VAERS 2021 Database www.vaers.hhs.gov

Main Page | All 2021 Deaths | Videos
VAERS Updated: 11/12/2021
** VAERS DATABASE Last updated: November 12, 2021**
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Manufacturers

Total Manufacturer
199,106MODERNA
36,710JANSSEN
5,381PFIZER\BIONTECH
2,555GLAXOSMITHKLINE BIOLOGICALS
1,469UNKNOWN MANUFACTURER
897MERCK & CO. INC.
627SEQIRUS, INC.
112DYNAVAX TECHNOLOGIES CORPORATION
91SANOFI PASTEUR
75NOVARTIS VACCINES AND DIAGNOSTICS
40EMERGENT BIOSOLUTIONS
14PAXVAX
12TEVA PHARMACEUTICALS
12PROTEIN SCIENCES CORPORATION
9PFIZER\WYETH
4BERNA BIOTECH, LTD.
4SMITHKLINE BEECHAM
3INTERCELL AG
1MEDIMMUNE VACCINES, INC.
1CSL LIMITED

COVID19 Lot Number

VAX LOT Total
2S9CL7,949
7,473
2,547
1,506
1,187
1,051
1,049
s0294561,043
866
IMM209861
816
UT7065MA766
657
579
U62828AA563
557
538
U6737AA516
515
S034636506
4F472471
458
P100253275449
444
276563436
429
418
4BH32414
MENVEO404
PP9L5362
UJ446AA337
319
306
290
271
49TM3270
R1B252M253
4F472179
933622147
C5763AA144
CW3116134
3Y7NL126
UNK114
113
ARBA141A105
104
103
96
300057A90
79
1F4EB73
R1B743M62
56
UJ090AA55
51
UH894AB46
45
UNK44
UNK42
42
EJ168638
Unknown36
35
34
32
32
26
el128424
24
A115A22
22
EN620222
21
UNK20
20
19
Z127A19
19
17
JEV18K95E15
12
111798PI12
10
A739088
No batch number8
3333324181078
6
6
TAR356
5
5
U6935AA5
UNK5
4
unknown4
3
2
55RB72
2
2
2
2
2
U7124AA2
JEV18A68E2
2
ABYB05BA1
1
1
1
1
AMVA436A1
1
1
TJ3521
A130A; VIS give1
1
U7140BB1
1
1
SP UP016AA1
1
1808P08802/ESV01
037K20A300,947
EL1284288,578
57,766
1,432

Incidents per State

State Total
82,750
CA62,821
FL38,209
TX36,512
NY34,921
PA23,646
IN23,622
IL20,597
MI19,590
OH19,426
NJ18,413
NC16,769
GA15,932
WA15,351
VA15,234
MA14,876
AZ14,206
MN12,940
MD12,656
CO11,908
WI11,425
MO10,240
TN9,685
OR8,768
KY8,437
CT8,300
SC6,700
OK6,293
AL5,692
LA5,025
IA4,825
KS4,821
UT4,637
NV4,374
NM3,967
AR3,807
ME3,161
NH3,096
NE2,918
MS2,859
ID2,785
WV2,469
HI2,459
PR2,417
MT2,414
RI2,076
DE1,868
AK1,830
VT1,734
DC1,715
ND1,388
SD1,269
WY866
GU118
VI69
AS47
MP29
MH8
XB6
FM4
QM3
XV2
XL1

ID: 1635254
Sex: M
Age: 56
State: CA

Vax Date: 03/26/2021
Onset Date: 04/23/2021
Rec V Date: 08/26/2021
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: 20210518; Test Name: blood pressure; Test Result: Inconclusive ; Result Unstructured Data: Patient's blood pressure at 08:30pm was 112/72 mmHg; Test Date: 20210518; Test Name: blood pressure; Test Result: Inconclusive ; Result Unstructured Data: Patient's blood pressure was 152/92 mmHg; Test Date: 2021; Test Name: blood pressure; Test Result: Inconclusive ; Result Unstructured Data: Patient's blood pressure was 144/88 mmHg; Test Date: 20210518; Test Name: body temperature; Test Result: Inconclusive ; Result Unstructured Data: Patient's body temperature was 98.4? F; Test Date: 2021; Test Name: body temperature; Test Result: Inconclusive ; Result Unstructured Data: Patient's body temperature was 98.4? F; Test Date: 20210518; Test Name: heart rate; Test Result: Inconclusive ; Result Unstructured Data: Patient's heart rate was 66 beats per minute; Test Date: 20210518; Test Name: heart rate; Test Result: Inconclusive ; Result Unstructured Data: Patient's heart rate was 106 beats per minute; Test Date: 20210518; Test Name: heart rate; Test Result: Inconclusive ; Result Unstructured Data: Patient's heart rate was 99 beats per minute; Test Date: 20210518; Test Name: heart rate; Test Result: Inconclusive ; Result Unstructured Data: Patient's heart rate was 89 beats per minute; Test Date: 20210518; Test Name: pulse; Test Result: Inconclusive ; Result Unstructured Data: 122 beats per minute; Test Date: 2021; Test Name: pulse; Test Result: Inconclusive ; Result Unstructured Data: 87 beats per minute; Test Date: 20210518; Test Name: oxygen saturation; Result Unstructured Data: Patient's O2 saturation was 98%; Test Date: 2021; Test Name: oxygen saturation; Result Unstructured Data: Patient's O2 saturation was 100%; Test Date: 20210423; Test Name: PSA test; Result Unstructured Data: Patient stated that before receiving his first dose of vaccine the PSA levels were 8.1-8.7 but after receiving his second dose it showed 17.6

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: elevated heart rate; anxiety; prostatic specific antigen increased; a little soreness on the arm; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (a little soreness on the arm), TACHYCARDIA (elevated heart rate), ANXIETY (anxiety) and PROSTATIC SPECIFIC ANTIGEN INCREASED (prostatic specific antigen increased) in a 56-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001B21A and 001A21A) for COVID-19 vaccination. The patient's past medical history included Surgery (Nose surgery). Concurrent medical conditions included Type 2 diabetes mellitus (Patient has a history of Type 2 Diabetes mellitus with hyperglycemia, with long term current use of insulin.), PSA (Elevated PSA), Benign prostatic hyperplasia (Benign prostatic hyperplasia without lower urinary tract symptoms.), Back pain (Patient has Lower back pain.), Vitamin D deficiency, Post-traumatic stress disorder, Essential hypertension, GERD (Patient has chronic Gastro esophageal reflux disease), Nasal congestion and Constipation. Concomitant products included LISINOPRIL from 25-Jan-2003 to an unknown date for Hypertension, INSULIN for Type 2 diabetes mellitus, TADALAFIL from 27-Aug-2018 to an unknown date, TAMSULOSIN from 21-Aug-2019 to an unknown date, ASPIRIN [ACETYLSALICYLIC ACID] from 21-Jan-2010 to an unknown date and ATENOLOL from 24-May-2021 to an unknown date for an unknown indication. On 26-Mar-2021 at 9:30 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Apr-2021 at 10:30 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced PAIN IN EXTREMITY (a little soreness on the arm) and PROSTATIC SPECIFIC ANTIGEN INCREASED (prostatic specific antigen increased). On an unknown date, the patient experienced TACHYCARDIA (elevated heart rate) and ANXIETY (anxiety). The patient was treated with LORAZEPAM (ATIVAN) on 24-Apr-2021 for Adverse event, at an unspecified dose and frequency; METOPROLOL TARTRATE (LOPRESSOR) on 25-Apr-2021 for Adverse event, at an unspecified dose and frequency; POTASSIUM CHLORIDE on 25-Apr-2021 for Adverse event, at an unspecified dose and frequency; NORMAL SALINE on 25-Apr-2021 for Adverse event, at an unspecified dose and frequency; ASPIRIN [ACETYLSALICYLIC ACID] on 24-Apr-2021 for Adverse event, at an unspecified dose and frequency and IBUPROFEN for Blood pressure, at an unspecified dose and frequency. At the time of the report, PAIN IN EXTREMITY (a little soreness on the arm), TACHYCARDIA (elevated heart rate), ANXIETY (anxiety) and PROSTATIC SPECIFIC ANTIGEN INCREASED (prostatic specific antigen increased) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 23-Apr-2021, Prostatic specific antigen: 17.6 (High) Patient stated that before receiving his first dose of vaccine the PSA levels were 8.1-8.7 but after receiving his second dose it showed 17.6. On 18-May-2021, Blood pressure measurement: 112/72 (Inconclusive) Patient's blood pressure at 08:30pm was 112/72 mmHg and 152/92 (Inconclusive) Patient's blood pressure was 152/92 mmHg. On 18-May-2021, Body temperature: 98.4 (Inconclusive) Patient's body temperature was 98.4? F. On 18-May-2021, Heart rate: 66 (Inconclusive) Patient's heart rate was 66 beats per minute, 106 (Inconclusive) Patient's heart rate was 106 beats per minute, 99 (Inconclusive) Patient's heart rate was 99 beats per minute, 89 (Inconclusive) Patient's heart rate was 89 beats per minute and 122 (Inconclusive) 122 beats per minute. On 18-May-2021, Oxygen saturation: 98 (normal) Patient's O2 saturation was 98%. In 2021, Blood pressure measurement: 144/88 (Inconclusive) Patient's blood pressure was 144/88 mmHg. In 2021, Body temperature: 98.4 (Inconclusive) Patient's body temperature was 98.4? F. In 2021, Heart rate: 87 (Inconclusive) 87 beats per minute. In 2021, Oxygen saturation: 100 (normal) Patient's O2 saturation was 100%. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Patient informed his physician and was advised to have another PSA next week and to consult a Urologist. On an unknown date, patient's respiration rate was 16 and on 18-May-2021, patient's respiration rate was 20. Patient reportedly had heart palpitations. On 24-Apr and 08-May-2021, patient's blood pressure and heart rate was elevated. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of events, a causal relationship cannot be excluded. However, patient's previous history of diabetes mellitus and hypertension could be confounders for tachycardia. Post-traumatic stress disorder could be a confounder for anxiety event as well as previous elevated prostatic antigen and benign prostatic hyperplasia could be confounders for the increased prostatic specific antigen. Further information has been requested. Most recent FOLLOW-UP information incorporated above includes: On 13-Aug-2021: Follow-up 4 received included lab investigation and medical history was updated On 13-Aug-2021: Follow-up 3 received contains no new information.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of events, a causal relationship cannot be excluded. However, patient's previous history of diabetes mellitus and hypertension could be confounders for tachycardia. Post-traumatic stress disorder could be a confounder for anxiety event as well as previous elevated prostatic antigen and benign prostatic hyperplasia could be confounders for the increased prostatic specific antigen. Further information has been requested.

