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: 1672367
Sex: M
Age:
State: WI

Vax Date:
Onset Date: 09/02/2021
Rec V Date: 09/04/2021
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: ADMINISTRATION OF VACCINE 1 HOUR PAST RECOMMENDED STORAGE TIME; This spontaneous report received from a health care professional concerned a 34 year old male. The patient's height, and weight were not reported. The patient's pre-existing medical conditions included: The patient had no known drug allergies. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 1816027, expiry: 29-SEP-2021) dose was not reported, administered on 02-SEP-2021 for prophylactic vaccination. No concomitant medications were reported. On 02-SEP-2021, the patient experienced administration of vaccine 1 hour past recommended storage time. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The outcome of administration of vaccine 1 hour past recommended storage time was not reported. This report was non-serious. This case, from the same reporter is linked to 20210905756 and 20210905816.

Other Meds:

Current Illness:

ID: 1672368
Sex: F
Age:
State: AZ

Vax Date:
Onset Date: 07/23/2021
Rec V Date: 09/04/2021
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: WEIRD DARK AND LIGHT SPOTS ON SKIN LIKE BRUISES, VARYING SIZES, DARKEST BETWEEN BONES IN HAND AND TOES ESPECIALLY, LARGEST ON THUMB, BOTH ARMS AND FEET AND TURNS INTO FUNNY BROWNISH/ PURPLE COLOR; ON AND OFF DIZZINESS; This spontaneous report received from a patient concerned an 89 year old female. The patient's weight was 160 pounds, and height was 64 inches. The patient's past medical history included: swollen throat, and skin reaction, and concurrent conditions included: scarring on the lungs, allergic to sulfa drugs, allergic to most antibiotics, penicillin allergy, non alcohol user, non smoker, skin tan, and small vein in legs, and other pre-existing medical conditions included: Patient always had a lot of trouble with shots. Patient tan easily. The patient received covid-19 vaccine ad26.cov2.s (suspension for injection, route of admin not reported, batch number: 043A21A, and expiry: 19-SEP-2021) dose was not reported, administered on 22-JUL-2021 for prophylactic vaccination. Concomitant medications included diphenhydramine hydrochloride for allergic reaction. On 23-JUL-2021, the patient experienced on and off dizziness. On 30-AUG-2021, the patient experienced weird dark and light spots on skin like bruises, varying sizes, darkest between bones in hand and toes especially, largest on thumb, both arms and feet and turns into funny brownish/ purple color. The action taken with covid-19 vaccine ad26.cov2.s was not applicable. The patient had not recovered from on and off dizziness, and weird dark and light spots on skin like bruises, varying sizes, darkest between bones in hand and toes especially, largest on thumb, both arms and feet and turns into funny brownish/ purple color. This report was non-serious.

Other Meds: BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]

Current Illness: Abstains from alcohol; Allergic reaction to antibiotics (she is allergic to "most antibiotics from the over use of Penicillin when it first was being used" (reports that she usually takes Benadryl with antibiotics to avoid side effects), such as skin reactions/throat swollen); Lung scarring (Scarring of lungs from unknown virus local to area in 1987.); Non-smoker; Penicillin allergy; Skin discoloration (Patient was tan and tan easily.); Spider vein; Sulfonamide allergy

ID: 1672369
Sex: F
Age:
State: TX

Vax Date: 03/09/2021
Onset Date: 03/01/2021
Rec V Date: 09/04/2021
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: lymph nodes till feel sore to this day; Sore arm and shoulder/soreness from neck to elbow; headaches for nearly 3 weeks; Sore arm and shoulder/soreness from neck to elbow; Sore arm and shoulder/soreness from neck to elbow; Fatigue for 3 weeks; injection site still itches to this day; This spontaneous case was reported by a consumer and describes the occurrence of NECK PAIN (Sore arm and shoulder/soreness from neck to elbow), PAIN IN EXTREMITY (Sore arm and shoulder/soreness from neck to elbow), VACCINATION SITE PRURITUS (injection site still itches to this day), LYMPH NODE PAIN (lymph nodes till feel sore to this day) and ARTHRALGIA (Sore arm and shoulder/soreness from neck to elbow) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Fish allergy and Drug allergy (allergy to codiene). Concomitant products included SERTRALINE HYDROCHLORIDE (ZOLOFT) from 15-Jan-2020 to an unknown date for Stress and Anxiety. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Mar-2021, the patient experienced NECK PAIN (Sore arm and shoulder/soreness from neck to elbow), PAIN IN EXTREMITY (Sore arm and shoulder/soreness from neck to elbow), LYMPH NODE PAIN (lymph nodes till feel sore to this day), ARTHRALGIA (Sore arm and shoulder/soreness from neck to elbow) and HEADACHE (headaches for nearly 3 weeks). In March 2021, the patient experienced FATIGUE (Fatigue for 3 weeks). In 2021, the patient experienced VACCINATION SITE PRURITUS (injection site still itches to this day). On 31-Mar-2021, HEADACHE (headaches for nearly 3 weeks) had resolved. In 2021, FATIGUE (Fatigue for 3 weeks) had resolved. At the time of the report, NECK PAIN (Sore arm and shoulder/soreness from neck to elbow), PAIN IN EXTREMITY (Sore arm and shoulder/soreness from neck to elbow) and VACCINATION SITE PRURITUS (injection site still itches to this day) had not resolved and LYMPH NODE PAIN (lymph nodes till feel sore to this day) and ARTHRALGIA (Sore arm and shoulder/soreness from neck to elbow) was resolving. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. No treatment medication reported. Patients shoulder and arm were extremely sore since first vaccine. shoulder and lymph nodes till feel sore to this day, 19-Aug-2021. It was getting better slowly. When she first got the vaccine it was sore from her neck to elbow to the point she could not touch it for a week. The headaches for nearly 3 weeks. fatigue for 3 weeks injection site still itches to this day. Patient received the 1st dose on 09-Mar-2021at 01:00 pm. This case was linked to MOD-2021-079907 (Patient Link).

Other Meds: ZOLOFT

Current Illness: Drug allergy (allergy to codiene); Fish allergy

ID: 1672370
Sex: M
Age: 79
State: NY

Vax Date: 04/01/2021
Onset Date: 04/01/2021
Rec V Date: 09/04/2021
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: he was swelling; felt sick for a whole day; it appears as if he is reacting to allergies in a more significant way than he has ever reacted to / after the second shot, he has been waking up and the allergies are really getting to him / the allergies are a constant thing; received both shots in April2021 (about 2-3 weeks apart); This spontaneous case was reported by a consumer and describes the occurrence of SWELLING (he was swelling), ILLNESS (felt sick for a whole day), ALLERGY TO VACCINE (it appears as if he is reacting to allergies in a more significant way than he has ever reacted to / after the second shot, he has been waking up and the allergies are really getting to him / the allergies are a constant thing) and INCORRECT DOSE ADMINISTERED (received both shots in April2021 (about 2-3 weeks apart)) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Seasonal allergy. Concomitant products included EPINEPHRINE (PRIMATENE [EPINEPHRINE]) for Allergy, VITAMIN C [ASCORBIC ACID] and MULTIVITAMIN [VITAMINS NOS] for an unknown indication. In April 2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In April 2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In April 2021, the patient experienced SWELLING (he was swelling), ILLNESS (felt sick for a whole day), ALLERGY TO VACCINE (it appears as if he is reacting to allergies in a more significant way than he has ever reacted to / after the second shot, he has been waking up and the allergies are really getting to him / the allergies are a constant thing) and INCORRECT DOSE ADMINISTERED (received both shots in April2021 (about 2-3 weeks apart)). At the time of the report, SWELLING (he was swelling), ILLNESS (felt sick for a whole day) and ALLERGY TO VACCINE (it appears as if he is reacting to allergies in a more significant way than he has ever reacted to / after the second shot, he has been waking up and the allergies are really getting to him / the allergies are a constant thing) outcome was unknown and INCORRECT DOSE ADMINISTERED (received both shots in April2021 (about 2-3 weeks apart)) had resolved. Patient took first dose vaccine on same month of April about 2-3 weeks prior to second dose. No treatment information was provided Most recent FOLLOW-UP information incorporated above includes: On 13-Aug-2021: significant follow received and contains events outcome updated to recovered.

Other Meds: VITAMIN C [ASCORBIC ACID]; PRIMATENE [EPINEPHRINE]; MULTIVITAMIN [VITAMINS NOS]

Current Illness: Seasonal allergy

ID: 1672371
Sex: F
Age: 71
State: CT

Vax Date: 03/02/2021
Onset Date: 02/04/2021
Rec V Date: 09/04/2021
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: 20210302; Test Name: Body temperature; Result Unstructured Data: Low grade Fever

Allergies:

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

Symptoms: intermittent Hives/urticaria; raised red rash that would disappear after a few minutes; Itchy; felt washed out; mild sore throat; low grade fever of 100 degrees Farenheight; slight nausea; sore injection site arm; This spontaneous case was reported by a consumer and describes the occurrence of URTICARIA (intermittent Hives/urticaria), OROPHARYNGEAL PAIN (mild sore throat), PYREXIA (low grade fever of 100 degrees Farenheight), NAUSEA (slight nausea) and FATIGUE (felt washed out) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 0020A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Drug allergy (codeine,monistat,robaxin). Concomitant products included VACCINIUM SPP. (CRANBERRY [VACCINIUM SPP.]) for UTI, COLECALCIFEROL (VIT D3) and PYRIDOXINE HYDROCHLORIDE (VIT B6) for an unknown indication. On 02-Mar-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE PAIN (sore injection site arm). On 02-Mar-2021, the patient experienced OROPHARYNGEAL PAIN (mild sore throat), PYREXIA (low grade fever of 100 degrees Farenheight) and NAUSEA (slight nausea). On 03-Mar-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FATIGUE (felt washed out). On 25-Apr-2021, the patient experienced RASH ERYTHEMATOUS (raised red rash that would disappear after a few minutes) and PRURITUS (Itchy). In May 2021, the patient experienced URTICARIA (intermittent Hives/urticaria). On 05-Feb-2021, VACCINATION SITE PAIN (sore injection site arm) had resolved. On 03-Mar-2021, OROPHARYNGEAL PAIN (mild sore throat), PYREXIA (low grade fever of 100 degrees Farenheight) and NAUSEA (slight nausea) had resolved. On 04-Mar-2021, FATIGUE (felt washed out) had resolved. On 25-Apr-2021, RASH ERYTHEMATOUS (raised red rash that would disappear after a few minutes) and PRURITUS (Itchy) had resolved. At the time of the report, URTICARIA (intermittent Hives/urticaria) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 02-Mar-2021, Body temperature: 100 (High) Low grade Fever. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient took Multi vitamin gummy. No treatment medications were provided. This case was linked to MOD-2021-238997. Most recent FOLLOW-UP information incorporated above includes: On 23-Jul-2021: Follow up report is Non significant report include reporter email information were added. On 18-Aug-2021: Follow up report received on 18-AUG-2021 with new medical history added. new concomitant medication added. new events added.

