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**
PLEASE CHECK BACK SOON
Download the files above while you wait.







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: 1552950
Sex: M
Age: 74
State: SC

Vax Date: 02/22/2021
Onset Date: 02/23/2021
Rec V Date: 08/13/2021
Hospital:

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

Lab Data: Test Date: 20210223; Test Name: Body temperature; Result Unstructured Data: recorded 98.5

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: Body Aches; Feverish (Normal 97.0, recorded 98.5); This spontaneous case was reported by a consumer and describes the occurrence of PAIN (Body Aches) and PYREXIA (Feverish (Normal 97.0, recorded 98.5)) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 31H20A) for COVID-19 vaccination. MEDICAL HISTORY (Parent): Unknown. MEDICAL HISTORY (Patient): Concurrent medical conditions included Diabetes. On 22-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced PAIN (Body Aches) and PYREXIA (Feverish (Normal 97.0, recorded 98.5)). At the time of the report, PAIN (Body Aches) and PYREXIA (Feverish (Normal 97.0, recorded 98.5)) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Feb-2021, Body temperature: 97 (normal) recorded 98.5. Patient took Advil as treatment medication for unknown use. No concomitant products were reported. For mRNA-1273 (COVID 19 Vaccine Moderna ) (Intramuscular), the reporter did not provide any causality assessments. Most recent FOLLOW-UP information incorporated above includes: On 08-Jul-2021: significant FU attached which contain AE outcome

Other Meds:

Current Illness: Diabetes

ID: 1552951
Sex: F
Age:
State: IN

Vax Date: 02/10/2021
Onset Date:
Rec V Date: 08/13/2021
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: sore arms; sweat; body aches; eyes are hurting and blurring; eyes are hurting and blurring; fever; headache; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arms), HYPERHIDROSIS (sweat), PAIN (body aches), EYE PAIN (eyes are hurting and blurring) and VISION BLURRED (eyes are hurting and blurring) in a 71-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. The patient's past medical history included COVID-19 in October 2020 and Pneumonia in October 2020. Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000), ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) and ZINC for an unknown indication. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arms), HYPERHIDROSIS (sweat), PAIN (body aches), EYE PAIN (eyes are hurting and blurring), VISION BLURRED (eyes are hurting and blurring), PYREXIA (fever) and HEADACHE (headache). The patient was treated with ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (sore arms), HYPERHIDROSIS (sweat), PAIN (body aches), EYE PAIN (eyes are hurting and blurring), VISION BLURRED (eyes are hurting and blurring), PYREXIA (fever) and HEADACHE (headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Added treatment medication from initial source. FU amended.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Headache and fever are consistent with the known safety profile of mRNA-1273.

Other Meds: VITAMIN D 2000; VITAMIN C & ROSEHIP; ZINC

Current Illness:

ID: 1552952
Sex: F
Age: 36
State: TX

Vax Date: 01/28/2021
Onset Date: 01/28/2021
Rec V Date: 08/13/2021
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: vaccine exposure during pregnancy; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) in a 36-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 004M20A) for COVID-19 vaccination. No Medical History information was reported. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. Last menstrual period and estimated date of delivery were not provided. On 28-Jan-2021, the patient experienced EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy). The delivery occurred on an unknown date. At the time of the report, EXPOSURE DURING PREGNANCY (vaccine exposure during pregnancy) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications were reported. No treatment information provided by reporter. This is a case of product exposure during pregnancy with no associated AEs for this 35-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy (or "patient declined further contact). Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 24-Jun-2021: Internal review on 24-JUN-2021 resulted in updates to pregnancy details.; Sender's Comments: This is a case of product exposure during pregnancy with no associated AEs for this 35-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy (or "patient declined further contact).

Other Meds:

Current Illness:

ID: 1552953
Sex: F
Age: 81
State: CA

Vax Date: 02/05/2021
Onset Date:
Rec V Date: 08/13/2021
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: Weakness; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of ASTHENIA (Weakness) and DIZZINESS (Dizziness) in an 81-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for an unknown indication. The patient's past medical history included No adverse event. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced ASTHENIA (Weakness) and DIZZINESS (Dizziness). For mRNA-1273 (Moderna COVID-19 Vaccine), the reporter did not provide any causality assessments.

Other Meds:

Current Illness:

ID: 1552954
Sex: F
Age:
State: OH

Vax Date: 02/13/2021
Onset Date: 02/13/2021
Rec V Date: 08/13/2021
Hospital:

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

Lab Data: Test Name: Biopsy; Test Result: Inconclusive ; Result Unstructured Data: It was a drug reaction and rare esoinophils.

Allergies:

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

Symptoms: Welty rash on her left and right thigh/welty rash on her belly button; dizziness; itching welty rash; Headache; Soreness in arm; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of URTICARIA (Welty rash on her left and right thigh/welty rash on her belly button), DIZZINESS (dizziness), PAIN IN EXTREMITY (Soreness in arm), RASH PRURITIC (itching welty rash) and HEADACHE (Headache) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. No Medical History information was reported. On 13-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 13-Feb-2021, the patient experienced PAIN IN EXTREMITY (Soreness in arm) and HEADACHE (Headache). On 15-Feb-2021, the patient experienced URTICARIA (Welty rash on her left and right thigh/welty rash on her belly button), DIZZINESS (dizziness) and RASH PRURITIC (itching welty rash). At the time of the report, URTICARIA (Welty rash on her left and right thigh/welty rash on her belly button), DIZZINESS (dizziness), PAIN IN EXTREMITY (Soreness in arm), RASH PRURITIC (itching welty rash) and HEADACHE (Headache) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Biopsy: rare (Inconclusive) It was a drug reaction and rare esoinophils.. Patient went to dermatologist and had a biopsy , the result was that it was a drug reaction and there was a rare eosinophil. No concomitant medications were provided. No treatment medications were provided. This case was linked to MOD21-041652 (E2B Linked Report). This case was linked to MOD-2021-017202 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 01-Mar-2021: Follow up was received on 01 March 2021. Primary dosage regimen was changed from first to second dose and action taken changed from unknown to not applicable.; Sender's Comments: MOD21-041652:CROSS-LINKED

Other Meds:

Current Illness:

ID: 1552955
Sex: F
Age: 57
State:

Vax Date: 02/06/2021
Onset Date: 02/06/2021
Rec V Date: 08/13/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Redness is covering a big zone of almost the half of her upper arm; Arm of the vaccine red; Arm of the vaccine hurting; Arm of the vaccine swollen; Had fever in the arm of the vaccine; Feeling dizzy; Headaches; A spontaneous report was received from a consumer concerning a 57-years-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced erythema (erythema redness in the arm, redness is covering a big zone of almost the half of her upper arm), vaccination site erythema ( arm of the vaccine red), vaccination site pain ( arm of the vaccine hurting), vaccination site swelling (arm of the vaccine swollen), vaccination site warmth (had fever in the arm of the vaccine), dizziness ( feeling dizzy) and headache. The patient's medical history was not provided. Concomitant medications reported were Vitamins for unknown indication. On 6 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 007MZ04) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 20 Feb 2021, the patient stated experiencing arm of the vaccine red, arm of the vaccine swollen, had fever in the arm of the vaccine, arm of the vaccine hurting. On 6 Feb 2021, the patient experienced redness in the arm, redness is covering a big zone of almost the half of her upper arm, feeling dizzy, headaches. Treatment details included Tylenol. Action taken with mRNA-1273 in response to the events was not reported. On 8 Feb 2021 the outcome of event, redness in the arm was resolved. The outcome of other events was unknown.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Headache, vaccination site erythema, vaccination site swelling and vaccination site pain is consistent with the known safety profile of mRNA-1273..