Other Meds: LISINOPRIL; TADALAFIL; TAMSULOSIN; ASPIRIN [ACETYLSALICYLIC ACID]; ATENOLOL; INSULIN

Current Illness: Back pain (Patient has Lower back pain.); Benign prostatic hyperplasia (Benign prostatic hyperplasia without lower urinary tract symptoms.); Constipation; Essential hypertension; GERD (Patient has chronic Gastro esophageal reflux disease); Nasal congestion; Post-traumatic stress disorder; PSA (Elevated PSA); Type 2 diabetes mellitus (Patient has a history of Type 2 Diabetes mellitus with hyperglycemia, with long term current use of insulin.); Vitamin D deficiency

ID: 1635255
Sex: F
Age: 63
State: NY

Vax Date: 03/02/2021
Onset Date: 03/30/2021
Rec V Date: 08/26/2021
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: Headache; Pain from her lower back on the right side to her toe; Nose was burning, she could smell burn and her "fingertips burning; Head eyes and nose itching; Right hand completely frozen; Joint pain up to upper arm; Dental work done; Sore arm/Pain from her upper right arm; Fatigue; Blurry vision; Dizziness; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache), DIZZINESS (Dizziness), PAIN (Pain from her lower back on the right side to her toe), FATIGUE (Fatigue) and VISION BLURRED (Blurry vision) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 011B21A and 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided y the reporter. Concomitant products included COLESEVELAM, ROSUVASTATIN, FAMCICLOVIR, Omeprazole, GABAPENTIN (GABAPENTIN "PCD"), METFORMIN HYDROCHLORIDE, SITAGLIPTIN PHOSPHATE MONOHYDRATE (JANUMET), FEXOFENADINE HYDROCHLORIDE (ALLEGRA), ZINC, ASCORBIC ACID, ROSA CANINA FRUIT (VITAMIN C & ROSEHIP) and CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 30-Mar-2021, the patient experienced DIZZINESS (Dizziness), FATIGUE (Fatigue), VISION BLURRED (Blurry vision) and MYALGIA (Sore arm/Pain from her upper right arm). On 05-Apr-2021, the patient experienced DENTAL CARE (Dental work done). On 14-Apr-2021, the patient experienced PAIN (Pain from her lower back on the right side to her toe), SKIN BURNING SENSATION (Nose was burning, she could smell burn and her "fingertips burning), PRURITUS (Head eyes and nose itching), INJECTED LIMB MOBILITY DECREASED (Right hand completely frozen) and ARTHRALGIA (Joint pain up to upper arm). On an unknown date, the patient experienced HEADACHE (Headache). On 03-Apr-2021, DIZZINESS (Dizziness), VISION BLURRED (Blurry vision) and MYALGIA (Sore arm/Pain from her upper right arm) had resolved, FATIGUE (Fatigue) outcome was unknown. At the time of the report, HEADACHE (Headache), PAIN (Pain from her lower back on the right side to her toe), SKIN BURNING SENSATION (Nose was burning, she could smell burn and her "fingertips burning), PRURITUS (Head eyes and nose itching), DENTAL CARE (Dental work done), INJECTED LIMB MOBILITY DECREASED (Right hand completely frozen) and ARTHRALGIA (Joint pain up to upper arm) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Cold water, aloe vera, cold showers, Benadry, Tylenol, Hydroxyzine, Allergy patches, cold pack were used as treatments. This case was linked to MOD-2021-089500 (Patient Link).

Other Meds: COLESEVELAM; ROSUVASTATIN; FAMCICLOVIR; Omeprazole; GABAPENTIN "PCD"; JANUMET; ALLEGRA; ZINC; VITAMIN C & ROSEHIP; VITAMIN D 2000

Current Illness:

ID: 1635256
Sex: F
Age: 71
State: KS

Vax Date: 03/24/2021
Onset Date: 04/22/2021
Rec V Date: 08/26/2021
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: Test Date: 2021; Test Name: Blood pressure; Result Unstructured Data: 164/90; Test Date: 2021; Test Name: Body temperature; Result Unstructured Data: 101.2; Test Date: 2021; Test Name: Body temperature; Result Unstructured Data: 102.9; Test Date: 2021; Test Name: Body temperature; Result Unstructured Data: 103; Test Date: 2021; Test Name: Pulse; Result Unstructured Data: 122; Test Date: 20201024; Test Name: nasal swab; Test Result: Positive ; Result Unstructured Data: the patient has been diagnosed with positive for COVID-19; Comments: .

Allergies:

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

Symptoms: Fever of 103; Headache; muscle ache; Weakness; extremely tired; dizziness; nausea; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Fever of 103), HEADACHE (Headache), MYALGIA (muscle ache), ASTHENIA (Weakness) and FATIGUE (extremely tired) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 030B21A and 030B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 on 24-Oct-2020 and Ileostomy on 02-Oct-2016. Concomitant products included GABAPENTIN from 15-Aug-2010 to an unknown date, DIAZEPAM from 13-Jul-2010 to an unknown date, BACLOFEN from 15-Aug-2020 to an unknown date, LEVOTHYROXINE and LOSARTAN from 12-Jul-2010 to an unknown date for an unknown indication. On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 22-Apr-2021, the patient experienced PYREXIA (Fever of 103), HEADACHE (Headache), MYALGIA (muscle ache), ASTHENIA (Weakness), FATIGUE (extremely tired), DIZZINESS (dizziness) and NAUSEA (nausea). The patient was treated with PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, PYREXIA (Fever of 103), HEADACHE (Headache), MYALGIA (muscle ache), ASTHENIA (Weakness), FATIGUE (extremely tired), DIZZINESS (dizziness) and NAUSEA (nausea) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 24-Oct-2020, Viral test: positive the patient has been diagnosed with positive for COVID-19. In 2021, Blood pressure measurement: 164/90 (abnormal) 164/90. In 2021, Body temperature: 101.2 (abnormal) 101.2, 102.9 (abnormal) 102.9 and 103 (abnormal) 103. In 2021, Heart rate: 122 (abnormal) 122. vaccine doses has been injected via Shoulder The patient had no Allergies to medications, food, and other products. This case was linked to US-MODERNATX, INC.-MOD-2021-089510 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 26-May-2021: Follow up received on 26-May-2021 contains non-significant information contact information updated. On 25-Jul-2021: Updated Reporter details, updated Patient demographics, added lab test, added Vaccine Facility information, Suspect product anatomical location has been updated, added Concomitant drugs, added Adverse Event start date, Outcome updated.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-089510:Dose 1

Other Meds: GABAPENTIN; DIAZEPAM; BACLOFEN; LEVOTHYROXINE; LOSARTAN

Current Illness:

ID: 1635257
Sex: M
Age:
State: FL

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
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: sore arm; diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm) and DIARRHOEA (diarrhea) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm) and DIARRHOEA (diarrhea). Not Provided This case was linked to MOD21-081406, MOD21-081427 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 23-Apr-2021: No specific follow-up information recorded.; Sender's Comments: MOD21-081406: MOD21-081427:for his brother , follow up

Other Meds:

Current Illness:

ID: 1635258
Sex: F
Age: 61
State: HI

Vax Date: 03/19/2021
Onset Date: 04/16/2021
Rec V Date: 08/26/2021
Hospital:

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

Lab Data: Test Date: 20210416; Test Name: Body temperature; Result Unstructured Data: High

Allergies:

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

Symptoms: left injection arm soreness; Felt dizzy; Ear pain; Covid arm; chills; Tiredness; headache; lymph node under the left injection arm was swollen; fever of 103F; sore left arm at injection site; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of PAIN IN EXTREMITY (left injection arm soreness), DIZZINESS (Felt dizzy), EAR PAIN (Ear pain), VACCINATION SITE REACTION (Covid arm) and CHILLS (chills) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 046A21A and 038B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included IBD (Microscopic Colitis) since 01-Jan-2021. Concomitant products included ATORVASTATIN for Hypercholesterolemia, BIFIDOBACTERIUM INFANTIS (ALIGN) for IBD, HYDROCHLOROTHIAZIDE, TRIAMTERENE (TRIAMTERENE HCTZ) for Vertigo, VITAMIN D3 for an unknown indication. On 19-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 16-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 16-Apr-2021, the patient experienced PAIN IN EXTREMITY (left injection arm soreness), DIZZINESS (Felt dizzy), EAR PAIN (Ear pain), VACCINATION SITE REACTION (Covid arm), CHILLS (chills), FATIGUE (Tiredness), HEADACHE (headache), LYMPHADENOPATHY (lymph node under the left injection arm was swollen), PYREXIA (fever of 103F) and VACCINATION SITE PAIN (sore left arm at injection site). The patient was treated with PARACETAMOL (TYLENOL) (oral) for Fever, at a dose of 500 milligram and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (topical) for Rash, at an unspecified dose and frequency. On 19-Apr-2021, PAIN IN EXTREMITY (left injection arm soreness), DIZZINESS (Felt dizzy), EAR PAIN (Ear pain), VACCINATION SITE REACTION (Covid arm), CHILLS (chills), FATIGUE (Tiredness), HEADACHE (headache), LYMPHADENOPATHY (lymph node under the left injection arm was swollen) and PYREXIA (fever of 103F) had resolved and VACCINATION SITE PAIN (sore left arm at injection site) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Apr-2021, Body temperature: 103 (High) High. The patient alternated between Advil and Tylenol for reducing fever. This case was linked to US-MODERNATX, INC.-MOD-2021-089677 (E2B Linked Report). Most recent FOLLOW-UP information incorporated above includes: On 29-May-2021: Updates concomitant product use and treatment medication use. Updated event start date and stop date.Updated patient's medical history.; Sender's Comments: US-MODERNATX, INC.-MOD-2021-089677:Crosse linked