Other Meds: VIT D3; CRANBERRY [VACCINIUM SPP.]; VIT B6

Current Illness: Drug allergy (codeine,monistat,robaxin)

ID: 1672372
Sex: M
Age: 78
State: MI

Vax Date: 02/17/2021
Onset Date:
Rec V Date: 09/04/2021
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: Test Date: 2021; Test Name: Red blood cell count; Result Unstructured Data: The value was low resulted in anemia.; Test Date: 20210705; Test Name: Red blood cell count; Result Unstructured Data: Decreased RBC count; Comments: RBC count decreased when compared to normal; Test Date: 20210716; Test Name: Red blood cell count; Result Unstructured Data: Decreased RBC count; Comments: RBC count decreased when compared to normal; Test Date: 20210809; Test Name: Red blood cell count; Result Unstructured Data: Normal RBC Count; Comments: Normal RBC Count

Allergies:

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

Symptoms: "significant" energy drop /Loss of energy,Low energy levels; Burning in legs /his legs would burn after exercise; Leg pain; Feel breathless/ out of breathe; Made him anemic; He just could do nothing; Couldn't exercise, walking up a set of stairs became a task; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA ("significant" energy drop /Loss of energy,Low energy levels), BURNING SENSATION (Burning in legs /his legs would burn after exercise), PAIN IN EXTREMITY (Leg pain), DYSPNOEA (Feel breathless/ out of breathe) and ANAEMIA (Made him anemic) in a 79-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 040A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Anemia and Bypass surgery. Concomitant products included CITALOPRAM, ATORVASTATIN CALCIUM (LIPITOR), BISOPROLOL FUMARATE, HYDROCHLOROTHIAZIDE (ZIAC [BISOPROLOL FUMARATE;HYDROCHLOROTHIAZIDE]) and BISOPROLOL FUMARATE, HYDROCHLOROTHIAZIDE (BISOPROLOL HCT) for an unknown indication. On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 17-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ASTHENIA ("significant" energy drop /Loss of energy,Low energy levels), BURNING SENSATION (Burning in legs /his legs would burn after exercise), PAIN IN EXTREMITY (Leg pain), DYSPNOEA (Feel breathless/ out of breathe), ANAEMIA (Made him anemic), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (He just could do nothing), EXERCISE TOLERANCE DECREASED (Couldn't exercise, walking up a set of stairs became a task) and FATIGUE (Fatigue). The patient was treated with IBUPROFEN for Adverse event, at an unspecified dose and frequency; CYANOCOBALAMIN (VITAMIN B12 [CYANOCOBALAMIN]) for Anemia, at an unspecified dose and frequency; IRON for Anemia, at an unspecified dose and frequency and COLECALCIFEROL (VITAMIN D [COLECALCIFEROL]) for Anemia, at an unspecified dose and frequency. At the time of the report, ASTHENIA ("significant" energy drop /Loss of energy,Low energy levels), PAIN IN EXTREMITY (Leg pain), LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES (He just could do nothing) and EXERCISE TOLERANCE DECREASED (Couldn't exercise, walking up a set of stairs became a task) outcome was unknown, BURNING SENSATION (Burning in legs /his legs would burn after exercise) had not resolved and DYSPNOEA (Feel breathless/ out of breathe), ANAEMIA (Made him anemic) and FATIGUE (Fatigue) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In 2021, Red blood cell count (4.6-6.2): low (Low) The value was low resulted in anemia.. On 05-Jul-2021, Red blood cell count (4.6-6.2): 3.73 (Low) Decreased RBC count. On 16-Jul-2021, Red blood cell count (4.6-6.2): 4.06 (Low) Decreased RBC count. On 09-Aug-2021, Red blood cell count (4.6-6.2): 4.64 (normal) Normal RBC Count. The consumer stated that after the second injection of Moderna COVID19 vaccine, he had a lot of trouble with fatigue and leg pain. The consumer stated that after many tests, his doctor told him he was anemic. He took vitamin D, iron, and B12 tablets,which brought it back up. The consumer stated that he is very active, but his legs would burn after exercise. This case was linked to MOD-2021-240639 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 09-Aug-2021: Follow-up received and contains significant information updated patient information, product information and events. On 18-Aug-2021: Significant Follow up contains updated laboratory data, updated treatment drug and additional events. On 27-Aug-2021: Significant Follow-up. New event- fatigue added. Patient's relevant history updated. Treatment medication-vitamin D included. Events outcome updated.

Other Meds: CITALOPRAM; LIPITOR; ZIAC [BISOPROLOL FUMARATE;HYDROCHLOROTHIAZIDE]; BISOPROLOL HCT

Current Illness:

ID: 1672373
Sex: M
Age:
State:

Vax Date: 05/18/2021
Onset Date: 05/20/2021
Rec V Date: 09/04/2021
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: Expired vaccine used; This spontaneous case was reported by a nurse and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 027C21A and 003C21A) for COVID-19 vaccination. No Medical History information was reported. On 18-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jun-2021, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 20-May-2021, the patient experienced EXPIRED PRODUCT ADMINISTERED (Expired vaccine used). On 20-May-2021, EXPIRED PRODUCT ADMINISTERED (Expired vaccine used) had resolved. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant products and Treatment medication were reported. This case was linked to MOD-2021-200231, MOD-2021-245676, MOD-2021-245668 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 28-Aug-2021: Follow up received, contains gender updated, dosage regimen details updated and race updated.

Other Meds:

Current Illness:

ID: 1672374
Sex: F
Age:
State:

Vax Date: 03/01/2021
Onset Date: 03/01/2021
Rec V Date: 09/04/2021
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: Hypoaesthesia; neurological problem s for the past 5 months; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Hypoaesthesia) and NERVOUS SYSTEM DISORDER (neurological problem s for the past 5 months) 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. In March 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In March 2021, the patient experienced HYPOAESTHESIA (Hypoaesthesia). In 2021, the patient experienced NERVOUS SYSTEM DISORDER (neurological problem s for the past 5 months). At the time of the report, HYPOAESTHESIA (Hypoaesthesia) and NERVOUS SYSTEM DISORDER (neurological problem s for the past 5 months) had not resolved. Concomitant product use was not provided by the reporter. Had multiple pathological and biopsy test. Treatment information was not provided. Most recent FOLLOW-UP information incorporated above includes: On 26-Aug-2021: Follow up received contains event of neurological disorder and action taken updated from unknown to not applicable.

Other Meds:

Current Illness:

ID: 1672375
Sex: F
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 09/04/2021
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: Covid rash on her arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE RASH (Covid rash on her arm) in a 54-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 TOLTERODINE L-TARTRATE (DETROL) for an unknown indication. 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 VACCINATION SITE RASH (Covid rash on her arm). At the time of the report, VACCINATION SITE RASH (Covid rash on her arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided (after first dose). The patient was going through menopause. She was having bladder problems before. This case was linked to MOD-2021-250643 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 27-Aug-2021: Non-significant Follow-up included narrative updated

Other Meds: DETROL

Current Illness:

ID: 1672376
Sex: F
Age: 69
State: FL

Vax Date: 05/27/2021
Onset Date: 07/06/2021
Rec V Date: 09/04/2021
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: 20210706; Test Name: Body temperature; Result Unstructured Data: 102.7

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Chest pain; Palpitation; Everything she tried to eat tasted like metal; Unusual headache; Fever of 102.7; Vomiting until the next day; Did not receive 2nd dose between 25-35 days after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain), PALPITATIONS (Palpitation), DYSGEUSIA (Everything she tried to eat tasted like metal), HEADACHE (Unusual headache) and PYREXIA (Fever of 102.7) in a 69-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039B21A and 021B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 06-Jul-2021, the patient experienced CHEST PAIN (Chest pain), PALPITATIONS (Palpitation), DYSGEUSIA (Everything she tried to eat tasted like metal), HEADACHE (Unusual headache), PYREXIA (Fever of 102.7) and VOMITING (Vomiting until the next day). 06-Jul-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not receive 2nd dose between 25-35 days after the 1st dose). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at an unspecified dose and frequency. On 06-Jul-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Did not receive 2nd dose between 25-35 days after the 1st dose) had resolved. On 07-Jul-2021, VOMITING (Vomiting until the next day) had resolved. At the time of the report, CHEST PAIN (Chest pain), PALPITATIONS (Palpitation), DYSGEUSIA (Everything she tried to eat tasted like metal), HEADACHE (Unusual headache) and PYREXIA (Fever of 102.7) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 06-Jul-2021, Body temperature: 102.7 (High) 102.7. No concomitant products were reported. Most recent FOLLOW-UP information incorporated above includes: On 30-Aug-2021: Follow up received and it contains no new information

Other Meds:

Current Illness:

ID: 1672377
Sex: M
Age: 29
State: FL

Vax Date: 12/28/2020
Onset Date:
Rec V Date: 09/04/2021
Hospital:

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

Lab Data: Test Name: comprehensive metabolic panel; Result Unstructured Data: CMP elevated; Comments: CMP elevated; Test Name: SARS-CoV-2 test; Test Result: Negative ; Result Unstructured Data: COVID- Negative

Allergies:

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

Symptoms: went to hospital in which they believed it was shingles and prescribed acyclovir which he did not take and the red lumps and inflammation went away however it is still ongoing; seasonal allergy type of issues; itching on his feet/ painful itching on hands and body/ itchy,/ painful and same time itches / whole body itches / feet itching / hand was itchng; Having painful pressure when sitting; He went to the hospital last April due to severe coughing and was put on isolation but tested negative for Covid.; Patient also experienced that his whole mouth was itching; The next day he was able to walk but was still painful/ Had a lot of pain / painful; Difficulty swallowing but able to breath; pain at his shoulder with pain scale of 6/10.; Had sores on armpit and stomach; pain at his right arm,States if he rides a motorcycle for too long his legs get swollen, itchy, and painful,he uses a machines my hands will bother me / Pain in feet; if he rides a motorcycle for too long his legs get swollen, itchy, and painful / hands got swollen / inner legs and thighs are extremely completely swollen / finger hands swollen; had a massage and was in a chair and after his whole body became full of red lumps; symptoms are getting worse; swelling; not able to walk; extremely hot / extremely warm to touch; could not even sleep; can't even make a fist / could not move from the pain; hives; chills; Inflammation / inflammatory response is not normal; developed bumps and rash that is more like shingles but went away the next day/red bumps / rash / rash type in belly; Patient also had extremely red and painful itching on hands and body/ a red spot also developed on the belt area//whole body became full of red lumps / red dot spot; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (went to hospital in which they believed it was shingles and prescribed acyclovir which he did not take and the red lumps and inflammation went away however it is still ongoing), SEASONAL ALLERGY (seasonal allergy type of issues), PRURITUS (itching on his feet/ painful itching on hands and body/ itchy,/ painful and same time itches / whole body itches / feet itching / hand was itchng), LIMB DISCOMFORT (Having painful pressure when sitting) and COUGH (He went to the hospital last April due to severe coughing and was put on isolation but tested negative for Covid.) in a 30-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. Concurrent medical conditions included Allergy to antibiotic (Allergy to Rocephin antibiotic) and Allergy to animal (Allergy to Dogs). Concomitant products included METHYLPREDNISOLONE ACETATE (DEPOMEDROL) and PREDNISONE for an unknown indication. On 28-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-Jan-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 HERPES ZOSTER (went to hospital in which they believed it was shingles and prescribed acyclovir which he did not take and the red lumps and inflammation went away however it is still ongoing), SEASONAL ALLERGY (seasonal allergy type of issues), PRURITUS (itching on his feet/ painful itching on hands and body/ itchy,/ painful and same time itches / whole body itches / feet itching / hand was itchng), LIMB DISCOMFORT (Having painful pressure when sitting), COUGH (He went to the hospital last April due to severe coughing and was put on isolation but tested negative for Covid.), ORAL PRURITUS (Patient also experienced that his whole mouth was itching), PAIN (The next day he was able to walk but was still painful/ Had a lot of pain / painful), DYSPHAGIA (Difficulty swallowing but able to breath), ARTHRALGIA (pain at his shoulder with pain scale of 6/10.), SKIN ULCER (Had sores on armpit and stomach), PAIN IN EXTREMITY (pain at his right arm,States if he rides a motorcycle for too long his legs get swollen, itchy, and painful,he uses a machines my hands will bother me / Pain in feet), PERIPHERAL SWELLING (if he rides a motorcycle for too long his legs get swollen, itchy, and painful / hands got swollen / inner legs and thighs are extremely completely swollen / finger hands swollen), MASS (had a massage and was in a chair and after his whole body became full of red lumps), CONDITION AGGRAVATED (symptoms are getting worse), SWELLING (swelling), GAIT DISTURBANCE (not able to walk), FEELING HOT (extremely hot / extremely warm to touch), INSOMNIA (could not even sleep), MOBILITY DECREASED (can't even make a fist / could not move from the pain), URTICARIA (hives), CHILLS (chills), INFLAMMATION (Inflammation / inflammatory response is not normal), RASH (developed bumps and rash that is more like shingles but went away the next day/red bumps / rash / rash type in belly) and ERYTHEMA (Patient also had extremely red and painful itching on hands and body/ a red spot also developed on the belt area//whole body became full of red lumps / red dot spot). At the time of the report, HERPES ZOSTER (went to hospital in which they believed it was shingles and prescribed acyclovir which he did not take and the red lumps and inflammation went away however it is still ongoing) had not resolved, SEASONAL ALLERGY (seasonal allergy type of issues), PRURITUS (itching on his feet/ painful itching on hands and body/ itchy,/ painful and same time itches / whole body itches / feet itching / hand was itchng), LIMB DISCOMFORT (Having painful pressure when sitting), COUGH (He went to the hospital last April due to severe coughing and was put on isolation but tested negative for Covid.), ORAL PRURITUS (Patient also experienced that his whole mouth was itching), PAIN (The next day he was able to walk but was still painful/ Had a lot of pain / painful), DYSPHAGIA (Difficulty swallowing but able to breath), ARTHRALGIA (pain at his shoulder with pain scale of 6/10.), SKIN ULCER (Had sores on armpit and stomach), PAIN IN EXTREMITY (pain at his right arm,States if he rides a motorcycle for too long his legs get swollen, itchy, and painful,he uses a machines my hands will bother me / Pain in feet), PERIPHERAL SWELLING (if he rides a motorcycle for too long his legs get swollen, itchy, and painful / hands got swollen / inner legs and thighs are extremely completely swollen / finger hands swollen), MASS (had a massage and was in a chair and after his whole body became full of red lumps), CONDITION AGGRAVATED (symptoms are getting worse), SWELLING (swelling), GAIT DISTURBANCE (not able to walk), FEELING HOT (extremely hot / extremely warm to touch), INSOMNIA (could not even sleep), MOBILITY DECREASED (can't even make a fist / could not move from the pain), URTICARIA (hives) and CHILLS (chills) outcome was unknown and INFLAMMATION (Inflammation / inflammatory response is not normal), RASH (developed bumps and rash that is more like shingles but went away the next day/red bumps / rash / rash type in belly) and ERYTHEMA (Patient also had extremely red and painful itching on hands and body/ a red spot also developed on the belt area//whole body became full of red lumps / red dot spot) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Metabolic function test: high (High) CMP elevated. On an unknown date, SARS-CoV-2 test: negative (Negative) COVID- Negative. No Treatment Medications were provided. Most recent FOLLOW-UP information incorporated above includes: On 23-Aug-2021: Additional events were added.

Other Meds: DEPOMEDROL; PREDNISONE

Current Illness: Allergy to animal (Allergy to Dogs); Allergy to antibiotic (Allergy to Rocephin antibiotic)

ID: 1672378
Sex: F
Age:
State: MS

Vax Date: 01/28/2021
Onset Date: 02/28/2021
Rec V Date: 09/04/2021
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: Stiffness all over; Constipation; Somehow my body seems to be slowing down; Felt cold; Loss of weight; Hair loss; blazing red itchy rash on my upper shot arm; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Stiffness all over), CONSTIPATION (Constipation), BRADYKINESIA (Somehow my body seems to be slowing down), FEELING COLD (Felt cold) and WEIGHT DECREASED (Loss of weight) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Penicillin allergy. Concomitant products included METOPROLOL TARTRATE (METAPRO [METOPROLOL TARTRATE]) for TIA, CANDESARTAN CILEXETIL, HYDROCHLOROTHIAZIDE (CANDEMOX [CANDESARTAN CILEXETIL;HYDROCHLOROTHIAZIDE]) for an unknown indication. On 28-Jan-2021, the patient 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 received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Feb-2021, the patient experienced RASH PRURITIC (blazing red itchy rash on my upper shot arm). On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Stiffness all over), CONSTIPATION (Constipation), BRADYKINESIA (Somehow my body seems to be slowing down), FEELING COLD (Felt cold), WEIGHT DECREASED (Loss of weight) and ALOPECIA (Hair loss). The patient was treated with METHYLCELLULOSE (CITRUCEL) for Constipation, at an unspecified dose and frequency. On 05-Mar-2021, RASH PRURITIC (blazing red itchy rash on my upper shot arm) had resolved. At the time of the report, MUSCULOSKELETAL STIFFNESS (Stiffness all over), CONSTIPATION (Constipation) and BRADYKINESIA (Somehow my body seems to be slowing down) had not resolved, FEELING COLD (Felt cold) and WEIGHT DECREASED (Loss of weight) outcome was unknown and ALOPECIA (Hair loss) had resolved. Most recent FOLLOW-UP information incorporated above includes: On 23-Aug-2021: Follow up received on 23 AUG 2021: Medical history, concomitant and treatment medications added, new events and outcomes were added

Other Meds: METAPRO [METOPROLOL TARTRATE]; CANDEMOX [CANDESARTAN CILEXETIL;HYDROCHLOROTHIAZIDE]

Current Illness: Penicillin allergy

ID: 1672379
Sex: F
Age: 76
State: TX

Vax Date: 05/04/2021
Onset Date: 07/27/2021
Rec V Date: 09/04/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Muscles has been locking up/Whole body just locking up; Stomach hurt and sides hurt; Could not move her head for two weeks; Can't sit to do anything; Sits in her wheelchair to keep her from falling; Feeling weak for a week after receiving the vaccine; Joint lock; In pain; Had a feeling of something crawling under the skin; Muscle pain/ whole body hurts ( legs, hands, shoulders, etc.).; Joint pain/Joint pain all over my body/Joint pain in ankles/Joints hurts; returned call from Safety; This spontaneous case was reported by a consumer and describes the occurrence of MUSCULOSKELETAL STIFFNESS (Muscles has been locking up/Whole body just locking up), ABDOMINAL PAIN UPPER (Stomach hurt and sides hurt), MOBILITY DECREASED (Could not move her head for two weeks), SITTING DISABILITY (Can't sit to do anything) and WHEELCHAIR USER (Sits in her wheelchair to keep her from falling) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 026C21A and 047B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Latex allergy, Seafood allergy, Fruit allergy (Oranges), Drug allergy (Steroids), Drug allergy (Stalin), Diabetes and Seizure. Concomitant products included METFORMIN for Diabetes, PRIMIDONE (MYSOLINE) for an unknown indication. On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 27-Jul-2021, the patient experienced UNEVALUABLE EVENT (returned call from Safety). On an unknown date, the patient experienced MUSCULOSKELETAL STIFFNESS (Muscles has been locking up/Whole body just locking up), ABDOMINAL PAIN UPPER (Stomach hurt and sides hurt), MOBILITY DECREASED (Could not move her head for two weeks), SITTING DISABILITY (Can't sit to do anything), WHEELCHAIR USER (Sits in her wheelchair to keep her from falling), ASTHENIA (Feeling weak for a week after receiving the vaccine), JOINT LOCK (Joint lock), PAIN (In pain), FORMICATION (Had a feeling of something crawling under the skin), MYALGIA (Muscle pain/ whole body hurts ( legs, hands, shoulders, etc.).) and ARTHRALGIA (Joint pain/Joint pain all over my body/Joint pain in ankles/Joints hurts). The patient was treated with PARACETAMOL (TYLENOL) on 01-Jun-2021 for Adverse event, at a dose of Every 5 hours. At the time of the report, MUSCULOSKELETAL STIFFNESS (Muscles has been locking up/Whole body just locking up), ABDOMINAL PAIN UPPER (Stomach hurt and sides hurt), MOBILITY DECREASED (Could not move her head for two weeks), SITTING DISABILITY (Can't sit to do anything), WHEELCHAIR USER (Sits in her wheelchair to keep her from falling), MYALGIA (Muscle pain/ whole body hurts ( legs, hands, shoulders, etc.).) and ARTHRALGIA (Joint pain/Joint pain all over my body/Joint pain in ankles/Joints hurts) had not resolved and ASTHENIA (Feeling weak for a week after receiving the vaccine), JOINT LOCK (Joint lock), PAIN (In pain), FORMICATION (Had a feeling of something crawling under the skin) and UNEVALUABLE EVENT (returned call from Safety) outcome was unknown. Concomitant medications also included two medications for seizures. It was reported that patient itself stated she would rather die before getting the booster dose. Most recent FOLLOW-UP information incorporated above includes: On 23-Aug-2021: Added concomitant medication ( Tylenol) start date, added new events ( mucoskeletal stiffness, sitting disability, abdominal pain upper, mobility decreased, wheel chair user)

Other Meds: METFORMIN; MYSOLINE

Current Illness: Diabetes; Drug allergy (Steroids); Drug allergy (Stalin); Fruit allergy (Oranges); Latex allergy; Seafood allergy; Seizure