Other Meds: VITAMINS A & D

Current Illness:

ID: 1552956
Sex: F
Age: 72
State: IL

Vax Date: 02/19/2021
Onset Date: 02/21/2021
Rec V Date: 08/13/2021
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: Pain in her arm; Swollen Lymphnodes underneath her armpit; A spontaneous report was received from a consumer, concerning a 72-year-old female patient, who received Moderna's COVID-19 vaccine and experienced pain in her arm, swollen lymph nodes underneath her armpit. The patient's medical history was not provided. No relevant concomitant medications were reported. On 19 FEB 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (lot/batch: Unknown) via unknown route on the left arm for prophylaxis of COVID-19 infection. On 21 FEB 2021, the patient experienced pain in her arm, swollen lymph nodes underneath her armpit. Treatment details was not reported. Action taken with mRNA-1273 in response to the events was not reported. At the time of the report, the outcome of event was unknown.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Axillary lymphadenopathy is consistent with the known safety profile of mRNA-1273.

Other Meds:

Current Illness:

ID: 1552957
Sex: F
Age: 85
State: FL

Vax Date: 01/16/2021
Onset Date: 01/16/2021
Rec V Date: 08/13/2021
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: red mark at the injection site that's about 6 inches long; felt like somebody grabbed me in the chest; I started pouring sweat; I could hardly catch my breath; Arm was sore at the injection site; A spontaneous report was received from a Consumer concerning a 87 Years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events- chest discomfort, hyperhidrosis, dyspnea, vaccination site pain and vaccination site erythema. The patient's medical history was not provided. No relevant concomitant medications were reported. On 16/Jan/2021, prior to the onset of the events, the patient received their first of two planned doses of mRNA-1273 (lot/batch: 011J20A) intramuscularly in the left arm for prophylaxis of COVID-19 infection. On 16 Jan 2021, the patient experienced that her arm was sore at the injection site that night. She also reported that on Tuesday night (02Feb2021), she bent over to pick something up and had a cardiac episode. She describes it as if "somebody grabbed me in the chest and I started pouring sweat, and I could hardly catch my breath." She reported 2 such episodes that same evening (02Feb2021). She also reported that she currently has a red mark at the injection site that's about 6 inches long (4 Feb 2021) Laboratory details were not provided. No treatment information was provided. The patient did not go to the hospital, but did inform her doctor and set an appointment. Action taken with mRNA-1273 in response to the events was not reported. At the time of this report, the outcome of the events- chest discomfort, hyperhidrosis, dyspnoea, vaccination site pain and vaccination site erythema was considered unknown.; Reporter's Comments: This case concerns a 87 Years-old, female patient who experienced events of chest discomfort, hyperhidrosis, dyspnea, vaccination site pain and vaccination site erythema. Based on the current available information and temporal association between the use of the product and the start date of the event, a causal relationship cannot be excluded. Further information has been requested.

Other Meds:

Current Illness:

ID: 1552958
Sex: F
Age:
State: PA

Vax Date: 02/04/2021
Onset Date:
Rec V Date: 08/13/2021
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: couldn't swallow very well at all - had to bend down to be able to swallow; lymph nodes were swollen; rash; swelling of the arm; A spontaneous report was received from a healthcare professional concerning a 72-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced dysphagia (couldn't swallow very well at all - had to bend down to be able to swallow), lymphadenopathy ( lymph nodes were swollen), rash and swelling (swelling of the arm) The patient's medical history was not provided. No relevant concomitant medications were reported. On 4 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 013L20A) via unknown route for prophylaxis of COVID-19 infection. On an unknown date, the patient stated experiencing swelling of the arm, rash, lymph nodes were swollen, she also stated that she couldn't swallow very well at all - had to bend down to be able to swallow. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events was unknown.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Rash is consistent with the known safety profile of mRNA-1273.

Other Meds:

Current Illness:

ID: 1552959
Sex: F
Age: 79
State:

Vax Date: 01/27/2021
Onset Date:
Rec V Date: 08/13/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: injection site red and spread; A spontaneous report was received from a concerning a 79-years-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced vaccination site erythema (injection site red and spread). The patient's medical history was not provided. Concomitant medications reported were High blood pressure, high cholesterol, thyroid C3 for unknown indication. 27 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 004M20A) via unknown route for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced injection site red and spread. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of event was unknown.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Injection site erythema is consistent with the known safety profile of mRNA-1273.

Other Meds: THYROID COMPLEX

Current Illness:

ID: 1552960
Sex: F
Age: 31
State: MN

Vax Date: 02/09/2021
Onset Date: 02/09/2021
Rec V Date: 08/13/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Pregnant (20 weeks gestation); Redness on injection site; This spontaneous prospective pregnancy case was reported by a consumer and describes the occurrence of EXPOSURE DURING PREGNANCY (Pregnant (20 weeks gestation)) and VACCINATION SITE ERYTHEMA (Redness on injection site) in a 31-year-old female patient (gravida 1) who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. The patient's past medical history included Alcohol use (one week prior use.) on 10-Aug-2020. Concurrent medical conditions included High cholesterol (The same) since 2018, Drug allergy (claritin for allergy) and Bone disorder (vitamin D for bones). Concomitant products included CLARITHROMYCIN from an unknown date to 08-Nov-2020 for Allergy, VITAMIN D [VITAMIN D NOS] from 08-Dec-2020 to an unknown date for Bone disorder, MINERALS NOS, VITAMINS NOS (PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]) and FISH OIL for an unknown indication. On 09-Feb-2021 at 4:00 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. The patient's last menstrual period was on 07-Oct-2020 and the estimated date of delivery was 14-Jul-2021. On 09-Feb-2021, the patient experienced EXPOSURE DURING PREGNANCY (Pregnant (20 weeks gestation)) and VACCINATION SITE ERYTHEMA (Redness on injection site). The patient received mRNA-1273 (Moderna COVID-19 Vaccine) beginning around the seventeenth week of the pregnancy. On 09-Feb-2021, EXPOSURE DURING PREGNANCY (Pregnant (20 weeks gestation)) had resolved. On 12-Feb-2021, VACCINATION SITE ERYTHEMA (Redness on injection site) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Pregnancy test was positive on 10-Nov-2020.; Reporter's Comments: This is a case of product exposure during pregnancy with vaccination site erythema for this 31-year-old female. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.

Other Meds: CLARITHROMYCIN; VITAMIN D [VITAMIN D NOS]; PRENATAL VITAMINS [MINERALS NOS;VITAMINS NOS]; FISH OIL

Current Illness: Bone disorder (vitamin D for bones); Drug allergy (claritin for allergy); High cholesterol (The same)

ID: 1552961
Sex: F
Age: 65
State: CA

Vax Date: 02/13/2021
Onset Date: 02/19/2021
Rec V Date: 08/13/2021
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: itching; swollen; very red; 5 inches long; 3 inches wide; A spontaneous report was received from a consumer concerning a 65-years-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events, itching , swollen, very red , 5 inches long, 3 inches wide. The patient's medical history was not provided. Concomitant medications was not reported. On 13 Feb 2021, prior to the onset of the events the patient received their first of two planned doses of mRNA-1273 (lot/batch:011M20A ) intramuscularly for prophylaxis of COVID-19 infection. On 19 Feb 2021, the patient experienced the events, itching, swollen, very red, 5 inches long, 3 inches wide. Treatment details was not included. Action taken with mRNA-1273 in response to the events was unknown. Outcomes of the events was unknown.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Injection site erythema, injection site swelling and injection site itching are consistent with the known safety profile of mRNA-1273.