Other Meds: TRIAMTERENE HCTZ; ATORVASTATIN; VITAMIN D3; ALIGN

Current Illness: IBD (Microscopic Colitis)

ID: 1635259
Sex: M
Age: 27
State: MA

Vax Date: 03/21/2021
Onset Date: 04/23/2021
Rec V Date: 08/26/2021
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: fatigue; sore arm at injection site; chills; body aches; headache; This spontaneous case was reported by an other health professional and describes the occurrence of FATIGUE (fatigue), INJECTION SITE PAIN (sore arm at injection site), CHILLS (chills), MYALGIA (body aches) and HEADACHE (headache) in a 27-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 039K20A and 011J20A) for COVID-19 vaccination. Concurrent medical conditions included Allergy to plants. Concomitant products included MELATONIN for Sleep deprivation. On 21-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, the patient experienced FATIGUE (fatigue), INJECTION SITE PAIN (sore arm at injection site), CHILLS (chills), MYALGIA (body aches) and HEADACHE (headache). On 25-Apr-2021, FATIGUE (fatigue), INJECTION SITE PAIN (sore arm at injection site), CHILLS (chills), MYALGIA (body aches) and HEADACHE (headache) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: other relevant history, concomitant drug, dose details of suspect drug, events and their outcomes were added

Other Meds: MELATONIN

Current Illness: Allergy to plants

ID: 1635260
Sex: F
Age: 39
State:

Vax Date: 03/27/2021
Onset Date:
Rec V Date: 08/26/2021
Hospital:

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

Lab Data: Test Name: Ct scan.

Allergies:

Symptom List: Pyrexia, White blood cell count decreased

Symptoms: neurological issues; left side of face numb/numbness and tingling in forearms/numbness and tingling in bottom of legs under knees/numbness and tingling in scalp/numbness and tingling sometimes in face; left side of face tingly/tingling in head/numbness and tingling in forearms/numbness and tingling in bottom of legs under knees/numbness and tingling in scalp/numbness and tingling sometimes in face; tingling in head; This spontaneous case was reported by a patient (subsequently medically confirmed) and describes the occurrence of NERVOUS SYSTEM DISORDER (neurological issues), HYPOAESTHESIA (left side of face numb/numbness and tingling in forearms/numbness and tingling in bottom of legs under knees/numbness and tingling in scalp/numbness and tingling sometimes in face), PARAESTHESIA (left side of face tingly/tingling in head/numbness and tingling in forearms/numbness and tingling in bottom of legs under knees/numbness and tingling in scalp/numbness and tingling sometimes in face) and HYPOAESTHESIA (tingling in head) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 027A21A) for COVID-19 vaccination. No Medical History information was reported. On 27-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On an unknown date, the patient experienced NERVOUS SYSTEM DISORDER (neurological issues), HYPOAESTHESIA (left side of face numb/numbness and tingling in forearms/numbness and tingling in bottom of legs under knees/numbness and tingling in scalp/numbness and tingling sometimes in face), PARAESTHESIA (left side of face tingly/tingling in head/numbness and tingling in forearms/numbness and tingling in bottom of legs under knees/numbness and tingling in scalp/numbness and tingling sometimes in face) and HYPOAESTHESIA (tingling in head). At the time of the report, NERVOUS SYSTEM DISORDER (neurological issues), HYPOAESTHESIA (left side of face numb/numbness and tingling in forearms/numbness and tingling in bottom of legs under knees/numbness and tingling in scalp/numbness and tingling sometimes in face), PARAESTHESIA (left side of face tingly/tingling in head/numbness and tingling in forearms/numbness and tingling in bottom of legs under knees/numbness and tingling in scalp/numbness and tingling sometimes in face) and HYPOAESTHESIA (tingling in head) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Computerised tomogram: unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route), the reporter did not provide any causality assessments. No concomitant medication included. Treatment medications included steroids and antibiotics.

Other Meds:

Current Illness:

ID: 1635261
Sex: F
Age:
State: CT

Vax Date: 04/22/2021
Onset Date: 04/23/2021
Rec V Date: 08/26/2021
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: Headaches; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headaches) 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-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, the patient experienced HEADACHE (Headaches). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, HEADACHE (Headaches) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medications were not reported. Treatment details include acetaminophen and that helps some

Other Meds:

Current Illness:

ID: 1635262
Sex: F
Age: 71
State: CA

Vax Date: 03/22/2021
Onset Date: 04/24/2021
Rec V Date: 08/26/2021
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: CHILLS; Feeling very tired; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (CHILLS) and FATIGUE (Feeling very tired) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 042B21A) for COVID-19 vaccination. Concomitant products included METFORMIN for an unknown indication. On 22-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 19-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 24-Apr-2021, the patient experienced CHILLS (CHILLS) and FATIGUE (Feeling very tired). At the time of the report, CHILLS (CHILLS) and FATIGUE (Feeling very tired) outcome was unknown. Not Provided concomitant medicine: blood pressure pill and cholesterol pills Treatment information as not reported.

Other Meds: METFORMIN

Current Illness:

ID: 1635263
Sex: F
Age: 65
State: KY

Vax Date: 04/15/2021
Onset Date: 04/22/2021
Rec V Date: 08/26/2021
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: Arm was swollen the size of a fist; Real hard; Real hot like you can light a cigarette off it; Fire engine red; Itch real bad; Light headedness; Chills; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm was swollen the size of a fist), INDURATION (Real hard), FEELING HOT (Real hot like you can light a cigarette off it), ERYTHEMA (Fire engine red) and PRURITUS (Itch real bad) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 037A21B) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced PERIPHERAL SWELLING (Arm was swollen the size of a fist), INDURATION (Real hard), FEELING HOT (Real hot like you can light a cigarette off it), ERYTHEMA (Fire engine red), PRURITUS (Itch real bad), DIZZINESS (Light headedness) and CHILLS (Chills). The patient was treated with LORATADINE, PSEUDOEPHEDRINE HYDROCHLORIDE (BENADRYL 24 D) at an unspecified dose and frequency. At the time of the report, PERIPHERAL SWELLING (Arm was swollen the size of a fist), INDURATION (Real hard), FEELING HOT (Real hot like you can light a cigarette off it), ERYTHEMA (Fire engine red), PRURITUS (Itch real bad), DIZZINESS (Light headedness) and CHILLS (Chills) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown.

Other Meds:

Current Illness:

ID: 1635264
Sex: F
Age: 55
State: MO

Vax Date: 03/26/2021
Onset Date: 03/26/2021
Rec V Date: 08/26/2021
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: Constipation; Muscle pain; Stomach cramps; Flu like symptoms; Chills; Diarrhea; This spontaneous case was reported by a consumer and describes the occurrence of CHILLS (Chills), DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach cramps), CONSTIPATION (Constipation) and INFLUENZA LIKE ILLNESS (Flu like symptoms) in a 55-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 002C21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) at an unspecified dose. On 22-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to at an unspecified dose. On 26-Mar-2021, the patient experienced CHILLS (Chills) and DIARRHOEA (Diarrhea). On 22-Apr-2021, the patient experienced ABDOMINAL PAIN UPPER (Stomach cramps) and INFLUENZA LIKE ILLNESS (Flu like symptoms). On an unknown date, the patient experienced CONSTIPATION (Constipation) and MYALGIA (Muscle pain). At the time of the report, CHILLS (Chills), DIARRHOEA (Diarrhea), ABDOMINAL PAIN UPPER (Stomach cramps), CONSTIPATION (Constipation), INFLUENZA LIKE ILLNESS (Flu like symptoms) and MYALGIA (Muscle pain) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1635265
Sex: F
Age: 54
State: NC

Vax Date: 03/02/2021
Onset Date: 03/31/2021
Rec V Date: 08/26/2021
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: visual migraine; visual issues; saw black floaters that turned into black zigzag lines in her visual field which lasted 10 minutes; experienced a fever 99.8; weakness; slight headache; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (experienced a fever 99.8), ASTHENIA (weakness), HEADACHE (slight headache), VISUAL IMPAIRMENT (visual issues) and VITREOUS FLOATERS (saw black floaters that turned into black zigzag lines in her visual field which lasted 10 minutes) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included No adverse event. On 02-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 31-Mar-2021, the patient experienced PYREXIA (experienced a fever 99.8), ASTHENIA (weakness) and HEADACHE (slight headache). On 03-Apr-2021, the patient experienced VISUAL IMPAIRMENT (visual issues) and VITREOUS FLOATERS (saw black floaters that turned into black zigzag lines in her visual field which lasted 10 minutes). On 26-Apr-2021, the patient experienced RETINAL MIGRAINE (visual migraine). On 01-Apr-2021, PYREXIA (experienced a fever 99.8) and ASTHENIA (weakness) had resolved, HEADACHE (slight headache) outcome was unknown. On 03-Apr-2021, VISUAL IMPAIRMENT (visual issues) and VITREOUS FLOATERS (saw black floaters that turned into black zigzag lines in her visual field which lasted 10 minutes) had resolved. At the time of the report, RETINAL MIGRAINE (visual migraine) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. This case was linked to MOD-2021-090202 (Patient Link).

