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: 1635705
Sex: F
Age: 74
State: MO

Vax Date: 04/28/2021
Onset Date: 05/29/2012
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: 20210529; Test Name: Heart rate; Result Unstructured Data: Low

Allergies:

Symptom List: Dysphagia, Epiglottitis

Symptoms: High blood pressure; Low blood pressure reading sometime; When i got the second shot i had after reactions to it; Erractic heart beat; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION COMPLICATION (When i got the second shot i had after reactions to it), HEART RATE IRREGULAR (Erractic heart beat), HYPERTENSION (High blood pressure) and HYPOTENSION (Low blood pressure reading sometime) in a 75-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 019B21A and 019B21A) for COVID-19 vaccination. The patient's past medical history included Parathyroid gland excision (Removed it 5 years back.). Concurrent medical conditions included Drug allergy (Statins Hmg Coa Reductase inhibitors), Drug allergy (Doxycycline), Drug allergy (Levothyroxine (Synthroid)), Drug allergy (Ibuprofen) and Hypercholesterolemia (Patient was told this was genetic by the endocrinologist.) since 1985. Concomitant products included FISH OIL for High cholesterol, MULTIVITAMIN [VITAMINS NOS], CURCUMA LONGA (TURMERIC [CURCUMA LONGA]) and CALCIUM for an unknown indication. On 28-Apr-2021 at 9:15 AM, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 26-May-2021 at 9:15 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 29-May-2012 at 6:00 AM, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced HEART RATE IRREGULAR (Erractic heart beat). On 29-May-2019, the patient experienced VACCINATION COMPLICATION (When I got the second shot I had after reactions to it). On 29-May-2021 at 6:00 AM, the patient experienced HYPERTENSION (High blood pressure) and HYPOTENSION (Low blood pressure reading sometime). At the time of the report, VACCINATION COMPLICATION (When i got the second shot i had after reactions to it), HEART RATE IRREGULAR (Erractic heart beat), HYPERTENSION (High blood pressure) and HYPOTENSION (Low blood pressure reading sometime) was resolving. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 29-May-2021, Heart rate: low (Low) Low. Treatment information was not provided. This case was linked to MOD-2021-122775 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 05-Jul-2021: Patient demographics updated, medical history added, and dose 2 information updated. Dose 2 events added. On 08-Jul-2021: Follow up received contains No new information. On 06-Aug-2021: Follow up received contains no new information.

Other Meds: MULTIVITAMIN [VITAMINS NOS]; FISH OIL; TURMERIC [CURCUMA LONGA]; CALCIUM

Current Illness: Drug allergy (Statins Hmg Coa Reductase inhibitors); Drug allergy (Levothyroxine (Synthroid)); Drug allergy (Ibuprofen); Drug allergy (Doxycycline); Hypercholesterolemia (Patient was told this was genetic by the endocrinologist.)

ID: 1635706
Sex: M
Age:
State: WA

Vax Date: 01/15/2021
Onset Date: 01/16/2021
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: got really sick; red dot on left arm; shakes; sweating; injection site itchy; injection site is the size of a baseball,injection site is growing; injection site painful; shaking; fever; muscle aches; exhaustion; headache; This spontaneous case was reported by a consumer and describes the occurrence of ILLNESS (got really sick), MACULE (red dot on left arm), TREMOR (shakes), HYPERHIDROSIS (sweating) and VACCINATION SITE PRURITUS (injection site itchy) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 037K20A and 010M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No medical history information was provided. Concomitant products included FINASTERIDE (PROPECIA), CITALOPRAM and PROPRANOLOL for an unknown indication. On 15-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 12-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 16-Jan-2021, the patient experienced ILLNESS (got really sick), MACULE (red dot on left arm), TREMOR (shakes), HYPERHIDROSIS (sweating), VACCINATION SITE PRURITUS (injection site itchy), VACCINATION SITE SWELLING (injection site is the size of a baseball,injection site is growing), VACCINATION SITE PAIN (injection site painful), TREMOR (shaking), PYREXIA (fever), MYALGIA (muscle aches), FATIGUE (exhaustion) and HEADACHE (headache). At the time of the report, ILLNESS (got really sick), MACULE (red dot on left arm), TREMOR (shakes), HYPERHIDROSIS (sweating), VACCINATION SITE PRURITUS (injection site itchy), VACCINATION SITE SWELLING (injection site is the size of a baseball,injection site is growing), VACCINATION SITE PAIN (injection site painful), TREMOR (shaking), PYREXIA (fever), MYALGIA (muscle aches), FATIGUE (exhaustion) and HEADACHE (headache) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment drug details was provided. This case was linked to MOD-2021-245590 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 02-Jul-2021: The follow-up document added on 02-jun-2021. Two new events were added, concomitants were added and Batch no for 2nd dose was also added.

Other Meds: PROPECIA; CITALOPRAM; PROPRANOLOL

Current Illness:

ID: 1635707
Sex: U
Age:
State:

Vax Date: 04/29/2021
Onset Date: 04/30/2021
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:

Allergies:

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

Symptoms: Missed his/her 2nd dose, more than 42 days; I broke out in hives after the 1st dose; I was fatigued after the 1st dose; Chills after the 1st dose; This spontaneous case was reported by a consumer and describes the occurrence of PRODUCT DOSE OMISSION ISSUE (Missed his/her 2nd dose, more than 42 days), URTICARIA (I broke out in hives after the 1st dose), FATIGUE (I was fatigued after the 1st dose) and CHILLS (Chills after the 1st dose) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 29-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 30-Apr-2021, the patient experienced FATIGUE (I was fatigued after the 1st dose) and CHILLS (Chills after the 1st dose). On 01-May-2021, the patient experienced URTICARIA (I broke out in hives after the 1st dose). On an unknown date, the patient experienced PRODUCT DOSE OMISSION ISSUE (Missed his/her 2nd dose, more than 42 days). At the time of the report, PRODUCT DOSE OMISSION ISSUE (Missed his/her 2nd dose, more than 42 days), URTICARIA (I broke out in hives after the 1st dose), FATIGUE (I was fatigued after the 1st dose) and CHILLS (Chills after the 1st dose) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant medication not reported. Treatment medication not provided.

Other Meds:

Current Illness:

ID: 1635708
Sex: F
Age: 27
State: CA

Vax Date: 01/13/2021
Onset Date: 02/10/2021
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: headache; This spontaneous case was reported by a nurse and describes the occurrence of HEADACHE (headache) in a 27-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 13-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 10-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 10-Feb-2021, the patient experienced HEADACHE (headache). The patient was treated with PARACETAMOL (TYLENOL) for Headache, at a dose of 1 dosage form. At the time of the report, HEADACHE (headache) outcome was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown), the reporter did not provide any causality assessments. No concomitant medication information was provided. Action taken with mRNA-1273 in response to the events was not applicable.

Other Meds:

Current Illness:

ID: 1635709
Sex: U
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: Injection site erythema, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: swollen lymph node; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (swollen lymph node) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced LYMPHADENOPATHY (swollen lymph node). At the time of the report, LYMPHADENOPATHY (swollen lymph node) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant product use was not provided by the reporter. Treatment information was not provided.

Other Meds:

Current Illness:

ID: 1635710
Sex: F
Age:
State: WA

Vax Date: 01/01/2021
Onset Date: 01/05/2021
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: Injection site reaction; Tenderness of the skin 2-3 inches from the injection site; Swelling of the skin 2-3 inches from the injection site; Redness in her skin; This spontaneous case was reported by a health care professional and describes the occurrence of VACCINATION SITE REACTION (Injection site reaction), VACCINATION SITE PAIN (Tenderness of the skin 2-3 inches from the injection site), VACCINATION SITE SWELLING (Swelling of the skin 2-3 inches from the injection site) and VACCINATION SITE ERYTHEMA (Redness in her skin) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 01-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Jan-2021, the patient experienced VACCINATION SITE PAIN (Tenderness of the skin 2-3 inches from the injection site), VACCINATION SITE SWELLING (Swelling of the skin 2-3 inches from the injection site) and VACCINATION SITE ERYTHEMA (Redness in her skin). On an unknown date, the patient experienced VACCINATION SITE REACTION (Injection site reaction). At the time of the report, VACCINATION SITE REACTION (Injection site reaction), VACCINATION SITE PAIN (Tenderness of the skin 2-3 inches from the injection site), VACCINATION SITE SWELLING (Swelling of the skin 2-3 inches from the injection site) and VACCINATION SITE ERYTHEMA (Redness in her skin) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication include birth control pills. No treatment information provided. This case was linked to MOD-2021-004542 (Patient Link). Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1635711
Sex: F
Age:
State: MD

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: Pyrexia, White blood cell count decreased

Symptoms: This spontaneous case reported by a consumer, describes the occurrence of pain in extremity (arm felt really bad for a couple of days) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On an unknown date, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), unknown route; 1 dosage form. On an unknown date, patient experienced pain in extremity (arm felt really bad for a couple of days). At the time of the report, pain in extremity (arm felt really bad for a couple of days) resolved. No concomitant medication use or treatment of events provided. This case linked to MOD-2021-132115 (patient link).