Other Meds:

Current Illness:

ID: 1552962
Sex: M
Age: 87
State: CA

Vax Date: 02/22/2021
Onset Date: 02/23/2021
Rec V Date: 08/13/2021
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: nausea; body and muscle aches; This spontaneous case was reported by a consumer and describes the occurrence of NAUSEA (nausea) and MYALGIA (body and muscle aches) in an 87-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 Ulcer stomach (By taking ibuprofen). Concomitant products included LOSARTAN, SIMVASTATIN, FISH OIL and COLECALCIFEROL (D3) for an unknown indication. On 22-Feb-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 23-Feb-2021, the patient experienced NAUSEA (nausea) and MYALGIA (body and muscle aches). At the time of the report, NAUSEA (nausea) and MYALGIA (body and muscle aches) outcome was unknown.; 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: LOSARTAN; SIMVASTATIN; FISH OIL; D3

Current Illness:

ID: 1552963
Sex: F
Age: 50
State: IL

Vax Date: 02/04/2021
Onset Date: 02/05/2021
Rec V Date: 08/13/2021
Hospital:

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

Lab Data: Test Date: 20210205; Test Name: Body temperature; Result Unstructured Data: Patient had fever of 100.5 F

Allergies:

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

Symptoms: stabbing pain; Fever; Chills; Headache; muscle aches , back in knots; This spontaneous case was reported by an other health care professional (subsequently medically confirmed) and describes the occurrence of PAIN (stabbing pain), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and MYALGIA (muscle aches , back in knots) in a 50-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History was provided by the reporter. On 04-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PAIN (stabbing pain), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and MYALGIA (muscle aches , back in knots). At the time of the report, PAIN (stabbing pain), PYREXIA (Fever), CHILLS (Chills), HEADACHE (Headache) and MYALGIA (muscle aches , back in knots) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant product use was not provided by the reporter. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1552964
Sex: F
Age: 75
State: NY

Vax Date: 02/10/2021
Onset Date: 02/18/2021
Rec V Date: 08/13/2021
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: Redness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (Redness) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 016M20A) for COVID-19 vaccination. No Medical History information was reported. On 10-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 18-Feb-2021, the patient experienced VACCINATION SITE ERYTHEMA (Redness). At the time of the report, VACCINATION SITE ERYTHEMA (Redness) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Injection site erythema is consistent with the known safety profile of mRNA-1273.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Injection site erythema is consistent with the known safety profile of mRNA-1273.

Other Meds:

Current Illness:

ID: 1552965
Sex: M
Age: 66
State: FL

Vax Date: 01/21/2021
Onset Date: 01/21/2021
Rec V Date: 08/13/2021
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: had a body ache different than the usual he gets from his arthritis, he had pain in his knee joint; He also had a headache, that was sharp and it came and subsided, came and subsided; sore arm; had a body ache different than the usual he gets from his arthritis, he had pain in his knee joint; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (had a body ache different than the usual he gets from his arthritis, he had pain in his knee joint), HEADACHE (He also had a headache, that was sharp and it came and subsided, came and subsided), PAIN IN EXTREMITY (sore arm) and ARTHRALGIA (had a body ache different than the usual he gets from his arthritis, he had pain in his knee joint) in a 66-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012L20A) for COVID-19 vaccination. Concurrent medical conditions included Arthritis. Concomitant products included ASPIRIN [ACETYLSALICYLIC ACID], LOSARTAN POTASSIUM (LOSARTAN POTASIUM FFP), METOPROLOL and APIXABAN (ELIQUIS) for an unknown indication. On 21-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Jan-2021, the patient experienced MYALGIA (had a body ache different than the usual he gets from his arthritis, he had pain in his knee joint), HEADACHE (He also had a headache, that was sharp and it came and subsided, came and subsided), PAIN IN EXTREMITY (sore arm) and ARTHRALGIA (had a body ache different than the usual he gets from his arthritis, he had pain in his knee joint). On 21-Jan-2021, MYALGIA (had a body ache different than the usual he gets from his arthritis, he had pain in his knee joint) had resolved. On 22-Jan-2021, HEADACHE (He also had a headache, that was sharp and it came and subsided, came and subsided) and PAIN IN EXTREMITY (sore arm) had resolved. At the time of the report, ARTHRALGIA (had a body ache different than the usual he gets from his arthritis, he had pain in his knee joint) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medications:two medications for anxiety, hydrocholon and albuterol sulphate inhaler. reatment medication were not provided. Reporter did not allow further contact Most recent FOLLOW-UP information incorporated above includes: On 21-Apr-2021: Patient reported about Dose-1 event outcome. Patient said he recovered from the events and there were no events after second dose

Other Meds: ASPIRIN [ACETYLSALICYLIC ACID]; LOSARTAN POTASIUM FFP; METOPROLOL; ELIQUIS

Current Illness: Arthritis

ID: 1552966
Sex: F
Age:
State: FL

Vax Date: 01/22/2021
Onset Date:
Rec V Date: 08/13/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Chills; fatigue, could hardly stand; Sore tongue; headache; lips swollen due to the soreness; muscles spasms; Sore mouth; low fever 100.1 F; A spontaneous report was received from a type concerning a 75-years-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills, fatigue, glossodynia (sore tongue), headache, lip swelling (lips swollen due to the soreness), muscle spasms, oral pain (sore mouth) and pyrexia (low fever 100.1 F). The patient's medical history was not provided. Concomitant medications reported were alpha lipoic acid, atorvastatin 40mg, calcium, flowfe iron supplements, letrozole 2,5mg, losartan 30mg, melatonin, omeprazole 40mg, sertraline 150mg, vitamin A, vitamin B, vitamin C, vitamin D3, zinc for unknown indication. On 22 Jan 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 013L20A) via unknown route for prophylaxis of COVID-19 infection. On 19 Feb 2021, prior to the onset of the events the patient received their second of two planned doses of mRNA-1273 (lot/batch: 023M20A) via unknown route for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced headache, muscles spasms, low fever 100.1 F, fatigue, could hardly stand, chills, sore mouth, sore tongue and lips swollen due to the soreness. Treatment details included : Tylenol every 5 hours since 4 in the morning on the 20 Feb 2021. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events was unknown.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Chills, fatigue and fever are consistent with the known safety profile of mRNA-1273

Other Meds: ALPHA LIPOIC ACID; ATORVASTATIN; CALCIUM; LETROZOLE; LOSARTAN; MELATONIN; OMEPRAZOLE; SERTRALINE; VITAMIN A & BETA CAROTENE; VITAMIN B 1-6-12; VITAMIN C & ROSEHIP; VITAMIN D 2000; ZINC

Current Illness:

ID: 1552967
Sex: F
Age: 80
State: PA

Vax Date: 02/12/2021
Onset Date: 02/12/2021
Rec V Date: 08/13/2021
Hospital:

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

Lab Data: Test Date: 20210212; Test Name: blood pressure increased; Result Unstructured Data: 180/135 mmHg

