Sex: F
Age: 53
State: TN

Vax Date: 05/28/2021
Onset Date: 06/08/2021
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: knot underneath; started to feel pain in that area; red; swollen; pain is severe; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (started to feel pain in that area), VACCINATION SITE ERYTHEMA (red), VACCINATION SITE SWELLING (swollen), VACCINATION SITE PAIN (pain is severe) and VACCINATION SITE MASS (knot underneath) in a 53-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 002C21A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included DULAGLUTIDE (TRULICITY), METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE MONOHYDRATE (JANUMET), CLOPIDOGREL BISULFATE (PLAVIX), LEVOTHYROXINE, HYDROCHLOROTHIAZIDE, Amitryptiline, LAMOTRIGINE, MIDODRINE, DESVENLAFAXINE, DIAZEPAM, OXYCODONE, TIZANIDINE, CETIRIZINE, METOPROLOL, PREGABALIN, PREGABALIN (LYRICA) and PANTOPRAZOLE 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 08-Jun-2021, the patient experienced VACCINATION SITE PAIN (started to feel pain in that area), VACCINATION SITE ERYTHEMA (red), VACCINATION SITE SWELLING (swollen) and VACCINATION SITE PAIN (pain is severe). On 10-Jun-2021, the patient experienced VACCINATION SITE MASS (knot underneath). The patient was treated with IBUPROFEN at a dose of UNK dosage form. At the time of the report, VACCINATION SITE PAIN (started to feel pain in that area), VACCINATION SITE ERYTHEMA (red), VACCINATION SITE SWELLING (swollen), VACCINATION SITE PAIN (pain is severe) and VACCINATION SITE MASS (knot underneath) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant: OTC vitamins Treatment Ice pack

Other Meds: TRULICITY; JANUMET; PLAVIX; LEVOTHYROXINE; HYDROCHLOROTHIAZIDE; Amitryptiline; LAMOTRIGINE; MIDODRINE; DESVENLAFAXINE; DIAZEPAM; OXYCODONE; TIZANIDINE; CETIRIZINE; METOPROLOL; PREGABALIN; LYRICA; PANTOPRAZOLE

Current Illness:

ID: 1627078
Sex: F
Age: 17
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: 039K20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data:

Allergies:

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

Symptoms: Received Moderna vaccine under 18 years of age; This spontaneous case was reported by a pharmacist and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received Moderna vaccine under 18 years of age) in a 17-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) 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 09-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received Moderna vaccine under 18 years of age). On 09-Jun-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Received Moderna vaccine under 18 years of age) 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. 17 years and 11 months old patient received vaccine. The patient's family member stated that they had contacted the patient's HCP who said it was ok to receive the Moderna vaccine, since its only one month less to become 18 years old. No information available regarding any side effect reported after receiving the vaccine.

Other Meds:

Current Illness:

ID: 1627079
Sex: F
Age:
State:

Vax Date:
Onset Date:
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: She is currently experiencing covid symptoms; This spontaneous case was reported by a consumer and describes the occurrence of SUSPECTED COVID-19 (She is currently experiencing covid symptoms) 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 first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced SUSPECTED COVID-19 (She is currently experiencing covid symptoms). At the time of the report, SUSPECTED COVID-19 (She is currently experiencing covid symptoms) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were provided by the reporter. Treatment information was not provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1627080
Sex: F
Age: 65
State: NY

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: 026LZOA
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

Symptom List: Vomiting

Symptoms: Arm started to burn; Intense itching on her face, chest, and all over her body; Diarrhea; Bumps; Very red; Painful; This spontaneous case was reported by a consumer and describes the occurrence of BURNING SENSATION (arm started to burn), PRURITUS (intense itching on her face, chest, and all over her body), DIARRHOEA (diarrhea), VACCINATION SITE SWELLING (bumps) and VACCINATION SITE ERYTHEMA (very red) in a 65-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. Concurrent medical conditions included Allergy (allergic reaction to the vaccine). On 08-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jun-2021, the patient experienced BURNING SENSATION (arm started to burn), PRURITUS (intense itching on her face, chest, and all over her body), DIARRHOEA (diarrhea), VACCINATION SITE SWELLING (bumps), VACCINATION SITE ERYTHEMA (very red) and VACCINATION SITE PAIN (painful). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) for Itching, at an unspecified dose and frequency. On 08-Jun-2021, VACCINATION SITE PAIN (painful) had resolved. On 09-Jun-2021, BURNING SENSATION (arm started to burn) and VACCINATION SITE ERYTHEMA (very red) had resolved. On 10-Jun-2021, DIARRHOEA (diarrhea) had resolved. At the time of the report, PRURITUS (intense itching on her face, chest, and all over her body) and VACCINATION SITE SWELLING (bumps) 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 is not on any concomitant medications currently. Patient received the shot on her right (dominant) arm. She states that as soon as the needle came out after administration, her arm started to burn and became very red and painful. She put ice on her arm for 20 minutes and repeated it throughout the day. In about 24 hours, the redness and burning were gone. She says that on the same day she received her shot, she started experiencing intense itching on her face, chest, and all over her body. She says that there is no visible rash but she does feel some bumps. Patient has been taking Benadryl for itching, but it does not seem to help. She also experienced diarrhea which started on the same day as receiving the 1st dose. She had diarrhea for two days and says that it has improved today on 10-Jun-2021. She has not taken any medications for the diarrhea but has kept herself hydrated. She is hesitant to receive her 2nd dose due to these reactions.