Other Meds:

Current Illness:

ID: 1635266
Sex: F
Age: 86
State: MI

Vax Date: 04/14/2021
Onset Date: 04/14/2021
Rec V Date: 08/26/2021
Hospital:

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

Lab Data: Test Date: 202011; Test Name: Covid-19; Test Result: Positive ; Result Unstructured Data: Positive; Test Date: 202011; Test Name: Blood pressure low; Result Unstructured Data: Blood pressure went very low.

Allergies:

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

Symptoms: scared to receive her 2nd vaccine; shoulder pain at injection site; muscle pain; joint pain; severe at times where she could hardly get out of bed to get to the restroom; This spontaneous case was reported by a consumer and describes the occurrence of FEAR (scared to receive her 2nd vaccine), VACCINATION SITE PAIN (shoulder pain at injection site), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and MOBILITY DECREASED (severe at times where she could hardly get out of bed to get to the restroom) in an 86-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination. The patient's past medical history included Emergency care examination abnormal (Patient tested positive for COVID-19 in nov2020 and went to the emergency department because her blood pressure went very low.) in November 2020 and Fluid replacement NOS (Patient received fluids in the emergency department.) in November 2020. On 14-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 14-Apr-2021, the patient experienced VACCINATION SITE PAIN (shoulder pain at injection site), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and MOBILITY DECREASED (severe at times where she could hardly get out of bed to get to the restroom). On an unknown date, the patient experienced FEAR (scared to receive her 2nd vaccine). On 16-Apr-2021, VACCINATION SITE PAIN (shoulder pain at injection site), MYALGIA (muscle pain), ARTHRALGIA (joint pain) and MOBILITY DECREASED (severe at times where she could hardly get out of bed to get to the restroom) had resolved. At the time of the report, FEAR (scared to receive her 2nd vaccine) had not resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): In November 2020, COVID-19: positive (Positive) Positive. In November 2020, Hypotension: low (Low) Blood pressure went very low.. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment information was not provided. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1635267
Sex: F
Age: 54
State: PA

Vax Date: 04/01/2021
Onset Date: 04/02/2021
Rec V Date: 08/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Hair loss; Fever; Nausea; Redness in their right arm; This spontaneous case was reported by a consumer and describes the occurrence of ERYTHEMA (Redness in their right arm), ALOPECIA (Hair loss), PYREXIA (Fever) and NAUSEA (Nausea) in a 54-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 018B21A) for COVID-19 vaccination. Concomitant products included LEVOTHYROXINE for an unknown indication. On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) .5 ml. On 02-Apr-2021, the patient experienced ERYTHEMA (Redness in their right arm), PYREXIA (Fever) and NAUSEA (Nausea). On 08-Apr-2021, the patient experienced ALOPECIA (Hair loss). On 05-Apr-2021, ERYTHEMA (Redness in their right arm), PYREXIA (Fever) and NAUSEA (Nausea) had resolved. At the time of the report, ALOPECIA (Hair loss) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant medication also included Vitamins. No treatment medication was reported. Most recent FOLLOW-UP information incorporated above includes: On 12-Jun-2021: Follow up received on 12-JUN-2021 contains no new information.

Other Meds: LEVOTHYROXINE

Current Illness:

ID: 1635268
Sex: F
Age: 48
State: IN

Vax Date: 04/17/2021
Onset Date: 04/17/2021
Rec V Date: 08/26/2021
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: chest pain; General fatigue; Itchy at the injection site; Redness on the injection site; "area felt warm"; Severe pain in arm; Slight head ache; general fatigue; This spontaneous case was reported by a consumer and describes the occurrence of CHEST PAIN (chest pain), VACCINATION SITE WARMTH ("area felt warm"), PAIN IN EXTREMITY (Severe pain in arm), HEADACHE (Slight head ache) and FATIGUE (general fatigue) in a 28-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included Asthma, Hyperthyroidism and Birth control. On 17-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 17-Apr-2021, the patient experienced PAIN IN EXTREMITY (Severe pain in arm), HEADACHE (Slight head ache) and FATIGUE (general fatigue). On 25-Apr-2021, the patient experienced VACCINATION SITE WARMTH ("area felt warm"), VACCINATION SITE PRURITUS (Itchy at the injection site) and VACCINATION SITE ERYTHEMA (Redness on the injection site). On 26-Apr-2021, the patient experienced CHEST PAIN (chest pain) and FATIGUE (General fatigue). At the time of the report, CHEST PAIN (chest pain), VACCINATION SITE WARMTH ("area felt warm"), PAIN IN EXTREMITY (Severe pain in arm), HEADACHE (Slight head ache), FATIGUE (general fatigue), VACCINATION SITE PRURITUS (Itchy at the injection site), VACCINATION SITE ERYTHEMA (Redness on the injection site) and FATIGUE (General fatigue) 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. Treatment Ibuprofen

Other Meds:

Current Illness:

ID: 1635269
Sex: F
Age: 75
State: IN

Vax Date: 04/05/2021
Onset Date:
Rec V Date: 08/26/2021
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: sore arm; Rash and redness; Rash and redness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (sore arm), RASH (Rash and redness) and ERYTHEMA (Rash and redness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 032B21A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 05-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (sore arm), RASH (Rash and redness) and ERYTHEMA (Rash and redness). The patient was treated with NAPROXEN SODIUM (ALEVE) at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (sore arm), RASH (Rash and redness) and ERYTHEMA (Rash and redness) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication were not reported .

Other Meds:

Current Illness:

ID: 1635270
Sex: M
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
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: Significant tenderness around the administering of the Moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE PAIN (Significant tenderness around the administering of the Moderna vaccine) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced INJECTION SITE PAIN (Significant tenderness around the administering of the Moderna vaccine). At the time of the report, INJECTION SITE PAIN (Significant tenderness around the administering of the Moderna vaccine) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication details were not reported by the reporter. Treatment details not reported by the reporter. Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1635271
Sex: U
Age:
State: TX

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

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

Lab Data:

Allergies:

Symptom List: Ear pain, Hypoaesthesia

Symptoms: overdue for second dose; 50+days; This spontaneous case was reported by a health care professional and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (overdue for second dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (50+days) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) at an unspecified dose. On an unknown date, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (overdue for second dose) and INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (50+days). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION (overdue for second dose) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine), the reporter did not provide any causality assessments. Caller was unable to provide any adverse effect details . Caller was a healthcare provider and had a patient who was overdue for their second vaccine dose. Caller wants to know what they should do This case was linked to US-MODERNATX, INC.-MOD-2021-090650 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-090650:cluster case for some contractors

Other Meds:

Current Illness:

ID: 1635272
Sex: F
Age: 46
State: GA

Vax Date: 03/26/2021
Onset Date: 04/23/2021
Rec V Date: 08/26/2021
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: shakes and tremors that are getting worse by the day; fever; felt okay not great; This spontaneous case was reported by a consumer and describes the occurrence of FEELING ABNORMAL (felt okay not great), TREMOR (shakes and tremors that are getting worse by the day) and PYREXIA (fever) in a 46-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 001C21A and 007B21A) for COVID-19 vaccination. The patient's past medical history included MS (Had inflammation but it got better after a few months) in 2004. Concurrent medical conditions included Gluten sensitivity, Sulfonamide allergy, Protein allergy and Depression. Concomitant products included BUPROPION HYDROCHLORIDE (WELLBUTRIN) for Depression. On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 23-Apr-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced FEELING ABNORMAL (felt okay not great). On 24-Apr-2021, the patient experienced TREMOR (shakes and tremors that are getting worse by the day). 24-Apr-2021, the patient experienced PYREXIA (fever). The patient was treated with CLONAZEPAM at a dose of 0.25 mg. At the time of the report, FEELING ABNORMAL (felt okay not great), TREMOR (shakes and tremors that are getting worse by the day) and PYREXIA (fever) had resolved. Treatment medication included CBD with THC3% and trying to eat but nothing is helping. Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Additional document received and contains no new information On 20-Jul-2021: Patient demographics were added.Allergies includes Sulpha,Gluten,Caesin were added.Medical condition includes MS was added.Dose 1 information was provided.Concomitant products include Welbutrin was added.Events outcome was updated from unknown to recovered.

Other Meds: WELLBUTRIN

Current Illness: Depression; Gluten sensitivity; Protein allergy; Sulfonamide allergy

ID: 1635273
Sex: F
Age: 74
State: MD

Vax Date: 01/25/2021
Onset Date:
Rec V Date: 08/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Headache; Fatigue; This spontaneous case was reported by a consumer and describes the occurrence of HEADACHE (Headache) and FATIGUE (Fatigue) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031M20A and 030L20A) for COVID-19 vaccination. Previously administered products included for an unreported indication: PREVNAR 13 (Allergy to Prevnar 13 causes swelling and rash). Concurrent medical conditions included Hypertension since 04-Sep-1998, Drug allergy (Lisinopril causes swelling), Shellfish allergy (Shellfish causes swelling) since 27-Jul-2017, Drug allergy (Amlodipine causes hives), Drug allergy (Polyethylene glycol causes hives, itching and swelling), Sulfonamide allergy (Sulfonamide antibiotics causes hives), Drug allergy (Augmentin causes hives), Drug allergy (Azithromycin causes hives), Drug allergy (Brimonidine Combigan causes hives), Seafood allergy (Shrimp causes swelling), Food allergy (Oats causes hives), Drug allergy (Clindamycin causes facial rash), Drug allergy (Doxycycline causes hives and rash) and Drug allergy (Omnipaque Rediflo 240 causes oral contrast). Concomitant products included ATENOLOL, PRAVASTATIN, ACETYLSALICYLIC ACID (ASPIRIN 81), CALCIUM CARBONATE, COLECALCIFEROL (CALCIUM D3), LATANOPROST from 10-Sep-2020 to an unknown date, EPINEPHRINE (EPIPEN 2-PAK) and CETIRIZINE for an unknown indication. On 25-Jan-2021 at 4:30 PM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 01-Mar-2021 at 4:30 PM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced HEADACHE (Headache) and FATIGUE (Fatigue). At the time of the report, HEADACHE (Headache) and FATIGUE (Fatigue) outcome was unknown. No treatment medications were reported. This case was linked to MOD-2021-029326 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Follow-up information received on 28-May-2021 contains Non-significant information.