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: red marks all over face and hands; felt hot; couldn't sleep; allergy reactions; lost depth perception; psychedelic pattern in vision; insignificant arm pain; Blood pressure increased; Rash on forehead; hives; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (red marks all over face and hands), FEELING HOT (felt hot), INSOMNIA (couldn't sleep), HYPERSENSITIVITY (allergy reactions) and ALTERED VISUAL DEPTH PERCEPTION (lost depth perception) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included METHENAMINE HIPPURATE (HIPREX [METHENAMINE HIPPURATE]) for Bladder infection, NORTRIPTYLINE for Facial pain, ATORVASTATIN, MULTIVITAMIN [VITAMINS NOS] and DENOSUMAB (PROLIA) for an unknown indication. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced BLOOD PRESSURE INCREASED (Blood pressure increased), RASH (Rash on forehead) and URTICARIA (hives). On an unknown date, the patient experienced ERYTHEMA (red marks all over face and hands), FEELING HOT (felt hot), INSOMNIA (couldn't sleep), HYPERSENSITIVITY (allergy reactions), ALTERED VISUAL DEPTH PERCEPTION (lost depth perception), VISUAL IMPAIRMENT (psychedelic pattern in vision) and MYALGIA (insignificant arm pain). On 15-Feb-2021, URTICARIA (hives) had resolved. At the time of the report, ERYTHEMA (red marks all over face and hands), FEELING HOT (felt hot), INSOMNIA (couldn't sleep), HYPERSENSITIVITY (allergy reactions), ALTERED VISUAL DEPTH PERCEPTION (lost depth perception), VISUAL IMPAIRMENT (psychedelic pattern in vision), BLOOD PRESSURE INCREASED (Blood pressure increased), RASH (Rash on forehead) and MYALGIA (insignificant arm pain) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Blood pressure increased: 180/135 (High) 180/135 mmHg. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Treatment medication used was Benadryl Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: No specific follow-up information recorded. On 28-Apr-2021: NNI, additional info 2 On 28-Apr-2021: Additional info 3 On 29-Apr-2021: No specific follow-up information recorded.

Other Meds: ATORVASTATIN; NORTRIPTYLINE; HIPREX [METHENAMINE HIPPURATE]; MULTIVITAMIN [VITAMINS NOS]; PROLIA

Current Illness:

ID: 1552968
Sex: M
Age: 82
State: CA

Vax Date: 01/24/2021
Onset Date: 01/24/2021
Rec V Date: 08/13/2021
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: fatigue many days; sleep disturbance; light vomit; This case was received via an unknown source (no reference has been entered for a Regulatory Authority) on 23-Feb-2021 and was forwarded to Moderna on 23-Feb-2021. This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (light vomit), FATIGUE (fatigue many days) and SLEEP DISORDER (sleep disturbance) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004M20A and 013M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 24-Jan-2021, the patient experienced VOMITING (light vomit). On an unknown date, the patient experienced FATIGUE (fatigue many days) and SLEEP DISORDER (sleep disturbance). At the time of the report, VOMITING (light vomit), FATIGUE (fatigue many days) and SLEEP DISORDER (sleep disturbance) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1552969
Sex: M
Age: 34
State: TX

Vax Date: 01/23/2021
Onset Date: 01/23/2021
Rec V Date: 08/13/2021
Hospital:

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

Lab Data: Test Name: Body temperature; Result Unstructured Data: 103.2F

Allergies:

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

Symptoms: Body aches; very sick; sweating; loss of appetite; vomiting; headache; high fever at 103.2F; light chills/ Severe Chill; soreness but nothing much; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness but nothing much), ILLNESS (very sick), HYPERHIDROSIS (sweating), DECREASED APPETITE (loss of appetite) and VOMITING (vomiting) in a 34-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Jan-2021, the patient experienced PAIN (soreness but nothing much) and CHILLS (light chills/ Severe Chill). On 28-Jan-2021, the patient experienced ILLNESS (very sick), HYPERHIDROSIS (sweating), DECREASED APPETITE (loss of appetite), VOMITING (vomiting), HEADACHE (headache) and PYREXIA (high fever at 103.2F). On an unknown date, the patient experienced MYALGIA (Body aches). The patient was treated with IBUPROFEN for Pain, at an unspecified dose and frequency. At the time of the report, PAIN (soreness but nothing much), ILLNESS (very sick), HYPERHIDROSIS (sweating), DECREASED APPETITE (loss of appetite), VOMITING (vomiting), HEADACHE (headache), PYREXIA (high fever at 103.2F) and CHILLS (light chills/ Severe Chill) had not resolved and MYALGIA (Body aches) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 103.2 (High) 103.2F. No concomitant drug reported. Action taken with mRNA-1273 in response to the events were Not Applicable. Most recent FOLLOW-UP information incorporated above includes: On 02-Mar-2021: Follow up received on 02-mar-2021 contains second dose information, new event updated. On 29-Apr-2021: Follow up received on 29-apr-2021 contains no new information.

Other Meds:

Current Illness:

ID: 1552970
Sex: F
Age:
State: OR

Vax Date:
Onset Date: 02/21/2021
Rec V Date: 08/13/2021
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: swelling in her eye; swelling in her face/ swelling in her cheek; chills; injection site pain - left arm; A spontaneous report was received from a healthcare professional concerning a patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced chills, vaccination site pain ( injection site pain - left arm), eye swelling (swelling in her eye) and swelling face (swelling in her cheek). The patient's medical history was not provided. No relevant concomitant medications were reported. On unknown date, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 032L20A) via unknown route in the left arm for prophylaxis of COVID-19 infection. On 21 Feb 2021, the patient experienced chills and injection site pain. On 22 Feb 2021, the patient experienced swelling in her face, swelling in her eye and swelling in her cheek. she also stated that on 23 Feb 2021, the swelling of the face had worsened. No treatment information was provided. Action taken with mRNA-1273 in response to the events was not reported. The outcome of events was unknown.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Chills and Injection site pain are consistent with the known safety profile of mRNA-1273.

Other Meds:

Current Illness:

ID: 1552971
Sex: F
Age: 62
State: NJ

Vax Date: 02/08/2021
Onset Date: 02/20/2021
Rec V Date: 08/13/2021
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: area of injection is also itchy but is not as bad as her back; experiencing terrible itching on her right shoulder and shoulder blade area/ no pain, only itchiness; rash on her right shoulder blade area of her back.; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PRURITUS (area of injection is also itchy but is not as bad as her back), PRURITUS (experiencing terrible itching on her right shoulder and shoulder blade area/ no pain, only itchiness) and RASH (rash on her right shoulder blade area of her back.) in a 62-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 08-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 20-Feb-2021, the patient experienced INJECTION SITE PRURITUS (area of injection is also itchy but is not as bad as her back), PRURITUS (experiencing terrible itching on her right shoulder and shoulder blade area/ no pain, only itchiness) and RASH (rash on her right shoulder blade area of her back.). At the time of the report, INJECTION SITE PRURITUS (area of injection is also itchy but is not as bad as her back), PRURITUS (experiencing terrible itching on her right shoulder and shoulder blade area/ no pain, only itchiness) and RASH (rash on her right shoulder blade area of her back.) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported. Treatment included Tigerbalm and Benadryl; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Rash and injection site pruritus are consistent with the known safety profile of mRNA-1273

Other Meds:

Current Illness:

ID: 1552972
Sex: F
Age:
State: CA

Vax Date: 02/16/2021
Onset Date: 02/16/2021
Rec V Date: 08/13/2021
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: ight-headed; listless; tired; headache; injection site soreness; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (tired), HEADACHE (headache), INJECTION SITE PAIN (injection site soreness), DIZZINESS (ight-headed) and LISTLESS (listless) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 immunization. The patient's past medical history included Pneumonia. Concomitant products included LISINOPRIL for an unknown indication. On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 16-Feb-2021, the patient experienced FATIGUE (tired), HEADACHE (headache), INJECTION SITE PAIN (injection site soreness) and LISTLESS (listless). On 23-Feb-2021, the patient experienced DIZZINESS (ight-headed). On 19-Feb-2021, INJECTION SITE PAIN (injection site soreness) had resolved. On 20-Feb-2021, FATIGUE (tired), HEADACHE (headache) and LISTLESS (listless) had resolved. At the time of the report, DIZZINESS (ight-headed) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications reported. Treatment included Tylenol; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Headache, injection site pain and fatigue are consistent with the known safety profile of mRNA-1273