Other Meds:

Current Illness:

ID: 1635712
Sex: F
Age: 42
State: NY

Vax Date: 12/26/2020
Onset Date: 01/23/2021
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: Test Name: body temperature; Result Unstructured Data: 99.1?F; Test Name: body temperature; Result Unstructured Data: 99.9?F

Allergies:

Symptom List: Pharyngeal swelling

Symptoms: Serum sickness; bronchitis; Hives; urticaria/dermatographism; urticaria/dermatographism; adverse reaction to Moderna COVID-19 vaccine; 3rd dose of Modema COVID-19 vaccine; aerobic bacteria; acne; Bug bite; Body temperature increased; chills; autoimmune disorder; insect bites noted, with some surrounding cellulitis; Short term memory loss; Vertigo; cough; Itchy all over body; Vomitting; Nausea; Rashes on both arms; This spontaneous case was reported by a consumer and describes the occurrence of AUTOIMMUNE DISORDER (autoimmune disorder) and CELLULITIS (insect bites noted, with some surrounding cellulitis) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 013L20A and 039K20-2A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Drug allergy, Drug allergy (NSAIDS) and Allergy to vaccine. Concomitant products included MUPIROCIN for an unknown indication. On 26-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Jan-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 23-Jan-2021, the patient experienced PRURITUS (Itchy all over body), VOMITING (Vomitting), NAUSEA (Nausea) and RASH (Rashes on both arms). On an unknown date, the patient experienced AUTOIMMUNE DISORDER (autoimmune disorder) (seriousness criterion medically significant), CELLULITIS (insect bites noted, with some surrounding cellulitis) (seriousness criterion medically significant), AMNESIA (Short term memory loss), VERTIGO (Vertigo), COUGH (cough), SERUM SICKNESS (Serum sickness), BRONCHITIS (bronchitis), URTICARIA (Hives), MECHANICAL URTICARIA (urticaria/dermatographism), URTICARIA (urticaria/dermatographism), VACCINATION COMPLICATION (adverse reaction to Moderna COVID-19 vaccine), OVERDOSE (3rd dose of Modema COVID-19 vaccine), BACTERIAL INFECTION (aerobic bacteria), ACNE (acne), ARTHROPOD BITE (Bug bite), BODY TEMPERATURE INCREASED (Body temperature increased) and CHILLS (chills). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (intramuscular) on 23-Jan-2021 at a dose of 50 mg/1 mL; TRIAMCINOLONE for Skin rash, at a dose of UNK, bid and CEFALEXIN (CEPHALEXINE) (oral) for Bacterial infection, at a dose of UNK, bid. At the time of the report, AUTOIMMUNE DISORDER (autoimmune disorder), CELLULITIS (insect bites noted, with some surrounding cellulitis), COUGH (cough), PRURITUS (Itchy all over body), SERUM SICKNESS (Serum sickness), BRONCHITIS (bronchitis), URTICARIA (Hives), MECHANICAL URTICARIA (urticaria/dermatographism), URTICARIA (urticaria/dermatographism), VACCINATION COMPLICATION (adverse reaction to Moderna COVID-19 vaccine), BACTERIAL INFECTION (aerobic bacteria), ACNE (acne), ARTHROPOD BITE (Bug bite), BODY TEMPERATURE INCREASED (Body temperature increased), CHILLS (chills), VOMITING (Vomitting), NAUSEA (Nausea) and RASH (Rashes on both arms) outcome was unknown, AMNESIA (Short term memory loss) and VERTIGO (Vertigo) had not resolved and OVERDOSE (3rd dose of Modema COVID-19 vaccine) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, Body temperature: 99.1 (High) 99.1?F and 99.9 (High) 99.9?F. High spike protein was noted Crosslinked with MOD21-119344 and others The patient need to be treated with a combination of antihistamines which would cause drowsiness, need to be executed for 2 weeks. The patient took Hydroxycholorqine an hour before her 3rd dose of Modema COVID-19 vaccine and no adverse reaction. The patient started Keflex Capsule, 500 MG, 1 capsule, Orally, BID, 10 days, 20 Capsule, Refills include O. The patient also had been swabbed for a culture for her acne and her lab results showed she had aerobic bacteria. The patient had Staph infection. Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. This case was linked to MOD-2021-064882 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 13-Jul-2021: Additional information received contains Non significant Information. On 13-Jul-2021: Additional information received new events were added On 13-Jul-2021: additional info received included no new significant information On 14-Jul-2021: Significant Follow Up included newevents (Bronchitis, Hives) updated. On 14-Jul-2021: Follow up correspondence attached included no new information On 14-Jul-2021: NNI Case On 14-Aug-2021: Follow-up received included: Medical history allergies to morphine derivatives, NSAIDS and COVID19 Vaccine IModerna were added. Lab data body temperature was added. Concomitant medication Mupirocin was added and treatment medications Triamcinolone and Cephalexin were added. Events Vertigo, short term memory loss, body temperature increased, urticaria, Dermatographism, chills, 3rd dose of Modema COVID-19 vaccine, autoimmune disorder, adverse reaction to Moderna COVID-19 vaccine, aerobic bacteria and acne were added.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded.

Other Meds: MUPIROCIN

Current Illness: Allergy to vaccine; Drug allergy (NSAIDS); Drug allergy

ID: 1635713
Sex: F
Age: 71
State: NY

Vax Date: 03/04/2021
Onset Date: 04/04/2021
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: Abdominal pain, Chills, Sleep disorder

Symptoms: Tinnitus; headache; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of TINNITUS (Tinnitus) and HEADACHE (headache) in a 72-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038A421A and 038A421A) for COVID-19 vaccination. Concurrent medical conditions included Seasonal allergy and Pollen allergy. Concomitant products included MULTIVITAMIN [VITAMINS NOS] and CLARITHROMYCIN (CLARITIN [CLARITHROMYCIN]) for an unknown indication. On 04-Mar-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-Apr-2021, the patient experienced TINNITUS (Tinnitus) and HEADACHE (headache). At the time of the report, TINNITUS (Tinnitus) and HEADACHE (headache) outcome was unknown. Concomitant medication also included unspecified spray for nose. Treatment medication was not reported.

Other Meds: MULTIVITAMIN [VITAMINS NOS]; CLARITIN [CLARITHROMYCIN]

Current Illness: Pollen allergy; Seasonal allergy

ID: 1635714
Sex: F
Age: 37
State: IL

Vax Date: 05/27/2021
Onset Date: 05/27/2021
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: Test Name: Blood pressure; Result Unstructured Data: her normal blood pressure was 106/72; Test Date: 20210527; Test Name: Blood pressure; Result Unstructured Data: following the first shot of vaccine BP was 140/90; Test Date: 20210527; Test Name: EKG; Result Unstructured Data: normal

Allergies:

Symptom List: Diarrhoea, Nasal congestion

Symptoms: Shortness of breath; Confused; Tightness in chest; Chest pain; Blood pressure high; Blood pressure increased from 106/72 mmhg to 140/90 mmHg; Headache; This spontaneous case was reported by a pharmacist (subsequently medically confirmed) and describes the occurrence of DYSPNOEA (Shortness of breath), CONFUSIONAL STATE (Confused), CHEST DISCOMFORT (Tightness in chest), CHEST PAIN (Chest pain) and HYPERTENSION (Blood pressure high) in a 37-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 022B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concomitant products included ESTRADIOL and GABAPENTIN for an unknown indication. On 27-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 27-May-2021, the patient experienced DYSPNOEA (Shortness of breath), CONFUSIONAL STATE (Confused), CHEST DISCOMFORT (Tightness in chest), CHEST PAIN (Chest pain), HYPERTENSION (Blood pressure high) and HEADACHE (Headache). 27-May-2021, the patient experienced BLOOD PRESSURE INCREASED (Blood pressure increased from 106/72 mmhg to 140/90 mmHg). On 27-May-2021, DYSPNOEA (Shortness of breath), CONFUSIONAL STATE (Confused), CHEST DISCOMFORT (Tightness in chest), CHEST PAIN (Chest pain), HYPERTENSION (Blood pressure high), BLOOD PRESSURE INCREASED (Blood pressure increased from 106/72 mmhg to 140/90 mmHg) and HEADACHE (Headache) had resolved. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 27-May-2021, Blood pressure measurement: 140/90 mmHg (abnormal) following the first shot of vaccine BP was 140/90. On 27-May-2021, Electrocardiogram: normal (normal) normal. On an unknown date, Blood pressure measurement: 106/72 mmHg (normal) her normal blood pressure was 106/72. 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. The patient reported 20 minutes after vaccination shot she experienced the reported adverse events for 30 seconds. The patient was transported to the ER and was discharged within 2 hrs. The treatment medications relevant to events were not reported. Company Comment: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.; Sender's Comments: Based on the current available information and temporal association between the use of the product and the start date of the events, a causal relationship cannot be excluded. Further information has been requested.