Other Meds: ATENOLOL; PRAVASTATIN; ASPIRIN 81; CALCIUM D3; LATANOPROST; EPIPEN 2-PAK; CETIRIZINE

Current Illness: Drug allergy (Polyethylene glycol causes hives, itching and swelling); Drug allergy (Omnipaque Rediflo 240 causes oral contrast); Drug allergy (Lisinopril causes swelling); Drug allergy (Doxycycline causes hives and rash); Drug allergy (Clindamycin causes facial rash); Drug allergy (Brimonidine Combigan causes hives); Drug allergy (Azithromycin causes hives); Drug allergy (Augmentin causes hives); Drug allergy (Amlodipine causes hives); Food allergy (Oats causes hives); Hypertension; Seafood allergy (Shrimp causes swelling); Shellfish allergy (Shellfish causes swelling); Sulfonamide allergy (Sulfonamide antibiotics causes hives)

ID: 1635274
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
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: felt fainty; sweaty; Burning where i was injected; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (felt fainty), HYPERHIDROSIS (sweaty) and VACCINATION SITE PAIN (Burning where i was injected) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced DIZZINESS (felt fainty), HYPERHIDROSIS (sweaty) and VACCINATION SITE PAIN (Burning where i was injected). At the time of the report, DIZZINESS (felt fainty), HYPERHIDROSIS (sweaty) and VACCINATION SITE PAIN (Burning where i was injected) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No treatment information was provided. No concomitant medication was provided. Company Comment: Very limited information regarding these non serious events has been provided at this time. Further information has been requested. Most recent FOLLOW-UP information incorporated above includes: On 27-Apr-2021: report contained no new information; Sender's Comments: Very limited information regarding these non serious events has been provided at this time. Further information has been requested.

Other Meds:

Current Illness:

ID: 1635275
Sex: F
Age:
State:

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
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: Pain; Flu like symptoms; Vaccination site tenderness; This spontaneous case was reported by a physician and describes the occurrence of PAIN (Pain), INFLUENZA LIKE ILLNESS (Flu like symptoms) and VACCINATION SITE PAIN (Vaccination site tenderness) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product ADALIMUMAB (HUMIRA) for Rheumatoid arthritis. Concomitant products included METHOTREXATE for an unknown indication. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form and ADALIMUMAB (HUMIRA) (Subcutaneous) dosage form. On an unknown date, the patient experienced PAIN (Pain), INFLUENZA LIKE ILLNESS (Flu like symptoms) and VACCINATION SITE PAIN (Vaccination site tenderness). At the time of the report, PAIN (Pain), INFLUENZA LIKE ILLNESS (Flu like symptoms) and VACCINATION SITE PAIN (Vaccination site tenderness) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment medications were reported. Reporter did not allow further contact

Other Meds: METHOTREXATE

Current Illness:

ID: 1635276
Sex: M
Age: 58
State: AR

Vax Date: 03/31/2021
Onset Date: 03/31/2021
Rec V Date: 08/26/2021
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: Couldn't turn his neck back because it hurt so bad; Pain continued to get worse, and affected entire side of his body (left side, same side he got his; Pain in his neck; Pain in his back; swelling of lymph nodes in his neck and under his arm; Fatigue; arm was hurting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (arm was hurting), MOBILITY DECREASED (Couldn't turn his neck back because it hurt so bad), PAIN (Pain continued to get worse, and affected entire side of his body (left side, same side he got his), NECK PAIN (Pain in his neck) and BACK PAIN (Pain in his back) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Blood pressure high, Thyroiditis and High cholesterol. On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced PAIN IN EXTREMITY (arm was hurting) and FATIGUE (Fatigue). On 01-Apr-2021, the patient experienced MOBILITY DECREASED (Couldn't turn his neck back because it hurt so bad), PAIN (Pain continued to get worse, and affected entire side of his body (left side, same side he got his), NECK PAIN (Pain in his neck), BACK PAIN (Pain in his back) and LYMPHADENOPATHY (swelling of lymph nodes in his neck and under his arm). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) at a dose of Two or three. On 02-Apr-2021, PAIN IN EXTREMITY (arm was hurting) and FATIGUE (Fatigue) had resolved. On 03-Apr-2021, MOBILITY DECREASED (Couldn't turn his neck back because it hurt so bad), PAIN (Pain continued to get worse, and affected entire side of his body (left side, same side he got his), NECK PAIN (Pain in his neck) and BACK PAIN (Pain in his back) had resolved. On 04-Apr-2021, LYMPHADENOPATHY (swelling of lymph nodes in his neck and under his arm) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Patient is on concomitant medicines like Blood pressure medication, Thyroid medication and Cholesterol medication. Advil two or three as treatment medication. Not sure if the patient also took Tylenol.

Other Meds:

Current Illness: Blood pressure high; High cholesterol; Thyroiditis

ID: 1635277
Sex: F
Age:
State: CA

Vax Date:
Onset Date: 01/01/1900
Rec V Date: 08/26/2021
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: could hardly walk; This spontaneous case was reported by a consumer and describes the occurrence of GAIT DISTURBANCE (could hardly walk) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. No concomitant medication was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jan-1900, the patient experienced GAIT DISTURBANCE (could hardly walk). At the time of the report, GAIT DISTURBANCE (could hardly walk) outcome was unknown. Not Provided Treatment medication was not provided. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. This case was linked to US-MODERNATX, INC.-MOD-2021-091925 (E2B Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-091925:Same reporter, different patient

Other Meds:

Current Illness:

ID: 1635278
Sex: F
Age:
State: TN

Vax Date: 03/31/2021
Onset Date: 03/31/2021
Rec V Date: 08/26/2021
Hospital:

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

Lab Data: Test Date: 20210401; Test Name: Body temperature; Result Unstructured Data: 102.6

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: Shortness of breath after covid; Tired; Fever of 102.6F; Could not sleep; Really freezing; Shivering; This spontaneous case was reported by a consumer and describes the occurrence of DYSPNOEA (Shortness of breath after covid), INSOMNIA (Could not sleep), FEELING COLD (Really freezing), CHILLS (Shivering) and FATIGUE (Tired) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. The patient's past medical history included COVID-19 pneumonia (Has been struggling on walks after having COVID due to shortness of breath) in 2020 and Shortness of breath. Concurrent medical conditions included Chronic sinusitis and Lung scarring. Concomitant products included ALBUTEROL [SALBUTAMOL], ATORVASTATIN CALCIUM (STATIN [ATORVASTATIN CALCIUM]) and ESTRADIOL (ESTROGEN) for an unknown indication. On 31-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 31-Mar-2021, the patient experienced INSOMNIA (Could not sleep), FEELING COLD (Really freezing) and CHILLS (Shivering). On 01-Apr-2021, the patient experienced PYREXIA (Fever of 102.6F). On 02-Apr-2021, the patient experienced FATIGUE (Tired). On an unknown date, the patient experienced DYSPNOEA (Shortness of breath after covid). The patient was treated with PARACETAMOL (TYLENOL) for Fever, at a dose of 2 dosage form. At the time of the report, DYSPNOEA (Shortness of breath after covid), INSOMNIA (Could not sleep), FEELING COLD (Really freezing), CHILLS (Shivering), FATIGUE (Tired) and PYREXIA (Fever of 102.6F) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 01-Apr-2021, Body temperature: 102.6 (High) Increased. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Other concomitant products include BP medications. This case was linked to MOD-2021-098685 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 27-May-2021: Follow-up information received contains non-significant information. On 29-Jun-2021: Follow-up information received contains non-significant information.

Other Meds: ALBUTEROL [SALBUTAMOL]; STATIN [ATORVASTATIN CALCIUM]; ESTROGEN

Current Illness: Chronic sinusitis; Lung scarring

ID: 1635279
Sex: M
Age:
State:

Vax Date: 03/24/2021
Onset Date:
Rec V Date: 08/26/2021
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: large red spot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (large red spot) in an 82-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 048B21A and 006B21A) for COVID-19 vaccination. No Medical History information was reported. On 24-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 21-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (large red spot). At the time of the report, VACCINATION SITE ERYTHEMA (large red spot) outcome was unknown. Not Provided Action taken with response to the events are not applicable

Other Meds:

Current Illness:

ID: 1635280
Sex: F
Age: 71
State: NJ

Vax Date: 03/11/2021
Onset Date:
Rec V Date: 08/26/2021
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: Weakness; Swollen tongue; Lips cracked; Toes were numb; Cold feet; Tingling fingers; sensation of hotness and coldness; Dizziness; shortness of breath; Headache; Sore throat; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of DIZZINESS (Dizziness), DYSPNOEA (shortness of breath), HEADACHE (Headache), OROPHARYNGEAL PAIN (Sore throat) and ASTHENIA (Weakness) in a 71-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 029L20A and 029L20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included CLONAZEPAM, GABAPENTIN, FAMOTIDINE, PRAVASTATIN, CALCIUM and TOCOPHEROL, UBIDECARENONE, ZINC (COENZYME Q10+) for an unknown indication. On 11-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 08-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient experienced DIZZINESS (Dizziness), DYSPNOEA (shortness of breath), HEADACHE (Headache), OROPHARYNGEAL PAIN (Sore throat), ASTHENIA (Weakness), SWOLLEN TONGUE (Swollen tongue), CHAPPED LIPS (Lips cracked), HYPOAESTHESIA (Toes were numb), PERIPHERAL COLDNESS (Cold feet), PARAESTHESIA (Tingling fingers) and FEELING OF BODY TEMPERATURE CHANGE (sensation of hotness and coldness). At the time of the report, DIZZINESS (Dizziness), DYSPNOEA (shortness of breath), HEADACHE (Headache), OROPHARYNGEAL PAIN (Sore throat), PERIPHERAL COLDNESS (Cold feet), PARAESTHESIA (Tingling fingers) and FEELING OF BODY TEMPERATURE CHANGE (sensation of hotness and coldness) outcome was unknown. Unknown The treatment history was not provided.