ID: 1672380
Sex: M
Age: 52
State: HI

Vax Date: 12/29/2020
Onset Date: 12/29/2020
Rec V Date: 09/04/2021
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: Sometimes he couldn't speak; Sever headaches; He states all of his lymph nodes got inflamed/lymph nodes were like little golf balls; He had body aches all around his body; His joints were all sore/His joints felt like there was broken glass in them; For the first 3 days, he could not lift his left arm/His left arm hurt so bad he couldn't move it; Since the vaccine he has been very sick/ his body never really stopped making the spike protein and that's why he has been so sick; He thought he was going to die/he thought it almost killed him; For the first 3 days, he could not lift his left arm/His left arm hurt so bad he couldn't move it; He did not want to get up/He slept 20 hours a day.; He was in bed for 14 days; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Since the vaccine he has been very sick/ his body never really stopped making the spike protein and that's why he has been so sick), FEELING ABNORMAL (He thought he was going to die/he thought it almost killed him), MOBILITY DECREASED (For the first 3 days, he could not lift his left arm/His left arm hurt so bad he couldn't move it), HYPERSOMNIA (He did not want to get up/He slept 20 hours a day.) and BEDRIDDEN (He was in bed for 14 days) in a 52-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Allergy multiple (lot of allergies). On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Dec-2020, the patient experienced ILLNESS (Since the vaccine he has been very sick/ his body never really stopped making the spike protein and that's why he has been so sick), FEELING ABNORMAL (He thought he was going to die/he thought it almost killed him), MOBILITY DECREASED (For the first 3 days, he could not lift his left arm/His left arm hurt so bad he couldn't move it), HYPERSOMNIA (He did not want to get up/He slept 20 hours a day.), BEDRIDDEN (He was in bed for 14 days), MYALGIA (He had body aches all around his body), ARTHRALGIA (His joints were all sore/His joints felt like there was broken glass in them) and VACCINATION SITE PAIN (For the first 3 days, he could not lift his left arm/His left arm hurt so bad he couldn't move it). On 31-Dec-2020, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced LYMPHADENOPATHY (He states all of his lymph nodes got inflamed/lymph nodes were like little golf balls). On an unknown date, the patient experienced SPEECH DISORDER (Sometimes he couldn't speak) and HEADACHE (Sever headaches). At the time of the report, ILLNESS (Since the vaccine he has been very sick/ his body never really stopped making the spike protein and that's why he has been so sick), FEELING ABNORMAL (He thought he was going to die/he thought it almost killed him), MOBILITY DECREASED (For the first 3 days, he could not lift his left arm/His left arm hurt so bad he couldn't move it), HYPERSOMNIA (He did not want to get up/He slept 20 hours a day.), BEDRIDDEN (He was in bed for 14 days), SPEECH DISORDER (Sometimes he couldn't speak), LYMPHADENOPATHY (He states all of his lymph nodes got inflamed/lymph nodes were like little golf balls), MYALGIA (He had body aches all around his body), ARTHRALGIA (His joints were all sore/His joints felt like there was broken glass in them), VACCINATION SITE PAIN (For the first 3 days, he could not lift his left arm/His left arm hurt so bad he couldn't move it) and HEADACHE (Sever headaches) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was reported. No treatment information was reported. Patient's weight was mentioned as 200 with unspecified unit. This case was linked to MOD-2021-270281 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 21-Aug-2021: Reporter Type, Intensity added for Headache. Speech disorder and Headache added as new event and narrative was update accordingly; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.

Other Meds:

Current Illness: Allergy multiple (lot of allergies)

ID: 1672381
Sex: F
Age:
State: PA

Vax Date: 04/06/2021
Onset Date: 04/06/2021
Rec V Date: 09/04/2021
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: This spontaneous case was reported by a consumer and describes the occurrence of DIARRHEA (Diarrhea), MALAISE (Feeling sick) and PRODUCT DOSE OMISSION ISSUE (Not yet taken her second shot of Moderna Covid-19 Vaccine since 6Apr2021) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. Concurrent medical conditions included Food allergy and Drug allergy. On 06-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 06-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Not yet taken her second shot of Moderna Covid-19 Vaccine since 6Apr2021). On 10-Apr-2021, the patient experienced DIARRHEA (Diarrhea) and MALAISE (Feeling sick). The patient was treated with BISMUTH SUBSALICYLATE (PEPTO-BISMOL) for Diarrhea, at an unspecified dose and frequency. At the time of the report, DIARRHEA (Diarrhea) and MALAISE (Feeling sick) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Not yet taken her second shot of Moderna Covid-19 Vaccine since 6Apr2021) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications were reported. No treatment information was reported. The patient took Pepto-Bismol and Kaopectate for the diarrhea, and an allergy pill. Side effects that were reported post vaccination were diarrhea and feeling sick for three weeks started 10-Apr-2021.

Other Meds:

Current Illness: Drug allergy; Food allergy

ID: 1672382
Sex: M
Age: 53
State: NY

Vax Date: 07/17/2021
Onset Date: 07/17/2021
Rec V Date: 09/04/2021
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: Stomach problems; Intestinal problems; Diarrhea; Bad headaches; Arm was hurting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm was hurting), ABDOMINAL DISCOMFORT (Stomach problems), FUNCTIONAL GASTROINTESTINAL DISORDER (Intestinal problems), DIARRHOEA (Diarrhea) and HEADACHE (Bad headaches) in a 53-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 17-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Jul-2021, the patient experienced PAIN IN EXTREMITY (Arm was hurting). On 29-Jul-2021, the patient experienced ABDOMINAL DISCOMFORT (Stomach problems), FUNCTIONAL GASTROINTESTINAL DISORDER (Intestinal problems), DIARRHOEA (Diarrhea) and HEADACHE (Bad headaches). At the time of the report, PAIN IN EXTREMITY (Arm was hurting), ABDOMINAL DISCOMFORT (Stomach problems), FUNCTIONAL GASTROINTESTINAL DISORDER (Intestinal problems), DIARRHOEA (Diarrhea) and HEADACHE (Bad headaches) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided. Treatment product information was not provided.

Other Meds:

Current Illness:

ID: 1672383
Sex: M
Age: 53
State: CA

Vax Date: 06/24/2021
Onset Date: 07/29/2021
Rec V Date: 09/04/2021
Hospital:

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

Lab Data: Test Date: 20210729; Test Name: COVID-19; Test Result: Negative ; Result Unstructured Data: Negative; Test Date: 20210729; Test Name: White blood cells; Result Unstructured Data: slight increased

Allergies:

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

Symptoms: Slight white blood cell count increase; slight on and off stomach symptoms; pain; Nausea; vomiting; cold chills; Feverish; stomach pain and tender/sore and tender stomach; dizziness; He felt like he had some cardiac angina; chest pain; though he was going to die; cold sweats; This spontaneous case was reported by a consumer and describes the occurrence of WHITE BLOOD CELL COUNT INCREASED (Slight white blood cell count increase), ABDOMINAL DISCOMFORT (slight on and off stomach symptoms), ABDOMINAL PAIN UPPER (stomach pain and tender/sore and tender stomach), DIZZINESS (dizziness) and CARDIAC DISCOMFORT (He felt like he had some cardiac angina) in a 59-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 053C21A and 053C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 24-Jun-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jul-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-Jul-2021, the patient experienced ABDOMINAL PAIN UPPER (stomach pain and tender/sore and tender stomach), DIZZINESS (dizziness), CARDIAC DISCOMFORT (He felt like he had some cardiac angina), CHEST PAIN (chest pain), FEELING ABNORMAL (though he was going to die), COLD SWEAT (cold sweats), NAUSEA (Nausea), VOMITING (vomiting), CHILLS (cold chills) and PYREXIA (Feverish). On an unknown date, the patient experienced WHITE BLOOD CELL COUNT INCREASED (Slight white blood cell count increase), ABDOMINAL DISCOMFORT (slight on and off stomach symptoms) and PAIN (pain). The patient was treated with IBUPROFEN for Pain and Nausea, at an unspecified dose and frequency and SULFIRAM (intravenous) for Pain and Nausea, at an unspecified dose and frequency. At the time of the report, WHITE BLOOD CELL COUNT INCREASED (Slight white blood cell count increase), ABDOMINAL DISCOMFORT (slight on and off stomach symptoms), ABDOMINAL PAIN UPPER (stomach pain and tender/sore and tender stomach), DIZZINESS (dizziness), CARDIAC DISCOMFORT (He felt like he had some cardiac angina), CHEST PAIN (chest pain), FEELING ABNORMAL (though he was going to die), COLD SWEAT (cold sweats), PAIN (pain), NAUSEA (Nausea), VOMITING (vomiting), CHILLS (cold chills) and PYREXIA (Feverish) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-Jul-2021, SARS-CoV-2 test: negative (Negative) Negative. On 29-Jul-2021, White blood cell count: increased (High) slight increased. No concomitant medications were provided by the reported. The Patient had no reactions with the first shot. Heart EKG, liver, chest x-ray and blood work were done at the emergency department. Results were not provided. The patient was treated with opioids, anti-nausea drugs and IV fluids. Most recent FOLLOW-UP information incorporated above includes: On 20-Aug-2021: Followup received, events slight on and off stomach symptoms and Slight white blood cell count increase added

Other Meds:

Current Illness:

ID: 1672384
Sex: F
Age:
State: CA

Vax Date: 06/01/2021
Onset Date: 06/01/2021
Rec V Date: 09/04/2021
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: Didn't get the second dose; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Didn't get the second dose) 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. In June 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In June 2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Didn't get the second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Didn't get the second dose) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No Concomitant medication was reported. No Treatment information was reported. Reporter said that patient received the first dose of the Moderna COVID-19 on the first week of June and "life got in the way", the patient never received the second dose. When asked for clarification the caller said that the patient did not get the second dose because of work. Upon follow up, the patient reported that the patient was doing fine, had received the second dose and the patient declined for follow up. Most recent FOLLOW-UP information incorporated above includes: On 17-Aug-2021: attached : narrative updated, Medication error ticked

Other Meds:

Current Illness:

ID: 1672385
Sex: F
Age:
State: OH

Vax Date: 07/26/2021
Onset Date: 07/26/2021
Rec V Date: 09/04/2021
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: This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE HAEMORRHAGE, MOBILITY DECREASED, VACCINATION SITE PAIN, GAIT DISTURBANCE, and VACCINATION SITE PAIN in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 26-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 26-Jul-2021, the patient experienced VACCINATION SITE HAEMORRHAGE and VACCINATION SITE PAIN. On 03-Aug-2021, the patient experienced MOBILITY DECREASED, VACCINATION SITE PAIN, and GAIT DISTURBANCE. At the time of the report, VACCINATION SITE HAEMORRHAGE, MOBILITY DECREASED, VACCINATION SITE PAIN, and GAIT DISTURBANCE outcome was unknown and VACCINATION SITE PAIN had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown. No Relevant concomitant medications were provided. No Treatment information was provided. The patient received vaccine around 03:30 PM. She preferred injection in left arm, due to ongoing issues with right elbow. Regarding issues with her elbow, her physicians are in process of ruling out fracture vs tendonitis. The nurse had to use a cotton ball, because she bled when she got the injection.

Other Meds:

Current Illness:

ID: 1672386
Sex: U
Age:
State: PA

Vax Date:
Onset Date:
Rec V Date: 09/04/2021
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: Received the vaccine that was on the counter in a punctured vial since 16Jul2021; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Received the vaccine that was on the counter in a punctured vial since 16Jul2021) 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 EXPIRED PRODUCT ADMINISTERED (Received the vaccine that was on the counter in a punctured vial since 16Jul2021). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Received the vaccine that was on the counter in a punctured vial since 16Jul2021) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant medications were reported. No Treatment information was reported.