Other Meds: ESTRADIOL; GABAPENTIN

Current Illness:

ID: 1635715
Sex: M
Age:
State:

Vax Date: 04/20/2021
Onset Date: 04/21/2021
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: 20210421; Test Name: Body temperature; Result Unstructured Data: 38C, 38.4C

Allergies:

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

Symptoms: Feeling unwell; Temperature 38C/Temperature 38.4C; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (Feeling unwell) and PYREXIA (Temperature 38C/Temperature 38.4C) 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 20-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 21-Apr-2021, the patient experienced MALAISE (Feeling unwell) and PYREXIA (Temperature 38C/Temperature 38.4C). The patient was treated with IBUPROFEN ongoing since an unknown date at a dose of 1 dosage form and PARACETAMOL ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, MALAISE (Feeling unwell) and PYREXIA (Temperature 38C/Temperature 38.4C) had resolved. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 21-Apr-2021, Body temperature: 38, 38.4 (High) 38, 38.4. No concomitant medication has been reported. Action taken with mRNA-1273 in response to the events was not applicable.

Other Meds:

Current Illness:

ID: 1635716
Sex: F
Age: 59
State: OH

Vax Date: 12/23/2020
Onset Date: 12/23/2020
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: she was smoking more and she does that when she's anxious; Head whozzy; she lost 4 pounds after 2 weeks although she gained 1 pound today; Couldnt walk; TSH has dropped; Feeling so tired; Sore arm; no appetite; Chest pain; So wired i couln't calm down; This spontaneous case was reported by an other health care professional and describes the occurrence of ANXIETY (So wired i couln't calm down), CHEST PAIN (Chest pain), ANXIETY (she was smoking more and she does that when she's anxious), DIZZINESS (Head whozzy) and DECREASED APPETITE (no appetite) in a 59-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 23-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 23-Dec-2020, the patient experienced ANXIETY (So wired i couln't calm down). On 24-Dec-2020, the patient experienced CHEST PAIN (Chest pain), DECREASED APPETITE (no appetite), FATIGUE (Feeling so tired) and VACCINATION SITE PAIN (Sore arm). On an unknown date, the patient experienced ANXIETY (she was smoking more and she does that when she's anxious), DIZZINESS (Head whozzy), WEIGHT FLUCTUATION (she lost 4 pounds after 2 weeks although she gained 1 pound today), GAIT DISTURBANCE (Couldnt walk) and BLOOD THYROID STIMULATING HORMONE DECREASED (TSH has dropped). At the time of the report, ANXIETY (So wired i couln't calm down), CHEST PAIN (Chest pain), ANXIETY (she was smoking more and she does that when she's anxious), DIZZINESS (Head whozzy), DECREASED APPETITE (no appetite), WEIGHT FLUCTUATION (she lost 4 pounds after 2 weeks although she gained 1 pound today), GAIT DISTURBANCE (Couldnt walk), BLOOD THYROID STIMULATING HORMONE DECREASED (TSH has dropped), FATIGUE (Feeling so tired) and VACCINATION SITE PAIN (Sore arm) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were provided by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 10-Jan-2021: No new information

Other Meds:

Current Illness:

ID: 1635717
Sex: F
Age:
State: WA

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

Lab Data:

Allergies:

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

Symptoms: injection site reaction; Tendernes of the skin 2-3 inches from the injection site; Swelling of the skin 2-3 inches from the injection site; Redness on skin; This spontaneous case was reported by an other health care professional and describes the occurrence of ERYTHEMA (Redness on skin), VACCINATION SITE REACTION (injection site reaction), VACCINATION SITE PAIN (Tendernes of the skin 2-3 inches from the injection site) and VACCINATION SITE SWELLING (Swelling of the skin 2-3 inches from the injection site) 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 05-Jan-2021, the patient experienced VACCINATION SITE PAIN (Tendernes of the skin 2-3 inches from the injection site) and VACCINATION SITE SWELLING (Swelling of the skin 2-3 inches from the injection site). In January 2021, the patient experienced ERYTHEMA (Redness on skin). On an unknown date, the patient experienced VACCINATION SITE REACTION (injection site reaction). At the time of the report, ERYTHEMA (Redness on skin), VACCINATION SITE REACTION (injection site reaction), VACCINATION SITE PAIN (Tendernes of the skin 2-3 inches from the injection site) and VACCINATION SITE SWELLING (Swelling of the skin 2-3 inches from the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. Concomitant medication included birth control pills No treatment medication were provided.

Other Meds:

Current Illness:

ID: 1635718
Sex: F
Age:
State: NY

Vax Date: 04/06/2021
Onset Date: 05/04/2021
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: lacked apetite; weak all day; body aches; chills; hot sweats; light sensitivity; This spontaneous case was reported by a consumer and describes the occurrence of PHOTOPHOBIA (light sensitivity), DECREASED APPETITE (lacked apetite), HYPERHIDROSIS (hot sweats), ASTHENIA (weak all day) and MYALGIA (body aches) in a 58-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 004C21A and 031B21A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Drug allergy (Allergic to Codeine), Blood pressure high since 2005, Vitreous floaters and Ocular Migraine (occurs less than twice a year) since 2008. Concomitant products included NEBIVOLOL HYDROCHLORIDE (BYSTOLIC) for Blood pressure high, WOMENS MULTI ONE A DAY for an unknown indication. On 06-Apr-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-May-2021 at 9:00 AM, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 04-May-2021, the patient experienced PHOTOPHOBIA (light sensitivity), HYPERHIDROSIS (hot sweats), MYALGIA (body aches) and CHILLS (chills). On 05-May-2021, the patient experienced DECREASED APPETITE (lacked apetite) and ASTHENIA (weak all day). On 05-May-2021, PHOTOPHOBIA (light sensitivity) had resolved. On 06-May-2021, DECREASED APPETITE (lacked apetite), HYPERHIDROSIS (hot sweats), ASTHENIA (weak all day), MYALGIA (body aches) and CHILLS (chills) had resolved. Not Provided For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No treatment information was reported. This case was linked to MOD-2021-068491 (Patient Link).

Other Meds: BYSTOLIC; WOMENS MULTI ONE A DAY

Current Illness: Blood pressure high; Drug allergy (Allergic to Codeine); Vitreous floaters

ID: 1635719
Sex: F
Age: 68
State: OK

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: 011J20A
Dose Series: 1
Vax Route: IM
Vax Site: LA

Lab Data: Test Date: 20210416; Test Name: Body temperature; Result Unstructured Data: 4 hours after the vaccine she had fever of 100.2F. She took her temperature before the vaccine and it was 96.4 F.; Test Name: Chest X-ray; Result Unstructured Data: HCP is aware of the symptoms. He sent her for chest X-ray, they notice infiltrate right lower lobe.; Test Date: 20210417; Test Name: Shingles; Test Result: Positive ; Result Unstructured Data: The next day she broke out in shingles

Allergies:

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

Symptoms: Broke out in shingles; Chills; Fever 100.2F was with Tylenol; Horrible right chest pain; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of CHILLS (Chills), PYREXIA (Fever 100.2F was with Tylenol), CHEST PAIN (Horrible right chest pain) and HERPES ZOSTER (Broke out in shingles) in a 68-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 038B21A and 014M20A) for COVID-19 vaccination. The patient's past medical history included Shingles (she had shingles once before.). Concurrent medical conditions included Pneumonia and Shingles since 17-Apr-2021. 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 CHILLS (Chills) and PYREXIA (Fever 100.2F was with Tylenol). 16-Apr-2021, the patient experienced CHEST PAIN (Horrible right chest pain). On 17-Apr-2021, the patient experienced HERPES ZOSTER (Broke out in shingles). The patient was treated with PARACETAMOL (TYLENOL) on 16-Apr-2021 for Fever, at an unspecified dose and frequency. At the time of the report, CHILLS (Chills), PYREXIA (Fever 100.2F was with Tylenol), CHEST PAIN (Horrible right chest pain) and HERPES ZOSTER (Broke out in shingles) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 16-Apr-2021, Body temperature: 100.2 (High) 4 hours after the vaccine she had fever of 100.2F. She took her temperature before the vaccine and it was 96.4 F.. On 17-Apr-2021, Herpes zoster: (Positive) The next day she broke out in shingles. On an unknown date, Chest X-ray: (abnormal) HCP is aware of the symptoms. He sent her for chest X-ray, they notice infiltrate right lower lobe.. Concomitant medications included patient is taking antibiotic for pneumonia. Patient stated that she is not comfortable taking the booster.