Other Meds: CLONAZEPAM; GABAPENTIN; FAMOTIDINE; PRAVASTATIN; CALCIUM; COENZYME Q10+

Current Illness:

ID: 1635281
Sex: F
Age: 31
State: AL

Vax Date: 04/22/2021
Onset Date: 04/22/2021
Rec V Date: 08/26/2021
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: Pain invloves the Left breast; Developed pain under her left arm and invloves the underarm; Pain at the injection site; This spontaneous case was reported by a consumer and describes the occurrence of BREAST PAIN (Pain invloves the Left breast), AXILLARY PAIN (Developed pain under her left arm and invloves the underarm) and VACCINATION SITE PAIN (Pain at the injection site) in a 31-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination. No Medical History information was reported. On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 22-Apr-2021, the patient experienced VACCINATION SITE PAIN (Pain at the injection site). On 25-Apr-2021, the patient experienced AXILLARY PAIN (Developed pain under her left arm and invloves the underarm). On 26-Apr-2021, the patient experienced BREAST PAIN (Pain invloves the Left breast). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Pain, at an unspecified dose and frequency. On 23-Apr-2021, VACCINATION SITE PAIN (Pain at the injection site) had resolved. At the time of the report, BREAST PAIN (Pain invloves the Left breast) and AXILLARY PAIN (Developed pain under her left arm and invloves the underarm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant product information was not provided.

Other Meds:

Current Illness:

ID: 1635282
Sex: M
Age: 63
State: NY

Vax Date: 04/21/2021
Onset Date: 04/21/2021
Rec V Date: 08/26/2021
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: Soreness on the left arm\soreness; This spontaneous case was reported by a consumer and describes the occurrence of MYALGIA (Soreness on the left arm\soreness) in a 63-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 044B21A) for COVID-19 vaccination. No Medical History information was reported. On 21-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 21-Apr-2021, the patient experienced MYALGIA (Soreness on the left arm\soreness). The patient was treated with PARACETAMOL (TYLENOL) for Pain in arm, at an unspecified dose and frequency. On 23-Apr-2021, MYALGIA (Soreness on the left arm\soreness) had resolved. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication details were provided. Treatment information provided was Tylenol. Patient called in stating that he had called in earlier and spoke to 2 other agents regarding his concern. He received a voicemail from Moderna asking about an adverse reaction. Stated he had soreness after his first dose on 21Apr2021 but this went away after a day or two but he has never called Moderna about this. Pertinent details regarding his vaccination was not gathered as caller insisted that agent look into a possible identity theft. Most recent FOLLOW-UP information incorporated above includes: On 29-May-2021: Follow-up received on 29-May-21. Nonserious event added

Other Meds:

Current Illness:

ID: 1635283
Sex: M
Age: 65
State: NJ

Vax Date: 04/22/2021
Onset Date: 04/23/2021
Rec V Date: 08/26/2021
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: facial swelling on the left side of face; rash on his forehead; This spontaneous case was reported by a consumer and describes the occurrence of SWELLING FACE (facial swelling on the left side of face) and RASH (rash on his forehead) in a 65-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination. Concomitant products included EMPAGLIFLOZIN (JARDIANCE), GLIMEPIRIDE, ROSUVASTATIN and LISINOPRIL for Product used for unknown indication. On 22-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 ml. On 23-Apr-2021, the patient experienced SWELLING FACE (facial swelling on the left side of face). 23-Apr-2021, the patient experienced RASH (rash on his forehead). At the time of the report, SWELLING FACE (facial swelling on the left side of face) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown.

Other Meds: JARDIANCE; GLIMEPIRIDE; ROSUVASTATIN; LISINOPRIL

Current Illness:

ID: 1635284
Sex: F
Age:
State: CA

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
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: Shingles; pain went from her armpit to her elbow; numbness through the armpit; had difficulty breathing; Lymph nodes were inflamed on the arm; Body aches; Hreadache; chills; This spontaneous case was reported by a consumer and describes the occurrence of HERPES ZOSTER (Shingles), PAIN IN EXTREMITY (pain went from her armpit to her elbow), HYPOAESTHESIA (numbness through the armpit), DYSPNOEA (had difficulty breathing) and LYMPHADENOPATHY (Lymph nodes were inflamed on the arm) in an adult female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 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 HERPES ZOSTER (Shingles), PAIN IN EXTREMITY (pain went from her armpit to her elbow), HYPOAESTHESIA (numbness through the armpit), DYSPNOEA (had difficulty breathing), LYMPHADENOPATHY (Lymph nodes were inflamed on the arm), MYALGIA (Body aches), HEADACHE (Hreadache) and CHILLS (chills). At the time of the report, HERPES ZOSTER (Shingles), PAIN IN EXTREMITY (pain went from her armpit to her elbow), HYPOAESTHESIA (numbness through the armpit), DYSPNOEA (had difficulty breathing), LYMPHADENOPATHY (Lymph nodes were inflamed on the arm), MYALGIA (Body aches), HEADACHE (Hreadache) and CHILLS (chills) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant details were provided No treatment details were provided Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1635285
Sex: M
Age: 59
State: CA

Vax Date: 04/01/2021
Onset Date:
Rec V Date: 08/26/2021
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: minor bronchial constriction, eoisode which is less than Asthmatic Attack; This spontaneous case was reported by a consumer and describes the occurrence of BRONCHOSPASM (minor bronchial constriction, eoisode which is less than Asthmatic Attack) in a 60-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 045A21A) for COVID-19 vaccination. The patient's past medical history included Psoriatic arthritis. Concomitant products included ATORVASTATIN, TEMAZEPAM and BUPROPION HYDROCHLORIDE for an unknown indication. On 01-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced BRONCHOSPASM (minor bronchial constriction, eoisode which is less than Asthmatic Attack). At the time of the report, BRONCHOSPASM (minor bronchial constriction, eoisode which is less than Asthmatic Attack) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No treatment details were provided.

Other Meds: ATORVASTATIN; TEMAZEPAM; BUPROPION HYDROCHLORIDE

Current Illness:

ID: 1635286
Sex: F
Age: 43
State: TX

Vax Date: 03/15/2021
Onset Date: 03/16/2021
Rec V Date: 08/26/2021
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: vision and anxiety; fever; permanent ringing on her head, intense headaches; This spontaneous case was reported by a consumer and describes the occurrence of ANXIETY (vision and anxiety), HEADACHE (permanent ringing on her head, intense headaches) and PYREXIA (fever) in a 43-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 031a21a and 008b21a) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included CALCIUM CARBONATE, COLECALCIFEROL (VITAMIN D 2000) for an unknown indication. On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Mar-2021, the patient experienced HEADACHE (permanent ringing on her head, intense headaches). On 12-Apr-2021, the patient experienced ANXIETY (vision and anxiety) and PYREXIA (fever). At the time of the report, ANXIETY (vision and anxiety), HEADACHE (permanent ringing on her head, intense headaches) and PYREXIA (fever) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) and mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Other Concomitant Medication provided was Cholesterol medication and Gastritis medication. No treatment was provided. This case was linked to MOD-2021-092382 (Patient Link).