Other Meds:

Current Illness: Allergy (allergic reaction to the vaccine)

ID: 1627081
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: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Headache, Limb discomfort, Nasal congestion

Symptoms: Shortness of breath; Dizzy spells; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath) and DIZZINESS (Dizzy spells) 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) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DYSPNOEA (Shortness of breath) and DIZZINESS (Dizzy spells). At the time of the report, DYSPNOEA (Shortness of breath) and DIZZINESS (Dizzy spells) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1627082
Sex: M
Age: 16
State: MO

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:
Dose Series: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

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

Symptoms: She administered Moderna COVID19 Vaccine to three sixteen years old individuals; This spontaneous case was reported by a physician and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (She administered Moderna COVID19 Vaccine to three sixteen years old individuals) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031b21a) 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) (unknown route) 1 dosage form. On 09-Jun-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (She administered Moderna COVID19 Vaccine to three sixteen years old individuals). On 09-Jun-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (She administered Moderna COVID19 Vaccine to three sixteen years old individuals) 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. Doctor confirmed that she administered Moderna COVID19 Vaccine to three sixteen years old individuals on 09June2021. Concomitant product use was not reported. Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 29-Jul-2021: Follow-up received: Ethnicity updated and Reporter added.

Other Meds:

Current Illness:

ID: 1627083
Sex: F
Age: 57
State: CT

Vax Date: 05/06/2021
Onset Date: 06/09/2021
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:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: Red rash from belly button up to neck; Was very tired; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Was very tired) and RASH ERYTHEMATOUS (Red rash from belly button up to neck) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016C21A and 06C21A) for COVID-19 vaccination. Concurrent medical conditions included Hay fever, Allergy to antibiotic (Clindamycin which causes rash), COPD and Cholesterol. Concomitant products included ATORVASTATIN, VITAMIN D3 and CALCIUM for an unknown indication. On 06-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 09-Jun-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (Was very tired). On 10-Jun-2021, the patient experienced RASH ERYTHEMATOUS (Red rash from belly button up to neck). On 12-Jun-2021, RASH ERYTHEMATOUS (Red rash from belly button up to neck) had resolved. At the time of the report, FATIGUE (Was very tired) outcome was unknown. No treatment information was provided. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: Follow up received on 02-JUL-2021 contains information about patient demographics and allergies of patient.Updated information on doses of vaccination,and concomitant medications were added.event outcome was updated and newevent added.

Other Meds: ATORVASTATIN; VITAMIN D3; CALCIUM

Current Illness: Allergy to antibiotic (Clindamycin which causes rash); Cholesterol; COPD; Hay fever

ID: 1627084
Sex: M
Age: 69
State: MD

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: 1
Vax Route: IM
Vax Site: RA

Lab Data:

Allergies:

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

Symptoms: Vaccine dose was administered from the vial punctured for > 12 hours; Flu like symptoms; This spontaneous case was reported by a health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Vaccine dose was administered from the vial punctured for > 12 hours) and INFLUENZA LIKE ILLNESS (Flu like symptoms) in a 69-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041C21A and 022C21A) for COVID-19 vaccination. Concurrent medical conditions included Hypertension (Long term) and Hyperlipidaemia (Long term). Concomitant products included SIMVASTATIN for Hyperlipidaemia, AMLODIPINE, CARVEDILOL and OLMESARTAN for Hypertension. On 09-Jun-2021 at 8:31 AM, 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) (unknown route) 1 dosage form. On 09-Jun-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms). On 09-Jun-2021 at 8:31 AM, the patient experienced EXPIRED PRODUCT ADMINISTERED (Vaccine dose was administered from the vial punctured for > 12 hours). On 09-Jun-2021 at 8:31 AM, EXPIRED PRODUCT ADMINISTERED (Vaccine dose was administered from the vial punctured for > 12 hours) had resolved. On 11-Jun-2021, INFLUENZA LIKE ILLNESS (Flu like symptoms) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter considered INFLUENZA LIKE ILLNESS (Flu like symptoms) to be not related. No further causality assessment was provided for EXPIRED PRODUCT ADMINISTERED (Vaccine dose was administered from the vial punctured for > 12 hours). Concomitant include Ivtz taken at a dose of 25. Patient was given Moderna vaccine forty-six hours after the vial was punctured. As per the manufacturer patient was encouraged to be re-vaccinated due to lack of effacious. Patient declined to be re-vaccinated due to the flu like symptoms that were resolved forty-eight hours after receiving the vaccine. Patient felt vaccine was effective. No treatment details were provided. Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Follow-up information received contains updated information on patient demographics, medical history, concomitants, route of suspect drug, event added.

Other Meds: AMLODIPINE; CARVEDILOL; SIMVASTATIN; OLMESARTAN

Current Illness: Hyperlipidaemia (Long term); Hypertension (Long term)

ID: 1627085
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: RA

Lab Data:

Allergies:

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

Symptoms: My arm keeps jump; This spontaneous case was reported by a consumer and describes the occurrence of MUSCLE TWITCHING (My arm keeps jump) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced MUSCLE TWITCHING (My arm keeps jump). At the time of the report, MUSCLE TWITCHING (My arm keeps jump) outcome was unknown. No relevant Concomitant Medications were reported. No Treatment Information Provided.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am