Other Meds:

Current Illness: Pneumonia; Shingles

ID: 1635720
Sex: U
Age:
State:

Vax Date:
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: my left arm is swollen; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (my left arm is swollen) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced PERIPHERAL SWELLING (my left arm is swollen). At the time of the report, PERIPHERAL SWELLING (my left arm is swollen) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medications were provided. No treatments were provided.

Other Meds:

Current Illness:

ID: 1635721
Sex: F
Age:
State: OH

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: So wired couln't calm down; This spontaneous case was reported by an other health care professional and describes the occurrence of ANXIETY (So wired couln't calm down) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 039K20A) 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 ANXIETY (So wired couln't calm down). At the time of the report, ANXIETY (So wired couln't calm down) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were provided by the reporter. Most recent FOLLOW-UP information incorporated above includes: On 10-Jan-2021: No new information was reported

Other Meds:

Current Illness:

ID: 1635722
Sex: F
Age:
State: OH

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: So wired couln't calm down; This spontaneous case was reported by an other health care professional and describes the occurrence of ANXIETY (So wired couln't calm down) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced ANXIETY (So wired couln't calm down). At the time of the report, ANXIETY (So wired couln't calm down) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No Concomitant Medication was provided. No treatment was provided.

Other Meds:

Current Illness:

ID: 1635723
Sex: U
Age:
State: NC

Vax Date:
Onset Date:
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: Side effects after receiving the moderna vaccine; This spontaneous case was reported by a consumer and describes the occurrence of ADVERSE EVENT (Side effects after receiving the moderna vaccine) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced ADVERSE EVENT (Side effects after receiving the moderna vaccine). At the time of the report, ADVERSE EVENT (Side effects after receiving the moderna vaccine) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication were provided. Treatment information not provided.

Other Meds:

Current Illness:

ID: 1635724
Sex: M
Age: 58
State: WA

Vax Date: 04/01/2021
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: side effects/unevaluable event; This spontaneous case was reported by a consumer and describes the occurrence of UNEVALUABLE EVENT (side effects/unevaluable event) in a 58-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Co-suspect product included non-company product DUPILUMAB (DUPIXENT) for Atopic dermatitis. Concurrent medical conditions included Atopic dermatitis. In April 2021, the patient started DUPILUMAB (DUPIXENT) (Subcutaneous) 300 milligram every two weeks. On 19-May-2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced UNEVALUABLE EVENT (side effects/unevaluable event). At the time of the report, UNEVALUABLE EVENT (side effects/unevaluable event) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No other concomitant medications were provided. No treatment information was provided.

Other Meds:

Current Illness: Atopic dermatitis

ID: 1635725
Sex: U
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: arm has red blotches; arm is hot to the touch; 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 RASH MACULAR (arm has red blotches) and SKIN WARM (arm is hot to the touch) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced RASH MACULAR (arm has red blotches) and SKIN WARM (arm is hot to the touch). At the time of the report, RASH MACULAR (arm has red blotches) and SKIN WARM (arm is hot to the touch) outcome was unknown. No concomitant medications were provided. No treatment details were provided.

Other Meds:

Current Illness:

ID: 1635726
Sex: F
Age: 84
State: MA

Vax Date: 02/02/2021
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: Unevaluable event

Symptoms: Right heel was hurting; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Right heel was hurting) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 02-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (Right heel was hurting). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form. At the time of the report, PAIN IN EXTREMITY (Right heel was hurting) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No relevant concomitant medications were reported.

Other Meds:

Current Illness:

ID: 1635727
Sex: F
Age:
State:

Vax Date: 02/09/2021
Onset Date: 02/12/2021
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: Lymph node in her clavicle area that is swollen and tender to touch; This spontaneous case was reported by a consumer and describes the occurrence of LYMPHADENOPATHY (Lymph node in her clavicle area that is swollen and tender to touch) in a 61-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 031L20A) for COVID-19 vaccination. No medical history was provided by the reporter. Concomitant products included ACETYLSALICYLIC ACID (ASPIRIN 81) for an unknown indication. On 09-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 12-Feb-2021, the patient experienced LYMPHADENOPATHY (Lymph node in her clavicle area that is swollen and tender to touch). The patient was treated with IBUPROFEN for Swelling, at a dose of 1 UNK. At the time of the report, LYMPHADENOPATHY (Lymph node in her clavicle area that is swollen and tender to touch) outcome was unknown.

Other Meds: ASPIRIN 81

Current Illness:

ID: 1635728
Sex: M
Age: 71
State: FL

Vax Date: 02/03/2021
Onset Date: 02/04/2021
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: not doing fine; achy; low grade fever; fatigue; This spontaneous case was reported by a consumer and describes the occurrence of MALAISE (not doing fine), PAIN (achy), PYREXIA (low grade fever) and FATIGUE (fatigue) in a 71-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 03-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 04-Feb-2021, the patient experienced MALAISE (not doing fine), PAIN (achy), PYREXIA (low grade fever) and FATIGUE (fatigue). At the time of the report, MALAISE (not doing fine), PAIN (achy), PYREXIA (low grade fever) and FATIGUE (fatigue) outcome was unknown. The action taken with mRNA-1273(Moderna COVID-19 vaccine) was not applicable No concomitant medications were reported No treatment drugs were reported

Other Meds:

Current Illness:

ID: 1635729
Sex: U
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: SYR
Vax Site: LA

Lab Data:

Allergies:

Symptom List: Injection site pain, Menorrhagia

Symptoms: report side effects; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a patient and describes the occurrence of VACCINATION COMPLICATION (report side effects) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VACCINATION COMPLICATION (report side effects). At the time of the report, VACCINATION COMPLICATION (report side effects) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No relevant concomitant medications were provided. No treatment information was provided.

Other Meds:

Current Illness:

ID: 1635730
Sex: F
Age: 65
State: AZ

Vax Date: 01/28/2021
Onset Date: 02/04/2021
Rec V Date: 08/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Arm swelling; warm; red hives; itching approximately 2x2 inches in size; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Arm swelling), FEELING HOT (warm), URTICARIA (red hives) and PRURITUS (itching approximately 2x2 inches in size) in a 65-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. No medical history was provided by reporter. Concomitant products included ACETYLSALICYLIC ACID (BABY ASPIRIN) for Anticoagulant therapy, CALCIUM for Calcium supplementation, FISH OIL for Nutritional supplementation, MONASCUS PURPUREUS (RED YEAST RICE) for Supplementation therapy, VITAMIN C [ASCORBIC ACID] for Vitamin C supplementation, VITAMIN D [VITAMIN D NOS] for Vitamin D supplementation, ZINC for Zinc supplementation. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 04-Feb-2021, the patient experienced PERIPHERAL SWELLING (Arm swelling), FEELING HOT (warm), URTICARIA (red hives) and PRURITUS (itching approximately 2x2 inches in size). The patient was treated with DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, PERIPHERAL SWELLING (Arm swelling), FEELING HOT (warm), URTICARIA (red hives) and PRURITUS (itching approximately 2x2 inches in size) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment medications also included ice.