Other Meds: LISINOPRIL

Current Illness:

ID: 1552973
Sex: M
Age:
State: KY

Vax Date: 01/27/2021
Onset Date: 01/27/2021
Rec V Date: 08/13/2021
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: Ache base of skull; Feeling listless, tired immediately after receiving the vaccine; Soreness of arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Soreness of arm), PAIN (Ache base of skull) and FATIGUE (Feeling listless, tired immediately after receiving the vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 27-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Jan-2021, the patient experienced PAIN IN EXTREMITY (Soreness of arm) and FATIGUE (Feeling listless, tired immediately after receiving the vaccine). On an unknown date, the patient experienced PAIN (Ache base of skull). At the time of the report, PAIN IN EXTREMITY (Soreness of arm), PAIN (Ache base of skull) and FATIGUE (Feeling listless, tired immediately after receiving the vaccine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Headache and fatigue are consistent with the known safety profile of mRNA-1273; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Headache and fatigue are consistent with the known safety profile of mRNA-1273

Other Meds:

Current Illness:

ID: 1552974
Sex: F
Age:
State: NV

Vax Date:
Onset Date:
Rec V Date: 08/13/2021
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: Arm was swelled up, it hurt and itch, and then the skin peeled off, and now it is slowly getting better; Arm was swelled up, it hurt and itch, and then the skin peeled off, and now it is slowly getting better; Arm was swelled up, it hurt and itch, and then the skin peeled off, and now it is slowly getting better; Arm was swelled up, it hurt and itch, and then the skin peeled off, and now it is slowly getting better; This spontaneous case was reported by a consumer and describes the occurrence of SKIN EXFOLIATION (Arm was swelled up, it hurt and itch, and then the skin peeled off, and now it is slowly getting better), PAIN IN EXTREMITY (Arm was swelled up, it hurt and itch, and then the skin peeled off, and now it is slowly getting better), INJECTION SITE PRURITUS (Arm was swelled up, it hurt and itch, and then the skin peeled off, and now it is slowly getting better) and INJECTION SITE SWELLING (Arm was swelled up, it hurt and itch, and then the skin peeled off, and now it is slowly getting better) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event. 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 SKIN EXFOLIATION (Arm was swelled up, it hurt and itch, and then the skin peeled off, and now it is slowly getting better), PAIN IN EXTREMITY (Arm was swelled up, it hurt and itch, and then the skin peeled off, and now it is slowly getting better), INJECTION SITE PRURITUS (Arm was swelled up, it hurt and itch, and then the skin peeled off, and now it is slowly getting better) and INJECTION SITE SWELLING (Arm was swelled up, it hurt and itch, and then the skin peeled off, and now it is slowly getting better). At the time of the report, SKIN EXFOLIATION (Arm was swelled up, it hurt and itch, and then the skin peeled off, and now it is slowly getting better), PAIN IN EXTREMITY (Arm was swelled up, it hurt and itch, and then the skin peeled off, and now it is slowly getting better), INJECTION SITE PRURITUS (Arm was swelled up, it hurt and itch, and then the skin peeled off, and now it is slowly getting better) and INJECTION SITE SWELLING (Arm was swelled up, it hurt and itch, and then the skin peeled off, and now it is slowly getting better) was resolving. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. No concomitant medications reported. No treatment information provided.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Injection site swelling is consistent with the known safety profile of mRNA-1273

Other Meds:

Current Illness:

ID: 1552975
Sex: F
Age: 89
State: NJ

Vax Date: 02/13/2021
Onset Date: 02/24/2021
Rec V Date: 08/13/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Fell in the kitchen; Bruise on her arm; This spontaneous case was reported by a consumer and describes the occurrence of FALL (Fell in the kitchen) and CONTUSION (Bruise on her arm) in an 89-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 029L20a) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 13-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 24-Feb-2021, the patient experienced FALL (Fell in the kitchen) and CONTUSION (Bruise on her arm). At the time of the report, FALL (Fell in the kitchen) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported. No treatment information provided.; Sender's Comments: There is not enough information to assess the relationship between the event of fall and the administration of mRNA-1273. Critical details such as the patient's medical history and latency from onset of the event to vaccine administration is lacking. the bruise resulted from the fall and is assessed as unlikely related to product use. All events are confounded by the patient's advanced age.

Other Meds:

Current Illness:

ID: 1552976
Sex: F
Age:
State: NC

Vax Date: 01/22/2021
Onset Date: 01/22/2021
Rec V Date: 08/13/2021
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: pain at injection; muscle swelling; hot; itching; red; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (pain at injection), INJECTION SITE SWELLING (muscle swelling), INJECTION SITE WARMTH (hot), INJECTION SITE PRURITUS (itching) and INJECTION SITE ERYTHEMA (red) 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 22-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Jan-2021, the patient experienced INJECTION SITE PAIN (pain at injection), INJECTION SITE SWELLING (muscle swelling), INJECTION SITE WARMTH (hot), INJECTION SITE PRURITUS (itching) and INJECTION SITE ERYTHEMA (red). At the time of the report, INJECTION SITE PAIN (pain at injection), INJECTION SITE SWELLING (muscle swelling), INJECTION SITE WARMTH (hot), INJECTION SITE PRURITUS (itching) and INJECTION SITE ERYTHEMA (red) was resolving. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1552977
Sex: F
Age:
State: VA

Vax Date:
Onset Date:
Rec V Date: 08/13/2021
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: Fever blister; This spontaneous case was reported by a consumer and describes the occurrence of ORAL HERPES (Fever blister) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced ORAL HERPES (Fever blister). At the time of the report, ORAL HERPES (Fever blister) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. The patient had acyclovir she usually took for the blisters but had not taken any yet. The patient had gotten fever blisters since the patient was a child and this was not out of the ordinary. No concomitant medications were reported. Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: Updated second dose had taken and event history. On 12-Jul-2021: Follow up received and contains No New Information.

Other Meds:

Current Illness:

ID: 1552978
Sex: M
Age:
State:

Vax Date: 01/28/2021
Onset Date:
Rec V Date: 08/13/2021
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: Little sore in the face; Soreness in the gums; Tooth infection; Strange headache; This spontaneous case was reported by a consumer and describes the occurrence of FACIAL PAIN (Little sore in the face), GINGIVAL PAIN (Soreness in the gums), TOOTH INFECTION (Tooth infection) and HEADACHE (Strange headache) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042L20A) for COVID-19 vaccination. No Medical History information was reported. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced FACIAL PAIN (Little sore in the face), GINGIVAL PAIN (Soreness in the gums), TOOTH INFECTION (Tooth infection) and HEADACHE (Strange headache). At the time of the report, FACIAL PAIN (Little sore in the face), GINGIVAL PAIN (Soreness in the gums), TOOTH INFECTION (Tooth infection) and HEADACHE (Strange headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Based on the information provide, the causal association between the reported events and the administration of the mRNA-1273 vaccine is assessed as unlikely. Event is assessed as due to the underlying infection although headache is consistent with the known profile of the vaccines. Tooth infection causing pain has also been found to cause headaches.; Sender's Comments: Based on the information provide, the causal association between the reported events and the administration of the mRNA-1273 vaccine is assessed as unlikely. Event is assessed as due to the underlying infection although headache is consistent with the known profile of the vaccines. Tooth infection causing pain has also been found to cause headaches.