Other Meds:

Current Illness:

ID: 1672387
Sex: F
Age: 46
State: TX

Vax Date: 07/18/2021
Onset Date: 07/19/2021
Rec V Date: 09/04/2021
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: Chest pain / woke up to soreness of the chest; Pressure in the chest, Tightness in chest; sensation of throat closing; Difficulty breathing / I could not breath; Numbness in my feet; Soreness of the arm; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (Chest pain / woke up to soreness of the chest), CHEST DISCOMFORT (Pressure in the chest, Tightness in chest), THROAT TIGHTNESS (sensation of throat closing), DYSPNOEA (Difficulty breathing / I could not breath) and HYPOAESTHESIA (Numbness in my feet) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Asthma. On 18-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Jul-2021, the patient experienced MYALGIA (Soreness of the arm). On 22-Jul-2021, the patient experienced CHEST DISCOMFORT (Pressure in the chest, Tightness in chest), THROAT TIGHTNESS (sensation of throat closing), DYSPNOEA (Difficulty breathing / I could not breath) and HYPOAESTHESIA (Numbness in my feet). On 22-Jul-2021 at 8:50 AM, the patient experienced CHEST PAIN (Chest pain / woke up to soreness of the chest). The patient was treated with NAPROXEN from 06-Aug-2021 to 18-Aug-2021 at a dose of 200 microgram twice a day. On 13-Aug-2021, CHEST DISCOMFORT (Pressure in the chest, Tightness in chest), THROAT TIGHTNESS (sensation of throat closing), DYSPNOEA (Difficulty breathing / I could not breath) and HYPOAESTHESIA (Numbness in my feet) had resolved. On 13-Aug-2021 at 4:15 PM, CHEST PAIN (Chest pain / woke up to soreness of the chest) had resolved. At the time of the report, MYALGIA (Soreness of the arm) 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 had started Concomitant medication on 12-MAY-2021 Natures bounty-iron (28mg, 1 day for vitamin D) and on 24-JUN-2021 It works-slim gummies(400 mg. 4 day) to reduce fat. Patient was received 2nd dose on 15-AUG-2021 in right arm and batch no.017E21A. Patient had an follow up visit with cardiologist on 13-SEP-2021. Most recent FOLLOW-UP information incorporated above includes: On 23-Aug-2021: Significant FU received contains second dose information,& Events added like sensation of throat Closing,Chest tightness,Numbness,Difficulty breathing.

Other Meds:

Current Illness: Asthma

ID: 1672388
Sex: F
Age: 48
State: TX

Vax Date: 08/02/2021
Onset Date: 08/03/2021
Rec V Date: 09/04/2021
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: Urinating a lot; Constant urge to urinate 3-4 times an hour; Urge to urinate got worst as the day went by; Unable to sleep; This spontaneous case was reported by a consumer and describes the occurrence of POLYURIA (Urinating a lot), POLLAKIURIA (Constant urge to urinate 3-4 times an hour), MICTURITION URGENCY (Urge to urinate got worst as the day went by) and INSOMNIA (Unable to sleep) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 088D21A) for COVID-19 vaccination. Concurrent medical conditions included Hypertension (Improvement with weight loss) since 2013 and Hypothyroidism since 2011. Concomitant products included HCTZ for Hypertension, LEVOTHYROXINE for Thyroid disorder. On 02-Aug-2021 at 7:45 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Aug-2021, the patient experienced POLYURIA (Urinating a lot), POLLAKIURIA (Constant urge to urinate 3-4 times an hour), MICTURITION URGENCY (Urge to urinate got worst as the day went by) and INSOMNIA (Unable to sleep). At the time of the report, POLYURIA (Urinating a lot), POLLAKIURIA (Constant urge to urinate 3-4 times an hour), MICTURITION URGENCY (Urge to urinate got worst as the day went by) and INSOMNIA (Unable to sleep) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The patient had zero spasms and zero pain while urinating and the urge to urinate went from a rating of 10/10 to 1/10. Patient reported that the patient had stopped taking HCTZ to help with the issue. The patient was going to the bathroom about 12 times in an hour. It was either a normal amount or just a few drops. The patient was unable to sleep on a night as the patient had to go to the bathroom all night. No treatment medication details was reported. Most recent FOLLOW-UP information incorporated above includes: On 24-Aug-2021: Follow-up received : updated patient demographics, added patient medical history,concomitant medications, added event of unable to sleep

Other Meds: HCTZ; LEVOTHYROXINE

Current Illness: Hypertension (Improvement with weight loss); Hypothyroidism.

ID: 1672389
Sex: M
Age:
State: LA

Vax Date: 01/01/2021
Onset Date:
Rec V Date: 09/04/2021
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: This spontaneous case was reported by a consumer and describes the occurrence of SOMNOLENCE and FATIGUE (A little tired) in a 77-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Disability NOS (Patient is disabled). In January 2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. In February 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 SOMNOLENCE (Slept several hours after he received the vaccine) and FATIGUE (A little tired). At the time of the report, SOMNOLENCE (Slept several hours after he received the vaccine) and FATIGUE (A little tired) outcome was unknown. No concomitant medication and treatment information was provided. This case was linked to MOD-2021-276487 (Patient Link).

Other Meds:

Current Illness: Disability NOS (Patient is disabled)

ID: 1672390
Sex: F
Age: 40
State: OH

Vax Date: 03/23/2021
Onset Date: 03/23/2021
Rec V Date: 09/04/2021
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: Affecting her health, mentally, and emotionally; Rash; Rash all over their face; Headache; Nose bleeds/ Nose bleed is ongoing; Left side of their face felt droopy; Face felt like it was on fire; Face was red; Itching; This spontaneous case was reported by a consumer and describes the occurrence of EPISTAXIS (Nose bleeds/ Nose bleed is ongoing), EMOTIONAL DISTRESS (Affecting her health, mentally, and emotionally), FACIAL PARALYSIS (Left side of their face felt droopy), BURNING SENSATION (Face felt like it was on fire) and ERYTHEMA (Face was red) in a 40-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history information was provided by the reporter. Concomitant products included LANSOPRAZOLE (PREVACID), LEVOCETIRIZINE DIHYDROCHLORIDE (XYZAL), BUSPIRONE, ALPRAZOLAM (XANAX), ACYCLOVIR [ACICLOVIR] and MULTIVITAMINS [VITAMINS NOS] for an unknown indication. On 23-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Mar-2021, the patient experienced EPISTAXIS (Nose bleeds/ Nose bleed is ongoing), FACIAL PARALYSIS (Left side of their face felt droopy), BURNING SENSATION (Face felt like it was on fire), ERYTHEMA (Face was red), PRURITUS (Itching), RASH (Rash all over their face) and HEADACHE (Headache). On 02-Apr-2021, the patient experienced RASH (Rash). On an unknown date, the patient experienced EMOTIONAL DISTRESS (Affecting her health, mentally, and emotionally). The patient was treated with ACETYLSALICYLIC ACID, CAFFEINE, PARACETAMOL (EXCEDRIN [ACETYLSALICYLIC ACID;CAFFEINE;PARACETAMOL]) for Headache, at an unspecified dose and frequency and HYDROXYZINE (ATARAX [HYDROXYZINE]) for Itching, at an unspecified dose and frequency. On 25-Mar-2021, FACIAL PARALYSIS (Left side of their face felt droopy), BURNING SENSATION (Face felt like it was on fire), ERYTHEMA (Face was red), PRURITUS (Itching), RASH (Rash all over their face) and HEADACHE (Headache) had resolved. On 03-Apr-2021, RASH (Rash) had resolved. At the time of the report, EPISTAXIS (Nose bleeds/ Nose bleed is ongoing) had not resolved and EMOTIONAL DISTRESS (Affecting her health, mentally, and emotionally) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. The patient has gone to see their health care provider, an allergist, and an ears, nose, throat provider to help with the nose bleeds, which have never resolved. The patient has had blood work done, a CT scan, and nose cauterization. The results for the tests are not reported. Other Concomitant medications included birth control. Most recent FOLLOW-UP information incorporated above includes: On 05-Aug-2021: Follow-up receive and contains No new information, Consent for follow-up denied On 31-Aug-2021: Follow up received as non-significant information regarding event but initially it was submitted as non serious case instead of serious case.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: PREVACID; XYZAL; BUSPIRONE; XANAX; ACYCLOVIR [ACICLOVIR]; MULTIVITAMINS [VITAMINS NOS]

Current Illness:

ID: 1672391
Sex: M
Age: 19
State: CA

Vax Date: 07/23/2021
Onset Date: 08/04/2021
Rec V Date: 09/04/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: Patient went to pharmacy to receive his 2nd dose of Moderna COVID 19 vaccine 12 days later; This spontaneous case was reported by a nurse and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient went to pharmacy to receive his 2nd dose of Moderna COVID 19 vaccine 12 days later) in a 19-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026C21A) for COVID-19 vaccination. No Medical History information was reported. On 23-Jul-2021 at 1:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Aug-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient went to pharmacy to receive his 2nd dose of Moderna COVID 19 vaccine 12 days later). On 04-Aug-2021, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (Patient went to pharmacy to receive his 2nd dose of Moderna COVID 19 vaccine 12 days later) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication information was provided. No treatment medication information was provided. Most recent FOLLOW-UP information incorporated above includes: On 27-Aug-2021: Follow up received contains non significant information. Phone number updated from original source document. Patient demographics updated. Vaccine facility information updated.

Other Meds:

Current Illness:

ID: 1672392
Sex: M
Age: 70
State: MS

Vax Date: 02/09/2021
Onset Date: 06/01/2021
Rec V Date: 09/04/2021
Hospital:

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

Lab Data: Test Name: Blood work; Result Unstructured Data: bloodwork done and Sjogren's disease was ruled out.

Allergies:

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

Symptoms: This spontaneous case was reported by a consumer and describes the occurrence of DRY MOUTH (Severe dry mouth) and DYSGEUSIA (Metallic taste in his mouth) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 03UA21A and 016M70A) for COVID-19 vaccination. Concurrent medical conditions included Sjogren's disease. On 09-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. In 2021, the patient experienced DYSGEUSIA (Metallic taste in his mouth). In June 2021, the patient experienced DRY MOUTH (Severe dry mouth). The patient was treated with PILOCARPINE ongoing since an unknown date for Dry mouth, at a dose of 5 mg; GLUCOSE OXIDASE, LACTOFERRIN, LACTOPEROXIDASE, LYSOZYME (BIOTENE [GLUCOSE OXIDASE;LACTOFERRIN;LACTOPEROXIDASE;LYSOZYME]) (oral) ongoing since an unknown date for Dry mouth, at a dose of 1 dosage form and XYLITOL (ACT DRY MOUTH LOZENGES) (oral) for Dry mouth, at a dose of 1 dosage form. At the time of the report, DRY MOUTH (Severe dry mouth) had not resolved and DYSGEUSIA (Metallic taste in his mouth) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood test: abnormal (abnormal) bloodwork done and Sjogren's disease was ruled out. An additional treatment medication is Xylomelts lozenges and ACT rinse was reported for an indication of dry mouth. No concomitant medications were reported. Most recent FOLLOW-UP information incorporated above includes: On 23-Aug-2021: Event and reporter information updated.