Other Meds: BABY ASPIRIN; VITAMIN C [ASCORBIC ACID]; VITAMIN D [VITAMIN D NOS]; FISH OIL; ZINC; CALCIUM; RED YEAST RICE

Current Illness:

ID: 1635731
Sex: F
Age:
State: CA

Vax Date: 04/15/2021
Onset Date: 04/15/2012
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: First shot on 15-Apr-2021, second shot not yet administered; 15yr old recived vaccine; This spontaneous case was reported by a pharmacist and describes the occurrence of INTENTIONAL PRODUCT USE ISSUE (First shot on 15-Apr-2021, second shot not yet administered) and PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15yr old recived vaccine) in a 15-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) 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) (Intramuscular) 1 dosage form. On 15-Apr-2012, the patient experienced PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15yr old recived vaccine). On an unknown date, the patient experienced INTENTIONAL PRODUCT USE ISSUE (First shot on 15-Apr-2021, second shot not yet administered). On 15-Apr-2021, PRODUCT ADMINISTERED TO PATIENT OF INAPPROPRIATE AGE (15yr old recived vaccine) had resolved. At the time of the report, INTENTIONAL PRODUCT USE ISSUE (First shot on 15-Apr-2021, second shot not yet administered) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medication was reported. No treatment information was provided. The patient was doing fine. Most recent FOLLOW-UP information incorporated above includes: On 27-Jul-2021: Follow-up contains updated patient details and updated narrative.

Other Meds:

Current Illness:

ID: 1635732
Sex: M
Age: 73
State: TX

Vax Date: 05/04/2021
Onset Date: 05/05/2021
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: mild headaches; This spontaneous case was reported by a patient and describes the occurrence of HEADACHE (mild headaches) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 048B21A) for COVID-19 vaccination. Concomitant products included OMEPRAZOLE for Acid reflux (oesophageal), BIMATOPROST for Eye drop instillation, LISINOPRIL for Hypertension, SIMVASTATIN for Lipids NOS high, LEVOTHYROXINE SODIUM (SYNTHROID), CETIRIZINE, MULTIVITAMINS [VITAMINS NOS] and NITROFURANTOIN for an unknown indication. On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-May-2021, the patient experienced HEADACHE (mild headaches). The patient was treated with PARACETAMOL (TYLENOL) ongoing since an unknown date for Headache, at a dose of 1 dosage form. On 08-May-2021, HEADACHE (mild headaches) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosing remained unchanged. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments.

Other Meds: LISINOPRIL; OMEPRAZOLE; SYNTHROID; SIMVASTATIN; CETIRIZINE; MULTIVITAMINS [VITAMINS NOS]; NITROFURANTOIN; BIMATOPROST

Current Illness:

ID: 1635733
Sex: F
Age:
State: MI

Vax Date: 02/03/2021
Onset Date: 02/04/2021
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: L arm Tenderness; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE PAIN (L arm Tenderness) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 007M20A) for COVID-19 vaccination. Concurrent medical conditions included Migraine and Multiple allergies (Unspecified). Concomitant products included OMEPRAZOLE (PROTONIX [OMEPRAZOLE]) for Gastrointestinal disorder, ALPRAZOLAM (XANAX), DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]), VORTIOXETINE HYDROBROMIDE (TRINTELLIX) and BACLOFEN for an unknown indication. On 03-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 03-Mar-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 04-Feb-2021, the patient experienced VACCINATION SITE PAIN (L arm Tenderness). The patient was treated with PARACETAMOL (TYLENOL) at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) at a dose of 1 dosage form. At the time of the report, VACCINATION SITE PAIN (L arm Tenderness) had resolved. mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) dosing remained unchanged. Other concomitant medicines included Loinzeff for gastrointestinal issues and migraine medicines which were stopped on 03-FEB-2021 advised by HCP to take once a month. This case was linked to MOD-2021-039177 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 10-Jul-2021: Significant follow-up The event outcome was updated from unknown to recovered/resolved.

Other Meds: XANAX; PROTONIX [OMEPRAZOLE]; BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]; TRINTELLIX; BACLOFEN

Current Illness: Migraine; Multiple allergies (Unspecified)

ID: 1635734
Sex: M
Age: 33
State: VA

Vax Date: 02/12/2021
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: Nausea

Symptoms: burning pain in the arm all the way down to the wrist; tingly in all limbs; slightly elevated heart rate; taste is off; eyes are sensitive to light and sudden movement; eyes are sensitive to light and sudden movement; cotton dry mouth; Dizzy; injection site is painfully tender to the touch; nauseated; stinging pain in arm pit during injection; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (burning pain in the arm all the way down to the wrist), PARAESTHESIA (tingly in all limbs), HEART RATE INCREASED (slightly elevated heart rate), AGEUSIA (taste is off) and PHOTOPHOBIA (eyes are sensitive to light and sudden movement) in a 33-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 12-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced PAIN IN EXTREMITY (burning pain in the arm all the way down to the wrist), PARAESTHESIA (tingly in all limbs), HEART RATE INCREASED (slightly elevated heart rate), AGEUSIA (taste is off), PHOTOPHOBIA (eyes are sensitive to light and sudden movement), EYE MOVEMENT DISORDER (eyes are sensitive to light and sudden movement), DRY MOUTH (cotton dry mouth), DIZZINESS (Dizzy), INJECTION SITE PAIN (injection site is painfully tender to the touch), NAUSEA (nauseated) and AXILLARY PAIN (stinging pain in arm pit during injection). At the time of the report, PAIN IN EXTREMITY (burning pain in the arm all the way down to the wrist), PARAESTHESIA (tingly in all limbs), HEART RATE INCREASED (slightly elevated heart rate), AGEUSIA (taste is off), PHOTOPHOBIA (eyes are sensitive to light and sudden movement), EYE MOVEMENT DISORDER (eyes are sensitive to light and sudden movement), DRY MOUTH (cotton dry mouth), DIZZINESS (Dizzy), INJECTION SITE PAIN (injection site is painfully tender to the touch), NAUSEA (nauseated) and AXILLARY PAIN (stinging pain in arm pit during injection) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. No concomitant medication was provided No treatment medication was provided

Other Meds:

Current Illness:

ID: 1635735
Sex: F
Age: 77
State:

Vax Date: 02/05/2021
Onset Date: 02/05/2021
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: Injection site pain

Symptoms: Itchiness in the injection site; Broke out (like a rash) in the injection site; Arm soreness; This spontaneous case was reported by a consumer and describes the occurrence of PAIN IN EXTREMITY (Arm soreness), VACCINATION SITE PRURITUS (Itchiness in the injection site) and VACCINATION SITE RASH (Broke out (like a rash) in the injection site) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 013M20A) for COVID-19 vaccination. No medical history provided by the reporter. Concomitant products included GABAPENTIN for Arthritis, OXYBUTYNIN for Bladder incontinence, DULOXETINE for Gastroesophageal reflux, PANTOPRAZOLE for an unknown indication. On 05-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 05-Feb-2021, the patient experienced PAIN IN EXTREMITY (Arm soreness). On 13-Feb-2021, after starting mRNA-1273 (Moderna COVID-19 Vaccine), the patient experienced VACCINATION SITE PRURITUS (Itchiness in the injection site) and VACCINATION SITE RASH (Broke out (like a rash) in the injection site). At the time of the report, PAIN IN EXTREMITY (Arm soreness), VACCINATION SITE PRURITUS (Itchiness in the injection site) and VACCINATION SITE RASH (Broke out (like a rash) in the injection site) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. Treatment include Put gold bond cream Reporter did not allow further contact

Other Meds: DULOXETINE; GABAPENTIN; OXYBUTYNIN; PANTOPRAZOLE

Current Illness:

ID: 1635736
Sex: F
Age:
State: KY

Vax Date: 05/02/2021
Onset Date: 05/01/2021
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: Injection site induration, Injection site pruritus, Injection site swelling, Injection site warmth