Other Meds:

Current Illness:

ID: 1552979
Sex: M
Age: 76
State: CA

Vax Date: 02/01/2021
Onset Date: 02/02/2021
Rec V Date: 08/13/2021
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: Severe head ache in the side of his head; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Severe head ache in the side of his head) in a 76-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 01-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced HEADACHE (Severe head ache in the side of his head). At the time of the report, HEADACHE (Severe head ache in the side of his head) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medications reported. Treatment included Acetaminophen; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded. Headache is consistent with the known safety profile of mRNA-1273.

Other Meds:

Current Illness:

ID: 1552980
Sex: F
Age:
State: MI

Vax Date: 02/20/2021
Onset Date: 02/23/2021
Rec V Date: 08/13/2021
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: swollen gland; very sore throat; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swollen gland) and OROPHARYNGEAL PAIN (very sore throat) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 20-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Feb-2021, the patient experienced LYMPHADENOPATHY (swollen gland) and OROPHARYNGEAL PAIN (very sore throat). At the time of the report, LYMPHADENOPATHY (swollen gland) and OROPHARYNGEAL PAIN (very sore throat) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications reported. No treatment information provided.; Sender's Comments: Based on the current available information which shows a temporal association between the use of mRNA-1273 and the onset of the events, a causal relationship cannot be excluded

Other Meds:

Current Illness:

ID: 1552981
Sex: F
Age: 42
State: PA

Vax Date: 01/29/2021
Onset Date:
Rec V Date: 08/13/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Enlarged spleen; Burning in her chest; Severe stomach pains; A spontaneous report was received from a consumer concerning for his wife, a 42-year-old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events burning in her chest/Chest pain, severe stomach pains/Abdominal pain upper, enlarged spleen/Splenomegaly. The patient's medical history was not provided. Concomitant product use was not provided by the reporter. On 29Jan2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 012M20A) intramuscularly in the right deltoid for prophylaxis of COVID-19 infection. On an unknown date, the patient experienced the events burning in her chest, severe stomach pains after her first shot, Physician said she has an enlarged spleen. Treatment information was not provided. The event severe stomach pains was considered as medically significant by reporter. Action taken with mRNA-1273 in response to the events was Unknown. The outcome of events, burning in her chest, severe stomach pains, enlarged spleen was unknown, at the time of this report.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1552982
Sex: F
Age:
State: MI

Vax Date:
Onset Date: 02/05/2021
Rec V Date: 08/13/2021
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: Hot; itch; hive; Swollen; red; soreness; Sore arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN (soreness), VACCINATION SITE WARMTH (Hot), VACCINATION SITE PRURITUS (itch), VACCINATION SITE URTICARIA (hive) and VACCINATION SITE SWELLING (Swollen) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (no historical condition was reported). On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PAIN (soreness) and VACCINATION SITE PAIN (Sore arm). On 21-Feb-2021, the patient experienced VACCINATION SITE WARMTH (Hot), VACCINATION SITE PRURITUS (itch), VACCINATION SITE URTICARIA (hive), VACCINATION SITE SWELLING (Swollen) and VACCINATION SITE ERYTHEMA (red). At the time of the report, PAIN (soreness), VACCINATION SITE WARMTH (Hot), VACCINATION SITE PRURITUS (itch), VACCINATION SITE URTICARIA (hive), VACCINATION SITE SWELLING (Swollen), VACCINATION SITE PAIN (Sore arm) and VACCINATION SITE ERYTHEMA (red) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.

Other Meds:

Current Illness:

ID: 1552983
Sex: F
Age: 80
State: UT

Vax Date: 02/11/2021
Onset Date:
Rec V Date: 08/13/2021
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: Left lower limb swelling; left leg pain; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of OEDEMA PERIPHERAL (Left lower limb swelling), PAIN IN EXTREMITY (left leg pain) and ARTHRALGIA (Joint pain) in an 80-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 012M20A) for COVID-19 vaccination. The patient's past medical history included Arthritis. On 11-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced OEDEMA PERIPHERAL (Left lower limb swelling), PAIN IN EXTREMITY (left leg pain) and ARTHRALGIA (Joint pain). The patient was treated with PARACETAMOL at an unspecified dose and frequency and CODEINE at an unspecified dose and frequency. At the time of the report, OEDEMA PERIPHERAL (Left lower limb swelling), PAIN IN EXTREMITY (left leg pain) and ARTHRALGIA (Joint pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. no concomitant medications reported. Most recent FOLLOW-UP information incorporated above includes: On 30-Apr-2021: F/U received on 30-APR-2021,No New Information reported.

Other Meds:

Current Illness:

ID: 1552984
Sex: F
Age:
State: MD

Vax Date: 02/22/2021
Onset Date: 02/22/2021
Rec V Date: 08/13/2021
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: Felt fatigue; Slight headache; Sore arm; could not sleep; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (Felt fatigue), HEADACHE (Slight headache), VACCINATION SITE PAIN (Sore arm) and INITIAL INSOMNIA (could not sleep) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 030M20A) for an unknown indication. The patient's past medical history included No adverse event. On 22-Feb-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 22-Feb-2021, the patient experienced FATIGUE (Felt fatigue), HEADACHE (Slight headache), VACCINATION SITE PAIN (Sore arm) and INITIAL INSOMNIA (could not sleep). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, FATIGUE (Felt fatigue), HEADACHE (Slight headache), VACCINATION SITE PAIN (Sore arm) and INITIAL INSOMNIA (could not sleep) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1552985
Sex: F
Age:
State: NJ

Vax Date: 02/23/2021
Onset Date: 02/23/2021
Rec V Date: 08/13/2021
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: Sore Arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Sore Arm) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 23-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Feb-2021, the patient experienced PAIN IN EXTREMITY (Sore Arm). At the time of the report, PAIN IN EXTREMITY (Sore Arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment details included Cold Compress. relevant concomitant products usage were not reported by the reporter Most recent FOLLOW-UP information incorporated above includes: On 28-Apr-2021: F/U received on 28-APR-2021,No New Information reported.

Other Meds:

Current Illness:

ID: 1552986
Sex: F
Age: 34
State: TX

Vax Date: 01/26/2021
Onset Date: 01/26/2021
Rec V Date: 08/13/2021
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: Fever; Chills; Ache; Pregnant; A spontaneous report was received from a consumer concerning his wife, a 35 years old, pregnant, female patient, who received Moderna's Covid-19 Vaccine (mRNA-1273) during pregnancy (vaccine exposure during pregnancy) and experienced chills (chills), fever (fever) and ache (myalgia). The patient's medical history was not provided. No allergy was reported. The patient had one prior pregnancy. The first pregnancy ended on 22 May 2016 with a live, full term birth. Concomitant product included vitamin once a day via oral route for multiple use (from 12 Jan 2020). On 26 Jan 2021, approximately 10:00 am the patient received their first of two planned doses of mRNA-1273 (Batch number: unknown) intramuscularly in the left arm for prophylaxis of COVID-19 infection. Her last period on 19 Jan 2021 and estimated conception date was 02 Feb 2021. The patient's estimated due date is on 14 Sep 2021. On 26 Jan 2021, the pregnant patient was exposed to the mRNA-1273 vaccine and experienced adverse events. Symptoms included pregnancy, chills, fever and ache. No treatment information was provided. Action taken with mRNA-1273 in response to the events were not provided. The outcome of the events, fever, chills and myalgia were resolved on 30 Jan 2021. The outcome, pregnant (vaccine exposure during pregnancy) was considered resolved on 26 Jan 2021.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events of chills, pyrexia and myalgia, a causal relationship cannot be excluded. The causality for the event of exposure during pregnancy is not applicable. Patient will continue to be contacted for further monitoring of AEs during the pregnancy.