Other Meds:

Current Illness: Sjogren's disease

ID: 1672393
Sex: M
Age: 44
State: NY

Vax Date: 01/11/2021
Onset Date: 02/08/2021
Rec V Date: 09/04/2021
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: tinnitus in left ear; heat at the injection site; rash at the injection site; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TINNITUS (tinnitus in left ear), VACCINATION SITE WARMTH (heat at the injection site) and VACCINATION SITE RASH (rash at the injection site) in a 45-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 059ELIA and 011520) for COVID-19 vaccination. Concurrent medical conditions included Type 1 diabetes mellitus (Diabetes type 1) since 01-Jan-1985 and Hypertension (Has become erratic since 02-Apr-2021) since 01-Jan-2002. Concomitant products included INSULIN, ROSUVASTATIN CALCIUM (CRESTOR), EZETIMIBE (ZETIA), OMEPRAZOLE and VALSARTAN for an unknown indication. On 11-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Feb-2021, the patient experienced TINNITUS (tinnitus in left ear), VACCINATION SITE WARMTH (heat at the injection site) and VACCINATION SITE RASH (rash at the injection site). At the time of the report, TINNITUS (tinnitus in left ear), VACCINATION SITE WARMTH (heat at the injection site) and VACCINATION SITE RASH (rash at the injection site) outcome was unknown. Not Provided The patient connected with primary care provider and the primary care provider recommended the patient to take ice and antihisthimine/Tylenol This case was linked to MOD-2021-066013 (Patient Link).

Other Meds: INSULIN; CRESTOR; ZETIA; OMEPRAZOLE; VALSARTAN

Current Illness: Hypertension (Has become erratic since 02-Apr-2021); Type 1 diabetes mellitus (Diabetes type 1)

ID: 1672394
Sex: U
Age:
State: OH

Vax Date:
Onset Date:
Rec V Date: 09/04/2021
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: has seen 4 breakthrough cases of COVID 19; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a physician and describes the occurrence of COVID-19 (has seen 4 breakthrough cases of COVID 19) 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 COVID-19 (has seen 4 breakthrough cases of COVID 19). At the time of the report, COVID-19 (has seen 4 breakthrough cases of COVID 19) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not provided by the reporter. Treatment medications were not provided by the reporter.

Other Meds:

Current Illness:

ID: 1672395
Sex: F
Age: 54
State: PA

Vax Date: 12/30/2020
Onset Date:
Rec V Date: 09/04/2021
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: really bad hot flushes; sweats all the time; rash started on her neck/rash all over/rash keeps getting worse; This spontaneous case was reported by a nurse and describes the occurrence of HOT FLUSH (really bad hot flushes), HYPERHIDROSIS (sweats all the time) and RASH (rash started on her neck/rash all over/rash keeps getting worse) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011J20A and 013C20A) for COVID-19 vaccination. No medical history provided by the reporter. Concomitant products included VITAMINS NOS for an unknown indication. On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Jan-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 HOT FLUSH (really bad hot flushes), HYPERHIDROSIS (sweats all the time) and RASH (rash started on her neck/rash all over/rash keeps getting worse). The patient was treated with PREDNISONE at a dose of 1 dosage form. At the time of the report, HOT FLUSH (really bad hot flushes), HYPERHIDROSIS (sweats all the time) and RASH (rash started on her neck/rash all over/rash keeps getting worse) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medication included inhaler for allergies. The patient thinks maybe her rash started since she began using a mask but around March it exacerbated. It started on her neck and now it's all over and keeps getting worse. She has been to her family doctor and her gynecologist, nobody seems to know what's going on. They keep saying it's contact dermatitis. She thinks it may be her menopause or a fungal infection as she has really bad hot flushes and sweats all the time. The doctor gave her hormone replacement therapy about three weeks ago. She also received Prednisone. She will visit an allergist in October. She takes vitamins and has an inhaler for allergies as needed.

Other Meds: VITAMINS NOS

Current Illness:

ID: 1672396
Sex: F
Age: 51
State: OH

Vax Date: 07/12/2021
Onset Date: 08/09/2021
Rec V Date: 09/04/2021
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: It's still itching now; I felt extremely tired; Sore at the injection site; I had a real bad headache (lasted 3 days); Dizziness when I stand up; I feel like I'm going to faint when I stand up; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS POSTURAL (Dizziness when I stand up), DIZZINESS (I feel like I'm going to faint when I stand up), PRURITUS (It's still itching now), FATIGUE (I felt extremely tired) and VACCINATION SITE PAIN (Sore at the injection site) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 045C21A and 038C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 12-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 09-Aug-2021, the patient experienced DIZZINESS POSTURAL (Dizziness when I stand up), DIZZINESS (I feel like I'm going to faint when I stand up), FATIGUE (I felt extremely tired), VACCINATION SITE PAIN (Sore at the injection site) and HEADACHE (I had a real bad headache (lasted 3 days)). On 12-Aug-2021, the patient experienced PRURITUS (It's still itching now). On 11-Aug-2021, HEADACHE (I had a real bad headache (lasted 3 days)) had resolved. At the time of the report, DIZZINESS POSTURAL (Dizziness when I stand up), DIZZINESS (I feel like I'm going to faint when I stand up), PRURITUS (It's still itching now), FATIGUE (I felt extremely tired) and VACCINATION SITE PAIN (Sore at the injection site) outcome was unknown. No concomitant medications were reported No treatment medications were reported Patient emailed her Doctor on 12-AUG-2021 regarding dizziness This case was linked to MOD-2021-284552 (Patient Link).

Other Meds:

Current Illness:

ID: 1672397
Sex: M
Age: 72
State: MD

Vax Date: 08/13/2021
Onset Date:
Rec V Date: 09/04/2021
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: Greater than 12 hours after initial vial; This spontaneous case was reported by an other health care professional and describes the occurrence of EXPIRED PRODUCT ADMINISTERED (Greater than 12 hours after initial vial) in a 72-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 13-Aug-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced EXPIRED PRODUCT ADMINISTERED (Greater than 12 hours after initial vial). At the time of the report, EXPIRED PRODUCT ADMINISTERED (Greater than 12 hours after initial vial) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications information was reported. No treatment medications were provided. It was reported that, patient received punctured vial that was 5 hours past the 12 hour temperature rule.

Other Meds:

Current Illness:

ID: 1672398
Sex: F
Age: 51
State: AR

Vax Date: 03/09/2021
Onset Date: 08/08/2021
Rec V Date: 09/04/2021
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: 20210808; Test Name: Body temperature; Result Unstructured Data: fever (99-100. something); Test Date: 20210808; Test Name: COVID-19 virus test; Test Result: Negative ; Result Unstructured Data: Covid-19 test was negative

Allergies:

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

Symptoms: Lost her voice; Could not eat; Productive of light green mucus; Very weak; Could barely walk; Nauseous; Chills; Was throwing up; This spontaneous case was reported by a consumer and describes the occurrence of APHONIA (Lost her voice), FEEDING DISORDER (Could not eat), SECRETION DISCHARGE (Productive of light green mucus), ASTHENIA (Very weak) and GAIT DISTURBANCE (Could barely walk) in a 51-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 016B21A and 027A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Pneumothorax. Concurrent medical conditions included Asthma. On 09-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 09-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 08-Aug-2021, the patient experienced APHONIA (Lost her voice), FEEDING DISORDER (Could not eat), SECRETION DISCHARGE (Productive of light green mucus), ASTHENIA (Very weak), GAIT DISTURBANCE (Could barely walk), NAUSEA (Nauseous), CHILLS (Chills) and VOMITING (Was throwing up). The patient was treated with CEFDINIR for Adverse event, at a dose of 300 milligram; PARACETAMOL (TYLENOL) for Fever and Chills, at an unspecified dose and frequency and IBUPROFEN for Fever and Chills, at an unspecified dose and frequency. At the time of the report, APHONIA (Lost her voice), FEEDING DISORDER (Could not eat), SECRETION DISCHARGE (Productive of light green mucus), ASTHENIA (Very weak), GAIT DISTURBANCE (Could barely walk), NAUSEA (Nauseous), CHILLS (Chills) and VOMITING (Was throwing up) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 08-Aug-2021, Body temperature: 100 (High) fever (99-100. something). On 08-Aug-2021, SARS-CoV-2 test: negative (Negative) Covid-19 test was negative. Medical history included unspecified disability. Reporter reported that On 09-Aug-2021, she consulted with her primary doctor and she was given a steroid and antibiotic shot.

Other Meds:

Current Illness: Asthma

ID: 1672399
Sex: F
Age:
State: AZ

Vax Date: 08/06/2021
Onset Date:
Rec V Date: 09/04/2021
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: Arm started to swell where she got the shot; Tingling in her fingertips; Swelling in her fingertips; Pain in her fingertips; Gets sick every time she eats; Arm started to hurt where she got the shot; Feels nauseated when she eats ,gets nauseous every time she eats; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm started to swell where she got the shot), PARAESTHESIA (Tingling in her fingertips), PERIPHERAL SWELLING (Swelling in her fingertips), PAIN IN EXTREMITY (Pain in her fingertips) and ILLNESS (Gets sick every time she eats) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 06-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (Arm started to swell where she got the shot), PARAESTHESIA (Tingling in her fingertips), PERIPHERAL SWELLING (Swelling in her fingertips), PAIN IN EXTREMITY (Pain in her fingertips), ILLNESS (Gets sick every time she eats), MYALGIA (Arm started to hurt where she got the shot) and NAUSEA (Feels nauseated when she eats ,gets nauseous every time she eats). At the time of the report, PERIPHERAL SWELLING (Arm started to swell where she got the shot), PARAESTHESIA (Tingling in her fingertips), PERIPHERAL SWELLING (Swelling in her fingertips), PAIN IN EXTREMITY (Pain in her fingertips), ILLNESS (Gets sick every time she eats), MYALGIA (Arm started to hurt where she got the shot) and NAUSEA (Feels nauseated when she eats ,gets nauseous every time she eats) outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. No concomitants medications was reported. No treatments medications was reported. Patient 2nd dose is scheduled on 4Sep2021.She has been hesitant to get her 2nd dose. noted

Other Meds:

Current Illness:

ID: 1672400
Sex: F
Age: 79
State: LA

Vax Date: 08/07/2021
Onset Date: 08/09/2021
Rec V Date: 09/04/2021
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: Bad reaction; Huge hives with water blisters on them mostly on left side on her arm shoulder and back with a few on hip); water blisters on left side on arm, shoulder and back with a few on her hip.; swelling, specifically in her left hand; Hand/wrist and thumb feel numb; Stinging; Burning like fire; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (Bad reaction), URTICARIA (Huge hives with water blisters on them mostly on left side on her arm shoulder and back with a few on hip)), BLISTER (water blisters on left side on arm, shoulder and back with a few on her hip.), PERIPHERAL SWELLING (swelling, specifically in her left hand) and HYPOAESTHESIA (Hand/wrist and thumb feel numb) in a 79-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 052E21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 07-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-2021, the patient experienced VACCINATION COMPLICATION (Bad reaction), URTICARIA (Huge hives with water blisters on them mostly on left side on her arm shoulder and back with a few on hip)), BLISTER (water blisters on left side on arm, shoulder and back with a few on her hip.), PERIPHERAL SWELLING (swelling, specifically in her left hand), HYPOAESTHESIA (Hand/wrist and thumb feel numb), PAIN (Stinging) and BURNING SENSATION (Burning like fire). At the time of the report, VACCINATION COMPLICATION (Bad reaction), URTICARIA (Huge hives with water blisters on them mostly on left side on her arm shoulder and back with a few on hip)), BLISTER (water blisters on left side on arm, shoulder and back with a few on her hip.), PERIPHERAL SWELLING (swelling, specifically in her left hand), HYPOAESTHESIA (Hand/wrist and thumb feel numb), PAIN (Stinging) and BURNING SENSATION (Burning like fire) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were not reported. Treatment details were not provided.