Symptoms: rash on face; presure in eyes dangerously high; change in her vision in her left eye; itching and burning of the eyes; eyes were red; eyes were red and inflamed; Corneas split; eye swollen shut; eye symptoms; itching and burning of the eyes; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of OCULAR HYPERAEMIA (eyes were red), EYE INFLAMMATION (eyes were red and inflamed), CORNEAL DISORDER (Corneas split), EYE SWELLING (eye swollen shut) and RASH (rash on face) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. Concurrent medical conditions included Dry eye, Allergy NOS, Penicillin allergy and Drug allergy (Prednisone). Concomitant products included LIFITEGRAST (XIIDRA) for Eye allergy. On 02-May-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 05-May-2021, the patient experienced EYE SYMPTOM (eye symptoms). In May 2021, the patient experienced EYE IRRITATION (itching and burning of the eyes). On an unknown date, the patient experienced OCULAR HYPERAEMIA (eyes were red), EYE INFLAMMATION (eyes were red and inflamed), CORNEAL DISORDER (Corneas split), EYE SWELLING (eye swollen shut), RASH (rash on face), INTRAOCULAR PRESSURE INCREASED (presure in eyes dangerously high), VISUAL IMPAIRMENT (change in her vision in her left eye) and EYE PRURITUS (itching and burning of the eyes). The patient was treated with ANTIBIOTICS for Eye symptom, at an unspecified dose and frequency; PREDNISONE (conjunctival) in May 2021 for Eye redness, at a dose of 1 UNK; LOTEPREDNOL ETABONATE (LOTEMAX) at an unspecified dose and frequency; PROPYLENE GLYCOL (SYSTANE BALANCE) ongoing since an unknown date at an unspecified dose and frequency; MUPIROCIN (BACTROBAN [MUPIROCIN]) at an unspecified dose and frequency; TRAVOPROST (TRAVATAN) (intraocular) on 31-May-2021 for Intraocular pressure increased, at an unspecified dose and frequency; ERYTHROMYCIN in May 2021 for Eye symptom, at an unspecified dose and frequency; NEPAFENAC (ILEVRO) ongoing since an unknown date for Eye symptom, at an unspecified dose and frequency; DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) (oral) for Eye pruritus and Eye irritation, at a dose of 1 dosage form and ANTIBIOTICS (oral) from May 2021 to June 2021 for Eye symptom, at a dose of 1 dosage form. At the time of the report, OCULAR HYPERAEMIA (eyes were red), EYE INFLAMMATION (eyes were red and inflamed), CORNEAL DISORDER (Corneas split), EYE SWELLING (eye swollen shut), RASH (rash on face), INTRAOCULAR PRESSURE INCREASED (presure in eyes dangerously high), EYE PRURITUS (itching and burning of the eyes), EYE IRRITATION (itching and burning of the eyes) and EYE SYMPTOM (eye symptoms) outcome was unknown and VISUAL IMPAIRMENT (change in her vision in her left eye) had not resolved. Treatment also included a mild moisturizer cold packs on eyes and contact patches over the eyes.

Other Meds: XIIDRA

Current Illness:

ID: 1635737
Sex: M
Age: 73
State: TX

Vax Date: 05/04/2021
Onset Date: 06/03/2021
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: Test Date: 20210613; Test Name: Heart rate; Result Unstructured Data: Heart rate going up and down at night.

Allergies:

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

Symptoms: lingering headaches; This spontaneous case was reported by a consumer (subsequently medically confirmed) and describes the occurrence of HEADACHE (lingering headaches) in a 73-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 009C21A and 048B21A) for COVID-19 vaccination. Concurrent medical conditions included Hypertension, Acid reflux (esophageal) and Lipids NOS abnormal (Antilipidemic). Concomitant products included OMEPRAZOLE for Acid reflux (oesophageal), SIMVASTATIN for Cholesterol, LISINOPRIL for Hypertension, LEVOTHYROXINE SODIUM (SYNTHROID), CETIRIZINE, MULTIVITAMINS [VITAMINS NOS], NITROFURANTOIN and BIMATOPROST for an unknown indication. On 04-May-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 01-Jun-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 03-Jun-2021, the patient experienced HEADACHE (lingering headaches). The patient was treated with PARACETAMOL (TYLENOL) for Headache NOS, at an unspecified dose and frequency and IBUPROFEN for Headache NOS, at an unspecified dose and frequency. At the time of the report, HEADACHE (lingering headaches) outcome was unknown. DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On 13-Jun-2021, Heart rate: abnormal (abnormal) Heart rate going up and down at night.. This case was linked to MOD-2021-221236 (Patient Link).

Other Meds: LISINOPRIL; OMEPRAZOLE; SYNTHROID; SIMVASTATIN; CETIRIZINE; MULTIVITAMINS [VITAMINS NOS]; NITROFURANTOIN; BIMATOPROST

Current Illness: Acid reflux (esophageal); Hypertension; Lipids NOS abnormal (Antilipidemic)

ID: 1635738
Sex: F
Age: 70
State: FL

Vax Date: 02/17/2021
Onset Date: 04/14/2021
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: Received Dose 2 on 14Apr2021; Left sore arm especially when lying on it; This spontaneous case was reported by a patient and describes the occurrence of INAPPROPRIATE SCHEDULE OF PRODUCT DISCONTINUATION (Received Dose 2 on 14Apr2021) and MYALGIA (Left sore arm especially when lying on it) in a 70-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 041B21A and 015M20A) for COVID-19 vaccination. No medical history was provided. Concomitant products included AMLODIPINE, ATENOLOL, METFORMIN, VITAMIN D [VITAMIN D NOS], ROSUVASTATIN, MECOBALAMIN (VITAMIN B12 [MECOBALAMIN]) and VITAMINS NOS for an unknown indication. On 17-Feb-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 14-Apr-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Apr-2021, the patient experienced INAPPROPRIATE SCHEDULE OF PRODUCT DISCONTINUATION (Received Dose 2 on 14Apr2021) and MYALGIA (Left sore arm especially when lying on it). At the time of the report, INAPPROPRIATE SCHEDULE OF PRODUCT DISCONTINUATION (Received Dose 2 on 14Apr2021) had resolved and MYALGIA (Left sore arm especially when lying on it) outcome was unknown. No treatment information was provided. This case was linked to MOD-2021-076941 (Patient Link).

Other Meds: AMLODIPINE; ATENOLOL; METFORMIN; VITAMIN D [VITAMIN D NOS]; ROSUVASTATIN; VITAMIN B12 [MECOBALAMIN]; VITAMINS NOS

Current Illness:

ID: 1635739
Sex: F
Age: 42
State: NJ

Vax Date: 01/07/2021
Onset Date: 01/15/2021
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: Golf ball size Lump on arm; Soreness of the Arm; Hot to Touch; Redness at injection site; This spontaneous case was reported by a consumer and describes the occurrence of PERIPHERAL SWELLING (Golf ball size Lump on arm), PAIN IN EXTREMITY (Soreness of the Arm), INJECTION SITE WARMTH (Hot to Touch) and INJECTION SITE ERYTHEMA (Redness at injection site) in a 42-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 026L20A) for COVID-19 vaccination. No Medical History information was reported. On 07-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 15-Jan-2021, the patient experienced PERIPHERAL SWELLING (Golf ball size Lump on arm), PAIN IN EXTREMITY (Soreness of the Arm), INJECTION SITE WARMTH (Hot to Touch) and INJECTION SITE ERYTHEMA (Redness at injection site). At the time of the report, PERIPHERAL SWELLING (Golf ball size Lump on arm), PAIN IN EXTREMITY (Soreness of the Arm), INJECTION SITE WARMTH (Hot to Touch) and INJECTION SITE ERYTHEMA (Redness at injection site) had resolved. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. No concomitant medication details were provided. No treatment medication details were provided. Most recent FOLLOW-UP information incorporated above includes: On 18-Jun-2021: Non-significant Follow-up appended

Other Meds:

Current Illness:

ID: 1635740
Sex: U
Age:
State:

Vax Date:
Onset Date:
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:

Allergies:

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

Symptoms: Developed rash over neck chest back and stomach; This spontaneous case was reported by a consumer and describes the occurrence of RASH (Developed rash over neck chest back and stomach) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On an unknown date, the patient experienced RASH (Developed rash over neck chest back and stomach). At the time of the report, RASH (Developed rash over neck chest back and stomach) outcome was unknown. No concomitant medications were reported by the reporter. The patient had the event a month after second dose. Treatment medication was not provided by the reporter.