Other Meds: VITAMINE

Current Illness:

ID: 1552987
Sex: F
Age:
State: NY

Vax Date: 01/14/2021
Onset Date: 01/15/2021
Rec V Date: 08/13/2021
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: Hot to the touch; Big large red circular spot underneath the injection site/giant red circle under the injection site,it was all red,filled in.; just a little ache; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE WARMTH (Hot to the touch), VACCINATION SITE PAIN (just a little ache) and VACCINATION SITE ERYTHEMA (Big large red circular spot underneath the injection site/giant red circle under the injection site,it was all red,filled in.) in a 47-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A-2A) for COVID-19 vaccination. The patient's past medical history included Heart murmur on 11-Jan-1993, Endometriosis on 10-Jan-2004 and Hypothyroidism on 05-Jan-2012. Concomitant products included LEVOTHYROXINE SODIUM (SYNTHROID), CETIRIZINE HYDROCHLORIDE (ZYRTEC [CETIRIZINE HYDROCHLORIDE]), ETHINYLESTRADIOL, LEVONORGESTREL (AVIANE) and LYSINE (L LYSINE [LYSINE]) for an unknown indication. On 14-Jan-2021 at 3:00 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 15-Jan-2021, the patient experienced VACCINATION SITE PAIN (just a little ache). On 23-Jan-2021 at 5:00 AM, the patient experienced VACCINATION SITE WARMTH (Hot to the touch). On 23-Jan-2021 at 5:00 AM, the patient experienced VACCINATION SITE ERYTHEMA (Big large red circular spot underneath the injection site/giant red circle under the injection site,it was all red,filled in.). On 31-Jan-2021, VACCINATION SITE WARMTH (Hot to the touch) and VACCINATION SITE ERYTHEMA (Big large red circular spot underneath the injection site/giant red circle under the injection site,it was all red,filled in.) had resolved. At the time of the report, VACCINATION SITE PAIN (just a little ache) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. This case was linked to US-MODERNATX, INC.-MOD-2021-020492 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 16-Apr-2021: Additional information received included reporter's contact information. On 19-Apr-2021: Additional information received included: Patient initials and demographic details, Other relevant history, concomitant medications. Additional event and details.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-020492:Same reporter/ Different patient (Neighbor case)

Other Meds: SYNTHROID; ZYRTEC [CETIRIZINE HYDROCHLORIDE]; AVIANE; L LYSINE [LYSINE]

Current Illness:

ID: 1552988
Sex: F
Age: 82
State: CA

Vax Date: 01/29/2021
Onset Date: 01/29/2021
Rec V Date: 08/13/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Back pain; Pelvic pain upto neck; Sick to her stomach; Chills; This spontaneous case was reported by a consumer and describes the occurrence of BACK PAIN (Back pain), PELVIC PAIN (Pelvic pain upto neck), ABDOMINAL DISCOMFORT (Sick to her stomach) and CHILLS (Chills) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. D30L20A) for COVID-19 vaccination. Patients medical history was not provided. Concomitant products included ROSUVASTATIN, LEVOTHYROXINE and AMLODIPINE for an unknown indication. On 29-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 29-Jan-2021, the patient experienced CHILLS (Chills). On 03-Feb-2021, the patient experienced BACK PAIN (Back pain), PELVIC PAIN (Pelvic pain upto neck) and ABDOMINAL DISCOMFORT (Sick to her stomach). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. On 30-Jan-2021, CHILLS (Chills) had resolved. On 05-Feb-2021, BACK PAIN (Back pain), PELVIC PAIN (Pelvic pain upto neck) and ABDOMINAL DISCOMFORT (Sick to her stomach) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds: ROSUVASTATIN; LEVOTHYROXINE; AMLODIPINE

Current Illness:

ID: 1552989
Sex: F
Age: 73
State: KS

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

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

Lab Data:

Allergies:

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

Symptoms: could not move her arm at all as it felt like a huge heavy weight on her; Pain and aching in her arm/ deep, aching, throbbing, stabbing pain in her arm; small black and blue bruise the size of nickel at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of LIMB DISCOMFORT (could not move her arm at all as it felt like a huge heavy weight on her), PAIN IN EXTREMITY (Pain and aching in her arm/ deep, aching, throbbing, stabbing pain in her arm) and VACCINATION SITE BRUISING (small black and blue bruise the size of nickel at the injection site) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. No Medical History information was reported. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 28-Jan-2021, the patient experienced LIMB DISCOMFORT (could not move her arm at all as it felt like a huge heavy weight on her), PAIN IN EXTREMITY (Pain and aching in her arm/ deep, aching, throbbing, stabbing pain in her arm) and VACCINATION SITE BRUISING (small black and blue bruise the size of nickel at the injection site). The patient was treated with IBUPROFEN at a dose of 1 dosage form and ASPIRIN [ACETYLSALICYLIC ACID] at an unspecified dose and frequency. At the time of the report, LIMB DISCOMFORT (could not move her arm at all as it felt like a huge heavy weight on her), PAIN IN EXTREMITY (Pain and aching in her arm/ deep, aching, throbbing, stabbing pain in her arm) and VACCINATION SITE BRUISING (small black and blue bruise the size of nickel at the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication were provided. This case was linked to MOD-2021-250952 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 07-Jul-2021: Significant FU was received on 07-jul-2021: Dose 2 details updated

Other Meds:

Current Illness:

ID: 1552990
Sex: F
Age: 44
State: TX

Vax Date: 01/25/2021
Onset Date:
Rec V Date: 08/13/2021
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: Losing her voice after receiving the second dose of Moderna COVID-19 vaccine; Chest pains; Diarrhea; Joint pain; This spontaneous case was reported by a consumer and describes the occurrence of APHONIA (Losing her voice after receiving the second dose of Moderna COVID-19 vaccine), CHEST PAIN (Chest pains), DIARRHOEA (Diarrhea) and ARTHRALGIA (Joint pain) in a 44-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 043L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No historical condition was reported.). On 25-Jan-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced APHONIA (Losing her voice after receiving the second dose of Moderna COVID-19 vaccine), CHEST PAIN (Chest pains), DIARRHOEA (Diarrhea) and ARTHRALGIA (Joint pain). At the time of the report, APHONIA (Losing her voice after receiving the second dose of Moderna COVID-19 vaccine), CHEST PAIN (Chest pains), DIARRHOEA (Diarrhea) and ARTHRALGIA (Joint pain) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product use was not provided by the reporter. Treatment for the event included steroids.

Other Meds:

Current Illness:

ID: 1552991
Sex: F
Age: 66
State: NC

Vax Date: 01/23/2021
Onset Date:
Rec V Date: 08/13/2021
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: got COVID after receiving first vaccination; loss of taste and smell; headache; body aches; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of COVID-19 (got COVID after receiving first vaccination), HEADACHE (headache), MYALGIA (body aches) and AGEUSIA (loss of taste and smell) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032L20A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 23-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (got COVID after receiving first vaccination), HEADACHE (headache), MYALGIA (body aches) and AGEUSIA (loss of taste and smell). At the time of the report, COVID-19 (got COVID after receiving first vaccination) outcome was unknown and HEADACHE (headache), MYALGIA (body aches) and AGEUSIA (loss of taste and smell) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1552992
Sex: M
Age: 82
State: CA

Vax Date: 01/24/2021
Onset Date:
Rec V Date: 08/13/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: fatigue; This spontaneous case was reported by a consumer and describes the occurrence of FATIGUE (fatigue) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013M20A and 004M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (No historical condition was reported.). On 24-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Feb-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 FATIGUE (fatigue). At the time of the report, FATIGUE (fatigue) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitants or treatment medications were reported. This case was linked to MOD21-036714 (Patient Link).