Other Meds:

Current Illness:

ID: 1672401
Sex: M
Age: 73
State: CA

Vax Date: 02/06/2021
Onset Date: 03/01/2021
Rec V Date: 09/04/2021
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: Has been sick; Doesn't feel good every day; Off balance; Light headed,been dizzy; Vertigo; Nauseous; Chronic fatigue; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (Has been sick), FEELING ABNORMAL (Doesn't feel good every day), BALANCE DISORDER (Off balance), DIZZINESS (Light headed,been dizzy) and VERTIGO (Vertigo) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 06-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 06-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. In March 2021, the patient experienced ILLNESS (Has been sick), FEELING ABNORMAL (Doesn't feel good every day), BALANCE DISORDER (Off balance), DIZZINESS (Light headed,been dizzy), VERTIGO (Vertigo), NAUSEA (Nauseous) and FATIGUE (Chronic fatigue). At the time of the report, ILLNESS (Has been sick), FEELING ABNORMAL (Doesn't feel good every day), BALANCE DISORDER (Off balance), DIZZINESS (Light headed,been dizzy), VERTIGO (Vertigo), NAUSEA (Nauseous) and FATIGUE (Chronic fatigue) outcome was unknown. Patient has no underlying issues, has had every test including a brain MRI. Patient has seen other doctors besides his primary including an alternative medicine doctor, a Naturopath, and Homeopath. Concomitant product information was not provided. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1672402
Sex: F
Age: 16
State: MS

Vax Date: 07/19/2021
Onset Date: 07/19/2021
Rec V Date: 09/04/2021
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: vaccine given to a 16 year old; This spontaneous case was reported by a nurse and describes the occurrence of OFF LABEL USE (vaccine given to a 16 year old) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 19-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 16-Aug-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to .5 milliliter. On 19-Jul-2021, the patient experienced OFF LABEL USE (vaccine given to a 16 year old). At the time of the report, OFF LABEL USE (vaccine given to a 16 year old) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was provided by reporter. No treatment medication was provided by reporter. The lot number of the vaccine is 041B21A.

Other Meds:

Current Illness:

ID: 1672403
Sex: F
Age: 34
State: WA

Vax Date: 07/14/2021
Onset Date:
Rec V Date: 09/04/2021
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: Could not sleep at night; After 1st dose, had a sore arm; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA, PAIN IN EXTREMITY, and FATIGUE in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 078C21A) for COVID-19 vaccination. No Medical History information was reported. On 14-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced INSOMNIA, PAIN IN EXTREMITY, and FATIGUE. The patient was treated with ALOE VERA for Adverse event, at an unspecified dose and frequency and WITCH HAZEL LEAVES for Adverse event, at an unspecified dose and frequency. At the time of the report, INSOMNIA, PAIN IN EXTREMITY, and FATIGUE outcome was unknown. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. No concomitant drugs were provided. Treatment medication included pain reliever. This case was linked to MOD-2021-288101 (Patient Link).

Other Meds:

Current Illness:

ID: 1672404
Sex: F
Age: 34
State: AZ

Vax Date: 04/12/2021
Onset Date: 05/17/2021
Rec V Date: 09/04/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Asthenia, Chills, Headache, Myalgia

Symptoms: Not sleeping well; Range of motion is completely messed up/ Can not find a position to sleep in; Hard to pick up my son with both hands/ Can only lift him to a certain height before I can not lift him anymore; Extreme pain inshoulders on the side where we got the vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INSOMNIA (Not sleeping well), JOINT RANGE OF MOTION DECREASED (Range of motion is completely messed up/ Can not find a position to sleep in), HYPOKINESIA (Hard to pick up my son with both hands/ Can only lift him to a certain height before I can not lift him anymore) and VACCINATION SITE PAIN (Extreme pain inshoulders on the side where we got the vaccine) in a 34-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 022B21A and 041B21A) for COVID-19 vaccination. No medical history was reported by the reporter. On 12-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 10-May-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 17-May-2021, the patient experienced INSOMNIA (Not sleeping well), JOINT RANGE OF MOTION DECREASED (Range of motion is completely messed up/ Can not find a position to sleep in) and HYPOKINESIA (Hard to pick up my son with both hands/ Can only lift him to a certain height before I can not lift him anymore). 17-May-2021, the patient experienced VACCINATION SITE PAIN (Extreme pain inshoulders on the side where we got the vaccine). The patient was treated with IBUPROFEN for Adverse event, at a dose of 1 dosage form and CYCLOBENZAPRINE for Adverse event, at a dose of 1 dosage form. At the time of the report, INSOMNIA (Not sleeping well), JOINT RANGE OF MOTION DECREASED (Range of motion is completely messed up/ Can not find a position to sleep in), HYPOKINESIA (Hard to pick up my son with both hands/ Can only lift him to a certain height before I can not lift him anymore) and VACCINATION SITE PAIN (Extreme pain inshoulders on the side where we got the vaccine) outcome was unknown. No concomitant medication was provided. On 29-Jul-2021, the patient consulted with the physician was who thought that the shoulder pain may be due to an injury during the administration of the vaccine. The patient was recommended physical therapy, use of pain killers, and taking sleeping pills as treatment medication. This case was linked to MOD-2021-288148 (Patient Link).

Other Meds:

Current Illness:

ID: 1672405
Sex: F
Age: 72
State: AR

Vax Date: 08/12/2021
Onset Date: 08/13/2021
Rec V Date: 09/04/2021
Hospital:

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

Lab Data: Test Date: 20210813; Test Name: Body temperature; Result Unstructured Data: 102.2 degree F in the evening and later decreased to 101.2 degree F; Test Date: 20210815; Test Name: Body temperature; Result Unstructured Data: 97.4 degree F; Test Date: 20210816; Test Name: Body temperature; Result Unstructured Data: 99.1 degree F.

Allergies:

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

Symptoms: Dizzy; Unsteady on her feet; Chills/ Chilling badly; Had temperature of 102.2 degree Fahrenheit; Cold; Could not wake up/ Wanted to sleep all day; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS, NASOPHARYNGITIS, HYPERSOMNIA, GAIT DISTURBANCE, and CHILLS in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040CZ1A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 in December 2020. Concurrent medical conditions included Breast cancer (left breast). Concomitant products included TAMOXIFEN for Cancer, METFORMIN for Diabetes, METOPROLOL for Tachycardia, SIMVASTATIN for an unknown indication. On 12-Aug-2021 at 2:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Aug-2021, the patient experienced NASOPHARYNGITIS, HYPERSOMNIA, and CHILLS. 13-Aug-2021, the patient experienced PYREXIA. On an unknown date, the patient experienced DIZZINESS and GAIT DISTURBANCE. At the time of the report, DIZZINESS, NASOPHARYNGITIS, HYPERSOMNIA, GAIT DISTURBANCE, CHILLS, and PYREXIA outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Aug-2021, Body temperature: high 102.2 degree F in the evening and later decreased to 101.2 degree F. On 15-Aug-2021, Body temperature: (normal) 97.4 degree F. On 16-Aug-2021, Body temperature: (normal) 99.1 degree F. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) was unknown. No treatment medication information was provided. Concomitant medication included diuretic every few days. Historical vaccine included shingles vaccine.

Other Meds: TAMOXIFEN; METOPROLOL; METFORMIN; SIMVASTATIN

Current Illness: Breast cancer (left breast)

ID: 1672406
Sex: F
Age:
State: PR

Vax Date:
Onset Date:
Rec V Date: 09/04/2021
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: Test Date: 20210810; Test Name: sonogram on the neck; Result Unstructured Data: 9 lymph nodules inflamed on the neck

Allergies:

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

Symptoms: 9 lymph nodules inflamed on the neck; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (9 lymph nodules inflamed on the neck) in a 48-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No medical history was reported. Concurrent medical conditions included Nodule (The patient said that had a nodule like lipoma 2 years ago) since 2019. Concomitant products included LEVOTHYROXINE, METFORMIN and ROSUVASTATIN for an unknown indication. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (9 lymph nodules inflamed on the neck). At the time of the report, LYMPHADENOPATHY (9 lymph nodules inflamed on the neck) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 10-Aug-2021, Ultrasound scan: 9 lymph nodules inflamed (abnormal) 9 lymph nodules inflamed on the neck. No treatment information was reported. The patient received both doses of the Moderna COVID-19 Vaccine between march and April (date not available).

Other Meds: LEVOTHYROXINE; METFORMIN; ROSUVASTATIN

Current Illness: Nodule (The patient said that had a nodule like lipoma 2 years ago)

ID: 1672407
Sex: F
Age: 15
State: MS

Vax Date: 07/27/2021
Onset Date: 07/27/2021
Rec V Date: 09/04/2021
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: Vaccine given to a 16 year old; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine given to a 16 year old) in a 16-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 041B21A) for COVID-19 vaccination. No Medical History information was reported. On 27-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 milliliter. On 27-Jul-2021, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine given to a 16 year old). On 27-Jul-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Vaccine given to a 16 year old) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment information was reported.

Other Meds:

Current Illness:

ID: 1672408
Sex: M
Age:
State: NY

Vax Date:
Onset Date:
Rec V Date: 09/04/2021
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: Someone the age of 16 got the first Moderna shot; This spontaneous case was reported by an other health care professional and describes the occurrence of PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Someone the age of 16 got the first Moderna shot) in a 16-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Someone the age of 16 got the first Moderna shot). At the time of the report, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (Someone the age of 16 got the first Moderna shot) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medications were reported. Treatment information was not provided. The patient came to a pediatric practice to get the second dose. The nurse supervisor wanted to know if they could complete the series.

Other Meds:

Current Illness:

ID: 1672409
Sex: F
Age: 19
State: AR

Vax Date: 07/24/2021
Onset Date: 07/24/2021
Rec V Date: 09/04/2021
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: 20210724; Test Name: Body temperature; Result Unstructured Data: Low grade fever at 99.8 F.