Other Meds:

Current Illness:

ID: 1635741
Sex: M
Age: 74
State: VA

Vax Date: 01/28/2021
Onset Date: 03/14/2021
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: Cough, Limb discomfort, Pain, SARS-CoV-2 test positive

Symptoms: Mild Dizziness; General feeling of mild energy; Heavy legs when walking; This spontaneous case was reported by a consumer and describes the occurrence of DIZZINESS (Mild Dizziness), ASTHENIA (General feeling of mild energy) and PAIN IN EXTREMITY (Heavy legs when walking) in a 74-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 028L20A and 039K20A) for COVID-19 vaccination. No Medical History information was reported. On 28-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 25-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 14-Mar-2021, the patient experienced DIZZINESS (Mild Dizziness), ASTHENIA (General feeling of mild energy) and PAIN IN EXTREMITY (Heavy legs when walking). The patient was treated with PERMETHRIN (PERMETHRIN lotion) ongoing since an unknown date at a dose of 1 dosage form and DIPHENHYDRAMINE HYDROCHLORIDE (BENADRYL [DIPHENHYDRAMINE HYDROCHLORIDE]) ongoing since an unknown date at a dose of 1 dosage form. At the time of the report, DIZZINESS (Mild Dizziness), ASTHENIA (General feeling of mild energy) and PAIN IN EXTREMITY (Heavy legs when walking) outcome was unknown. This case was linked to MOD-2021-047874 (Patient Link). Reporter did not allow further contact

Other Meds:

Current Illness:

ID: 1635742
Sex: F
Age: 84
State: MN

Vax Date: 12/30/2020
Onset Date: 01/08/2021
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: Fever; Sore throat; Cough; Body aches; Weakness; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (Fever), OROPHARYNGEAL PAIN (Sore throat), COUGH (Cough), PAIN (Body aches) and ASTHENIA (Weakness) in an 84-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced PYREXIA (Fever), OROPHARYNGEAL PAIN (Sore throat), COUGH (Cough), PAIN (Body aches) and ASTHENIA (Weakness). At the time of the report, PYREXIA (Fever), OROPHARYNGEAL PAIN (Sore throat), COUGH (Cough), PAIN (Body aches) and ASTHENIA (Weakness) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment information was provided. Company Comment: This case concerns a 84-year-old female who had NS events of unexpected oropharyngeal pain, cough, pain, asthenia and expected pyrexia. Event onset Day 10 after first dose mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.; Reporter's Comments: .; Sender's Comments: This case concerns a 84-year-old female who had NS events of unexpected oropharyngeal pain, cough, pain, asthenia and expected pyrexia. Event onset Day 10 after first dose mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1635743
Sex: F
Age: 76
State: MN

Vax Date: 12/30/2020
Onset Date: 01/08/2021
Rec V Date: 08/26/2021
Hospital:

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

Lab Data:

Allergies:

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

Symptoms: Fever; Sore throat; Cough; Body aches; Weakness; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (Fever), OROPHARYNGEAL PAIN (Sore throat), COUGH (Cough), PAIN (Body aches) and ASTHENIA (Weakness) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced PYREXIA (Fever), OROPHARYNGEAL PAIN (Sore throat), COUGH (Cough), PAIN (Body aches) and ASTHENIA (Weakness). At the time of the report, PYREXIA (Fever), OROPHARYNGEAL PAIN (Sore throat), COUGH (Cough), PAIN (Body aches) and ASTHENIA (Weakness) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment information was provided. Company Comment: This case concerns a 76-year-old female who had NS events of unexpected oropharyngeal pain, cough, pain, asthenia and expected pyrexia. Event onset Day 10 after first dose mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.; Reporter's Comments: .; Sender's Comments: This case concerns a 76-year-old female who had NS events of unexpected oropharyngeal pain, cough, pain, asthenia and expected pyrexia. Event onset Day 10 after first dose mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1635744
Sex: M
Age: 94
State: MN

Vax Date: 12/30/2020
Onset Date: 01/08/2021
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: Fever; Sore throat; Cough; Body aches; Weakness; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (Fever), OROPHARYNGEAL PAIN (Sore throat), COUGH (Cough), PAIN (Body aches) and ASTHENIA (Weakness) in a 94-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced PYREXIA (Fever), OROPHARYNGEAL PAIN (Sore throat), COUGH (Cough), PAIN (Body aches) and ASTHENIA (Weakness). At the time of the report, PYREXIA (Fever), OROPHARYNGEAL PAIN (Sore throat), COUGH (Cough), PAIN (Body aches) and ASTHENIA (Weakness) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment information was provided. Company Comment: This case concerns a 94-year-old male who had NS events of unexpected oropharyngeal pain, cough, pain, asthenia and expected pyrexia. Event onset Day 10 after first dose mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.; Reporter's Comments: .; Sender's Comments: This case concerns a 94-year-old male who had NS events of unexpected oropharyngeal pain, cough, pain, asthenia and expected pyrexia. Event onset Day 10 after first dose mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1635745
Sex: F
Age: 74
State: MN

Vax Date: 12/30/2020
Onset Date: 01/08/2021
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: Fever; Sore throat; Cough; Body aches; Weakness; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (Fever), OROPHARYNGEAL PAIN (Sore throat), COUGH (Cough), PAIN (Body aches) and ASTHENIA (Weakness) in a 74-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced PYREXIA (Fever), OROPHARYNGEAL PAIN (Sore throat), COUGH (Cough), PAIN (Body aches) and ASTHENIA (Weakness). At the time of the report, PYREXIA (Fever), OROPHARYNGEAL PAIN (Sore throat), COUGH (Cough), PAIN (Body aches) and ASTHENIA (Weakness) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment information was provided. Company Comment: This case concerns a 74-year-old female who had NS events of unexpected oropharyngeal pain, cough, pain, asthenia and expected pyrexia. Event onset Day 10 after first dose mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.; Reporter's Comments: .; Sender's Comments: This case concerns a 74-year-old female who had NS events of unexpected oropharyngeal pain, cough, pain, asthenia and expected pyrexia. Event onset Day 10 after first dose mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1635746
Sex: M
Age: 80
State: MN

Vax Date: 12/30/2020
Onset Date: 01/08/2021
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: Fever; Sore throat; Cough; Body aches; Weakness; This spontaneous case was reported by a nurse and describes the occurrence of PYREXIA (Fever), OROPHARYNGEAL PAIN (Sore throat), COUGH (Cough), PAIN (Body aches) and ASTHENIA (Weakness) in an 80-year-old male patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On 30-Dec-2020, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 08-Jan-2021, the patient experienced PYREXIA (Fever), OROPHARYNGEAL PAIN (Sore throat), COUGH (Cough), PAIN (Body aches) and ASTHENIA (Weakness). At the time of the report, PYREXIA (Fever), OROPHARYNGEAL PAIN (Sore throat), COUGH (Cough), PAIN (Body aches) and ASTHENIA (Weakness) outcome was unknown. Not Provided The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment information was provided. Company Comment: This case concerns a 80-year-old male who had NS events of unexpected oropharyngeal pain, cough, pain, asthenia and expected pyrexia. Event onset Day 10 after first dose mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.; Reporter's Comments: .; Sender's Comments: This case concerns a 80-year-old male who had NS events of unexpected oropharyngeal pain, cough, pain, asthenia and expected pyrexia. Event onset Day 10 after first dose mRNA-1273. Treatment not reported. Event outcomes unknown. Based on current available information and temporal association between use of the product and the start date of the event, a causal relationship cannot be excluded.

Other Meds:

Current Illness:

ID: 1635747
Sex: U
Age:
State:

Vax Date: 02/01/2021
Onset Date: 02/01/2021
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: got vaccinated in Feb and until now haven't suffered from any headaches or earaches of any kind since then; This spontaneous case was reported by a consumer and describes the occurrence of THERAPEUTIC RESPONSE UNEXPECTED (got vaccinated in Feb and until now haven't suffered from any headaches or earaches of any kind since then) in a 68-year-old patient of an unknown gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. The patient's past medical history included Headache, Earache and Sinus disorder NOS (Sinus) since an unknown date. In February 2021, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. In February 2021, the patient experienced THERAPEUTIC RESPONSE UNEXPECTED (got vaccinated in Feb and until now haven't suffered from any headaches or earaches of any kind since then). At the time of the report, THERAPEUTIC RESPONSE UNEXPECTED (got vaccinated in Feb and until now haven't suffered from any headaches or earaches of any kind since then) outcome was unknown. Headaches The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown) was unknown. Concomitant products included unknown pain pills for the treatment of headache and earache, nose sprays for the treatment of sinus. On a social media platform the patient stated that after vaccination the patient's headaches, earaches and pain pills were "put away". No other treatment information was provided by the reporter.

Other Meds:

Current Illness: Sinus disorder NOS (Sinus)

ID: 1635748
Sex: F
Age: 77
State: TN

Vax Date: 01/26/2021
Onset Date: 02/03/2021
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: Hypotonia, Lethargy, Respiratory rate decreased, Screaming, Skin warm

Symptoms: Inflamed; Has a lump on it, the size of a small egg; Very itchy; Real red; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION SITE INFLAMMATION (Inflamed), VACCINATION SITE MASS (Has a lump on it, the size of a small egg), VACCINATION SITE PRURITUS (Very itchy) and VACCINATION SITE ERYTHEMA (Real red) in a 77-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch no. 010M20A) for COVID-19 vaccination. The patient's past medical history included Heart rate irregular. Concomitant products included ATENOLOL for an unknown indication. On 26-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On 03-Feb-2021, the patient experienced VACCINATION SITE INFLAMMATION (Inflamed), VACCINATION SITE MASS (Has a lump on it, the size of a small egg), VACCINATION SITE PRURITUS (Very itchy) and VACCINATION SITE ERYTHEMA (Real red). On 06-Feb-2021, VACCINATION SITE MASS (Has a lump on it, the size of a small egg) and VACCINATION SITE ERYTHEMA (Real red) had resolved. At the time of the report, VACCINATION SITE INFLAMMATION (Inflamed) and VACCINATION SITE PRURITUS (Very itchy) 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 information was not provided.