Other Meds: VITAMIN D 2000

Current Illness:

ID: 1635287
Sex: F
Age: 39
State: GA

Vax Date: 02/02/2021
Onset Date: 02/02/2021
Rec V Date: 08/26/2021
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: dime sized raised scar mark at injection site of left arm; red scar mark at injection site of left arm; Flu like symptoms; fever; chills; soreness at injection site of left arm; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (soreness at injection site of left arm), INFLUENZA LIKE ILLNESS (Flu like symptoms), PYREXIA (fever), CHILLS (chills) and SCAR (dime sized raised scar mark at injection site of left arm) in a 39-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 012L20A and 013A21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history was provided by the reporter. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 02-Feb-2021, the patient experienced VACCINATION SITE PAIN (soreness at injection site of left arm). On 02-Mar-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu like symptoms), PYREXIA (fever) and CHILLS (chills). On an unknown date, the patient experienced SCAR (dime sized raised scar mark at injection site of left arm) and INJECTION SITE SCAR (red scar mark at injection site of left arm). The patient was treated with IBUPROFEN (ADVIL [IBUPROFEN]) for Antidepressant therapy, at an unspecified dose and frequency and PARACETAMOL (TYLENOL) at an unspecified dose and frequency. At the time of the report, VACCINATION SITE PAIN (soreness at injection site of left arm), INFLUENZA LIKE ILLNESS (Flu like symptoms), PYREXIA (fever), CHILLS (chills), SCAR (dime sized raised scar mark at injection site of left arm) and INJECTION SITE SCAR (red scar mark at injection site of left arm) outcome was unknown. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment with Advil medication was provided for first dose events. This case was linked to US-MODERNATX, INC.-MOD-2021-092455 (Linked Report).; Sender's Comments: US-MODERNATX, INC.-MOD-2021-092455:2nd Dose events

Other Meds:

Current Illness:

ID: 1635288
Sex: F
Age:
State: NY

Vax Date:
Onset Date: 01/01/2021
Rec V Date: 08/26/2021
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: Itching on 8th day after 1st vaccine; redness on 8th day after 1st vaccine; swollen arm on 8th day after 1st vaccine; Itching on Injection Site; This spontaneous case was reported by a consumer and describes the occurrence of PRURITUS (Itching on 8th day after 1st vaccine), ERYTHEMA (redness on 8th day after 1st vaccine), PERIPHERAL SWELLING (swollen arm on 8th day after 1st vaccine) and VACCINATION SITE PRURITUS (Itching on Injection Site) in an 82-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 120L20A) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jan-2021, the patient experienced VACCINATION SITE PRURITUS (Itching on Injection Site). On an unknown date, the patient experienced PRURITUS (Itching on 8th day after 1st vaccine), ERYTHEMA (redness on 8th day after 1st vaccine) and PERIPHERAL SWELLING (swollen arm on 8th day after 1st vaccine). On 12-Feb-2021, VACCINATION SITE PRURITUS (Itching on Injection Site) had resolved. At the time of the report, PRURITUS (Itching on 8th day after 1st vaccine), ERYTHEMA (redness on 8th day after 1st vaccine) and PERIPHERAL SWELLING (swollen arm on 8th day after 1st vaccine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Concomitant information was not provided. Treatment information was nor provided. This case was linked to US-MODERNATX, INC.-MOD-2021-092047, US-MODERNATX, INC.-MOD-2021-028972 (E2B Linked Report). This case was linked to MOD-2021-091728 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Additional information received On 29-Jun-2021: F/U-2 : To confirm NNI; Sender's Comments: US-MODERNATX, INC.-MOD-2021-092047:Daughter's case US-MODERNATX, INC.-MOD-2021-028972:Son-in-law case -Phone number is same in mother case and this case

Other Meds:

Current Illness:

ID: 1635289
Sex: M
Age: 74
State: NY

Vax Date: 02/26/2021
Onset Date: 03/24/2021
Rec V Date: 08/26/2021
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: Test Date: 20210318; Test Name: COVID-19 Test; Test Result: Negative ; Result Unstructured Data: Negative; Test Date: 20210324; Test Name: COVID-19 Test; Test Result: Positive ; Result Unstructured Data: Positive; Test Date: 20210409; Test Name: COVID-19 Test; Test Result: Negative ; Result Unstructured Data: On 8-9 Apr 2021

Allergies:

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

Symptoms: Drowsiness; stuffy nose; fatigue; now a month past his scheduled second dose appointment; tested positive for COVID; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (now a month past his scheduled second dose appointment), SOMNOLENCE (Drowsiness), COVID-19 (tested positive for COVID), NASAL CONGESTION (stuffy nose) and FATIGUE (fatigue) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 025A21A) for COVID-19 vaccination. No concomitant medications provided. On 26-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 24-Mar-2021, the patient experienced COVID-19 (tested positive for COVID). On 27-Mar-2021, the patient experienced PRODUCT DOSE OMISSION ISSUE (now a month past his scheduled second dose appointment). On an unknown date, the patient experienced SOMNOLENCE (Drowsiness), NASAL CONGESTION (stuffy nose) and FATIGUE (fatigue). At the time of the report, PRODUCT DOSE OMISSION ISSUE (now a month past his scheduled second dose appointment) had resolved and SOMNOLENCE (Drowsiness), COVID-19 (tested positive for COVID), NASAL CONGESTION (stuffy nose) and FATIGUE (fatigue) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 18-Mar-2021, SARS-CoV-2 test: negative Negative. On 24-Mar-2021, SARS-CoV-2 test: positive Positive. On 09-Apr-2021, SARS-CoV-2 test: negative (Negative) On 8-9 Apr 2021. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant drug was not reported. Treatment medication was not reported. .Patient received first dose on 26 Feb 2021 with lot (025A21A) in left upper arm(non-dominant). He was a little drowsy, fatigue and stuffy nose after first dose. He was scheduled for second dose on 26 March. On 15 March exposed to COVID, 18 March tested negative for COVID at urgent care, 24 March tested positive for COVID. He quarantined. He tested negative for COVID around 8-9 April. Patient is now a month past his scheduled second dose appointment. Most recent FOLLOW-UP information incorporated above includes: On 10-May-2021: Added Patient's phone number.

Other Meds:

Current Illness:

ID: 1635290
Sex: M
Age:
State: GA

Vax Date:
Onset Date:
Rec V Date: 08/26/2021
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: Deathly sick; Diarrhea; Weak; Throwing up; Running a fever; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Deathly sick), DIARRHOEA (Diarrhea), ASTHENIA (Weak), VOMITING (Throwing up) and PYREXIA (Running a fever) in a male patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced MALAISE (Deathly sick), DIARRHOEA (Diarrhea), ASTHENIA (Weak), VOMITING (Throwing up) and PYREXIA (Running a fever). At the time of the report, MALAISE (Deathly sick), DIARRHOEA (Diarrhea), ASTHENIA (Weak), VOMITING (Throwing up) and PYREXIA (Running a fever) outcome was unknown. No concomitant medications were provided. No treatment details pertained to the events were provided. The action taken with mRNA-1273 in response to the events was not applicable. This case was linked to MOD-2021-092650 (Patient Link).

Other Meds:

Current Illness:

ID: 1635291
Sex: F
Age: 65
State: MN

Vax Date: 03/26/2021
Onset Date: 04/23/2021
Rec V Date: 08/26/2021
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: injection site lump size of a quarter; slight sore throat; injection site soreness; headache; This spontaneous case was reported by a consumer and describes the occurrence of INJECTION SITE MASS (injection site lump size of a quarter), OROPHARYNGEAL PAIN (slight sore throat), INJECTION SITE PAIN (injection site soreness) and HEADACHE (headache) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 001C21A) for COVID-19 vaccination. No Medical History information was reported. On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 23-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 2 dosage form. On 23-Apr-2021, the patient experienced INJECTION SITE MASS (injection site lump size of a quarter), OROPHARYNGEAL PAIN (slight sore throat), INJECTION SITE PAIN (injection site soreness) and HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency and HYDROCORTISONE ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, INJECTION SITE MASS (injection site lump size of a quarter), OROPHARYNGEAL PAIN (slight sore throat), INJECTION SITE PAIN (injection site soreness) and HEADACHE (headache) outcome was unknown. Patient stated that she received her second shot on 23Apr2021 (Lot # 001C21A) and now she experiencing injection site soreness and a lump at the injection site, the size of a quarter. Caller also had a headache and slight sore throat.

Other Meds:

Current Illness:

ID: 1635292
Sex: M
Age: 70
State: PA

Vax Date: 04/16/2021
Onset Date:
Rec V Date: 08/26/2021
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: Itchy rash on thigh and arm; rash feels scaly and hardens; This spontaneous case was reported by a consumer and describes the occurrence of RASH PRURITIC (Itchy rash on thigh and arm) and EXFOLIATIVE RASH (rash feels scaly and hardens) in a 70-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 020B21A) for COVID-19 vaccination. No Medical History information was reported. On 16-Apr-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH PRURITIC (Itchy rash on thigh and arm) and EXFOLIATIVE RASH (rash feels scaly and hardens). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at an unspecified dose and frequency. At the time of the report, RASH PRURITIC (Itchy rash on thigh and arm) and EXFOLIATIVE RASH (rash feels scaly and hardens) outcome was unknown. Not Provided No concomitant medication was reported.Treatment medication included Benadryl lotion. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was not applicable. This case was linked to MOD-2021-066515 (Patient Link).

Other Meds:

Current Illness:

ID: 1635293
Sex: M
Age: 64
State: MO

Vax Date: 04/15/2021
Onset Date: 04/15/2021
Rec V Date: 08/26/2021
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: surgery scheduled before date of 2nd dose.; sore arm at vaccine site. right arm; This spontaneous case was reported by a consumer and describes the occurrence of PREOPERATIVE CARE (surgery scheduled before date of 2nd dose.) and VACCINATION SITE PAIN (sore arm at vaccine site. right arm) in a 64-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 019B21A) for COVID-19 vaccination. No Medical History information was reported. On 15-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Apr-2021, the patient experienced VACCINATION SITE PAIN (sore arm at vaccine site. right arm). On an unknown date, the patient experienced PREOPERATIVE CARE (surgery scheduled before date of 2nd dose.). In April 2021, VACCINATION SITE PAIN (sore arm at vaccine site. right arm) had resolved. At the time of the report, PREOPERATIVE CARE (surgery scheduled before date of 2nd dose.) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Concomitant medications were not provided. Treatment information was not provided. Patient had 2nd dose and no issues. Most recent FOLLOW-UP information incorporated above includes: On 28-May-2021: Follow-up information received on 28-MAY-2021 contains non-significant information.