Other Meds:

Current Illness:

ID: 1552993
Sex: U
Age:
State: OH

Vax Date: 02/02/2021
Onset Date: 02/02/2021
Rec V Date: 08/13/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: hives; itchy scalp; burning tongue; itchy/swelling throat; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (itchy scalp), TONGUE DISCOMFORT (burning tongue), THROAT IRRITATION (itchy/swelling throat) and URTICARIA (hives) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (no medical history was reported). On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 02-Feb-2021, the patient experienced PRURITUS (itchy scalp), TONGUE DISCOMFORT (burning tongue) and THROAT IRRITATION (itchy/swelling throat). On 05-Feb-2021, the patient experienced URTICARIA (hives). At the time of the report, PRURITUS (itchy scalp), TONGUE DISCOMFORT (burning tongue), THROAT IRRITATION (itchy/swelling throat) and URTICARIA (hives) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1552994
Sex: F
Age: 68
State: PR

Vax Date: 02/10/2021
Onset Date: 02/10/2021
Rec V Date: 08/13/2021
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: blurry vision; numb hands; soreness; A spontaneous report was received from a healthcare professional concerning a 67-years-old patient who received Moderna's COVID-19 vaccine (mRNA-1273) and experienced events soreness, numb hands, blurry vision. The patient's medical history was not provided. No relevant concomitant medications were reported. On 10 Feb 2021, prior to the onset of the events the patient received first of two planned doses of mRNA-1273 (lot/batch: 011M20A) intramuscularly for prophylaxis of COVID-19 infection. On 10 Feb 2021, the patient experienced the event(s) soreness. On 20 Feb 2021, the patient experienced the event(s) numb hands, blurry vision. Treatment details included Paracetamol + concomitant. Action taken with mRNA-1273 in response to the events was not reported. On 17 Feb 2021 the outcome of event(s), soreness was resolved. The outcome of event(s), numb hands, blurry vision was unknown.

Other Meds:

Current Illness:

ID: 1552995
Sex: F
Age: 72
State: TX

Vax Date: 02/19/2021
Onset Date: 02/19/2021
Rec V Date: 08/13/2021
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: Sore on her neck; Sore on her back; Allergy; Rash; Hands went numb; Short of breath; Red; Welts; Sore on her arm; This spontaneous case was reported by a consumer and describes the occurrence of HYPOAESTHESIA (Hands went numb), DYSPNOEA (Short of breath), ERYTHEMA (Red), URTICARIA (Welts) and PAIN IN EXTREMITY (Sore on her arm) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 011M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event (no historical condition was reported). Concomitant products included VITAMIN C [ASCORBIC ACID], VITAMIN E NOS, VITAMIN D NOS, IRON, ZINC and PROBIOTICS NOS for an unknown indication. On 19-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 19-Feb-2021, the patient experienced HYPOAESTHESIA (Hands went numb), DYSPNOEA (Short of breath), ERYTHEMA (Red), URTICARIA (Welts), PAIN IN EXTREMITY (Sore on her arm), HYPERSENSITIVITY (Allergy) and RASH (Rash). On 20-Feb-2021, the patient experienced NECK PAIN (Sore on her neck ) and BACK PAIN (Sore on her back). On 19-Feb-2021, HYPOAESTHESIA (Hands went numb) and DYSPNOEA (Short of breath) had resolved. At the time of the report, ERYTHEMA (Red), URTICARIA (Welts), HYPERSENSITIVITY (Allergy) and RASH (Rash) had resolved and PAIN IN EXTREMITY (Sore on her arm), NECK PAIN (Sore on her neck ) and BACK PAIN (Sore on her back) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds: VITAMIN C [ASCORBIC ACID]; VITAMIN E NOS; VITAMIN D NOS; IRON; ZINC; PROBIOTICS NOS

Current Illness:

ID: 1552996
Sex: F
Age: 64
State: FL

Vax Date: 02/16/2021
Onset Date: 02/17/2021
Rec V Date: 08/13/2021
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: arm was a little sore; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was a little sore) in a 64-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (no medical history was reported). On 16-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced PAIN IN EXTREMITY (arm was a little sore). On 19-Feb-2021, PAIN IN EXTREMITY (arm was a little sore) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1552997
Sex: F
Age:
State: OH

Vax Date:
Onset Date:
Rec V Date: 08/13/2021
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: deep purple toes; elevated BP; her toes felt numb; cold and look like a deep purple color with blisters; This spontaneous case was reported by a consumer and describes the occurrence of BLUE TOE SYNDROME (deep purple toes), BLOOD PRESSURE INCREASED (elevated BP), HYPOAESTHESIA (her toes felt numb) and BLISTER (cold and look like a deep purple color with blisters) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included No adverse event (no medical history was reported). Concomitant products included AMLODIPINE BESILATE (NORVASC) 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 BLUE TOE SYNDROME (deep purple toes), BLOOD PRESSURE INCREASED (elevated BP), HYPOAESTHESIA (her toes felt numb) and BLISTER (cold and look like a deep purple color with blisters). At the time of the report, BLUE TOE SYNDROME (deep purple toes), BLOOD PRESSURE INCREASED (elevated BP), HYPOAESTHESIA (her toes felt numb) and BLISTER (cold and look like a deep purple color with blisters) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds: NORVASC

Current Illness:

ID: 1552998
Sex: F
Age: 39
State: FL

Vax Date: 01/01/2021
Onset Date: 01/01/2021
Rec V Date: 08/13/2021
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: Rash on the face and arm; Rash on the face and arm; swelling in the legs, feet, ankle and knees; Fever 103f; severe chills; A spontaneous report was received from a consumer (patient's mother) which concerns a 39 year old female patient who received Moderna's COVID-19 vaccine (mRNA-1273) and who experienced fever of 103f, severe chills, rash on the face and arm as well swelling in the legs, feet, ankle and knees. The patient's medical history was not provided. No concomitant product use was reported. On an unknown date ??-Jan-2021, the patient received first of two planned doses of mRNA-1273 (Lot number: unknown) for prophylaxis of COVID-19 infection. On an unknown date on ??- Jan-2021, the next day after receiving the vaccine, the patient experienced a fever 103f and severe chills. The patient also experienced a rash on the face and arm as well swelling in the legs, feet, ankle and knees. The patient's chills and fever have lasted for 4 weeks. The patient had to visit 2 internists, an endocrinologist, and a rheumatologist. The patient experienced Kawasaki disease as a child and the reporter felt the symptoms were similar. The patient was prescribed an antihistamine meloxicam to relieve her side effects. Action taken with mRNA-1273 was unknown. The outcome of all the events was unknown. No further information was provided.; Reporter's Comments: Based on the current available information and temporal association between the use of the product and the start date of these events, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1552999
Sex: F
Age: 71
State: NJ

Vax Date: 02/17/2021
Onset Date: 02/17/2021
Rec V Date: 08/13/2021
Hospital:

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

Lab Data: Test Name: fever

Allergies:

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

Symptoms: No appetite; Fever of 101 F; Tired and could not get out of bed; This spontaneous case was reported by a consumer and describes the occurrence of DECREASED APPETITE (No appetite), PYREXIA (Fever of 101 F) and FATIGUE (Tired and could not get out of bed) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 023M20A) for COVID-19 vaccination. The patient's past medical history included No adverse event (no historical condition was reported). On 17-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Feb-2021, the patient experienced DECREASED APPETITE (No appetite), PYREXIA (Fever of 101 F) and FATIGUE (Tired and could not get out of bed). On 18-Feb-2021, DECREASED APPETITE (No appetite), PYREXIA (Fever of 101 F) and FATIGUE (Tired and could not get out of bed) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 101 f. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am