Allergies:

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

Symptoms: Low grade fever at 99.8; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade fever at 99.8) in a 19-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 006D21A) for COVID-19 vaccination. No Medical History information was reported. On 24-Jul-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Jul-2021, the patient experienced PYREXIA (Low grade fever at 99.8). The patient was treated with ACETAMINOPHEN for Fever, at a dose of 2500 milligram once a day. At the time of the report, PYREXIA (Low grade fever at 99.8) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Jul-2021, Body temperature: 99.8 (High) Low grade fever at 99.8. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. The normal body temperature was normally around 97.2. No concomitant medications information was reported.

Other Meds:

Current Illness:

ID: 1672410
Sex: F
Age: 60
State: FL

Vax Date: 08/13/2021
Onset Date: 08/14/2021
Rec V Date: 09/04/2021
Hospital:

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

Lab Data: Test Date: 20210814; Test Name: Blood pressure; Result Unstructured Data: blood pressure was elevated to 147/102; Test Date: 20210814; Test Name: Pulse rate; Result Unstructured Data: pulse rate was elevated to 105 as of the same evening; Test Date: 20210815; Test Name: Pulse rate; Result Unstructured Data: pulse rate was elevated to 105/pulse rate was 111

Allergies:

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

Symptoms: Felt like she was going to pass out / dizziness; weakness; Itching in the back of her throat; Heavy cough; High temperature; Headache; Nausea; This spontaneous case was reported by a non-health professional and describes the occurrence of COUGH (Heavy cough), ASTHENIA (weakness), THROAT IRRITATION (Itching in the back of her throat), DIZZINESS (Felt like she was going to pass out / dizziness) and PYREXIA (High temperature) in a 60-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 009C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Hypertension and Cholesterol. Concomitant products included ROSUVASTATIN for Cholesterol, AMLODIPINE and HCTZ for Hypertension, CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]) for an unknown indication. On 13-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Aug-2021, the patient experienced COUGH (Heavy cough), PYREXIA (High temperature), HEADACHE (Headache) and NAUSEA (Nausea). On 15-Aug-2021, the patient experienced ASTHENIA (weakness) and THROAT IRRITATION (Itching in the back of her throat). On 16-Aug-2021, the patient experienced DIZZINESS (Felt like she was going to pass out / dizziness). The patient was treated with ACETAMINOPHEN for Adverse event, at an unspecified dose and frequency. At the time of the report, COUGH (Heavy cough), ASTHENIA (weakness), THROAT IRRITATION (Itching in the back of her throat), DIZZINESS (Felt like she was going to pass out / dizziness), PYREXIA (High temperature), HEADACHE (Headache) and NAUSEA (Nausea) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 14-Aug-2021, Blood pressure measurement: 147/102 (High) blood pressure was elevated to 147/102. On 14-Aug-2021, Heart rate: 105 (High) pulse rate was elevated to 105 as of the same evening. On 15-Aug-2021, Heart rate: 111 (High) pulse rate was elevated to 105/pulse rate was 111. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown.

Other Meds: AMLODIPINE; HCTZ; ROSUVASTATIN; ZYRTEC [CETIRIZINE HYDROCHLORIDE]

Current Illness: Cholesterol; Hypertension

ID: 1672411
Sex: F
Age:
State: NJ

Vax Date: 04/01/2021
Onset Date: 04/01/2021
Rec V Date: 09/04/2021
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: Patient hasn't received second dose (4 months since first one); Eye infection; Shingles; This spontaneous case was reported by a pharmacist and describes the occurrence of EYE INFECTION (Eye infection), HERPES ZOSTER (Shingles) and PRODUCT DOSE OMISSION ISSUE (Patient hasn't received second dose (4 months since first one)) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Apr-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (Patient hasn't received second dose (4 months since first one)). In April 2021, the patient experienced EYE INFECTION (Eye infection) and HERPES ZOSTER (Shingles). At the time of the report, EYE INFECTION (Eye infection) and HERPES ZOSTER (Shingles) outcome was unknown and PRODUCT DOSE OMISSION ISSUE (Patient hasn't received second dose (4 months since first one)) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No Concomitant medications were reported. No Treatment information was reported.

Other Meds:

Current Illness:

ID: 1672412
Sex: M
Age: 66
State: GA

Vax Date: 08/09/2021
Onset Date: 08/09/2021
Rec V Date: 09/04/2021
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: Couldn't taste; Lost any appetite; I'm kind of dizzy/light headed; my stomach seems like I'm gonna throw up; Couldn't smell; fever; Cough; The arm hurt; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (The arm hurt), COUGH (Cough), AGEUSIA (Couldn't taste), DECREASED APPETITE (Lost any appetite) and DIZZINESS (I'm kind of dizzy/light headed) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. Unknown) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history information was provided. Concomitant products included PARACETAMOL (TYLENOL) for an unknown indication. On 09-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 09-Aug-2021, the patient experienced PAIN (The arm hurt). On 11-Aug-2021, the patient experienced COUGH (Cough). On 12-Aug-2021, the patient experienced AGEUSIA (Couldn't taste), DECREASED APPETITE (Lost any appetite), DIZZINESS (I'm kind of dizzy/light headed), ABDOMINAL DISCOMFORT (my stomach seems like I'm gonna throw up), ANOSMIA (Couldn't smell) and PYREXIA (fever). On 10-Aug-2021, PAIN (The arm hurt) had resolved. At the time of the report, COUGH (Cough), AGEUSIA (Couldn't taste), DECREASED APPETITE (Lost any appetite), DIZZINESS (I'm kind of dizzy/light headed), ABDOMINAL DISCOMFORT (my stomach seems like I'm gonna throw up), ANOSMIA (Couldn't smell) and PYREXIA (fever) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication included that Medicine for Pressure, Cholesterol, Arthritis. No treatment information was provided. This case was linked to MOD-2021-288160 (Patient Link).

Other Meds: TYLENOL

Current Illness:

ID: 1672413
Sex: F
Age: 66
State: FL

Vax Date: 12/29/2020
Onset Date: 01/28/2021
Rec V Date: 09/04/2021
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: felt colder than usual; left injection site arm was sore; This spontaneous case was reported by a consumer and describes the occurrence of FEELING COLD (felt colder than usual) and VACCINATION SITE PAIN (left injection site arm was sore) in a 67-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029K20A and 039K20A) for COVID-19 vaccination. No Medical History information was reported. On 29-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 28-Jan-2021, the patient experienced FEELING COLD (felt colder than usual) and VACCINATION SITE PAIN (left injection site arm was sore). On 28-Jan-2021, FEELING COLD (felt colder than usual) and VACCINATION SITE PAIN (left injection site arm was sore) outcome was unknown. No concomitant medications was provided by the reporter. No treatment medications was provided by the reporter. This case was linked to MOD-2021-288144 (Patient Link).

Other Meds:

Current Illness:

ID: 1672414
Sex: M
Age: 57
State: NY

Vax Date: 02/11/2021
Onset Date: 02/11/2021
Rec V Date: 09/04/2021
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: Body aches; Arm was swollen/forearm swelled; Was sore; Tired; Body chills; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body aches), PERIPHERAL SWELLING (Arm was swollen/forearm swelled), MYALGIA (Was sore), FATIGUE (Tired) and CHILLS (Body chills) in a 57-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 024M20A) for COVID-19 vaccination. The patient's past medical history included Testicular cancer (Patient's left testes was removed) from 1998 to 1999, Orchiectomy (left testes was removed ) and Pneumonectomy (took two pieces of his lung out (he had a black spot) because it was cancer) on 04-May-2020. Concurrent medical conditions included Lung cancer and Knee swelling. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 11-Feb-2021, the patient experienced PAIN (Body aches), PERIPHERAL SWELLING (Arm was swollen/forearm swelled), MYALGIA (Was sore), FATIGUE (Tired) and CHILLS (Body chills). In February 2021, PAIN (Body aches), MYALGIA (Was sore), FATIGUE (Tired) and CHILLS (Body chills) had resolved. In March 2021, PERIPHERAL SWELLING (Arm was swollen/forearm swelled) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant products were not provided. Treatment medication were not reported. This case was linked to MOD-2021-288194 (Patient Link).

Other Meds:

Current Illness: Knee swelling; Lung cancer

ID: 1672415
Sex: U
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 09/04/2021
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: Loss of appetite; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (Loss of appetite) 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 DECREASED APPETITE (Loss of appetite). At the time of the report, DECREASED APPETITE (Loss of appetite) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant and treatment information was reported.

Other Meds:

Current Illness:

ID: 1672416
Sex: M
Age: 35
State: AR

Vax Date: 08/07/2021
Onset Date: 08/01/2021
Rec V Date: 09/04/2021
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: it's making his entire arm hurt. It happened exactly 7 days after the shot.; on the same arm of his shot, his elbow swelled up and started in the middle of the night; It was red. It hurt, but it didn't have inflammation in it / down to where his elbow is and all the way around it; It looked like it had fluid in it and it kept getting bigger; It was red. It hurt, but it didn't have inflammation in it / down to where his elbow is and all the way around it; it turned brown after a few days; it felt cold to the touch, not hot; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL COLDNESS (it felt cold to the touch, not hot), JOINT SWELLING (on the same arm of his shot, his elbow swelled up and started in the middle of the night), PAIN IN EXTREMITY (it's making his entire arm hurt. It happened exactly 7 days after the shot.), ERYTHEMA (It was red. It hurt, but it didn't have inflammation in it / down to where his elbow is and all the way around it) and SKIN DISCOLOURATION (it turned brown after a few days) in a 35-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 040C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 07-Aug-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Aug-2021, the patient experienced JOINT SWELLING (on the same arm of his shot, his elbow swelled up and started in the middle of the night), PAIN IN EXTREMITY (it's making his entire arm hurt. It happened exactly 7 days after the shot.), ERYTHEMA (It was red. It hurt, but it didn't have inflammation in it / down to where his elbow is and all the way around it), OEDEMA PERIPHERAL (It looked like it had fluid in it and it kept getting bigger) and ARTHRALGIA (It was red. It hurt, but it didn't have inflammation in it / down to where his elbow is and all the way around it). In August 2021, the patient experienced PERIPHERAL COLDNESS (it felt cold to the touch, not hot) and SKIN DISCOLOURATION (it turned brown after a few days). The patient was treated with IBUPROFEN in August 2021 for Pain in extremity, at an unspecified dose and frequency and MENTHOL (BIOFREEZE PAIN RELIEVING) in August 2021 for Pain in extremity, at an unspecified dose and frequency. At the time of the report, PERIPHERAL COLDNESS (it felt cold to the touch, not hot), JOINT SWELLING (on the same arm of his shot, his elbow swelled up and started in the middle of the night), ERYTHEMA (It was red. It hurt, but it didn't have inflammation in it / down to where his elbow is and all the way around it), SKIN DISCOLOURATION (it turned brown after a few days), OEDEMA PERIPHERAL (It looked like it had fluid in it and it kept getting bigger) and ARTHRALGIA (It was red. It hurt, but it didn't have inflammation in it / down to where his elbow is and all the way around it) was resolving and PAIN IN EXTREMITY (it's making his entire arm hurt. It happened exactly 7 days after the shot.) had not resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication details were provided.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am