Other Meds:

Current Illness:

ID: 1635294
Sex: F
Age:
State: NC

Vax Date: 02/02/2021
Onset Date: 03/04/2021
Rec V Date: 08/26/2021
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: Heat slightly below area of injection; Rash slightly below area of injection; Redness slightly below area of injection; This spontaneous case was reported by a consumer and describes the occurrence of FEELING HOT (Heat slightly below area of injection), RASH (Rash slightly below area of injection) and ERYTHEMA (Redness slightly below area of injection) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 003A21A and 012M204) for COVID-19 vaccination. Concurrent medical conditions included Thyroid nodule since 1992. Concomitant products included LEVOTHYROXINE for Thyroid nodule, CENTRUM SILVER WOMEN 50+, ZINC, NICOTINAMIDE, PYRIDOXINE HYDROCHLORIDE, RIBOFLAVIN, THIAMINE HYDROCHLORIDE (VITAMIN-B COMPLEX), BIOTIN, VITAMIN D NOS, ACETYLSALICYLIC ACID (ASPIRIN 81) and PSYLLIUM HUSK [PLANTAGO OVATA HUSK] for an unknown indication. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Mar-2021, the patient experienced FEELING HOT (Heat slightly below area of injection), RASH (Rash slightly below area of injection) and ERYTHEMA (Redness slightly below area of injection). On 05-Mar-2021, FEELING HOT (Heat slightly below area of injection), RASH (Rash slightly below area of injection) and ERYTHEMA (Redness slightly below area of injection) had resolved. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment was provided by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 06-Aug-2021: Non significant Information updated.

Other Meds: LEVOTHYROXINE; CENTRUM SILVER WOMEN 50+; ZINC; VITAMIN-B COMPLEX; BIOTIN; VITAMIN D NOS; ASPIRIN 81; PSYLLIUM HUSK [PLANTAGO OVATA HUSK]

Current Illness: Thyroid nodule

ID: 1635295
Sex: F
Age: 73
State: CT

Vax Date: 04/01/2021
Onset Date: 04/01/2021
Rec V Date: 08/26/2021
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: Vaginal bleeding; Felt tired; This spontaneous case was reported by a consumer and describes the occurrence of VAGINAL HAEMORRHAGE (Vaginal bleeding) and FATIGUE (Felt tired) in a 73-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 01-Apr-2021, the patient received 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 01-Apr-2021, the patient experienced VAGINAL HAEMORRHAGE (Vaginal bleeding) and FATIGUE (Felt tired). At the time of the report, VAGINAL HAEMORRHAGE (Vaginal bleeding) had not resolved and FATIGUE (Felt tired) outcome was unknown. Concomitant products included Blood pressure medications. Treatment information was unknown. Most recent FOLLOW-UP information incorporated above includes: On 03-Jun-2021: Follow up received on 03-JUN-2021, contain significant follow up information including outcome of events not resolved. contact information updated

Other Meds:

Current Illness:

ID: 1635296
Sex: F
Age: 76
State: AZ

Vax Date: 04/26/2021
Onset Date: 04/27/2021
Rec V Date: 08/26/2021
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: swollen lip,upper lip that is hard and swollen; Aches and pains; fever; This spontaneous case was reported by a physician and describes the occurrence of LIP SWELLING (swollen lip,upper lip that is hard and swollen), PAIN (Aches and pains) and PYREXIA (fever) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007C21A) for COVID-19 vaccination. Concurrent medical conditions included High cholesterol. Concomitant products included ATORVASTATIN CALCIUM (LIPICOR) for High cholesterol. On 26-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-Apr-2021, the patient experienced PAIN (Aches and pains) and PYREXIA (fever). On 28-Apr-2021, the patient experienced LIP SWELLING (swollen lip,upper lip that is hard and swollen). On 27-Apr-2021, PAIN (Aches and pains) and PYREXIA (fever) had resolved. At the time of the report, LIP SWELLING (swollen lip,upper lip that is hard and swollen) 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. Treatment details was not reported by the reporter.

Other Meds: LIPICOR

Current Illness: High cholesterol

ID: 1635297
Sex: F
Age: 63
State: MN

Vax Date: 03/25/2021
Onset Date:
Rec V Date: 08/26/2021
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: Some discomfort; Mild headache; This spontaneous case was reported by a consumer and describes the occurrence of DISCOMFORT (Some discomfort) and HEADACHE (Mild headache) in a 63-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 25-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced DISCOMFORT (Some discomfort) and HEADACHE (Mild headache). The patient was treated with TRAMADOL at an unspecified dose and frequency. At the time of the report, DISCOMFORT (Some discomfort) and HEADACHE (Mild headache) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. This case was linked to MOD-2021-094832 (Patient Link).

Other Meds:

Current Illness:

ID: 1635298
Sex: F
Age:
State: NY

Vax Date: 04/02/2021
Onset Date: 04/02/2021
Rec V Date: 08/26/2021
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: Itchiness on neck / mouth / face; Feel weird for 6 days; Sore throat; Watery eye; This spontaneous case was reported by a consumer and describes the occurrence of OROPHARYNGEAL PAIN (Sore throat), LACRIMATION INCREASED (Watery eye), PRURITUS (Itchiness on neck / mouth / face) and FEELING ABNORMAL (Feel weird for 6 days) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031B21A) for COVID-19 vaccination. No Medical History information was reported. On 02-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 02-Apr-2021, the patient experienced OROPHARYNGEAL PAIN (Sore throat), LACRIMATION INCREASED (Watery eye) and FEELING ABNORMAL (Feel weird for 6 days). On an unknown date, the patient experienced PRURITUS (Itchiness on neck / mouth / face). On 07-Apr-2021, FEELING ABNORMAL (Feel weird for 6 days) had resolved. At the time of the report, OROPHARYNGEAL PAIN (Sore throat), LACRIMATION INCREASED (Watery eye) and PRURITUS (Itchiness on neck / mouth / face) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No relevant concomitant medications were reported. Treatment Medications were not provided by the reporter.

Other Meds:

Current Illness:

ID: 1635299
Sex: M
Age: 35
State: MT

Vax Date: 03/30/2021
Onset Date: 03/30/2021
Rec V Date: 08/26/2021
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: mild body aches; low grade fever; This spontaneous case was reported by a health care professional and describes the occurrence of PAIN (mild body aches) and PYREXIA (low grade fever) in a 36-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 038A21A) for COVID-19 vaccination. No Medical History information was reported. On 30-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 30-Mar-2021, the patient experienced PAIN (mild body aches) and PYREXIA (low grade fever). On 31-Mar-2021, PAIN (mild body aches) and PYREXIA (low grade fever) 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. First dose was given on 30Mar2021, Lot# 038A21A, IM injection in the right arm (non-dominant) symptoms started same day he had low grade fever, mild body aches lasted for 24 hours. This case was linked to MOD-2021-094896 (Patient Link).

Other Meds:

Current Illness:

ID: 1635300
Sex: F
Age: 35
State: TX

Vax Date: 04/27/2021
Onset Date: 04/28/2021
Rec V Date: 08/26/2021
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: Low grade fever; Chills; Cough; Body aches; This spontaneous case was reported by a consumer and describes the occurrence of PYREXIA (Low grade fever), CHILLS (Chills), COUGH (Cough) and MYALGIA (Body aches) in a 35-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 reaction. On 27-Apr-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 28-Apr-2021, the patient experienced PYREXIA (Low grade fever), CHILLS (Chills), COUGH (Cough) and MYALGIA (Body aches). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, PYREXIA (Low grade fever), CHILLS (Chills), COUGH (Cough) and MYALGIA (Body aches) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication was reported.

Other Meds:

Current Illness:

ID: 1635301
Sex: F
Age:
State:

Vax Date: 03/26/2021
Onset Date:
Rec V Date: 08/26/2021
Hospital:

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

Lab Data:

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: red, itchy spot 3-4 inches down from the injection site; Itchy spot 3-4 inches down from the injection site; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE ERYTHEMA (red, itchy spot 3-4 inches down from the injection site) and VACCINATION SITE PRURITUS (Itchy spot 3-4 inches down from the injection site) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007B21A) for COVID-19 vaccination. The patient's past medical history included No adverse event. On 26-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION SITE ERYTHEMA (red, itchy spot 3-4 inches down from the injection site) and VACCINATION SITE PRURITUS (Itchy spot 3-4 inches down from the injection site). At the time of the report, VACCINATION SITE ERYTHEMA (red, itchy spot 3-4 inches down from the injection site) and VACCINATION SITE PRURITUS (Itchy spot 3-4 inches down from the injection site) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment medicines were not reported.

Other Meds:

Current Illness:

ID: 1635302
Sex: F
Age: 88
State: TX

Vax Date: 03/15/2021
Onset Date:
Rec V Date: 08/26/2021
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: Cancelled second dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Cancelled second dose) in an 88-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031A21A) for COVID-19 vaccination. No Medical History information was reported. On 15-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Cancelled second dose). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Cancelled second dose) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments.

Other Meds:

Current Illness:

ID: 1635303
Sex: F
Age: 66
State: VT

Vax Date: 04/02/2021
Onset Date: 04/22/2021
Rec V Date: 08/26/2021
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 Date: 20210422; Test Name: Blood work; Result Unstructured Data: Elevated Sedimentation rate

Allergies:

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

Symptoms: Elevated sedimentation Rate; This spontaneous case was reported by a consumer and describes the occurrence of RED BLOOD CELL SEDIMENTATION RATE INCREASED (Elevated sedimentation Rate) in a 66-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 036A21A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included PAROXETINE HYDROCHLORIDE (PAXIL [PAROXETINE HYDROCHLORIDE]) and LORAZEPAM for an unknown indication. On 02-Apr-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-Apr-2021, the patient experienced RED BLOOD CELL SEDIMENTATION RATE INCREASED (Elevated sedimentation Rate). At the time of the report, RED BLOOD CELL SEDIMENTATION RATE INCREASED (Elevated sedimentation Rate) outcome was unknown. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 22-Apr-2021, Blood test: unknown (High) Elevated Sedimentation rate. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. Treatment information was not provided.

Other Meds: PAXIL [PAROXETINE HYDROCHLORIDE]; LORAZEPAM

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am