Other Meds: ATENOLOL

Current Illness:

ID: 1635749
Sex: F
Age: 35
State: VA

Vax Date: 01/30/2021
Onset Date: 02/27/2021
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: Vaccinated too low on her arm; Her skin became purple and green; Arm of the injection inflamed; Pain in also on the left side of her neck and goes down her chest; It is pain with burning sensation; Injection arm hurts a lot; This spontaneous case was reported by a consumer and describes the occurrence of VACCINATION ERROR (Vaccinated too low on her arm), VACCINATION SITE DISCOLOURATION (Her skin became purple and green), VACCINATION SITE INFLAMMATION (Arm of the injection inflamed), NECK PAIN (Pain in also on the left side of her neck and goes down her chest) and PAIN (It is pain with burning sensation) in a 35-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) (batch nos. 024M20A and 001M20A) for COVID-19 vaccination. The occurrence of additional non-serious events is detailed below. No Medical History information was reported. On 30-Jan-2021, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On 27-Feb-2021, received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On 27-Feb-2021, the patient experienced VACCINATION ERROR (Vaccinated too low on her arm), VACCINATION SITE DISCOLOURATION (Her skin became purple and green), VACCINATION SITE INFLAMMATION (Arm of the injection inflamed), NECK PAIN (Pain in also on the left side of her neck and goes down her chest), PAIN (It is pain with burning sensation) and VACCINATION SITE PAIN (Injection arm hurts a lot). The patient was treated with IBUPROFEN at an unspecified dose and frequency. On 27-Feb-2021, VACCINATION ERROR (Vaccinated too low on her arm) had resolved. At the time of the report, VACCINATION SITE DISCOLOURATION (Her skin became purple and green) and NECK PAIN (Pain in also on the left side of her neck and goes down her chest) outcome was unknown and VACCINATION SITE INFLAMMATION (Arm of the injection inflamed), PAIN (It is pain with burning sensation) and VACCINATION SITE PAIN (Injection arm hurts a lot) had not resolved. The patient post receiving their second dose of vaccine complains of having vaccinated too low on their arm and not as high as the patient supposed it should be. The patient also reported that around the injection site and close to a vein that passes there, their skin became purple and green and was inflamed and was hurting a lot. Reportedly, the pain was also there on the left side of their neck and it went down their chest. The patient's arm was hurting a lot whenever they wanted to exercise, and it was inflamed. The patient took ibuprofen, but the pain continued, and it was pain with burning sensation. No Concomitant product use was reported. Action taken with mRNA-1273 in response to the event was not applicable. This case was linked to MOD-2021-031334 (Patient Link).

Other Meds:

Current Illness:

ID: 1635750
Sex: F
Age:
State: TX

Vax Date:
Onset Date:
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: flu; sore arm; fever; chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA (flu), LIMB DISCOMFORT (sore arm), PYREXIA (fever) and CHILLS (chills) in a female patient of an unknown age who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. Concurrent medical conditions included Atopic dermatitis and Dermatitis (The current event is unspecified dermatitis). Concomitant products included DUPILUMAB (DUPIXENT) for an unknown indication. On an unknown date, the patient received dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage form. On an unknown date, the patient experienced INFLUENZA (flu), LIMB DISCOMFORT (sore arm), PYREXIA (fever) and CHILLS (chills). At the time of the report, INFLUENZA (flu), LIMB DISCOMFORT (sore arm), PYREXIA (fever) and CHILLS (chills) outcome was unknown. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Unknown Route) was unknown. No treatment information was provided by the reporter. The case is an medication error spontaneous case.

Other Meds: DUPIXENT

Current Illness: Atopic dermatitis; Dermatitis (The current event is unspecified dermatitis)

ID: 1635751
Sex: F
Age:
State: IL

Vax Date:
Onset Date: 01/26/2021
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: Flu-like symptoms; body aches; chills; This spontaneous case was reported by a consumer and describes the occurrence of INFLUENZA LIKE ILLNESS (Flu-like symptoms), MYALGIA (body aches) and CHILLS (chills) in a 76-year-old female patient who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) dosage was changed to 1 dosage form. On 26-Jan-2021, the patient experienced INFLUENZA LIKE ILLNESS (Flu-like symptoms), MYALGIA (body aches) and CHILLS (chills). At the time of the report, INFLUENZA LIKE ILLNESS (Flu-like symptoms), MYALGIA (body aches) and CHILLS (chills) had resolved. Concomitant medications were not provided. Treatment information was not provided by reporter. This case was linked to MOD-2021-025737 (Patient Link). Most recent FOLLOW-UP information incorporated above includes: On 18-Apr-2021: TCR of Both Doses . patient state that she had the reported symptoms for about 1.5-2days after each shot, then the symptoms resolved.and she didn't have email for follow up

Other Meds:

Current Illness:

ID: 1635752
Sex: U
Age:
State: TX

Vax Date:
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: Test Name: COVID-19; Test Result: Positive ; Result Unstructured Data: Positive

Allergies:

Symptom List: Injection site swelling, Limb discomfort

Symptoms: COVID positive; Based on the current case data, this case has been classified as invalid. This spontaneous case was reported by a health care professional and describes the occurrence of COVID-19 (COVID positive) in a patient of an unknown age and gender who received mRNA-1273 (Moderna COVID-19 Vaccine) for COVID-19 vaccination. No Medical History information was reported. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) 1 dosage form. On an unknown date, the patient experienced COVID-19 (COVID positive). At the time of the report, COVID-19 (COVID positive) had not resolved. Not Provided DIAGNOSTIC RESULTS (normal ranges are provided in parenthesis if available): On an unknown date, SARS-CoV-2 test: positive (Positive) Positive. The action taken with mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular) was unknown. For mRNA-1273 (Moderna COVID-19 Vaccine) (Intramuscular), the reporter did not provide any causality assessments. No concomitant medications were reported. No treatment medications were provided by the reporter.

Other Meds:

Current Illness:

ID: 1635753
Sex: F
Age:
State:

Vax Date: 02/24/2021
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: Vomiting for 3 days; Headache; This spontaneous case was reported by a consumer and describes the occurrence of VOMITING (Vomiting for 3 days) and HEADACHE (Headache) 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 24-Feb-2021, the patient received second dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) dosage was changed to 1 dosage form. On an unknown date, the patient received first dose of mRNA-1273 (Moderna COVID-19 Vaccine) (unknown route) 1 dosage form. On an unknown date, the patient experienced VOMITING (Vomiting for 3 days) and HEADACHE (Headache). The patient was treated with ONDANSETRON (ZOFRAN [ONDANSETRON]) for Vomiting, at an unspecified dose and frequency. At the time of the report, VOMITING (Vomiting for 3 days) and HEADACHE (Headache) outcome was unknown. No concomitant medication were reported . Pharmacist gave her Zofran as a treatment medication for vomiting , Patient refused to take Zofran because it messes with her brain. This case was linked to MOD-2021-221341 (Patient Link).

Other Meds:

Current Illness:

ID: 1635754
Sex: F
Age:
State:

Vax Date: 02/24/2021
Onset Date: 02/24/2021
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:

Allergies:

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

Symptoms: This spontaneous case reported by a consumer, describes the occurrence of headache and vomiting in a female patient, of an unknown age, who received mRNA-1273 (Moderna COVID-19 vaccine) for COVID-19 immunization. No medical history reported. On Feb 24, 2021, patient received the second dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On an unknown date, patient received the first dose of mRNA-1273 (Moderna COVID-19 vaccine), intramuscular; 1 dosage form. On Feb 24, 2021, patient experienced headache and vomiting. Patient treated with Zofran (ondansetron hydrochloride dihydrate) ongoing since an unknown date; at an unspecified dose and frequency. At the time of the report, headache and vomiting outcome: unknown/not provided. Action taken with mRNA-1273 in response to the events: not applicable. Concomitant product use not provided. This case linked to MOD-2021-221339 (patient link).

Other Meds:

Current Illness:

Total 2021 VAERS Injuries: 654,986

Page last modified: 13 November 2021 9:17am